WorldWideScience

Sample records for generic drug policy

  1. Policies and perceptions on generic drugs: The case of Greece.

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    Xanthopoulou, Sofia-Sotiria; Katsaliaki, Korina

    2018-01-01

    The increase in the consumption of generic drugs to reduce pharmaceutical expenditure is a challenge for many countries, especially during the economic crisis. The purpose of the present study is to review the Greek market of generic drugs and the decisions that shape it, to determine the factors that affect Greek patients' and doctors' attitudes about generic substitution and present a set of measures for all stakeholders based on the findings of the secondary and primary analysis. The study includes (a) an analysis of international and national reports and legislation on drugs policies and (b) a questionnaire survey of 242 hospital patients and 85 doctors regarding their perceptions on generics. A small increase in the volume of generics is recorded, yet not followed by sales value, over the recent years that the measures for promoting generics prescription took effect. Distrust from both patients and doctors was observed toward generics' effectiveness and toward the appropriateness of the regulatory authorities' quality controls. The study presents a structured set of viable measures, applicable to many countries, for promoting generic drug consumption that can lead to economic efficiency without degrading the health care quality.

  2. [Policies encouraging price competition in the generic drug market: Lessons from the European experience].

    Science.gov (United States)

    Puig-Junoy, Jaume

    2010-01-01

    To describe alternative policies aimed at encouraging price competition in generic drug markets in countries with strict price regulation, and to present some case studies drawn from the European experience. Systematic literature review of articles and technical reports published after 1999. The shortcomings in consumer price competition observed in some European generic markets, including Spain, may be reduced through three types of public reimbursement or financing reforms: policies aimed at improving the design of current maximum reimbursement level policies; policies aimed at monitoring competitive prices in order to reimburse real acquisition cost to pharmacies; and, more radical and market-oriented policies such as competitive tendering of public drug purchases. The experience of recent reforms adopted in Germany, Belgium, Holland, Norway, and Sweden offers a useful guide for highly price-regulated European countries, such as Spain, currently characterized by limited consumer price competition and the high discounts offered to pharmacy purchases. Direct price regulation and/or the generic reference pricing systems used to reduce generic drug prices in many European countries can be successfully reformed by adopting measures more closely aimed at encouraging consumer price competition in generic drug markets. Copyright 2009 SESPAS. Published by Elsevier Espana. All rights reserved.

  3. Generic drug policy in Australia: a community pharmacy perspective

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    Beecroft, Grahame

    2007-01-01

    This article provides a commentary, from a community pharmacy perspective, on the policy environment for the pharmacy sector in Australia, with a particular focus on present challenges arising from proposals to achieve substantial PBS cost savings from an anticipated surge of new generic drugs. Some $2 billion of medicines currently on the PBS will come off patent in the next 4 years. This growth comes from a low base where generics currently account for only 15% of the total PBS budget. Remuneration for PBS dispensing is fixed through five year agreements with the government, so trading terms on generics are important for the cross-subsidy of other dispensing activities and professional services. These trading terms (discounts provided by generics suppliers) have become part of the overall cost and revenue structure of pharmacies. Despite these arrangements, generic substitution rates in Australia are lower than in most comparable countries, which the government views as an opportunity to promote generic use. The future of generic drug supply via the PBS is important to allow consumers access to medications at the lowest possible price and to provide space for PBS listing of new and expensive drugs. But considerations of PBS reform need to take account of the role and viability of community pharmacy sector as provider of pharmaceuticals in a timely and efficient manner to Australian residents. PMID:17543112

  4. [Generic drugs: good or bad? Physician's knowledge of generic drugs and prescribing habits].

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    García, A J; Martos, F; Leiva, F; Sánchez de la Cuesta, F

    2003-01-01

    In this article we analyze the responses of 1220 Spanish physicians who participated in a survery about generic drugs. A previously validated questionnaire was sent to physicians through the Spanish Medical Councils of the different provinces. Four items were analyzed: what doctors know about generic drugs (knowledge); physicians' prescribing habits concerning these drugs (attitude and professional competence); how prescription of generic drugs effects pharmaceutical costs amd, finally, what doctors believe a generic drug should be. The influence of physician-related variables (age, type of contract, specialty, workload, etc.) on prescribing of generic drugs was also analyzed. In view of the results, we believe that to rationalize expenditure through and appropriate policy on generic drugs Spanish health authorities should offer more and better training and information (clear and independent) about what generic drugs are.

  5. Influencers of generic drug utilization: A systematic review.

    Science.gov (United States)

    Howard, Jennifer N; Harris, Ilene; Frank, Gavriella; Kiptanui, Zippora; Qian, Jingjing; Hansen, Richard

    2017-08-04

    With an increase in prescription drug spending and rising drug costs there is a need to encourage the use of generic prescription drugs. However, maximizing generic drug use is not possible without the public's positive perception and meeting their informational needs about generic drugs. Thus, improving the public's confidence in, and knowledge of generic drugs on the market is critical. The objective of this systematic review is to examine and evaluate the studies focusing on the nature and extent of key factors influencing generic drug use in the United States in order to help guide policy, education and practice interventions. Using multiple search engines and key word screening criteria, empirical studies published in English between January 1, 2005 and December 31, 2015 were identified. A qualitative synthesis of the evidence identified domains of key factors that influenced generic drug use across studies. Over 3000 citations met the key word screening criteria; 67 of these met inclusion criteria for the systematic review. Seven domains of factors that influence generic drug utilization were identified: 1) patient-related factors, 2) formulary management or cost containment, 3) healthcare policies, 4) promotional activities, 5) educational initiatives, 6) technology, and 7) physician-related factors. Patients, physicians, pharmacists, formulary managers, and policymakers play an important role in generic drug use. Understanding the factors influencing generic drug use can help guide future policy, education, and practice interventions to increase generic drug use. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy.

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    Löfgren, Hans

    2007-06-01

    This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products.

  7. Generic policy in Bulgaria: a policy of failure or success?

    Directory of Open Access Journals (Sweden)

    Assena Stoimenova

    2016-09-01

    Full Text Available Generic medicines play a key role in managing the financial resources for pharmaceuticals in every country. This study analysed the generic policy legislative framework in Bulgaria with the aim to identify whether the policy implementation can be considered successful in the light of an international review of such policies introduced in other countries, or on the contrary, it has failed to deliver the main benefits. Legislative analysis, desktop study and macroeconomic overview of the Bulgarian pharmaceutical market were included. The study showed that only 3 out of 11 important policy elements are implemented in the country. Bulgaria has one of the highest shares of generics, an average of 81.39% (volume, for the studied period (2006–2014. However, further research is needed to evaluate the success of the existing generic policy in Bulgaria, as the market share of generic drugs is not the only measure of the policy efficiency.

  8. Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending.

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    Wouters, Olivier J; Kanavos, Panos G; McKEE, Martin

    2017-09-01

    Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. Rising drug prices are putting pressure on health care budgets. Policymakers are assessing how they can save money through generic drugs. We compared generic drug prices and market shares in 13 European countries, using data from 2013, to assess the amount of variation that exists between countries. To place these results in context, we reviewed evidence from recent studies on the prices and use of generics in Europe and the United States. We also surveyed peer-reviewed studies, gray literature, and books published since 2000 to (1) outline existing generic drug policies in European countries and the United States; (2) identify ways to increase generic drug use and to promote price competition among generic drug companies; and (3) explore barriers to implementing reform of generic drug policies, using a historical example from the United States as a case study. The prices and market shares of generics vary widely across Europe. For example, prices charged by manufacturers in Switzerland are, on average, more than 2.5 times those in Germany and more than 6 times those in the United Kingdom, based on the results of a commonly used price index. The proportion of prescriptions filled with generics ranges from 17% in Switzerland to 83% in the United Kingdom. By comparison, the United States has historically had low generic drug prices and high rates of generic drug use (84% in 2013), but has in recent years experienced sharp price increases for some off-patent products. There are policy

  9. Why do generic drugs fail to achieve an adequate market share in Greece? Empirical findings and policy suggestions.

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    Balasopoulos, T; Charonis, A; Athanasakis, K; Kyriopoulos, J; Pavi, E

    2017-03-01

    Since 2010, the memoranda of understanding were implemented in Greece as a measure of fiscal adjustment. Public pharmaceutical expenditure was one of the main focuses of this implementation. Numerous policies, targeted on pharma spending, reduced the pharmaceutical budget by 60.5%. Yet, generics' penetration in Greece remained among the lowest among OECD countries. This study aims to highlight the factors that affect the perceptions of the population on generic drugs and to suggest effective policy measures. The empirical analysis is based on a national cross-sectional survey that was conducted through a sample of 2003 individuals, representative of the general population. Two ordinal logistic regression models were constructed in order to identify the determinants that affect the respondents' beliefs on the safety and the effectiveness of generic drugs. The empirical findings presented a positive and statistically significant correlation with income, bill payment difficulties, safety and effectiveness of drugs, prescription and dispensing preferences and the views toward pharmaceutical companies. Also, age and trust toward medical community have a positive and statistically significant correlation with the perception on the safety of generic drugs. Policy interventions are suggested on the bases of the empirical results on 3 major categories; (a) information campaigns, (b) incentives to doctors and pharmacists and (c) to strengthen the bioequivalence control framework and the dissemination of results. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Leveraging consumer's behaviour to promote generic drugs in Italy.

    Science.gov (United States)

    Zerbini, Cristina; Luceri, Beatrice; Vergura, Donata Tania

    2017-04-01

    The aim of this study was to fill the lack of knowledge regarding a more grounded exploration of the consumer's decision-making process in the context of generic drugs. In this perspective, a model, within the theoretical framework of the Theory of Planned Behaviour (TPB), for studying the consumers' purchase intention of generic drugs was developed. An online survey on 2,222 Italian people who bought drugs in the past was conducted. The proposed model was tested through structural equation modelling (SEM). Almost all the constructs considered in the model, except the perceived behavioural control, contribute to explain the consumer's purchase intention of generic drugs, after controlling for demographic variables (age, income, education). Specifically, attitude, subjective norm, past behaviour, self-identity and trust in the pharmacist have a positive influence on the intention to buy generic drugs. On the contrary, perceived risk towards products and brand sensitivity act negatively. The results of the present study could be useful to public policy makers in developing effective policies and educational campaigns aimed at promoting generic drugs. Specifically, marketing efforts should be directed to inform consumers about the generic drugs' characteristics to mitigate the perceived risk towards these products and to raise awareness during their decision-making process. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. Comparison of generic-to-brand switchback patterns for generic and authorized generic drugs

    Science.gov (United States)

    Hansen, Richard A.; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K.; Raofi, Saeid; Page, C. David; Peissig, Peggy

    2018-01-01

    Background While generic drugs are therapeutically equivalent to brand drugs, some patients and healthcare providers remain uncertain about whether they produce identical outcomes. Authorized generics, which are identical in formulation to corresponding brand drugs but marketed as a generic, provide a unique post-marketing opportunity to study whether utilization patterns are influenced by perceptions of generic drugs. Objectives To compare generic-to-brand switchback rates between generics and authorized generics. Methods A retrospective cohort study was conducted using claims and electronic health records data from a regional U.S. healthcare system. Ten drugs with authorized generics and generics marketed between 1999 and 2014 were evaluated. Eligible adult patients received a brand drug during the 6 months preceding generic entry, and then switched to a generic or authorized generic. Patients in this cohort were followed for up to 30 months from the index switch date to evaluate occurrence of generic-to-brand switchbacks. Switchback rates were compared between patients on authorized generics versus generics using Kaplan-Meier curves and Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson comorbidity score, pre-index drug use characteristics, and pre-index healthcare utilization. Results Among 5,542 unique patients that switched from brand-to-generic or brand-to-authorized generic, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for authorized generics compared with generics (HR=0.86; 95% CI 0.65-1.15). The likelihood of switchback was higher for alendronate (HR=1.64; 95% CI 1.20-2.23) and simvastatin (HR=1.81; 95% CI 1.30-2.54) and lower for amlodipine (HR=0.27; 95% CI 0.17-0.42) compared with other drugs in the cohort. Conclusions Overall switchback rates were similar between authorized generic and generic drug users, indirectly supporting similar efficacy and tolerability profiles for

  12. Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

    Science.gov (United States)

    Hansen, Richard A; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K; Raofi, Saeid; Page, C David; Peissig, Peggy

    2017-04-01

    Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs. Retrospective cohort study. Claims and electronic health record data from a regional U.S. health care system. The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. Ten drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15). The likelihood of switchback was higher for alendronate (HR 1.64, 95% CI 1.20-2.23) and simvastatin (HR 1.81, 95% CI 1.30-2.54) and lower for amlodipine (HR 0.27, 95% CI 0.17-0.42) compared with the other drugs evaluated. Overall switchback rates were similar

  13. Generic medicines: solutions for a sustainable drug market?

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Godman, Brian; Simoens, Steven

    2013-10-01

    Generic medicines offer equally high-quality treatment as originator medicines do at much lower prices. As such, they represent a considerable opportunity for authorities to obtain substantial savings. At the moment, the pharmaceutical landscape is changing and many pharmaceutical companies have altered their development and commercial strategies, combining both originator and generic divisions. In spite of this, the generic medicines industry is currently facing a number of challenges: delayed market access; the limited price differential with originator medicines; the continuous downwards pressure on prices; and the negative perception regarding generic medicines held by some key stakeholder groups. This could jeopardize the long-term sustainability of the generic manufacturing industry. Therefore, governments must focus on demand-side policies, alongside policies to accelerate market access, as the generic medicines industry will only be able to deliver competitive and sustainable prices if they are ensured a high volume. In the future, the generic medicines industry will increasingly look to biosimilars and generic versions of orphan drugs to expand their business.

  14. Canada's New Generic Pricing Policy: A Reasoned Approach to a Challenging Problem.

    Science.gov (United States)

    Hollis, Aidan; Grootendorst, Paul

    2015-08-01

    Alberta, quickly followed by other Canadian provinces, has introduced a new pricing model for generic drugs, in which prices are inversely related to the number of generic manufacturers of the drug. This paper examines the rationale for the new policy. Copyright © 2015 Longwoods Publishing.

  15. Policy objective of generic medicines from the investment perspective: The case of clopidogrel.

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    Elek, Péter; Harsányi, András; Zelei, Tamás; Csetneki, Kata; Kaló, Zoltán

    2017-05-01

    The objective of generic drug policies in most countries is defined from a disinvestment perspective: reduction in expenditures without compromising health outcomes. However, in countries with restricted access of patients to original patented drugs, the objective of generic drug policies can also be defined from an investment perspective: health gain by improved patient access without need for additional health budget. This study examines the investment aspect of generic medicines by analyzing clopidogrel utilization in European countries between 2004 and 2014 using multilevel panel data models. We find that clopidogrel consumption was strongly affected by affordability constraints before the generic entry around 2009, but this effect decayed by 2014. After controlling for other variables, utilization had a substantially larger trend increase in lower-income European countries than in the higher-income ones. Generic entry increased clopidogrel consumption only in lower- and average-income countries but not in the highest-income ones. An earlier generic entry was associated with a larger effect. The case of clopidogrel indicates that the entrance of generics may increase patient access to effective medicines, most notably in lower-income countries, thereby reducing inequalities between European patients. Policymakers should also consider this investment aspect of generic medicines when designing pharmaceutical policies. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Do national drug policies influence antiretroviral drug prices? Evidence from the Southern African Development community.

    Science.gov (United States)

    Liu, Yao; Galárraga, Omar

    2017-03-01

    The efficacy of low- and middle-income countries’ (LMIC) national drug policies in managing antiretroviral (ARV) pharmaceutical prices is not well understood. Though ARV drug prices have been declining in LMIC over the past decade, little research has been done on the role of their national drug policies. This study aims to (i) analyse global ARV prices from 2004 to 2013 and (ii) examine the relationship of national drug policies to ARV prices. Analysis of ARV drug prices utilized data from the Global Price Reporting Mechanism from the World Health Organization (WHO). Ten of the most common ARV drugs (first-line and second-line) were selected. National drug policies were also assessed for 12 countries in the South African Development Community (SADC), which self-reported their policies through WHO surveys. The best predictor of ARV drug price was generic status—the generic versions of 8 out of 10 ARV drugs were priced lower than branded versions. However, other factors such as transaction volume, HIV prevalence, national drug policies and PEPFAR/CHAI involvement were either not associated with ARV drug price or were not consistent predictors of price across different ARV drugs. In the context of emerging international trade agreements, which aim to strengthen patent protections internationally and potentially delay the sale of generic drugs in LMIC, this study shines a spotlight on the importance of generic drugs in controlling ARV prices. Further research is needed to understand the impact of national drug policies on ARV prices.

  17. The Impact of Information on Doctors’ Attitudes Toward Generic Drugs

    Directory of Open Access Journals (Sweden)

    Aggeliki V. Tsaprantzi MD

    2016-03-01

    Full Text Available The objective of this study is to assess the impact of information on doctors’ attitudes and perceptions toward generics. A cross-sectional survey based on a specially designed 21-item questionnaire was conducted. The survey involved doctors of different specialties working in a public hospital in Greece. The analysis includes descriptive and inferential statistics, reliability and validity tests, as well as structural equation modeling to evaluate the causal model. Statistical analysis was accomplished by using SPSS 20 and Amos 20. A total of 134 questionnaires out of 162 were received, providing a response rate of 82.71%. A number of significant associations were found between information and perceptions about generic medicines with demographic characteristics. It seems that the provision of quality information on generic drugs influences doctors’ attitudes and prescription practices toward generic drugs. This is not a static process but a rather dynamic issue involving information provision policies for strengthening the proper doctors’ attitudes toward generic drugs.

  18. 42 CFR 447.506 - Authorized generic drugs.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

  19. Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South Africa?

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    Varsha Bangalee

    2016-10-01

    Objective: To examine the relationship between originator drug prices and the number of generic brands within the cardiovascular class of drugs and to compare South African prices with international reference prices. Method: Data on private sector drug prices was sourced from the South African Medicine Price Registry. The relationship between the median proportional price and the number of brands in the therapeutic class was analysed using correlation analysis. International reference prices were obtained from the Management Sciences for Health International Drug Price Indicator Guide (2012 edition. Results: A weak correlation between originator and generic drug prices and the number of available brands was observed, the exception being diuretic drugs. The median prices per strength of the originator generic were still higher than the most expensive generic version manufactured by any other company, the exception being telmisartan. Comparison of price ratios between the originator drug, lowest priced generic and international reference price values revealed that the originator drug prices had a median price ratio of 20.99 (interquartile range 7.31—53.46 and the lowest priced generics had a median price ratio of 4.28 (interquartile range 2.10—8.47. Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

  20. Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South Africa?

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-12-01

    Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

  1. Retailing policies for generic medicines.

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    Narciso, Susana

    2005-06-01

    As there is general disagreement about the way generic medicines should be commercialized, two retailing policies are analyzed, taking into account their effects on the welfare of patients, government, pharmacies and physicians. In the first policy scenario, pharmacies are allowed to substitute generic medicines for branded ones, while in the second, substitution is forbidden. In both cases a pharmacies association is allowed to have a share in the production of generic medicines. The model predicts that under some conditions patients may prefer substitution by pharmacies but when doctors' decisions are binding, they are never "excessively bad". However, the policy choice belongs to the government, which prefers to allow for substitution more often than patients would like.

  2. A comparison of generic drug prices in seven European countries: a methodological analysis.

    Science.gov (United States)

    Wouters, Olivier J; Kanavos, Panos G

    2017-03-31

    Policymakers and researchers frequently compare the prices of medicines between countries. Such comparisons often serve as barometers of how pricing and reimbursement policies are performing. The aim of this study was to examine methodological challenges to comparing generic drug prices. We calculated all commonly used price indices based on 2013 IMS Health data on sales of 3156 generic drugs in seven European countries. There were large differences in generic drug prices between countries. However, the results varied depending on the choice of index, base country, unit of volume, method of currency conversion, and therapeutic category. The results also differed depending on whether one looked at the prices charged by manufacturers or those charged by pharmacists. Price indices are a useful statistical approach for comparing drug prices across countries, but researchers and policymakers should interpret price indices with caution given their limitations. Price-index results are highly sensitive to the choice of method and sample. More research is needed to determine the drivers of price differences between countries. The data suggest that some governments should aim to reduce distribution costs for generic drugs.

  3. The impact of South Korea's new drug-pricing policy on market competition among off-patent drugs.

    Science.gov (United States)

    Kwon, Hye-Young; Kim, Hyungmin; Godman, Brian; Reich, Michael R

    2015-01-01

    A new pricing policy was introduced in Korea in April 2012 with the aim of strengthening competition among off-patent drugs by eliminating price gaps between originators and generics. Examine the effect of newly implemented pricing policy. Retrospectively examining the effects through extracting from the National Health Insurance claims data a 30-month panel dataset (January 2011-June 2013) containing consumption data in four major therapeutic classes (antihypertensives, lipid-lowering drugs, antiulcerants and antidepressants). Proxies for market competition were examined before and after the policy. The new pricing policy did not enhance competition among off-patent drugs. In fact, price dispersion significantly decreased as opposed to the expected change. Originator-to-generic utilization increased 6.12 times (p = 0.000) after the new policy. The new pricing policy made no impact on competition among off-patent drugs. Competition in the off-patent market cannot be enhanced unless both supply and demand side measures are coordinated.

  4. Generic Drugs: Questions and Answers

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    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Resources for You Information for Consumers (Drugs) Questions & Answers Generic Drugs: Questions & Answers Share Tweet Linkedin Pin it More ...

  5. Multisource drug policies in Latin America: survey of 10 countries.

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    Homedes, Núria; Ugalde, Antonio

    2005-01-01

    Essential drug lists and generic drug policies have been promoted as strategies to improve access to pharmaceuticals and control their rapidly escalating costs. This article reports the results of a preliminary survey conducted in 10 Latin American countries. The study aimed to document the experiences of different countries in defining and implementing generic drug policies, determine the cost of registering different types of pharmaceutical products and the time needed to register them, and uncover the incentives governments have developed to promote the use of multisource drugs. The survey instrument was administered in person in Chile, Ecuador and Peru and by email in Argentina, Brazil, Bolivia, Colombia, Costa Rica, Nicaragua and Uruguay. There was a total of 22 respondents. Survey responses indicated that countries use the terms generic and bioequivalence differently. We suggest there is a need to harmonize definitions and technical concepts. PMID:15682251

  6. 78 FR 22553 - Generic Drug Facilities, Sites, and Organizations

    Science.gov (United States)

    2013-04-16

    ...] Generic Drug Facilities, Sites, and Organizations AGENCY: Food and Drug Administration, HHS. ACTION.... Generic drug facilities, certain sites, and organizations identified in a generic drug submission are... active pharmaceutical ingredients and certain other sites and organizations that support the manufacture...

  7. The short-term impact of Ontario's generic pricing reforms.

    Directory of Open Access Journals (Sweden)

    Michael R Law

    Full Text Available Canadians pay amongst the highest generic drug prices in the world. In July 2010, the province of Ontario enacted a policy that halved reimbursement for generic drugs from the public drug plan, and substantially lowered prices for private purchases. We quantified the impact of this policy on overall generic drug expenditures in the province, and projected the impact in other provinces had they mimicked this pricing change.We used quarterly prescription generic drug dispensing data from the IMS-Brogan CompuScript Audit. We used the price per unit in both the pre- and post-policy period and two economics price indexes to estimate the expenditure reduction in Ontario. Further, we used the post-policy Ontario prices to estimate the potential reduction in other provinces.We estimate that total expenditure on generic drugs in Ontario during the second half of 2010 was between $181 and $194 million below what would be expected if prices had remained at pre-policy level. Over half of the reduction in spending was due to savings on just 10 generic ingredients. If other provinces had matched Ontario's prices, their expenditures over during the latter half of 2010 would have been $445 million lower.We found that if Ontario's pricing scheme were adopted nationally, overall spending on generic drugs in Canada would drop at least $1.28 billion annually--a 5% decrease in total prescription drug expenditure. Other provinces should seriously consider both changes to their generic drug prices and the use of more competitive bulk purchasing policies.

  8. [Users sceptical about generic drugs: an anthropological approach].

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    Sarradon-Eck, A; Blanc, M-A; Faure, M

    2007-06-01

    Since the enactment of the 2002 legislative measures favoring the prescription of generic drugs, various quantitative studies have shown that approval by prescribers and users has risen in France. Nevertheless, scepticism remains as well as distrust towards these drugs focusing on their effectiveness compared with brand-name drugs, on potential dangers, and on the interruption they cause in prescription and consumption habits. Using a comprehensive approach, this article analyzes the social and cultural logic behind the negative image of generic drugs. The materials issued from an ethnographic study on the prescription of drugs for high blood pressure. Sixty-eight interviews were undertaken between April 2002 and October 2004 with people (39 women and 29 men, between the age of 40 and 95, 52 over the age of 60) treated for over a year for high blood pressure in rural areas in the Southeast of France. Thirteen people provided unsolicited opinions about generic drugs. Analysis of the information collected shows that users have various representations of generic drugs, including the idea of counterfeited and foreign drugs. These representations interfere with the adjustment process and the development of consumer loyalty. They are part of a set of social representations about drugs which form and express the user's reality. In these representations, the drug is an ambivalent object, carrier of both biological effectiveness and toxicity; it is also the metonymical extension of the prescriber, bestowing upon the prescription a symbolic value. By placing the generic drug in its network of symbolic and social meaning, this study highlights the coherence of the scepticism towards generic drugs by consumers (and prescribers) with a system of common opinion in which drugs are everyday things, personalized and compatible with users, symbolic exchange carriers in the physician-patient relationship, and in which confidence in the drug is also that given to the health care

  9. GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

    OpenAIRE

    Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

    2017-01-01

    Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

  10. Merger mania: mergers and acquisitions in the generic drug sector from 1995 to 2016.

    Science.gov (United States)

    Gagnon, Marc-André; Volesky, Karena D

    2017-08-22

    Drug shortages and increasing generic drug prices are associated with low levels of competition. Mergers and acquisitions impact the level of competition. Record merger and acquisition activity was reported for the pharmaceutical sector in 2014/15, yet information on mergers and acquisitions in the generic drug sector are absent from the literature. This information is necessary to understand if and how such mergers and acquisitions can be a factor in drug shortages and increasing prices. Data on completed merger and acquisition deals that had a generic drug company being taken over (i.e. 'target') were extracted from Bloomberg Finance L.P. The number and announced value of deals are presented globally, for the United States, and globally excluding the United States annually from 1995 to 2016 in United States dollars. Generic drug companies comprised 9.3% of the value of all deals with pharmaceutical targets occurring from 1995 to 2016. Globally, in 1995 there were no deals, in 2014 there were 22 deals worth $1.86 billion, in 2015 there were 34 deals totalling $33.56 billion, and in 2016 there were 42 deals worth in excess of $44 billion. This substantial increase was partially attributed to Teva's 2016 acquisition of Allergan's generic drug business. The surge in mergers and acquisitions for 2015/16 was driven by deals in the United States, where they represented 89.7% of the dollar value of deals in those years. The recent blitz in mergers and acquisitions signals that the generic drug industry is undergoing a transformation, especially in the United States. This restructuring can negatively affect the level of competition that might impact prices and shortages for some products, emphasizing the importance of updating regulations and procurement policies.

  11. Promoting and regulating generic medicines: Brazil in comparative perspective

    Directory of Open Access Journals (Sweden)

    Elize Massard da Fonseca

    2017-04-01

    Full Text Available ABSTRACT Promoting the use of generic drugs can constitute a core instrument for countries’ national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug policy to assess and compare. This report fills that gap by considering national rules and regulations across four dimensions deemed crucial to any evaluation: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution. Furthermore, this report examines how the diverse interests of public and private sector stakeholders might shape generic drug policy and its implementation. To illustrate the challenges and conflicts behind policy development and implementation, this report focuses on the case of Brazil.

  12. Firm- and drug-specific patterns of generic drug payments by US medicaid programs: 1991-2008.

    Science.gov (United States)

    Kelton, Christina M L; Chang, Lenisa V; Guo, Jeff J; Yu, Yan; Berry, Edmund A; Bian, Boyang; Heaton, Pamela C

    2014-04-01

    The entry of generic drugs into markets previously monopolized by patented, branded drugs often represents large potential savings for healthcare payers in the USA. Our objectives were to describe and explain the trends in drug reimbursement by public Medicaid programmes post-generic entry for as many drug markets and for as long a time period as possible. The data were the Medicaid State Drug Utilization Data maintained by the Centers for Medicare and Medicaid Services. Quarterly utilization and expenditure data from 1991 to 2008 were extracted for 83 drugs, produced by 229 firms, that experienced initial generic entry between 1992 and 2004. A relative 'price' for a specific drug, firm and quarter was constructed as Medicaid reimbursement per unit (e.g. tablet, capsule or vial) divided by average reimbursement per unit for the branded drug the year before entry. Fixed-effects models controlling for time-, firm- and drug-specific differences were estimated to explain reimbursement. Twelve quarters after generic entry, 18 % of drugs had average per-unit reimbursement less than 50 % of the original branded-drug reimbursement. For each additional firm manufacturing the drug, reimbursement per unit, relative to the pre-generic-entry branded-drug reimbursement, was estimated to fall by 17 (p < 0.01) and 3 (p < 0.01) percentage points for generic and branded-drug companies, respectively. Each additional quarter post-generic entry brought a 2 (p < 0.01) percentage point drop in relative reimbursement. State Medicaid programmes generally have been able to obtain relief from high drug prices following patent expirations for many branded-drug medications by adjusting reimbursement following the expanded competition in the pharmaceutical market.

  13. Generic drugs: Review and experiences from South India

    Directory of Open Access Journals (Sweden)

    Philip Mathew

    2015-01-01

    Full Text Available The cost of pharmaceuticals, as a percentage of total healthcare spending, has been rising worldwide. This has resulted in strained national budgets and a high proportion of people without access to essential medications. Though India has become a global hub of generic drug manufacturing, the expected benefits of cheaper drugs are not translating into savings for ordinary people. This is in part due to the rise of branded generics, which are marketed at a price point close to the innovator brands. Unbranded generic medicines are not finding their way into prescriptions due to issues of confidence and perception, though they are proven to be much cheaper and comparable in efficacy to branded medicines. The drug inventory of unbranded generic manufacturers fares reasonably when reviewed using the World Health Organization-Health Action International (WHO-HAI tool for analysing drug availability. Also, unbranded generic medicines are much cheaper when compared to the most selling brands and they can bring down the treatment costs in primary care and family practice. We share our experience in running a community pharmacy for an urban health center in the Pathanamthitta district of Kerala State, which is run solely on generic medicines. The drug availability at the community pharmacy was 73.3% when analyzed using WHO-HAI tool and the savings for the final consumers were up to 93.1%, when compared with most-selling brand of the same formulation.

  14. 77 FR 60125 - Generic Drug Facilities, Sites and Organizations

    Science.gov (United States)

    2012-10-02

    ...] Generic Drug Facilities, Sites and Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice..., and certain sites and organizations identified in a generic drug submission, that they must provide... and Innovation Act (FDASIA). This notice is intended to help organizations ascertain if they need to...

  15. Lawsuits allege price fixing by generic drug makers

    Directory of Open Access Journals (Sweden)

    Robbins RA

    2016-12-01

    Full Text Available No abstract available. Article truncated at 150 words. Two years after high generic drug prices became a public controversy, Reuters is reporting that 20 states filed a lawsuit Thursday against Mylan, Teva Pharmaceuticals and four other generic drug makers (1. The suit alleges the companies conspired to fix prices or allocated markets to prop up prices. The civil lawsuit, led by antitrust investigators in Connecticut, comes one day after the U.S. Department of Justice filed criminal charges against two former executives of the generic drug maker, Heritage. The states attorneys general asked the court to order the companies to disgorge ill-gotten gains, which were not defined, pay attorneys' fees and stop collusion. Of the states in the Southwest only Nevada is participating in the lawsuit. The cases are part of a broader generic drug pricing probe that remains under way at the state and federal level, as well as in the U.S. Congress. In 2014, media reports of …

  16. Mixed WTO ruling on generic drug development.

    Science.gov (United States)

    Elliott, R

    2000-01-01

    On 17 March 2000, the World Trade Organization upheld the provision in Canada's patent laws that allows generic drug manufacturers to develop (but not sell) their cheaper versions of patented medicines before the 20-year patients expire. The decision prevents pharmaceutical companies from enjoying market monopolies beyond their patent terms, avoiding what would otherwise be even lengthier delays in the sale of cheaper, generic drugs in Canada. This decision is of significance not only to Canada, but also to other WTO member countries and to all individuals who use pharmaceutical products. However, the decision is not all positive: the WTO also ruled that Canada is violating international agreements by letting generic manufacturers stockpile their versions of patented drugs before patents expire. This article explains the issues, the arguments, and the decision.

  17. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

    Science.gov (United States)

    Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen F; Lii, Joyce; Rogers, James R; Dutcher, Sarah K; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael A; Kesselheim, Aaron S; Gagne, Joshua J

    2018-01-01

    Abstract Objectives To compare rates of switchbacks to branded drug products for patients switched from branded to authorized generic drug products, which have the same active ingredients, appearance, and excipients as the branded product, with patients switched from branded to generic drug products, which have the same active ingredients as the branded product but may differ in appearance and excipients. Design Observational cohort study. Setting Private (a large commercial health plan) and public (Medicaid) insurance programs in the US. Participants Beneficiaries of a large US commercial health insurer between 2004 and 2013 (primary cohort) and Medicaid beneficiaries between 2000 and 2010 (replication cohort). Main outcome measures Patients taking branded products for one of the study drugs (alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended release tablets, quinapril tablets, and sertraline tablets) were identified when they switched to an authorized generic or a generic drug product after the date of market entry of generic drug products. These patients were followed for switchbacks to the branded drug product in the year after their switch to an authorized generic or a generic drug product. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals after adjusting for demographics, including age, sex, and calendar year. Inverse variance meta-analysis was used to pool adjusted hazard ratios across all drug products. Results A total of 94 909 patients switched from branded to authorized generic drug products and 116 017 patients switched from branded to generic drug products and contributed to the switchback analysis. Unadjusted incidence rates of switchback varied across drug products, ranging from a low of 3.8 per 100 person years (for alendronate tablets) to a high of 17.8 per 100 person years (for amlodipine

  18. Encouraging the use of generic medicines: implications for transition economies.

    Science.gov (United States)

    King, Derek R; Kanavos, Panos

    2002-08-01

    Generic drugs have a key role to play in the efficient allocation of financial resources for pharmaceutical medicines. Policies implemented in the countries with a high rate of generic drug use, such as Canada, Denmark, Germany, the Netherlands, the United Kingdom, and the United States, are reviewed, with consideration of the market structures that facilitate strong competition. Savings in these countries are realized through increases in the volume of generic drugs used and the frequently significant differences in the price between generic medicines and branded originator medicines. Their policy tools include the mix of supply-side measures and demand-side measures that are relevant for generic promotion and higher generic use. On the supply-side, key policy measures include generic drug marketing regulation that facilitates market entry soon after patent expiration, reference pricing, the pricing of branded originator products, and the degree of price competition in pharmaceutical markets. On the demand-side, measures typically encompass influencing prescribing and dispensing patterns as well as introducing a co-payment structure for consumers/patients that takes into consideration the difference in cost between branded and generic medicines. Quality of generic medicines is a pre-condition for all other measures discussed to take effect. The paper concludes by offering a list of policy options for decision-makers in Central and Eastern European economies in transition.

  19. Generic drugs: myths, facts, and limitations

    Directory of Open Access Journals (Sweden)

    Antonio Marzo

    2012-10-01

    Full Text Available Bioequivalence (BE has always been an important pharmaceutical area, particularly (but not solely in Mediterranean region, where the use of generic drugs is a relatively recent development. The lack of new therapeutic molecules has concentrated primary research in the hands of a few large pharmaceutical companies. For smaller companies, this has created opportunities for the development of new formulations of existing drugs (orodispersible tablets that dissolve in the mouth, extended-release tablets, transdermal delivery systems, generic drugs. These applications take advantage of the Abridged New Drug Application (ANDA procedure, which exempts them from a series of expensive investigations and limits the requirement for clinical testing to bioequivalence trials. Since 1991, bioequivalence trials have been regulated by US Food and Drug Administration (FDA and European Medicines Agency (EMA guidelines that provide precise indications on the most specific procedures to be adopted. In spite of these guidelines, however, some aspects of the process have not been fully defined, the most important of which regards the management of endogenous substances. Additional problems are how to manage bioequivalence protocols with drugs that have long half-lives and those whose clearance is characterized by high intrinsic variability. The view that bioequivalence data would be more reliable if they were based on studies in target populations is a myth to be discredited. The present paper reviews issues relative to pharmacokinetics (PK, bioavailability (BA, and bioequivalence, also from an historical viewpoint, and includes a stimulating “questions and answers” section on some key aspects of the bioequivalence of generic drugs.

  20. South African patient's acceptance of generic drugs

    African Journals Online (AJOL)

    mechanism in this regard for final consumers, insurance providers, and ... facilities are viewed as inferior, treated with sus- picion and ... to choose a generic drug if the decision was supported by their doctor ... The effect of brand to generic and ...

  1. [Generic drugs and the consumption trends of antihypertensives in Morocco].

    Science.gov (United States)

    Berrada El Azizi, Ghizlane; Ahid, Samir; Ghanname, Imane; Ghannam, Imane; Belaiche, Abdelmajid; Hassar, Mohammed; Cherrah, Yahia

    2013-01-01

    To evaluate the evolution of consumption of antihypertensive drugs generic among 1991-2010, to assess the impacts after the institution of Mandatory Health Insurance and the marketing of generic drugs. We used sales data from the Moroccan subsidiary of IMS Health Intercontinental Marketing Service. Consumption of generic antihypertensive drugs increased from 0.08 to 10.65 DDD/1 000 inhabitants/day between 1991 and 2010. In 2010, generic of the calcium channel blockers (CCBs) represented 4.08 DDD/1 000 inhabitants/day (82.09%), followed by angiotensin converting enzyme inhibitors (ACEI) by 2.40 DDD/1 000 inhabitants/day (48.29%). The generics market of CCBs is the most dominant and represented in 2010, 79.21% in volume and 62.58% in value. In developing countries like Morocco, the generic drug is a key element for access to treatment especially for the poor population. © 2013 Société Française de Pharmacologie et de Thérapeutique.

  2. 76 FR 79198 - Generic Drug User Fee; Public Meeting; Correction

    Science.gov (United States)

    2011-12-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION... meeting entitled ``Generic Drug User Fee.'' The document published with an inadvertent error in the Dates...

  3. Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.

    Science.gov (United States)

    Kuribayashi, Ryosuke; Appleton, Scott

    2017-09-01

    Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. The objective of this study was to examine generic drug reviews in Japan and Canada. We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.

  4. European healthcare policies for controlling drug expenditure.

    Science.gov (United States)

    Ess, Silvia M; Schneeweiss, Sebastian; Szucs, Thomas D

    2003-01-01

    In the last 20 years, expenditures on pharmaceuticals - as well as total health expenditures - have grown faster than the gross national product in all European countries. The aim of this paper was to review policies that European governments apply to reduce or at least slow down public expenditure on pharmaceutical products. Such policies can target the industry, the wholesalers and retailers, prescribers, and patients. The objectives of pharmaceutical policies are multidimensional and must take into account issues relating to public health, public expenditure and industrial incentives. Both price levels and consumption patterns determine the level of total drug expenditure in a particular country, and both factors vary greatly across countries. Licensing and pricing policies intend to influence the supply side. Three types of pricing policies can be recognised: product price control, reference pricing and profit control. Profit control is mainly used in the UK. Reference pricing systems were first used in Germany and The Netherlands and are being considered in other countries. Product price control is still the most common method for establishing the price of drugs. For the aim of fiscal consolidation, price-freeze and price-cut measures have been frequently used in the 1980s and 1990s. They have affected all types of schemes. For drug wholesalers and retailers, most governments have defined profit margins. The differences in price levels as well as the introduction of a Single European Pharmaceutical Market has led to the phenomenon of parallel imports among member countries of the European Union. This may be facilitated by larger and more powerful wholesalers and the vertical integration between wholesalers and retailers. To control costs, the use of generic drugs is encouraged in most countries, but only few countries allow pharmacists to substitute generic drugs for proprietary brands. Various interventions are used to reduce the patients' demand for drugs by

  5. Determinants of generic drug substitution in Switzerland

    Directory of Open Access Journals (Sweden)

    Lufkin Thomas M

    2011-01-01

    Full Text Available Abstract Background Since generic drugs have the same therapeutic effect as the original formulation but at generally lower costs, their use should be more heavily promoted. However, a considerable number of barriers to their wider use have been observed in many countries. The present study examines the influence of patients, physicians and certain characteristics of the generics' market on generic substitution in Switzerland. Methods We used reimbursement claims' data submitted to a large health insurer by insured individuals living in one of Switzerland's three linguistic regions during 2003. All dispensed drugs studied here were substitutable. The outcome (use of a generic or not was modelled by logistic regression, adjusted for patients' characteristics (gender, age, treatment complexity, substitution groups and with several variables describing reimbursement incentives (deductible, co-payments and the generics' market (prices, packaging, co-branded original, number of available generics, etc.. Results The overall generics' substitution rate for 173,212 dispensed prescriptions was 31%, though this varied considerably across cantons. Poor health status (older patients, complex treatments was associated with lower generic use. Higher rates were associated with higher out-of-pocket costs, greater price differences between the original and the generic, and with the number of generics on the market, while reformulation and repackaging were associated with lower rates. The substitution rate was 13% lower among hospital physicians. The adoption of the prescribing practices of the canton with the highest substitution rate would increase substitution in other cantons to as much as 26%. Conclusions Patient health status explained a part of the reluctance to substitute an original formulation by a generic. Economic incentives were efficient, but with a moderate global effect. The huge interregional differences indicated that prescribing behaviours and

  6. Generic legislation of new psychoactive drugs.

    Science.gov (United States)

    van Amsterdam, Jan; Nutt, David; van den Brink, Wim

    2013-03-01

    New psychoactive drugs (NPDs, new psychoactive substances) enter the market all the time. However, it takes several months to ban these NPDs and immediate action is generally not possible. Several European countries and drug enforcement officers insist on a faster procedure to ban NPDs. Introduction of generic legislation, in which clusters of psychotropic drugs are banned in advance, has been mentioned as a possible solution. Here we discuss the pros and cons of such an approach. First, generic legislation could unintentionally increase the expenditures of enforcement, black market practices, administrative burden and health risks for users. Second, it may have a negative impact on research and the development of new treatments. Third, due to the complexity of generic legislation, problems in the enforcement are anticipated due to lack of knowledge about the chemical nomenclature. Finally, various legal options are already available to ban the use, sale and trade of NPDs. We therefore conclude that the currently used scientific benefit-risk evaluation should be continued to limit the adverse health effects of NPDs. Only in emergency cases, where fatal incidents (may) occur, should this approach be overruled.

  7. Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city.

    Science.gov (United States)

    Guttier, Marília Cruz; Silveira, Marysabel Pinto Telis; Luiza, Vera Lucia; Bertoldi, Andréa Dâmaso

    2017-06-26

    The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old). The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. The preference for purchasing generic drugs was 63.2% (95%CI 61.4-64.9). The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03-1.14), age of 20-39 years (PR = 1.10; 95%CI 1.02-1.20), low socioeconomic status (PR = 1.15; 95%CI 1.03-1.28), and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89-7.52). Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic) with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93-2.41). Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil.

  8. Relevance of variation in use of terminology to define generic pharmaceutical products

    Directory of Open Access Journals (Sweden)

    Elize Massard da Fonseca

    2015-02-01

    Full Text Available The World Health Organization (WHO promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.

  9. Relevance of variation in use of terminology to define generic pharmaceutical products.

    Science.gov (United States)

    Fonseca, Elize Massard da

    2015-02-01

    The World Health Organization (WHO) promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country) and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.

  10. [The patents game. Generic and biosimilar drugs].

    Science.gov (United States)

    Villamañán, E; González, D; Armada, E; Ruano, M; Álvarez-Sala, R; Herrero, A

    2016-01-01

    The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

  11. Perception of the value of generic drugs in São Paulo, Brazil

    Directory of Open Access Journals (Sweden)

    Elene Paltrinieri Nardi

    2016-01-01

    Full Text Available Abstract The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%, and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

  12. Perception of the value of generic drugs in São Paulo, Brazil.

    Science.gov (United States)

    Nardi, Elene Paltrinieri; Ferraz, Marcos Bosi

    2016-02-01

    The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i) 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii) 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii) 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%), and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

  13. Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city

    Directory of Open Access Journals (Sweden)

    Marília Cruz Guttier

    Full Text Available ABSTRACT OBJECTIVE The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. METHODS We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old. The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. RESULTS The preference for purchasing generic drugs was 63.2% (95%CI 61.4–64.9. The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03–1.14, age of 20–39 years (PR = 1.10; 95%CI 1.02–1.20, low socioeconomic status (PR = 1.15; 95%CI 1.03–1.28, and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89–7.52. Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93–2.41. CONCLUSIONS Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil.

  14. Generic medicine and prescribing: A quick assessment

    Directory of Open Access Journals (Sweden)

    Mainul Haque

    2017-01-01

    Full Text Available Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts. The Food and Drug Administration (FDA describes that generic drugs are essential possibilities that allow better access to healthcare for all Americans. They are replicas of brand-name drugs and are the identical as those of brand-name drugs in dosage form, safety, strength, route of administration, quality, performance features, and anticipated to use. Healthcare authorities and users can be guaranteed that FDA-approved generic drug products have met the same stiff principles as the innovator drug. The company that made Bayer aspirin fought in court enthusiastically to keep generic versions off the shelves, in the 1920s. The company lost in court, and consumers suddenly had an array of choices in generic aspirin. The Supreme Court of India uttering ‘the Supreme Court's ruling will prevent companies from further seeking unwarranted patents on HIV and other essential medicines.’ Generic medicine cannot be sold at a price higher than the branded medicine, so it is regularly a low-priced option. Thereafter, both the end user and the government who pay for part of the price of the medicine under the Pharmaceutical Benefits Scheme in Australia are benefitted. The treatment of diseases using essential drugs, prescribed by their generic names, has been emphasised by the WHO and many national health policies. Although there are some improvements in generic medicine prescribing, it has been advised by the WHO that ‘countries should intensify efforts to measure and regularly monitor medicine prices and availability, and adopt policy measures to address the issues identified.’

  15. Generic Drugs: The Same Medicine for Less Money

    Science.gov (United States)

    ... about brand-name drugs. Resources Consumer Reports Best Buy Drugs can help you find lower-cost generic drugs. ... produced by Consumers Union and Consumer Reports Best Buy Drugs , a public information project supported by grants from ...

  16. The generic drug user fee amendments: an economic perspective

    Science.gov (United States)

    Berndt, Ernst R; Murphy, Stephen J

    2018-01-01

    Abstract Since the vast majority of prescription drugs consumed by Americans are off patent (‘generic’), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I’s FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II’s implementation among other outcomes. PMID:29707218

  17. Drug policy, harm and human rights: a rationalist approach.

    Science.gov (United States)

    Stevens, Alex

    2011-05-01

    It has recently been argued that drug-related harms cannot be compared, so making it impossible to choose rationally between various drug policy options. Attempts to apply international human rights law to this area are valid, but have found it difficult to overcome the problems in applying codified human rights to issues of drug policy. This article applies the rationalist ethical argument of Gewirth (1978) to this issue. It outlines his argument to the 'principle of generic consistency' and the hierarchy of basic, nonsubtractive and additive rights that it entails. It then applies these ideas to drug policy issues, such as whether there is a right to use drugs, whether the rights of drug 'addicts' can be limited, and how different harms can be compared in choosing between policies. There is an additive right to use drugs, but only insofar as this right does not conflict with the basic and nonsubtractive rights of others. People whose freedom to choose whether to use drugs is compromised by compulsion have a right to receive treatment. They retain enforceable duties not to inflict harms on others. Policies which reduce harms to basic and nonsubtractive rights should be pursued, even if they lead to harms to additive rights. There exists a sound, rational, extra-legal basis for the discussion of drug policy and related harms which enables commensurable discussion of drug policy options. Copyright © 2011 Elsevier B.V. All rights reserved.

  18. Innovation strategies for generic drug companies: moving into supergenerics.

    Science.gov (United States)

    Ross, Malcolm S F

    2010-04-01

    Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.

  19. Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

    Directory of Open Access Journals (Sweden)

    Garth Boehm

    2013-09-01

    Full Text Available The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.

  20. Safety and efficacy of generic drugs with respect to brand formulation.

    Science.gov (United States)

    Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

    2013-12-01

    Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

  1. Factors influencing anti-asthmatic generic drug consumption in Morocco: 1999-2010.

    Science.gov (United States)

    Ghanname, Imane; Ahid, Samir; Berrada, Ghizlane; Belaiche, Abdelmjid; Hassar, Mohammed; Cherrah, Yahia

    2014-01-01

    The increasing availability of generic drugs (GD) resulted in a remarkable reduction in treatment costs that allowed a better access to health care.The aim of this study is to evaluate the share of anti-asthmatic generic drugs during the period 1999-2010 in Morocco and to look at the factors influencing generic development. In this study, we used Moroccan sales data from IMS Health (Intercontinental Marketing Services). The consumption of the drugs was expressed in DDD/1000 inhabitants/day according to the WHO ATC/DDD methodology. Between 1999 and 2010, anti-asthmatic consumption increased from 3.91 to 14.43 DDD/1000 inhabitants/day. The market of anti-asthmatic generic drugs progressed from 1.83 (47%) to 2.18 (23%) DDD/1000 inhabitants/day from 1999 to 2010. In 2010, inhaled glucocorticosteroids ranked first (0.83 DDD/1000 inhabitants/day), followed by inhaled short acting beta agonists (0.73 DDD/1000 inhabitants/day). The number of brands went from 27 in 1999 to 34 in 2010, with a generic share increasing from 55.55% to 70.59%. The number of anti-asthmatic pharmaceutical preparations increased from 57 to 64 during the same period, of which 31 and 42 were generic preparations. In 2010, the total cost of anti-asthmatic dugs was about 22 million euro, the generics representing 14 million euro. Despite the introduction of a compulsory insurance scheme called "AMO", that allows a refund for 69.5% of anti-asthmatic specialties marketed in Morocco, anti-asthmatic generic drug consumption remains limited. The Moroccan market is still largely dominated by the originator drugs with still valid patents.

  2. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study.

    Science.gov (United States)

    Dave, Chintan V; Kesselheim, Aaron S; Fox, Erin R; Qiu, Peihua; Hartzema, Abraham

    2017-08-01

    Prices for some generic drugs have increased in recent years, adversely affecting patients who rely on them. To determine the association between market competition levels and the change in generic drug prices in the United States. Retrospective cohort study. Prescription claims from commercial health plans between 2008 and 2013. The 5.5 years of data were divided into 11 study periods of 6 months each. The Herfindahl-Hirschman Index (HHI)-calculated by summing the squares of individual manufacturers' market shares, with higher values indicating a less competitive market-and average drug prices were estimated for the generic drugs in each period. The HHI value estimated in the baseline period (first half of 2008) was modeled as a fixed covariate. Models estimated price changes over time by level of competition, adjusting for drug shortages, market size, and dosage forms. From 1.08 billion prescription claims, a cohort of 1120 generic drugs was identified. After adjustment, drugs with quadropoly (HHI value of 2500, indicating relatively high levels of competition), duopoly (HHI value of 5000), near-monopoly (HHI value of 8000), and monopoly (HHI value of 10 000) levels of baseline competition were associated with price changes of -31.7% (95% CI, -34.4% to -28.9%), -11.8% (CI, -18.6% to -4.4%), 20.1% (CI, 5.5% to 36.6%), and 47.4% (CI, 25.4% to 73.2%), respectively, over the study period. Study findings may not be generalizable to drugs that became generic after 2008. Market competition levels were associated with a change in generic drug prices. Such measurements may be helpful in identifying older prescription drugs at higher risk for price change in the future. None.

  3. The importance of being first: evidence from Canadian generic pharmaceuticals.

    Science.gov (United States)

    Hollis, Aidan

    2002-12-01

    This paper uses pooled cross-section data on Canadian ethical drug sales to examine the effect of entry timing on sales of generic drugs. The data is for all drugs for which the first generic competitor entered during the years 1994-1997. It is found that the first generic entrant has a lasting competitive advantage: being first into the market appears to lead to an increase of around 30% in market share (among generics) over a period of at least 4 years. This finding has considerable implications for the current policy of allowing brandname drug companies to issue pseudo-generic equivalents as a preemptive strike against true generic competitors. Copyright 2002 John Wiley & Sons, Ltd.

  4. 76 FR 44014 - Generic Drug User Fee; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-07-22

    ... generic drug user fees. New legislation would be required for FDA to establish and collect user fees for... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS...

  5. 76 FR 24035 - Generic Drug User Fee; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-04-29

    ... legislation would be required for FDA to establish and collect user fees for generic drugs, and FDA is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS...

  6. Hospitals plan to start their own generic drug company

    Directory of Open Access Journals (Sweden)

    Robbins RA

    2018-01-01

    Full Text Available The New York Times reports that groups representing more than 450 hospitals plan to form their own generic drug company (1. Intermountain Healthcare is leading the collaboration with several other large hospital groups, Ascension, SSM Health and Trinity Health, in consultation with the U.S. Department of Veterans Affairs, to form a not-for-profit drug company. The new firm is looking to create generic versions of about 20 existing drugs that the group says cost too much now or are in short supply. The article did not name the drugs targeted but expects the first of its pharmaceutical products to become available in 2019. Members of the consortium will contribute funds to finance the new drug company.

  7. HIV/AIDS drugs for Sub-Saharan Africa: how do brand and generic supply compare?

    Directory of Open Access Journals (Sweden)

    Colleen V Chien

    Full Text Available BACKGROUND: Significant quantities of antiretroviral drugs (ARVs to treat HIV/AIDS have been procured for Sub-Saharan Africa for the first time in their 20-year history. This presents a novel opportunity to empirically study the roles of brand and generic suppliers in providing access to ARVs. METHODOLOGY/PRINCIPAL FINDINGS: An observational study of brand and generic supply based on a dataset of 2,162 orders of AIDS drugs for Sub-Saharan Africa reported to the Global Price Reporting Mechanism at the World Health Organization from January 2004-March 2006 was performed. Generic companies supplied 63% of the drugs studied, at prices that were on average about a third of the prices charged by brand companies. 96% of the procurement was of first line drugs, which were provided mostly by generic firms, while the remaining 4%, of second line drugs, was sourced primarily from brand companies. 85% of the generic drugs in the sample were manufactured in India, where the majority of the drugs procured were ineligible for patent protection. The remaining 15% was manufactured in South Africa, mostly under voluntary licenses provided by brand companies to a single generic company. In Sub-Saharan African countries, four first line drugs in the dataset were widely patented, however no general deterrent to generic purchasing based on a patent was detected. CONCLUSIONS/SIGNIFICANCE: Generic and brand companies have played distinct roles in increasing the availability of ARVs in Sub-Saharan Africa. Generic companies provided most of the drugs studied, at prices below those charged by brand companies, and until now, almost exclusively supplied several fixed-dose combination drugs. Brand companies have supplied almost all second line drugs, signed voluntary licenses with generic companies, and are not strictly enforcing patents in certain countries. Further investigation into how price reductions in second line drugs can be achieved and the cheapest drugs can

  8. Some drugs more equal than others: pseudo-generics and commercial practice.

    Science.gov (United States)

    Probyn, Andrew J

    2004-11-08

    This article analyses the impact of the Department of Health and Ageing's brand price premium policy for some products listed on the Pharmaceutical Benefits Scheme. The policy, introduced in 1990, allows pharmaceutical companies to charge patients an out-of-pocket expense for post-patent brands of pharmaceuticals. One of the policy's intended goals was to increase consumer awareness of price differentials between competing brands, with a view to encouraging greater use of cheaper generic products. More than fourteen years since its introduction, it is debatable whether the policy has achieved this aim. This article looks at how the brand price premium policy can be exploited by global pharmaceutical giants to entrench big-name brands in the Australian pharmaceutical market and, in some cases, prevent 'true' competition from generic pharmaceuticals. This is being done through the establishment of 'pseudo-generics' that are sourced from the same factory floor as the original product.

  9. Generic versus brand-name drugs used in cardiovascular diseases.

    Science.gov (United States)

    Manzoli, Lamberto; Flacco, Maria Elena; Boccia, Stefania; D'Andrea, Elvira; Panic, Nikola; Marzuillo, Carolina; Siliquini, Roberta; Ricciardi, Walter; Villari, Paolo; Ioannidis, John P A

    2016-04-01

    This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI -0.05; 0.08) for soft outcomes; -0.06 (-0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (-0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40-7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider

  10. Legal and policy foundations for global generic competition: Promoting affordable drug pricing in developing societies.

    Science.gov (United States)

    Zapatero Miguel, Pablo

    2015-01-01

    The so-called 'TRIPS flexibilities' restated in 2001 by the World Trade Organization's Doha Declaration on TRIPS and Public Health offer a variety of policy avenues for promoting global price-based competition for essential medicines, and thus for improving access to affordable medicines in the developing world. In recent years, developing countries and international organisations alike have begun to explore the potentialities of global generic markets and competition generally, and also of using compulsory licensing to remedy anti-competitive practices (e.g. excessive pricing) through TRIPS-compatible antitrust enforcement. These and other 'pro-competitive' TRIPS flexibilities currently available provide the critical leverage and policy space necessary to improve access to affordable medicines in the developing world.

  11. Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

    Science.gov (United States)

    Hansen, R A; Qian, J; Berg, R L; Linneman, J G; Seoane-Vazquez, E; Dutcher, S; Raofi, S; Page, C D; Peissig, P L

    2018-02-01

    Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  12. Factors influencing consumer purchasing patterns of generic versus brand name over-the-counter drugs.

    Science.gov (United States)

    Kohli, Erol; Buller, Allison

    2013-02-01

    US consumers spend more than $20 billion/year on over-the-counter (OTC) drugs. Although generic and brand name OTC drugs share the same active ingredients and undergo the same rigorous Food and Drug Administration approval process, brand name formulations continue to lead the OTC drug market with a higher market share. There is a limited amount of publicly available information regarding consumer perceptions and awareness about generic and brand name OTC drugs. The main objective of this research was to understand what factors influence US consumers to purchase generic versus brand name OTC drugs. The researchers used a 20-question, self-administered, multiple-choice survey to collect data on the factors influencing consumers' preferences for generic versus brand name OTC drugs. Results revealed that the single most influential factor for participants when purchasing OTC drugs was lower cost. Although economic factors play an important role in influencing consumers to choose generic formulations, a variety of other factors including advertisements, duration of the OTC effectiveness, severity of sickness, preferable form of OTC medication, safety of the OTC, relief of multiple symptoms, and preferred company will persuade others to pay more for brand name drugs. Ultimately, increased awareness and use of generic OTC drugs may result in substantial cost savings for consumers.

  13. Medicamentos genéricos no Brasil: impactos das políticas públicas sobre a indústria nacional Generic drugs in Brazil: impacts of public policies upon the national industry

    Directory of Open Access Journals (Sweden)

    Cristiane Quental

    2008-04-01

    Full Text Available O presente artigo faz eco a trabalhos recentes da Abrasco¹, Gadelha² e Guimarães³, que enfatizam a necessidade de uma maior integração entre as políticas voltadas para o desenvolvimento do sistema de saúde e aquelas voltadas para a promoção do desenvolvimento industrial e da inovação, como forma de garantir para o país os benefícios econômicos gerados pelos gastos em saúde, assegurando a continuidade da política social, num círculo virtuoso. Embora apresente o caso dos medicamentos genéricos como uma experiência de sucesso na integração das políticas sociais voltadas para um maior acesso da população a medicamentos com qualidade garantida, com as políticas econômicas voltadas para o desenvolvimento industrial, discute os impactos e as limitações da política dialogando com a análise da competitividade da indústria de medicamentos genéricos brasileira realizada por Abreu4.This paper echoes recent works of Abrasco¹, Gadelha² and Guimarães³ emphasizing the need for a better integration between health policies and industrial development and innovation policies as the only way to keep the economic benefits generated by health expenditures in the country instead of letting them escape through imports and threaten the continuity of the social policy by growing trade deficits. Although presenting the generic drug policy as a successful case in integrating social policies aimed at a better access to quality drugs for the population with economic policies aimed at industrial development, this paper discusses the impacts and limitations of the referred policy in a dialog with Abreu's analysis of industrial competitiveness in the Brazilian generics industry.

  14. Factors affecting the opinions of family physicians regarding generic drugs – a questionnaire based study

    Directory of Open Access Journals (Sweden)

    Pawel Lewek

    2014-12-01

    Full Text Available A range of factors are believed to exert a negative influence on opinions of physicians about generic drugs.The aim of this study was to survey the opinions of primary care doctors on generics, and determine the factors which may affect them. A questionnaire comprising thirty eight questions was distributed among primary care doctors working in seventy out-patient clinics of the Lodzkie province, Poland, during the period of January 1, 2010 – December 31, 2010. A total of170 of 183 participants completed the survey (average age 48.5; 70.0% women: a 92.9%response rate. While 38.8% of physicians claimed that generics were worse than brand name drugs, 54.1% considered them to be better. However, 36.5% of the doctors did not choose generics for their own use. Two key opinions were identified among the responses concerning the effectiveness of generic drugs: use of generic drugs by the physician (p<0.001, and their opinion that pharmacists do inform patients about generic drugs (p<0.05. Although existing evidence confirms that generic and brand name drugs are equally effective, many physicians doubt this, which prevents them from being used as cost effective drug therapy. In order to increase healthcare savings through the use of generics, these factors should be addressed: for example, convincing a physician to adopt generics for personal use may be an efficient way to support more cost effective treatment of his patients.

  15. Optimal Anti-cancer Drug Profiles for Effective Penetration of the Anti-cancer Drug Market by Generic Drugs in Japan.

    Science.gov (United States)

    Shibata, Shoyo; Matsushita, Maiko; Saito, Yoshimasa; Suzuki, Takeshi

    2017-01-01

    The increased use of generic drugs is a good indicator of the need to reduce the increasing costs of prescription drugs. Since there are more expensive drugs compared with other therapeutic areas, "oncology" is an important one for generic drugs. The primary objective of this article was to quantify the extent to which generic drugs in Japan occupy each level of the Anatomical Therapeutic Chemical (ATC) classification system. The dataset used in this study was created from publicly available information obtained from the IMS Japan Pharmaceutical Market database. Data on the total amount of sales and number of prescriptions for anti-cancer drugs between 2010 and 2016 in Japan were selected. The data were categorized according to the third level of the ATC classification system. All categories of the ATC classification system had increased market shares in Japan between 2010 and 2016. The barriers to market entry were relatively low in L01F (platinum anti-neoplastics), L01C (plant-based neoplastics), L02B (cytostatic hormone antagonists), and L01D (anti-neoplastic antibiotics) but were high in L02A (cytostatic hormones), L01H (protein kinase inhibitors), and L01B (anti-metabolites). Generic cancer drugs could bring savings to Japanese health care systems. Therefore, their development should be directed toward niche markets, such as L02A, L01H, and L01B, and not competitive markets.

  16. Has the increase in the availability of generic drugs lowered the ...

    African Journals Online (AJOL)

    Comparison of price ratios between the originator drug, lowest priced generic and international reference price values revealed that the originator drug prices had a median price ratio of 20.99 (interquartile range 7.31e53.46) and the lowest priced generics had a median price ratio of 4.28 (interquartile range 2.10e8.47).

  17. 77 FR 45629 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013

    Science.gov (United States)

    2012-08-01

    ..., beginning with the letters ``AG'', from the upper right-hand corner of your completed Animal Generic Drug...] Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013 AGENCY: Food and Drug... payment procedures for fiscal year (FY) 2013 generic new animal drug user fees. The Federal Food, Drug...

  18. Deeply discounted medications: Implications of generic prescription drug wars.

    Science.gov (United States)

    Czechowski, Jessica L; Tjia, Jennifer; Triller, Darren M

    2010-01-01

    To describe the history of generic prescription pricing programs at major pharmacy chains and their potential implications on prescribing, quality of care, and patient safety. Publicly available generic prescription discount program drug lists as of May 1, 2009. Fierce competition among major pharmacy chains such as Walgreens, CVS, and Walmart has led to a generic prescription pricing war with unclear public health implications. Introduced in 2006, currently 7 of the 10 largest pharmacy chains advertise a version of a deeply discounted medication (DDM) program, accounting for more than 25,000 locations nationally. By early 2008, almost 70 million Americans had used these programs. Although DDM programs lower drug costs for many patients, DDM formularies include potentially ineffective or harmful medications, have the potential to influence physician prescribing behavior, and may impair pharmacists' ability to review complete drug-dispensing records. DDMs are widespread but have the potential for unintended consequences on patients, providers, and the health care system. A systematic review of DDMs needs to evaluate the clinical, economic, and system-level implications of such programs.

  19. Competition in prescription drug markets: the roles of trademarks, advertising, and generic names.

    Science.gov (United States)

    Feldman, Roger; Lobo, Félix

    2013-08-01

    We take on two subjects of controversy among economists-advertising and trademarks-in the context of the market for generic drugs. We outline a model in which trademarks for drug names reduce search costs but increase product differentiation. In this particular framework, trademarks may not benefit consumers. In contrast, the generic names of drugs or "International Nonproprietary Names" (INN) have unquestionable benefits in both economic theory and empirical studies. We offer a second model where advertising of a brand-name drug creates recognition for the generic name. The monopoly patent-holder advertises less than in the absence of a competitive spillover.

  20. Toward a generic approach for : Stress testing of drug substances and drug products

    NARCIS (Netherlands)

    Klick, Silke; Muijselaar, Pim G.; Waterval, Joop; Eichinger, Thomas; Korn, Christian; Gerding, Thijs K.; Debets, Alexander J.; Sänger-Van De Griend, Cari; Van Den Beld, Cas; Somsen, Govert W.; De Jong, Gerhardus J.

    The Impurity Profiling Group has developed a generic approach for conducting stress testing on drug substances and drug products. The proposed strategy is evaluated and verified with historical data and new experiments. Results demonstrate that the proposed approach is reasonable and generates

  1. Potential Cost Savings from Generic Medicines - Protecting the ...

    African Journals Online (AJOL)

    ... a pro-generic policy since the introduction of the National Drug Policy in 1996. ... Medicines provided outside of hospitals accounted for 17% of medical aid ... in the chronic disease algorithms set out by the Council for Medical Schemes ...

  2. Safety and efficacy of generic drugs with respect to brand formulation

    OpenAIRE

    Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

    2013-01-01

    Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to gener...

  3. Multiple drug cost containment policies in Michigan's Medicaid program saved money overall, although some increased costs.

    Science.gov (United States)

    Kibicho, Jennifer; Pinkerton, Steven D

    2012-04-01

    Michigan's Medicaid program implemented four cost containment policies--preferred drug lists, joint and multistate purchasing arrangements, and maximum allowable cost--during 2002-04. The goal was to control growth of drug spending for beneficiaries who were enrolled in both Medicaid and Medicare and taking antihypertensive or antihyperlipidemic prescription drugs. We analyzed the impact of each policy while holding the effect of all other policies constant. Preferred drug lists increased both preferred and generic drugs' market share and reduced daily cost--the cost per day for each prescription provided to a beneficiary. In contrast, the maximum allowable cost policy increased daily cost and was the only policy that did not generate cost savings. The joint and multistate arrangements did not affect daily cost. Despite these policy trade-offs, the cumulative effect was a 10 percent decrease in daily cost and a total cost savings of $46,195 per year. Our findings suggest that policy makers need to evaluate the impact of multiple policies aimed at restraining drug spending, and further evaluate the policy trade-offs, to ensure that scarce public dollars achieve the greatest return for money spent.

  4. Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

    2017-09-01

    Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected Pbrand and generics for all three drugs of interest (Breslow-Day Pbrands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. An audit of generic prescribing in a general surgical department.

    LENUS (Irish Health Repository)

    Gleeson, M

    2013-01-17

    BACKGROUND: The Health Service Executive introduced a generic prescription policy to reduce costs. Despite this, generic prescription rates remain low. AIM: To audit in-patient prescription practice in a single surgical department and identify potential savings which could be realised by adherence to the generic prescribing policy. METHODS: Surgical in-patient charts were obtained at the point of discharge and their drug prescription information was recorded. RESULTS: 51 % of prescriptions involved a trade-name prescription where an appropriate generic equivalent existed. The cost implications for hospital and community patients were found to be greatly affected by substitution policies that exist at hospital pharmacy level. CONCLUSION: There is a need to promote greater adherence to generic prescribing amongst hospital doctors in line with international best practice. It can have a positive impact in terms of safe prescribing and can have cost implications at both hospital and community level.

  6. Security Policy for a Generic Space Exploration Communication Network Architecture

    Science.gov (United States)

    Ivancic, William D.; Sheehe, Charles J.; Vaden, Karl R.

    2016-01-01

    This document is one of three. It describes various security mechanisms and a security policy profile for a generic space-based communication architecture. Two other documents accompany this document- an Operations Concept (OpsCon) and a communication architecture document. The OpsCon should be read first followed by the security policy profile described by this document and then the architecture document. The overall goal is to design a generic space exploration communication network architecture that is affordable, deployable, maintainable, securable, evolvable, reliable, and adaptable. The architecture should also require limited reconfiguration throughout system development and deployment. System deployment includes subsystem development in a factory setting, system integration in a laboratory setting, launch preparation, launch, and deployment and operation in space.

  7. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.

    Science.gov (United States)

    Kesselheim, Aaron S; Misono, Alexander S; Lee, Joy L; Stedman, Margaret R; Brookhart, M Alan; Choudhry, Niteesh K; Shrank, William H

    2008-12-03

    Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs. To summarize clinical evidence comparing generic and brand-name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral. We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of beta-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of alpha-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was -0.03 (95% confidence interval, -0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution. Whereas evidence does not

  8. Patent extension policy for paediatric indications: an evaluation of the impact within three drug classes in a state Medicaid programme.

    Science.gov (United States)

    Nelson, Richard E; McAdam-Marx, Carrie; Evans, Megan L; Ward, Robert; Campbell, Benjamin; Brixner, Diana; Lafleur, Joanne

    2011-05-01

    The Food and Drug Administration Modernization Act (FDAMA) of 1997, Best Pharmaceuticals for Children Act (BPCA) of 2002 and Pediatric Research Equity Act of 2007 provide an extended period of 6 months of marketing exclusivity (i.e. patent extension) to prescription drug manufacturers that conduct paediatric studies. Branded drugs in the statin, ACE inhibitor and selective serotonin reuptake inhibitor (SSRI) classes were three of many classes with drugs granted patent extensions. We estimated the cost impact of the 6-month exclusivity extension policy on the Utah Medicaid drug programme by comparing actual costs to projected costs had the 6-month exclusivity extension not been granted for these drugs and thus less expensive generic alternatives been available sooner. Using these results, we then projected the cost impact of this policy on Medicaid programmes in the US during the 18 months following patent expiration. The Utah Medicaid prescription claims obtained for statins, ACE inhibitors and SSRIs included reimbursement amount, number of units dispensed, days supplied, date of service and drug strength. Actual expenditures for each drug were calculated for the 6 months before and 12 months after generic availability. The percentage difference between the brand name prescription reimbursement amount to Medicaid in the last 2 months of the 6-month extension and the generic prescription reimbursement amount to Medicaid in the first 2 months following exclusivity expiration was then calculated for each drug. This was done using data from the 5 months surrounding the exclusivity expiration by regressing the log-transformed Utah Medicaid reimbursement amount on an indicator for patent expiration, controlling for number of units, volume of sales, month filled and strength. This was used to estimate what the initial generic prescription price would have been without the 6-month patent extension and what costs would have been in the 18 months following the original

  9. Economic Impacts of the Generic Drug User Fee Act Fee Structure.

    Science.gov (United States)

    Dong, Ke; Boehm, Garth; Zheng, Qiang

    2017-06-01

    A Food and Drug Administration (FDA) Generic Drug User system, Generic Drug User Fee Amendment of 2012 (GDUFA), started October 1, 2012, and has been in place for over 3 years. There is controversy about the GDUFA fee structure but no analysis of GDUFA data that we could find. To look at the economic impact of the GDUFA fee structure. We compared the structure of GDUFA with that of other FDA Human Drug User fees. We then, using FDA-published information, analyzed where GDUFA facility and Drug Master File fees are coming from. We used the Orange Book to identify the sponsors of all approved Abbreviated New Drug Applications (ANDAs) and the S&P Capital IQ database to find the ultimate parent companies of sponsors of approved ANDAs. The key differences between the previous structure for Human Drug User fees and the GDUFA are as follows: GDUFA has no approved product fee and no first-time or small business fee exemptions and GDUFA charges facility fees from the time of filing and charges a foreign facility levy. Most GDUFA fees are paid by or on behalf of foreign entities. The top 10 companies hold nearly 50% of all approved ANDAs but pay about 14% of GDUFA facility fees. We conclude that the regressive nature of the GDUFA fee structure penalizes small, new, and foreign firms while benefiting the large established firms. A progressive fee structure in line with other human drug user fees is needed to ensure a healthy generic drug industry. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  10. Radiopharmaceutical regulation and Food and Drug Administration policy.

    Science.gov (United States)

    Rotman, M; Laven, D; Levine, G

    1996-04-01

    The regulatory policy of the Food and Drug Administration (FDA) on radiopharmaceuticals flows from a rigid, traditional, drug-like interpretation of the FDC Act on the licensing of radiopharmaceuticals. This contributes to significant delays in the drug-approval process for radiopharmaceuticals, which are very costly to the nuclear medicine community and the American public. It seems that radiopharmaceuticals would be better characterized as molecular devices. Good generic rule-making principles include: use of a risk/benefit/cost analysis; intent based on sound science; performance standards prepared by outside experts; a definite need shown by the regulatory agency; to live with the consequences of any erroneous cost estimates; and design individual credential requirements so that additional training results in enhanced professional responsibility. When these common elements are applied to current FDA policy, it seems that the agency is out of sync with the stated goals for revitalizing federal regulatory policies as deemed necessary by the Clinton administration. Recent FDA rulings on positron-emission tomography, Patient Package inserts, and on medical device service accentuate the degree of such asynchronization. Radiopharmaceutical review and licensing flexibility could be dramatically improved by excluding radiopharmaceuticals from the drug category and reviewing them as separate entities. This new category would take into account their excellent record of safety and their lack of pharmacological action. Additionally, their evaluation of efficacy should be based on their ability to provide useful scintiphotos, data, or responses of the physiological system it portends to image, quantitate, or describe. To accomplish the goal of transforming the FDA's rigid, prescriptive policy into a streamlined flexible performance-based policy, the Council on Radionuclides and Radiopharmaceuticals proposal has been presented. In addition, it is suggested that the United

  11. Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis.

    Science.gov (United States)

    Vial, Jérôme; Cohen, Mélanie; Sassiat, Patrick; Thiébaut, Didier

    2008-07-01

    The aim of this study was to evaluate the quality of 31 commercially available generic formulations of docetaxel purchased in 14 countries by comparing their docetaxel content, impurity levels and pH versus those of the proprietary product Taxotere (Tx). Generic formulations were purchased in 14 countries in Asia, Africa, the Middle East and Latin America. Levels of docetaxel and impurities (chromatographic peaks above 0.05%) were obtained for each sample using reverse-phase liquid chromatography with ultraviolet detection. The pH of aqueous solutions of generic docetaxel formulations and Tx was also measured. A global evaluation of quality was conducted on each product using a multicriteria desirability analysis based on standards defined by the International Conference on Harmonisation guidelines and the US Pharmacopeia paclitaxel injection monograph. Most generic formulations contained a lower than expected amount of docetaxel and/or a high level of impurities: 21 generic docetaxel formulations had an average mass of docetaxel that was generic docetaxel formulations had a total impurity content of >3.0%, almost twice the level of impurities in Tx 20 mg. In total, 33 impurities not present in Tx were detected in the generic samples. Desirability analysis demonstrated that none of the generic docetaxel formulations had composition characteristics similar to those of Tx. This study demonstrated that from an analytical point of view, 90% of the generic docetaxel formulations evaluated contained insufficient active drug, high levels of impurities or both. This has the potential to affect both efficacy and safety of the drug.

  12. [Intention of purchasing generic prescription drugs on the part of consumers in Asturias, Spain].

    Science.gov (United States)

    González Hernando, Santiago; González Mieres, Celina; Díaz Martín, Ana M

    2003-01-01

    Ascertaining how consumers perceive the risk related to the use of generic prescription drugs and those factors which have the greatest impact on the intention to request a generic drug from the prescribing physician and/or the pharmacist for the purpose of determining any possible barriers or hindrances to the acceptance of generics and to gather information to aid healthcare managers in their decision-making processes. Study on prescription drug use revolving around the degree to which patients are willing to request an EFG. In this quantitative transversal study, a total of 542 individuals were individually surveyed upon exiting a healthcare center or pharmacy in Asturias. A scale for measuring the perceived risk involved in the purchase of a prescription drug including 15 attributes grouped into five aspects was included in the questionnaire. Information was also gathered regarding the intention of using generic prescription drugs and on the demographic and socioeconomic characteristics of those surveyed. For the analysis of the results, a factorial confirmational analysis, multiple regression and univariate analysis were used. The data was processed using the EQS and SPSS statistics programs. Mean perception of the risk (scales 1-7): functional: 2.75; physical: 2.68: financial: 2.19; psychological: 1.99; social: 1.42. Factors having a bearing on the intention of requesting generic prescription drugs from their physician: psychological risk (p = 0.000). On requesting the same from their pharmacist: psychological risk (p = 0.000) and social risk (p = 0.020). The agents interested in the development on the EFG market should target their communication efforts on putting the functional and financial aspects of the manufacturer's specialties and generic specialties on the same level, but should not leave out psychological and social aspects of the consumers' purchasing behavior.

  13. The impact of generic-only drug benefits on patients' use of inhaled corticosteroids in a Medicare population with asthma

    Directory of Open Access Journals (Sweden)

    Newhouse Joseph P

    2008-07-01

    Full Text Available Abstract Background Patients face increasing insurance restrictions on prescription drugs, including generic-only coverage. There are no generic inhaled corticosteroids (ICS, which are a mainstay of asthma therapy, and patients pay the full price for these drugs under generic-only policies. We examined changes in ICS use following the introduction of generic-only coverage in a Medicare Advantage population from 2003–2004. Methods Subjects were age 65+, with asthma, prior ICS use, and no chronic obstructive pulmonary disorder (n = 1,802. In 2004, 74.0% switched from having a $30 brand-copayment plan to a generic-only coverage plan (restricted coverage; 26% had $15–25 brand copayments in 2003–2004 (unrestricted coverage. Using linear difference-in-difference models, we examined annual changes in ICS use (measured by days-of-supply dispensed. There was a lower-cost ICS available within the study setting and we also examined changes in drug choice (higher- vs. lower-cost ICS. In multivariable models we adjusted for socio-demographic, clinical, and asthma characteristics. Results In 2003 subjects had an average of 188 days of ICS supply. Restricted compared with unrestricted coverage was associated with reductions in ICS use from 2003–2004 (-15.5 days-of-supply, 95% confidence interval (CI: -25.0 to -6.0. Among patients using higher-cost ICS drugs in 2003 (n = 662, more restricted versus unrestricted coverage subjects switched to the lower-cost ICS in 2004 (39.8% vs. 10.3%. Restricted coverage was not associated with decreased ICS use (2003–2004 among patients who switched to the lower-cost ICS (18.7 days-of-supply, CI: -27.5 to 65.0, but was among patients who did not switch (-38.6 days-of-supply, CI: -57.0 to -20.3. In addition, restricted coverage was associated with decreases in ICS use among patients with both higher- and lower-risk asthma (-15.0 days-of-supply, CI: -41.4 to 11.44; and -15.6 days-of-supply, CI: -25.8 to -5

  14. Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies

    Directory of Open Access Journals (Sweden)

    Michael A. Partridge

    2016-01-01

    Full Text Available Anti-drug antibodies induced by biologic therapeutics often impact drug pharmacokinetics, pharmacodynamics response, clinical efficacy, and patient safety. It is critical to assess the immunogenicity risk of potential biotherapeutics in producing neutralizing and nonneutralizing anti-drug antibodies, especially in clinical phases of drug development. Different assay methodologies have been used to detect all anti-drug antibodies, including ELISA, radioimmunoassay, surface plasmon resonance, and electrochemiluminescence-based technologies. The most commonly used method is a bridging assay, performed in an ELISA or on the Meso Scale Discovery platform. In this report, we aim to review the emerging new assay technologies that can complement or address challenges associated with the bridging assay format in screening and confirmation of ADAs. We also summarize generic anti-drug antibody assays that do not require drug-specific reagents for nonclinical studies. These generic assays significantly reduce assay development efforts and, therefore, shorten the assay readiness timeline.

  15. [Sustainability of Brazilian policy for access to antiretroviral drugs].

    Science.gov (United States)

    Grangeiro, Alexandre; Teixeira, Luciana; Bastos, Francisco I; Teixeira, Paulo

    2006-04-01

    The expense of acquiring antiretroviral drugs in Brazil has given rise to debate about the sustainability of the policy of universal access to AIDS medications, despite the evident benefits. The objective of this study was to analyze the evolution of the Ministry of Health's spending on acquiring antiretroviral drugs from 1998 to 2005, the determining factors and the medium-term sustainability of this policy (2006-2008). The study on the evolution of spending on antiretrovirals included analysis of their prices, the year-by-year expenditure, the number of patients utilizing the medication, the mean expenditure per patient and the strategies for reducing the prices maintained during this period. To analyze the sustainability of the policy for access to antiretrovirals, the cost of acquiring the drugs over the period from 2006 to 2008 was estimated, along with the proportion of gross domestic product and federal health expenditure represented by this spending. The data were collected from the Ministry of Health, the Brazilian Institute for Geography and Statistics (IBGE) and the Ministry of Planning. The expenditure on antiretrovirals increased by 66% in 2005, breaking the declining trend observed over the period from 2000 to 2004. The main factors associated with this increase were the weakening of the national generics industry and the unsatisfactory results from the process of negotiating with pharmaceutical companies. The Brazilian policy for universal access is unsustainable at the present growth rates of the gross domestic product, unless the country compromises its investments in other fields.

  16. Generic antibiotics in Japan.

    Science.gov (United States)

    Fujimura, Shigeru; Watanabe, Akira

    2012-08-01

    Generic drugs have been used extensively in many developed countries, although their use in Japan has been limited. Generic drugs reduce drug expenses and thereby national medical expenditure. Because generic drugs provide advantages for both public administration and consumers, it is expected that they will be more widely used in the future. However, the diffusion rate of generic drugs in Japan is quite low compared with that of other developed countries. An investigation on generic drugs conducted by the Ministry of Health, Labour and Welfare in Japan revealed that 17.2 % of doctors and 37.2 % of patients had not used generic drugs. The major reasons for this low use rate included distrust of off-patent products and lower drug price margin compared with the brand name drug. The generic drugs available in the market include external drugs such as wet packs, antihypertensive agents, analgesics, anticancer drugs, and antibiotics. Among them, antibiotics are frequently used in cases of acute infectious diseases. When the treatment of these infections is delayed, the infection might be aggravated rapidly. The pharmacokinetics-pharmacodynamics (PK-PD) theory has been adopted in recent chemotherapy, and in many cases, the most appropriate dosage and administration of antibiotics are determined for individual patients considering renal function; high-dosage antibiotics are used preferably for a short duration. Therefore, a highly detailed antimicrobial agent is necessary. However, some of the generic antibiotics have less antibacterial potency or solubility than the brand name products. We showed that the potency of the generic products of vancomycin and teicoplanin is lower than that of the branded drugs by 14.6 % and 17.3 %, respectively. Furthermore, we confirmed that a generic meropenem drug for injection required about 82 s to solubilize in saline, whereas the brand product required only about 21 s. It was thought that the cause may be the difference in size of bulk

  17. Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs - provision of due diligence in the treatment process.

    Science.gov (United States)

    Zajdel, Justyna; Zajdel, Radosław

    2013-01-01

    Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on "off-label use". The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug.

  18. Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.

    Science.gov (United States)

    Rostron, Allen

    2011-02-01

    Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

  19. Drug policy constellations: A Habermasian approach for understanding English drug policy.

    Science.gov (United States)

    Stevens, Alex; Zampini, Giulia Federica

    2018-07-01

    It is increasingly accepted that a view of policy as a rational process of fitting evidence-based means to rationally justified ends is inadequate for understanding the actual processes of drug policy making. We aim to provide a better description and explanation of recent English drug policy decisions. We develop the policy constellation concept from the work of Habermas, in dialogue with data from two contemporary debates in English policy; on decriminalisation of drug possession and on recovery in drug treatment. We collect data on these debates through long-term participant observation, stakeholder interviews (n = 15) and documentary analysis. We show the importance of social asymmetries in power in enabling structurally advantaged groups to achieve the institutionalisation of their moral preferences as well as the reproduction of their social and economic power through the deployment of policies that reflect their material interests and normative beliefs. The most influential actors in English drug policy come together in a 'medico-penal constellation', in which the aims and practices of public health and social control overlap. Formal decriminalisation of possession has not occurred, despite the efforts of members of a challenging constellation which supports it. Recovery was put forward as the aim of drug treatment by members of a more powerfully connected constellation. It has been absorbed into the practice of 'recovery-oriented' drug treatment in a way that maintains the power of public health professionals to determine the form of treatment. Actors who share interests and norms come together in policy constellations. Strategic action within and between constellations creates policies that may not take the form that was intended by any individual actor. These policies do not result from purely rational deliberation, but are produced through 'systematically distorted communication'. They enable the most structurally favoured actors to institutionalise

  20. Creating New Economic Incentives for Repurposing Generic Drugs for Unsolved Diseases Using Social Finance.

    Science.gov (United States)

    Bloom, Bruce E

    2015-12-01

    Repurposing research improves patient lives by taking drugs approved for one disease and clinically testing them to create a treatment for a different disease. Repurposing drugs that are generic, inexpensive, and widely available and that can be taken in their current dosage and formulation in the new indication provide a quick, affordable, and effective way to create "new" treatments. However, generic drug repurposing often provides no profit potential, and so there is no economic incentive for industry to pursue this, and philanthropy and government funds are often insufficient. One way to create new economic incentive for the repurposing of generic drugs is through social finance. This perspective describes how social finance can create a new economic incentive by using a social impact bond, or similar financial structure, to repay for-profit investors who fund the repurposing research from the proceeds of healthcare cost reductions generated when these affordable, effective, and widely available repurposed therapies improve healthcare outcomes.

  1. Reference drug programs: Effectiveness and policy implications☆

    Science.gov (United States)

    Schneeweiss, Sebastian

    2010-01-01

    In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs (RDPs) or similar therapeutic substitution programs. This paper summarizes the mechanism and rationale of RDPs and presents evidence of their economic effectiveness and clinical safety. RDPs for pharmaceutical reimbursement are based on the assumption that drugs within specified medication groups are therapeutically equivalent and clinically interchangeable and that a common reimbursement level can thus be established. If the evidence documents that a higher price for a given drug does not buy greater effectiveness or reduced toxicity, then under RDP such extra costs are not covered. RDPs or therapeutic substitutions based on therapeutic equivalence are seen as logical extensions of generic substitution that is based on bioequivalence of drugs. If the goal is to achieve full drug coverage for as many patients as possible in the most efficient manner, then RDPs in combination with prior authorization programs are safer and more effective than simplistic fiscal drug policies, including fixed co-payments, co-insurances, or deductibles. RDPs will reduce spending in the less innovative but largest market, while fully covering all patients. Prior authorization will ensure that patients with a specified indication will benefit from the most innovative therapies with full coverage. In practice, however, not all patients and drugs will fit exactly into one of the two categories. Therefore, a process of medically indicated exemptions that will consider full coverage should accompany an RDP. In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs, and others are considering

  2. The use of generic drugs in prevention of chronic disease is far more cost-effective than thought, and may save money.

    Science.gov (United States)

    Shrank, William H; Choudhry, Niteesh K; Liberman, Joshua N; Brennan, Troyen A

    2011-07-01

    In this article we highlight the important role that medication therapy can play in preventing disease and controlling costs. Focusing on coronary artery disease, we demonstrate that prevention, with the appropriate use of generic medications, appears far more cost-effective than previously documented, and it may even save on costs. For example, an earlier study estimated that reducing blood pressure to widely established clinical guidelines in nondiabetic patients cost an estimated $52,983 per quality-adjusted life-year if a brand-name drug was used. However, we estimate that the cost is just $7,753 per quality-adjusted life-year at generic medication prices. As the nation attempts to find strategies to improve population health without adding to the unsustainably high cost of care, policy makers should focus on ensuring that patients have access to essential generic medications.

  3. Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs – provision of due diligence in the treatment process

    Science.gov (United States)

    Zajdel, Justyna

    2013-01-01

    Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on “off-label use”. The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug. PMID:24592133

  4. Extent of Drug Coverage across Generic Drug Discount Programs offered by Community Pharmacies: A look at five Chronic Conditions

    Directory of Open Access Journals (Sweden)

    Harshali K. Patel, MS

    2012-01-01

    Full Text Available Background: Chronic conditions are expensive to treat because of the ongoing prescription cost burden. Generic drug discount programs (GDDPs that offer generics at discounted price may prove beneficial to reduce pharmacy costs for the same.Objective: The objective of this study was to assess the extent to which GDDPs provide drug coverage for five common chronic conditions.Methods: A content analyses of preexisting information was conducted. Extent of coverage based on top 200 generic drugs prescribed during 2008 for the treatment of chronic conditions such as hypertension, mental disorders, arthritis, pulmonary/respiratory conditions, and diabetes were identified. Commonly prescribed medications for these diseases were identified using published peer reviewed clinical guidelines. List of drugs covered under a GDDP for stores, Wal-Mart, Walgreens, CVS, Kroger, HEB, Target, and Randalls were obtained and compared to assess drug coverage by retail dollar sales and sales volume. Descriptive statistics and frequency/percentage of coverage were reported using SAS 9.2.Results: GDDPs covered the highest number of drugs for hypertension (21-27 across different GDDPs and the least (3-5 across different GDDPs for pulmonary/respiratory conditions. Arthritis (5-11, mental disorders (6-11 and diabetes (5-7 had similar coverage. When compared to the top 200 drugs by retail dollars spent during 2008, hypertension (68%-87% and diabetes (63%-88% had the highest coverage followed by respiratory conditions (30%-50%, arthritis (22%-48%, and mental disorders (21%-38%. Similar result was obtained when GDDP coverage was compared with the top 200 generic drugs by sales volume, where diabetes (63-88% and hypertension (57%-74% had the highest coverage and mental disorders remained the lowest (23%-37%.Conclusion/Implications: Drug coverage in GDDPs varied by pharmacies across the five common chronic conditions evaluated which may limit accessibility of these programs for

  5. Impacts of generic competition and benefit management practices on spending for prescription drugs: evidence from Medicare's Part D benefit.

    Science.gov (United States)

    Sheingold, Steven; Nguyen, Nguyen Xuan

    2014-01-01

    This study estimates the effects of generic competition, increased cost-sharing, and benefit practices on utilization and spending for prescription drugs. We examined changes in Medicare price and utilization from 2007 to 2009 of all drugs in 28 therapeutic classes. The classes accounted for 80% of Medicare Part D spending in 2009 and included the 6 protected classes and 6 classes with practically no generic competition. All variables were constructed to measure each drug relative to its class at a specific plan sponsor. We estimated that the shift toward generic utilization had cut in half the rate of increase in the price of a prescription during 2007-2009. Specifically, the results showed that (1) rapid generic penetration had significantly held down costs per prescription, (2) copayment and other benefit practices shifted utilization to generics and favored brands, and (3) price increases were generally greater in less competitive classes of drugs. In many ways, Part D was implemented at a fortuitous time; since 2006, there have been relatively few new blockbuster drugs introduced, and many existing high-volume drugs used by beneficiaries were in therapeutic classes with multiple brands and generic alternatives. Under these conditions, our paper showed that plan sponsors have been able to contain costs by encouraging use of generics or drugs offering greater value within therapeutic classes. It is less clear what will happen to future Part D costs if a number of new and effective drugs for beneficiaries enter the market with no real competitors.

  6. Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

    Science.gov (United States)

    Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

    2018-06-01

    Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

  7. 76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

    ... . (The Pay.gov payment option is available to you after you submit a cover sheet. Click the ``Pay Now... generic new animal drugs, FDA is assuming that the number of applications that will pay fees in FY 2012... submissions of abbreviated applications for generic new animal drugs is 14.5 per year, which is the average of...

  8. Financial incentives for generic drugs: case study on a reimbursement program

    Directory of Open Access Journals (Sweden)

    Marcos Inocencio

    2010-06-01

    Full Text Available Objective: To discuss the use of financial incentives in choice of medication and to assess the economic results concerning the use of financial incentives to promote the use of genetic medication in lieu of reference drugs in a company with a reimbursement program. Methods: A case study was carried out in a large supermarket. The data was obtained in the company responsible for managing medication. The study reached 83,625 users between August 2005 and July 2007. The data was submitted to regressions in order to analyze trends and hypothesis tests to assess differences in medication consumption. The results were compared with general data regarding medication consumption of five other organizations and also with data about the national consumption of generic medication in Brazil. Results: The use of financial incentives to replace brand medications for generics, in the company studied, increased the consumption of generic drugs without reducing the company expenses with the reimbursement programs. Conclusions: This study show the occurrence of unplanned results (increase in the consumption of medications and the positive consequences of the reimbursement program concerning access to medication.

  9. Modeling HIV/AIDS drug price determinants in Brazil: is generic competition a myth?

    Science.gov (United States)

    Meiners, Constance; Sagaon-Teyssier, Luis; Hasenclever, Lia; Moatti, Jean-Paul

    2011-01-01

    Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care. Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition. In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies.

  10. Modeling HIV/AIDS drug price determinants in Brazil: is generic competition a myth?

    Directory of Open Access Journals (Sweden)

    Constance Meiners

    Full Text Available BACKGROUND: Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care. METHODS AND FINDINGS: Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition. SIGNIFICANCE: In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies.

  11. A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate design trials.

    Science.gov (United States)

    Yu, Yang; Teerenstra, Steven; Neef, Cees; Burger, David; Maliepaard, Marc

    2016-04-01

    The aim of the present study was to investigate whether differences in total and peak drug exposure upon generic substitution are due to differences between formulations or to intrasubject pharmacokinetic variability of the active substance. The study was designed as a retrospective reanalysis of existing studies. Nine replicate design bioequivalence studies representing six drug classes - i.e. for alendronate, atorvastatin, cyclosporin, ebastine, exemestane, mycophenolate mofetil, and ropinirole - were retrieved from the Dutch Medicines Regulatory Authority. In most studies, the intrasubject variability in total and peak drug exposure was comparable for the brand-name [in the range 0.01-0.24 for area under the concentration-time curve (AUCt ) and 0.02-0.29 for peak plasma concentration (Cmax ) on a log scale] and generic (0.01-0.23 for AUCt and 0.08-0.33 for Cmax ) drugs, and was comparable with the intrasubject variability upon switching between those drugs (0.01-0.23 for AUCt and 0.06-0.33 for Cmax ). The variance related to subject-by-formulation interaction could be considered negligible (-0.069 to 0.047 for AUCt and -0.091 to 0.02 for Cmax ). In the investigated studies, the variation in total and peak exposure seen when a patient is switched from a brand-name to a generic drug is comparable with that seen following repeated administration of the brand-name drug in the patient. Only the intrasubject variability seems to play a crucial and decisive role in the variation in drug exposure seen; no additional formulation-dependent variation in exposure is observed upon switching. Thus, our data support that, for the medicines that were included in the present investigation, from a clinical pharmacological perspective, the benefit-risk balance of a generic drug is comparable with that of the brand-name drug. © 2015 The British Pharmacological Society.

  12. Impact of Spacing of Practice on Learning Brand Name and Generic Drugs.

    Science.gov (United States)

    Terenyi, James; Anksorus, Heidi; Persky, Adam M

    2018-02-01

    Objective. To test the impact of schedules of retrieval practice on learning brand and generic name drug information in a self-paced course. Methods. Students completed weekly quizzes on brand and generic name conversions for 100 commonly prescribed drugs. Each student completed part of the drug list on a schedule of equal, expanding, or contracting spacing, one practice (massed) or study only in a partial block design. Results. On measures of long-term retention, the contracting spacing schedule led to superior retention (67%) compared to the massed practice (50%) and study-only condition (46%); contracting practice also was significantly higher than expanding practice (58%,) or equal practice (59%). Overall performance decreased by almost 50% (final exam 95%, long-term retention 55%) over a 6-week period. Conclusion. A contracting spacing schedule was the most effective schedule of practice, and all spacing schedules were superior to massed practice or study-only conditions.

  13. [Consensus clinical practice guidelines of the Andalusian Epilepsy Society on prescribing generic antiepileptic drugs].

    Science.gov (United States)

    Cañadillas-Hidalgo, F M; Sánchez-Alvarez, J C; Serrano-Castro, P J; Mercadé-Cerdá, J M

    Pharmaceutical spending in Spain accounts for 1.2-1.4% of the gross domestic product and is increasing by 5-12% per year. One of the measures adopted by the government to cut this spending is the possible substitution of original prescribed drugs by generics. In the case of antiepileptic drugs (AED), which are characterised by a scant therapeutic margin, these steps have sparked a scientific debate about their repercussion on the control of epileptic patients. We propose to draw up a set of implicit evidence-based consensus practice guidelines concerning issues related with this topic. A selective search for quality scientific information on the subject was conducted on PubMed-Medline, Tripdatabase and the Biblioteca Cochrane Plus. The selected references were analysed and discussed by the authors, and the recommendations deriving from them were collected. A total of 21 primary documents and 16 practice guidelines, protocols or experts' recommendations were identified. Our recommendations were explicitly included at the end of the text. The Andalusian Epilepsy Society makes the following recommendations: 1) not replacing an innovative AED by its generic in a controlled patient; 2) beginning treatment with a generic AED in monotherapy or in association is acceptable; 3) not exchanging generic AED from different pharmaceutical companies; 4) explaining to the patient the rules governing the authorization of generics and the importance of avoiding exchanges between different generic AED; and 5) if there is some worsening of the clinical condition or side effects appear following the introduction of a generic, the causes must be investigated and communicated to the bodies responsible for pharmacovigilance.

  14. Responsiveness to physicians' requests for information concerning drug interactions: a comparison of brand and generic companies.

    Science.gov (United States)

    Thomas, M; Lexchin, J

    1990-01-01

    Research-based pharmaceutical companies maintain that there are important differences between themselves and their generic competitors. Prominent among them is an alleged greater ability to provide accurate and rapid responses to requests from physicians for information about drug products. This study evaluates pharmaceutical company behavior with regard to these issues. Two drug-drug interactions were identified, along with all of the companies in Canada marketing any of the four drugs involved. Each company received a letter describing symptoms suggestive of an interaction in a patient taking its particular product and the relevant second drug. The companies were asked if they were aware of any evidence of an interaction involving the two drugs. They were also asked to provide references regarding the interaction. Responses were received from all companies contacted except one. There were no significant differences (in the hypothesized direction) between the generic and brand companies with regard to either the accuracy or promptness of the response, or the usefulness of the references cited. On the contrary, generic firms were markedly quicker to respond than were brand manufacturers. The latter were slightly more likely to acknowledge evidence of an adverse drug interaction, and to provide useful references to relevant published research.

  15. Assessment of prescribing information for generic drugs manufactured in the Middle East and marketed in Saudi Arabia

    International Nuclear Information System (INIS)

    Gebran, N.; Al-Haldari, K.

    2006-01-01

    Little research has assessed the quality of manufacturer provided prescribing information or documented difference in key aspects of drug information among different marketed generic products of the same drug particularly in Middle East and Arabian Gulf. We assessed the quality of written prescribing information for selected generic drugs marketed in Saudi Arabia and manufactured in various countries of Middle East. We assessed the correctness and completeness of information pertaining to indications, dosage cautions/contraindications, side effects and drug interactions in 37 packages inserts for generic products registered in Saudi Arabia and manufactured in the Middle East, including atenolol (6 inserts), fluoxetine (4 inserts), ciprofloxacin (11 inserts), melformin (7 inserts) and omeprazole (9 inserts). We also described deficiencies in quality and quantity of manufacturers provided information that could be misleading to patients and prescribes. We found substantial disagreement in information between generic packages inserts versus the British National Formulary and the package insert of the brand product marketed in Saudi Arabia. A cumulative average of 63.16% of drug information indicators were in agreement with these standard references. Section headings with the least conformity with study references were those related to dosage (57, 28%) and side effects (54+-30%). Our results indicate that national authorities should implement appropriate measures aimed at removing misleading and incorrect information in generic package inserts and incorporating crucial prescribing information that is missing. National authorities in the Middle East and Arabian Gulf should strengthen collaboration and information interchange among each other and with international agencies to maintain common quality standards for delivering information through package inserts. (author)

  16. Encouraging generic use can yield significant savings.

    Science.gov (United States)

    Zimmerman, Christina

    2012-11-01

    Key findings. (1) Zero copayment for generic drugs is the greatest influencer of generic statin utilization. (2) Both higher copayments for generic drugs and lower copayments for competing brands are associated with a decreased probability of using generic statins. (3) Prior authorization and step therapy requirements for brand-name statins are associated with an increased use of generic drugs. (4) Greater use of generic statins should reduce costs for patients, plans, and Medicare.

  17. Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs.

    Science.gov (United States)

    Cheng, Ning; Rahman, Md Motiur; Alatawi, Yasser; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, C David; Hansen, Richard A

    2018-04-01

    Several different types of drugs acting on the central nervous system (CNS) have previously been associated with an increased risk of suicide and suicidal ideation (broadly referred to as suicide). However, a differential association between brand and generic CNS drugs and suicide has not been reported. This study compares suicide adverse event rates for brand versus generic CNS drugs using multiple sources of data. Selected examples of CNS drugs (sertraline, gabapentin, zolpidem, and methylphenidate) were evaluated via the US FDA Adverse Event Reporting System (FAERS) for a hypothesis-generating study, and then via administrative claims and electronic health record (EHR) data for a more rigorous retrospective cohort study. Disproportionality analyses with reporting odds ratios and 95% confidence intervals (CIs) were used in the FAERS analyses to quantify the association between each drug and reported suicide. For the cohort studies, Cox proportional hazards models were used, controlling for demographic and clinical characteristics as well as the background risk of suicide in the insured population. The FAERS analyses found significantly lower suicide reporting rates for brands compared with generics for all four studied products (Breslow-Day P brand CNS drugs in FAERS and adjusted retrospective cohort analyses remained significant only for sertraline. However, even for sertraline, temporal confounding related to the close proximity of black box warnings and generic availability is possible. Additional analyses in larger data sources with additional drugs are needed.

  18. Drug Policy: the "Dutch Model"

    NARCIS (Netherlands)

    van Ooijen-Houben, M.M.J.; Kleemans, E.R.

    2015-01-01

    Dutch drug policy, once considered pragmatic and lenient and rooted in a generally tolerant attitude toward drug use, has slowly but surely shifted from a primarily public health focus to an increasing focus on law enforcement. The "coffee shop" policy and the policy toward MDMA/ecstasy are

  19. Generic medicines and generic substitution: contrasting perspectives of stakeholders in Ireland.

    Science.gov (United States)

    O'Leary, A; Usher, C; Lynch, M; Hall, M; Hemeryk, L; Spillane, S; Gallagher, P; Barry, M

    2015-12-15

    The Health (Pricing and Supply of Medical Goods) Act 2013 passed into law in July 2013 and legislated for generic substitution in Ireland. The aim of the study was to ascertain the knowledge and perceptions of stakeholders i.e. patients, pharmacists and prescribers, of generic medicines and to generic substitution with the passing of legislation. Three stakeholder specific questionnaires were developed to assess knowledge of and perceptions to generic medicines and generic substitution. Purposive samples of patients, prescribers and pharmacists were analysed. Descriptive quantitative and qualitative analyses were undertaken. A total of 762 healthcare professionals and 353 patients were recruited. The study highlighted that over 84% of patients were familiar with generic medicines and are supportive of the concept of generic substitution. Approximately 74% of prescribers and 84% of pharmacists were supportive of generic substitution in most cases. The main areas of concern highlighted by the healthcare professionals that might impact on the successful implementation of the policy, were the issue of bioequivalence with generic medicines, the computer software systems used at present in general practitioner (GP) surgeries and the availability of branded generics. The findings from this study identify a high baseline rate of acceptance to generic medicines and generic substitution among patients, prescribers and pharmacists in the Irish setting. The concerns of the main stakeholders provide a valuable insight into the potential difficulties that may arise in its implementation, and the need for on-going reassurance and proactive dissemination of the impact of the generic substitution policy. The existing positive attitude to generic medicines and generic substitution among key stakeholders in Ireland to generic substitution, combined with appropriate support and collaboration should result in the desired increase in rates of prescribing, dispensing and use of generic

  20. [Competition between branded and generic drugs in Austria: evidence from the market for ACE inhibitors].

    Science.gov (United States)

    Mahlich, J C; Stadler, I

    2012-01-01

    The market for pharmaceuticals in Austria is highly regulated and manufacturers cannot set prices freely after patent expiration of the pioneer drug. We wanted to examine the effect of price regulation on price competition between branded and generic drugs in Austria. We examined the Austrian market for ACE inhibitors and describe competitive dynamics by means of 6 indices. We compared our results with those of Grabowski and Vernon who studied the US market. According to our analysis the competition amongst the producers of generic drugs is not great and consequently, compared to the USA, over time the prices for generic products decrease less and their market share increases less. This is due to a market-oriented system in the USA which waives most regulatory provisions. Our conclusions are in line with the findings by Danzon und Chao (2000) who argue that in a price-regulated market competitive dynamics are less strongly developed. From a politico-economic view, the necessity of price regulations in the pharmaceutical market seems questionable, as price regulations generally also cause other negative effects, such as distorted economic incentives for research and development investments. © Georg Thieme Verlag KG Stuttgart · New York.

  1. From generic to biosimilar drugs: why take an innovative pace?

    Directory of Open Access Journals (Sweden)

    Fereshteh Barei

    2012-12-01

    Full Text Available BACKGROUND: The transition of the generic/biotechnology industry to innovation by investing in innovative R&D will enhance business expertise in biopharmaceutical development and manufacturing. The major impact of this evolution is on patient access to treatment and savings for the health care systems. OBJECTIVES: The aim of this paper is to investigate the innovative aspect of biosimilar and biobetter products, manufactured by some big generic companies. We will also try to explore the innovative business strategy, implementing this high risk product differentiation policy. METHODS: This qualitative research is conducted by a series of interviews with CEOs, physicians, and academics in different countries. The qualitative data obtained were analyzed by Nvivo9.2 software. A literature review has also contributed to our key findings. RESULTS: The results show that switching into biosimilars/biobetters is an innovative strategic choice, approved by some big generic pharmaceutical companies. The biosimilar/biobetter products can be considered innovative because of their value added quality. CONCLUSION: Expanding the product portfolio to biosimilars/biobetter can be considered as a long run strategy in the innovative business plans aiming to ensure the market access. Patients and their access to better treatments are major components of these innovative business models.

  2. Brand and generic medications: Are they interchangeable

    International Nuclear Information System (INIS)

    Al-Jazairi, Abdulrazak S.; Blhareth, S.; Eqtefan, Iyad S.; Al-Suwayeh, Saleh A.

    2008-01-01

    Generic substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety and the Food and Drug Administration (FDA) standards for bioequivalence. In Saudi Arabia, the increasing number of local products raised several concerns with regard to switching from brands to generics. Our objective was to review and examine the basis of the controversy surrounding brand and generic interchangeability and to explore a practical approach in pursuing a switch. Articles indexed initially under terms such as generic medications, generic substitution, bioequivalence and bioinequivalence were identified. These terms were used to search the indexing service, MEDLINE (1966-2006). References from the extracted articles and additional data sources, including the Code of Federal Regulations and Regulatory Guidelines from the FDA Center for Drug Evaluation and research were also reviewed. Foe most drugs, bioequivalence testing generally should enable clinicians to routinely substitute generic for innovator products. However, for narrow therapeutic, critical dose drugs, or for highly variable drugs, safe switching between products can not be assured. These drugs need special precautions and blood level monitoring upon switching. FDA firmly believes that approved generic and brand drugs can be dispensed with the full expectation that the consumer will receive the same clinical benefit. Performing the switch process is an advisable practice to reduce health care costs in countries with strong post-marketing surveillance program, but caution is to be exercised when narrow therapeutic index drugs or highly variable drugs are prescribed. (author)

  3. Drug Policy in Cyprus

    Directory of Open Access Journals (Sweden)

    George Charalambous

    2012-01-01

    Full Text Available Background: The provision of pharmaceutical drugs is of enormous significance in our lives. Notable progress made inthe domain of Public Health, combined with a general increase in the standard of living, has had a direct impact on thediscovery of new drugs and cures and has shifted pharmaceutical policies further in line with the current needs of boththe country’s health system and, its population.Aim: This research aims to both shed light on and analyse the current state of pharmaceutical policy in Cyprus, as well asto try to seek out its weaknesses, making suggestions, where possible, as to how to keep these to the minimum.Results, and Conclusions: The lack of both high level research and major industrial facilities relating to the discovery ofnew pharmaceutical drugs in Cyprus, has hindered the effectiveness of pharmaceutical policy in general domains such ascontrol over the circulation and production of pharmaceutical products in the country, their pricing and distribution andthe monitoring of our drug supplies. The lack of transparency in a number of pharmaceutical procedures, and ofinformation on drugs does not enhance the industry’s reliability, but rather exacerbates an underlying feeling of insecurityrelating to it among the population.

  4. Evaluation of the quality and pharmacoeconomics of some generic drugs versus their reputed counterpart brands in the Saudi market

    Directory of Open Access Journals (Sweden)

    Farouk M Sakr

    2016-01-01

    Conclusions: Pharmacopeial examinations showed that generic tablets are quantitatively and qualitatively equivalent to their internationally reputed brands within the tested tablet groups with the advantage for the generic drugs being significantly the cheapest.

  5. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-08-27

    ... generic drugs program. GDUFA will also significantly improve global supply chain transparency by requiring... promote global supply chain transparency. The information provided through self-identification will enable... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD...

  6. A new approach to formulating and appraising drug policy: A multi-criterion decision analysis applied to alcohol and cannabis regulation.

    Science.gov (United States)

    Rogeberg, Ole; Bergsvik, Daniel; Phillips, Lawrence D; van Amsterdam, Jan; Eastwood, Niamh; Henderson, Graeme; Lynskey, Micheal; Measham, Fiona; Ponton, Rhys; Rolles, Steve; Schlag, Anne Katrin; Taylor, Polly; Nutt, David

    2018-02-16

    Drug policy, whether for legal or illegal substances, is a controversial field that encompasses many complex issues. Policies can have effects on a myriad of outcomes and stakeholders differ in the outcomes they consider and value, while relevant knowledge on policy effects is dispersed across multiple research disciplines making integrated judgements difficult. Experts on drug harms, addiction, criminology and drug policy were invited to a decision conference to develop a multi-criterion decision analysis (MCDA) model for appraising alternative regulatory regimes. Participants collectively defined regulatory regimes and identified outcome criteria reflecting ethical and normative concerns. For cannabis and alcohol separately, participants evaluated each regulatory regime on each criterion and weighted the criteria to provide summary scores for comparing different regimes. Four generic regulatory regimes were defined: absolute prohibition, decriminalisation, state control and free market. Participants also identified 27 relevant criteria which were organised into seven thematically related clusters. State control was the preferred regime for both alcohol and cannabis. The ranking of the regimes was robust to variations in the criterion-specific weights. The MCDA process allowed the participants to deconstruct complex drug policy issues into a set of simpler judgements that led to consensus about the results. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

  7. Representations of women and drug use in policy: A critical policy analysis.

    Science.gov (United States)

    Thomas, Natalie; Bull, Melissa

    2018-06-01

    Contemporary research in the drugs field has demonstrated a number of gender differences in patterns and experiences of substance use, and the design and provision of gender-responsive interventions has been identified as an important policy issue. Consequently, whether and how domestic drug policies attend to women and gender issues is an important question for investigation. This article presents a policy audit and critical analysis of Australian national and state and territory policy documents. It identifies and discusses two key styles of problematisation of women's drug use in policy: 1) drug use and its effect on women's reproductive role (including a focus on pregnant women and women who are mothers), and 2) drug use and its relationship to women's vulnerability to harm (including violent and sexual victimisation, trauma, and mental health issues). Whilst these are important areas for policy to address, we argue that such representations of women who use drugs tend to reinforce particular understandings of women and drug use, while at the same time contributing to areas of 'policy silence' or neglect. In particular, the policy documents analysed are largely silent about the harm reduction needs of all women, as well as the needs of women who are not mothers, young women, older women, transwomen or other women deemed to be outside of dominant normative reproductive discourse. This analysis is important because understanding how women's drug use is problematised and identifying areas of policy silence provides a foundation for redressing gaps in policy, and for assessing the likely effectiveness of current and future policy approaches. Copyright © 2018 Elsevier B.V. All rights reserved.

  8. Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

    2017-12-01

    The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

  9. Mexico's "ley de narcomenudeo" drug policy reform and the international drug control regime.

    Science.gov (United States)

    Mackey, Tim K; Werb, Daniel; Beletsky, Leo; Rangel, Gudelia; Arredondo, Jaime; Strathdee, Steffanie A

    2014-11-14

    It has been over half a century since the landmark Single Convention on Narcotic Drugs was adopted, for the first time unifying international drug policy under a single treaty aimed at limiting use, manufacture, trade, possession, and trafficking of opiates, cannabis, and other narcotics. Since then, other international drug policy measures have been adopted, largely emphasizing enforcement-based approaches to reducing drug supply and use. Recently, in response to concerns that the historic focus on criminalization and enforcement has had limited effectiveness, international drug policies have begun to undergo a paradigm shift as countries seek to enact their own reforms to partially depenalize or deregulate personal drug use and possession. This includes Mexico, which in 2009 enacted national drug policy reform partially decriminalizing possession of small quantities of narcotics for personal consumption while also requiring drug treatment for repeat offenders. As countries move forward with their own reform models, critical assessment of their legal compatibility and effectiveness is necessary. In this commentary we conduct a critical assessment of the compatibility of Mexico's reform policy to the international drug policy regime and describe its role in the current evolving drug policy environment. We argue that Mexico's reform is consistent with flexibilities allowed under international drug treaty instruments and related commentaries. We also advocate that drug policy reforms and future governance efforts should be based on empirical evidence, emphasize harm reduction practices, and integrate evidence-based evaluation and implementation of drug reform measures.

  10. Consumers' views on generic medicines: a review of the literature.

    Science.gov (United States)

    Hassali, Mohamed A A; Shafie, Asrul A; Jamshed, Shazia; Ibrahim, Mohamed I M; Awaisu, Ahmed

    2009-04-01

    To review the literature on consumers' knowledge, attitudes and opinions of the use of generic medicines. A narrative review of studies conducted from 1970 to 2008 on consumers perceptions and views towards generic medicines was performed. An extensive literature search was undertaken using indexing services available at the authors' institution library. The following keywords were used for the search: brand, generic, multisource, medications, medicines, drugs, pharmaceuticals and consumers, customers, and patients. Electronic databases searched were Medline, Inside Web, ISI Web of Knowledge, Science Direct, Springer Link, JSTOR, Proquest, Ebsco Host and Google Scholar. These electronic databases were searched for full text papers published in English from 1970 to October 2008. Twenty studies were identified. Eleven were from the USA, four were from Europe, two were from Canada and one each was from Australia, Brazil and Malaysia. In general, consumers showed mixed reactions towards the use of generic medicines. This was evident from the divergence of views observed by country development level, consumers' socioeconomic characteristics, drug product characteristics, pharmaceutical reimbursement system, policy environment, contact with health care professionals, past experience with medications, and knowledge of the seriousness of a medical condition. Patient confidence and knowledge pertaining to generic medicines use have increased over the past four decades, especially in developed countries. Mass educational efforts, financial incentives, and greater communication among patients and health care professionals were seen as major drivers to the uptake of generic medicines among consumers.

  11. Formulation of Dihydroartemisinin-Piperaquine (DHP Generic Tablet as Antimalarials Drug

    Directory of Open Access Journals (Sweden)

    Nanang Yunarto

    2016-09-01

    Full Text Available The incidence of malaria in Indonesia is about two million cases annually. Dihydroartemisinin-piperaquine (DHP is the first line therapy recommended for uncomplicated malaria treatment, whereas  DHP is still fully imported. The generic DHP tablet formulation has the potential to become the first of DHP drug which is locally produced. This study is aimed to formulate generic DHP film coated tablets for antimalaria drug. Tablets were compressed with the combination of wet granulation for piperaquine phosphate (PQP and direct compression method for DHA and coated with a moisture barier coating material. The parameters to evaluate the quality of DHP tablets are physical properties, assay, and dissolution test. DHA and PQP assay were performed by HPLC method. The dissolution testing was conducted by in house method using HCl 0.1 N medium. The result shows physical properties of film-coated tablets meet the requirement, i.e. uniform weight, 7.0-8.5 kp hardness, 0.02% friability and 3 minute 22 seconds disintegration. The assay to determine  DHA in tablet was 95.17% and PQP was 97.05%. The result of dissolution testing shows the content of DHA and PQP in the tablet were 113.51% and 96.55%, respesctively. The formulation which is developed meets the general requirement of API in tablet 90–110% and dissolution requirement >75%.

  12. PHARMACEUTICAL QUALITY OF GENERIC ATORVASTATIN PRODUCTS COMPARED WITH THE INNOVATOR PRODUCT: A NEED FOR REVISING PRICING POLICY IN PALESTINE.

    Science.gov (United States)

    Shawahna, Ramzi; Hroub, Abdel Kareem; Abed, Eliama; Jibali, Sondos; Al-Saghir, Ruba; Zaid, Abdel Naser

    2016-01-01

    Atorvastatin reduces morbidity and mortality due to cardiovascular events. This study was conducted to assess the prices and pharmaceutical quality of innovator atorvastatin 20 mg with its locally available generics in Palestine and to assess the suitability of their interchangeability. The prices of innovator and generic atorvastatin 20 mg were determined and compared. Innovator atorvastatin and four generic products were tested for their pharmaceutical quality. Tablets were tested for their drug contents, weight uniformity, hardness, disintegration and dissolution. Three out of four generics were less expensive than the innovator. Pharmaceutical quality assessments were satisfactory and within limits for all atorvastatin tested products. The average weight ranged from 206.6 ± 8.40 to 330 ± 3.92 mg and the %RSDs were within the permitted limits as per USP. Tablet hardness ranged from 102 ± 1.41 to 197.4 ± 6.88 kg and drug contents ranged from 92.2% to 105.3%. All products disintegrated within permitted time limits and showed very rapid dissolution. Products released more than 85% of their drug contents in less than 15 min. Our results showed that all tested innovator and generic atorvastatin products were of good pharmaceutical quality. Despite the lack of in vivo evaluation, our results indicate that these products are equivalent in vitro. Considering the in vitro release characteristics, these products might be used interchangeably. However, regulatory authorities permit the use of in vitro data in establishing similarity between immediate release oral dosage forms containing biopharmaceutical classification system class I and III drugs only.

  13. PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES

    Directory of Open Access Journals (Sweden)

    S. N. Tolpygina

    2009-01-01

    Full Text Available The main differences between original and generic drugs as well as registration criteria for generics are described. Possible reasons of discrepancy in bioequivalence and therapeutic equivalence of original and generic drugs are reviewed. The examples of such a discrepancy as a result of comparative clinical trails (enalapril maleate are discussed. Approaches to planning of comparative trails on drug therapeutic equivalence are presented. 

  14. Generic solid phase extraction-liquid chromatography-tandem mass spectrometry method for fast determination of drugs in biological fluids

    NARCIS (Netherlands)

    Schellen, A.; Ooms, B.; Lagemaat, D. van de; Vreeken, R.; Dongen, W.D. van

    2003-01-01

    A generic method was developed for the fast determination of a wide range of drugs in serum or plasma. The methodology comprises generic solid-phase extraction, on-line coupled to gradient HPLC with tandem mass spectrometric detection (SPE-LC-MS/MS). The individual components of the SPE-LC-MS/MS

  15. Drugs and drug policy in the Netherlands

    NARCIS (Netherlands)

    Leuw, Ed.

    1991-01-01

    The Dutch parliament enacted the revised Opium Act in 1976. This penal law is part of the Dutch drug policy framework that includes tolerance for nonconforming lifestyles, risk reduction in regard to the harmful health and social consequences of drug taking, and penal measures directed against

  16. Generic drug discount programs: are prescriptions being submitted for pharmacy benefit adjudication?

    Science.gov (United States)

    Tungol, Alexandra; Starner, Catherine I; Gunderson, Brent W; Schafer, Jeremy A; Qiu, Yang; Gleason, Patrick P

    2012-01-01

      In 2006, pharmacies began offering select generic prescription drugs at discount prices (e.g., $4 for a 30-day supply) through nonmembership and membership programs. As part of the contract in membership generic drug discount programs, the member agrees to forgo submission of the claim to the insurance company. Claims not submitted for insurance adjudication may result in incomplete pharmacy benefit manager (PBM) and health plan data, which could negatively influence adherence reporting and clinical programs. To address potentially missing claims data, the Centers for Medicare Medicaid Services (CMS) encourages Medicare Part D sponsors to incentivize network pharmacies to submit claims directly to the plan for drugs dispensed outside of a member's Part D benefit, unless a member refuses. The extent of PBM and health plan claims capture loss due to generic drug discount programs is unknown. To identify changes in levothyroxine utilizers' prescription claims capture rate following the advent of generic drug discount membership and nonmembership programs. This retrospective concurrent cohort study used claims data from 3.5 million commercially insured members enrolled in health plans located in the central and southern United States with Prime Therapeutics pharmacy benefit coverage. Members were required to be 18 years or older and younger than 60 years as of January 1, 2006, and continuously enrolled from January 1, 2006, through December 31, 2010. Members utilizing generic levothyroxine for at least 120 days during January 1, 2006, through June 30, 2006 (baseline period) from the same pharmacy group with supply on July 1, 2006, were placed into 1 of 3 pharmacy groups: (1) nonmembership (Walmart, Sam's Club, Target, Kroger, City Market, and King Soopers pharmacies), (2) membership (Walgreens, CVS, Albertsons, and Savon pharmacies), or (3) the reference group of all other pharmacies. The index date was defined as July 1, 2006. The levothyroxine claim providing

  17. Explaining drug policy: Towards an historical sociology of policy change.

    Science.gov (United States)

    Seddon, Toby

    2011-11-01

    The goal of seeking to understand the development over time of drug policies is a specific version of the more general intellectual project of finding ways of explaining social change. The latter has been a preoccupation of some of the greatest thinkers within the social sciences of the last 200 years, from Foucault all the way back to the three nineteenth-century pioneers, Marx, Durkheim and Weber. I describe this body of work as 'historical sociology'. In this paper, I outline how a particular approach to historical sociology can be fruitfully drawn upon to understand the development of drug policy, using by way of illustration the example of the analysis of a recent transformation in British drug policy: the rise of the criminal justice agenda. I conclude by arguing that by looking at developments in drug policy in this way, some new insights are opened up. Copyright © 2011 Elsevier B.V. All rights reserved.

  18. Generic maintenance immunosuppression in solid organ transplant recipients.

    Science.gov (United States)

    Ensor, Christopher R; Trofe-Clark, Jennifer; Gabardi, Steven; McDevitt-Potter, Lisa M; Shullo, Michael A

    2011-11-01

    Survival after solid organ transplantation has increased in the era of tacrolimus and mycophenolate. This increased survival could be due in part to the broad clinical use of these potent and specific agents for maintenance immunosuppression. These drugs have enhanced specificity and potency for T and B lymphocytes compared with their predecessors, cyclosporine and azathioprine. Between 2008 and 2010, the United States Food and Drug Administration approved several generic formulations of both tacrolimus and mycophenolate mofetil. Deciding whether generic products can be safely substituted for the innovator product is a clinical dilemma similar to that which occurred when generic formulations of cyclosporine became available. We describe the concerns regarding generic immunosuppression use, summarize expert opinion and consensus statements in transplantation, analyze the potential impact of generic substitution, and provide estimates of populations affected based on generic drug market penetration. Formulary considerations such as cost, availability, and potential drug ordering and drug selection errors are described, and transplant coordinator and patient perspectives are reviewed. Finally, general recommendations about the use of generic maintenance immunosuppression in solid organ transplant recipients are provided. Although more research is needed to confirm clinical and therapeutic equivalence and pharmacoeconomic benefit, generic immunosuppressants can be safely substituted for innovator products as long as patients consistently receive the same product, patients and clinicians are aware of when substitutions occur, and enhanced therapeutic drug monitoring is provided during the transition.

  19. Knowledge and perceptions of physicians from private medical centres towards generic medicines: a nationwide survey from Malaysia.

    Science.gov (United States)

    Kumar, Rohit; Hassali, Mohamed Azmi; Saleem, Fahad; Alrasheedy, Alian A; Kaur, Navneet; Wong, Zhi Yen; Kader, Muhamad Ali Sk Abdul

    2015-01-01

    medicines with regard to their bioequivalence, quality, efficacy and safety. Apart from the policy on generic substitution, it would also be recommended to have a national medicine pricing policy, which controls drug prices, in both the public and private sector. These efforts are worthwhile to reduce the drug expenditure and improve the medicine affordability in Malaysia.

  20. Modified enforcement policy relating to 10 CFR 50.49, ''Environmental qualification of electrical equipment important to safety for nuclear power plants'' (Generic Letter 88-07)

    International Nuclear Information System (INIS)

    Miraglia, F.J.

    1992-01-01

    Generic Letters, Bulletins, and Information Notices have been issued to provide guidance regarding the application and enforcement of 10 CFR 50.49, ''Environmental Qualification of Electric Equipment Important to Safety for Nuclear Power Plants.'' Generic Letter 85-15, issued August 6, 1985, and Generic Letter 86-15, issued September 22, 1986, provided information related to the deadlines for compliance with 10 CFR 50.49 and possible civil penalties applicable to licensees who were not in compliance with the rule as of the November 30, 1985 deadline. Upon review, the Commission found that the EQ Enforcement Policy promulgated in Generic Letter 86-15, could result in imposition of civil penalties that did not properly reflect the safety significance of EQ violations with respect to civil penalties imposed in the past. In the interest of continuing a tough but fair enforcement policy, the Commission determined that the EQ Enforcement Policy should be revised. The purpose of this letter is to provide a modification to the NRC's enforcement policy, as approved by the Commission, for environmental qualification (EQ) violations. This letter replaces the guidance provided in Generic Letters 85-15 and 86-15

  1. Public Health and International Drug Policy

    Science.gov (United States)

    Csete, Joanne; Kamarulzaman, Adeeba; Kazatchkine, Michel; Altice, Frederick; Balicki, Marek; Buxton, Julia; Cepeda, Javier; Comfort, Megan; Goosby, Eric; Goulão, João; Hart, Carl; Horton, Richard; Kerr, Thomas; Lajous, Alejandro Madrazo; Lewis, Stephen; Martin, Natasha; Mejía, Daniel; Mathiesson, David; Obot, Isidore; Ogunrombi, Adeolu; Sherman, Susan; Stone, Jack; Vallath, Nandini; Vickerman, Peter; Zábranský, Tomáš; Beyrer, Chris

    2016-01-01

    Executive summary In September 2015, the member states of the United Nations endorsed sustainable development goals (SDG) for 2030 that aspire to human rights-centered approaches to ensuring the health and well-being of all people. The SDGs embody both the UN Charter values of rights and justice for all and the responsibility of states to rely on the best scientific evidence as they seek to better humankind. In April 2016, these same states will consider control of illicit drugs, an area of social policy that has been fraught with controversy, seen as inconsistent with human rights norms, and for which scientific evidence and public health approaches have arguably played too limited a role. The previous UN General Assembly Special Session (UNGASS) on drugs in 1998 – convened under the theme “a drug-free world, we can do it!” – endorsed drug control policies based on the goal of prohibiting all use, possession, production, and trafficking of illicit drugs. This goal is enshrined in national law in many countries. In pronouncing drugs a “grave threat to the health and well-being of all mankind,” the 1998 UNGASS echoed the foundational 1961 convention of the international drug control regime, which justified eliminating the “evil” of drugs in the name of “the health and welfare of mankind.” But neither of these international agreements refers to the ways in which pursuing drug prohibition itself might affect public health. The “war on drugs” and “zero-tolerance” policies that grew out of the prohibitionist consensus are now being challenged on multiple fronts, including their health, human rights, and development impact. The Johns Hopkins – Lancet Commission on Drug Policy and Health has sought to examine the emerging scientific evidence on public health issues arising from drug control policy and to inform and encourage a central focus on public health evidence and outcomes in drug policy debates, such as the important deliberations of

  2. Generic medicines: Perceptions of Physicians in Basrah, Iraq

    Directory of Open Access Journals (Sweden)

    Adheed Khalid Sharrad

    2009-08-01

    Full Text Available BackgroundThe use of cheaper generic medicines is a strategy promotedin many countries to reduce rising health care costs. The aimof this study was to explore factors affecting generic medicineprescribing by physicians in Basrah, Iraq.MethodologyA purposive sample of ten physicians practicing in Basrahwas interviewed using a semi-structured interview guide.ResultsAnalysis of the interviews identified seven major themes:medicine prescribing practice, knowledge of therapeuticequivalency of generic medicine, patients’ acceptance ofgeneric medicine, counterfeit medicine, drug informationsource and effect of drug advertising on medicines choice,brand substitution practice by community pharmacists, and,finally strategies to improve generic medicine usefulness.Participants identified helpful strategies to increase genericprescribing including; physician and patient education ongeneric medicine; persuading physicians about the safety andefficacy of generic medicines; and finally educating seniormedical students on generic prescribing.ConclusionThe data suggest that participants were enthusiasticabout prescribing generic medicines. However physiciansinsist that pharmacists should not be allowed tosubstitute generic drugs without prior approval ofdoctors.

  3. Exploring the opinions and experiences of patients with generic substitution: a representative study of Polish society.

    Science.gov (United States)

    Drozdowska, Aleksandra; Hermanowski, Tomasz

    2015-02-01

    Generics have the potential to contain drug therapy costs; successful implementation of generic substitution policy largely depends on consumers' willingness to choose generics. This study aims to analyse the opinions, experiences and preferences of Polish patients towards generic medicines. The study was performed in Poland. The survey was conducted in June 2013 by means of face-to-face interviews. Respondents were drawn from the general population according to a population structure. The study covered a representative sample of 1,000 Poles; the results can be generalized to apply to the Polish population at large. Fifty-two percent of respondents declared to be more often choosing generics, twenty-three percent did not have any specific preferences, and twenty-five percent were more willing to choose brand-name medicines. Past experience with cheaper generic medicines, secondary or lower education, low income and residence in specific regions of Poland were all significantly associated with an increased willingness to choose generics. Respondents' attitudes towards generics were mostly influenced by the opinions of doctors and pharmacists. According to respondents, attitudes towards generics among doctors, pharmacists, family and friends, and in the mass media were mostly positive. There was no relationship between the preference of respondents for generics and factors such as their age, life stage, gender, household size or urban/rural locality. As a result of substituting a brand-name drug with its generic equivalent, 72 % of respondents reported that they had not noticed any difference in drug effectiveness; 21 % had experienced a reduced effectiveness of treatment or increased side effects at least once; and 7 % claimed the generic worked better. The majority of respondents who used cheaper substitutes claimed that generics represented good or very good quality. The study demonstrates that, when choosing medicines, Poles rely mainly on the opinions of their

  4. Evaluation of Patient Assistance Program Eligibility and Availability for Top 200 Brand Name and Generic Drugs in the United States

    Directory of Open Access Journals (Sweden)

    Chin-Fun Chu

    2012-01-01

    Full Text Available One strategy to encourage uninsured and underinsured patients' compliance with medication regimen is to refer them to pharmaceutical industry-sponsored patient assistance programs (PAPs. In order to receive the requested medications, patients should be qualified based on the program eligibility requirements. The purpose of this study was to examine PAP eligibility criteria for the most commonly dispensed prescriptions in the United States. We identified 136 unique chemical entities in the Top 200 drug list and 111 (82% of these pharmaceutical products were offered by PAPs. Among the available medications, 69 (62% were brand name; 29 (26% were generic, and 13 (12% had both brand name/generic forms. In terms of the availability of types of drugs (brand name vs. generic provided by PAPs, differences in PAP eligibility requirements were found for citizenship (p < 0.001, permanent residency (p < 0.001, and prescription drug coverage (p< 0.001, but not for income limits (p= 0.051. Overall, PAPs could help low-income patients to obtain necessary medications; however, U.S. citizenship/permanent residency and restriction on prescription coverage are more likely to be required for brand name drugs rather than for generics. PAPs also provide some options for the underinsured and those with private insurance or Medicare Part D plan that offers inadequate prescription coverage.   Type: Original Research

  5. Evaluation of Patient Assistance Program Eligibility and Availability for Top 200 Brand Name and Generic Drugs in the United States

    Directory of Open Access Journals (Sweden)

    Chin-Fun Chu

    2012-01-01

    Full Text Available One strategy to encourage uninsured and underinsured patients’ compliance with medication regimen is to refer them to pharmaceutical industry–sponsored patient assistance programs (PAPs. In order to receive the requested medications, patients should be qualified based on the program eligibility requirements. The purpose of this study was to examine PAP eligibility criteria for the most commonly dispensed prescriptions in the United States. We identified 136 unique chemical entities in the Top 200 drug list and 111 (82% of these pharmaceutical products were offered by PAPs. Among the available medications, 69 (62% were brand name; 29 (26% were generic, and 13 (12% had both brand name/generic forms. In terms of the availability of types of drugs (brand name vs. generic provided by PAPs, differences in PAP eligibility requirements were found for citizenship (p < 0.001, permanent residency (p < 0.001, and prescription drug coverage (p< 0.001, but not for income limits (p= 0.051. Overall, PAPs could help low-income patients to obtain necessary medications; however, U.S. citizenship/permanent residency and restriction on prescription coverage are more likely to be required for brand name drugs rather than for generics. PAPs also provide some options for the underinsured and those with private insurance or Medicare Part D plan that offers inadequate prescription coverage.

  6. Searches for Randomized Controlled Trials of Drugs in MEDLINE and EMBASE Using Only Generic Drug Names Compared with Searches Applied in Current Practice in Systematic Reviews

    Science.gov (United States)

    Waffenschmidt, Siw; Guddat, Charlotte

    2015-01-01

    Background: It is unclear which terms should be included in bibliographic searches for randomized controlled trials (RCTs) of drugs, and identifying relevant drug terms can be extremely laborious. The aim of our analysis was to determine whether a bibliographic search using only the generic drug name produces sufficient results for the generation…

  7. Generic solid phase extraction-liquid chromatography-tandem mass spectrometry method for fast determination of drugs in biological fluids.

    Science.gov (United States)

    Schellen, Anniek; Ooms, Bert; van de Lagemaat, Dick; Vreeken, Rob; van Dongen, William D

    2003-05-25

    A generic method was developed for the fast determination of a wide range of drugs in serum or plasma. The methodology comprises generic solid-phase extraction, on-line coupled to gradient HPLC with tandem mass spectrometric detection (SPE-LC-MS/MS). The individual components of the SPE-LC-MS/MS system were optimized in an integrated approach to maximize the application range and minimize the method development time. The optimized generic SPE-LC-MS/MS protocol was evaluated for 11 drugs with different physicochemical properties. Good quantification for 10 out of 11 of the pharmaceuticals in serum or plasma could be readily achieved. The quantitative assays gave recoveries better than 95%, lower quantification limits of 0.2-2.0 ng/ml, acceptable precision and accuracy and good linearity over 2-4 orders of magnitude. Carry-over was determined to be in the range of 0.02-0.10%, without optimization.

  8. Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies.

    Science.gov (United States)

    Acosta, Angela; Ciapponi, Agustín; Aaserud, Morten; Vietto, Valeria; Austvoll-Dahlgren, Astrid; Kösters, Jan Peter; Vacca, Claudia; Machado, Manuel; Diaz Ayala, Diana Hazbeydy; Oxman, Andrew D

    2014-10-16

    , healthcare utilisation and health outcomes or costs (expenditures); the study had to be a randomised trial, non-randomised trial, interrupted time series (ITS), repeated measures (RM) study or a controlled before-after study of a pharmaceutical pricing or purchasing policy for a large jurisdiction or system of care. Two review authors independently extracted data and assessed the risk of bias. Results were summarised in tables. There were too few comparisons with similar outcomes across studies to allow for meta-analysis or meaningful exploration of heterogeneity. We included 18 studies (seven identified in the update): 17 of reference pricing, one of which also assessed maximum prices, and one of index pricing. None of the studies were trials. All included studies used ITS or RM analyses. The quality of the evidence was low or very low for all outcomes. Three reference pricing studies reported cumulative drug expenditures at one year after the transition period. Two studies reported the median relative insurer's cumulative expenditures, on both reference drugs and cost share drugs, of -18%, ranging from -36% to 3%. The third study reported relative insurer's cumulative expenditures on total market of -1.5%. Four reference pricing studies reported median relative insurer's expenditures on both reference drugs and cost share drugs of -10%, ranging from -53% to 4% at one year after the transition period. Four reference pricing studies reported a median relative change of 15% in reference drugs prescriptions at one year (range -14% to 166%). Three reference pricing studies reported a median relative change of -39% in cost share drugs prescriptions at one year (range -87% to -17%). One study of index pricing reported a relative change of 55% (95% CI 11% to 98%) in the use of generic drugs and -43% relative change (95% CI -67% to -18%) in brand drugs at six months after the transition period. The same study reported a price change of -5.3% and -1.1% for generic and brand drugs

  9. Antimalarial drug policy in India: past, present & future.

    Science.gov (United States)

    Anvikar, Anupkumar R; Arora, Usha; Sonal, G S; Mishra, Neelima; Shahi, Bharatendu; Savargaonkar, Deepali; Kumar, Navin; Shah, Naman K; Valecha, Neena

    2014-02-01

    The use of antimalarial drugs in India has evolved since the introduction of quinine in the 17 th century. Since the formal establishment of a malaria control programme in 1953, shortly after independence, treatments provided by the public sector ranged from chloroquine, the mainstay drug for many decades, to the newer, recently introduced artemisinin based combination therapy. The complexity of considerations in antimalarial treatment led to the formulation of a National Antimalarial Drug Policy to guide procurement as well as communicate best practices to both public and private healthcare providers. Challenges addressed in the policy include the use of presumptive treatment, the introduction of alternate treatments for drug-resistant malaria, the duration of primaquine therapy to prevent relapses of vivax malaria, the treatment of malaria in pregnancy, and the choice of drugs for chemoprophylaxis. While data on antimalarial drug resistance and both public and private sector treatment practices have been recently reviewed, the policy process of setting national standards has not. In this perspective on antimalarial drug policy, this review highlights its relevant history, analyzes the current policy, and examines future directions.

  10. Comparison of the effectiveness of brand-name and generic antipsychotic drugs for treating patients with schizophrenia in Taiwan.

    Science.gov (United States)

    Hsu, Chih-Wei; Lee, Sheng-Yu; Wang, Liang-Jen

    2018-03-01

    The purpose of this nationwide population-based study is to compare the long-term effectiveness of brand-name antipsychotics with generic antipsychotics for treating schizophrenia. We identified patients with schizophrenia who were prescribed antipsychotics from a random sample of one million records from Taiwan's National Health Insurance database, observed between January 1, 2000 and December 31, 2012. Only those with no prior use of antipsychotics for at least 180days were included. We selected patients who were prescribed brand-name risperidone (N=404), generic risperidone (N=145), brand-name sulpiride (N=334), or generic sulpiride (N=991). The effectiveness of the treatments researched in this study consisted of average daily doses, rates of treatment discontinuation, augmentation therapy, and psychiatric hospitalization. We found that compared to patients treated with generic risperidone, those treated with brand-name risperidone required lower daily doses (2.14mg vs. 2.61mg). However, the two groups demonstrated similar rates of treatment discontinuation, augmentation, and psychiatric hospitalization. On the other hand, in comparison with patients prescribed generic sulpiride, those treated with brand-name sulpiride not only required lower daily doses (302.72mg vs. 340.71mg) but also had lower psychiatric admission rates (adjusted hazard ratio: 0.24, 95% confidence interval: 0.10-0.56). In conclusion, for both risperidone and sulpiride, higher daily doses of the respective generic drugs were prescribed than with brand-name drugs in clinical settings. Furthermore, the brand-name sulpiride is more effective at preventing patients from hospitalization than generic sulpiride. These findings can serve as an important reference for clinical practices and healthcare economics for treating schizophrenic patients. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. Generics Pricing: The Greek Paradox.

    Science.gov (United States)

    Karafyllis, Ioannis; Variti, Lamprini

    2017-01-01

    This paper explains and develops a methodological framework to help evaluate the performance of generic pharmaceutical policies and the correct evaluation of generics sales. Until today erroneous recording of generics does not help proper pricing and their penetration in the Greek market. This classifies Greece on the outliners in every study or comparison that is referred on papers or studies.

  12. Is bioavailability altered in generic versus brand anticonvulsants?

    Science.gov (United States)

    Jankovic, Slobodan M; Ignjatovic Ristic, Dragana

    2015-03-01

    Therapeutic window of anticonvulsants is not a wide one, with phenytoin being one extreme, which can be classified as a narrow therapeutic index drug, since its ratio between the least toxic and the least effective concentration is less than twofold. In order to obtain marketing authorization, a generic anticonvulsant should demonstrate relative bioequivalence with its brand-name counterpart. However, although bioequivalent, generic anticonvulsants still do not have the same bioavailability as brand-name drugs, which may lead to larger fluctuations of steady-state plasma concentrations, and sometimes to loss of seizure control if a patient is switched from brand-name to generic or from generic to generic anticonvulsant. Generic anticonvulsants are effective, safe and affordable drugs for treatment of epilepsy, and patients could be successfully treated with them from the very beginning. It is switching from brand-name to generic anticonvulsant or from one generic anticonvulsant to another that should be avoided in clinical practice, since subtle differences in bioavailability may disturb optimal degree of seizure control to which the patient was previously successfully titrated.

  13. Quality of generic medicines in South Africa

    DEFF Research Database (Denmark)

    Patel, Aarti; Gauld, Robin; Norris, Pauline

    2012-01-01

    Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines ...

  14. Sharing, samples, and generics: an antitrust framework.

    Science.gov (United States)

    Carrier, Michael A

    Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition. But these regimes can only be effectuated through generic entry. And that entry can take place only if a generic can use a brand's sample to show that its product is equivalent. More than 100 generic firms have complained that they have not been able to access needed samples. One study of 40 drugs subject to restricted access programs found that generics' inability to enter cost more than $5 billion a year. Brand firms have contended that antitrust law does not compel them to deal with their competitors and have highlighted concerns related to safety and product liability in justifying their refusals. This Article rebuts these claims. It highlights the importance of samples in the regulatory regime and the FDA's inability to address the issue. It shows how a sharing requirement in this setting is consistent with Supreme Court caselaw. And it demonstrates that the brands' behavior fails the defendant-friendly "no economic sense" test because the conduct literally makes no sense other than by harming generics. Brands' denial of samples offers a textbook case of monopolization. In the universe of pharmaceutical antitrust behavior, other conduct--such as "pay for delay" settlements between brands and generics and "product hopping" from one drug to a slightly modified

  15. Generic atorvastatin is as effective as the brand-name drug (LIPITOR®) in lowering cholesterol levels: a cross-sectional retrospective cohort study.

    Science.gov (United States)

    Loch, Alexander; Bewersdorf, Jan Philipp; Kofink, Daniel; Ismail, Dzafir; Abidin, Imran Zainal; Veriah, Ramesh Singh

    2017-07-17

    In a world of ever increasing health care costs, generic drugs represent a major opportunity to ensure access to essential medicines for people who otherwise would be unable to afford them. However, some clinicians and patients are still questioning the safety and effectiveness of generic formulations compared to the proprietary drugs necessitating further systematic research analyzing the generic drugs' efficacy. Our objective was to compare the lipid lowering effects of generic and branded atorvastatin. This cross-sectional, retrospective cohort study was conducted at the University of Malaya Medical Centre from 1 May 2013 until 30 May 2013. We analyzed the lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) of 629 patients before and at least 3 months after switching them from proprietary atorvastatin (Lipitor ® ) to generic atorvastatin (atorvastatin calcium from Ranbaxy Laboratories, Inc.). We also investigated if there was any difference in the effectiveness of both atorvastatin formulations in various ethnic groups. 266 patients were included in this study. When comparing the median values we found no statistically significant differences (Wilcoxon signed-rank test; p atorvastatin in lowering total cholesterol (4.60 mmol/l pre-transition vs. 4.50 mmol/l post-transition; p = 0.583), LDL-cholesterol (2.42 mmol/l vs. 2.41 mmol/l; p = 0.923) and triglycerides (1.50 mmol/l vs. 1.50 mmol/l; p = 0.513). While there was a statistically significant (p = 0.009) difference in HDL-cholesterol levels favouring proprietary atorvastatin, the extent of this change (1.26 mmol/l vs. 1.25 mmol/l) was deemed not to be clinically relevant. There was no statistically significant difference when analyzing the effects on various ethnic groups. Substituting proprietary atorvastatin for its generic formulation atorvastatin calcium does not result in a less effective management of hyperlipidemia. Our findings lend support to the

  16. Skin rash during treatment with generic itraconazole

    OpenAIRE

    De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

    2014-01-01

    Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re...

  17. Potential impact of policy regulation and generic competition on sales of cholesterol lowering medication, antidepressants and acid blocking agents in Belgium.

    Science.gov (United States)

    Fraeyman, J; Van Hal, G; De Loof, H; Remmen, R; De Meyer, G R Y; Beutels, P

    2012-01-01

    Pharmaceutical expenditures are increasing as a proportion of health expenditures in most rich countries. Antidepressants, acid blocking agents and cholesterol lowering medication are major contributors to medicine sales around the globe. We aimed to document the possible impact of policy regulations and generic market penetration on the evolution of sales volume and average cost per unit (Defined Daily Doses and packages) of antidepressants, acid blocking agents and cholesterol lowering medication. We extracted data from the IMS health database regarding the public price and sales volume of the antidepressants (selective serotonin reuptake inhibitors (SSRI's), monoamine oxidase inhibitors (MAOl's) and tricyclic and remaining antidepressants (TCA's)), acid blocking agents (proton pump inhibitors (PPl's) and H2 receptor antagonists) and cholesterol lowering medication (statins and fibrates) in Belgium between 1995 and 2009. We describe these sales data in relation to various national policy measures which were systematically searched in official records. Our analysis suggests that particular policy regulations have had immediate impact on sales figures and expenditures on pharmaceuticals in Belgium: changes in reimbursement conditions, a public tender and entry of generic competitors in a reference pricing system. However, possible sustainable effects seem to be counteracted by other mechanisms such as marketing strategies, prescribing behaviour, brand loyalty and the entry of pseudogenerics. It is likely that demand-side measures have a more sustainable impact on expenditure. Compared with other European countries, generic penetration in Belgium remains low. Alternative policy regulations aimed at enlarging the generic market and influencing pharmaceutical expenditures deserve consideration. This should include policies aiming to influence physicians' prescribing and a shared responsibility of pharmacists, physicians and patients towards expenditures.

  18. Antimalarial drug policy in India: Past, present & future

    Directory of Open Access Journals (Sweden)

    Anupkumar R Anvikar

    2014-01-01

    Full Text Available The use of antimalarial drugs in India has evolved since the introduction of quinine in the 17 th century. Since the formal establishment of a malaria control programme in 1953, shortly after independence, treatments provided by the public sector ranged from chloroquine, the mainstay drug for many decades, to the newer, recently introduced artemisinin based combination therapy. The complexity of considerations in antimalarial treatment led to the formulation of a National Antimalarial Drug Policy to guide procurement as well as communicate best practices to both public and private healthcare providers. Challenges addressed in the policy include the use of presumptive treatment, the introduction of alternate treatments for drug-resistant malaria, the duration of primaquine therapy to prevent relapses of vivax malaria, the treatment of malaria in pregnancy, and the choice of drugs for chemoprophylaxis. While data on antimalarial drug resistance and both public and private sector treatment practices have been recently reviewed, the policy process of setting national standards has not. In this perspective on antimalarial drug policy, this review highlights its relevant history, analyzes the current policy, and examines future directions.

  19. Avoidance of generic competition by Abbott Laboratories' fenofibrate franchise.

    Science.gov (United States)

    Downing, Nicholas S; Ross, Joseph S; Jackevicius, Cynthia A; Krumholz, Harlan M

    2012-05-14

    The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug's history: Abbott Laboratories, the maker of branded fenofibrate, has produced several bioequivalent reformulations that dominate the market, although generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on the US health care system. Abbott Laboratories maintained its dominance of the fenofibrate market in part through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first-generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented their substitution with generics of older-generation products. As soon as direct generic competition seemed likely at the new dose level, where substitution would be allowed, Abbott would launch another reformulation, and the cycle would repeat. Based on the fenofibrate example, our objective is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications, without demonstrating the superiority of next-generation products.

  20. [Analysis of generic drug supply in France].

    Science.gov (United States)

    Taboulet, F; Haramburu, F; Latry, Ph

    2003-09-01

    The list of generic medicines (LGM), published since 1997 by the Agence Française de Sécurité Sanitaire des Produits de Santé (AFFSSaPS), the French Medicine Agency, concerns a special part of the medicines reimbursed by the National Health Insurance (Social Security). The objectives of the present study were: i) to describe the components of this list, based on pharmaceutical, economical and therapeutic characteristics, ii) to study differences between generic and reference products (formulations, excipients, prices, etc.), iii) to analyze information on excipients provided to health care professionals. The 21st version of the LGM (April 2001) was used. Therapeutic value was retrieved from the 2001 AFSSaPS report on the therapeutic value of 4490 reimbursed medicines. Information on excipients in the LGM and the Vidal dictionary (reference prescription book in France) was compared. The products included in the LGM represent 20% of all reimbursed medicines. The mean price differences between generics and their reference products vary between 30 and 50% for more than two thirds of the generic groups. The therapeutic value of the products of the LGM was judged important in 71% of cases (vs 63% for the 4409 assessed medicines) and insufficient in 13% of cases (vs 19%). Information on excipients is often missing and sometimes erroneous. Although the LGM is regularly revised and thus the generic market in perpetual change, the 2001 cross description of this pharmaceutical market provides much informations and raises some concern.

  1. Corporate Strategies for Generic Medicines in Brazil: A Study with the Sector’s Ten Largest CompaniesHttp://Dx.Doi.Org/10.5585/Riae.V10i1.1710

    Directory of Open Access Journals (Sweden)

    Silvia Antonio Sfair

    2011-06-01

    Full Text Available In Brazil, generic drugs are considered safe and effective and substantially cheaper than the so-called reference medicinal products. Due to this, generic drugs have become an important sector within the pharmaceutical market. However, topical studies are scarce and researchers focus on health professionals and direct sales. This article looks to expand on the understanding concerning the subject investigating the vision of those responsible for production, its relationship with physicians, government policies and delivery chain management in serving the consumer. To present this objective, in-depth interviews were conducted with ten executives occupying strategic positions in the pharmaceutical industry in general. The sample represents approximately 84% of generic drug sales in Brazil. The results have demonstrated that government performance plays an important role in the marketing of generic drugs to the population, while the drugstore and distributors were identified in this market as growth barriers, due to the practices used at point of sale. Doctors are considered the prime agent in popularizing the use of generic drugs in Brazil.

  2. What is good governance in the context of drug policy?

    Science.gov (United States)

    Singleton, Nicola; Rubin, Jennifer

    2014-09-01

    The concept of governance is applied in a wide range of contexts, but this paper focuses on governance in relation to public administration, i.e. states and how they take action, and specifically governance of particular policy areas. In the current context of financial austerity and an era of globalisation, policy-makers face pressures and challenges from a growing range of interests and local, national and supranational actors. Drug policy is an example of a particularly contentious and polarised area in which governance-related challenges abound. In response to these challenges, interest has grown in developing agreed policy governance standards and processes and articulating policy-making guidelines, including the use of available evidence to inform policy-making. Attempts have been made to identify 'policy fundamentals' - factors or aspects of policy-making apparently associated with successful policy development and implementation (Hallsworth & Rutter, 2011; Laughrin, 2011) and, in the drug policy field, Hughes et al. (2010) reflecting on the co-ordination of Australian drug policy highlighted some of what they considered principles of good governance. But how useful is the concept of 'good governance'; how well can it be defined, and to what purpose? As part of a wider project considering the governance of drug policy, RAND Europe and the UK Drug Policy Commission undertook a targeted review of other research and sought expert views, from within and beyond drug policy, on principles, processes, structures and stakeholders associated with good drug policy governance. From this emerged some perceived characteristics of good governance that were then used by the UK Drug Policy Commission to assess the extent to which drug policy making in the UK fits with these perceived good governance characteristics, and to suggest possible improvements. Particular consideration was given to the range of interests at stake, the overarching aims of drug policy and the

  3. A Generic Multi-Compartmental CNS Distribution Model Structure for 9 Drugs Allows Prediction of Human Brain Target Site Concentrations

    NARCIS (Netherlands)

    Yamamoto, Yumi; Valitalo, Pyry A.; van den Berg, Dirk-Jan; Hartman, Robin; van den Brink, Willem; Wong, Yin Cheong; Huntjens, Dymphy R.; Proost, Johannes H.; Vermeulen, An; Krauwinkel, Walter; Bakshi, Suruchi; Aranzana-Climent, Vincent; Marchand, Sandrine; Dahyot-Fizelier, Claire; Couet, William; Danhof, Meindert; van Hasselt, Johan G. C.; de lange, Elizabeth C. M.

    Purpose Predicting target site drug concentration in the brain is of key importance for the successful development of drugs acting on the central nervous system. We propose a generic mathematical model to describe the pharmacokinetics in brain compartments, and apply this model to predict human

  4. [Availability of generic drugs in the public sector and prices in the private sector in different regions of Brazil].

    Science.gov (United States)

    Miranda, Elaine Silva; Pinto, Cláudia Du Bocage Santos; dos Reis, André Luis de Almeida; Emmerick, Isabel Cristina Martins; Campos, Mônica Rodrigues; Luiza, Vera Lucia; Osorio-de-Castro, Claudia Garcia Serpa

    2009-10-01

    A study to identify availability and prices of medicines, according to type of provider, was conducted in the five regions of Brazil. A list of medicines to treat prevalent diseases was investigated, using the medicines price methodology developed by the World Health Organization and Health Action International, adapted for Brazil. In the public sector, bioequivalent (vis-à-vis reference brand) generics are less available than multisource products. For most medicines (71.4%), the availability of bioequivalent generics was less than 10%. In the private sector, the average number of different bioequivalent generic versions in the outlets was far smaller than the number of versions on the market. There was a positive correlation between the number of generics on the market, or those found at outlets, and the price variation in bioequivalent generic products, in relation to the maximum consumer price. It is estimated that price competition is occurring among bioequivalent generic drugs and between them and multisource products for the same substance, but not with reference brands.

  5. Impact of alternative interventions on changes in generic dispensing rates.

    Science.gov (United States)

    O'Malley, A James; Frank, Richard G; Kaddis, Atheer; Rothenberg, Barbara M; McNeil, Barbara J

    2006-10-01

    To evaluate the effectiveness of four alternative interventions (member mailings, advertising campaigns, free generic drug samples to physicians, and physician financial incentives) used by a major health insurer to encourage its members to switch to generic drugs. Using claim-level data from Blue Cross Blue Shield of Michigan, we evaluated the success of four interventions implemented during 2000-2003 designed to increase the use of generic drugs among its members. Around 13 million claims involving seven important classes of drugs were used to assess the effectiveness of the interventions. For each intervention a control group was developed that most closely resembled the corresponding intervention group. Logistic regression models with interaction effects between the treatment group (intervention versus control) and the status of the intervention (active versus not active) were used to evaluate if the interventions had an effect on the generic dispensing rate (GDR). Because the mail order pharmacy was considered more aggressive at converting prescriptions to generics, separate generic purchasing models were fitted to retail and mail order claims. In secondary analyses separate models were also fitted to claims involving a new condition and claims refilled for preexisting conditions. The interventions did not appear to increase the market penetration of generic drugs for either retail or mail order claims, or for claims involving new or preexisting conditions. In addition, we found that the ratio of copayments for brand name to generic drugs had a large positive effect on the GDR. The interventions did not appear to directly influence the GDR. Financial incentives expressed to consumers through benefit designs have a large influence on their switching to generic drugs and on the less-costly mail-order mode of purchase.

  6. Drug policy in United States of America

    OpenAIRE

    Stahl, Edmundo G.; Médico internista, President and Chief Executive Officer, LatAmScience. Florida, USA.

    2009-01-01

    The USA federal prescription drug policies are inconsistent. The federal government regulates the development, production, marketing and safety of prescription drugs in the country through various legal mechanisms as well as private and governmental institutions. Patent laws also play an important role in this process protecting the pharmaceutical industry. The government has no direct mechanism to control prices of prescription drugs nor does it have a policy to cover the whole US popula...

  7. Drug Testing in Schools: Implications for Policy.

    Science.gov (United States)

    Bozeman, William C.; And Others

    1987-01-01

    Public concern about substance abuse, fueled by political and media attention, is causing school administrators to consider a variety of approaches beyond traditional drug education. No procedures, methods, or rules regarding drug testing should be established in the absence of clear school board policy, and no policy decisions should be made…

  8. The impact of price-cap regulations on market entry by generic pharmaceutical firms.

    Science.gov (United States)

    Zhang, Wei; Sun, Huiying; Guh, Daphne; Anis, Aslam H

    2017-04-01

    In 1998, the province of Ontario, Canada implemented price-cap '70/90' regulations: the first generic must be priced at ≤70% of the associated brand-name price and subsequent generics must be priced at ≤90% of the first generics' price. The price-cap was further lowered to 50% in 2006 and 25% in 2010 for all generic drugs regardless of the first or subsequent generic entrants. This study assessed the impact of such price-cap regulations on market entry by generic firms using the formulary database from 9 provinces (January 2004-March 2013). A logistic regression was estimated to compare the probability of entry during the three policy periods in Ontario ('70/90', '25', versus '50'). Since different price-caps were subsequently introduced in other provinces, Alberta, British Columbia, New Brunswick and Saskatchewan, difference-in-differences was used to compare market entry. In Ontario, compared with the period '50', generic firms were 76% and 63% less likely to enter markets in the periods '25' and '70/90', respectively. The difference-in-differences showed that the entry probability decreased the most in Ontario during the '25' period from the '50' period. Lowering the price-cap level to 25% leads to a significantly lower probability of market entry by generic firms.

  9. ACHIEVEMENT OF TARGET BLOOD PRESSURE LEVEL IN HYPERTENSIVE PATIENTS WITH AMLODIDINE: ORIGINAL DRUG VERSUS GENERIC

    Directory of Open Access Journals (Sweden)

    S. Yu. Martsevich

    2009-01-01

    Full Text Available Aim. To evaluate antihypertensive effects of new generic amlodipine (Stamlo M in comparison with original amlodipine (Norvasc in monotherapy and in combination with angiotensin converting enzyme (ACE inhibitor and diuretic in patients with arterial hypertension (HT of 1-2 degree.Material and methods. 60 patients with HT of 1-2 degree were included in the open randomized parallel comparative study. Patients were split into 2 groups. Study duration was 10 weeks. Efficacy control, dose correction, addition of ACE inhibitor and diuretic was performed each 2 weeks.Results. The significant antihypertensive effect of monotherapy was observed in both groups already by the 2-4 weeks of therapy. Significant differences between amlodipines in influence on blood pressure (BP level and heart rate was not found. Monotherapy with generic amlodipine (10 mg OD provided target BP level more than in half of patients. Achievement of target BP levels was found in 89% and 96% of patients treated with generic and original amlodipine, respectively, when they were combined with lisinopril (10 mg OD and hydrochlorothiazide (12,5 mg OD.Conclusion. New generic amlodipine (Stamlo M is an effective and safe antihypertensive drug comparable with original amlodipine in clinical efficacy.

  10. Development and validation of a tool to assess knowledge and attitudes towards generic medicines among students in Greece: The ATtitude TOwards GENerics (ATTOGEN questionnaire.

    Directory of Open Access Journals (Sweden)

    Philip J Domeyer

    Full Text Available The use of generic medicines is a cost-effective policy, often dictated by fiscal restraints. To our knowledge, no fully validated tool exploring the students' knowledge and attitudes towards generic medicines exists. The aim of our study was to develop and validate a questionnaire exploring the knowledge and attitudes of M.Sc. in Health Care Management students and recent alumni's towards generic drugs in Greece.The development of the questionnaire was a result of literature review and pilot-testing of its preliminary versions to researchers and students. The final version of the questionnaire contains 18 items measuring the respondents' knowledge and attitude towards generic medicines on a 5-point Likert scale. Given the ordinal nature of the data, ordinal alpha and polychoric correlations were computed. The sample was randomly split into two halves. Exploratory factor analysis, performed in the first sample, was used for the creation of multi-item scales. Confirmatory factor analysis and Generalized Linear Latent and Mixed Model analysis (GLLAMM with the use of the rating scale model were used in the second sample to assess goodness of fit. An assessment of internal consistency reliability, test-retest reliability, and construct validity was also performed.Among 1402 persons contacted, 986 persons completed our questionnaire (response rate = 70.3%. Overall Cronbach's alpha was 0.871. The conjoint use of exploratory and confirmatory factor analysis resulted in a six-scale model, which seemed to fit the data well. Five of the six scales, namely trust, drug quality, state audit, fiscal impact and drug substitution were found to be valid and reliable, while the knowledge scale suffered only from low inter-scale correlations and a ceiling effect. However, the subsequent confirmatory factor and GLLAMM analyses indicated a good fit of the model to the data.The ATTOGEN instrument proved to be a reliable and valid tool, suitable for assessing students

  11. Advertising and generic market entry.

    Science.gov (United States)

    Königbauer, Ingrid

    2007-03-01

    The effect of purely persuasive advertising on generic market entry and social welfare is analysed. An incumbent has the possibility to invest in advertising which affects the prescribing physician's perceived relative qualities of the brand-name and the generic version of the drug. Advertising creates product differentiation and can induce generic market entry which is deterred without differentiation due to strong Bertrand competition. However, over-investment in advertising can deter generic market entry under certain conditions and reduces welfare as compared to accommodated market entry.

  12. Distribution and trends in outpatient utilization of generic versus brand name psychopharmaceuticals during a ten-year period in Croatia.

    Science.gov (United States)

    Polić-ViŽintin, Marina; Stimac, Danijela; Sostar, Zvonimir; Tripković, Ingrid

    2014-08-15

    Drug costs increasingly pose a burden upon the otherwise inadequate health care resources and rational drug utilization is an important segment of every national health policy. Optimal patient care should be the goal of rational pharmacotherapy, whereby the economic burden of treatment is just one of the elements to be considered on choosing appropriate therapy.The aim of this study was to determine distribution and trends in the outpatient utilization of generic versus brand name psychopharmaceuticals and to evaluate the rationality of prescribing psychopharmaceuticals during a ten-year period. Using the World Health Organization Anatomical-Therapeutic-Chemical classification/Defined Daily Doses (ATC/DDD) methodology, the number of DDD was calculated from data collected from pharmacies on the number and size of drug packages. The ratio of generic and brand name drug costs served as an indicator on assessing the rationality of drug utilization. Total cost for psychopharmaceuticals increased by 20.1%, more for brand name than for generic agents (32.7% vs. 7.4%). The highest share of generic psychopharmaceuticals as compared with brand name drugs according to DDD per 1000 inhabitants per day (DDD/1000/day) was in the group of psycholeptics (83.6% in 2001 vs. 82.2% in 2010), most in hypnotics and sedatives, and least in antipsychotics. The share of generic psychopharmaceuticals in total drug utilization according to financial indicators decreased by 9.6% and according to DDD/1000/day by 12%. The greatest decrease was in antidepressants, i.e. by 33.8% according to financial indicators and by 46% according to DDD/1000/day; and in antipsychotics by 30.9% according to DDD/1000/day, while showing an increase by 8.5% according to financial indicators. In the therapeutic subgroup of mood stabilizers, the share of generic drugs in total drug utilization declined by 32% according to DDD/1000/day, but increased by 25.1% according to financial indicators. The lack of uniform

  13. Drug Addiction and Pregnancy: Policy Crossroads.

    Science.gov (United States)

    Chavkin, Wendy

    1990-01-01

    Explores the following policy approaches to drug use by pregnant women: (1) criminal prosecution of the mother; (2) allegations of child neglect against the mother with interruption of custody; and (3) drug treatment. Discusses whether each reduces drug use during pregnancy or improves maternal and infant health and well-being. (JS)

  14. Similarity between generic and brand-name antihypertensive drugs for primary prevention of cardiovascular disease: evidence from a large population-based study.

    Science.gov (United States)

    Corrao, Giovanni; Soranna, Davide; Merlino, Luca; Mancia, Giuseppe

    2014-10-01

    Although generic and earlier brand-name counterparts are bioequivalent, their equivalence in preventing relevant clinical outcomes is of concern. To compare effectiveness of generic and brand-name antihypertensive drugs for preventing the onset of cardiovascular (CV) outcomes. A population-based, nested case-control study was carried out by including the cohort of 78 520 patients from Lombardy (Italy) aged 18 years or older who were newly treated with antihypertensive drugs during 2005. Cases were the 2206 patients who experienced a hospitalization for CV disease from initial prescription until 2011. One control for each case was randomly selected from the same cohort that generated cases. Logistic regression was used to model the CV risk associated with starting on and/or continuing with generic or brand-name agents. There was no evidence that patients who started on generics experienced different CV risk than those on brand-name product (OR 0·86; 95% CI 0·63-1·17). Patients at whom generics were main dispensed had not significantly difference in CV outcomes than those mainly on brand-name agents (OR 1·19; 95% CI 0·86-1·63). Compared with patients who kept initial brand-name therapy, those who experienced brand-to-generic or generic-to-brand switches, and those always on generics, did not show differential CV risks, being the corresponding ORs (and 95% CIs), 1·18 (0·96-1·47), 0·87 (0·63-1·21) and 1·08 (0·80-1·46). Our findings do not support the notion that brand-name antihypertensive agents are superior to generics for preventing CV outcomes in the real-world clinical practice. © 2014 Stichting European Society for Clinical Investigation Journal Foundation.

  15. Drug Policy in Bulgaria.

    Science.gov (United States)

    Dimova, Antoniya; Rohova, Maria; Atanasova, Elka; Kawalec, Paweł; Czok, Katarzyna

    2017-09-01

    Bulgaria has a mixed public-private health care financing system. Health care is financed mainly from compulsory health insurance contributions and out-of-pocket payments. Out-of-pocket payments constitute a large share of the total health care expenditure (44.14% in 2014). The share of drugs expenditure for outpatient treatment was 42.3% of the total health care expenditure in 2014, covered mainly by private payments (78.6% of the total pharmaceutical expenditure). The drug policy is run by the Ministry of Health (MoH), the National Council on Prices and Reimbursement of Medicinal Products, and the Health Technology Assessment Commission. The MoH defines diseases for which the National Health Insurance Fund (NHIF) pays for medicines. The National Council on Prices and Reimbursement of Medicinal Products maintains a positive drug list (PDL) and sets drug prices. Health technology assessment was introduced in 2015 for medicinal products belonging to a new international nonproprietary name group. The PDL defines prescription medicines that are paid for by the NHIF, the MoH, and the health care establishments; exact patient co-payments and reimbursement levels; as well as the ceiling prices for drugs not covered by the NHIF, including over-the-counter medicines. The reimbursement level can be 100%, 75%, or up to 50%. The PDL is revised monthly in all cases except for price increase. Physicians are not assigned with pharmaceutical budgets, there is a brand prescribing practice, and the substitution of prescribed medicines by pharmacists is prohibited. Policies toward cost containment and effectiveness increase include introduction of a reference pricing system, obligation to the NHIF to conduct mandatory centralized bargaining of discounts for medicinal products included in the PDL, public tendering for medicines for hospital treatment, reduction of markup margins of wholesalers and retailers, patient co-payment, and the introduction of health technology assessment

  16. Drug Policy in Poland.

    Science.gov (United States)

    Jahnz-Różyk, Karina; Kawalec, Pawel; Malinowski, Krzysztof; Czok, Katarzyna

    2017-09-01

    We presented a general overview of the health care system as well as the pricing and reimbursement environment in Poland. Poland aims to ensure proper access to safe and effective medicines while reducing patients' share in treatment costs. Nevertheless, the co-payment for pharmacotherapy is still high (more than 60%). The key policymaker and regulator in the system is the Ministry of Health, which is supported by the Polish Agency for Health Technology Assessment and Tariff System (Agencja Oceny Technologii Medycznych i Taryfikacji), responsible for evaluating applicant drugs, and the Economic Commission, responsible for negotiating the official sales prices and conditions for reimbursement with pharmaceutical companies (e.g., level of reimbursement and risk-sharing scheme agreements). The Agency for Health Technology Assessment and Tariff System dossier is obligatory for reimbursement application and includes the analysis of clinical effectiveness, economic analysis (with the threshold of quality-adjusted life-year established as no more than 3 times the gross domestic product per capita), and the analysis of budget impact. In Poland, only a positive list of reimbursed drugs is published and it is updated every 2 months. The following levels of reimbursement are in use: 100%, 70%, 50%, and lump sum (about €0.8). The first reimbursement decision is given for a period of 2 years only, the second for 3 years, and the third for 5 years. There is no separate budget or special legal regulations for orphan drugs. Generic substitution of drugs is desired but not mandatory. Physicians are not assigned with pharmaceutical budgets. The access to real-world data is limited; the only registers available are for drugs used in drug programs. Copyright © 2017. Published by Elsevier Inc.

  17. Skin rash during treatment with generic itraconazole.

    Science.gov (United States)

    De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

    2014-04-01

    Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re-challenge confirmed the association between itraconazole and skin rash. Both Naranjo probability scale and World Health Organization causality assessment scale documented a probable association between generic-itraconazole and skin rash. The switch from generic formulation to brand one induced an improvement of symptoms. Since we are unable to evaluate the role of each excipient in the development of skin rash, we cannot rule out their involvement. However, more data are necessary to better define the similarities or differences between branded and generic formulations.

  18. Multi-level governance: The way forward for European illicit drug policy?

    Science.gov (United States)

    Chatwin, Caroline

    2007-12-01

    Illicit drug policy has long been an area that has attracted international policy intervention, however, the European Union has declared it an area of subsidiarity, leaving ultimate control to national governments. Nevertheless, European Union preoccupation with the illicit drug issue and international drug trafficking and organised crime concerns have ensured that continued and increased cooperation in illicit drug policy is never off the agenda. This article examines the history of European integration in contrasting areas of policy and considers both the desirability and the viability of an increasingly harmonised drug policy for Europe. Finally, it proposes a model of integrated illicit drug policy that is strongly connected to developing patterns of European social policy, calling on multi-level governance and close involvement at the level of the citizen.

  19. [Acceptance of generic prescribing in general practice: effect of patient education and reference prices].

    Science.gov (United States)

    Vallès, J A; Barreiro, M; Cereza, G; Ferro, J J; Martínez, M J; Cucurull, E; Barceló, E

    2002-01-01

    To assess patient acceptance of the substitution of brand-name drugs for generic equivalents in the context of repeat prescriptions for chronic diseases. A prospective multicenter study of drug use was performed. Of the 31 centers included in the study, 8 were randomized to the intervention group and 23 to the control group. For 1 year, patients in the intervention group who visited the center to collect repeat prescriptions received verbal and written information on the advantages and disadvantages of generic and brand name drugs. Data on the number of patients taking brand-name drugs for which generic equivalents were available, as well as the reasons and variables related to refusal of generic drugs (age, gender, education, primary care centre, general practitioner, type of drug and total number of repeat prescriptions) were collected. The percentage of generic drugs among the total number of drugs prescribed was calculated at 2-monthly intervals. A total of 98.9% of the 4620 patients in the intervention group agreed to change to a generic formulation. The percentage of patients accepting generic drugs was significantly associated with the primary care centre, the class of drug, doctors' influence, and patient satisfaction with the drug. Generic prescriptions represented 5.9% in the intervention practices compared with 2.8% in controls. After the intervention, and before the application of reference prices, the percentages were 6.7% and 3.9%, respectively. Immediately after application of the reference prices, the percentages were 8.6% and 6.3%, respectively. Direct patient education is an effective strategy in increasing the prescription of generic equivalents. General practitioners' motivation and knowledge of generic drugs influenced their use. The application of reference prices increased the use of generic equivalents.

  20. Associations between generic substitution and patients' attitudes, beliefs and experience

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette; Larsen, Pia Veldt; Andersen, Morten

    2013-01-01

    Abstract Background Generic substitution has been implemented in many countries, but knowledge about patients’ attitudes, beliefs and experiences is still sparse. Aim To assess associations between generic switching and patients’ attitudes, beliefs and experiences with previous generic switching...... on generic medicine and confidence in the healthcare system. Only prescriptions issued by the general practitioners were included. For each patient we focused on one purchase of a generically substitutable drug (index drug). Patients were identified by means of a dispensing database. Results Earlier generic...... switches within the index ATC code were statistically significantly associated with experience of a generic switch (adjusted OR 5.93 95% CI 4.70; 7.49). Having had more than 5 earlier switches within other ATC codes and having negative views on generic medicines reduced the odds of experiencing a generic...

  1. Generic substitution: micro evidence from register data in Norway.

    Science.gov (United States)

    Dalen, Dag Morten; Furu, Kari; Locatelli, Marilena; Strøm, Steinar

    2011-02-01

    The importance of prices, doctor and patient characteristics, and market institutions for the likelihood of choosing generic drugs instead of the more expensive original brand-name version are examined. Using an extensive dataset extracted from The Norwegian Prescription Database containing all prescriptions dispensed to individuals in February 2004 and 2006 on 23 different drugs (chemical substances) in Norway, we find strong evidence for the importance of both doctor and patient characteristics for the choice probabilities. The price difference between brand and generic versions and insurance coverage both affect generic substitution. Moreover, controlling for the retail chain affiliation of the dispensing pharmacy, we find that pharmacies play an important role in promoting generic substitution. In markets with more recent entry of generic drugs, brand-name loyalty proves to be much stronger, giving less explanatory power to our demand model.

  2. A multicenter experience with generic tacrolimus conversion.

    Science.gov (United States)

    McDevitt-Potter, Lisa M; Sadaka, Basma; Tichy, Eric M; Rogers, Christin C; Gabardi, Steven

    2011-09-27

    The first generic tacrolimus product gained Food and Drug Administration approval in August 2009. This prospective, observational trial sought to determine the need for dose titrations and measure drug cost savings on conversion to generic tacrolimus. Transplant recipients on stable tacrolimus doses were converted from brand to generic tacrolimus on a mg:mg basis. Data were collected at the time of generic conversion (study arm) and at a time point exactly 6 months before conversion (control arm) for all subjects. Seventy conversions from four centers are reported. Subjects were a mean of 70 months after kidney (n=37), liver (n=28), or multiorgan (n=5) transplant. In the study arm, mean tacrolimus doses were 4.4 and 4.5 mg/d and mean tacrolimus trough concentrations were 5.8 and 5.9 ng/mL before and after conversion, respectively. In the control arm, mean tacrolimus doses were 4.6 and 4.6 mg/d and mean tacrolimus trough concentrations were 6.1 and 5.9 ng/mL before and after the control time point, respectively. Dose titrations occurred in five patients (7%) in the control arm and 15 patients (21%) in the study arm (P=0.028). Mean monthly drug costs were $645 for brand, $593 for generic, and $595 for generic after dose titrations. Mean monthly patient copays were $38 for brand and $15 for generic. These cumulative data show that dose requirements and trough levels are similar between brand and generic tacrolimus and that generic substitution allows for savings. However, postconversion monitoring is prudent as patients may require dose titration.

  3. Quality of generic medicines in South Africa: Perceptions versus Reality – A qualitative study

    Directory of Open Access Journals (Sweden)

    Patel Aarti

    2012-09-01

    Full Text Available Abstract Background Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines must be addressed to ensure that people use them with confidence. Campaigns to increase the uptake of generic medicines by consumers and providers of healthcare need to be informed by local norms and practices. This study sought to compare South African consumers’ and healthcare providers’ perceptions of quality of generics to the actual quality of selected products. Methods The study was conducted at the local level in three cities of South Africa: Johannesburg, Durban and Cape Town. Purposive sampling was used to recruit consumer participants (n = 73 and random sampling used to recruit healthcare providers from public and private sectors (n = 15. Data were obtained through twelve focus group discussions with consumers and semi-structured interviews (n = 15 with healthcare providers in order to gain familiarity with perceptions of quality. One hundred and thirty five products comprising paracetamol tablets (n = 47, amoxicillin capsules (n = 45 and hydrochlorothiazide tablets (n = 43 were sourced from public and private sector healthcare providers. These products were subjected to in vitro dissolution, uniformity of weight and identity (Fourier Transformed Infrared Spectroscopy tests using prescribed methods from the British (2005 and United States Pharmacopeias (2006. Results Respondents described drug quality in relation to the effect on symptoms. Procurement and use behavior of healthcare providers was influenced by prior experience, manufacturers’ names and consumers’ ability to pay. All formulations passed the in vitro tests for quality. Conclusions This study showed clear differences between

  4. Nonmedical Prescription Drug Use: Theory and Policy Implications

    OpenAIRE

    Gabriele Camera; Bryan Engelhardt

    2014-01-01

    The illicit nonmedical use of prescription drugs is studied in a model where individuals with imperfectly observable health conditions seek prescription drugs for either medical or nonmedical reasons. The equilibrium number of medical and nonmedical users is endogenous and depends on economic and non-economic barriers to drugs consumption, such as pricing, health care costs, refill policies, monitoring programs, and the medical community’s prescription standards. The results show policies cen...

  5. IMPROVING ACCESS TO DRUGS

    Directory of Open Access Journals (Sweden)

    Max Joseph Herman

    2012-11-01

    Full Text Available Although essentially not all therapies need drug intervention, drugs is still an important components in health sector, either in preventive, curative, rehabilitative or promotion efforts. Hence the access to drugs is a main problem, either in international or national scale even to the smallest unit. The problem on access to drugs is very complicated and cannot be separated especially from pharmacy management problems; moreover in general from the overall lack of policy development and effective of health policy, and also the implementation process. With the policy development and effective health policy, rational drug uses, sufficient health service budget so a country can overcome the health problems. Besides infrastructures, regulations, distribution and cultural influences; the main obstacles for drug access is drugs affordability if the price of drugs is an important part and determined by many factors, especially the drug status whether is still patent orgenerics that significantly decrease cost of health cares and enhance the drugs affordability. The determination of essential drug prices in developing countries should based on equity principal so that poor people pay cheaper and could afford the essential drugs. WHO predicts two third of world population can not afford the essential drugs in which in developing countries, some are because of in efficient budget allocation in consequence of drug distribution management, including incorrect selection and allocation and also irrational uses. In part these could be overcome by enhancing performances on the allocation pharmacy needs, including the management of information system, inventory management, stock management and the distribution. Key words: access, drugs, essential drugs, generic drugs

  6. Endogenous versus exogenous generic reference pricing for pharmaceuticals.

    Science.gov (United States)

    Antoñanzas, F; Juárez-Castelló, C A; Rodríguez-Ibeas, R

    2017-12-01

    In this paper we carry out a vertical differentiation duopoly model applied to pharmaceutical markets to analyze how endogenous and exogenous generic reference pricing influence competition between generic and branded drugs producers. Unlike the literature, we characterize for the exogenous case the equilibrium prices for all feasible relevant reference prices. Competition is enhanced after the introduction of a reference pricing system. We also compare both reference pricing systems on welfare grounds, assuming two different objective functions for health authorities: (i) standard social welfare and (ii) gross consumer surplus net of total pharmaceutical expenditures. We show that regardless of the objective function, health authorities will never choose endogenous reference pricing. When health authorities are paternalistic, the exogenous reference price that maximizes standard social welfare is such that the price of the generic drug is the reference price while the price of the branded drug is higher than the reference price. When health authorities are not paternalistic, the optimal exogenous reference price is such that the price of the branded drug is the reference price while the price of the generic drug is lower than the reference price.

  7. 'Worth the test?' Pragmatism, pill testing and drug policy in Australia.

    Science.gov (United States)

    Groves, Andrew

    2018-04-10

    Recent deaths of young Australian music festival attendees from 'party-drug' overdoses have sparked debate about the effectiveness of drug policies. Australia is widely lauded for its harm minimisation approach to drugs, and yet, over the last 30 years, it can be argued its policies have been fragmented, sometimes inconsistent and contradictory. The present article examines the root of this inconsistency, using it as a foundation to advocate for drug policy reform. In keeping with the goals of the National Drug Strategy to promote policy innovation, there is an opportunity to learn from international studies which have shown promising findings in the reduction of party-drug use and its harms through application of pill testing. This paper evaluates Australia's National Drug Strategy and pill testing through a lens of pragmatism, to determine whether there is space for testing practices in contemporary policy. Specifically, the paper analyses current drug policy literature and research studies, examining a range of key drug use indicators, social and political debate and research evidence. The need for policy reform, attitudinal and cultural shifts and development of stronger cross-sectoral partnerships is highlighted, to ensure a rational and logical approach that genuinely tackles drug policy-making and strategy from a broad public health perspective. Using a theoretical frame of pragmatism and drawing from national and international research evidence, this paper recommends the integration of pill testing into Australia's harm minimisation strategy.

  8. Improving drug policy: The potential of broader democratic participation.

    Science.gov (United States)

    Ritter, Alison; Lancaster, Kari; Diprose, Rosalyn

    2018-05-01

    Policies concerned with illicit drugs vex governments. While the 'evidence-based policy' paradigm argues that governments should be informed by 'what works', in practice policy makers rarely operate this way. Moreover the evidence-based policy paradigm fails to account for democratic participatory processes, particularly how community members and people who use drugs might be included. The aim of this paper is to explore the political science thinking about democratic participation and the potential afforded in 'deliberative democracy' approaches, such as Citizens Juries and other mini-publics for improved drug policy processes. Deliberative democracy, through its focus on inclusion, equality and reasoned discussion, shows potential for drug policy reform and shifts the focus from reliance on and privileging of experts and scientific evidence. But the very nature of this kind of 'deliberation' may delimit participation, notably through its insistence on authorised modes of communication. Other forms of participation beyond reasoned deliberation aligned with the ontological view that participatory processes themselves are constitutive of subject positions and policy problems, may generate opportunities for considering how the deleterious effects of authorised modes of communication might be overcome. Copyright © 2018 Elsevier B.V. All rights reserved.

  9. Rethinking generic skills

    Directory of Open Access Journals (Sweden)

    Roy Canning

    2013-10-01

    Full Text Available The paper provides a critical analysis of the notion of generic or transversal skillscontained with European Union policy discourses. The author presents a conceptualframework that challenges the idea that generic skills are universal, transferable andautonomous. An alternative analysis is put forward that argues the case forcontextualising skills and knowledge within particular understandings and cultures thatare more collective than individualistic in nature. The arguments are framed withinwider cross-disciplinary debates in linguistics, geosemiotics and social-cultural theoryand build upon an earlier paper exploring core skills in the UK (Canning, 2007.

  10. Generic drugs in Brazil: known by many, used by few Medicamentos genéricos no Brasil: conhecidos por muitos, usados por poucos

    Directory of Open Access Journals (Sweden)

    Andréa D. Bertoldi

    2005-12-01

    Full Text Available This study evaluated knowledge and use of generic drugs in a population-based sample of adults from a southern Brazilian city. The outcomes were: the proportion of generics in total medicines used; theoretical and practical knowledge about generics; and strategies used to buy medicines on medical prescriptions. The recall period for drug utilization was 15 days. The proportion of generics in total medicines was 3.9%. While 86.0% knew that generics cost less and 70.0% that the quality is similar to brand name medicines, only 57.0% knew any packaging characteristics that distinguish generics from other medicines. The highest proportion of generic drug utilization was in the antimicrobial pharmacological group. A brand name medicine (with a brand similar to the generic name was mistakenly classified as a generic through photos by 48.0% of the interviewees. Among subjects who bought medicines in the 15-day period, 18.9% reported buying a generic, but this result should be interpreted with caution, because the population frequently fails to differentiate between generics and other medicines.Este estudo avaliou o conhecimento e utilização de medicamentos genéricos em uma amostra populacional de adultos de uma cidade no sul do Brasil. Os desfechos foram: proporção de genéricos sobre o total de medicamentos usados; conhecimento teórico e prático sobre medicamentos genéricos; estratégias usadas para compra de medicamentos com prescrição médica. O período recordatório para uso de medicamentos foi de 15 dias. A proporção de genéricos no total de medicamentos foi de 3,9%. Enquanto 86,0% sabiam que o preço dos genéricos era menor e 70,0% que a qualidade era equivalente aos medicamentos de marca, apenas 57,0% conheciam alguma característica da embalagem que diferencia os genéricos de outros medicamentos. A maior proporção de uso de genéricos foi encontrada no grupo farmacológico dos antimicrobianos. Um medicamento de marca (com nome

  11. Patented drug extension strategies on healthcare spending: a cost-evaluation analysis.

    Science.gov (United States)

    Vernaz, Nathalie; Haller, Guy; Girardin, François; Huttner, Benedikt; Combescure, Christophe; Dayer, Pierre; Muscionico, Daniel; Salomon, Jean-Luc; Bonnabry, Pascal

    2013-01-01

    Drug manufacturers have developed "evergreening" strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole ("spillover effect"). We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. "Extra costs" were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community. Estimated "extra costs" over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover "extra cost" of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in "extra costs" of €503,600 (95% CI 444,500; 563,100). Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to increased overall healthcare costs by listing follow-on drugs in

  12. Making drug policy together: reflections on evidence, engagement and participation.

    Science.gov (United States)

    Roberts, Marcus

    2014-09-01

    This commentary considers the relationship between evidence, engagement and participation in drug policy governance. It argues that the use of various forms of evidence (for example, statistical data and service user narratives) is critical for meaningful stakeholder engagement and public participation in drug policy, as well as effective policy design and implementation. The respective roles of these different kinds of evidence in consultation processes need to be better understood. It discusses the limits of evidence, which it suggests is rarely conclusive or decisive for drug policy. This is partly because of the incompleteness of most research agendas and the lack of consensus among researchers, but also because issues in drug policy are inherently contestable, involving considerations that lie outside the competency of drug policy specialist as such. In particular, this is because they involve normative and evaluative issues that are properly political (for example, about the relative weight to be accorded to different kinds of harm and benefit). It concludes by supporting calls for a more nuanced understanding of the relationship between evidence, engagement and politics than is implicit in the term 'evidence based policy'. It also argues that we should view the inherent contestability of drug policy not as something that can or should be resolved by 'objective' evidence, but as a source of vitality and creativity in policy development and evaluation. Copyright © 2014 Elsevier B.V. All rights reserved.

  13. The impact of drug policy liberalisation on willingness to seek help for problem drug use: A comparison of 20 countries.

    Science.gov (United States)

    Benfer, Isabella; Zahnow, Renee; Barratt, Monica J; Maier, Larissa; Winstock, Adam; Ferris, Jason

    2018-06-01

    While the impact of changing drug policies on rates of drug use has been investigated, research into how help-seeking behaviour changes as drug policies become more public-health focused is limited. This paper investigates reported changes in confidence to utilise drug services following hypothetical changes in national drug policy among a sample of individuals who report recent illicit drug use. We predict that liberalising national drug policy will increase the propensity for people who take illegal drugs to utilise health services. The data were drawn from a sample of self-reported responses to the 2014 Global Drug Survey. Respondents were asked if they would be more confident seeking help if each of the following policy changes were made in their country; a) drugs were legalised; b) penalties for possession of small amounts of drugs were reduced to a fine only; c) drugs were legally available through governments outlets. Multiple correspondence analysis and multinomial logistic regression with post-estimation linear hypothesis testing were conducted. Individuals residing in countries with relatively liberal drug policy regimes report their help-seeking behaviour is unlikely to change given the hypothetical policy amendments. Individuals from countries with prohibition-based drug policies reported a far greater propensity for changing their help-seeking behaviour in the event of hypothetical policy amendments, citing reduced fear of criminal sanctions as the major reason. Age and sex differences were also found. The current study demonstrates the capacity for national drug policy reform to influence drug use risk by facilitating or impeding health service engagement among individuals who use illicit substances. We suggest national drug policy requires careful consideration of both prevention goals and the needs of individuals already engaged in illicit substance use; more liberal drug policies may actually encourage the adoption of harm reduction strategies such

  14. The Impact of College Drug Policy on Students' Drug Usage

    Science.gov (United States)

    Sawyer, Holly N.

    2012-01-01

    Illicit drug usage at Historically Black Colleges and Universities (HBCU) is a topic of limited research. The research questions that guided this study were (a) What is the relationship between college policy on illicit drugs and students' frequency of drug usage after controlling for college location (urban or rural) and students' age,…

  15. The generics in transplantation and the rules on their use.

    Science.gov (United States)

    Masri, Marwan

    2003-06-01

    By definition a product identified by its official chemical name rather than an advertised brand name is called a generic. If a drug exert its pharmacological effects at the same site, have the same potency, same dosage form and same bioavailability as a brand name, reference listed drug (RLD), is considered as a generic. However inactive ingredients can differ between brand name and generic. It is through the regulations of the FDA that the generics gained many ground in the drug market, they currently account to more than 42% of the total prescription in the USA. These regulations include the abbreviated new drug application (ANDA) for the registration process and drug substitution at the pharmacy level without patient or physician consent. This coupled with a keen interest of third party payers and the health authorities to reduce the high transplant health budget (over 2 Billion US $) made it a necessity to introduce the generics into the field of transplantation. Using the above mentioned definition we can theoretically say that all anti-lymphocytes, produced in the same animal species, are generic of each. Moreover, monoclonal antibodies that are directed against the same target and have the same bioavailability are also consider generics to each other. Of all the immunosuppressive drugs that have been introduced into the field of transplantation none has been as dominant as Cyclosporine. Cyclosporine became and still is the backbone for any immunosuppressive protocol. In the year 1992, Consupren, the first, non-FDA approved, generic to Sandimmun was introduced. Although Consupren was not bioequivalent to Neoral, however, long-term results in kidney transplantation have been similar for both drugs. The introduction of Consupren resulted in a near 40% reduction in the total cost of immunosuppressive therapy. Interestingly the cost of the brand name drug Neoral was also reduced by 20%. The cost reduction allowed the introduction of the new immunosuppressive

  16. Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

    Energy Technology Data Exchange (ETDEWEB)

    Szebeni, Janos, E-mail: jszebeni2@gmail.com [Nanomedicine Research and Education Center, Semmelweis University, Budapest & SeroScience Ltd, Budapest (Hungary); Storm, Gert [Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht (Netherlands)

    2015-12-18

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

  17. Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

    International Nuclear Information System (INIS)

    Szebeni, Janos; Storm, Gert

    2015-01-01

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

  18. Understanding policy persistence-The case of police drug detection dog policy in NSW, Australia.

    Science.gov (United States)

    Hughes, Caitlin E; Ritter, Alison; Lancaster, Kari; Hoppe, Robert

    2017-06-01

    Significant research attention has been given to understanding the processes of drug policy reform. However, there has been surprisingly little analysis of the persistence of policy in the face of opposition and evidence of ineffectiveness. In this article we analysed just such a case - police drug detection dog policy in NSW, Australia. We sought to identify factors which may account for the continuation of this policy, in spite of counter-evidence and concerted advocacy. The analysis was conducted using the Advocacy Coalition Framework (ACF). We collated documents relating to NSW drug detection dog policy from 1995 to 2016, including parliamentary records (NSW Parliament Hansard), government and institutional reports, legislation, police procedures, books, media, and academic publications. Texts were then read, coded and classified against the core dimensions of the ACF, including subsystem actors and coalitions, their belief systems and resources and venues employed for policy debate. Three coalitions were identified as competing in the policy subsystem: security/law and order, civil liberties and harm reduction. Factors that aided policy stability were the continued dominance of the security/law and order coalition since they introduced the drug dog policy; a power imbalance enabling the ruling coalition to limit when and where the policy was discussed; and a highly adversarial policy subsystem. In this context even technical knowledge that dogs infringed civil liberties and increased risks of overdose were readily downplayed, leading to only incremental changes in implementation rather than policy cessation or wholesale revision. The analysis provides new insights into why the accumulation of new evidence and advocacy efforts can be insufficient to drive significant policy change. It poses a challenge for the evidence-based paradigm suggesting that in highly adversarial policy subsystems new evidence is unlikely to generate policy change without broader

  19. Canada ordered to implement WTO ruling against "stockpiling" of generic drugs.

    Science.gov (United States)

    Elliott, R

    2000-01-01

    In the last issue, we reported on a mixed World Trade Organization (WTO) ruling regarding Canada's patent laws, based on a complaint by the member states of the European Communities (joined by the United States). In March 2000, a WTO Panel accepted the provision in Canada's Patent Act that creates an "early working exception" to patent rights--in other words, that allows a third party to use a patented invention during the term of patent protection, as long as the use is for obtaining regulatory approval of an equivalent product to be sold once the patent expires. This was an important victory from the perspective of allowing earlier access to generic versions of patented drugs.

  20. Brand loyalty, patients and limited generic medicines uptake.

    Science.gov (United States)

    Costa-Font, Joan; Rudisill, Caroline; Tan, Stefanie

    2014-06-01

    The sluggish development of European generic drug markets depends heavily on demand side factors, and more specifically, patients' and doctors' loyalty to branded products. Loyalty to originator drugs, to the point where originator prices rise upon generic entry has been described as the 'generics paradox'. Originator loyalty can emerge for a plethora of reasons; including costs, perceptions about quality and physician advice. We know very little about the behavioural underpinnings of brand loyalty from the consumer or patient standpoint. This paper attempts to test the extent to which patients are brand loyal by drawing upon Spain's 2002 Health Barometer survey as it includes questions about consumer acceptance of generics in a country with exceptionally low generic uptake and substitution at the time of the study. Our findings suggest that at least 13% of the population would not accept generics as substitutes to the originator. These results confirm evidence of brand loyalty for a minority. Alongside high levels of awareness of generics, we find that low cost-sharing levels explain consumer brand loyalty but their impact on acceptance of generic substitution is very small. Higher cost-sharing and exempting fewer patients from cost-sharing have the potential to encourage generic acceptance. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  1. Drug policy in sport: hidden assumptions and inherent contradictions.

    Science.gov (United States)

    Smith, Aaron C T; Stewart, Bob

    2008-03-01

    This paper considers the assumptions underpinning the current drugs-in-sport policy arrangements. We examine the assumptions and contradictions inherent in the policy approach, paying particular attention to the evidence that supports different policy arrangements. We find that the current anti-doping policy of the World Anti-Doping Agency (WADA) contains inconsistencies and ambiguities. WADA's policy position is predicated upon four fundamental principles; first, the need for sport to set a good example; secondly, the necessity of ensuring a level playing field; thirdly, the responsibility to protect the health of athletes; and fourthly, the importance of preserving the integrity of sport. A review of the evidence, however, suggests that sport is a problematic institution when it comes to setting a good example for the rest of society. Neither is it clear that sport has an inherent or essential integrity that can only be sustained through regulation. Furthermore, it is doubtful that WADA's anti-doping policy is effective in maintaining a level playing field, or is the best means of protecting the health of athletes. The WADA anti-doping policy is based too heavily on principals of minimising drug use, and gives insufficient weight to the minimisation of drug-related harms. As a result drug-related harms are being poorly managed in sport. We argue that anti-doping policy in sport would benefit from placing greater emphasis on a harm minimisation model.

  2. Generic tacrolimus in solid organ transplantation

    DEFF Research Database (Denmark)

    Taube, D; Jones, G; O'Beirne, J

    2014-01-01

    The availability of a wide range of immunosuppressive therapies has revolutionized the management of patients who have undergone solid organ transplantation (SOT). However, the cost of immunosuppressive drugs remains high. This situation has led to the development of generic equivalents, which...... innovator tacrolimus drug (Prograf) in both healthy volunteers and kidney transplant patients. Clinical experience with this generic tacrolimus formulation has also been established in both de novo and conversion patients who have undergone kidney and liver transplantation, as well as in conversion of other...

  3. Patients' concern about their medicine after a generic switch

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette; Søndergaard, Jens; Jarbøl, Dorte E

    2014-01-01

    PURPOSE: This study aims to investigate the possible association between patients' concerns about their medicine and generic switch. METHODS: Cross-sectional survey was carried out comprising responses from 2217 randomly selected persons aged 20 years or older and living in the Region of Southern...... Denmark, who had redeemed generically substitutable drugs in September 2008. For each patient, we focused on the purchase of one generically substitutable drug (index drug). We applied the specific concerns subscale from the Beliefs about Medicine Questionnaire (BMQ) to analyse lack of confidence....... RESULTS: No statistically significant associations were found between concerns about the index medicine and the generic switch (-0.02 95% CI: -0.10; 0.05). Viewing medicines as harmful in general was associated with increased concerns (BMQ general harm: 0.39 95% CI: 0.30; 0.47 and BMQ general overuse: 0...

  4. Impact of price deregulation policy on the affordability of essential medicines for women's health: a panel data analysis.

    Science.gov (United States)

    Liu, Junjie; Wang, Liming; Liu, Chenxi; Zhang, Xinping

    2017-12-01

    A new policy which required deregulation on prices of off-patent medicines for women's health during procurement was introduced in China in September 2015. The current study examines this policy's impact on the affordability of essential medicines for women's health. Based on product-level panel data, a fixed effect regression model is employed by using procurement records from Hubei Centralist Tender for Drug Purchase platform. In the model, Affordability was measured with prices. The Competition consists of two parts: generic competition and therapeutic class competition which are measured with generic competitors and therapeutic substitutes. Instrument variable is used to deal with endogeneity. The policy helped control prices of essential medicines for women's health. Generic competition helped control prices, however, therapeutic class competition caused higher prices. The new policy helped enhance the affordability of essential medicines for women's health as expected, which provides empirical evidence on price deregulation. Besides, generic competition is important in price control despite strict regulatory system in China.

  5. Cisplatin-induced hyponatremia in malignancy: comparison between brand-name and generic formulation.

    Science.gov (United States)

    Ochi, Nobuaki; Yamane, Hiromichi; Hotta, Katsuyuki; Fujii, Hiromi; Isozaki, Hideko; Honda, Yoshihiro; Yamagishi, Tomoko; Kubo, Toshio; Tanimoto, Mitsune; Kiura, Katsuyuki; Takigawa, Nagio

    2014-01-01

    Widespread use of generic drugs is considered to be indispensable if reductions in total health care costs are to be achieved, but the market share of such drugs remains low. In general, generic drugs have the same active ingredients as brand-name drugs, but this is not always the case. Thus, toxicity profiles may vary when brand-name and generic drugs are compared. We retrospectively investigated the incidence of hyponatremia in patients receiving brand-name cisplatin (CDDP) and a generic counterpart thereof. We reviewed the medical records of patients treated with brand-name CDDP (n=53) and a generic formulation (n=26), and compared the incidences of hyponatremia and renal toxicity. Toxicities were graded using the Common Terminology Criteria for Adverse Events, version 4.0. Differences between groups were evaluated using the Student's t-test, and the odds ratio for hyponatremia was estimated via logistic regression analysis. Serum creatinine levels after chemotherapy increased significantly in both the brand-name and generic CDDP groups; no significant difference was evident between the two groups. Hyponatremia of grade 3 or above developed in 30.7% of the generic CDDP group compared to 15.1% of the brand-name CDDP group (P=0.011). Multivariate analysis showed that the use of generic CDDP increased the incidence of hyponatremia (odds ratio =5.661, 95% confidence interval =1.403-22.839; P=0.015). Oncologists should be aware that use of a generic CDDP might be associated with more hyponatremia than would use of brand-name CDDP.

  6. Canadian Drug Policy and the Reproduction of Indigenous Inequities

    Directory of Open Access Journals (Sweden)

    Shelley G. Marshall

    2015-01-01

    Full Text Available Canada’s federal drug policy under the Harper government (2006 to present is “tough on crime” and dismissive of public health and harm reduction approaches to problematic drug use. Drawing on insights from discourse and critical race theories, and Bacchi’s (2009 poststructural policy analysis framework, problematic representations in Canada’s federal drug policy discourse are examined through proposed and passed legislation, government documents, and parliamentary speaker notes. These problem representations are situated within their social, historical, and colonial context to demonstrate how this policy is poised to intersect with persistent racial inequalities that position Indigenous peoples for involvement with illicit substances and markets, and racialized discourses and practices within law and law enforcement that perpetuate Indigenous over-representation in the criminal justice system.

  7. The evolution of Israeli public policy for drug-using backpackers.

    Science.gov (United States)

    Bonny-Noach, Hagit

    2018-05-04

    Over the past 20 years, the young-adult backpacking trip has emerged as a significant social phenomenon in Israeli society. This has received attention from scholars specializing in anthropology and tourism research, but only a few analytical studies exist on the drug policy processes and few provide Israeli social and health perspectives. The interaction of policymakers, media, and health deviancy is an important focus of inquiry. This study charts the establishment of a drug policy for Israeli backpackers. It covers the period from the emergence of the problem in the early 1990s until the present. This study employs content analysis of newspaper articles and official documents, protocols, and reports written by policymakers and professionals. The latter were mostly produced by the Israel Anti-Drug Authority (IADA) and the Special Committee on Drug and Alcohol Abuse (SCDAA) in the Israeli Knesset. These are the two major Israeli agencies responsible for drug policy. Three periods in the establishment of backpacker drug policy can be identified. First period - until late 1995: No drug problem was recognized. The subject was not part of the public agenda. Even so, many backpackers were actually taking drugs. Second Period - late 1995 to 2000: The Israeli media started to report intensively on backpacker drug use. The issue then flared up into a significant 'social problem' demanding health and social solutions. In this phase, policymakers capitalized on a window of opportunity, and formulated a policy emphasizing prevention. Third period - from 2001 until the present: A sea change in institutional attitude occurred. In this period, drug-policy emphasis shifted from prevention to therapeutic-treatment approaches. As a result, harm reduction and unique treatment strategies were developed. Policymakers should continue to improve health prevention, treatment, and harm reduction resources. It is recommended that the Ministry of Health set up consultation centers at

  8. Issues surrounding orphan disease and orphan drug policies in Europe.

    Science.gov (United States)

    Denis, Alain; Mergaert, Lut; Fostier, Christel; Cleemput, Irina; Simoens, Steven

    2010-01-01

    An orphan disease is a disease with a very low prevalence. Although there are 5000-7000 orphan diseases, only 50 orphan drugs (i.e. drugs developed to treat orphan diseases) were marketed in the EU by the end of 2008. In 2000, the EU implemented policies specifically designed to stimulate the development of orphan drugs. While decisions on orphan designation and the marketing authorization of orphan drugs are made at the EU level, decisions on drug reimbursement are made at the member state level. The specific features of orphan diseases and orphan drugs make them a high-priority issue for policy makers. The aim of this article is to identify and discuss several issues surrounding orphan disease and drug policies in Europe. The present system of orphan designation allows for drugs for non-orphan diseases to be designated as orphan drugs. The economic factors underlying orphan designation can be questioned in some cases, as a low prevalence of a certain indication does not equal a low return on investment for the drug across its indications. High-quality evidence about the clinical added value of orphan drugs is rarely available at the time of marketing authorization, due to the low number of patients. A balance must be struck between ethical and economic concerns. To this effect, there is a need to initiate a societal dialogue on this issue, to clarify what society wants and accepts in terms of ethical and economic consequences. The growing budgetary impact of orphan drugs puts pressure on drug expenditure. Indications can be extended for an orphan drug and the total prevalence across indications is not considered. Finally, cooperation needs to be fostered in the EU, particularly through a standardized approach to the creation and use of registries. These issues require further attention from researchers, policy makers, health professionals, patients, pharmaceutical companies and other stakeholders with a view to optimizing orphan disease and drug policies in

  9. Patented drug extension strategies on healthcare spending: a cost-evaluation analysis.

    Directory of Open Access Journals (Sweden)

    Nathalie Vernaz

    Full Text Available BACKGROUND: Drug manufacturers have developed "evergreening" strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs on the healthcare system as a whole ("spillover effect". METHODS AND FINDINGS: We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. "Extra costs" were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1 all brand (i.e., initially patented drugs, (2 all follow-on drugs, or (3 brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community. Estimated "extra costs" over the study period were €15.9 (95% CI 15.5; 16.2 million for scenario 1, €14.4 (95% CI 14.1; 14.7 million for scenario 2, and €30.3 (95% CI 29.8; 30.8 million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover "extra cost" of €330,300 (95% CI 276,100; 383,800, whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100. Overall we estimated that the RDF resulted in "extra costs" of €503,600 (95% CI 444,500; 563,100. CONCLUSIONS: Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to increased

  10. Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis

    Science.gov (United States)

    Vernaz, Nathalie; Haller, Guy; Girardin, François; Huttner, Benedikt; Combescure, Christophe; Dayer, Pierre; Muscionico, Daniel; Salomon, Jean-Luc; Bonnabry, Pascal

    2013-01-01

    Background Drug manufacturers have developed “evergreening” strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole (“spillover effect”). Methods and Findings We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. “Extra costs” were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community. Estimated “extra costs” over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover “extra cost” of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in “extra costs” of €503,600 (95% CI 444,500; 563,100). Conclusions Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to

  11. Developing competitive and sustainable Polish generic medicines market.

    Science.gov (United States)

    Simoens, Steven

    2009-10-01

    To descriptively analyze the policy environment surrounding the Polish generic medicines retail market. The policy analysis was based on an international literature review. Also, a simulation exercise was carried out to compute potential savings from substituting generic for originator medicines in Poland using IMS Health pharmaceutical intelligence data. Poland has a mature, high-volume, low-value generic medicines market, primarily driven by the establishment of the reference price at the price of the cheapest medicine in combination with pricing regulation and the low level of medicine prices. The practice of discounting in the distribution chain implies that the National Health Fund and patients do not capture the potential savings from a generic medicines market where companies compete on price. This high-volume market has benefited in the past from the limited availability of originator medicines and a short data exclusivity period, even though there are no incentives for physicians to prescribe generic medicines and a financial disincentive for pharmacists to dispense generic medicines. Increased generic substitution would be expected to reduce public expenditure on originator medicines by 21%. To develop a competitive and sustainable market, Poland needs to consider moving away from competition by discount to competition by price. This could be achieved by replacing maximum distribution margins by fixed margins. Also, Poland may wish to raise reference prices as a temporary measure to boost market entry for medicine classes with few generic medicines.

  12. Medication persistence and the use of generic and brand-name blood pressure-lowering agents.

    Science.gov (United States)

    Corrao, Giovanni; Soranna, Davide; La Vecchia, Carlo; Catapano, Alberico; Agabiti-Rosei, Enrico; Gensini, Gianfranco; Merlino, Luca; Mancia, Giuseppe

    2014-05-01

    Because of their lower cost, healthcare systems recommend physicians to prefer generic products, rather than brand-name medicaments. There is then considerable interest and debate concerning safety and effectiveness of generic products. Few studies have compared patients treated with brand-name and generic drugs for adherence to treatment, with somewhat inconsistent results. The primary objective of this study was to compare the risk of discontinuing antihypertensive drug therapy in patients treated with generic or brand-name agents. The 101,618 beneficiaries of the Healthcare system of Lombardy, Italy, aged 18 years or older who were newly treated on monotherapy with antihypertensive generic or brand-name drugs during 2008, were followed until the earliest date among those of the occurrence of treatment discontinuation to whatever antihypertensive drug therapy (outcome), or censoring (death, emigration, 12 months after treatment initiation). Hazard ratios of discontinuation associated with starting on generic or brand-name products (intention-to-treat analysis), and incidence rate ratio of discontinuation during periods on generic and brand-name products (as-treated analysis) were respectively estimated from a cohort and self-controlled case series analyses. Patients who started on generics did not experience a different risk of discontinuation compared with those starting on brand-name agents (hazard ratio: 1.00; 95% confidence interval 0.98-1.02). Discontinuation did not occur with different rates during periods covered by generics or brand-name agents (incidence rate ratio: 1.01; 95% confidence interval 0.96-1.11) within the same individuals. A number of sensitivity and subgroup analyses confirmed the robustness of these findings. Generic products are not responsible for the high rate of discontinuation from antihypertensive drug therapy. Assuming therapeutic equivalence, clinical implication is of prescribing generic drug therapies.

  13. [HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

    Science.gov (United States)

    Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

    2017-04-01

    In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands

  14. Orphan drug: Development trends and strategies

    Directory of Open Access Journals (Sweden)

    Aarti Sharma

    2010-01-01

    Full Text Available The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity in next 5 years. Therefore, the current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies from the essential medicines to the new business model - niche busters, also called orphan drugs. Orphan drugs may help pharma companies to reduce the impact of revenue loss caused by patent expiries of blockbuster drugs. The new business model of orphan drugs could offer an integrated healthcare solution that enables pharma companies to develop newer areas of therapeutics, diagnosis, treatment, monitoring, and patient support. Incentives for drug development provided by governments, as well as support from the FDA and EU Commission in special protocols, are a further boost for the companies developing orphan drugs. Although there may still be challenges ahead for the pharmaceutical industry, orphan drugs seem to offer the key to recovery and stability within the market. In our study, we have compared the policies and orphan drug incentives worldwide alongwith the challenges faced by the pharmaceutical companies. Recent developments are seen in orphan drug approval, the various drugs in orphan drug pipeline, and the future prospectives for orphan drugs and diseases.

  15. Challenges in orphan drug development and regulatory policy in China.

    Science.gov (United States)

    Cheng, Alice; Xie, Zhi

    2017-01-18

    While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements have begun to support rare disease patients and facilitate drug discovery through research. Recently, the Chinese FDA set new regulatory guidelines for drugs being developed in China, including an expedited review process for life-saving treatments. In this review, we discuss the effects of these new policy changes on and suggest potential solutions to innovate orphan drug development in China.

  16. The politics of drug control in Nigeria: Exclusion, repression and obstacles to policy change.

    Science.gov (United States)

    Klantschnig, Gernot

    2016-04-01

    International agencies have viewed West Africa as a major player in the global trade in cocaine and heroin and in efforts to control that trade, as there have been reports of escalating arrests of drug smugglers, large-scale drug seizures and 'narco-states' in the subregion. It is claimed that a substantial share of the drugs available in Western markets transit through West Africa today and are increasingly used there as well. Notwithstanding this growing alarm, there is little serious scholarship addressing the issue of drugs and drug policy in West Africa. The article assesses and challenges some of the existing depictions of drugs and drug policy in West Africa through an empirical case study of drug control in Nigeria - one of West Africa's most notorious 'drug hubs' and recently hailed as a policy model by international experts. Based on previously inaccessible government documents, interviews with key officials in Nigeria, as well as ethnographic work at Nigeria's key drug agency, the article provides a unique insight into the politics of drug policy-making and implementation in West Africa. After describing the dominant official narratives of Nigeria's drug control, the article shows how the key political dynamics underlying drug policy remain obscured by these narratives. Nigerian drug policy has been characterised by a highly exclusive policy-making process, repression as the sole means of implementation and a strong bond with international drug agencies. This policy emerged in the 1980s and 1990s and has remained the unchallenged norm until today. The political processes underlying Nigerian drug policy also explain why policy reform has been and will be difficult to accomplish. These domestic political processes have largely been ignored in the existing depictions of drugs in West Africa, as they have mainly focused on externally driven drug threats and foreign policy responses. Most importantly, they have ignored the role played by the state. Rather

  17. [Analysis of the decision to buy medicine in light of the existence of generic products: a study in the city of Belo Horizonte, Brazil].

    Science.gov (United States)

    Sousa, Caissa Veloso E; Mesquita, Jose Marcos Carvalho de; Lara, José Edson

    2013-11-01

    The scope of this study is to identify the factors that influence the consumer's decision when buying medicine. Prior to the Generics Act (Lei dos Genéricos), consumers had at their disposal two product purchase options in the private market, namely buying a reference drug and a similar one. Generic drugs are part of a public policy which was intended to broaden access to medication by the general population at more accessible costs, while maintaining the same quality as the reference drug, as ensured by bioequivalence tests from the national health surveillance agency ANVISA. Nevertheless, a question arises as to whether the potential consumer knows the difference between generic, similar and reference drugs, especially when taking into account the decision at the moment of purchase. In order to fulfill the proposed objective, a survey was conducted with 403 residents in Belo Horizonte, Brazil. The data gathered was tabulated and analyzed using factor analysis and crosstab. The results made it possible to infer that there is a strong predisposition among consumers to accept the suggestions of the pharmacists and/or salesman, and a significant portion of the population is confused at the moment of purchase.

  18. Drug and therapeutics committees in Danish hospitals: a survey of organization, activities and drug selection procedures

    DEFF Research Database (Denmark)

    Plet, H. T.; Hallas, J.; Nielsen, Gitte S.

    2013-01-01

    To implement rational pharmacotherapy in hospitals, it is important to develop, implement and evaluate hospital drug formularies (HDFs). A report from Denmark recommended standardizing activities of the drug and therapeutics committees (DTCs) in Denmark, but little is known about their current...... organization. The aim of the study was to describe the organization of DTCs in Denmark, how HDFs are developed and implemented, and to what extent policies that support the use of HDFs exist. A questionnaire was developed based on previous research and guidelines and contained 20 questions, which were divided...... of the meetings lasted between 1 and 2.5 hr. Eight (89%) DTCs developed HDFs, policies and guidelines (P&Gs) that supported the use of HDFs. Eight (89%) had established criteria for inclusion of drugs on the HDFs, and seven had developed criteria for generic substitution and therapeutic interchange. The number...

  19. Do higher-priced generic medicines enjoy a competitive advantage under reference pricing?

    Science.gov (United States)

    Puig-Junoy, Jaume

    2012-11-01

    In many countries with generic reference pricing, generic producers and distributors compete by means of undisclosed discounts offered to pharmacies in order to reduce acquisition costs and to induce them to dispense their generic to patients in preference over others. The objective of this article is to test the hypothesis that under prevailing reference pricing systems for generic medicines, those medicines sold at a higher consumer price may enjoy a competitive advantage. Real transaction prices for 179 generic medicines acquired by pharmacies in Spain have been used to calculate the discount rate on acquisition versus reimbursed costs to pharmacies. Two empirical hypotheses are tested: the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical presentations for which there are more generic competitors; and, the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical forms for which the consumer price has declined less in relation to the consumer price of the brand drug before generic entry (higher-priced generic medicines). An average discount rate of 39.3% on acquisition versus reimbursed costs to pharmacies has been observed. The magnitude of the discount positively depends on the number of competitors in the market. The higher the ratio of the consumer price of the generic to that of the brand drug prior to generic entry (i.e. the smaller the price reduction of the generic in relation to the brand drug), the larger the discount rate. Under reference pricing there is intense price competition among generic firms in the form of unusually high discounts to pharmacies on official ex-factory prices reimbursed to pharmacies. However, this effect is highly distorting because it favours those medicines with a higher relative price in relation to the brand price before generic entry.

  20. Generic Switching and Non-Persistence among Medicine Users

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette; Andersen, Morten; Jarbøl, Dorte Ejg

    2015-01-01

    BACKGROUND: Generic substitution means that one medicinal product is replaced by another product containing the same active substance. It is strictly regulated with respect to its bioequivalence, and all products must have undergone appropriate studies. Although generic substitution is widely...... implemented, it still remains to be answered how generic switch influences persistence to long-term treatment, and if it is modified by patients' concerns about medicine and views on generic medicine. This study focuses on users of antidepressants and antiepileptics, and their experience of generic switching....... METHODS: The study was an observational cohort study. By use of a prescription database, we identified patients who had redeemed prescriptions on generically substitutable drugs, and a questionnaire was mailed to them. We analyzed predictors of discontinuation in relation to generic switch and patients...

  1. Alcohol and drug policy model for the Canadian upstream petroleum industry

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-09-15

    This alcohol and drug policy model was developed to help employers manage and reduce the risks associated with drug and alcohol use in the workplace. The policy model outlined guidelines for establishing and implementing drug and alcohol policies, and discussed treatment programs and opportunities for re-employment. The model was developed by Enform, the upstream petroleum industry's safety and training arm, who used a previous guide developed by the Construction Owner's Association of Alberta (COAA) as a model. Enform's model provided a summary of key accountabilities across all levels of industry as well as the accepted minimum criteria for developing alcohol and drug policies. The model included guidelines and recommendations for employees, supervisors, and owners, employers, and contractors. The responsibilities of associations, organizations, and private companies were also outlined. An overview of recommended implementation plans was provided, as well as details of alcohol and drug use education programs and workplace rules. A supervisor's guide to implementation provided outlines of the causes of drug use among employees. tabs.

  2. Generic Penetration of the SSRI Market.

    Science.gov (United States)

    Cascade, Elisa F; Kalali, Amir H

    2008-04-01

    In this article, we investigate the penetration of generic selective serotonin reuptake inhibitors (SSRIs) in the US market and the implications for patient out-of-pocket expense. The data suggest that generic penetration into the SSRI market has grown from approximately nine percent in 2000, the year that the patent for Prozac((R)) expired, to 72 percent in 2007. For December, 2007, the difference in patient out-of-pocket expense for branded vs. generic agents was, on average, $55.42 for patients paying by cash (i.e., they had no prescription drug insurance) and $22.39 for patients with insurance coverage.

  3. A critical examination of the definition of 'psychoactive effect' in Australian drug legislation.

    Science.gov (United States)

    Barratt, Monica J; Seear, Kate; Lancaster, Kari

    2017-02-01

    As the number of new 'psychoactive substances' detected globally has risen exponentially, the policy response of assessing and prohibiting each new substance individually has become increasingly unworkable. In an attempt to disrupt the availability of new as-yet-unscheduled substances, Ireland (2010), Poland (2011), Romania (2012), New Zealand (2013), Australia (2015) and the United Kingdom (2016) have enacted generic or blanket ban legislation that prohibits all 'psychoactive substances' that are not already regulated or belong to exempt categories. How such generic legislation defines 'psychoactive substance' is therefore crucial. While there is a growing critical literature relating to blanket bans of 'psychoactive substances', the Australian legislation is yet to be described or critically analysed. In this commentary, we aim to draw the attention of local and international drug policy scholars to Australia's newest legislative approach to 'psychoactive substances'. Using the Australian experience as a case study, we first describe and trace the origins of this generic banning approach, especially focusing on how 'psychoactive effect' came to be defined. Then, we critically examine the assumptions underpinning this definition and the possibilities silenced by it, drawing on the work of poststructuralist and critical scholars. In doing so, we explore and raise a series of questions about how this legislation works to stabilise drugs, drug harms and drug effects, as well as addiction realities; how the category of 'psychoactive substances' is produced through this legislation; and some of the material-discursive effects which accompany this rendering of the 'problem'. We offer this commentary not as a comprehensive discussion of each of these elements but rather as a starting-point to promote further discussion and debate within the drug policy field. To this end, we conclude with a suggested research agenda that may help guide such future work. Copyright © 2016

  4. Addition of generic medication vouchers to a pharmacist academic detailing program: effects on the generic dispensing ratio in a physician-hospital organization.

    Science.gov (United States)

    Bhargava, Vinay; Greg, Mark E; Shields, Mark C

    2010-01-01

    Generic dispensing ratio (GDR) is an important measure of efficiency in pharmacy benefit management. A few studies have examined the effects of academic detailing or generic drug samples on GDR. On July 1, 2007, a physician-hospital organization (PHO) with a pay-for-performance incentive for generic utilization initiated a pilot generic medication voucher program that augmented its existing pharmacist-led academic detailing efforts. No published studies have examined the role of generic medication vouchers in promoting generic drug utilization. To determine if supplementing an existing academic detailing initiative in a PHO with a generic medication voucher program would be more effective in increasing the GDR compared with academic detailing alone. The intervention took place over the 9-month period from July 1, 2007, through March 31, 2008. Vouchers provided patients with the first fill of a 30-day supply of a generic drug at no cost to the patient for 8 specific generic medications obtained through a national community pharmacy chain. The study was conducted in a PHO composed of 7 hospitals and approximately 2,900 physicians (900 primary care providers [PCPs] and 2,000 specialists). Of the approximately 300 PCP practices, 21 practices with at least 2 physicians each were selected on the basis of high prescription volume (more than 500 pharmacy claims for the practice over a 12-month pre-baseline period) and low GDR (practice GDR less than 55% in the 12-month pre-baseline period). These 21 practices were then randomized to a control group of academic detailing alone or the intervention group that received academic detailing plus generic medication vouchers. One of 10 intervention groups declined to participate, and 2 of 11 control groups dropped out of the PHO. GDR was calculated monthly for all pharmacy claims including the 8 voucher medications. GDR was defined as the ratio of the total number of paid generic pharmacy claims divided by the total number of paid

  5. Seeing through the public health smoke-screen in drug policy.

    Science.gov (United States)

    Csete, Joanne; Wolfe, Daniel

    2017-05-01

    In deliberations on drug policy in United Nations fora, a consensus has emerged that drug use and drug dependence should be treated primarily as public health concerns rather than as crimes. But what some member states mean by "public health approach" merits scrutiny. Some governments that espouse treating people who use drugs as "patients, not criminals" still subject them to prison-like detention in the name of drug-dependence treatment or otherwise do not take measures to provide scientifically sound treatment and humane social support to those who need them. Even drug treatment courts, which the U.S. and other countries hold up as examples of a public health approach to drug dependence, can serve rather to tighten the hold of the criminal justice sector on concerns that should be addressed in the health sector. The political popularity of demonisation of drugs and visibly repressive approaches is an obvious challenge to leadership for truly health-oriented drug control. This commentary offers some thoughts for judging whether a public health approach is worthy of the name and cautions drug policy reformers not to rely on facile commitments to health approaches that are largely rhetorical or that mask policies and activities not in keeping with good public health practise. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. New High: A Future-Oriented Study of American Drug Policy

    Science.gov (United States)

    2017-12-01

    physical health , leading to a decrease in morbidity and mortality from obesity. Nootropics on pharmacy shelves combat hunger, low energy, and...office of the future. 14. SUBJECT TERMS futures, megatrends, emerging technologies, drug policy, public health , war on drugs, forecasting, behavioral... health , scenarios, trends, innovation, regulation, policy, artificial intelligence, brain-computer interface, neural stimulation, nootropics

  7. Pharmaceutical policies for the Third World--whose responsibility?

    Science.gov (United States)

    1983-07-16

    Several developing countries, such as Bangladesh, Cuba, India, and Mozambique, are currently formulating national pharmaceutical policies to reduce expenditures on drugs while increasing their availability to those in greatest need. 5 components of such national policies have been identified: 1) elimination of ineffective and inappropriate preparations through concentrating on a selection such as the World Health Organization's 200 "basic and essential drugs", coupled with national drug pricing policies that discriminate between essential drugs and non-essential or luxury drugs; 2) public systems of drug distribution which would reduce costs to the consumer; 3) importation of the limited number of drugs distributed through the public system in bulk, which might reduce costs by 20-25%; 4) use of generic rather than brand name drugs; and 5) establishment of domestic pharmaceutical industries within developing countries to encourage research into drugs for local health problems, reduce use of foreign exchange to import drugs, and increase local self-reliance in dealing with disease. In November 1982, Health Action International, a coordinating body for more than 50 publish interest groups seeking to promote rational use of pharmaceuticals, presented a draft internationl code on pharmaceuticals to the UN Conference on Trade and Development. A voluntary code produced in 1981 by the International Federation of Pharmaceutical Manufacturers' Associations paid little attention to monitoring and enforcement. Little progress has been made, and the need for sensible policy making at the international and national levels has long been apparent.

  8. Comparative study of the pharmacopeial quality and dissolution profiles of generic and other drug forms of sodium metamizole (dipyrone sold in Brazil

    Directory of Open Access Journals (Sweden)

    Morenna Alana Giordani

    2012-08-01

    Full Text Available In Brazil, in order for a pharmaceutical company to register a drug form as generic or ‘similar’ with the Brazilian food and drug agency (Anvisa, it must be proved bioequivalent to its innovatory branded form (reference drug. This requires comparative trials, carried out in conformity with official compendia (Brazilian Pharmacopeia or another officially recognized code. Additionally, according to the Anvisa resolution RDC 31/2010, the dissolution profile of the drug must be tested and compared with that of the branded reference, as a benchmark of quality. The aim of this study was to assess the quality of 500 mg sodium metamizole (dipyrone tablets produced by seven different laboratories in Brazil: three generic drugs (G1, G2, G3, three (branded similar drugs (S1, S2,S3 and their reference branded product (Novalgina®, Sanofi-Aventis, drug R. All tests were carried out by methods specified in the Brazilian Pharmacopeia 4th edition (Farmacopeia Brasileira IV. The following tests were performed: uniformity of mass, friability, disintegration time, hardness, assay, uniformity of dosage units, salicylic acid limit assay, dissolution and identification. The dissolution profile was also recorded, as recommended in RDC 31/2010. Whereas every sample was approved in all the Farmacopeia Brasileira IV tests, the results in the dissolution profile test showed that four of the test drugs (G1, G2, S1 and S2 were notpharmaceutically equivalent to drug R. Thus, only drugs G3 and S3 showed dissolution profiles similar to that of drug R and the other four drugs could not be considered equivalent to it and were not approved.

  9. International Guidelines on Human Rights and Drug Control: A Tool for Securing Women's Rights in Drug Control Policy.

    Science.gov (United States)

    Schleifer, Rebecca; Pol, Luciana

    2017-06-01

    Discrimination and inequality shape women's experiences of drug use and in the drug trade and the impact of drug control efforts on them, with disproportionate burdens faced by poor and otherwise marginalized women. In recent years, UN member states and UN drug control and human rights entities have recognized this issue and made commitments to integrate a 'gender perspective' into drug control policies, with 'gender' limited to those conventionally deemed women. But the concept of gender in international law is broader, rooted in socially constructed and culturally determined norms and expectations around gender roles, sex, and sexuality. Also, drug control policies often fail to meaningfully address the specific needs and circumstances of women (inclusively defined), leaving them at risk of recurrent violations of their rights in the context of drugs. This article explores what it means to 'mainstream' this narrower version of gender into drug control efforts, using as examples various women's experiences as people who use drugs, in the drug trade, and in the criminal justice system. It points to international guidelines on human rights and drug control as an important tool to ensure attention to women's rights in drug control policy design and implementation.

  10. [National and regional market penetration rates of generic's high dosage buprenorphine: its evolution from 2006 to 2008, using reimbursed drug database].

    Science.gov (United States)

    Boczek, Christelle; Frauger, Elisabeth; Micallef, Joëlle; Allaria-Lapierre, Véronique; Reggio, Patrick; Sciortino, Vincent

    2012-01-01

    To assess the national market penetration rate (PR) of generic high-dosage buprenorphine (HDB) in 2008 and its evolution since their marketing (2006), and making a point for each dosage and at regional level. Retrospective study over data using national and regional health reimbursement database over three years (2006-2008). In 2008, the generic HDB's national MPR was 31%. The PR for each dosage were 45% for 0.4 mg, 36% for 2 mg and 19% for 8 mg. The (PR) based on Defined Daily Dose (DDD) was 23% in 2008, 15% in 2007 and 4% in 2006. In 2008, at the regional level, disparities were observed in the adjusted penetration rate from 15% in Île de France to 39% in Champagne Ardennes Lorraine. The national PR of generic HDB has increased. There are differences in MPR in terms of dosage and area. However, this PR is still low (in 2008, 82% of the delivered drugs are generics). © 2012 Société Française de Pharmacologie et de Thérapeutique.

  11. Comparison of adherence to generic multi-tablet regimens vs. brand multi-tablet and brand single-tablet regimens likely to incorporate generic antiretroviral drugs by breaking or not fixed-dose combinations in HIV-infected patients.

    Science.gov (United States)

    Rwagitinywa, Joseph; Lapeyre-Mestre, Maryse; Bourrel, Robert; Montastruc, Jean-Louis; Sommet, Agnès

    2018-03-05

    Adherence to antiretroviral (ARV) is crucial to achieve viral load suppression in HIV-infected patients. This study aimed to compare adherence to generic multi-tablet regimens (MTR) vs. brand MTR likely to incorporate ARV drugs without breaking fixed-dose combinations (FDC) and brand single-tablet regimens (STR) likely to incorporate generics by breaking the FDC. Patients aged of 18 years or over exposed to one of the generic or the brand of lamivudine (3TC), zidovudine/lamivudine (AZT/TC), nevirapine (NVP), or efavirenz (EFV), or the brand STR of efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). Adherence was measured by medication possession ratio (MPR) using both defined daily dose (DDD) and daily number of tablet recommended for adults (DNT). Adherence to generic MTR vs. brand MTR and brand STR was compared using Kruskal-Wallis. The overall median adherence was 0.97 (IQR 0.13) by DNT method and 0.97 (0.14) by DDD method. Adherence in patients exposed to generic MTR (n = 165) vs. brand MTR (n = 481) and brand STR (n = 470) was comparable by DNT and DDD methods. In conclusion, adherence to generic MTR was high and comparable with adherence to brand MTR and to STR. Utilization of DDD instead DNT to measure the MPR led to small but nonsignificant difference that has no clinical impact. © 2018 Société Française de Pharmacologie et de Thérapeutique.

  12. “No generics, Doctor!” The perspective of general practitioners in two French regions

    Directory of Open Access Journals (Sweden)

    Béatrice Riner

    2017-11-01

    Full Text Available Abstract Background Generic medicines are essential to controlling health expenditures. Their market share is still small in France. The discourse and practices of prescribers may play a major role in their use. The purpose of this study was to explore the knowledge, attitudes and practices of general practitioners (GPs toward generic medicines in two French regions with the lowest penetration rate of these products. Methods An observational study was carried out from October 2015 to February 2016 in Guadeloupe and Martinique. The first qualitative phase involved a diversified sample of 14 GPs who underwent semi-structured interviews. The second phase involved a random sample of 316 GPs (response rate = 74% who were administered a structured questionnaire developed from the results of the first phase. Results Seventy-eight percent of the participants defined a generic drug as a drug containing an active substance identical to a brand-name drug, but only 11% considered generic drugs to be equivalent to brand-name drugs, and the same proportion believed that the generic drugs were of doubtful quality. The primary recognized advantage of generic medicines was their lower cost (82%. The main drawbacks cited were the variability of their presentation (44%, the confusion that they caused for some patients (47%, frequent allegations of adverse side effects (37% and a lack of efficacy (24%, and frequent refusal by patients (26%. Seventy-four percent of the participants stated that they adapted their prescribing practices to the situation, and of this group, 47% prescribed the originator product simply on demand. Conclusion Most surveyed GPs were not hostile towards generic medicines. They were caught between the requirements of health insurance regimes and the opposition of numerous users and suggested that the patient information provided by health authorities should be improved and that drug composition and packaging should be made uniform.

  13. Drug Testing in the Schools. Implications for Policy.

    Science.gov (United States)

    Bozeman, William C.; And Others

    Drug testing of district employees and students is examined from several perspectives: implications for school policy, legality, administration and protocol, and test reliability and accuracy. Substance abuse has become a major concern for educators, parents, and citizens as illegal drugs are more readily available. It is also pointed out that the…

  14. Why are generic drugs being held up in transit? Intellectual property rights, international trade, and the right to health in Brazil and beyond.

    Science.gov (United States)

    Rosina, Mônica Steffen Guise; Shaver, Lea

    2012-01-01

    Access to medicines faces a new legal threat: "border enforcement" of drug patents. Using Brazil as an example, this article shows how the right to health depends on international trade. Border seizures of generic drugs present human rights and trade institutions with a unique challenge. Can public health advocates rise to meet it? © 2012 American Society of Law, Medicine & Ethics, Inc.

  15. Spread of anti-malarial drug resistance: Mathematical model with implications for ACT drug policies

    Directory of Open Access Journals (Sweden)

    Dondorp Arjen M

    2008-11-01

    Full Text Available Abstract Background Most malaria-endemic countries are implementing a change in anti-malarial drug policy to artemisinin-based combination therapy (ACT. The impact of different drug choices and implementation strategies is uncertain. Data from many epidemiological studies in different levels of malaria endemicity and in areas with the highest prevalence of drug resistance like borders of Thailand are certainly valuable. Formulating an appropriate dynamic data-driven model is a powerful predictive tool for exploring the impact of these strategies quantitatively. Methods A comprehensive model was constructed incorporating important epidemiological and biological factors of human, mosquito, parasite and treatment. The iterative process of developing the model, identifying data needed, and parameterization has been taken to strongly link the model to the empirical evidence. The model provides quantitative measures of outcomes, such as malaria prevalence/incidence and treatment failure, and illustrates the spread of resistance in low and high transmission settings. The model was used to evaluate different anti-malarial policy options focusing on ACT deployment. Results The model predicts robustly that in low transmission settings drug resistance spreads faster than in high transmission settings, and treatment failure is the main force driving the spread of drug resistance. In low transmission settings, ACT slows the spread of drug resistance to a partner drug, especially at high coverage rates. This effect decreases exponentially with increasing delay in deploying the ACT and decreasing rates of coverage. In the high transmission settings, however, drug resistance is driven by the proportion of the human population with a residual drug level, which gives resistant parasites some survival advantage. The spread of drug resistance could be slowed down by controlling presumptive drug use and avoiding the use of combination therapies containing drugs with

  16. Interest Groups' Influence over Drug Pricing Policy Reform in South Korea

    Science.gov (United States)

    Chung, Woojin

    2005-01-01

    In 1999, the Korean government made a drug pricing policy reform to improve the efficiency and transparency of the drug distribution system. Yet, its policy formation process was far from being rational. Facing harsh resistance from various interest groups, the government changed its details into something different from what was initially investigated and planned. So far, little evidence supports any improvement in Korea's drug distribution system. Instead, the new drug pricing policy has deteriorated Korea's national health insurance budget, indicating a heavier economic burden for the general public. From Korea's experience, we may draw some lessons for the future development of a better health care system. As a society becomes more pluralistic, the government should come out of authoritarianism and thoroughly prepare in advance for resistance to reform, by making greater efforts to persuade strong interest groups while informing the general public of potential benefits of the reform. Additionally, facing developing civic groups, the government should listen but not rely too much on them at the final stage of the policy formation. Many of the civic groups lack expertise to evaluate the details of policy and tend to act in a somewhat emotional way. PMID:15988802

  17. Interest groups' influence over drug pricing policy reform in South Korea.

    Science.gov (United States)

    Chung, Woo Jin; Kim, Han Joong

    2005-06-30

    In 1999, the Korean government made a drug pricing policy reform to improve the efficiency and transparency of the drug distribution system. Yet, its policy formation process was far from being rational. Facing harsh resistance from various interest groups, the government changed its details into something different from what was initially investigated and planned. So far, little evidence supports any improvement in Korea's drug distribution system. Instead, the new drug pricing policy has deteriorated Korea's national health insurance budget, indicating a heavier economic burden for the general public. From Korea's experience, we may draw some lessons for the future development of a better health care system. As a society becomes more pluralistic, the government should come out of authoritarianism and thoroughly prepare in advance for resistance to reform, by making greater efforts to persuade strong interest groups while informing the general public of potential benefits of the reform. Additionally, facing developing civic groups, the government should listen but not rely too much on them at the final stage of the policy formation. Many of the civic groups lack expertise to evaluate the details of policy and tend to act in a somewhat emotional way.

  18. Some Numbers behind Canada's Decision to Adopt an Orphan Drug Policy: US Orphan Drug Approvals in Canada, 1997-2012.

    Science.gov (United States)

    Herder, Matthew; Krahn, Timothy Mark

    2016-05-01

    We examined whether access to US-approved orphan drugs in Canada has changed between 1997 (when Canada chose not to adopt an orphan drug policy) and 2012 (when Canada reversed its policy decision). Specifically, we looked at two dimensions of access to US-approved orphan drugs in Canada: (1) regulatory access; and (2) temporal access. Whereas only 63% of US-approved orphan drugs were granted regulatory approval in 1997, we found that regulatory access to US-approved orphan drugs in Canada increased to 74% between 1997 and 2012. However, temporal access to orphan drugs is slower in Canada: in a head-on comparison of 40 matched drugs, only two were submitted and four were approved first in Canada; moreover, the mean review time in Canada (423 days) was longer than that in the US (mean = 341 days), a statistically significant difference (t[39] = 2.04, p = 0.048). These results raise questions about what motivated Canada's apparent shift in orphan drug policy. Copyright © 2016 Longwoods Publishing.

  19. Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries.

    Science.gov (United States)

    Gammie, Todd; Lu, Christine Y; Babar, Zaheer Ud-Din

    2015-01-01

    To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country's legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country's pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access. Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.

  20. Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries.

    Directory of Open Access Journals (Sweden)

    Todd Gammie

    Full Text Available To review existing regulations and policies utilised by countries to enable patient access to orphan drugs.A review of the literature (1998 to 2014 was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country.Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country's legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35 had in place orphan drug legislation. Access to orphan drugs depends on individual country's pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access.Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.

  1. 21 CFR 1401.2 - The Office of National Drug Control Policy-organization and functions.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false The Office of National Drug Control Policy-organization and functions. 1401.2 Section 1401.2 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY PUBLIC AVAILABILITY OF INFORMATION § 1401.2 The Office of National Drug Control Policy—organization and functions. (a) The Office of National Drug...

  2. Optimal Drug Policy in Low-Income Neighborhoods

    Science.gov (United States)

    Chang, Sheng-Wen; Coulson, N. Edward; Wang, Ping

    2015-01-01

    The control of drug activity currently favors supply-side policies: drug suppliers in the U.S. face a higher arrest rate and longer sentences than demanders. We construct a simple model of drug activity with search and entry frictions in labor and drug markets. Our calibration analysis suggests a strong “dealer replacement effect.” As a result, given a variety of community objectives, it is beneficial to lower supplier arrests and raise the demand arrest rate from current values. A 10% shift from supply-side to demand-side arrests can reduce the population of potential drug dealers by 22–25,000 and raise aggregate local income by $380–400 million, at 2002 prices. (JEL Classification: D60, J60, K42, H70) PMID:27616878

  3. Associations between generic substitution and patient-related factors

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette

    Associations between generic substitution and patient-related factors Jette Østergaard Rathe1, Pia V. Larsen1, Morten Andersen2, Janus L. Thomsen3, Maja S. Paulsen1, Jens Søndergaard1 1. Research Unit of General Practice, Institute of Public Health, University of Southern Denmark 2. Centre...... for Pharmacoepidemiology, Karolinska Institutet, Department of Medicine Solna, Stockholm, Sweden 3. Danish Quality Unit of General Practice, Odense, Denmark Background Generic substitution means that chemically equivalent but less expensive drugs are dispensed in place of a brand name product. Although generic medicines...... by definition are bioequivalent to their brand name counterparts there are concerns about whether generic substitution is always accompanied by clinical equivalence in terms of effectiveness and that it may cause concerns and thereby causing some skepticism towards generic substitution. There is, however...

  4. "This body does not want free medicines": South African consumer perceptions of drug quality.

    Science.gov (United States)

    Patel, Aarti; Gauld, Robin; Norris, Pauline; Rades, Thomas

    2010-01-01

    OBJECTIVES Like many other developing countries, South Africa provides free medicines through its public health care facilities. Recent policies encourage generic substitution in the private sector. This study explored South African consumer perceptions of drug quality and whether these perceptions influenced how people procured and used their medicines. METHODS The study was undertaken in Durban, Cape Town and Johannesburg in South Africa between December 2005 and January 2006. A combination of purposive and snowball sampling was used to recruit participants from low and middle socio-economic groups as well as the elderly and teenagers. Data were collected through 12 focus group discussions involving a total of 73 participants. Interviews were tape-recorded. Thematic analysis was performed on the transcripts. RESULTS Irrespective of socio-economic status, respondents described medicine quality in terms of the effect the medicine produced on felt symptoms. Generic medicines, as well as medicines supplied without charge by the state, were considered to be poor quality and treated with suspicion. Respondents obtained medicines from three sources: public sector hospitals and/or clinics, dispensing doctors and community pharmacies. Cost, avoidance of feeling 'second-class', receiving individualized care and choice in drug selection were the main determinants influencing their procurement behaviour. Selection of over-the-counter medicines was influenced by prior knowledge of products, through advertising and previous use. Participants perceived that they had limited influence on selection of prescription medicines. Generic substitution would be supported if the doctor, rather than the pharmacist, recommended it. CONCLUSIONS Our findings emphasize the importance of meaningful consumer involvement in the development of national medicines policies, and strategic campaigns targeting consumers and prescribers regarding the quality of generic and essential medicines. Where

  5. Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries

    Science.gov (United States)

    Gammie, Todd

    2015-01-01

    Objective To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. Methods A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Results Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country’s legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country’s pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access. Conclusions Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases. PMID:26451948

  6. International experiences of promoting generics use and its implications to China.

    Science.gov (United States)

    Sun, Jing

    2013-05-01

    To summarize international experiences in promoting use of generics and to extract essence for China's reference. This is a commentary of two systematic reviews about policies to promote use of generics and its implications to China. Price, reimbursement, and generic substitution policies in European countries, and approaches in low and middle income countries in promoting market competition, appropriate intellectual property right protection strategy, and necessary demand side incentives, are all meaningful for China to contain soaring pharmaceutical expenditures, and to maintain the achievements and outcomes of the national health system reform. Effective promotion of generics use must be practice based on the real situation. Tailor-made and comprehensive measures are needed to address both demand and supply sides barriers before achieving tangible cost containment effect without unexpected side effects. © 2013 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

  7. Comparative effectiveness of generic versus brand-name antiepileptic medications.

    Science.gov (United States)

    Gagne, Joshua J; Kesselheim, Aaron S; Choudhry, Niteesh K; Polinski, Jennifer M; Hutchins, David; Matlin, Olga S; Brennan, Troyen A; Avorn, Jerry; Shrank, William H

    2015-11-01

    The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a brand-name product. We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus brand-name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and brand-name initiators. We also compared treatment persistence, measured as time to first 14-day treatment gap, between generic and brand-name initiators. We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among brand-name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2 days (standard deviation [sd], 125.8) for brand-name initiators and 137.9 (sd, 148.6) for generic initiators. Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated brand-name versions. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Intended and unintended consequences of China's zero markup drug policy.

    Science.gov (United States)

    Yi, Hongmei; Miller, Grant; Zhang, Linxiu; Li, Shaoping; Rozelle, Scott

    2015-08-01

    Since economic liberalization in the late 1970s, China's health care providers have grown heavily reliant on revenue from drugs, which they both prescribe and sell. To curb abuse and to promote the availability, safety, and appropriate use of essential drugs, China introduced its national essential drug list in 2009 and implemented a zero markup policy designed to decouple provider compensation from drug prescription and sales. We collected and analyzed representative data from China's township health centers and their catchment-area populations both before and after the reform. We found large reductions in drug revenue, as intended by policy makers. However, we also found a doubling of inpatient care that appeared to be driven by supply, instead of demand. Thus, the reform had an important unintended consequence: China's health care providers have sought new, potentially inappropriate, forms of revenue. Project HOPE—The People-to-People Health Foundation, Inc.

  9. Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

    Directory of Open Access Journals (Sweden)

    M Venkatesh

    2011-01-01

    Full Text Available Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20 th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.

  10. Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

    Science.gov (United States)

    Venkatesh, M.; Bairavi, V. G.; Sasikumar, K. C.

    2011-01-01

    Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.. PMID:21430959

  11. Is There Evidence to Support Brand to Generic Interchange of the Mycophenolic Acid Products?

    Science.gov (United States)

    Phillips, Karen; Reddy, Prabashni; Gabardi, Steven

    2017-02-01

    The uptake of generic immunosuppressants lags comparatively to other drug classes, despite that the Food and Drug Administration (FDA) uses identical bioequivalence standards for all drugs. Transplant societies acknowledge the cost savings associated with generic immunosuppressants and support their use following heart, lung, kidney, or bone marrow transplantation. Seven studies of the pharmacokinetics or clinical efficacy of generic mycophenolate mofetil compared to the innovator product are published; all studies and products were ex-United States. Three studies did not demonstrate any pharmacokinetic differences between generic and innovator products in healthy subjects, achieving FDA bioequivalence requirements. Two studies in renal allograft recipients demonstrated no difference in area under the curves between generic and innovator products, and in one, the maximum concentration (Cmax) fell outside the FDA regulatory range. Two studies revealed no difference in acute organ rejection or graft function in renal allograft recipients. Patient surveys indicate that cost is a barrier to immunosuppressant adherence. Generics present a viable method to reduce costs to payers, patients, and health care systems. Adherence to immunosuppressants is crucial to prevent graft failure. An affordable regimen potentially confers greater adherence. Concerns regarding the presumed inferiority of generic immunosuppressants should be assuaged by regulatory requirements for bioequivalency testing, transplant society position statements, and pharmacokinetic and clinical studies.

  12. Maximum potential cost-savings attributable to generic substitution ...

    African Journals Online (AJOL)

    D. Husselmann

    community. ... Conclusions: Potential economic benefits can be generated with generic substitution. ... Available online at www.sciencedirect.com ... supply of safe, cost-effective drugs of acceptable quality to all citizens of South Africa, and the rational use of drugs by .... different types of schizophrenic diagnosis) with a claim.

  13. Predictors of generic substitution: The role of psychological, sociodemographic, and contextual factors.

    Science.gov (United States)

    Drozdowska, Aleksandra; Hermanowski, Tomasz

    2016-01-01

    Escalating pharmaceutical costs have become a global challenge for both governments and patients. Generic substitution is one way of decreasing these costs. The aim of this study was to investigate factors associated with patients' choice between generic drugs and innovator drugs. The survey was conducted in June 2013, 1000 people from across Poland were chosen as a representative population sample. The outcome (a preference for generics/a preference for innovator pharmaceuticals/no preference) was modeled by multinomial logistic regression, adjusted for several variables describing patients' sensitivity to selected generic features (price, brand, and country of origin), to third-party opinions about generics (information on generics in the mass media, opinions of health professionals (i.e. physicians, pharmacists), relatives/friends), as well as patients' personal experiences and income per household. The results supported the predictive capacity of most independent variables (except for patient sensitivity to the country of origin and to the information on generics in the mass media), denoting patients' preferences toward generic substitution. Patient sensitivity to recommendations by physicians, generic brand, and household income were the strongest predictors of the choice between generic and innovator pharmaceuticals (P brand or their physician's opinion, as well as in respondents who were sensitive to recommendations by pharmacists or attached a greater value to a past experience with generics (their own experience or that of relatives/friends). In consideration of the foregoing, awareness-raising campaigns may be recommended, supported by a variety of systemic solutions and tools to encourage generic substitution. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Impacts of Generic Competition and Benefit Management...

    Data.gov (United States)

    U.S. Department of Health & Human Services — According to findings reported in Impacts of Generic Competition and Benefit Management Practices on Spending for Prescription Drugs - Evidence from Medicares Part D...

  15. Partnerships and communities in English drug policy: the challenge of deprivation.

    Science.gov (United States)

    Macgregor, Susanne; Thickett, Anthony

    2011-11-01

    From the mid-1990s, UK governments developed partnerships to tackle drugs nationally and locally. Over time, increased resources focused on communities and localities in greatest need. This reflected growing awareness of the concentration of problems in deprived areas, with social and spatial segregation being a feature of post-industrial urban areas. A review of English drug policy since the 1990s, drawing on:- analysis of documents; a review of sociological studies; an illustrative case-study of one northern town; interviews with local policy players; statistical analysis of key indicators with some of these data presented using Geographical Information System (GIS) mapping. In-depth sociological studies demonstrate interconnections between historical patterns, socio-economic change, cultural complexity, deprivation, limited opportunities and illicit drugs. At local level, there are links between concentrated multiple deprivation, poor health, acquisitive crime and problematic drug use. Partnership policies, encouraged by the provision of ring-fenced funds, have been effective in containing problems. Underlying issues of inequality are however neglected in political debates. The article argues that post-industrial towns and cities are characterised by an increase in problems related to poverty and drugs. Both the real shape and perceptions of what is the problem change over time. In England, the profile of the problem drug user was described in a number of sociological studies conducted from the 1980s onwards. Key features were the concentration of problems in certain social groups (such as the poorly educated or unemployed) and in certain areas (inner cities or outer estates). Responding to rising public concern, national drug strategies developed and the New Labour Government after 1997 prioritised the issue of drugs, directing increased resources to drug treatment with tight control over the use of these new monies through target setting and measurement of

  16. What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs.

    LENUS (Irish Health Repository)

    Dunne, Suzanne S

    2015-07-01

    Considerable emphasis is presently being placed on usage of generic medicines by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generic medicines. The objective of this paper is to report the outcomes of a systematic search for peer-reviewed, published studies that focus on physician, pharmacist and patient\\/consumer perspectives of generic medicines.

  17. Illicit Drugs, Policing and the Evidence-Based Policy Paradigm

    Science.gov (United States)

    Ritter, Alison; Lancaster, Kari

    2013-01-01

    The mantra of evidence-based policy (EBP) suggests that endeavours to implement evidence-based policing will produce better outcomes. However there is dissonance between the rhetoric of EBP and the actuality of policing policy. This disjuncture is critically analysed using the case study of illicit drugs policing. The dissonance may be ameliorated…

  18. Generic switching of warfarin and risk of excessive anticoagulation

    DEFF Research Database (Denmark)

    Hellfritzsch, Maja; Rathe, Jette; Stage, Tore Bjerregaard

    2016-01-01

    PURPOSE: Generic switching of warfarin was recently repealed in Denmark, as adverse drug reaction (ADR) reports suggested risk of excessive anticoagulation following switches from branded to generic warfarin. We investigated this putative association in a formalized pharmacoepidemiological analysis....... METHODS: We conducted a nationwide cohort study based on Danish healthcare registries, including data from the introduction of generic warfarin until the repeal (January 2011-April 2015). We followed Danish warfarin users over time and compared the rate of incident hospitalizations due to excessive...... anticoagulation (i.e. increased INR or any bleeding requiring hospitalization) in periods following a recent switch to generic warfarin to the rate in periods without a recent switch. RESULTS: We included 105,751 warfarin users, filling a total of 1,539,640 prescriptions for warfarin (2.5% for generic warfarin...

  19. Cost-Effectiveness and Cost Thresholds of Generic and Brand Drugs in a National Chronic Hepatitis B Treatment Program in China.

    Directory of Open Access Journals (Sweden)

    Mehlika Toy

    Full Text Available Chronic liver disease and liver cancer associated with chronic hepatitis B (CHB are leading causes of death among adults in China. Although newborn hepatitis B immunization has successfully reduced the prevalence of CHB in children, about 100 million Chinese adults remain chronically infected. If left unmanaged, 15-25% will die from liver cancer or liver cirrhosis. Antiviral treatment is not necessary for all patients with CHB, but when it is indicated, good response to treatment would prevent disease progression and reduce disease mortality and morbidity, and costly complications. The aim of this study is to analyze the cost-effectiveness of generic and brand antiviral drugs for CHB treatment in China, and assessing various thresholds at which a highly potent, low resistance antiviral drug would be cost-saving and/or cost-effective to introduce in a national treatment program. We developed a Markov simulation model of disease progression using effectiveness and cost data from the medical literature. We measured life-time costs, quality adjusted life years (QALYs, incremental cost-effectiveness ratios (ICERs, and clinical outcomes. The no treatment strategy incurred the highest health care costs ($12,932-$25,293 per patient, and the worst health outcomes, compared to the antiviral treatment strategies. Monotherapy with either entecavir or tenofovir yielded the most QALYs (14.10-19.02 for both HBeAg-positive and negative patients, with or without cirrhosis. Threshold analysis showed entercavir or tenofovir treatment would be cost saving if the drug price is $32-75 (195-460 RMB per month, highly cost-effective at $62-110 (379-670 RMB per month and cost-effective at $63-120 (384-734 RMB per month. This study can support policy decisions regarding the implementation of a national health program for chronic hepatitis B treatment in China at the population level.

  20. Clinical and economic consequences of treating patients with peripheral neuropathic pain with brand name or generic drugs in routine clinical practice: The effects of age and sex.

    Science.gov (United States)

    Navarro-Artieda, R; Rejas-Gutiérrez, J; Pérez-Paramo, M; Sicras-Mainar, A

    2018-04-01

    We aimed to analyse the effects of age and sex on pain and cost for patients with chronic peripheral neuropathic pain (PNP) who have started treatment with brand name gabapentin versus generic gabapentin (EFG). We conducted a retrospective multicentre study using electronic medical records (EMR) for patients of both sexes, older than 18, who began treatment with brand name or generic gabapentin. Adherence (medication possession ratio [MPR]), persistence, use of healthcare resources, cost, and pain reduction were measured for one year. We analysed 1369 EMRs [61.1% women; mean age 64.6 (15.9), 52.4%≥65 years]; 400 used brand name drugs while 969 used generic gabapentin. Persistence and adherence were higher in patients using brand name gabapentin (7.3 vs 6.3 months, Pbrand-name gabapentin in both age groups (brand treatment showed greater pain relief: 13.5% (10.9-16.2) and 10.8% (8.2-13.5) in brand name medication showed greater persistence and adherence to treatment than those taking generic drugs. Brand name treatment also involved lower healthcare costs, and greater pain relief. Copyright © 2016 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  1. Drug Policy and Indigenous Peoples.

    Science.gov (United States)

    Burger, Julian; Kapron, Mary

    2017-06-01

    This paper identifies the principal concerns of indigenous peoples with regard to current international treaties on certain psychoactive substances and policies to control and eradicate their production, trafficking, and sale. Indigenous peoples have a specific interest in the issue since their traditional lands have become integrated over time into the large-scale production of coca, opium poppy, and cannabis crops, in response to high demand from the American and European markets, among others. As a consequence, indigenous peoples are persecuted because of their traditional use of these and other plant-based narcotics and hallucinogens. They are also victims of the drug producers who remove them from their lands or forcibly recruit them into the production process. As indigenous peoples are caught in the violent world of illicit drug production, law enforcement often targets them first, resulting in disproportionate rates of criminalization and incarceration.

  2. HIV and AIDS among adolescents who use drugs: opportunities for drug policy reform within the sustainable development agenda.

    Science.gov (United States)

    Tinasti, Khalid

    2018-02-01

    The international community's commitment to halve by 2015 the HIV transmission among people who inject drugs has not only been largely missed, instead new HIV infections have increased by 30%. Moreover, drug injection remains one of the drivers of new HIV infections due to punitive responses and lack of harm reduction resourcing. In the midst of this situation, adolescents are a forgotten component of the global response to illegal drugs and their link with HIV infection. The Sustainable Development Goals (SDGs) present an opportunity to achieve the global objective of ending AIDS among adolescents who use drugs, by addressing the structural vulnerabilities they face be they economic, social, criminal, health-related or environmental. The implementation of the SDGs presents an opportunity to address the horizontal nature of drug policy and to efficiently address the drugs-adolescents-HIV risk nexus. Adolescent-focused drug policies are linked to goals 1, 3, 4, 10, 16 and 17. Goals 3 and 16 are the most relevant; the targets of the latter link to the criminalization of drug use and punitive policy environments and their impact on adolescents' health and HIV transmission risks. Moreover, it presents an opportunity to include adolescent needs that are missing in the three drug control conventions (1961, 1971 and 1988), and link them with the provisions of the Convention on the Rights of the Child (1989). Finally, the six principles to deliver on sustainable development are also an opportunity to divert adolescents who use drugs away from criminalization and punitive environments in which their vulnerability to HIV is greater. Addressing HIV among adolescents who use drugs is an extremely complex policy issue depending on different sets of binding and non-binding commitments, interventions and stakeholders. The complexity requires a horizontal response provided by the SDGs framework, starting with the collection of disaggregated data on this specific subgroup. Ending

  3. Drugs, money, and power: the Canadian drug shortage.

    Science.gov (United States)

    Kaposy, Chris

    2014-03-01

    This article describes the shortage of generic injectable medications in Canada that affected hospitals in 2012. It traces the events leading up to the drug shortage, the causes of the shortage, and the responses by health administrators, pharmacists, and ethicists. The article argues that generic drug shortages are an ethical problem because health care organizations and governments have an obligation to avoid exposing patients to resource scarcity. The article also discusses some options governments could pursue in order to secure the drug supply and thereby fulfill their ethical obligations.

  4. Impact of European pharmaceutical price regulation on generic price competition: a review.

    Science.gov (United States)

    Puig-Junoy, Jaume

    2010-01-01

    Although economic theory indicates that it should not be necessary to intervene in the generic drug market through price regulation, most EU countries intervene in this market, both by regulating the maximum sale price of generics (price cap) and by setting the maximum reimbursement rate, especially by means of reference pricing systems. We analyse current knowledge of the impact of direct price-cap regulation of generic drugs and the implementation of systems regulating the reimbursement rate, particularly through reference pricing and similar tools, on dynamic price competition between generic competitors in Europe. A literature search was carried out in the EconLit and PubMed databases, and on Google Scholar. The search included papers published in English or Spanish between January 2000 and July 2009. Inclusion criteria included that studies had to present empirical results of a quantitative nature for EU countries of the impact of price capping and/or regulation of the reimbursement rate (reference pricing or similar systems) on price dynamics, corresponding to pharmacy sales, in the generic drug market. The available evidence indicates that price-cap regulation leads to a levelling off of generic prices at a higher level than would occur in the absence of this regulation. Reference pricing systems cause an obvious and almost compulsory reduction in the consumer price of all pharmaceuticals subject to this system, to a varying degree in different countries and periods, the reduction being greater for originator-branded drugs than for generics. In several countries with a reference pricing system, it was observed that generics with a consumer price lower than the reference price do not undergo price reductions until the reference price is reduced, even when there are other lower-priced generics on the market (absence of price competition below the reference price). Beyond the price reduction forced by the price-cap and/or reference pricing regulation itself

  5. Models of policy-making and their relevance for drug research.

    Science.gov (United States)

    Ritter, Alison; Bammer, Gabriele

    2010-07-01

    Researchers are often frustrated by their inability to influence policy. We describe models of policy-making to provide new insights and a more realistic assessment of research impacts on policy. We describe five prominent models of policy-making and illustrate them with examples from the alcohol and drugs field, before drawing lessons for researchers. Policy-making is a complex and messy process, with different models describing different elements. We start with the incrementalist model, which highlights small amendments to policy, as occurs in school-based drug education. A technical/rational approach then outlines the key steps in a policy process from identification of problems and their causes, through to examination and choice of response options, and subsequent implementation and evaluation. There is a clear role for research, as we illustrate with the introduction of new medications, but this model largely ignores the dominant political aspects of policy-making. Such political aspects include the influence of interest groups, and we describe models about power and pressure groups, as well as advocacy coalitions, and the challenges they pose for researchers. These are illustrated with reference to the alcohol industry, and interest group conflicts in establishing a Medically Supervised Injecting Centre. Finally, we describe the multiple streams framework, which alerts researchers to 'windows of opportunity', and we show how these were effectively exploited in policy for cannabis law reform in Western Australia. Understanding models of policy-making can help researchers maximise the uptake of their work and advance evidence-informed policy.

  6. From chloroquine to artemether-lumefantrine: the process of drug policy change in Zambia

    Directory of Open Access Journals (Sweden)

    Snow Robert W

    2008-01-01

    Full Text Available Abstract Background Following the recognition that morbidity and mortality due to malaria had dramatically increased in the last three decades, in 2002 the government of Zambia reviewed its efforts to prevent and treat malaria. Convincing evidence of the failing efficacy of chloroquine resulted in the initiation of a process that eventually led to the development and implementation of a new national drug policy based on artemisinin-based combination therapy (ACT. Methods All published and unpublished documented evidence dealing with the antimalarial drug policy change was reviewed. These data were supplemented by the authors' observations of the policy change process. The information has been structured to capture the timing of events, the challenges encountered, and the resolutions reached in order to achieve implementation of the new treatment policy. Results A decision was made to change national drug policy to artemether-lumefantrine (AL in the first quarter of 2002, with a formal announcement made in October 2002. During this period, efforts were undertaken to identify funding for the procurement of AL and to develop new malaria treatment guidelines, training materials, and plans for implementation of the policy. In order to avoid a delay in implementation, the policy change decision required a formal adoption within existing legislation. Starting with donated drug, a phased deployment of AL began in January 2003 with initial use in seven districts followed by scaling up to 28 districts in the second half of 2003 and then to all 72 districts countrywide in early 2004. Conclusion Drug policy changes are not without difficulties and demand a sustained international financing strategy for them to succeed. The Zambian experience demonstrates the need for a harmonized national consensus among many stakeholders and a political commitment to ensure that new policies are translated into practice quickly. To guarantee effective policies requires

  7. Mobilizing Drug Consumption Rooms: inter-place networks and harm reduction drug policy.

    Science.gov (United States)

    McCann, Eugene; Temenos, Cristina

    2015-01-01

    This article discusses the learning and politics involved in spreading Drug Consumption Rooms (DCRs) globally. DCRs are health facilities, operating under a harm reduction philosophy, where people consume illicit drugs in a supervised setting. Approximately 90 are located in almost 60 cities in 11 countries. They are intensely local attempts to improve the lives of specific populations and urban neighborhoods. DCRs are also global models that travel. This article examines the relationship between DCRs as facilities that are fixed in place and DCRs as globally-mobilized models of drug policy and public health practice. Drawing on research from seven countries, we apply concepts from the policy mobilities literature to analyze the travels of the DCR model and the political strategies involved in the siting of these public health service facilities. We detail the networked mobilization of the DCR model from Europe to Canada and Australia, the learning among facilities, the strategies used to mold the DCR model to local contexts, and the role of DCR staff in promoting continued proliferation of DCRs. We conclude by identifying some immobilities of DCRs to identify questions about practices, principles and future directions of harm reduction. Copyright © 2014 Elsevier Ltd. All rights reserved.

  8. Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure.

    Science.gov (United States)

    Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo

    2004-06-01

    This paper investigates patterns of industrial dynamics and competition in the pharmaceutical industry, with particular reference to the consequences of patent expiry in different countries. We focus on the competition at the level of single chemical entities, distinguishing between original brands and generic products. Quarterly data, spanning from July 1987 to December 1998, on sales of pharmaceutical products in four countries (USA, UK, Germany, and France) constitute the basis of our analysis. All the products containing major molecules whose patent expiration date lies between 1986 and 1996 are included in our sample. We show how diffusion of generics is linked to the characteristics of the market and investigate how price dynamics of original products are affected by generic competition. Our empirical investigation shows that the dynamics of drug prices and the competition by generic drugs vary significantly across countries. This heterogeneity notwithstanding, a clear distinction seems to emerge. On the one hand, systems that rely on market-based competition in pharmaceuticals promote a clear distinction between firms that act as innovators and firms that act as imitators after patent expiry. Here, original products enjoy premium prices and exclusivity profits under patent protection, and face fierce price competition after patent expiry. On the other hand, in systems that rely on administered prices, penetration by generic drugs tends to be rather limited. Its descriptive and preliminary nature notwithstanding, our analysis seems to have relevant implications at different levels of generality, especially for Europe.

  9. Stigma, discrimination, treatment effectiveness, and policy: public views about drug addiction and mental illness.

    Science.gov (United States)

    Barry, Colleen L; McGinty, Emma E; Pescosolido, Bernice A; Goldman, Howard H

    2014-10-01

    Public attitudes about drug addiction and mental illness were compared. A Web-based national survey (N=709) was conducted to compare attitudes about stigma, discrimination, treatment effectiveness, and policy support in regard to drug addiction and mental illness. Respondents held significantly more negative views toward persons with drug addiction. More respondents were unwilling to have a person with drug addiction marry into their family or work closely with them. Respondents were more willing to accept discriminatory practices against persons with drug addiction, more skeptical about the effectiveness of treatments, and more likely to oppose policies aimed at helping them. Drug addiction is often treated as a subcategory of mental illness, and insurance plans group them together under the rubric of "behavioral health." Given starkly different public views about drug addiction and mental illness, advocates may need to adopt differing approaches to reducing stigma and advancing public policy.

  10. A review of illicit psychoactive drug use in elective surgery patients: Detection, effects, and policy.

    Science.gov (United States)

    Selvaggi, Gennaro; Spagnolo, Antonio G; Elander, Anna

    2017-12-01

    Limited information is present in literature regarding detection of illicit drug users visiting physicians when planning elective surgery; also, there is no update manuscript that is illustrating the effects of illicit drugs use that require reconstructive surgery interventions. Aims of this manuscript are: 1) to summarize existing knowledge, and give surgeons information how to detect patients who might possible use illicit drugs; 2) to review the effects of illicit drug use that specifically require reconstructive surgery interventions; 3) to assess on existing policies on asymptomatic illicit drug users when planning elective surgery. Studies were identified by searching systematically in the electronic databases PubMed, Medline, The Cochrane Library and SveMed+. Because of the nature of research questions to be investigated (drug policy and surgery), a "systematic review" was not possible. In spite of some existing policies to detect illicit drug use in specific situations such as workplaces or acute trauma patients, there is a lack of data and lack of information, and subsequently no policy has ever been made, for detection and management of illicit drug use asymptomatic patients requesting or referred for plastic surgery interventions. This manuscript poses questions for further ethical evaluations and future policy. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  11. Drug policing assemblages: Repressive drug policies and the zonal banning of drug users in Denmark’s club land

    DEFF Research Database (Denmark)

    Søgaard, Thomas F.; Houborg, Esben; Pedersen, Michael M.

    2017-01-01

    in local ‘drug policing assemblages’ characterized by inter-agency relation-building, the creative combination of public and private (legal) resources and internal power struggles. It also provides evidence of how drug policing assemblages give rise to many different, and often surprising, forms...... how zonal banning is also used to target drug-using clubbers in Denmark. Methods: Based on ethnographic observations and interviews with nightlife control agents in two Danish cities, the article aims to provide new insights into how the enforcement of national drug policies on drug-using clubbers......, is shaped by plural nightlife policing complexes. Results: The paper demonstrates how the policing of drug-using clubbers is a growing priority for both police and private security agents. The article also demonstrates how the enforcement of zonal bans on drug-using clubbers involves complex collaborative...

  12. Impact of the trade-related aspects of intellectual property rights (TRIPS) agreement on India as a supplier of generic antiretrovirals.

    Science.gov (United States)

    Babovic, Sonja; Wasan, Kishor M

    2011-03-01

    This is a commentary on how the trade-related aspects of intellectual property rights (TRIPS) agreement has impacted India as a supplier of generic antiretrovirals (ARVs). We provide a systematic review of the issues related to the TRIPS agreement that affects India. This includes discussion around (a) the legal landscape underpinning India as a supplier of generic ARVs; (b) supply of second-line ARVs; and (c) the future of generic drug production in India. The proclamation into force of TRIPS-compliant intellectual property law in India is likely to affect its position as a supplier of affordable ARVs, especially drugs brought to market after 2005. Currently, mechanisms exist for the generic production of almost all ARVs in India, including second-line drugs; however, the manufacture of these drugs by generic pharmaceutical companies may require additional market incentives. Compulsory licensing may emerge as an additional mechanism by which India can provide affordable versions of patented drugs to Least Developed Countries (LDCs). Copyright © 2010 Wiley-Liss, Inc.

  13. Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets.

    Science.gov (United States)

    Vaithianathan, Soundarya; Raman, Siddarth; Jiang, Wenlei; Ting, Tricia Y; Kane, Maureen A; Polli, James E

    2015-07-06

    The therapeutic equivalence of generic and brand name antiepileptic drugs has been questioned by neurologists and the epilepsy community. A potential contributor to such concerns is pharmaceutical quality. The objective was to assess the biopharmaceutic risk of brand name Lamictal 100 mg tablets and generic lamotrigine 100 mg tablets from several manufacturers. Lamotrigine was characterized in terms of the Biopharmaceutics Classification System (BCS), including aqueous solubility and Caco-2 permeability. A panel of pharmaceutical quality tests was also performed on three batches of Lamictal, three batches of Teva generic, and one batch of each of four other generics: appearance, identity, assay, impurity, uniformity of dosage units, disintegration, dissolution, friability, and loss on drying. These market surveillance results indicate that all brand name and generic lamotrigine 100 mg tablets passed all tests and showed acceptable pharmaceutical quality and low biopharmaceutic risk. Lamotrigine was classified as a BCS class IIb drug, exhibiting pH-dependent aqueous solubility and dissolution. At pH 1.2 and 4.5, lamotrigine exhibited high solubility, whereas lamotrigine exhibited low solubility at pH 6.8, including non-sink dissolution. Lamotrigine showed high Caco-2 permeability. The apparent permeability (Papp) of lamotrigine was (73.7 ± 8.7) × 10(-6) cm/s in the apical-to-basolateral (AP-BL) direction and (41.4 ± 1.6) × 10(-6) cm/s in the BL-AP direction, which were higher than metoprolol's AP-BL Papp of (21.2 ± 0.9) × 10(-6) cm/s and BL-AP Papp of (34.6 ± 4.6) × 10(-6) cm/s. Overall, lamotrigine's favorable biopharmaceutics from a drug substance perspective and favorable quality characteristics from a tablet formulation perspective suggest that multisource lamotrigine tablets exhibit a low biopharmaceutic risk.

  14. Problem Drug Use, Marijuana, and European Projects: How Epidemiology Helped Czech Policy Reformers

    Directory of Open Access Journals (Sweden)

    Jan Morávek

    2008-12-01

    Full Text Available I examine the transfer of the Problem Drug Use (PDU concept into Czech scientific discourse through European institutions’ projects, and view PDU’s utilization by Czech researchers in relation to marijuana decriminalization efforts.PDU is defined as intravenous and/or long-term and regular use of opiates, cocaine, or amphetamines. Out of a vast array of illicit drug use patterns, this concept isolates a relatively small population with the riskiest use patterns to become the focus of public policies. A series of European Union and Council of Europe projects in 1990’s helped bring PDU into European research mainstream. The new common standard, promoted by the European Monitoring Centre for Drugs and Drug Addiction, was utilized by Czech authors in a 2001 policy analysis entitled “Impact Analysis Project of the New Drug Legislation in the Czech Republic” (PAD. PDU played a crucial role in PAD’s drug problem modeling, focusing on a “hard core” of opiate and methamphetamine users, while diverting attention from a large group of cannabis users.By using the new European methodological standard, PAD’s authors constructed marijuana as a non-problem. This helped drug policy reformers in the Czech Government legitimize their focus on “harder” drugs, and subsequently propose more lenient sanctions for the possession and cultivation of marijuana. I argue that continued ignorance of marijuana problems might jeopardize the tolerant expert-driven drug policy in the Czech Republic. Measurement of problem cannabis use should be introduced.

  15. Comparative analysis of the cost and effectiveness of generic and brand-name antibiotics: the case of uncomplicated urinary tract infection.

    Science.gov (United States)

    Lin, Yu-Shiuan; Jan, I-Shiow; Cheng, Shou-Hsia

    2017-03-01

    Generic medications used for chronic diseases are beneficial in containing healthcare costs and improving drug accessibility. However, the effects of generic drugs in acute and severe illness remain controversial. This study aims to investigate treatment costs and outcomes of generic antibiotics prescribed for adults with a urinary tract infection in outpatient settings. The data source was the Longitudinal Health Insurance Database of Taiwan. We included outpatients aged 20 years and above with a urinary tract infection who required one oral antibiotic for which brand-name and generic products were simultaneously available. Drug cost and overall healthcare expense of the index consultation, healthcare cost during a 42-day follow-up period, and treatment failure rates were the main dependent variables. Data were compared between brand-name and generic users from the entire cohort and a propensity score-matched samples. Results from the entire cohort and propensity score-matched samples were similar. Daily antibiotic cost was significantly lower among generic users than brand-name users. Significant lower total drug claims of the index consultation only existed in patients receiving the investigated antibiotics, while the drug price between brand-name and generic versions were relatively large (e.g., >50%). The overall healthcare cost of the index consultation, healthcare expenditure during a 42-day follow-up period, and treatment failure rates were similar between the two groups. Compared with those treated with brand-name antibiotics, outpatients who received generic antibiotics had equivalent treatment outcomes with lower drug costs. Generic antibiotics are effective and worthy of adoption among outpatients with simple infections indicating oral antibiotic treatment. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  16. THERAPEUTIC EQUIVALENCE OF ORIGINAL CLOPIDOGREL (PLAVIX AND ITS GENERIC (EGITROMB. RESULTS OF COMPARATIVE RANDOMIZED CROSS-OVER BLIND STUDY

    Directory of Open Access Journals (Sweden)

    V. V. Yakusevich

    2011-01-01

    Full Text Available Aim. To study therapeutic equivalence (efficacy, safety and tolerability of original clopidogrel (Plavix and its generic (Egitromb in patients of high cardiovascular risk. Material and methods. Thirty one patients with coronary heart disease and indications for clopidogrel therapy were involved into the randomized cross-over blind study. Half of the patients received original clopidogrel (75 mg daily during the first 2 weeks and then they received generic clopidogrel in the same dose during next 2 weeks. Another half of the patients received the drugs in reverse order. Antiplatelet activity of Plavix and Egitromb was estimated by effects on ADP-induced platelet aggregation initially and after 2 weeks of treatment with each drug. Study blinding was provided by the following approach: doctors of cardiology clinic performed clinical monitoring and drug distribution; coded blood samples for platelet aggregation assessment were studied in independent laboratory of thrombosis; statistical data analysis was performed by biostatistics expert in other research center. Results. 2-week therapy with each drug led to a significant decrease of ADP-induced platelet aggregation which remained low after switching from original drug to generic and vice versa. Aggregation dynamics did not depend on the first administered drug. There were no significant differences between aggregation changes as a result of treatment with original or generic drug. No one adverse event was observed in association with both drugs therapy. Conclusion. Generic drug Egitromb (Egis, Hungary and original clopidogrel Plavix (Sanofi-Aventis, France have equivalent antiplatelet effect.

  17. On illicit drug policies; methods of evaluation and comments on recent practices.

    Science.gov (United States)

    Trovato, Giovanni; Vezzani, Antonio

    2013-06-01

    This contribution provides an overview of different approaches used to analyse drug policies within and across countries. Besides the great number of cost of illness studies which have contributed to the assessment of health harms and risks associated to the drug use, most of the recent efforts have focused on the creation of synthetic indices to classify countries around the world or to evaluate particular law enforcement policies in some countries. This is probably due to a general lack of comparable data across countries. The wide variety of budgetary practices in the drugs field in Europe contributes to the problems that exist in estimating drug-related public expenditure. These heterogeneous accounting practices, together with the complexity of the drug phenomenon and the multiplicity of perspectives on the issue, strongly constrains the possibility of economically evaluate and compare drug laws across countries.

  18. Does educational intervention improve doctors’ knowledge and perceptions of generic medicines and their generic prescribing rate? A study from Malaysia

    Science.gov (United States)

    Wong, Zhi Yen; Alrasheedy, Alian A.; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham

    2014-01-01

    Objectives: To investigate the impact of an educational intervention on doctors’ knowledge and perceptions towards generic medicines and their generic (international non-proprietary name) prescribing practice. Methods: This is a single-cohort pre-/post-intervention pilot study. The study was conducted in a tertiary care hospital in Perak, Malaysia. All doctors from the internal medicine department were invited to participate in the educational intervention. The intervention consisted of an interactive lecture, an educational booklet and a drug list. Doctors’ knowledge and perceptions were assessed by using a validated questionnaire, while the international non-proprietary name prescribing practice was assessed by screening the prescription before and after the intervention. Results: The intervention was effective in improving doctors’ knowledge towards bioequivalence, similarity of generic medicines and safety standards required for generic medicine registration (p = 0.034, p = 0.034 and p = 0.022, respectively). In terms of perceptions towards generic medicines, no significant changes were noted (p > 0.05). Similarly, no impact on international non-proprietary name prescribing practice was observed after the intervention (p > 0.05). Conclusion: Doctors had inadequate knowledge and misconceptions about generic medicines before the intervention. Moreover, international non-proprietary name prescribing was not a common practice. However, the educational intervention was only effective in improving doctors’ knowledge of generic medicines. PMID:26770747

  19. Are generic and brand-name statins clinically equivalent? Evidence from a real data-base.

    Science.gov (United States)

    Corrao, Giovanni; Soranna, Davide; Arfè, Andrea; Casula, Manuela; Tragni, Elena; Merlino, Luca; Mancia, Giuseppe; Catapano, Alberico L

    2014-10-01

    Use of generic drugs can help contain drug spending. However, there is concern among patients and physicians that generic drugs may be clinically inferior to brand-name ones. This study aimed to compare patients treated with generic and brand-name statins in terms of therapeutic interruption and cardiovascular (CV) outcomes. 13,799 beneficiaries of the health care system of Lombardy, Italy, aged 40 years or older who were newly treated with generic or brand-name simvastatin during 2008, were followed until 2011 for the occurrence of two outcomes: 1) therapeutic discontinuation and 2) hospitalization for CV events. Hazard ratios (HR) associated with use of generic or brand-name at starting therapy (intention-to-treat analysis) and during follow-up (as-treated analysis) were estimated by fitting proportional hazard Cox models. A Monte-Carlo sensitivity analysis was performed to account for unmeasured confounders. Patients who started on generic did not experience a different risk of discontinuation (HR: 0.98; 95% CI 0.94 to 1.02) nor of CV outcomes (HR: 0.98; 95% CI 0.79 to 1.22) from those starting on brand-name. Patients who spent >75% of time of follow-up with statin available on generics did not experience a different risk of discontinuation (HR: 0.94; 95% CI 0.87 to 1.01), nor of CV outcomes (HR: 1.06; 95% CI 0.83 to 1.34), compared with those who mainly or only used brand-name statin. Our findings do not support the notion that in the real world clinical practice brand-name statins are superior to generics for keeping therapy and preventing CV outcomes. Copyright © 2014. Published by Elsevier B.V.

  20. The assessment on impact of essential drugs policy on primary health care system in rural areas of Shandong Province policy and regulation division of the Health Department of Shandong Province.

    Science.gov (United States)

    Li, Zhuge; Shu, Defeng; Xia, Mei; Gao, Dehai; Lu, Dan; Huang, Ning; Tian, Xiaoqing; An, Limei; Li, Shixue; Li, Sheng

    2015-01-01

    At present, China has achieved an initial establishment and gradual implementation of a framework for national essential drugs policy. With the further implementation of the national essential drugs policy, it is not clear how the policy works, whether it achieves the original intention of essential drugs policy, and what impact essential drugs policy exerts on the primary health care system. In view of it, we conducted a field research on sample areas of Shandong Province to understand the conditions of the implementation of the essential drugs policy in Shandong Province. From three perspectives of medical institutions, patients and medical staff, this thesis analyzes the impact of essential drugs policy on village-level and township-level health service system, summarizes the effectiveness of implementing essential drugs policy, discovers the problems of various aspects and conducts an in-depth analysis of the causes, and puts forward feasible suggestions to provide reference for improving the essential drugs policy. The assessment results show that the implementation of essential drugs policy in Shandong Province has played a positive role in promoting the sound development of the primary health care system, changed the situation of covering hospital expenses with medicine revenue in the past, contributed to the return of medical institutions to public welfare, and reduced the patient's economic burden of disease. But there emerge many problems as follows: impact on the doctor's diagnosis and treatment due to incompleteness of drug types, and distribution not in place, patient loss and operational difficulty of village clinic. Thus, this thesis makes recommendations of drugs catalog formulation, drug procurement, sales and use, and meanwhile points out that the supporting financial compensation policy and performance appraisal policy and other measures in place are a prerequisite for a positive role of essential drugs policy.

  1. Implementation of public policy on alcohol and other drugs in Brazilian municipalities: comparative studies.

    Science.gov (United States)

    Mota, Daniela Belchior; Ronzani, Telmo Mota

    2016-07-01

    One of the challenges with respect to public health and the abuse of alcohol and other drugs is to implement policies in support of greater co-ordination among various levels of government. In Brazil, policies are formulated by the Secretaria Nacional de Políticas sobre Drogas (SENAD - State Department for Policies on Drugs) and the Ministério da Saúde (MS - Ministry of Health). This study aims to compare implementation of policies adopted by SENAD and MS at the municipal level. Three municipalities were intentionally selected: Juiz de Fora having a larger network of treatment services for alcohol and drug users; Lima Duarte, a small municipality, which promotes the political participation of local actors (COMAD - Municipal Council on Alcohol and Drugs); and São João Nepomuceno, also a small municipality, chosen because it has neither public services specialised to assist alcohol and other drugs users, nor COMAD. Data collection was conducted through interviews with key informants (n = 19) and a review of key documents concerned with municipal policies. Data analysis was performed using content analysis. In Juiz de Fora, there are obstacles regarding the integration of the service network for alcohol and other drug users and also the articulation of local actors, who are predominant in the mental health sector. In Lima Duarte, while there is a link between local actors through COMAD, their actions within the local service network have not been effective. In São João Nepomuceno, there were no public actions in the area of alcohol and drugs, and consequently insufficient local debate. However, some voluntary, non-governmental work has been undertaken. There were weaknesses in the implementation of national-level policies by SENAD and the MS, due to the limited supply of available treatment, assistance and the lack of integration among local actors. © 2015 John Wiley & Sons Ltd.

  2. Impact of brand or generic labeling on medication effectiveness and side effects.

    Science.gov (United States)

    Faasse, Kate; Martin, Leslie R; Grey, Andrew; Gamble, Greg; Petrie, Keith J

    2016-02-01

    Branding medication with a known pharmaceutical company name or product name bestows on the drug an added assurance of authenticity and effectiveness compared to a generic preparation. This study examined the impact of brand name and generic labeling on medication effectiveness and side effects. 87 undergraduate students with frequent headaches took part in the study. Using a within-subjects counterbalanced design, each participant took tablets labeled either as brand name "Nurofen" or "Generic Ibuprofen" to treat each of 4 headaches. In reality, half of the tablets were placebos, and half were active ibuprofen (400 mg). Participants recorded their headache pain on a verbal descriptor and visual analogue scale prior to taking the tablets, and again 1 hour afterward. Medication side effects were also reported. Pain reduction following the use of brand name labeled tablets was similar in active ibuprofen or a placebo. However, if the tablets had a generic label, placebo tablets were significantly less effective compared to active ibuprofen. Fewer side effects were attributed to placebo tablets with brand name labeling compared to the same placebo tablets with a generic label. Branding of a tablet appears to have conferred a treatment benefit in the absence of an active ingredient, while generic labeled tablets were substantially less effective if they contained no active ingredient. Branding is also associated with reduced attribution of side effects to placebo tablets. Future interventions to improve perceptions of generics may have utility in improving treatment outcomes from generic drugs. (c) 2016 APA, all rights reserved).

  3. The effect of generic switching on concerns about medicine and non-persistence among Danish adults in a general practice setting

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette

    BACKGROUND: Generic substitution means that one medicinal product is replaced by another product containing the same active substance. Generic substitution has existed in Denmark since 1991, and pharmacies are obliged to substitute a generic version of a medication, unless the general practitioner...... international studies have shown that most patients have positive attitudes towards generic substitution. The severity of disease is known to be associated with patients being more concerned about generic substitution. The generic substitution scheme implies changing from one drug to another that may vary...... in brand-name, form, size, colour and taste. Speculations have been raised as to whether these medication changes between generic brands or from brand-name drugs to generics or vice versa may cause patient concerns. Qualitative studies have shown problems in recognising the substituted medicine and lack...

  4. How Abbott’s Fenofibrate Franchise Avoided Generic Competition

    Science.gov (United States)

    Downing, Nicholas S.; Ross, Joseph S.; Jackevicius, Cynthia A.; Krumholz, Harlan M.

    2013-01-01

    The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug’s history: Abbott, the maker of branded fenofibrate, has produced several bioequivalent reformulations, which dominate the market even though generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on our healthcare system. Abbott maintained its dominance of the fenofibrate market, in part, through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented substitution with generics of older generation products. As soon as direct generic competition seemed likely at the new dose level where substitution would be allowed, Abbott would launch another reformulation and the cycle would repeat. Our objective, using the fenofibrate example, is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications without demonstrating the superiority of next generation products. PMID:22493409

  5. Generic programming for deterministic neutron transport codes

    International Nuclear Information System (INIS)

    Plagne, L.; Poncot, A.

    2005-01-01

    This paper discusses the implementation of neutron transport codes via generic programming techniques. Two different Boltzmann equation approximations have been implemented, namely the Sn and SPn methods. This implementation experiment shows that generic programming allows us to improve maintainability and readability of source codes with no performance penalties compared to classical approaches. In the present implementation, matrices and vectors as well as linear algebra algorithms are treated separately from the rest of source code and gathered in a tool library called 'Generic Linear Algebra Solver System' (GLASS). Such a code architecture, based on a linear algebra library, allows us to separate the three different scientific fields involved in transport codes design: numerical analysis, reactor physics and computer science. Our library handles matrices with optional storage policies and thus applies both to Sn code, where the matrix elements are computed on the fly, and to SPn code where stored matrices are used. Thus, using GLASS allows us to share a large fraction of source code between Sn and SPn implementations. Moreover, the GLASS high level of abstraction allows the writing of numerical algorithms in a form which is very close to their textbook descriptions. Hence the GLASS algorithms collection, disconnected from computer science considerations (e.g. storage policy), is very easy to read, to maintain and to extend. (authors)

  6. Generic substitution of antiretrovirals: patients' and health care providers' opinions.

    Science.gov (United States)

    Kieran, Jennifer A; O'Reilly, Eimear; O'Dea, Siobhan; Bergin, Colm; O'Leary, Aisling

    2017-10-01

    There is interest in introducing generic antiretroviral drugs (ARVs) into high-income countries in order to maximise efficiency in health care budgets. Studies examining patients' and providers' knowledge and attitudes to generic substitution in HIV are few. This was a cross-sectional, observational study with a convenience sample of adult HIV-infected patients and health care providers (HCPs). Data on demographics, knowledge of generic medicine and facilitators of generic substitution were collected. Descriptive and univariate analysis was performed using SPSS V.23™. Questionnaires were completed by 66 patients. Seventy-one per cent would have no concerns with the introduction of generic ARVs. An increase in frequency of administration (61%) or pill burden (53%) would make patients less likely to accept generic ARVs. There were 30 respondents to the HCP survey. Concerns included the supply chain of generics, loss of fixed dose combinations, adherence and use of older medications. An increase in dosing frequency (76%) or an increase in pill burden (50%) would make HCPs less likely to prescribe a generic ARV. The main perceived advantage was financial. Generic substitution of ARVs would be acceptable to the majority of patients and HCPs. Reinvesting savings back into HIV services would facilitate the success of such a programme.

  7. Paradigms of public policies for licit and illicit drugs in Brazil.

    Science.gov (United States)

    Gigliotti, Analice; Ribeiro, Marcelo; Tapia Aguilera, Amarílis; Rezende, Elton; Ogata Perrenoud, Luciane

    2014-01-01

    Brazil is a country of continental dimensions that, over the last 3 decades, has been making increased efforts to develop effective public policies for controlling the use of both licit and illicit psychoactive substances. In the case of licit drugs, Brazil was a pioneer in following the guidance of the World Health Organization for tobacco control and has witnessed surprising results relating to reduction of smoking prevalence and correlated morbidity and mortality. Today, Brazil has a national structure for organizing, applying, and monitoring laws relating to tobacco. However, in the field of illicit drugs, with crack consumption as a paradigm, the situation is the opposite: its use has been increasing year by year and is being consumed at increasingly young ages and by all social classes. Thus, it is becoming an enormous challenge for public policies relating to prevention and treatment. In this context, the aim of this article is to present a review of the epidemiological data relating to tobacco and crack use in Brazil, with an analysis on the impact of public policies for controlling consumption over recent years. Despite the efforts made over the last 3 decades, Brazil still has a long way to go in order to construct a consistent and effective national drugs policy.

  8. Establishment of in vitro-in vivo equivalence of highly variable drugs - a generic product development perspective.

    Science.gov (United States)

    Pathak, Shriram M; Aggarwal, Deepika; Venkateswarlu, V

    2014-06-01

    In vivo equivalence of highly variable drugs (HVD) has always been a subject of great concern, in terms of both safety and efficacy, for regulatory agencies. Successful demonstration of their bioequivalence thus presents the most crucial component of a generic application, significantly contributing toward the cost and time of development. For poorly soluble drugs, such as telmisartan, dissolution represents the rate-limiting step in the gastric region and in many cases may not be complete, thereby contributing to low and highly variable bioavailability. Consequently, simulation of gastrointestinal conditions is essential to adequately predict the in vivo behavior of drug formulations. In this study, we evaluated usefulness of physiologically relevant dissolution method over commonly used acidic media to forecast comparable in vivo performance of telmisartan formulation to that of reference samples. In the present study, telmisartan was classified as a HVD and a partial replicate design with repeating the reference product and scaling the bioequivalence for the reference variability has been presented. The design has effectively decreased sample size, without increasing patient risk. Results from this project suggest that scaled average bioequivalence (SABE) provides a good approach for evaluating the bioequivalence of HVD, meeting the need for international guidelines for bioequivalence.

  9. Drug plan design incentives among Medicare prescription drug plans.

    Science.gov (United States)

    Huskamp, Haiden A; Keating, Nancy L; Dalton, Jesse B; Chernew, Michael E; Newhouse, Joseph P

    2014-07-01

    Medicare Advantage prescription drug plans (MA-PDs) and standalone prescription drug plans (PDPs) face different incentives for plan design resulting from the scope of covered benefits (only outpatient drugs for PDPs versus all drug and nondrug services for Medicare Advantage [MA]/MA-PDs). The objective is to begin to explore how MA-PDs and PDPs may be responding to their different incentives related to benefit design. We compared 2012 PDP and MA-PD average formulary coverage, prior authorization (PA) or step therapy use, and copayment requirements for drugs in 6 classes used commonly among Medicare beneficiaries. We primarily used 2012 Prescription Drug Plan Formulary and Pharmacy Network Files and MA enrollment data. 2011 Truven Health MarketScan claims were used to estimate drug prices and to compute drug market share. Average coverage and PA/step rates, and average copayment requirements, were weighted by plan enrollment and drug market share. MA-PDs are generally more likely to cover and less likely to require PA/step for brand name drugs with generic alternatives than PDPs, and MA-PDs often have lower copayment requirements for these drugs. For brands without generics, we generally found no differences in average rates of coverage or PA/step, but MA-PDs were more likely to cover all brands without generics in a class. We found modest, confirmatory evidence suggesting that PDPs and MA-PDs respond to different incentives for plan design. Future research is needed to understand the factors that influence Medicare drug plan design decisions.

  10. Colombian drugs policy. The dose for personal and health rights

    Directory of Open Access Journals (Sweden)

    Juan Camilo Fischer Rodríguez

    2013-07-01

    Full Text Available This article is a review of Colombian law on drugs, with special emphasis on the so-called dose for personal and health rights that relate to the use of legal or illegal drugs. A brief contextualization of international treaties on drugs is presented, as well as presenting some cases representing the current debate on trade control measures and use of illegal drugs. The article argues that in the international and Colombian debate there are no homogeneous positions, and the repressive policies towards illegal drug use coexist with approaches from the public health that point to the recognition of the rights of people who use legal or illegal substances.

  11. QUALITATIVE DRUG: WHAT SHOULD IT LOOK LIKE?

    Directory of Open Access Journals (Sweden)

    V. V. Iakusevich

    2006-01-01

    Full Text Available Drug quality in modern market is discussed. There is an increase of a number of drugs that don’t meet to the quality requirements.Most of them are produced by Russian manufacturers, which number has also increased recently. According to official data 6-10%of all medicines are counterfeit. Quality reduction is also connected with a huge number (80% of reproduced drugs (generics. Considerable part among generics doesn’t pass required evaluation of equivalence with original product. Approved deviations (according to Russian regulative rules in pharmacological equivalence may reach 5%, and in pharmacokinetic equivalence -25%. Evidences of pharmacodynamic (therapeutic equivalence are not required at all. At the same time, author advocates the production of qualitative generics that can providemodern and accessible treatment. Generic quality should be confirmed by randomized studies with cross-over designed comparison with original drug in parallel groups. The examples of the generics with such evidences are demonstrated. The requirements to the data about drugs are given to help the physician to make a right independent estimation of its quality.

  12. Societal value of generic medicines beyond cost-saving through reduced prices.

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Simoens, Steven

    2015-01-01

    This paper aims to provide an overview of the added societal value of generic medicines beyond their cost-saving potential through reduced prices. In addition, an observational case study will document the impact of generic entry on access to pharmacotherapy in The Netherlands and an illustrative exercise was carried out to highlight the budget impact of generic entry. A narrative literature review was carried out to explore the impact of generic medicines on access to pharmacotherapy, innovation and medication adherence. Data from the Medicines and Medical Devices Information Project database in The Netherlands were used for the case study in which the impact of generic medicine entrance on the budget and the number of users was calculated as an illustrative exercise. Generic medicines have an additional societal value beyond their cost-saving potential through reduced prices. Generic medicines increase access to pharmacotherapy, provide a stimulus for innovation by both originator companies and generic companies and, under the right circumstances, have a positive impact on medication adherence. Generic medicines offer more to society than just their cost-saving potential through reduced prices. As such, governments must not focus only on the prices of generic medicines as this will threaten their long-term sustainability. Governments must therefore act appropriately and implement a coherent set of policies to increase the use of generic medicines.

  13. Illicit drug policy in Spain: the opinion of health and legal professionals.

    Science.gov (United States)

    Rossi, Paola; Blay, Ester; Costela, Víctor; Torrens, Marta

    2018-01-01

    The high frequency of criminal behaviour and related legal problems associated with substance addiction generates a field of interaction between legal and healthcare systems. This study was developed as a multicentre project to investigate the opinions of professionals from legal and healthcare systems about policies on illegal drugs and their implementation in practice. A multiple choice questionnaire designed ad hoc was administered to a sample of 230 professionals from legal and healthcare fields working in the cities of Barcelona, Granada and Bilbao. The questionnaire included sociodemographic and work-related data, and assessed interviewees' information about the response to drug-related crime and opinion on drug policy issues. This article presents the results from Spain. The main results showed that both groups of professionals value alternative measures to imprisonment (AMI) as useful tools to prevent offenses related to drug use and claim a broader application of AMI. They also evaluated positively the regulations on cannabis use in effect. Though the attitude of healthcare professionals towards the application of AMI is more permissive, both groups favour restricting these sanctions in cases of recidivism. Both groups show mild satisfaction with the current addiction healthcare system and express dissatisfaction with actual drug policies in Spain.

  14. Drugs for cardiovascular disease in India: perspectives of pharmaceutical executives and government officials on access and development-a qualitative analysis.

    Science.gov (United States)

    Newman, Charles; Ajay, Vamadevan S; Srinivas, Ravi; Bhalla, Sandeep; Prabhakaran, Dorairaj; Banerjee, Amitava

    2016-01-01

    India shoulders the greatest global burden of cardiovascular diseases (CVDs), which are the leading cause of mortality worldwide. Drugs are the bedrock of treatment and prevention of CVD. India's pharmaceutical industry is the third largest, by volume, globally, but access to CVD drugs in India is poor. There is a lack of qualitative data from government and pharmaceutical sectors regarding CVD drug development and access in India. By purposive sampling, we recruited either Indian government officials, or pharmaceutical company executives. We conducted a stakeholder analysis via semi-structured, face-to-face interviews in India. Topic guides allow for the exploration of key issues across multiple interviews, along with affording the interviewer the flexibility to examine matters arising from the discussions themselves. After transcription, interviews underwent inductive thematic analysis. Ten participants were interviewed (Government Officials: n = 5, and Pharmaceutical Executives: n = 5). Two themes emerged: i) 'Policy-derived Factors'; ii) 'Patient- derived Factors' with three findings. First, both government and pharmaceutical participants felt that the focus of Indian pharma is shifting to more complex, high-quality generics and to new drug development, but production of generic drugs rather than new molecular entities will remain a major activity. Second, current trial regulations in India may restrict India's potential role in the future development of CVD drugs. Third, it is likely that the Indian government will tighten its intellectual property regime in future, with potentially far-reaching implications on CVD drug development and access. Our stakeholder analysis provides some support for present patent regulations, whilst suggesting areas for further research in order to inform future policy decisions regarding CVD drug development and availability. Whilst interviewees suggested government policy plays an important role in shaping the industry, a

  15. How Drug Control Policy and Practice Undermine Access to Controlled Medicines.

    Science.gov (United States)

    Burke-Shyne, Naomi; Csete, Joanne; Wilson, Duncan; Fox, Edward; Wolfe, Daniel; Rasanathan, Jennifer J K

    2017-06-01

    Drug conventions serve as the cornerstone for domestic drug laws and impose a dual obligation upon states to prevent the misuse of controlled substances while ensuring their adequate availability for medical and scientific purposes. Despite the mandate that these obligations be enforced equally, the dominant paradigm enshrined in the drug conventions is an enforcement-heavy criminal justice response to controlled substances that prohibits and penalizes their misuse. Prioritizing restrictive control is to the detriment of ensuring adequate availability of and access to controlled medicines, thereby violating the rights of people who need them. This paper argues that the drug conventions' prioritization of criminal justice measures-including efforts to prevent non-medical use of controlled substances-undermines access to medicines and infringes upon the right to health and the right to enjoy the benefits of scientific progress. While the effects of criminalization under drug policy limit the right to health in multiple ways, we draw on research and documented examples to highlight the impact of drug control and criminalization on access to medicines. The prioritization and protection of human rights-specifically the right to health and the right to enjoy the benefits of scientific progress-are critical to rebalancing drug policy.

  16. Generic legislation of new psychoactive drugs

    NARCIS (Netherlands)

    van Amsterdam, Jan; Nutt, David; van den Brink, Wim

    2013-01-01

    New psychoactive drugs (NPDs, new psychoactive substances) enter the market all the time. However, it takes several months to ban these NPDs and immediate action is generally not possible. Several European countries and drug enforcement officers insist on a faster procedure to ban NPDs. Introduction

  17. Critérios de Beers-Fick e medicamentos genéricos no Brasil Beer-Fick criteria and generic drugs in Brazil

    Directory of Open Access Journals (Sweden)

    Milton Luiz Gorzoni

    2008-08-01

    Full Text Available OBJETIVO: Determinar a prevalência de fármacos potencialmente inapropriados para idosos em medicamentos genéricos brasileiros pelos critérios de Beers-Fick. MÉTODOS: Análise da lista de medicamentos genéricos publicada no Diário Oficial da União de 12 de julho de 2004 e copiada da página da Agência Nacional de Vigilância Sanitária (ANVISA - www.anvisa.gov.br, utilizando-se os critérios de Beers-Fick. RESULTADOS: Contendo 299 produtos e/ou apresentações, a lista analisada apresentava 20 deles (6,7% do total incluídos nos critérios de Beers-Fick, concentrados nas categorias de ansiolíticos, antiagregantes plaquetários, antialérgicos, antiangionosos e vasodilatadores, antiarrítmicos, antidepressivos, antiespasmódicos, anti-hipertensivos, antiinflamatórios não esteroidais, antiulcerosos e glicosídeos cardíacos. Esses critérios não incluem fármacos como antitussígenos, cinarizina, diltiazem, piracetam, quinolonas, xantinas, cremes, pomadas e colírios que fazem parte dessa lista de medicamentos genéricos. CONCLUSÃO: Critérios de Beers-Fick são úteis para a prevenção do uso de fármacos potencialmente inapropriados em idosos, com a ressalva de que não são completos para medicamentos genéricos brasileiros.BACKGROUND: Determine, according to the Beer-Fick criteria, the prevalence of drugs potentially inappropriate for the elderly available as generic medication in Brazil. METHODS: Analysis of the list of generic medications issued by " Diário Oficial da União" on July/12/2004 and of the page of the National Agency for Sanitary Surveillance (ANVISA - www.anvisa.gov.br, using the Beers-Fick criteria. RESULTS: From the list of 299 products 20 (6.7% of the total included in the Beers-Fick criteria were analyzed, mainly in the categories of anxiolytics, platelet antiaggregants, antiallergics, anti-angina and vasodilators, antiarrythmics, antidepressants, antispasmodics, anti-hypertensive's, non steroid

  18. Variation in cash price of the generic medications most prescribed by dermatologists in pharmacies across the United States.

    Science.gov (United States)

    Alghanem, Noor; Abokwidir, Manal; Fleischer, Alan B; Feldman, Steven R; Alghanem, Ward

    2017-03-01

    The United States has the highest drug costs in the world. Consumers complain about large price differences at pharmacies on generic drugs. To evaluate variation in cash prices of generic medications most prescribed in dermatology across different drugstores and states in United States. The 11 generic drugs most prescribed by dermatologists according to National Ambulatory Medical Care Survey were assessed. By using Google, the most common used pharmacies in United States were listed, which are located at a random selection of six states. By calling the first available number of each pharmacy in the six states and asking about the generic cash price of the smallest stock size and the most prescribed type, the data were collected. Drug prices varied; the median cumulative price of the 11 medications was highest at Rite Aid ($1226) and lowest at Walmart ($795.34) with 35% difference. The prices at CVS differed by 20% across different states; however, the prices at Walmart, Rite Aid and Walgreens were consistent. New York has the highest and Iowa the lowest prices, especially at CVS, ($1160.79) versus ($931.32). There are varieties in the prices for the generic medications in different pharmacies and States.

  19. Peer, professional, and public: an analysis of the drugs policy advocacy community in Europe.

    Science.gov (United States)

    O'Gorman, Aileen; Quigley, Eoghan; Zobel, Frank; Moore, Kerri

    2014-09-01

    In recent decades a range of advocacy organisations have emerged on the drugs policy landscape seeking to shape the development of policy at national and international levels. This development has been facilitated by the expansion of 'democratic spaces' for civil society participation in governance fora at national and supranational level. However, little is known about these policy actors - their aims, scope, organisational structure, or the purpose of their engagement. Drug policy advocacy organisations were defined as organisations with a clearly stated aim to influence policy and which were based in Europe. Data on these organisations was collected through a systematic tri-lingual (English, French and Spanish) Internet search, supplemented by information provided by national agencies in the 28 EU member states, Norway and Turkey. In order to differentiate between the diverse range of activities, strategies and standpoints of these groups, information from the websites was used to categorise the organisations by their scope of operation, advocacy tools and policy constituencies; and by three key typologies - the type of advocacy they engaged in, their organisational type, and their advocacy objectives and orientation. The study identified over two hundred EU-based advocacy organisations (N=218) which included civil society associations, NGOs, and large-scale alliances and coalitions, operating at local, national and European levels. Three forms of advocacy emerged from the data analysis - peer, professional and public policy. These groups focused their campaigns on practice development (harm reduction or abstinence) and legislative reform (reducing or strengthening drug controls). The findings from this study provide a nuanced profile of civil society advocacy as a policy community in the drugs field; their legitimacy to represent cases, causes, social values and ideals; and their focus on both insider and outsider strategies to achieve their goals. The level of

  20. Exploring the Knowledge and Perception of Generic Medicines among Final Year Undergraduate Medical, Pharmacy, and Nursing Students in Sierra Leone: A Comparative Cross-Sectional Approach

    Directory of Open Access Journals (Sweden)

    Peter Bai James

    2018-01-01

    Full Text Available Most low-income nations have national medicine policy that emphasized the use of generic medicines in the public health sector. However, the use of generics is often debatable as there are concerns over its efficacy, quality, and safety compared to their branded counterparts. This study was conducted to compare the knowledge and perception of generic medicines among final year undergraduate medical, pharmacy, and nursing students in Sierra Leone. We conducted a questionnaire-based cross-sectional study among these students at the College of Medicine and Allied Health Sciences University of Sierra Leone. Out of the 62 students, only two (2/62, 3.2% knew about the acceptable bioequivalence limit. At least half of respondents in all three groups agreed that all generics are therapeutically equivalent to their innovator brand. At least half of the medicine (21/42, 50% and nursing (6/9, 66.6% students, compared to pharmacy students (5/11, 45.5%, believed that higher safety standards are required for proprietary medicines than for generic medicines. Most of them agreed that they need more information on the safety, quality, and efficacy aspects of generics (59/62, 95.2%. All three groups of healthcare students, despite variations in their responses, demonstrated a deficiency in knowledge and misconception regarding generic medicines. Training on issues surrounding generic drugs in healthcare training institutions is highly needed among future healthcare providers in Sierra Leone.

  1. Drugs Approved for Neuroblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  2. From Imitation to Innovation: A Study of China’s Drug R&D and Relevant National Policies

    Directory of Open Access Journals (Sweden)

    Jinxi Ding

    2011-06-01

    Full Text Available Research & Development (R&D plays an increasingly important role in China’s pharmaceutical industry. To gain a competitive edge in the global pharmaceutical market, the current national strategy of China forcefully pushes for independent drug innovations. This article investigates the historical, legal, and institutional contexts in which China’s drug R&D has evolved. Based on an analysis of the drug R&D evolution and national policies in China, it predicts the future trend of China’s policies relevant to drug innovations. This paper helps to understand the impact of national policies on drug R&D in China, which can be used to inform decision-making on investments in China’s pharmaceutical market or conducting technology trade and international cooperation with Chinese partners.

  3. Drugs Approved for Retinoblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  4. Pricing of drugs with heterogeneous health insurance coverage.

    Science.gov (United States)

    Ferrara, Ida; Missios, Paul

    2012-03-01

    In this paper, we examine the role of insurance coverage in explaining the generic competition paradox in a two-stage game involving a single producer of brand-name drugs and n quantity-competing producers of generic drugs. Independently of brand loyalty, which some studies rely upon to explain the paradox, we show that heterogeneity in insurance coverage may result in higher prices of brand-name drugs following generic entry. With market segmentation based on insurance coverage present in both the pre- and post-entry stages, the paradox can arise when the two types of drugs are highly substitutable and the market is quite profitable but does not have to arise when the two types of drugs are highly differentiated. However, with market segmentation occurring only after generic entry, the paradox can arise when the two types of drugs are weakly substitutable, provided, however, that the industry is not very profitable. In both cases, that is, when market segmentation is present in the pre-entry stage and when it is not, the paradox becomes more likely to arise as the market expands and/or insurance companies decrease deductibles applied on the purchase of generic drugs. Copyright © 2012 Elsevier B.V. All rights reserved.

  5. The cocaine and heroin markets in the era of globalisation and drug reduction policies.

    Science.gov (United States)

    Costa Storti, Cláudia; De Grauwe, Paul

    2009-11-01

    Despite the large volume of public effort devoted to restrain drug supply and the growing attention given to drug demand reduction policies, the use of cocaine and heroin remains steady. Furthermore, retail drug prices have fallen significantly in Europe and the US. This puzzling evidence leads us to develop a model aiming at systematically analysing illicit drug markets. We model the markets of cocaine and heroin from production to the final retail markets. One novelty of the analysis consists in characterising the retail market as a monopolistic competitive one. Then, upper level dealers have some market power in the retail market. This allows them to charge a markup and to earn extra profits. These extra profits attract newcomers so that profits tend to fall over time. Theoretical model was used to analyse the effect of supply containment policies on the retail market, the producer market and the export-import business. This introduces the discussion of the impact of demand reduction policies on the high level traffickers' profit. Finally, globalisation enters in the model. Law enforcement measures increase the risk premia received by the lower and higher level traffickers. Consequently, trafficking intermediation margins tend to increase. However, globalisation has the opposite effect. It lowers intermediation margins and, then, pushes retail prices down, thereby stimulating consumption. In doing so, globalisation offsets the effects of supply containment policies. Finally, we discuss how the effectiveness of supply containment policies can be enhanced by combining them with demand reduction policies.

  6. Analysis of the Italian generic medicines retail market: recommendations to enhance long-term sustainability.

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Simoens, Steven

    2015-02-01

    Italy is among the European countries with the lowest uptake of generic medicines. This paper provides a perspective on the Italian generic medicines retail market. Fast market entrance of generic medicines in Italy is hindered by several factors: the existence of Complementary Protection Certificates in the past, the large market for copies and multiple cases of patent linkage. Prices of generic medicines in Italy are low compared to other European countries. To contain pharmaceutical expenditure, pharmaceutical companies are currently forced to pay back in case of overspending, which disproportionally penalizes small and fast growing companies, to which most generic companies belong to. Current demand-side policies do not successfully stimulate the use of generic medicines. The current market environment surrounding the Italian generic medicines retail market (i.e., low prices, low volumes) threatens its long-term sustainability. Recommendations to enhance the long-term sustainability of the Italian generic medicines retail market round off this perspective paper.

  7. Generic substitution of antidiabetic drugs in the elderly does not affect adherence

    Directory of Open Access Journals (Sweden)

    Francesco Trotta

    2014-12-01

    Full Text Available INTRODUCTION: The possibility that variation in packaging and pill appearance may reduce adherence is a reason for concern, especially for chronic diseases. The objectives of the study were to quantify the extent of switches between generic antidiabetics and to verify whether switching between different products of the same substance affects adherence. MATERIALS AND METHODS: All elderly residents of the Umbria Region who received at least 2 prescriptions of antidiabetics in 2010 and 2011 were included in the study. Switching was defined as the dispensing of two different products of the same substance in a series of two prescriptions. Single and multiple switchers were identified according to the number of switches during 2011. Switching relevant to the three off-patent substances with generic use ≥ 5% (metformin, gliclazide and repaglinide was quantified. The effect of switching on adherence, defined as the proportion of days in 2011 covered by prescriptions (Medication Possession Ratio, MPR, was estimated. RESULTS: Among the 15 964 patients receiving antidiabetics (14.4% of the elderly population 9211 were prescribed at least one of the generic substances. Of these patients, 23.3% experienced a single switch and 15.7% were multiple switchers (61.0% never switched. The proportion of multiple switchers increased with the number of prescriptions, reaching 26% among patients with ≥ 11 prescriptions. MPR was 62%, 62% and 72%, respectively among non-switchers, single and multiple switchers. CONCLUSIONS: In elderly patients treated with antidiabetics, the substitution between branded and unbranded products (as well as between generics of the same substance, did not negatively affect adherence.

  8. Information for Consumers (Drugs)

    Science.gov (United States)

    ... approved drugs Drugs@FDA Information on FDA-approved brand name and generic drugs including labeling and regulatory history Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) REMS is a risk management plan required by FDA for certain prescription drugs, ...

  9. An In Vitro Aerosolization Efficiency Comparison of Generic and Branded Salbutamol Metered Dose Inhalers

    Directory of Open Access Journals (Sweden)

    Sara Rahimkhani, Saeed Ghanbarzadeh, Ali Nokhodchi, Hamed Hamishehkar

    2017-03-01

    Full Text Available Background: Due to the high rate of pulmonary diseases, respiratory drug delivery systems have been attracted excessive attention for the past decades. Because of limitations and growing drug bill, physicians are encouraged to prescribe generically whenever possible. The purpose of this study was to evaluate whether there was any significant difference in aerosolization performance between a reference brand Salbutamol (A Metered Dose Inhalers (MDIs and two generic products (B and C. Methods: The aerosolization performance of MDIs was evaluated by calculating aerosolization indexes including fine particle fraction (FPF, fine particle dose (FPD, geometric standard deviation (GSD and mass median aerodynamic diameters (MMAD by using the next generation impactor. Results: Although aerosolization indexes of MDI A were superior than the Iranian brands, but the differences were not statistically significant. Conclusion: These results verified that generic MDIs deliver similar quantities of Salbutamol to the reference brand and aerosolization performance parameters of generic Salbutamol MDIs did not differ significantly from the reference brand.

  10. Psychedelics and cognitive liberty: Reimagining drug policy through the prism of human rights.

    Science.gov (United States)

    Walsh, Charlotte

    2016-03-01

    This paper reimagines drug policy--specifically psychedelic drug policy--through the prism of human rights. Challenges to the incumbent prohibitionist paradigm that have been brought from this perspective to date--namely by calling for exemptions from criminalisation on therapeutic or religious grounds--are considered, before the assertion is made that there is a need to go beyond such reified constructs, calling for an end to psychedelic drug prohibitions on the basis of the more fundamental right to cognitive liberty. This central concept is explicated, asserted as being a crucial component of freedom of thought, as enshrined within Article 9 of the European Convention on Human Rights (ECHR). It is argued that the right to cognitive liberty is routinely breached by the existence of the system of drug prohibition in the United Kingdom (UK), as encoded within the Misuse of Drugs Act 1971 (MDA). On this basis, it is proposed that Article 9 could be wielded to challenge the prohibitive system in the courts. This legal argument is supported by a parallel and entwined argument grounded in the political philosophy of classical liberalism: namely, that the state should only deploy the criminal law where an individual's actions demonstrably run a high risk of causing harm to others. Beyond the courts, it is recommended that this liberal, rights-based approach also inform psychedelic drug policy activism, moving past the current predominant focus on harm reduction, towards a prioritization of benefit maximization. How this might translate in to a different regulatory model for psychedelic drugs, a third way, distinct from the traditional criminal and medical systems of control, is tentatively considered. However, given the dominant political climate in the UK--with its move away from rights and towards a more authoritarian drug policy--the possibility that it is only through underground movements that cognitive liberty will be assured in the foreseeable future is

  11. Drug utilization study of gynecology OPD: In a tertiary care hospital.

    Directory of Open Access Journals (Sweden)

    Baig MS, Bagle TR,Gadappa SN, Deshpande Sonali, Doifode SM

    2013-04-01

    Full Text Available Background: The treatment of diseases by use of essential medicines, prescribed by generic names, has been emphasized by WHO and National Health Policy of India. Drugs used in gynaecology are one of the top selling drugs in India; however they are least studied with respect to drug utilization. Thus present study was undertaken to analyze drug utilization pattern of gynecology OPD in a tertiary care hospital. Materials and Methods: A retrospective, cross sectional, observational study of prescriptions in Gynecology OPD. Data was obtained from an electronic medical record database of patients that attended Gynecology OPD during the study period. Prescription records of patients were screened as per inclusion and exclusion criteria and 300 prescriptions were randomly selected by Openepi software. Patient related and drug related information was collected on a customized data collection sheet. Results: The mean age of patients was 30.19+9.83 years and common age of presentation was >18-30 years. In infective cases, vaginal discharge (10.33% was common, and in non-infective cases, menstrual disorders (24% were common. The average number of drugs per prescription was 3.47+1.53. In drug category, minerals (30.94% were most commonly prescribed, followed by antimicrobials (24.98%, and NSAIDs (13.37%. Polypharmacy was observed in 96.33% of the prescriptions. Conclusion: It is only by drug utilization studies that burden of diseases and corresponding utilization of drugs in gynecology can be measured. In our study majority of the drugs prescribed were generic which were from the essential medical list NLEM and WHO.

  12. Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard.

    Science.gov (United States)

    Ting, Tricia Y; Jiang, Wenlei; Lionberger, Robert; Wong, Jessica; Jones, Jace W; Kane, Maureen A; Krumholz, Allan; Temple, Robert; Polli, James E

    2015-09-01

    To test the current U.S. Food and Drug Administration (FDA) bioequivalence standard in a comparison of generic and brand-name drug pharmacokinetic (PK) performance in "generic-brittle" patients with epilepsy under clinical use conditions. This randomized, double-blind, multiple-dose, steady-state, fully replicated bioequivalence study compared generic lamotrigine to brand-name Lamictal in "generic-brittle" patients with epilepsy (n = 34) who were already taking lamotrigine. Patients were repeatedly switched between masked Lamictal and generic lamotrigine. Intensive PK blood sampling at the end of each 2-week treatment period yielded two 12-h PK profiles for brand-name and generic forms for each patient. Steady-state area under the curve (AUC), peak plasma concentration (Cmax ), and minimum plasma concentration (Cmin ) data were subjected to conventional average bioequivalence (ABE) analysis, reference-scaled ABE analysis, and within-subject variability (WSV) comparisons. In addition, generic-versus-brand comparisons in individual patients were performed. Secondary clinical outcomes included seizure frequency and adverse events. Generic demonstrated bioequivalence to brand. The 90% confidence intervals of the mean for steady-state AUC, Cmax , and Cmin for generic-versus-brand were 97.2-101.6%, 98.8-104.5%, and 93.4-101.0%, respectively. The WSV of generic and brand were also similar. Individual patient PK ratios for generic-versus-brand were similar but not identical, in part because brand-versus-brand profiles were not identical, even though subjects were rechallenged with the same product. Few subjects had seizure exacerbations or tolerability issues with product switching. One subject, however, reported 267 focal motor seizures, primarily on generic, although his brand and generic PK profiles were practically identical. Some neurologists question whether bioequivalence in healthy volunteers ensures therapeutic equivalence of brand and generic antiepileptic drugs

  13. 36 CFR 1280.20 - What is your policy on illegal drugs and alcohol?

    Science.gov (United States)

    2010-07-01

    ... illegal drugs and alcohol? 1280.20 Section 1280.20 Parks, Forests, and Public Property NATIONAL ARCHIVES... Conduct on NARA Property? Prohibited Activities § 1280.20 What is your policy on illegal drugs and alcohol... property while under the influence of illegal drugs or alcohol. Using alcoholic beverages on NARA property...

  14. Essential to increase the use of generics in Europe to maintain comprehensive health care?

    Directory of Open Access Journals (Sweden)

    Brian Godman

    2012-12-01

    Full Text Available INTRODUCTION: Reforms have been introduced across Europe to increase prescribing efficiency with existing drugs. These include measures to lower prices of generics as well as increase their prescribing versus originators and patented products in a class or related class. This is essential to maintain comprehensive health care in Europe given continued pressures. The alternative is insufficient funds for new innovative drugs and increasing drug volumes with ageing populations. OBJECTIVE: To review the influence of measures and initiatives to increase the prescribing and dispensing of generics at low prices on ambulatory care prescribing efficiency. In view of this, provide guidance as authorities strive to introduce further reforms to meet their goals. METHODOLOGY: A narrative review of published papers combined with case histories. RESULTS: The different supply- and demand-side measures have reduced generic prices to as low as 2% to 3% of pre-patent loss prices in some cases as well as appreciably enhanced their utilisation. As a result, prescribing efficiency has increased without compromising care. In some cases, the reforms have led to expenditure actually falling despite appreciably increased volumes. CONCLUSIONS: Increasing use of generics at low prices will help maintain the European ideals of comprehensive and equitable health care. However, countries will continually need to learn from each other.

  15. A Profile of Substance Abuse, Gender, Crime, and Drug Policy in the United States and Canada

    Science.gov (United States)

    Grant, Judith

    2009-01-01

    The climate of domestic drug policy in the United States as it pertains to both women and men at the beginning of the 21st century is the criminalization mode of regulation--a mode that is based on the model of addiction as a crime and one that is used to prohibit the use of illegal drugs. In Canada, drug policy is based mainly on the harm…

  16. The challenges of changing national malaria drug policy to artemisinin-based combinations in Kenya

    Directory of Open Access Journals (Sweden)

    Otieno Dorothy N

    2007-05-01

    Full Text Available Abstract Backgound Sulphadoxine/sulphalene-pyrimethamine (SP was adopted in Kenya as first line therapeutic for uncomplicated malaria in 1998. By the second half of 2003, there was convincing evidence that SP was failing and had to be replaced. Despite several descriptive investigations of policy change and implementation when countries moved from chloroquine to SP, the different constraints of moving to artemisinin-based combination therapy (ACT in Africa are less well documented. Methods A narrative description of the process of anti-malarial drug policy change, financing and implementation in Kenya is assembled from discussions with stakeholders, reports, newspaper articles, minutes of meetings and email correspondence between actors in the policy change process. The narrative has been structured to capture the timing of events, the difficulties and hurdles faced and the resolutions reached to the final implementation of a new treatment policy. Results Following a recognition that SP was failing there was a rapid technical appraisal of available data and replacement options resulting in a decision to adopt artemether-lumefantrine (AL as the recommended first-line therapy in Kenya, announced in April 2004. Funding requirements were approved by the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM and over 60 million US$ were agreed in principle in July 2004 to procure AL and implement the policy change. AL arrived in Kenya in May 2006, distribution to health facilities began in July 2006 coincidental with cascade in-service training in the revised national guidelines. Both training and drug distribution were almost complete by the end of 2006. The article examines why it took over 32 months from announcing a drug policy change to completing early implementation. Reasons included: lack of clarity on sustainable financing of an expensive therapeutic for a common disease, a delay in release of funding, a lack of comparative efficacy data

  17. Drugs Approved for Rhabdomyosarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for rhabdomyosarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries. There may be drugs used in rhabdomyosarcoma that are not listed here.

  18. Drugs Approved for Leukemia

    Science.gov (United States)

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  19. Stigma, Discrimination, Treatment Effectiveness and Policy Support: Comparing Public Views about Drug Addiction with Mental Illness

    Science.gov (United States)

    Barry, Colleen L; McGinty, Emma Elizabeth; Pescosolido, Bernice; Goldman, Howard H.

    2014-01-01

    Objective This study compares current public attitudes about drug addiction with attitudes about mental illness. Methods A web-based national public opinion survey (N=709) was conducted to compare attitudes about stigma, discrimination, treatment effectiveness, and policy support. Results Respondents hold significantly more negative views toward persons with drug addiction compared to those with mental illness. More respondents were unwilling to have a person with drug addiction marry into their family or work closely with them on a job. Respondents were more willing to accept discriminatory practices, more skeptical about the effectiveness of available treatments, and more likely to oppose public policies aimed at helping persons with drug addiction. Conclusions Drug addiction is often treated as a sub-category of mental illness, and health insurance benefits group these conditions together under the rubric of behavioral health. Given starkly different public views about drug addiction and mental illness, advocates may need to adopt differing approaches for advancing stigma reduction and public policy. PMID:25270497

  20. 21 CFR 1404.635 - May the Office of National Drug Control Policy settle a debarment or suspension action?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false May the Office of National Drug Control Policy settle a debarment or suspension action? 1404.635 Section 1404.635 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) General Principles Relating to Suspension and Debarment Actions § 1404.635...

  1. Management of clandestine drug laboratories: need for evidence-based environmental health policies.

    Science.gov (United States)

    Al-Obaidi, Tamara A; Fletcher, Stephanie M

    2014-01-01

    Clandestine drug laboratories (CDLs) have been emerging and increasing as a public health problem in Australia, with methamphetamine being the dominant illegally manufactured drug. However, management and remediation of contaminated properties are still limited in terms of regulation and direction, especially in relation to public and environmental health practice. Therefore, this review provides an update on the hazards and health effects associated with CDLs, with a specific look at the management of these labs from an Australian perspective. Particularly, the paper attempts to describe the policy landscape for management of CDLs, and identifies current gaps and how further research may be utilised to advance understanding and management of CDLs and inform public health policies. The paper highlights a significant lack of evidence-based policies and guidelines to guide regulatory authority including environmental health officers in Australia. Only recently, the national Clandestine Drug Laboratory Guidelines were developed to assist relevant authority and specialists manage and carry out investigations and remediation of contaminated sites. However, only three states have developed state-based guidelines, some of which are inadequate to meet environmental health requirements. The review recommends well-needed inter-sectoral collaborations and further research to provide an evidence base for the development of robust policies and standard operating procedures for safe and effective environmental health management and remediation of CDLs.

  2. EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA

    Directory of Open Access Journals (Sweden)

    J. E. Semyonova

    2015-12-01

    Full Text Available Aim. To assess in a short-term study efficiency and safety of hypolipidemic therapy with atorvastatine generic, Tulip, in comparison with simvastatine generic, Vasilip, in hyperlipidemic patients.Material and methods. Open, randomized, comparative, cross over study included 87 patients with hyperlipidemia, who didn’t receive hypolipidemic drugs within 6 weeks, or followed hypolipidemic diet for 4 weeks. Each patient received therapy with one of the studied drugs within 6 weeks. Then after 4-week wash-out period the second therapy with the other drug was held. Consequence of courses with each drug was set by randomization. Initial dose of both drugs was 10 mg daily. Dose was adjusted after 3 weeks. The dose was increased to 20 mg daily if cholesterol of low density lipoproteid (CLDL hadn’t reached target level (< 115 mg/dl. of Treatment safety was assessed on the basis of clinical data, hepatic enzymes activity and creatine phosphokinase levels.Results. It is shown, that to reach target figures of plasma lipid spectrum, Vasilip dose was increased significantly more often, than Tulip dose. Average Tulip dose after titration was 14,8 mg daily, Vasilip dose – 15,6 mg daily. Patients with initially higher level of triglycerides (TG > 170 mg/dl after 6 weeks with Tulip treatment showed TG reduction by 38% and with Vasilip treatment – by 20%. Both drugs showed good tolerance, no significant differences in number of side-effects were observed.Conclusion. 6-week treatment with atorvastatine generic Tulip shows significant hypolipidemic effect, which appears in significant reduction of CLDL, total cholesterol, TG compared to the initial levels. Degree of total cholesterol reduction is significantly higher with Tulip treatment compared to Vasilip treatment. Analyses shown that target levels of the assessed figures were reached in more patients, treated with Tulip. Side-effects in Tulip treatment were not severe.

  3. EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA

    Directory of Open Access Journals (Sweden)

    J. E. Semyonova

    2005-01-01

    Full Text Available Aim. To assess in a short-term study efficiency and safety of hypolipidemic therapy with atorvastatine generic, Tulip, in comparison with simvastatine generic, Vasilip, in hyperlipidemic patients.Material and methods. Open, randomized, comparative, cross over study included 87 patients with hyperlipidemia, who didn’t receive hypolipidemic drugs within 6 weeks, or followed hypolipidemic diet for 4 weeks. Each patient received therapy with one of the studied drugs within 6 weeks. Then after 4-week wash-out period the second therapy with the other drug was held. Consequence of courses with each drug was set by randomization. Initial dose of both drugs was 10 mg daily. Dose was adjusted after 3 weeks. The dose was increased to 20 mg daily if cholesterol of low density lipoproteid (CLDL hadn’t reached target level (< 115 mg/dl. of Treatment safety was assessed on the basis of clinical data, hepatic enzymes activity and creatine phosphokinase levels.Results. It is shown, that to reach target figures of plasma lipid spectrum, Vasilip dose was increased significantly more often, than Tulip dose. Average Tulip dose after titration was 14,8 mg daily, Vasilip dose – 15,6 mg daily. Patients with initially higher level of triglycerides (TG > 170 mg/dl after 6 weeks with Tulip treatment showed TG reduction by 38% and with Vasilip treatment – by 20%. Both drugs showed good tolerance, no significant differences in number of side-effects were observed.Conclusion. 6-week treatment with atorvastatine generic Tulip shows significant hypolipidemic effect, which appears in significant reduction of CLDL, total cholesterol, TG compared to the initial levels. Degree of total cholesterol reduction is significantly higher with Tulip treatment compared to Vasilip treatment. Analyses shown that target levels of the assessed figures were reached in more patients, treated with Tulip. Side-effects in Tulip treatment were not severe.

  4. Drugs@FDA Database

    Data.gov (United States)

    U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...

  5. Drugs Approved for Esophageal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  6. Drugs Approved for Kaposi Sarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  7. Drugs Approved for Skin Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  8. Drugs Approved for Vulvar Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  9. Drugs Approved for Bone Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  10. Drugs Approved for Malignant Mesothelioma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for malignant mesothelioma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  11. Drugs Approved for Endometrial Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  12. Just don`t do it: zero tolerance alcohol and drug policy in place

    Energy Technology Data Exchange (ETDEWEB)

    Anon.

    1997-10-01

    Safety policies in effect on the Hibernia offshore platform in the Hibernia Field, 300 km off the Newfoundland coast, were described, especially with regard to alcohol and drugs. No alcohol of any type is allowed on the platform. Each employee departing for the platform must take a breathalyzer test prior to boarding the helicopter. The tolerance level at the heliport is .05 per cent and anyone exceeding that is not permitted to board the aircraft. Employees must also be drug-free to be permitted to travel offshore. There is a policy of random testing on the platform for illicit or `recreational` drugs. All employees must agree in writing to taking these tests through provision of a urine sample on demand, as a condition of employment. The use of alcohol offshore or the detection of illegal drugs through the random testing program are grounds for dismissal, although team leaders have some discretion to judge each situation on its own set of circumstances. The company also has the right to search individuals, their sleeping quarters, lockers and other property for alcohol, drugs or other controlled substances in situations where reasonable doubt exists. To date there has been very little resistance within Hibernia to its random testing and zero tolerance policies. Employees understand that this is a safety issue and that they serve to protect everyone who works on the offshore platform.

  13. Balancing health and industrial policy objectives in the pharmaceutical sector: lessons from Australia.

    Science.gov (United States)

    Morgan, Steve; McMahon, Meghan; Greyson, Devon

    2008-08-01

    Policy-makers worldwide struggle to balance health with industrial policy objectives in the pharmaceutical sector. Tensions arise over pricing and reimbursement in particular. What health plans view as necessary to maintain equitable access to medicines, industry views as inimical to R&D and innovation. Australia has grappled with this issue for years, even incorporating the goal of "maintaining a responsible and viable medicines industry" into its National Medicines Policy. This case study was conducted via a narrative review that examined Australia's experiences balancing health and industrial policy objectives in the pharmaceutical sector. The review included electronic databases, grey literature and government publications for reports on relevant Australian policy published over the period 1985-2007. While pharmaceutical companies claim that Australia's pricing and reimbursement policies suppress drug prices and reduce profits, national policy audits indicate these claims are misguided. Australia appears to have secured relatively low prices for generics and "me-too drugs" while paying internationally competitive prices for "breakthrough" medicines. Simultaneously, Australia has focused efforts on local pharmaceutical investment through a variety of industry-targeted R&D incentive policies. Despite the fact that policy reviews suggest that Australia has achieved balance between health and industrial policy objectives, the country continues to face criticism from industry that its health goals harm innovation and R&D. Recent reforms raise the question whether Australia can sustain the apparent balance.

  14. Pharmaceutical policies in European countries.

    Science.gov (United States)

    Barros, Pedro Pita

    2010-01-01

    Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

  15. Drugs Approved for Liver Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  16. Drugs Approved for Penile Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  17. Illicit drugs policy through the lens of regulation.

    Science.gov (United States)

    Ritter, Alison

    2010-07-01

    The application of regulatory theory to the problem of illicit drugs has generally been thought about only in terms of 'command and control'. The international treaties governing global illicit drug control and the use of law enforcement to dissuade and punish offenders have been primary strategies. In this paper I explore the application of other aspects of regulatory theory to illicit drugs-primarily self-regulation and market regulation. There has been an overreliance on strategies from the top of the regulatory pyramid. Two other regulatory strategies--self-regulation and market regulation--can be applied to illicit drugs. Self-regulation, driven by the proactive support of consumer groups may reduce drug-related harms. Market strategies such as pill-testing can change consumer preferences and encourage alternate seller behaviour. Regulatory theory is also concerned with partnerships between the state and third parties: strategies in these areas include partnerships between police and pharmacies regarding sale of potential precursor chemicals. Regulatory theory and practice is a rich and well-developed field in the social sciences. I argue that governments should consider the full array of regulatory strategies. Using regulatory theory provides a rationale and justification to strategies that are currently at the whim of politics, such as funding for user groups. The greater application of regulatory approaches may produce more flexible and structured illicit drug policies. Copyright (c) 2009 Elsevier B.V. All rights reserved.

  18. Big Data: transforming drug development and health policy decision making.

    Science.gov (United States)

    Alemayehu, Demissie; Berger, Marc L

    The explosion of data sources, accompanied by the evolution of technology and analytical techniques, has created considerable challenges and opportunities for drug development and healthcare resource utilization. We present a systematic overview these phenomena, and suggest measures to be taken for effective integration of the new developments in the traditional medical research paradigm and health policy decision making. Special attention is paid to pertinent issues in emerging areas, including rare disease drug development, personalized medicine, Comparative Effectiveness Research, and privacy and confidentiality concerns.

  19. Drugs Approved for Vaginal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  20. The impact on health outcomes and healthcare utilisation of switching to generic medicines consequent to reference pricing: the case of lamotrigine in New Zealand.

    Science.gov (United States)

    Lessing, Charon; Ashton, Toni; Davis, Peter

    2014-10-01

    Many countries have implemented generic reference pricing and substitution as methods of containing pharmaceutical expenditure. However, resistance to switching between medicines is apparent, especially in the case of anti-epileptic medicines. This study sought to exploit a nation-wide policy intervention on generic reference pricing in New Zealand to evaluate the health outcomes of patients switching from originator to generic lamotrigine, an anti-epileptic medicine. A retrospective study using the national health collections and prescription records was conducted comparing patients who switched from originator brand to generic lamotrigine with patients who remained on the originator brand. Primary outcome measures included switch behaviour, changes in utilisation of healthcare services at emergency departments, hospitalisations and use of specialist services, and mortality. Approximately one-quarter of all patients using the originator brand of lamotrigine switched to generic lamotrigine, half of whom made the switch within 60 days of the policy implementation. Multiple switches (three or more) between generic and brand products were evident for around 10% of switchers. Switch-back rates of 3% were apparent within 30 days post-switch. No difference in heath outcome measures was associated with switching from originator lamotrigine to a generic equivalent and hence no increased costs could be found for switchers. Switching from brand to generic lamotrigine is largely devoid of adverse health outcomes; however, creating an incentive to ensure a greater proportion of patients switch to generic lamotrigine is required to achieve maximal financial savings from a policy of generic reference pricing.

  1. Institutional stakeholder perceptions of barriers to addiction treatment under Mexico's drug policy reform.

    Science.gov (United States)

    Werb, Dan; Strathdee, Steffanie A; Meza, Emilo; Rangel Gomez, Maria Gudelia; Palinkas, Lawrence; Medina-Mora, Maria Elena; Beletsky, Leo

    2017-05-01

    Mexico has experienced disproportionate drug-related harms given its role as a production and transit zone for illegal drugs destined primarily for the USA. In response, in 2009, the Mexican federal government passed legislation mandating pre-arrest diversion of drug-dependent individuals towards addiction treatment. However, this federal law was not specific about how the scale-up of the addiction treatment sector was to be operationalised. We therefore conducted in-depth qualitative interviews with key 'interactors' in fields affected by the federal legislation, including participants from the law enforcement, public health, addiction treatment, and governmental administration sectors. Among 19 participants from the municipal, state and federal levels were interviewed and multiple barriers to policy reform were identified. First, there is a lack of institutional expertise to implement the reform. Second, the operationalisation of the reform was not accompanied by a coordinated action plan. Third, the law is an unfunded mandate. Institutional barriers are likely hampering the implementation of Mexico's policy reform. Addressing the concerns expressed by interactors through the scale-up of services, the provision of increased training and education programmes for stakeholders and a coordinated action plan to operationalise the policy reform are likely needed to improve the policy reform process.

  2. Drugs Approved for Cervical Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for cervical cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  3. Drugs Approved for Testicular Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for testicular cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  4. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  5. Drugs Approved for Myeloproliferative Neoplasms

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  6. New Drug Reimbursement and Pricing Policy in Taiwan.

    Science.gov (United States)

    Chen, Gau-Tzu; Chang, Shu-Chen; Chang, Chee-Jen

    2018-05-01

    Taiwan has implemented a national health insurance system for more than 20 years now. The benefits of pharmaceutical products and new drug reimbursement scheme are determined by the Expert Advisory Meeting and the Pharmaceutical Benefit and Reimbursement Scheme (PBRS) Joint Committee in Taiwan. To depict the pharmaceutical benefits and reimbursement scheme for new drugs and the role of health technology assessment (HTA) in drug policy in Taiwan. All data were collected from the Expert Advisory Meeting and the PBRS meeting minutes; new drug applications with HTA reports were derived from the National Health Insurance Administration Web site. Descriptive statistics were used to analyze the timeline of a new drug from application submission to reimbursement effective, the distribution of approved price, and the approval rate for a new drug with/without local pharmacoeconomic study. After the second-generation national health insurance system, the timeline for a new drug from submission to reimbursement effective averages at 436 days, and that for an oncology drug reaches an average of 742 days. New drug approval rate is 67% and the effective rate (through the approval of the PBRS Joint Committee and the acceptance of the manufacturer) is 53%. The final approved price is 53.6% of the international median price and 70% of the proposed price by the manufacturer. Out of 95 HTA reports released during the period January 2011 to February 2017, 28 applications (30%) conducted an HTA with a local pharmacoeconomic study, and all (100%) received reimbursement approval. For the remaining 67 applications (70%) for which HTA was conducted without a local pharmacoeconomic analysis, 54 cases (81%) were reimbursed. New drug applications with local pharmacoeconomic studies are more likely to get reimbursement. Copyright © 2018. Published by Elsevier Inc.

  7. The Family and Federal Drug Abuse Policies--Programs: Toward Making the Invisible Family Visible.

    Science.gov (United States)

    Clayton, Richard R.

    1979-01-01

    Notes why the family is not considered in drug policy and programing and asserts that existing conditions demand conscious consideration of the family in efforts of federal drug agencies. Data show changing parameters of drug use-abuse. A research and prevention agenda that integrates the family is presented. (Author/BEF)

  8. Effect of generic issues program on improving safety

    International Nuclear Information System (INIS)

    Fard, M. R.; Kauffman, J. V.

    2010-01-01

    The U.S. Nuclear Regulatory Commission (NRC) identifies (by its assessment of plant operation) certain issues involving public health and safety, the common defense and security, or the environment that could affect multiple entities under NRC jurisdiction. The Generic Issues Program (GIP) addresses the resolution of these Generic Issues (GIs). The resolution of these issues may involve new or revised rules, new or revised guidance, or revised interpretation of rules or guidance that affect nuclear power plant licensees, nuclear material certificate holders, or holders of other regulatory approvals. U.S. NRC provides information related to the past and ongoing GIP activities to the general public by the use of three main resources, namely NUREG-0933, 'Resolution of Generic Safety Issues, ' Generic Issues Management Control System (GIMCS), and GIP public web page. GIP information resources provide information such as historical information on resolved GIs, current status of the open GIs, policy documents, program procedures, GIP annual and quarterly reports and the process to contact GIP and propose a GI This paper provides an overview of the GIP and several examples of safety improvements resulting from the resolution of GIs. In addition, the paper provides a brief discussion of a few recent GIs to illustrate how the program functions to improve safety. (authors)

  9. 21 CFR 1405.400 - What are my responsibilities as a(n) Office of National Drug Control Policy awarding official?

    Science.gov (United States)

    2010-04-01

    ...) Responsibilities of Office of National Drug Control Policy Awarding Officials § 1405.400 What are my... 21 Food and Drugs 9 2010-04-01 2010-04-01 false What are my responsibilities as a(n) Office of National Drug Control Policy awarding official? 1405.400 Section 1405.400 Food and Drugs OFFICE OF NATIONAL...

  10. 21 CFR 1404.610 - What procedures does the Office of National Drug Control Policy use in suspension and debarment...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false What procedures does the Office of National Drug Control Policy use in suspension and debarment actions? 1404.610 Section 1404.610 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) General Principles Relating to Suspension and Debarment...

  11. Postabsorption concentration peaks with brand-name and generic verapamil: a double-blind, crossover study in elderly hypertensive patients.

    Science.gov (United States)

    Saseen, J J; Porter, J A; Barnette, D J; Bauman, J L; Zajac, E J; Carter, B L

    1997-06-01

    The pharmacokinetic actions, bioequivalence, and cardiovascular effects of two verapamil products were studied in a randomized, double-blind, crossover study in eight elderly hypertensive patients (median age, 69.5 years; range, 60-79 years) given brand-name or generic immediate-release verapamil in 120-mg twice-daily doses for 14 days. Blood pressures, heart rates, P-R intervals; and serum concentrations of R-/S-verapamil and norverapamil were measured multiple times in patients during the last day of each therapy. Median blood pressure decreased more with generic verapamil than with the brand-name drug, with the largest difference occurring at 0.5 hours (137/74 mmHg versus 144.5/80.5 mmHg; P = 0.05 and 0.091, respectively). Pharmacokinetic parameters were not different for the two products (P generic product, compared with the brand-name drug, had mean area under the concentration-time curve (time 0 to 12 hours) ratios (90% CI) of 1.09 (0.78-1.52), 1.16 (0.87-1.55) and 1.11 (0.81-1.52) for R-, S-, and total verapamil. Seventy concentration peaks (31 with the brand-name drug, 39 with the generic drug) appeared between 8 and 24 hours. Median percentages of increase of these peaks, compared with those of previous concentrations, were 48.3% and 36.3% for brand-name and generic drugs, respectively. Fifty of the 70 peaks (71%) were associated with a stereospecific concentration peak of norverapamil and, temporally, with meals. Our findings suggest that whereas the two verapamil products may not be bioequivalent by Food and Drug Administration criteria, the observed differences in effects were not clinically significant in this elderly population. Multiple concentration peaks after absorption were observed in all patients with both verapamil products and were perhaps related to enterohepatic recirculation.

  12. Entry decisions in the generic pharmaceutical industry.

    Science.gov (United States)

    Morton, F M

    1999-01-01

    Data on all generic drug entries in the period 1984-1994 are used to estimate which markets heterogeneous potential entrants will decide to enter. I find that organizational experience predicts entry. Firms tend to enter markets with supply and demand characteristics similar to the firm's existing drugs. Larger revenue markets, markets with more hospital sales, and products that treat chronic conditions attract more entry. The simultaneous nature of entry leads to an additional interpretation: specialization is profitable because of the severe risk to profits when a market is "overentered." However, I am unable to make any conclusions about the efficiency of entry decisions.

  13. Drugs Approved for Wilms Tumor

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  14. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  15. Drugs Approved for Lung Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  16. Drugs Approved for Bladder Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  17. 21 CFR 1404.630 - May the Office of National Drug Control Policy impute conduct of one person to another?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false May the Office of National Drug Control Policy impute conduct of one person to another? 1404.630 Section 1404.630 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) General Principles Relating to Suspension and Debarment Actions § 1404.630...

  18. 21 CFR 1404.135 - May the Office of National Drug Control Policy exclude a person who is not currently...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false May the Office of National Drug Control Policy exclude a person who is not currently participating in a nonprocurement transaction? 1404.135 Section 1404.135 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) General § 1404.135 May the...

  19. Cost Evaluation of Commonly Prescribed Antihypertensive Drugs ...

    African Journals Online (AJOL)

    It was also concluded that generic prescription should be encouraged among prescribers to lessen the financial burden of patients because drugs marketed under generic names are usually cheaper than those with brand names. Key words: Brand, Generic,Prescription, Antihypertensives,Cost. [Nig. Jnl Health & Biomedical ...

  20. Lack of efficacy during the switch from brand to generic allopurinol.

    Science.gov (United States)

    De Vuono, Antonio; Scicchitano, Francesca; Palleria, Caterina; Russo, Emilio; De Sarro, Giovambattista; Gallelli, Luca

    2013-07-01

    We report for the first time the lack of therapeutic effects after the switch from a brand formulation of allopurinol to a generic one. A 56-year-old man, with a 5 years history of well-treated gout arthropathy with allopurinol (Zyloric(®) 300 mg/die), developed acute gout arthropathy after the switch from the brand formulation of allopurinol to a generic one. Clinical evaluation and laboratory findings confirmed the diagnosis of acute gout arthropathy. Generic formulation of the drug was dismissed and Zyloric(®) was administered with an improvement of both clinical symptoms and laboratory findings. In conclusion, even if generic formulations are considered to have the same effects in comparison to the brand one, more data are necessaries in order to well define their effectiveness and rationale use. Copyright © 2013 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

  1. Examining the Spatial Distribution of Law Enforcement Encounters among People Who Inject Drugs after Implementation of Mexico’s Drug Policy Reform

    OpenAIRE

    Gaines, Tommi L.; Beletsky, Leo; Arredondo, Jaime; Werb, Daniel; Rangel, Gudelia; Vera, Alicia; Brouwer, Kimberly

    2014-01-01

    In 2009, Mexico decriminalized the possession of small amounts of illicit drugs for personal use in order to refocus law enforcement resources on drug dealers and traffickers. This study examines the spatial distribution of law enforcement encounters reported by people who inject drugs (PWID) in Tijuana, Mexico to identify concentrated areas of policing activity after implementation of the new drug policy. Mapping the physical location of law enforcement encounters provided by PWID (n = 461) ...

  2. Social policy and drug dependence: an historical case study.

    Science.gov (United States)

    Smart, C

    1985-11-01

    A detailed examination is presented of the background to the reports and policy developments concerning drug dependence which emerged in Britain during the 1960s. Analysis of documents and interviews with policy makers, officials and doctors involved in the events of the period, reveal that explanatory models in terms of 'moral panic' or 'power struggle' tend to oversimplify the complex processes involved. The role in policy formation of the media, government departments and groups within the medical profession is considered. The patterns of conflict and convergence are seen to overlap simple lines of 'interest'--we find conflict within the medical profession, convergence between the Home Office (legal) and elements of the medical professions (medical). The resulting legal and institutional framework involved only loose guidelines from the centre about treatment, and the shape of policy was determined by individual doctors in the new hospital treatment centres. The apparent re-run of the 1960s being staged in the 1980s will require detailed research in the future in order to avoid superficial comparisons.

  3. Reimbursement-Based Economics--What Is It and How Can We Use It to Inform Drug Policy Reform?

    Science.gov (United States)

    Coyle, Doug; Lee, Karen M; Mamdani, Muhammad; Sabarre, Kelley-Anne; Tingley, Kylie

    2015-01-01

    In Ontario, approximately $3.8 billion is spent annually on publicly funded drug programs. The annual growth in Ontario Public Drug Program (OPDP) expenditure has been limited to 1.2% over the course of 3 years. Concurrently, the Ontario Drug Policy Research Network (ODPRN) was appointed to conduct drug class review research relating to formulary modernization within the OPDP. Drug class reviews by ODPRN incorporate a novel methodological technique called reimbursement-based economics, which focuses on reimbursement strategies and may be particularly relevant for policy-makers. To describe the reimbursement-based economics approach. Reimbursement-based economics aims to identify the optimal reimbursement strategy for drug classes by incorporating a review of economic literature, comprehensive budget impact analyses, and consideration of cost-effectiveness. This 3-step approach is novel in its focus on the economic impact of alternate reimbursement strategies rather than individual therapies. The methods involved within the reimbursement-based approach are detailed. To facilitate the description, summary methods and findings from a recent application to formulary modernization with respect to the drug class tryptamine-based selective serotonin receptor agonists (triptans) used to treat migraine headaches are presented. The application of reimbursement-based economics in drug policy reforms allows policy-makers to consider the cost-effectiveness and budget impact of different reimbursement strategies allowing consideration of the trade-off between potential cost savings vs increased access to cost-effective treatments. © 2015 American Headache Society.

  4. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for stomach (gastric) cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  5. Drugs Approved for Soft Tissue Sarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for soft tissue sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  6. Drugs Approved for Gestational Trophoblastic Disease

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for gestational trophoblastic disease. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  7. Comparison of Compounded, Generic, and Innovator-Formulated Itraconazole in Dogs and Cats.

    Science.gov (United States)

    Renschler, Janelle; Albers, Amanda; Sinclair-Mackling, Hanna; Wheat, Lawrence Joseph

    2018-05-14

    The triazole antifungal itraconazole may be cost prohibitive in brand name form; therefore, compounded and generic products are often used as alternatives. Itraconazole blood concentrations have not been studied in clinical patients receiving these formulations. Itraconazole bioassay was performed on serum/plasma from 95 dogs and 20 cats receiving itraconazole (compounded from bulk powder, generic pelletized, or brand name) for systemic mycosis treatment. Mean itraconazole concentration was lower in the compounded group (n = 42) as compared with the generic (n = 40) or brand name (n = 33) groups (0.5 µg/mL versus 8.3 µg/mL and 6.5 µg/mL, respectively; P 10 µg/mL; 37.5 and 24%, respectively). Compounded itraconazole should be avoided, but generic itraconazole appears to serve as a reasonable alternative to brand name itraconazole. Therapeutic drug monitoring may be beneficial in all cases.

  8. Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? Findings from across Europe and their implications.

    Science.gov (United States)

    Godman, Brian; Petzold, Max; Bennett, Kathleen; Bennie, Marion; Bucsics, Anna; Finlayson, Alexander E; Martin, Andrew; Persson, Marie; Piessnegger, Jutta; Raschi, Emanuel; Simoens, Steven; Zara, Corinne; Barbui, Corrado

    2014-06-13

    Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders.The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone. Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)). There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72% in Ireland. Consistent

  9. Drugs Approved for Multiple Myeloma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  10. Examining the spatial distribution of law enforcement encounters among people who inject drugs after implementation of Mexico's drug policy reform.

    Science.gov (United States)

    Gaines, Tommi L; Beletsky, Leo; Arredondo, Jaime; Werb, Daniel; Rangel, Gudelia; Vera, Alicia; Brouwer, Kimberly

    2015-04-01

    In 2009, Mexico decriminalized the possession of small amounts of illicit drugs for personal use in order to refocus law enforcement resources on drug dealers and traffickers. This study examines the spatial distribution of law enforcement encounters reported by people who inject drugs (PWID) in Tijuana, Mexico to identify concentrated areas of policing activity after implementation of the new drug policy. Mapping the physical location of law enforcement encounters provided by PWID (n = 461) recruited through targeted sampling, we identified hotspots of extra-judicial encounters (e.g., physical/sexual abuse, syringe confiscation, and money extortion by law enforcement) and routine authorized encounters (e.g., being arrested or stopped but not arrested) using point density maps and the Getis-Ord Gi* statistic calculated at the neighborhood-level. Approximately half of the participants encountered law enforcement more than once in a calendar year and nearly one third of these encounters did not result in arrest but involved harassment or abuse by law enforcement. Statistically significant hotspots of law enforcement encounters were identified in a limited number of neighborhoods located in areas with known drug markets. At the local-level, law enforcement activities continue to target drug users despite a national drug policy that emphasizes drug treatment diversion rather than punitive enforcement. There is a need for law enforcement training and improved monitoring of policing tactics to better align policing with public health goals.

  11. Drugs Approved for Gastrointestinal Stromal Tumors

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for gastrointestinal stromal tumors (GIST). The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  12. 75 FR 47599 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and...

    Science.gov (United States)

    2010-08-06

    ... frequency of response was determined by the maximum number of questionnaires that will be sent to any... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0380] Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug...

  13. [Improve the accessibility of essential drugs for the populations of one medical region in Burkina Faso].

    Science.gov (United States)

    Ridde, Valéry; Nitièma, Abdoulaye P; Dadjoari, Moussa

    2005-01-01

    Despite the formulation of the Bamako initiative in 1992 in Burkina Faso, not until 2001 and the launching of a project by a nongovernmental organization was the policy really implemented in a region of the country. One of the goals of this policy is to improve access to health care by using generic essential drugs. The objective of this article is to summarize the results of the evaluation of the project's ability to improve the population's access to drugs. The project lasted three years (2001-2003) and the interventions took place in 41 basic health centres of three districts. According to WHO, improving access to drugs requires consideration of four essential factors: rational use, affordable prices, financial viability, and effectiveness of the distribution. The average number of drugs prescribed per prescription sheet (n = 1061) was 2.4; 93% of the drugs were prescribed by their generic name (international non-proprietary names); 44% of infant diarrheas were treated with oral rehydration salt. National drug prices were respected but not the directives aiming at exempting from payment or subsidizing certain population sub-groups (children, indigents). The average annual cash flow of the basic health centres was 1.2 million F CFA and it increased by 854% compared to the beginning of the project. The cost-recovery scheme for administrative expenses was 106%. The average annual availability of the 10 essential drugs was 89%. Utilization rates increased (0.13 in 1999 to 0.21 in 2003) but not significantly differently than in other basic health centres of the area not supported by the project (p = 0.084). The project succeeded in improving access to these drugs for the overall population but not for the worst-off. The drugs are now geographically available for all and financially accessible for those who can afford to pay. The intervention strategy supported the sustainability of the project's activities but much remains to be done to provide the poorest with

  14. [Three types of brand name loyalty strategies set up by drug manufacturers].

    Science.gov (United States)

    PréMont, Marie-Claude; Gagnon, Marc-André

    2014-11-01

    The recent restructuring of the pharmaceutical industry has led to three new types of promotional strategies to build patient loyalty to brand name drugs: loyalty through rebates, patient support, and compassion programs. Loyalty through rebates seeks to keep patients on a brand name drug and prevent their switch to the generic equivalent. Loyalty through patient support provides aftersales services to help and support patients (by phone or home visits) in order to improve adherence to their treatments. Finally, compassion programs offer patients access to drugs still awaiting regulatory approval or reimbursement by insurers. When and if the approval process is successful, the manufacturer puts an end to the compassion program and benefits from a significant cohort of patients already taking a very expensive drug for which reimbursement is assured. The impact of these programs on public policies and patients' rights raises numerous concerns, among which the direct access to patients and their health information by drug manufacturers and upward pressure on costs for drug insurance plans.

  15. COMPARISON OF PHARMACOKINETICS AND PHARMACODYNAMICS OF THE ORIGINAL AND GENERIC ENALAPRIL IN THE ELDERLY PATIENTS WITH ARTERIAL HYPERTENSION

    Directory of Open Access Journals (Sweden)

    O. P. Bobrova

    2015-12-01

    Full Text Available Aim. To study the pharmacokinetic, pharmacodynamic and pharmacoeconomic parameters of the original and generic enalaprils in the treatment of the elderly patients with hypertension (HT. Material and Methods. Patients (n=40 75–90 years with HT were included in the open randomized comparative study. Patients were randomized into two groups. Patients of the group 1 received generic enalapril, patients of the group 2 — the original enalapril consisting of combined therapy. Pharmacokinetic single-dose study of original and generic enalapril were carried out with high-performance liquid chromatography. Pharmacodynamic study was carried out in single-dose administration as well as after 2 and 4 weeks of treatment with original and generic enalapril. Pharmacoeconomic evaluation of antihypertensive drugs was carried out on the basis of cost minimization analysis. Results. Original enalapril dose necessary to achieve the target blood pressure (BP was 10 mg/day as a part of two-component therapy. This for generic enalapril was 20 mg/day consisting of three- or four-component therapy. Both drugs have shown an acceptable safety profile. Pharmacokinetic differences were revealed between original and generic enalapril: area under pharmacokinetic curve 204.14 (202.25–206.05 vs 136.23 (134.17–137.65 ng*h/ml, respectively; time of the drug retention in the blood plasma 5.42 (5.26–5.76 vs 4.88 (4.86–4.94 hours, respectively; p<0.001. Original enalapril demonstrated more stable 24-hour antihypertensive effect in once daily administration in comparison with this in generic enalapril: trough/peak ratio 78.67% (47.61–91.35% vs 44.96% (32.44–55.49%, respectively , p<0.01. The average daily cost of combined therapy containing generic enalapril was 15.91 rubles per patient, while this in combined therapy containing original enalapril — 13.78 rubles per patient. Conclusion. Medicines on the basis of original and generic enalapril have pharmacokinetic

  16. U.S. Drug Policy: Shaping Relations With Latin America

    Science.gov (United States)

    2014-06-01

    90  Figure 12.  Management levels within Colombian wheel network. ...................................91  x THIS PAGE... environmental and community damage in Latin America, citing coca eradication programs that have an adverse effect on community ecosystems. The effects of U.S...favor of drug policy change but endorse arbitrary or minuscule legislation that would not pose a great political risk to their careers. MacCoun and

  17. Addiction research centres and the nurturing of creativity. National institute on alcohol and drugs policies, Brazil.

    Science.gov (United States)

    Laranjeira, Ronaldo; Mitsuhiro, Sandro Sendin

    2012-04-01

    The National Institute of Public Policy for Alcohol and Other Drugs (INPAD) is based at the Federal University of São Paulo, Brazil, and was created to collect scientific evidence regarding epidemiology, develop new therapeutic approaches, study health economics and provide education to subsidize the proper measures to change the Brazilian scenario of alcohol and drug consumption. Policies directed towards the control of alcohol and drugs in Brazil are fragmented, poorly enforced and therefore ineffective. The unregulated market of alcohol in Brazil has contributed to the worsening health of the Brazilian population. Since 1994, INPAD has participated actively in academic debates and discussions about alcohol and drug policies and their effects on the political welfare of the country. Many scientific papers and books have been published on this subject, and the internet and other media have provided excellent opportunities for the dissemination of specialized information to the general population. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  18. [Pharmacoeconomic indicators of cardiovascular drug utilization in the Republic of Croatia and city of Zagreb in 2008].

    Science.gov (United States)

    Stimac, Danijela; Stambuk, Ivanka

    2010-12-01

    In comparison with original drugs, generic drugs have the same efficacy but considerably lower price and should therefore be preferred to original drugs on prescribing. The aim of the present study was to assess outpatient utilization and rationality of cardiovascular drug prescribing in the City of Zagreb and Republic of Croatia based on the generic to original drug prescribing ratio. Data on the financial indicators and number of cardiovascular drug packages issued in 2008 were obtained from the Croatian Institute of Health Insurance. These data were used to calculate the number of defined daily doses (DDD) and number of DDD per 1000 inhabitants per day (DDD/1000/day). The index of generic/original drug utilization was determined for Zagreb and Croatia as a measure for assessment of prescribing rationality; the significance of difference was determined by X2-test. The rate of prescribing original cardiovascular drugs was significantly higher in Zagreb as compared with Croatia as a whole. The index of prescribing generic versus original drugs was 1.20 (249/208 DDD/1000/day) in Zagreb and 1.65 (249/151 DDD/1000/day) in Croatia. Difference in the utilization of generic drugs between Zagreb and Croatia as determined by X2-test (the level of statistical significance was set at PZagreb and 2.02 in Croatia; and hypolipemics with the generic/original drug index of 0.96 in Zagreb and 1.34 in Croatia. According to financial indicators, the generic/original drug index was 1.44 in Croatia and only 0.96 in Zagreb. The significantly greater influence of pharmaceutical industry marketing in Zagreb entailed the significantly higher rate of original drug prescribing, which is associated with considerably greater drug expenses. Measures to stimulate prescribing generic drugs should be launched at the national level.

  19. Unofficial policy: access to housing, housing information and social services among homeless drug users in Hartford, Connecticut

    Directory of Open Access Journals (Sweden)

    Corbett A Michelle

    2007-03-01

    Full Text Available Abstract Background Much research has shown that the homeless have higher rates of substance abuse problems than housed populations and that substance abuse increases individuals' vulnerability to homelessness. However, the effects of housing policies on drug users' access to housing have been understudied to date. This paper will look at the "unofficial" housing policies that affect drug users' access to housing. Methods Qualitative interviews were conducted with 65 active users of heroin and cocaine at baseline, 3 and 6 months. Participants were purposively sampled to reflect a variety of housing statuses including homeless on the streets, in shelters, "doubled-up" with family or friends, or permanently housed in subsidized, unsubsidized or supportive housing. Key informant interviews and two focus group interviews were conducted with 15 housing caseworkers. Data were analyzed to explore the processes by which drug users receive information about different housing subsidies and welfare benefits, and their experiences in applying for these. Results A number of unofficial policy mechanisms limit drug users' access to housing, information and services, including limited outreach to non-shelter using homeless regarding housing programs, service provider priorities, and service provider discretion in processing applications and providing services. Conclusion Unofficial policy, i.e. the mechanisms used by caseworkers to ration scarce housing resources, is as important as official housing policies in limiting drug users' access to housing. Drug users' descriptions of their experiences working with caseworkers to obtain permanent, affordable housing, provide insights as to how access to supportive and subsidized housing can be improved for this population.

  20. Establishing a Link Between Prescription Drug Abuse and Illicit Online Pharmacies: Analysis of Twitter Data.

    Science.gov (United States)

    Katsuki, Takeo; Mackey, Tim Ken; Cuomo, Raphael

    2015-12-16

    Youth and adolescent non-medical use of prescription medications (NUPM) has become a national epidemic. However, little is known about the association between promotion of NUPM behavior and access via the popular social media microblogging site, Twitter, which is currently used by a third of all teens. In order to better assess NUPM behavior online, this study conducts surveillance and analysis of Twitter data to characterize the frequency of NUPM-related tweets and also identifies illegal access to drugs of abuse via online pharmacies. Tweets were collected over a 2-week period from April 1-14, 2015, by applying NUPM keyword filters for both generic/chemical and street names associated with drugs of abuse using the Twitter public streaming application programming interface. Tweets were then analyzed for relevance to NUPM and whether they promoted illegal online access to prescription drugs using a protocol of content coding and supervised machine learning. A total of 2,417,662 tweets were collected and analyzed for this study. Tweets filtered for generic drugs names comprised 232,108 tweets, including 22,174 unique associated uniform resource locators (URLs), and 2,185,554 tweets (376,304 unique URLs) filtered for street names. Applying an iterative process of manual content coding and supervised machine learning, 81.72% of the generic and 12.28% of the street NUPM datasets were predicted as having content relevant to NUPM respectively. By examining hyperlinks associated with NUPM relevant content for the generic Twitter dataset, we discovered that 75.72% of the tweets with URLs included a hyperlink to an online marketing affiliate that directly linked to an illicit online pharmacy advertising the sale of Valium without a prescription. This study examined the association between Twitter content, NUPM behavior promotion, and online access to drugs using a broad set of prescription drug keywords. Initial results are concerning, as our study found over 45,000 tweets

  1. Impact of the zero-markup drug policy on hospitalisation expenditure in western rural China: an interrupted time series analysis.

    Science.gov (United States)

    Yang, Caijun; Shen, Qian; Cai, Wenfang; Zhu, Wenwen; Li, Zongjie; Wu, Lina; Fang, Yu

    2017-02-01

    To assess the long-term effects of the introduction of China's zero-markup drug policy on hospitalisation expenditure and hospitalisation expenditures after reimbursement. An interrupted time series was used to evaluate the impact of the zero-markup drug policy on hospitalisation expenditure and hospitalisation expenditure after reimbursement at primary health institutions in Fufeng County of Shaanxi Province, western China. Two regression models were developed. Monthly average hospitalisation expenditure and monthly average hospitalisation expenditure after reimbursement in primary health institutions were analysed covering the period 2009 through to 2013. For the monthly average hospitalisation expenditure, the increasing trend was slowed down after the introduction of the zero-markup drug policy (coefficient = -16.49, P = 0.009). For the monthly average hospitalisation expenditure after reimbursement, the increasing trend was slowed down after the introduction of the zero-markup drug policy (coefficient = -10.84, P = 0.064), and a significant decrease in the intercept was noted after the second intervention of changes in reimbursement schemes of the new rural cooperative medical insurance (coefficient = -220.64, P markup drug policy in western China. However, hospitalisation expenditure and hospitalisation expenditure after reimbursement were still increasing. More effective policies are needed to prevent these costs from continuing to rise. © 2016 John Wiley & Sons Ltd.

  2. The generic article

    NARCIS (Netherlands)

    Farkas, D.F.; Swart, Henriëtte de

    2005-01-01

    We take a fresh look at the connection between genericity and (in)definiteness by reconsidering a long-standing puzzle concerning the relation between definiteness and genericity. We contrast English on the one hand and Romance languages and Hungarian on the other, focusing on generic sentences

  3. Analysis of treatment patterns and persistence on branded and generic medications in major depressive disorder using retrospective claims data

    Directory of Open Access Journals (Sweden)

    Solem CT

    2016-10-01

    Full Text Available Caitlyn T Solem,1 Ahmed Shelbaya,2,3 Yin Wan,1 Chinmay G Deshpande,1 Jose Alvir,2 Elizabeth Pappadopulos2 1Pharmerit International, Real World Evidence/Data Analytics, Bethesda, MD, 2Pfizer, Inc., Global Health Outcomes, New York, NY, 3Epidemiology Department of Mailman’s School of Public Health, Columbia University Mailman School of Public Health, New York, NY, USA Background: In major depressive disorder (MDD, treatment persistence is critical to optimize symptom remission, functional recovery, and health care costs. Desvenlafaxine tends to have fewer drug interactions and better tolerability than other MDD drugs; however, its use has not been assessed in the real world.Objective: The aim of the present study is to compare medication persistence and concomitant MDD drug use with branded desvenlafaxine (Pristiq® compared with antidepressant drug groups classified as 1 branded selective serotonin reuptake inhibitors (SSRIs; ie, escitalopram [Lexapro™] and selective serotonin–norepinephrine reuptake inhibitors (SNRIs; ie, venlafaxine [Effexor®], duloxetine [Cymbalta®] and 2 generic SSRIs/SNRIs (ie, escitalopram, citalopram, venlafaxine, fluvoxamine, fluoxetine, sertraline, paroxetine, and duloxetine.Patients and methods: MDD patients (ICD-9-CM codes 296.2, 296.3, with ≥2 prescription fills for study drugs and 12-month preindex continuous enrollment from the MarketScan Commercial Claims and Encounters Database (2009–2013, were included. Time-to-treatment discontinuation (prescription gap ≥45 days was assessed using the Kaplan–Meier curve and Cox model. Concomitant MDD drug use was compared.Results: Of the 273,514 patients included, 14,379 patients were initiated with branded desvenlafaxine, 50,937 patients with other branded SSRIs/SNRIs, and 208,198 patients with generic SSRIs/SNRIs. The number of weeks for treatment discontinuation for branded desvenlafaxine were longer (40.7 [95% CI: 39.3, 42.0] compared with other branded

  4. Doctors commitment and long-term effectiveness for cost containment policies: lesson learned from biosimilar drugs

    Directory of Open Access Journals (Sweden)

    Menditto E

    2015-11-01

    Full Text Available Enrica Menditto,1 Valentina Orlando,1 Silvia Coretti,2 Daria Putignano,1 Denise Fiorentino,1 Matteo Ruggeri2 1CIRFF, Center of Pharmacoeconomics, Federico II University of Naples, Naples, 2Postgraduate School of Health Economics and Management (ALTEMS, Università Cattolica del Sacro Cuore, School of Economics, Rome, Italy Background: Agency is a pervasive feature of the health care market, with doctors acting as agents for both patients and the health care system. In a context of scarce resources, doctors are required to take opportunity cost into account when prescribing treatments, while cost containment policies cannot overlook their active role in determining health care resource allocation. This paper addresses this issue, investigating the effects of cost containment measures in the market of biosimilar drugs that represent a viable and cost-saving strategy for the reduction of health care expenditure. The analysis focuses on a particular region in Italy, where several timely policies to incentivize biosimilar prescribing were launched. Methods: Drugs were identified by the anatomical therapeutic chemical classification system. Information about biosimilar drugs and their originator biological products was extracted from the IMS Health regional database. Drug consumption was expressed in terms of counting units, while expenditure was evaluated in Euro (€.The market penetration of biosimilars was analyzed by year and quarterly. Results: In the Campania region of Italy, the effects of cost containment policies, launched between 2009 and 2013, showed the prescription of biosimilars strongly increasing in 2010 until prescribing levels reached and exceeded the market share of the reference biological products in 2012. After a slight reduction, a plateau was observed at the beginning of 2013. At the same time, the use of the originator products had been decreasing until the first quarter of 2011. However, after a 1-year plateau, this trend

  5. Problems in the regulatory policy of the drug market

    Science.gov (United States)

    Miziara, Nathália Molleis; Coutinho, Diogo Rosenthal

    2015-01-01

    OBJECTIVE Analyze the implementation of drug price regulation policy by the Drug Market Regulation Chamber. METHODS This is an interview-based study, which was undertaken in 2012, using semi-structured questionnaires with social actors from the pharmaceutical market, the pharmaceuticals industry, consumers and the regulatory agency. In addition, drug prices were compiled based on surveys conducted in the state of Sao Paulo, at the point of sale, between February 2009 and May 2012. RESULTS The mean drug prices charged at the point of sale (pharmacies) were well below the maximum price to the consumer, compared with many drugs sold in Brazil. Between 2009 and 2012, 44 of the 129 prices, corresponding to 99 drugs listed in the database of compiled prices, showed a variation of more than 20.0% in the mean prices at the point of sale and the maximum price to the consumer. In addition, many laboratories have refused to apply the price adequacy coefficient in their sales to government agencies. CONCLUSIONS The regulation implemented by the pharmaceutical market regulator was unable to significantly control prices of marketed drugs, without succeeding to push them to levels lower than those determined by the pharmaceutical industry and failing, therefore, in its objective to promote pharmaceutical support for the public. It is necessary reconstruct the regulatory law to allow market prices to be reduced by the regulator as well as institutional strengthen this government body. PMID:26083945

  6. Analiza nawyków i zachowań związanych ze stosowaniem leków oryginalnych i generycznych = The analysis of behaviour related to the use of original and generic drugs

    Directory of Open Access Journals (Sweden)

    Piotr Kozłowski

    2015-08-01

    generic drugs. The study included 108 people. In the study group, women accounted for 67.6% of respondents, while 32.4% were men. The age of the respondents ranged from 20 to 60. The study was conducted in the period from January to February 2015 and it employed standardized interview research method. Research tool, which was used for data collection was a questionnaire consisted of 29 questions multiple-choice questions. Statistical analysis was performed using the chi-square test. All values for which p <0.05 (probability of error were considered statistically significant.                 For the participants, the most important factor influencing the choice of particular drug was the price of the product. The difference was related to gender as 58.9% of female and only 37.1% male respondents agreed on the relevance of the price. The majority of the respondents (60.2% had never been asked by a pharmacist about their price-dependent preferences. One third of the respondents (32.4% had never been offered a cheaper generic equivalent for a brand-name drug. Most participants of the study (69.4% always or occasionally chose to buy a cheaper generic equivalent fro a brand-name drug. The participants knowledge about original and generic drugs was also analysed and evaluated. According to one third (34.3% of the respondents the generic products had effects identical to the original drugs. Being asked if the two groups products have the same composition, 50.9% of respondents did not know the answer.   Key words: generic drug, generics.

  7. Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study.

    Science.gov (United States)

    Chenu, Franck; Batten, Lisa A; Zernig, Gerald; Ladstaetter, Elisabeth; Hébert, Chantal; Blier, Pierre

    2009-07-01

    Generic drugs are lower-cost versions of patent-expired brand-name medications. Bioequivalence is decreed when the 90% confidence intervals for the ratios of the generic to the reference compound for the area under the curve and maximum plasma concentration (C(max)) fall within a 0.80 to 1.25 range. The aim of the present pilot study was to compare the pharmacokinetic profiles of brand-name and generic formulations of citalopram and extended-release venlafaxine. Effexor XR/Novo-venlafaxine XR 75 mg and Celexa/Gen-citalopram 40 mg were studied in a randomized crossover design. Healthy male volunteers took either Effexor XR or Novo-venlafaxine XR for 4 days, a 4-day washout was allowed, and then participants took the other venlafaxine formulation for 4 days. This was followed by a washout of at least 7 days. The participants then took Celexa or Gen-citalopram for 8 days, a 14-day washout was allowed, and then participants took the other citalopram formulation for 8 days. In each of the study phases, the sequence of treatment (brand-name x generic) was randomly assigned. Plasma levels of drugs were measured at fixed intervals after participants took the drugs and at steady state. The study was conducted from November 2007 through July 2008. Twelve participants completed the venlafaxine study. Nine of the participants, plus 3 new participants, were then enrolled in the citalopram study, to maintain a total of 12. The plasma levels of citalopram were similar after ingestion of the brand-name and generic drugs. After ingestion of venlafaxine, the C(max) values were 36 +/- 6 ng/mL and 52 +/- 8 ng/mL in the brand-name and generic groups, respectively. The ratio of the log-transformed values of C(max) was 150% and, therefore, not within the acceptable 80% to 125% range. The concentration of the active metabolite of venlafaxine (O-desmethyl-venlafaxine [ODV]) was also significantly increased in the generic group (+43% higher in the generic group at 3 h; +48% higher at 5 h; p

  8. Legislating thresholds for drug trafficking: a policy development case study from New South Wales, Australia.

    Science.gov (United States)

    Hughes, Caitlin Elizabeth; Ritter, Alison; Cowdery, Nicholas

    2014-09-01

    Legal thresholds are used in many parts of the world to define the quantity of illicit drugs over which possession is deemed "trafficking" as opposed to "possession for personal use". There is limited knowledge about why or how such laws were developed. In this study we analyse the policy processes underpinning the introduction and expansion of the drug trafficking legal threshold system in New South Wales (NSW), Australia. A critical legal and historical analysis was undertaken sourcing data from legislation, Parliamentary Hansard debates, government inquiries, police reports and research. A timeline of policy developments was constructed from 1970 until 2013 outlining key steps including threshold introduction (1970), expansion (1985), and wholesale revision (1988). We then critically analysed the drivers of each step and the roles played by formal policy actors, public opinion, research/data and the drug trafficking problem. We find evidence that while justified as a necessary tool for effective law enforcement of drug trafficking, their introduction largely preceded overt police calls for reform or actual increases in drug trafficking. Moreover, while the expansion from one to four thresholds had the intent of differentiating small from large scale traffickers, the quantities employed were based on government assumptions which led to "manifest problems" and the revision in 1988 of over 100 different quantities. Despite the revisions, there has remained no further formal review and new quantities for "legal highs" continue to be added based on assumption and an uncertain evidence-base. The development of legal thresholds for drug trafficking in NSW has been arbitrary and messy. That the arbitrariness persists from 1970 until the present day makes it hard to conclude the thresholds have been well designed. Our narrative provides a platform for future policy reform. Copyright © 2014 Elsevier B.V. All rights reserved.

  9. Sameness and difference: metaphor and politics in the constitution of addiction, social exclusion and gender in Australian and Swedish drug policy.

    Science.gov (United States)

    Moore, David; Fraser, Suzanne; Törrönen, Jukka; Tinghög, Mimmi Eriksson

    2015-04-01

    Like any other discourse, drug policy is imagined and articulated through metaphors. In this article, we explore the metaphors and meanings at work in the current national drug policies of Australia and Sweden. Australia's approach to welfare is usually characterised as liberal-welfarist, emphasising individual difference and 'freedom'. Sweden's approach is usually characterised as social-democratic, universalistic and paternalistic, with an emphasis on social rights, equity and sameness. How do these models of citizenship--difference versus sameness--play out in national drug policies? What are the risks and benefits of these models and the claims they allow? In the textual analysis presented here, we focus on metaphors and meanings relating to the themes of addiction, social exclusion and gender. We choose metaphor as our major analytical tool because we think that the risks and benefits of adopting different models of citizenship in drug policy need to be understood to operate at many levels and with a high degree of subtlety and abstraction. In the cases of addiction and social exclusion, a complicated picture emerges. In Australia, drug users are offered two options: sameness (and reintegration into society) or difference (and re-connection). In Sweden, drug users are excluded from society but not because they are fundamentally different from non-users. Because drug users are understood to be suffering from a temporary and curable personal affliction, the goal is to return them to sameness through care and treatment. With respect to gender, although differently expressed in the two national contexts and differently shaped by national imaginaries, both national policies adopt similar approaches: the unequal treatment of women transcends differences in national setting. Accounts of drug policy usually focus on the degree to which drug policy is, or should be, 'evidence-based', or on the complex political negotiations involving diverse stakeholders and interests

  10. Intellectual property policy on pharmaceutical products: a view in the beginning of the 2000 decade - DOI: 10.3395/reciis.v2i2.191en

    Directory of Open Access Journals (Sweden)

    Sergio M Paulino de Carvalho

    2009-03-01

    Full Text Available This paper aims at an analysis of the intellectual property policy in the health field by emphasizing the program of production and distribution of antiretrovirals and the generic drugs market, also reviewing the process of articulation and implementation of the intellectual property policy in this sector. From a methodological viewpoint, the paper favors the analysis of data related to the structuring of the pharmaceutical products market and of impacts both from the new institutionality and the intellectual property policies developed by the Ministry of Health in the first half of the 2000’s decade.

  11. [Access to drugs and the situation of the pharmaceutical market in Ecuador].

    Science.gov (United States)

    Ortiz-Prado, Esteban; Galarza, Claudio; León, Fernando Cornejo; Ponce, Jorge

    2014-07-01

    In the area of public health, it is fundamental to understand the structure and dynamics of the Ecuadorian pharmaceutical market, its segmentation between the public and private sectors, and its relationship with supply and demand, both for generic and brand-name drugs. To achieve this, an observational descriptive study was conducted with information obtained from the available scientific, institutional, technical-administrative, and economic databases. Furthermore, the scientific information concerning the Ecuadorian and regional pharmaceutical market was reviewed through the PubMed and Ovid search engines. In Ecuador, 69.6% of dispensed drugs are brand-name and 30.4% are generics. Of all registered drugs in the country, 1,829 (13.6%) are considered over-the-counter and 11,622 (86.4%) are for sale under medical prescription. In terms of sales, 93.15% correspond to brand-name drugs and only 6.85% to generics. Ninety percent of the pharmacies are located in urban areas and only 10% in rural areas. In the last five years, prices have increased by 12.5% for brand-name drugs and 0.86% for generics. Brand-name drugs are dispensed and consumed 2.3 times more than generics. The majority of pharmacies are located in urban areas, showing that there is a relationship between purchasing power and access to drugs. Although the regulatory authority stipulates that 13% of drugs should be over-the-counter, approximately 60% of the population acquires drugs without a medical prescription.

  12. Malaria healthcare policy change in Kenya: implications on sales and marketing of antimalarials.

    Science.gov (United States)

    Ngure, Peter K; Nyaoke, Lorraine; Minja, David

    2012-03-01

    Malaria healthcare policy change in Kenya aimed at improving the control of malaria but faced a number of challenges in implementation related to marketing of the drugs. This research investigated the effect of the change of the national malaria policy on drug sales and strategic marketing responses of antimalarial pharmaceutical companies in Kenya. A descriptive cross-sectional design was employed to describe the existing state of antimalarials market in Kenya after the change of the malaria healthcare policy. Policy change did result in an increase in the sales of Coartem®. Novartis Pharma recorded a 97% growth in sales of Coartem® between 2003 and 2004. However, this increase was not experienced by all the companies. Further, SPs (which had been replaced as first-line therapy for malaria) registered good sales. In most cases, these sales were higher than the sales of Coartem®. Generally, the sales contribution of SPs and generic antimalarial medicines exceeded that of Coartem® for most distributors. The most common change made to marketing strategies by distributors (62.5%) was to increase imports of antimalarials. A total of 40% of the manufacturers preferred to increase their budgetary allocation for marketing activities. In view of the fact that continued sale of SP drugs and limited availability of AL poses the risk of increasing the incidence of malaria in Kenya, it is therefore, recommended that pharmacy surveillance systems be strengthened to ensure drugs that have been rendered non-viable or that prescription-only medicines are not sold contrary to the national guidelines.

  13. Drug policy and global regulatory capitalism: the case of new psychoactive substances (NPS).

    Science.gov (United States)

    Seddon, Toby

    2014-09-01

    The recent emergence of vibrant markets in 'new psychoactive substances' or 'legal highs' has posed significant new challenges for drug policy. These partly concern what to do about them but the speed and complexity of change has also raised difficulties for how policy responses should be developed. Existing drug policy systems appear too slow and cumbersome to keep up with the pace of change, remaining locked in large part within 'old' ways of thinking that centre almost exclusively around the deployment (or not) of the criminal law and its related enforcement apparatus. In this paper, it is argued that we need to rethink the problem through the lens of regulation, in order to learn lessons from other sectors where more agile responses to changing markets and business innovation have often proved possible. By examining examples drawn from these other areas, an alternative policy-making framework can be developed, involving a more flexible mix of state regulation, civil society action and private law mechanisms. This new approach is founded on a recognition of the networked and polycentric character of effective market governance in an era of global regulatory capitalism. Copyright © 2014 Elsevier B.V. All rights reserved.

  14. Drugs Approved for Head and Neck Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for head and neck cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  15. Illicit drugs and the media: models of media effects for use in drug policy research.

    Science.gov (United States)

    Lancaster, Kari; Hughes, Caitlin E; Spicer, Bridget; Matthew-Simmons, Francis; Dillon, Paul

    2011-07-01

    Illicit drugs are never far from the media gaze and although identified almost a decade ago as 'a new battleground' for the alcohol and other drug (AOD) field there has been limited research examining the role of the news media and its effects on audiences and policy. This paper draws together media theories from communication literature to examine media functions. We illustrate how each function is relevant for media and drugs research by drawing upon the existing literature examining Australian media coverage during the late 1990s of escalating heroin-related problems and proposed solutions. Media can influence audiences in four key ways: by setting the agenda and defining public interest; framing issues through selection and salience; indirectly shaping individual and community attitudes towards risk; and feeding into political debate and decision making. Each has relevance for the AOD field. For example, media coverage of the escalating heroin-related problems in Australia played a strong role in generating interest in heroin overdoses, framing public discourse in terms of a health and/or criminal issue and affecting political decisions. Implications AND CONCLUSION: Media coverage in relation to illicit drugs can have multifarious effects. Incorporating media communication theories into future research and actions is critical to facilitate understanding of the short- and long-term impacts of media coverage on illicit drugs and the avenues by which the AOD field can mitigate or inform future media debates on illicit drugs. © 2010 Australasian Professional Society on Alcohol and other Drugs.

  16. 21 CFR 1404.615 - How does the Office of National Drug Control Policy notify a person of a suspension or debarment...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false How does the Office of National Drug Control Policy notify a person of a suspension or debarment action? 1404.615 Section 1404.615 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) General Principles Relating to Suspension and Debarment...

  17. The impact of reference pricing and extension of generic substitution on the daily cost of antipsychotic medication in Finland.

    Science.gov (United States)

    Koskinen, Hanna; Ahola, Elina; Saastamoinen, Leena K; Mikkola, Hennamari; Martikainen, Jaana E

    2014-12-01

    To assess the impact of reference pricing and extension of generic substitution on the daily cost of antipsychotic drugs in Finland during the first year after its launch. Furthermore, the additional impact of reference pricing on prior implemented generic substitution is assessed. A retrospective analysis was performed between 2006 and 2010. A segmented linear regression analysis of interrupted time series was used to estimate changes in the levels and trends in the cost of one day of treatment. Of the study drugs, clozapine belonged to generic substitution already at the start of the study period while olanzapine and quetiapine were included in generic substitution alongside with reference pricing in 2009. Risperidone was included in generic substitution in 2008, before reference pricing. A substantial decrease in the daily cost of all four antipsychotic substances was seen after one year of the implementation of reference pricing and the extension of generic substitution. The impact ranged from -29.9% to -66.3%, and it was most substantial on the daily cost of olanzapine. Also in the daily cost of risperidone a substantial decrease of -43.3% was observed. However, most of these savings, -32.6%, were generated by generic substitution which had been adopted prior. Reference pricing and the extension of generic substitution produced substantial savings on antipsychotic medication costs during the first year after its launch, but the intensity of the impact differed between active substances. Furthermore, our results suggest that the additional cost savings from reference pricing after prior implemented generic substitution, are comparatively low.

  18. Generic and crime type specific correlates of youth crime: a Finnish population-based study.

    Science.gov (United States)

    Elonheimo, Henrik; Sourander, Andre; Niemelä, Solja; Helenius, Hans

    2011-09-01

    The aim of this study was to examine the psychosocial correlates of various crime types among adolescent males born in Finland in 1981. Data on crime registered in the Finnish National Police Register between 1998 and 2001 were received for 2,866 boys, of whom 81% (n = 2,330) filled in a questionnaire at obligatory military call-up at age 18 in 1999. Crime was divided into five types: drug, violent, property, traffic, and drunk driving offences. Of the 2,866 boys, 23% had been registered for offending; 4% for drug, 7% for violent, 11% for property, 11% for traffic, and 5% for drunk driving offences during the 4-year period in late adolescence. All the crime types correlated with each other and shared many of the psychosocial problems. Small community size, parents' divorce, aggressiveness, daily smoking, and weekly drunkenness were generic correlates of crime, being independently related to various crime types. The results support general rather than specific accounts of youth crime. In particular, measures moderating the adverse effects of divorce, alleviating parental adversities and supporting parenthood, and tackling substance abuse seem relevant in social and criminal policy because they address psychosocial problems characterizing youth crime in general.

  19. Security, development and human rights: normative, legal and policy challenges for the international drug control system.

    Science.gov (United States)

    Barrett, Damon

    2010-03-01

    This commentary addresses some of the challenges posed by the broader normative, legal and policy framework of the United Nations for the international drug control system. The 'purposes and principles' of the United Nations are presented and set against the threat based rhetoric of the drug control system and the negative consequences of that system. Some of the challenges posed by human rights law and norms to the international drug control system are also described, and the need for an impact assessment of the current system alongside alternative policy options is highlighted as a necessary consequence of these analyses. Copyright (c) 2010 Elsevier B.V. All rights reserved.

  20. Brand name to generic substitution of antiepileptic drugs does not lead to seizure-related hospitalization: a population-based case-crossover study.

    Science.gov (United States)

    Polard, Elisabeth; Nowak, Emmanuel; Happe, André; Biraben, Arnaud; Oger, Emmanuel

    2015-11-01

    There is still controversy on brand-to-generic (B-G) antiepileptic drugs (AEDs) substitution. To assess association between B-G AED substitution and seizure-related hospitalization, we designed a case crossover using the French National Health Insurance Database. We identified a cohort of adult patients who filled a prescription in 2009-2011 for AEDs with at least one brand name and one generic form. The outcome date was defined as the date of hospitalization, coded G40.x or G41.x, with a G40/G41 hospitalization-free period of at least 1 year. Patients with a medical history of cancer and women who gave birth in 2009-2011 were excluded. We required individuals to have regular dispensations of AEDs within the year preceding the outcome date. Free patients were defined as patients who had only brand name dispensations before the control period. Eight thousand three hundred seventy nine patients (mean age ± standard deviation, 52.7 ± 18.8 years; sex ratio male/female, 1.27) were analyzed. Discordant pairs were 491 with B-G substitution in the control period only and 478 with B-G substitution in the case period only; odds ratio (95% confidence interval) 0.97 (0.86-1.10). No statistically significant interaction was detected among the four prespecified subgroup analyses (gender, age strata, free or non-free, and strict AED monotherapy or not). Controlling for non-seizure-related hospitalizations made no material difference. Sensitivity analyses yielded similar results. Brand-to-generic AED substitution was not associated with an elevated risk of seizure-related hospitalization. Copyright © 2015 John Wiley & Sons, Ltd.

  1. Valuation of Drug Abuse: A Review of Current Methodologies and Implications for Policy Making

    Science.gov (United States)

    Schori, Maayan

    2011-01-01

    This article reviews the use of several valuation methods as they relate to drug abuse and places them within the context of U.S. policy. First, cost-of-illness (COI) studies are reviewed and their limitations discussed. Second, three additional economic methods of valuing drug abuse are reviewed, including cost-effectiveness analysis (CEA),…

  2. Projecting future drug expenditures--2009.

    Science.gov (United States)

    Hoffman, James M; Shah, Nilay D; Vermeulen, Lee C; Doloresco, Fred; Martin, Patrick K; Blake, Sharon; Matusiak, Linda; Hunkler, Robert J; Schumock, Glen T

    2009-02-01

    Drug expenditure trends in 2007 and 2008, projected drug expenditures for 2009, and factors likely to influence drug expenditures are discussed. Various factors are likely to influence drug expenditures in 2009, including drugs in development, the diffusion of new drugs, drug safety concerns, generic drugs, Medicare Part D, and changes in the drug supply chain. The increasing availability of important generic drugs and drug safety concerns continue to moderate growth in drug expenditures. The drug supply chain remains dynamic and may influence drug expenditures, particularly in specialized therapeutic areas. Initial data suggest that the Medicare Part D benefit has influenced drug expenditures, but the ultimate impact of the benefit on drug expenditures remains unclear. From 2006 to 2007, total U.S. drug expenditures increased by 4.0%, with total spending rising from $276 billion to $287 billion. Drug expenditures in clinics continue to grow more rapidly than in other settings, with a 9.9% increase from 2006 to 2007. Hospital drug expenditures increased at a moderate rate of only 1.6% from 2006 to 2007; through the first nine months of 2008, hospital drug expenditures increased by only 2.8% compared with the same period in 2007. In 2009, we project a 0-2% increase in drug expenditures in outpatient settings, a 1-3% increase in expenditures for clinic-administered drugs, and a 1-3% increase in hospital drug expenditures.

  3. Acceptability and confidence in antiretroviral generics of physicians and HIV-infected patients in France.

    Science.gov (United States)

    Allavena, Clotilde; Jacomet, Christine; Pereira, Bruno; Morand-Joubert, Laurence; Bagheri, Haleh; Cotte, Laurent; Garaffo, Rodolphe; Gerbaud, Laurent; Dellamonica, Pierre

    2014-01-01

    Switching brand name medications to generics is recommended in France in the interest of cost effectiveness but patients and physicians are sometimes not convinced that switching is appropriate. Some antiretroviral (ARV) generics (ZDV, 3TC, NVP) have been marketed in France since 2013. A multicentric cross-sectional survey was performed in September 2013 to evaluate the perception of generics overall and ARV generics in physicians and HIV-infected patients and factors associated to their acceptability. Adult HIV outpatients were asked to complete a self-questionnaire on their perception of generics. Physicians completed a questionnaire on the acceptability of generics and ARV generics. Socio-demographic data, medical history and HIV history were collected. 116 physicians in 33 clinics (68% in University Hospital) included 556 patients (France-native 77%, active employment 59%, covered by social Insurance 100%, homosexual/bisexual contamination 47%, median HIV duration 13 years, hepatitis coinfection 16%, on ARV therapy 95%). Overall, patients accepted and had confidence in generics in 76% and 55% of the cases, respectively. Switching ARVs for generics was accepted by 44% of the patients but only by 17% if the pill burden was going to increase. 75% of the physicians would prescribe generics, but this decreased to only 26% if the combo had to be broken. The main reasons for non-prescription of generics were previous brand name ARV-induced side effects (35%), refusal of generics overall (37%), lack of understanding of generics (26%), risk of non-observance of treatment (44%), anxiety (47%) and depressive symptoms (25%). In multivariate analysis, factors associated with the acceptability of ARV generics in patients were the use of generics overall (p<0.001) and in physicians, the absence of concern regarding the drug efficacy (p<0.001) and being aware that the patient would accept generics overall (p=0.03) and ARV generics (p=0.04). No factors related to

  4. Generic Pharmaceutical Association (GPhA) - 2015 Annual Meeting (February 9-11, 2015 - Miami Beach, Florida, USA).

    Science.gov (United States)

    Bowman, M

    2015-02-01

    The Generic Pharmaceutical Association (GPhA) chairman Craig Wheeler (Momenta Pharmaceuticals), welcomed attendees to the 2015 Annual Meeting by reflecting on the contributions of the generic industry over the past year and some of the challenges that lie ahead. In 2014, 86% of prescriptions dispensed in the U.S. were generic, contributing to the USD 1.4 trillion savings generated by the industry since its inception; however, there are still many challenges to face, including consolidation of customers, lag in Abbreviated New Drug Application (ANDA) approval timelines, restrictive Risk Evaluation and Mitigation Strategy (REMS) programs and labeling legislations. The continued drive into the branded business by many GPhA member companies has resulted in the association planning a structural division for companies involved in biologic and biosimilar products. During the 3-day meeting, attendees listened to expert panels discuss major business, regulatory and market trends developing in the generic industry, with insights from the U.S. Food and Drug Administration (FDA) and market analysts. The meeting also provided attendees with numerous opportunities to socialize and network with key decision makers in the industry. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

  5. Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.

    Directory of Open Access Journals (Sweden)

    Rita R Alloway

    2017-11-01

    Full Text Available Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, "brand" product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns. Such concerns have been fueled by anecdotal observations and retrospective and uncontrolled published studies, while well-designed, controlled prospective studies testing the validity of the regulatory bioequivalence testing approach for narrow therapeutic index immunosuppressants in transplant recipients have been lacking. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant.From December 2013 through October 2014, a prospective, replicate dosing, partially blinded, randomized, 3-treatment, 6-period crossover bioequivalence study was conducted at the University of Cincinnati in individuals with a kidney (n = 35 or liver transplant (n = 36. Abbreviated New Drug Applications (ANDA data that included manufacturing and healthy individual pharmacokinetic data for all generics were evaluated to select the 2 most disparate generics from innovator, and these were named Generic Hi and Generic Lo. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed. All products fell within the US Food and Drug

  6. Doctors commitment and long-term effectiveness for cost containment policies: lesson learned from biosimilar drugs.

    Science.gov (United States)

    Menditto, Enrica; Orlando, Valentina; Coretti, Silvia; Putignano, Daria; Fiorentino, Denise; Ruggeri, Matteo

    2015-01-01

    Agency is a pervasive feature of the health care market, with doctors acting as agents for both patients and the health care system. In a context of scarce resources, doctors are required to take opportunity cost into account when prescribing treatments, while cost containment policies cannot overlook their active role in determining health care resource allocation. This paper addresses this issue, investigating the effects of cost containment measures in the market of biosimilar drugs that represent a viable and cost-saving strategy for the reduction of health care expenditure. The analysis focuses on a particular region in Italy, where several timely policies to incentivize biosimilar prescribing were launched. Drugs were identified by the anatomical therapeutic chemical classification system. Information about biosimilar drugs and their originator biological products was extracted from the IMS Health regional database. Drug consumption was expressed in terms of counting units, while expenditure was evaluated in Euro (€). The market penetration of biosimilars was analyzed by year and quarterly. In the Campania region of Italy, the effects of cost containment policies, launched between 2009 and 2013, showed the prescription of biosimilars strongly increasing in 2010 until prescribing levels reached and exceeded the market share of the reference biological products in 2012. After a slight reduction, a plateau was observed at the beginning of 2013. At the same time, the use of the originator products had been decreasing until the first quarter of 2011. However, after a 1-year plateau, this trend was reversed, with a new increase in the consumption of the originators observed. Results show that the cost containment policies, applied to cut health expenditure "to cure and not to care", did not produce the cultural change necessary to make these policies effective in the long run. Therefore, top-down policies for cost containment are not successful; rather, a bottom

  7. International Drug Control Policy

    Science.gov (United States)

    2009-08-24

    Common illegal drugs include cannabis, cocaine, opiates, and synthetic drugs. International trade in these drugs represents a lucrative and what...into effect, decriminalizing “personal use” amounts of marijuana , heroin, cocaine, methamphetamine, and other internationally sanctioned drugs.15 While...President Calls for Legalizing Marijuana ,”CNN.com, May 13, 2009. 15 “Mexico Legalizes Drug Possession,” Associated Press, August 21, 2009. 16 In support

  8. Position paper: A generic approach for security policies composition

    DEFF Research Database (Denmark)

    Hernandez, Alejandro Mario; Nielson, Flemming

    2012-01-01

    When modelling access control in distributed systems, the problem of security policies composition arises. Much work has been done on different ways of combining policies, and using different logics to do this. In this paper, we propose a more general approach based on a 4-valued logic, that abst...

  9. Exploring knowledge perceptions and attitudes about generic medicines among finalyear health science students

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-05-01

    Full Text Available Background. The use of generic medicines to reduce healthcare costs has become a mandated policy in South Africa. An increase in the use of generics can be achieved through improved knowledge, attitudes and perceptions of generic medicine among healthcare professionals. Objective. To explore knowledge, attitudes and perceptions among final-year health science students on generic medication. Methods. A cross-sectional survey was carried out among the final-year audiology, dental therapy, pharmacy, physiotherapy, occupational therapy, optometry, speech-language and sport science students enrolled at the University of KwaZulu-Natal. A questionnaire was used as the study tool, developed using information adapted from literature reviews. Data analysis was completed using Statistical Package for the Social Sciences (SPSS version 21, and computed using descriptive statistics. Results. Total number of participants was 211, as follows: audiology (n=14, dental therapy (n=15, pharmacy (n=81, physiotherapy (n=41, occupational therapy (n=6, optometry (n=25, speech-language (n=6 and sport science (n=23. A total of 90.0% of students had heard of generic medicines, with 20.9% of them agreeing that generic medicines are less effective than brand-name medicines. Concerning safety, 30.4% believed that brand-name medicines are required to meet higher safety standards than generic medicines. Regarding the need for information on issues pertaining to safety and efficacy of medicines, 53.3% of participants felt that this need was not being met. Conclusion. All groups had knowledge deficits about the safety, quality and efficacy of generic medicines. The dissemination of information about generic medicines may strengthen future knowledge, attitudes and perceptions.

  10. Innovation policy for directing technical change in the power sector

    International Nuclear Information System (INIS)

    Aalbers, Rob; Shestalova, Victoria; Kocsis, Viktória

    2013-01-01

    This paper discusses policy instruments for redirecting technical change within the electricity sector to mitigate climate change. First, we unravel the mechanism behind directed technical change, explaining why markets may underprovide innovations in expensive renewable technologies in comparison to innovations in energy-efficient fossil-fuel generators. Subsequently, we characterize technical change in electricity generation technologies, stressing the heterogeneity of knowledge spillovers both within and between clean electricity generation technologies. We argue that there exists a rationale for a portfolio approach to innovation in the electricity sector, i.e., optimal innovation policies are neither fully generic nor fully specific; and they need to be adapted, in response to new information learned by the government. The existing innovation literature does not, however, provide a clear-cut answer for designing such a policy. We compare policy instruments and argue that public R and D support to clean technologies, either in the form of subsidies or prizes, seems to be the prime candidate for implementing non-generic innovation policy. - Highlights: • We analyze policies for spurring innovations in renewable electricity technologies. • The analysis unravels why research markets underprovide such innovations. • We conclude that non-generic R and D subsidies and prizes are the most suitable policies

  11. The influence of hospital drug formulary policies on the prescribing patterns of proton pump inhibitors in primary care

    DEFF Research Database (Denmark)

    Larsen, Michael Due; Schou, Mette; Kristiansen, Anja Sparre

    2014-01-01

    decreased from 33.5 to 9.4 %, corresponding to a risk ratio of 0.28. In primary care after discharge, 13.4 % of esomeprazole use was initiated in the hospital, and this was 8.4 % for PPIs in general. After the change of hospital drug policy, this decreased to 6.5 % for esomeprazole and increased......AIM: This study had two aims: Firstly, to describe how prescriptions for proton pump inhibitor (PPI) in primary care were influenced by a change of the hospital drug policy, and secondly, to describe if a large discount on an expensive PPI (esomeprazole) to a hospital would influence prescribing...... policy on prescribings in primary care was measured by the likelihood of having a high-cost PPI prescribed before and after change of drug policy. RESULTS: In total, 9,341 hospital stays in 2009 and 2010 were included. The probability of a patient to be prescribed an expensive PPI after discharge...

  12. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for use in colon cancer and rectal cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  13. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Science.gov (United States)

    2012-08-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  14. Introduction of direct-to-consumer advertising of prescription drugs in Canada: an opinion survey on regulatory policy.

    Science.gov (United States)

    Mintzes, Barbara; Barer, Morris; Lexchin, Joel; Bassett, Ken L

    2005-06-01

    Canada is strongly influenced by US cross-border direct-to-consumer advertising (DTCA) and has held consultations to discuss introduction of DTCA since 1996. This article describes a survey of Canadian drug policy experts carried out in 2001, during one such legislative review. The survey results are compared to more recent DTCA policy developments. We recruited key informants on pharmaceutical policy to complete a faxed questionnaire that queried their opinions on DTCA information quality, effects on drug and health care use, and regulatory issues. Respondents were asked about the evidence they had used to back their opinions. Analysis was descriptive. Of 79 identified potential participants, 60 (76%) participated, 40% of whom were from federal and provincial government; 3% were private insurers; 18%, 15%, and 8% were from health professional groups, consumer groups, and patient groups, respectively; 8% and 7% were from pharmaceutical and advertising industries, respectively. Opinions were highly polarized on the effects of DTCA on drug and health care use. Advertising and pharmaceutical industry respondents were generally positive, public sector, health professional and consumer groups generally negative. Over 80% believed DTCA leads to higher private and public drug costs and more frequent physician visits. Fewer judged billboards or television to be appropriate media for DTCA than magazines or the Internet, and most believed that children and adolescents should not be targeted. Given the polarization observed within this survey, we examined how DTCA policy has evolved in Canada since 2001. The federal government has legislative authority over DTCA, but bears few of the additional costs potentially incurred through policy change. These fall to the provinces, which provide an eroding patchwork of public coverage for prescription drugs in the face of rapidly increasing costs. No new federal legislation has been tabled since 2001. However, considerable shifts in

  15. [The War on "Red Drugs": Anticommunism and Drug Policy in Republic of Korea, 1945-1960].

    Science.gov (United States)

    Park, Ji-Young

    2016-04-01

    This paper investigates the discourses and policies on narcotics in Republic of Korea from 1945 to 1960. Since the Liberation the narcotic problem was regarded as the vestige of Japanese imperialism. which was expected to be cleaned up. The image of narcotic crimes as the legacy of the colonial past was turned into as the result of the Red Army's tactics to attack on the liberalist camp around the Korean war. The government of ROK represented the source of the illegal drugs as the Red army and the spy from North Korea. The anticommunist discourse about narcotics described the spies, who introduced the enormous amount of poppies into ROK and brought about the addicts, as the social evil. Through this discourse on poppies from North Korea, the government of ROK emphasized the immorality of the communists reinforcing the anticommunist regime, which was inevitable for the government of ROK to legitimize the division of Korea and the establishment of the government alone. This paper examines how the discourses and policies on narcotics in ROK was shaped and transformed from 1945 to 1960 focusing the relationship between the them and the political context such as anticommunism, Korean war, the division of Korea, and etc. This approach would be helpful to reveal the effect of the ROK's own political situation to the public health system involving the management for drugs.

  16. Measuring improvement in knowledge of drug policy reforms following a police education program in Tijuana, Mexico

    Directory of Open Access Journals (Sweden)

    J. Arredondo

    2017-11-01

    Full Text Available Abstract Background Mexico’s 2009 “narcomenudeo reform” decriminalized small amounts of drugs, shifting some drug law enforcement to the states and mandating drug treatment diversion instead of incarceration. Data from Tijuana suggested limited implementation of this harm reduction-oriented policy. We studied whether a police education program (PEP improved officers’ drug and syringe policy knowledge, and aimed to identify participant characteristics associated with improvement of drug policy knowledge. Methods Pre- and post-training surveys were self-administered by municipal police officers to measure legal knowledge. Training impact was assessed through matched paired nominal data using McNemar’s tests. Multivariable logistic regression was used to identify predictors of improved legal knowledge, as measured by officers’ ability to identify conceptual legal provisions related to syringe possession and thresholds of drugs covered under the reform. Results Of 1750 respondents comparing pre- versus post training, officers reported significant improvement (p < 0.001 in their technical understanding of syringe possession (56 to 91% and drug amounts decriminalized, including marijuana (9 to 52%, heroin (8 to 71%, and methamphetamine (7 to 70%. The training was associated with even greater success in improving conceptual legal knowledge for syringe possession (67 to 96% (p < 0.001, marijuana (16 to 91%, heroin (11 to 91%, and methamphetamine (11 to 89%. In multivariable modeling, those with at least a high school education were more likely to exhibit improvement of conceptual legal knowledge of syringe possession (adjusted odds ratio [aOR] 2.6, 95% CI 1.4–3.2 and decriminalization for heroin (aOR 2.7, 95% CI 1.3–4.3, methamphetamine (aOR 2.2, 95% CI 1.4–3.2, and marijuana (aOR 2.5, 95% CI 1.6–4. Conclusions Drug policy reform is often necessary, but not sufficient to achieve public health goals because of gaps in translating

  17. Measuring improvement in knowledge of drug policy reforms following a police education program in Tijuana, Mexico.

    Science.gov (United States)

    Arredondo, J; Strathdee, S A; Cepeda, J; Abramovitz, D; Artamonova, I; Clairgue, E; Bustamante, E; Mittal, M L; Rocha, T; Bañuelos, A; Olivarria, H O; Morales, M; Rangel, G; Magis, C; Beletsky, L

    2017-11-08

    Mexico's 2009 "narcomenudeo reform" decriminalized small amounts of drugs, shifting some drug law enforcement to the states and mandating drug treatment diversion instead of incarceration. Data from Tijuana suggested limited implementation of this harm reduction-oriented policy. We studied whether a police education program (PEP) improved officers' drug and syringe policy knowledge, and aimed to identify participant characteristics associated with improvement of drug policy knowledge. Pre- and post-training surveys were self-administered by municipal police officers to measure legal knowledge. Training impact was assessed through matched paired nominal data using McNemar's tests. Multivariable logistic regression was used to identify predictors of improved legal knowledge, as measured by officers' ability to identify conceptual legal provisions related to syringe possession and thresholds of drugs covered under the reform. Of 1750 respondents comparing pre- versus post training, officers reported significant improvement (p < 0.001) in their technical understanding of syringe possession (56 to 91%) and drug amounts decriminalized, including marijuana (9 to 52%), heroin (8 to 71%), and methamphetamine (7 to 70%). The training was associated with even greater success in improving conceptual legal knowledge for syringe possession (67 to 96%) (p < 0.001), marijuana (16 to 91%), heroin (11 to 91%), and methamphetamine (11 to 89%). In multivariable modeling, those with at least a high school education were more likely to exhibit improvement of conceptual legal knowledge of syringe possession (adjusted odds ratio [aOR] 2.6, 95% CI 1.4-3.2) and decriminalization for heroin (aOR 2.7, 95% CI 1.3-4.3), methamphetamine (aOR 2.2, 95% CI 1.4-3.2), and marijuana (aOR 2.5, 95% CI 1.6-4). Drug policy reform is often necessary, but not sufficient to achieve public health goals because of gaps in translating formal laws to policing practice. To close such gaps, PEP initiatives

  18. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

    Atanassow, F.; Clarke, D.; Jeuring, J.T.

    2003-01-01

    A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

  19. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

    Atanassow, F.; Clarke, D.; Jeuring, J.T.

    2007-01-01

    A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

  20. Product-line extensions and pricing strategies of brand-name drugs facing patent expiration.

    Science.gov (United States)

    Hong, Song Hee; Shepherd, Marvin D; Scoones, David; Wan, Thomas T H

    2005-01-01

    This study proposed an alternative to brand loyalty as the explanation for the continued price rigidity of patent-expired brand-name prescription drugs despite the increase in market entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act. Study hypotheses were to test (1) whether market entries of new-product extensions are associated with market success of original brand-name drugs before generic drug entry, and (2) whether original brand-name drugs exhibit price rigidity to generic entry only when they are extended. The design is a retrospective follow-up study for the prescription drug brands that lost their patents between 1987 and 1992. The drug brands were limited to nonantibiotic, orally administered drugs containing only 1 active pharmaceutical ingredient. Information on patent expiration, entry of a product extension, and market success were determined from the U.S. Food and Drug Administration.s Orange Book, First DataBank, and American Druggist, respectively. Market success was defined as whether an original drug brand was listed in the top 100 prescriptions most frequently dispensed before facing generic entry. Product-line extension was defined as the appearance of another product that a company introduces within the same market after its existing product. Drug prices were average wholesale prices from the Drug Topics Red Book. The relationship between product-line extension and market success was examined using a logistic regression analysis. The price rigidity to entry was tested using a panel regression analysis. A total of 27 drug brands lost their patents between 1987 and 1992. Drug brands that achieved market success were 16 times more likely to be extended than were those that did not (OR=16, 95% confidence interval, 2.12-120.65). The price rigidity to entry existed in drug brands with extensions (beta=2.65%, P new product-line extension introduced for an original brand helps the original price be

  1. Reframing the science and policy of nicotine, illegal drugs and alcohol - conclusions of the ALICE RAP Project.

    Science.gov (United States)

    Anderson, Peter; Berridge, Virginia; Conrod, Patricia; Dudley, Robert; Hellman, Matilda; Lachenmeier, Dirk; Lingford-Hughes, Anne; Miller, David; Rehm, Jürgen; Room, Robin; Schmidt, Laura; Sullivan, Roger; Ysa, Tamyko; Gual, Antoni

    2017-01-01

    In 2013, illegal drug use was responsible for 1.8% of years of life lost in the European Union, alcohol was responsible for 8.2% and tobacco for 18.2%, imposing economic burdens in excess of 2.5% of GDP. No single European country has optimal governance structures for reducing the harm done by nicotine, illegal drugs and alcohol, and existing ones are poorly designed, fragmented, and sometimes cause harm. Reporting the main science and policy conclusions of a transdisciplinary five-year analysis of the place of addictions in Europe, researchers from 67 scientific institutions addressed these problems by reframing an understanding of addictions.  A new paradigm needs to account for evolutionary evidence which suggests that humans are biologically predisposed to seek out drugs, and that, today, individuals face availability of high drug doses, consequently increasing the risk of harm.  New definitions need to acknowledge that the defining element of addictive drugs is 'heavy use over time', a concept that could replace the diagnostic artefact captured by the clinical term 'substance use disorder', thus opening the door for new substances to be considered such as sugar. Tools of quantitative risk assessment that recognize drugs as toxins could be further deployed to assess regulatory approaches to reducing harm. Re-designed governance of drugs requires embedding policy within a comprehensive societal well-being frame that encompasses a range of domains of well-being, including quality of life, material living conditions and sustainability over time; such a frame adds arguments to the inappropriateness of policies that criminalize individuals for using drugs and that continue to categorize certain drugs as illegal. A health footprint, modelled on the carbon footprint, and using quantitative measures such as years of life lost due to death or disability, could serve as the accountability tool that apportions responsibility for who and what causes drug-related harm.

  2. Responding to the challenge of antimalarial drug resistance by routine monitoring to update national malaria treatment policies

    DEFF Research Database (Denmark)

    Vestergaard, Lasse S; Ringwald, Pascal

    2007-01-01

    of rational and updated malaria treatment policies, but defining and updating such policies requires a sufficient volume of high-quality drug-resistance data collected at national and regional levels. Three main tools are used for drug resistance monitoring, including therapeutic efficacy tests, in vitro...... additional information about changing patterns of resistance. However, some of the tests are technically demanding, and thus there is a need for more resources for training and capacity building in endemic countries to be able to adequately respond to the challenge of drug resistance.......Reduced sensitivity of Plasmodium falciparum to formerly recommended cheap and well-known antimalarial drugs places an increasing burden on malaria control programs and national health systems in endemic countries. The high costs of the new artemisinin-based combination treatments underline the use...

  3. Impact of pharmaceutical policy interventions on utilization of antipsychotic medicines in Finland and Portugal in times of economic recession: interrupted time series analyses.

    Science.gov (United States)

    Leopold, Christine; Zhang, Fang; Mantel-Teeuwisse, Aukje K; Vogler, Sabine; Valkova, Silvia; Ross-Degnan, Dennis; Wagner, Anita K

    2014-07-25

    To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession--a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal - on utilization of, as a proxy for access to, antipsychotic medicines. We obtained monthly IMS Health sales data in standard units of antipsychotic medicines in Portugal and Finland for the period January 2007 to December 2011. We used an interrupted time series design to estimate changes in overall use and generic market shares by comparing pre-policy and post-policy levels and trends. Both countries' policy approaches were associated with slight, likely unintended, decreases in overall use of antipsychotic medicines and with increases in generic market shares of major antipsychotic products. In Finland, quetiapine and risperidone generic market shares increased substantially (estimates one year post-policy compared to before, quetiapine: 6.80% [3.92%, 9.68%]; risperidone: 11.13% [6.79%, 15.48%]. The policy interventions in Portugal resulted in a substantially increased generic market share for amisulpride (estimate one year post-policy compared to before: 22.95% [21.01%, 24.90%]; generic risperidone already dominated the market prior to the policy interventions. Different policy approaches to contain pharmaceutical expenditures in times of the economic recession in Finland and Portugal had intended--increased use of generics--and likely unintended--slightly decreased overall sales, possibly consistent with decreased access to needed medicines--impacts. These findings highlight the importance of monitoring and evaluating the effects of pharmaceutical policy interventions on use of medicines and health outcomes.

  4. Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs.

    Science.gov (United States)

    van Gelder, Teun; Gabardi, Steven

    2013-08-01

    Within the field of solid organ transplantation, the patents for a number of immunosuppressive drugs have expired in the last few years. Tacrolimus, cyclosporine, and mycophenolate mofetil are now available as generic drugs. In some countries, the market penetration of these generic formulations is as high as 70%, whereas in some other countries, this figure is below 10%. Several professional societies have published position papers on the risks and benefits of generic substitution of immunosuppressive drugs. It often appears that transplant professionals are not fully aware of the requirements for registration of generic drugs. This article describes the registration requirements with a focus on bioequivalence testing, the strengths and weaknesses in this process, and the differences between Europe and the US. © 2013 The Authors Transplant International © 2013 European Society for Organ Transplantation. Published by Blackwell Publishing Ltd.

  5. Effects of reference pricing in pharmaceutical markets: a review.

    Science.gov (United States)

    Galizzi, Matteo Maria; Ghislandi, Simone; Miraldo, Marisa

    2011-01-01

    This work aims to provide a systematic and updated survey of original scientific studies on the effect of the introduction of reference pricing (RP) policies in Organisation for Economic Co-operation and Development (OECD) countries. We searched PubMed, EconLit and Web of Knowledge for articles on RP. We reviewed studies that met the inclusion criteria established in the search strategy. From a total of 468 references, we selected the 35 that met all of the inclusion criteria. Some common themes emerged in the literature. The first was that RP was generally associated with a decrease in the prices of the drugs subject to the policy. In particular, price drops seem to have been experienced in virtually every country that implemented a generic RP (GRP) policy. A GRP policy applies only to products with expired patents and generic competition, and clusters drugs according to chemical equivalence (same form and active compound). More significant price decreases were observed in the sub-markets in which drugs were already facing generic competition prior to RP. Price drops varied widely according to the amount of generic competition and industrial strategies: brand-named drugs originally priced above RP values decreased their prices to a greater extent. A second common theme was that both therapeutic RP (TRP) and GRP have been associated with significant and consistent savings in the first years of application. A third general result is that generic market shares significantly increased whenever the firms producing brand-named drugs did not adopt one of the following strategies: lowering prices to RP values; launching new dosages and/or formulations; or marketing substitute drugs still under patent protection. Finally, concerning TRP, although more evidence is needed, studies based on a large number of patient-level observations showed no association between the RP policy and health outcomes.

  6. Brands or generics: the dilemma of pharmaceutical marketing in a developing country.

    Science.gov (United States)

    Quraeshi, Z A; Luqmani, M; Malhotra, N

    1983-01-01

    A significant issue in pharmaceutical marketing in many developing countries is whether drugs should be sold by generic or by brand names. In Pakistan, legislation prohibited the sale of brand name drugs in order to increase price competition, and strengthen the market position of indigenous manufacturers to compete against multinationals. However, the government's objectives were not achieved for reasons discussed in the article. The Pakistan case has implications for multinational firms and for other developing countries in similar situations.

  7. Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: In Vitro Cellular Uptake

    Directory of Open Access Journals (Sweden)

    Min Wu

    2017-12-01

    Full Text Available Iron deficiency anemia is a common clinical consequence for people who suffer from chronic kidney disease, especially those requiring dialysis. Intravenous (IV iron therapy is a widely accepted safe and efficacious treatment for iron deficiency anemia. Numerous IV iron drugs have been approved by U.S. Food and Drug Administration (FDA, including a single generic product, sodium ferric gluconate complex in sucrose. In this study, we compared the cellular iron uptake profiles of the brand (Ferrlecit® and generic sodium ferric gluconate (SFG products. We used a colorimetric assay to examine the amount of iron uptake by three human macrophage cell lines. This is the first published study to provide a parallel evaluation of the cellular uptake of a brand and a generic IV iron drug in a mononuclear phagocyte system. The results showed no difference in iron uptake across all cell lines, tested doses, and time points. The matching iron uptake profiles of Ferrlecit® and its generic product support the FDA’s present position detailed in the draft guidance on development of SFG complex products that bioequivalence can be based on qualitative (Q1 and quantitative (Q2 formulation sameness, similar physiochemical characterization, and pharmacokinetic bioequivalence studies.

  8. The Politics and Policies of Regulating Generics in Latin America: A Survey of Seventeen States.

    Science.gov (United States)

    Sweet, Cassandra M

    2017-06-01

    When patents expire, are equivalent generic alternatives available to citizens? This article contributes to current discussion on access to medicine in the aftermath of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The focus is on off-patent or "generic" medicines: their product definitions, quality standards and prescription procedures. Drawing from a survey conducted of seventeen countries across the Latin American region, this article examines the differences in definition of off-patent products and the paradox of their relatively lower consumption across multiple developing states. The findings point to pathways for improving standards, consumer information, and access in off-patent pharmaceutical markets. Copyright © 2017 by Duke University Press.

  9. Abbreviated New Drug Applications (ANDAS): Future trend in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kishore, R.

    1990-01-01

    The Drug Price Competition and Patent Term Restoration Act (commonly called Waxman Hatch Amendment) of 1984, to the Federal Food, Drug, and Cosmetic Act provided for abbreviated new drug applications (ANDAs) if the conditions specified in the Code of Federal Regulations (CFR) Title 21, subsection 312.55 are met. Under this subsection, reports of nonclinical laboratory studies and clinical investigations can be omitted. New drugs approved under these regulations are so called generic drugs as opposed to listed or pioneer (innovator) drugs. As the patents on more and more radiopharmaceuticals reach their expiration, the radiopharmaceutical industry is likely to produce more of these generic versions of innovator drugs. The ANDAs are required to contain information specified under subsections 314.50(a), (b), (d)(1) and (3), (e), and (g)

  10. Designing ARVs Patent Pool Up to Trade & Policy Evolutionary Dynamics.

    Science.gov (United States)

    Dionisio, Daniele; Racalbuto, Vincenzo; Messeri, Daniela

    2010-01-19

    Patent pools for second and third-line Fixed Dose Combination (FDC) antiretroviral drugs (ARVs) should not be delayed as they are instrumental to urgent public health needs in the under-served markets.Nonetheless, multinational originator companies still seem to perceive patent pooling for ARVs as a minefield that would offer the generic competitors lots of deeply exploitable opportunities, to the detriment of patent owner's rights.This paper analyses the brand industry concerns, while looking for a strategy up to a really equitable and free world market, without any discrimination between end-users in wealthy and resource-limited countries.This strategy would urge partnerships between originator companies first to make newer FDC ARVs quickly available and allow patent pool agreements with generic counterparts to be negotiated straight afterwards.The patent pool strategy highlighted in this paper would assert the primacy of health over for-profit policies, while aligning with the 61(st) WHO's Assembly recommendations and G7, G8 and World Trade Organisation's warnings and pledges against trade protectionism.

  11. Interventions promoting the acceptance and uptake of generic medicines: a narrative review of the literature.

    Science.gov (United States)

    Babar, Z U D; Kan, S W; Scahill, S

    2014-09-01

    The objective of this paper was to undertake a narrative review of the literature regarding strategies and interventions promoting the acceptance and uptake of generic medicines. A literature search was performed between November 2011 and January 2012 to identify published full text original research articles documenting interventions to promote the use of generic medicines. Keywords used were: "generic medicine", "generic drug", "intervention", "promotion", "acceptance", "uptake", "generic/therapeutic substitution" and their related root words. The electronic databases comprised of Embase (1980 - present), Google, Google Scholar, Medline (1948 - present), PubMed, Science Direct, Scopus, Springer Link and The Cochrane Library. An interpretative narrative synthesis was undertaken and emergent themes analysed and reported. Eighteen studies were included in the final analysis. There were seven main themes which including; education, financial incentives, advertising to promote generic medicines, free generic medicine trials, administrative forms and medicines use review (MUR). These themes were further classified into subthemes. Education was subdivided into consumer and physician education. Financial incentives included the influence of financial incentives on both consumers and physicians. The subthemes in the financial incentives category included the changes in co-payment for consumers, reward payment for physicians and fund-holding schemes. Advertising included the sub-themes of print media and the use of anthropomorphic images, while free generic medicines trial was made up of free vouchers for generic medicines and generic medicines sampling system. The studies have mixed results; some interventions in some settings were useful, while others were not. Not all interventions consistently improved the uptake of generic medicines. There was limited literature available and further work is required to develop a range of interventions to support the uptake of generic

  12. Exploiting Specific Interactions toward Next-Generation Polymeric Drug Transporters

    NARCIS (Netherlands)

    Wieczorek, Sebastian; Krause, Eberhard; Hackbarth, Steffen; Roeder, Beate; Hirsch, Anna K. H.; Boerner, Hans G.

    2013-01-01

    A generic method describes advanced tailoring of polymer drug carriers based on polymer-block-peptides. Combinatorial means are used to select suitable peptide segments to specifically complex small-molecule drugs. The resulting specific drug formulation agents render insoluble drugs water-soluble

  13. 78 FR 16679 - Center for Drug Evaluation and Research Medical Policy Council; Request for Comments

    Science.gov (United States)

    2013-03-18

    ... consistent, predictable communication of medical policy decisions to the public through guidance, notice and... protection, (6) bioresearch monitoring, (7) good clinical practice, (8) counter-terrorism drug development...

  14. Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study.

    Science.gov (United States)

    Shraim, Naser Y; Al Taha, Tasneem A; Qawasmeh, Rawan F; Jarrar, Hiba N; Shtaya, Maram A N; Shayeb, Lama A; Sweileh, Waleed M

    2017-12-28

    Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic medicine. However, their knowledge score pertaining the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters in particular was insufficient.

  15. Randomized, double blind comparison of brand and generic antibiotic suspensions: II. A study of taste and compliance in children.

    Science.gov (United States)

    El-Chaar, G M; Mardy, G; Wehlou, K; Rubin, L G

    1996-01-01

    The taste of oral liquid medications influences compliance in children. Generic preparations are prescribed to reduce cost and may taste worse than brand name products. This was a prospective, randomized, double blind, crossover trial of the differences in taste and compliance between brand and generic antibiotic suspensions in children 3 to 14 years of age. Verbal and visual assessment methods were used to assess taste, and compliance was measured by the amount of drug returned after use. Ten children in each of the cephalexin and erythromycin-sulfisoxazole groups did not report that the brand and generic formulations tasted differently. Fifteen children thought that brand trimethoprim-sulfamethoxazole tasted better than the generic preparation. Brand name oral liquid antibiotics do not necessarily taste better than their generic counterparts. Despite preference for the taste of brand trimethoprim-sulfamethoxazole, all of the children in this study were compliant with both brand and generic medications.

  16. DRUG POLICY AND DRUG ADDICTION IN TURKEY

    OpenAIRE

    İLHAN, Mustafa Necmi

    2018-01-01

    The NationalStrategy Document on Drugs and Emergency Action Plan started with thecontributions of all the relevant institutions within the year of 2014 wasprepared and after that in accordance with the Prime Ministry Notice entitledFight Against Drugs published within this scope, the committees for FightAgainst Drugs were established (under the presidency of Deputy Prime Ministerand with the help of Ministry of Health, Ministry of Justice, Ministry of Laborand Social Security, Ministry of Fam...

  17. How large are the differences between originator and generic prices? Analysis of five molecules in 16 European countries

    Directory of Open Access Journals (Sweden)

    Sabine Vogler

    2012-12-01

    Full Text Available OBJECTIVE: To survey the price differences between originators and generics for a selected basket of molecules and to analyze similarities and differences with regard to the countries included and their generic policies. METHODS: Ex-factory prices as of November 2011 of five molecules provided from the Pharma Price Information (PPI service of the Austrian Health Institute were analyzed for 16 European countries (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Switzerland, Sweden, UK. The selected molecules were gemcitabine, mycophenolate mofetil, olanzapine, risperidone and sumatriptan. For a specific presentation (same pack size, dosage and pharmaceutical form of each molecule, the prices of the original product and the “most common generic” as defined by PPI were compared. RESULTS: Considerable variations among the extent of price differences between originator and generic were identified (gemicitabine: lowest price difference of 1.4% between originator and generic in Belgium and highest difference of 73.4% in Portugal; mycophenolate mofetil: 3.4% Norway – 71.7% Netherlands; olanzapine: 0.1% Spain – 97.1% Sweden; risperidone: 0.9% Netherlands – 97.3% UK; sumatriptan: 5.8% Greece – 95.0% Denmark. Further, no difference at all between originator and generic prices was found for some molecules in a few countries (Norway: for 4 of the 5 molecules analyzed; Spain: 3; Belgium: 2; in Austria, France and Greece for one molecule respectively. For the five molecules of the sample, Greece, Spain, Ireland and Norway consistently displayed lower price differences whereas Denmark, Finland and Sweden tended to show higher differences between originator and generic prices. CONCLUSION: Even if this research is illustrative and not representative due to the small sample size, results suggest confirming large differences across Europe. It appears that countries (e.g. Denmark

  18. Market Exclusivity Time for Top Selling Originator Drugs in Canada: A Cohort Study.

    Science.gov (United States)

    Lexchin, Joel

    2017-09-01

    This study looks at market exclusivity time for the top selling originator drugs in Canada. Total sales for drugs without competition were also calculated. A list of the top selling originator drugs by dollar sales from 2009 to 2015 inclusive, except for 2010, was compiled along with their annual sales. Health Canada databases were used to extract the following information: generic name, date of Notice of Compliance (NOC, date of marketing authorization), whether the product was a small molecule drug or a biologic, and date of NOC for a generic or biosimilar. Market exclusivity time was calculated in days for drugs. A total of 121 drugs were identified. There were 96 small molecule drugs (63 with a generic competitor and 33 with no generic competitor) and 25 biologics (none with a biosimilar competitor). The 63 drugs with a competitor had a mean market exclusivity time of 4478 days (12.3 years) (95% CI 4159-4798). The 58 drugs without competition had total annual sales of Can$8.59 billion and were on the market for a median of 5357 days (14.7 years) (interquartile range 3291-6679) as of January 31, 2017. Top selling originator drugs in Canada have a considerably longer period of market exclusivity than the 8 to 10 years that the research-based pharmaceutical industry claims. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  19. Prescription drug samples--does this marketing strategy counteract policies for quality use of medicines?

    Science.gov (United States)

    Groves, K E M; Sketris, I; Tett, S E

    2003-08-01

    Prescription drug samples, as used by the pharmaceutical industry to market their products, are of current interest because of their influence on prescribing, and their potential impact on consumer safety. Very little research has been conducted into the use and misuse of prescription drug samples, and the influence of samples on health policies designed to improve the rational use of medicines. This is a topical issue in the prescription drug debate, with increasing costs and increasing concerns about optimizing use of medicines. This manuscript critically evaluates the research that has been conducted to date about prescription drug samples, discusses the issues raised in the context of traditional marketing theory, and suggests possible alternatives for the future.

  20. Optimizing Generic Functions

    NARCIS (Netherlands)

    Alimarine, A.; Smetsers, J.E.W.

    2004-01-01

    Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular type. An instance on a specific type is generated by interpretation of the type's structure. A direct

  1. Oral drug delivery system based on interpolymer complex formation between poly(acrylic acid) and poly(vinyl pyrrolidone-co-vinyl acetate)

    CSIR Research Space (South Africa)

    Germishuizen, A

    2005-07-01

    Full Text Available A number of the most successful drugs are going off patent in the next 5 years. Generic prescription drugs are continuously making up a larger proportion of the total drug market. Therefore, the drug delivery systems used to deliver the generic...

  2. Pharmaceutical expenditure forecast model to support health policy decision making.

    Science.gov (United States)

    Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project 'European Union (EU) Pharmaceutical expenditure forecast' - http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). A model was built to assess policy scenarios' impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate, and distribution. Reducing, even slightly, the prices of

  3. The Relationship of Students' Awareness on Drug Policy, Procedures, and Intervention Programs to the Drug and Alcohol Use on College Campuses: A Correlational Study

    Science.gov (United States)

    Love-Quick, Sharon J.

    2016-01-01

    One of the most pressing concerns that universities and colleges face today is the drug and alcohol abuse of students. In order to address this, there is a need to strengthen university policies in order to mitigate the increasing rate and cases of drug and alcohol abuse among students. The purpose of this quantitative study was to examine the…

  4. Peter Bourne's drug policy and the perils of a public health ethic, 1976-1978.

    Science.gov (United States)

    Clark, Claire D; Dufton, Emily

    2015-02-01

    As President Jimmy Carter's advisor for health issues, Peter Bourne promoted a rational and comprehensive drug strategy that combined new supply-side efforts to prevent drug use with previously established demand-side addiction treatment programs. Using a public health ethic that allowed the impact of substances on overall population health to guide drug control, Bourne advocated for marijuana decriminalization as well as increased regulations for barbiturates. A hostile political climate, a series of rumors, and pressure from both drug legalizers and prohibitionists caused Bourne to resign in disgrace in 1978. We argue that Bourne's critics used his own public health framework to challenge him, describe the health critiques that contributed to Bourne's resignation, and present the story of his departure as a cautionary tale for today's drug policy reformers.

  5. Consumers devise drug cost-cutting measures: medical and legal issues to consider.

    Science.gov (United States)

    Ganguli, Gouranga

    2003-01-01

    Health care costs in general, and prescription drug costs in particular, are rapidly rising. Between 1996 and 2007 the average annual per capita health care cost is projected to increase from dollar 3,781 to dollar 7,100. [AQ1] The single leading component of health care cost is the cost of prescription drugs (currently 10% of total health care spending, projected to become 18% in 2008). The average cost per drug increased 40% during the 1993-1998 period. Forty-one million Americans have no health insurance, and those who have, have inadequate prescription drug coverage. [AQ2] To cope with this situation, many consumers are trying to economize by doing without the prescriptions or the appropriate doses, buying generics or medicines from Canada or Mexico, or splitting pills of higher doses to take advantage of the pricing policy of drug manufacturers. Some of these approaches are medically and/or legally acceptable, while some are dubious. Most adversely affected are the seniors and poor; for certain groups of seniors prescription drugs account for 30% of their health care spending. The problem must receive prompt concerted attention from consumers, insurers, pharmaceutical companies, and lawmakers before it gets out of hand.

  6. 78 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement...

    Science.gov (United States)

    2013-02-06

    ... utility of the prescription drug labeling as a communication tool and to discuss strategies for making it... the Web site after this document publishes in the Federal Register.) All holders of marketing... before June 30, 2001, and for generic drugs. The initiative is anticipated to take place over several...

  7. Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for ovarian cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  8. 77 FR 65198 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug...

    Science.gov (United States)

    2012-10-25

    ..., U.S. postal money order, or wire transfer. FDA has partnered with the U.S. Department of the... money order and make payable to the order of the Food and Drug Administration. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks are to be...

  9. Medicamentos: o preço da saúde / Drugs: The Health Price

    Directory of Open Access Journals (Sweden)

    Joedson de Souza Delgado

    2016-05-01

    Full Text Available Purpose – This paper analyzes the structure of government control in drug prices between sector agents, to facilitate its reach to the population in the face of fierce competition for brand positioning in relation to generic manufacturers produced and developed in Brazil. Methodology – Based on empirical data and making use of a literature review, the paper discusses the model of maximum pricing in pharmacies, records the changes of the regulatory environment of the Brazilian pharmaceutical industry, describes the branded drug access policy and discusses the effectiveness and efficiency of intervention. Findings – The state interference in the drug market denotes the search for the containment of economic and social disparities by expanding the opportunity of choice and the offer of prices that are more competitive. Even so, there are still discussions about the quantum to be paid for effective and innovative drugs under patent protection. Practical implications – The critical discussion reveals the need for good sectorial regulation in order to maximize the welfare of society and consumers by increasing competition between laboratories.

  10. Legal Drugs Are Good Drugs and Illegal Drugs Are Bad Drugs

    OpenAIRE

    Indrati, Dina; Prasetyo, Herry

    2011-01-01

    ABSTRACT : Labelling drugs are important issue nowadays in a modern society. Although it is generally believed that legal drugs are good drugs and illegal drugs are bad drugs, it is evident that some people do not aware about the side effects of drugs used. Therefore, a key contention of this philosophical essay is that explores harms minimisation policy, discuss whether legal drugs are good drugs and illegal drugs are bad drugs and explores relation of drugs misuse in a psychiatric nursing s...

  11. Optimal Temporal Policies in Fluid Milk Advertising

    OpenAIRE

    Vande Kamp, Philip R.; Kaiser, Harry M.

    1998-01-01

    This study develops an approach to obtain optimal temporal advertising strategies when consumers' response to advertising is asymmetric. Using this approach, optimal strategies for generic fluid milk advertising in New York City are determined. Results indicate that pulsed advertising policies are significantly more effective in increasing demand than a uniform advertising policy. Sensitivity analyses show that the optimal advertising policies are insensitive to reasonable variations in inter...

  12. 78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  13. Generic Example Proving Criteria for All

    Science.gov (United States)

    Yopp, David; Ely, Rob; Johnson­-Leung, Jennifer

    2015-01-01

    We review literature that discusses generic example proving and highlight ambiguities that pervade our research community's discourse about generic example arguments. We distinguish between pedagogical advice for choosing good examples that can serve as generic examples when teaching and advice for developing generic example arguments. We provide…

  14. Drugs indicated for use during pregnancy.

    Science.gov (United States)

    Lalonde, André B

    2011-01-01

    The Society of Obstetricians and Gynaecologists of Canada (SOGC) advocates that drugs used during pregnancy be tested exclusively in women. The SOGC holds the opinion that drugs to be used exclusively in men or in women should not be tested in a small number of men and women. The SOGC, always cautious with the choice of pharmacological treatments recommended for use during pregnancy, welcomes the increased options resulting from the introduction of generic formulations of drugs shown to be bioequivalent to currently available brand name products. These formulations provide less expensive options to Canadian women in need of drug therapy. However, the Society does not believe that drugs should be substituted without the patient and the physician both agreeing to such a change. Generic substitutions of some products may mean a potentially clinically significant difference in drug dose, possibly resulting in a changed patient effect. Furthermore, substituting a product on the basis of price alone is not acceptable.The SOGC, as an organization with the role of advising its members on clinical practice, calls on Health Canada to review its guideline on testing of drugs for vulnerable populations, especially pregnant women.

  15. Generic and biosimilar medicines: quid?

    Directory of Open Access Journals (Sweden)

    Steven Simoens

    2012-12-01

    Full Text Available Once intellectual property protection, data and marketing exclusivity of reference medicines have expired, generic medicines and biosimilar medicines can enter the off-patent market. This market entry is conditional on the approval of marketing authorization, pricing and reimbursement. Given that there tends to be confusion surrounding generic and biosimilar medicines, this Editorial introduces basic concepts related to generic and biosimilar medicines and presents the different studies and articles included in this supplement dedicated to generic and biosimilar medicines.

  16. Drug usage by outpatients in Croatia during an 8-year period: Influence of changes in pricing policy.

    Science.gov (United States)

    Vitezic, Dinko; Madjarevic, Tomislav; Gantumur, Monja; Buble, Tonci; Vitezic, Miomira; Kovacevic, Miljenko; Mrsic-Pelcic, Jasenka; Sestan, Branko

    2012-07-01

    The aim of our study was to investigate the changes in drug usage and financial expenditure according to legal changes in Croatia during the period 2001 - 2008, especially considering pricing policy. The data on outpatient drug usage during the studied period was obtained from the Croatian National Health Insurance (CNHI). CNHI maintains a database on drugs prescribed by primary health care physicians and dispensed by pharmacies. The data was calculated and presented in defined daily doses (DDD) per inhabitant per year for antibiotics and in DDD/1,000 inhabitants/day for other drugs. The data is also presented in Euro/DDD and the financial expenditures are presented in Euros. During the investigated period drug usage increased 81.33%, while financial expenditure increased 77.23%. While total DDD/1,000 increased ~ 10% every year, financial expenditure increased 10 - 20% annually until 2006, but since then there have been no significant changes. Pricing policy changes could influence drug financial expenditure considerably in the short-term, but it is also important to apply a combination of measures for drug expenditure control. Numerous interventions from authorities from different countries all over the world, prove that there is still no so called "gold standard" which could restrain growing usage and expenditure of drugs. Clinical pharmacologists and clinical pharmacists should be included in these processes.

  17. How drug life-cycle management patent strategies may impact formulary management.

    Science.gov (United States)

    Berger, Jan; Dunn, Jeffrey D; Johnson, Margaret M; Karst, Kurt R; Shear, W Chad

    2016-10-01

    Drug manufacturers may employ various life-cycle management patent strategies, which may impact managed care decision making regarding formulary planning and management strategies when single-source, branded oral pharmaceutical products move to generic status. Passage of the Hatch-Waxman Act enabled more rapid access to generic medications through the abbreviated new drug application process. Patent expirations of small-molecule medications and approvals of generic versions have led to substantial cost savings for health plans, government programs, insurers, pharmacy benefits managers, and their customers. However, considering that the cost of developing a single medication is estimated at $2.6 billion (2013 dollars), pharmaceutical patent protection enables companies to recoup investments, creating an incentive for innovation. Under current law, patent protection holds for 20 years from time of patent filing, although much of this time is spent in product development and regulatory review, leaving an effective remaining patent life of 7 to 10 years at the time of approval. To extend the product life cycle, drug manufacturers may develop variations of originator products and file for patents on isomers, metabolites, prodrugs, new drug formulations (eg, extended-release versions), and fixed-dose combinations. These additional patents and the complexities surrounding the timing of generic availability create challenges for managed care stakeholders attempting to gauge when generics may enter the market. An understanding of pharmaceutical patents and how intellectual property protection may be extended would benefit managed care stakeholders and help inform decisions regarding benefit management.

  18. Beyond America's War on Drugs: Developing Public Policy to Navigate the Prevailing Pharmacological Revolution.

    Science.gov (United States)

    Golub, Andrew; Bennett, Alex S; Elliott, Luther

    2015-03-30

    This paper places America's "war on drugs" in perspective in order to develop a new metaphor for control of drug misuse. A brief and focused history of America's experience with substance use and substance use policy over the past several hundred years provides background and a framework to compare the current Pharmacological Revolution with America's Nineteenth Century Industrial Revolution. The paper concludes with cautions about growing challenges and provides suggestions for navigating this revolution and reducing its negative impact on individuals and society.

  19. An Optimization Model for Expired Drug Recycling Logistics Networks and Government Subsidy Policy Design Based on Tri-level Programming.

    Science.gov (United States)

    Huang, Hui; Li, Yuyu; Huang, Bo; Pi, Xing

    2015-07-09

    In order to recycle and dispose of all people's expired drugs, the government should design a subsidy policy to stimulate users to return their expired drugs, and drug-stores should take the responsibility of recycling expired drugs, in other words, to be recycling stations. For this purpose it is necessary for the government to select the right recycling stations and treatment stations to optimize the expired drug recycling logistics network and minimize the total costs of recycling and disposal. This paper establishes a tri-level programming model to study how the government can optimize an expired drug recycling logistics network and the appropriate subsidy policies. Furthermore, a Hybrid Genetic Simulated Annealing Algorithm (HGSAA) is proposed to search for the optimal solution of the model. An experiment is discussed to illustrate the good quality of the recycling logistics network and government subsides obtained by the HGSAA. The HGSAA is proven to have the ability to converge on the global optimal solution, and to act as an effective algorithm for solving the optimization problem of expired drug recycling logistics network and government subsidies.

  20. Substandard drugs: a potential crisis for public health

    Science.gov (United States)

    Johnston, Atholl; Holt, David W

    2014-01-01

    Poor-quality medicines present a serious public health problem, particularly in emerging economies and developing countries, and may have a significant impact on the national clinical and economic burden. Attention has largely focused on the increasing availability of deliberately falsified drugs, but substandard medicines are also reaching patients because of poor manufacturing and quality-control practices in the production of genuine drugs (either branded or generic). Substandard medicines are widespread and represent a threat to health because they can inadvertently lead to healthcare failures, such as antibiotic resistance and the spread of disease within a community, as well as death or additional illness in individuals. This article reviews the different aspects of substandard drug formulation that can occur (for example, pharmacological variability between drug batches or between generic and originator drugs, incorrect drug quantity and presence of impurities). The possible means of addressing substandard manufacturing practices are also discussed. A concerted effort is required on the part of governments, drug manufacturers, charities and healthcare providers to ensure that only drugs of acceptable quality reach the patient. PMID:24286459

  1. Drug decriminalization and the price of illicit drugs.

    Science.gov (United States)

    Félix, Sónia; Portugal, Pedro

    2017-01-01

    This study is an empirical assessment of the impact of the drug decriminalization policy followed by Portugal in July 2001, on the price of illicit drugs. The analysis is performed using a difference-in-differences approach and the Synthetic Control Method in order to construct a synthetic control unit from a convex combination of countries. The results suggest that the prices of opiates and cocaine in the post-treatment period did not decrease in the sequence of the policy change. We conclude that the drug decriminalization policy seems to have caused no harm through lower illicit drugs prices, which would lead to higher drug usage and dependence. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. Evaluating the impact of Mexico's drug policy reforms on people who inject drugs in Tijuana, B.C., Mexico, and San Diego, CA, United States: a binational mixed methods research agenda.

    Science.gov (United States)

    Robertson, Angela M; Garfein, Richard S; Wagner, Karla D; Mehta, Sanjay R; Magis-Rodriguez, Carlos; Cuevas-Mota, Jazmine; Moreno-Zuniga, Patricia Gonzalez; Strathdee, Steffanie A

    2014-02-12

    Policymakers and researchers seek answers to how liberalized drug policies affect people who inject drugs (PWID). In response to concerns about the failing "war on drugs," Mexico recently implemented drug policy reforms that partially decriminalized possession of small amounts of drugs for personal use while promoting drug treatment. Recognizing important epidemiologic, policy, and socioeconomic differences between the United States-where possession of any psychoactive drugs without a prescription remains illegal-and Mexico-where possession of small quantities for personal use was partially decriminalized, we sought to assess changes over time in knowledge, attitudes, behaviors, and infectious disease profiles among PWID in the adjacent border cities of San Diego, CA, USA, and Tijuana, Baja California, Mexico. Based on extensive binational experience and collaboration, from 2012-2014 we initiated two parallel, prospective, mixed methods studies: Proyecto El Cuete IV in Tijuana (n = 785) and the STAHR II Study in San Diego (n = 575). Methods for sampling, recruitment, and data collection were designed to be compatible in both studies. All participants completed quantitative behavioral and geographic assessments and serological testing (HIV in both studies; hepatitis C virus and tuberculosis in STAHR II) at baseline and four semi-annual follow-up visits. Between follow-up assessment visits, subsets of participants completed qualitative interviews to explore contextual factors relating to study aims and other emergent phenomena. Planned analyses include descriptive and inferential statistics for quantitative data, content analysis and other mixed-methods approaches for qualitative data, and phylogenetic analysis of HIV-positive samples to understand cross-border transmission dynamics. Investigators and research staff shared preliminary findings across studies to provide feedback on instruments and insights regarding local phenomena. As a result, recruitment and data

  3. A new approach to formulating and appraising drug policy: A multi-criterion decision analysis applied to alcohol and cannabis regulation

    NARCIS (Netherlands)

    Rogeberg, Ole; Bergsvik, Daniel; Phillips, Lawrence D.; van Amsterdam, Jan; Eastwood, Niamh; Henderson, Graeme; Lynskey, Micheal; Measham, Fiona; Ponton, Rhys; Rolles, Steve; Schlag, Anne Katrin; Taylor, Polly; Nutt, David

    2018-01-01

    Drug policy, whether for legal or illegal substances, is a controversial field that encompasses many complex issues. Policies can have effects on a myriad of outcomes and stakeholders differ in the outcomes they consider and value, while relevant knowledge on policy effects is dispersed across

  4. Legal Drugs Are Good Drugs And Illegal Drugs Are Bad Drugs

    Directory of Open Access Journals (Sweden)

    Dina Indrati

    2011-07-01

    Full Text Available ABSTRACT : Labelling drugs are important issue nowadays in a modern society. Although it is generally believed that legal drugs are good drugs and illegal drugs are bad drugs, it is evident that some people do not aware about the side effects of drugs used. Therefore, a key contention of this philosophical essay is that explores harms minimisation policy, discuss whether legal drugs are good drugs and illegal drugs are bad drugs and explores relation of drugs misuse in a psychiatric nursing setting and dual diagnosis.Key words: Legal, good drugs, illegal, bad drugs.

  5. 76 FR 57767 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-16

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors AGENCY: Nuclear Regulatory Commission... FR 54507), that requested public comment on Draft NRC Generic Letter 2011- XX: Seismic Risk...

  6. A dawning demand for a new cannabis policy: A study of Swedish online drug discussions.

    Science.gov (United States)

    Månsson, Josefin

    2014-07-01

    This study examines how online discussions on drug policy are formulating an oppositional cannabis discourse in an otherwise prohibitionist country like Sweden. The focus of the paper is to identify demands for an alternative cannabis policy as well as analysing how these demands are linked to governance. The empirical material is 56 discussion-threads from the online message-board Flashback Forum that were active during the first eight months of 2012. Discourse theory was used to locate the discourse, and governmentality theory was used to locate the political belonging of the discourse. On Flashback Forum demands for a new cannabis policy are articulated in opposition to Swedish prohibitionist discourse. The oppositional discourse is constructed around the nodal points cannabis, harm, state and freedom that fill legalisation/decriminalisation/liberalisation with meaning. The nodal points are surrounded by policy demands that get their meaning through the particular nodal. These demands originate from neo-liberal and welfarist political rationalities. Neo-liberal and welfarist demands are mixed, and participants are simultaneously asking for state and individual approaches to handle the cannabis issue. Swedish online discourse on cannabis widens the scope beyond the confines of drug policy to broader demands such as social justice, individual choice and increased welfare. These demands are not essentially linked together and many are politically contradictory. This is also significant for the discourse; it is not hegemonised by a political ideology. The discourse is negotiated between the neo-liberal version of an alternative policy demanding individual freedom, and the welfarist version demanding social responsibility. This implies the influence of the heritage from the social-democratic discourse, centred on state responsibility, which have been dominating Swedish politics in modern times. Consequently, this study refutes that the demand for a new cannabis

  7. Estimated generic prices of cancer medicines deemed cost-ineffective in England: a cost estimation analysis.

    Science.gov (United States)

    Hill, Andrew; Redd, Christopher; Gotham, Dzintars; Erbacher, Isabelle; Meldrum, Jonathan; Harada, Ryo

    2017-01-20

    The aim of this study was to estimate lowest possible treatment costs for four novel cancer drugs, hypothesising that generic manufacturing could significantly reduce treatment costs. This research was carried out in a non-clinical research setting using secondary data. There were no human participants in the study. Four drugs were selected for the study: bortezomib, dasatinib, everolimus and gefitinib. These medications were selected according to their clinical importance, novel pharmaceutical actions and the availability of generic price data. Target costs for treatment were to be generated for each indication for each treatment. The primary outcome measure was the target cost according to a production cost calculation algorithm. The secondary outcome measure was the target cost as the lowest available generic price; this was necessary where export data were not available to generate an estimate from our cost calculation algorithm. Other outcomes included patent expiry dates and total eligible treatment populations. Target prices were £411 per cycle for bortezomib, £9 per month for dasatinib, £852 per month for everolimus and £10 per month for gefitinib. Compared with current list prices in England, these target prices would represent reductions of 74-99.6%. Patent expiry dates were bortezomib 2014-22, dasatinib 2020-26, everolimus 2019-25 and gefitinib 2017. The total global eligible treatment population in 1 year is 769 736. Our findings demonstrate that affordable drug treatment costs are possible for novel cancer drugs, suggesting that new therapeutic options can be made available to patients and doctors worldwide. Assessing treatment cost estimations alongside cost-effectiveness evaluations is an important area of future research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  8. A Case Study of Pharmaceutical Pricing in China: Setting the Price for Off-Patent Originators.

    Science.gov (United States)

    Hu, Shanlian; Zhang, Yabing; He, Jiangjiang; Du, Lixia; Xu, Mingfei; Xie, Chunyan; Peng, Ying; Wang, Linan

    2015-08-01

    This article aims to define a value-based approach to pricing and reimbursement for off-patent originators using a multiple criteria decision analysis (MCDA) approach centered on a systematic analysis of current pricing and reimbursement policies in China. A drug price policy review was combined with a quantitative analysis of China's drug purchasing database. Policy preferences were identified through a MCDA performed by interviewing well-known academic experts and industry stakeholders. The study findings indicate that the current Chinese price policy includes cost-based pricing and the establishment of maximum retail prices and premiums for off-patent originators, whereas reference pricing may be adopted in the future. The literature review revealed significant differences in the dissolution profiles between originators and generics; therefore, dissolution profiles need to be improved. Market data analysis showed that the overall price ratio of generics and off-patent originators was around 0.54-0.59 in 2002-2011, with a 40% price difference, on average. Ten differentiating value attributes were identified and MCDA was applied to test the impact of three pricing policy scenarios. With the condition of implementing quality consistency regulations and controls, a reduction in the price gap between high-quality off-patent products (including originator and generics) seemed to be the preferred policy. Patents of many drugs will expire within the next 10 years; thus, pricing will be an issue of importance for off-patent originators and generic alternatives.

  9. Might generic OCs create contraceptive price war?

    Science.gov (United States)

    1987-02-01

    Genora 1/35 and 1/50, the 1st generic oral contraceptives (OCs) in the world, are now being marketed in the US. Clinicians interviewed by "Contraceptive Technology Update" (CTU) offer differing opinions as to what this new OC may mean in the marketplace. Products of Rugby Laboratories, the pills are copy products of Ortho Pharmaceutical's ON 1/35 and ON 1/50 formulations. Most clinicians believe that Genora's success or failure in the OC market depends on its eventual retail price. The price difference of $3-$4 may be sufficiently substantial for retailers to charge less for the generic OCs. If that is the case, many doctors may prescribe a pill which will save their patients $4/month. Dr. Mildred Hanson, a Minneapolis gynecologist/obstetrician, feels any cost savings from Genora will have a significant impact on the OC market. She suggests that the less expensive OCs will catch the attention of health maintenance organizations (HMOs) and the business of women who participate in such health plans. Yet James Burns, director of family planning services for the Hartford City Health Department, thinks that even a full-scale retail price war won't have much effect from a clinic standpoint. He reports that clinics are able to obtain contraceptive supplies rather inexpensively through the contracting system. Hanson also expressed doubt over the potential popularity of Genora 1/50 as clinical concerns about the effects of combined OCs on serum lipid levels and carbohydrate metabolism have resulted in a nationwide push toward OCs containing less than 50 micrograms of estrogen. He indicated concern that declines in pharmaceutical house products from pricing competition with generic pills might have a negative impact on contraceptive research and development. Dick Haskitt, director of business planning for Syntex Laboratories, Inc., who will produce the OCs for Rugby, reports that their market research shows that people are very interested in having a generic OC available

  10. Pharmaceutical expenditure forecast model to support health policy decision making

    Science.gov (United States)

    Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    Background and objective With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project ‘European Union (EU) Pharmaceutical expenditure forecast’ – http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Methods A model was built to assess policy scenarios’ impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Results Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Conclusions Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate

  11. In vitro disintegration studies of weekly generic and branded risedronate sodium formulations available in Canada.

    Science.gov (United States)

    Walker, A D; Adachi, J D

    2011-09-01

    The aim of this study was to evaluate the in vitro disintegration of the five newly available Canadian generic risedronate 35 mg tablets compared to the innovator (branded) product, ACTONEL * *ACTONEL is a registered trade name of Warner Chilcott Company, LLC. (risedronate sodium) 35 mg. Tablets were inspected for colour and appearance. Disintegration times were determined using United States Pharmacopeia 33 (USP33-NF 28) methods. Disintegration onset time was also evaluated. The mean disintegration onset time values for the generic risedronate 35 mg tablets ranged from 2 to 29 seconds, and the mean disintegration completion times ranged from 81 to 260 seconds. The mean disintegration onset and completion time values for the ACTONEL 35 mg tablets were 23 and 43 seconds respectively. Four out of the five generic tablets tested had shorter disintegration onset times than the branded product; two of the generic tablet products had very fast disintegration onset times i.e. 2-3 seconds. Disintegration completion time for all five generic products tested was longer than that observed for the branded product; two generic products had disintegration completion time values five to six times longer than the branded product. Differences in the in vitro disintegration times were observed between the generic risedronate 35 mg tablets commercially available in Canada and the branded product, ACTONEL. The rapid disintegration onset times of two generic products may be important as this could increase the possibility of drug exposure in both the mouth and the esophagus during swallowing, resulting in unwanted localized irritation. However, it should be noted that an in vitro/in vivo correlation has not been established. Until such studies are completed it may be important to be aware of such in vitro disintegration differences when evaluating patients with newly presenting upper gastrointestinal complaints upon being switched from the branded product to generic formulations.

  12. A propósito de un caso: ¿Sirven los genéricos para moderar el gasto en hipertensión? Apropos of a case: do generic drugs help control expenditure on hypertension?

    Directory of Open Access Journals (Sweden)

    Antonio J. García

    2004-04-01

    farmacia.Objetive: In this article we analyze the influence of generic drugs on pharmaceutical expenditure on hypertension from the payer's perspective (the public health service, by examining the most widely used drugs: angiotensin converting enzyme inhibitors (ACEi and angiotensin II receptor blockers (ARBs. Methods: Based on billing data to the public health service from all the pharmacies in the Health Area of Malaga, we studied the utilization (containers and cost of ACEi (generic drugs -ACEi+G- and brand name and ARBs (brand name only (subgroup C09 - ATC index from 1999 to 2002. The mean price (weighted according to sales and the percentage of deviation of prescriptions from one group of drugs to another was also studied. Results: The increase in consumption of packages in subgroup C09 was 20.79%; the increase was greater for ARBs (136% and for ACEi+G (177%. The total amount spent during the study period increased by more than 42%. Expenditure on ACEis decreased by almost 7%, despite the increase in expenditure on ACEi+G, whereas expenditure on ARBs increased by more than 154%. The mean price of this subgroup, weighted according to sales, increased by nearly 18%. The mean weighted price of the generic drugs, captopril and enalapril, and that of the brand name, trandolapril, decrea sed. Notable among ARBs was the increase in mean price weighted according to sales of irbesartan (9% and valsartan (16%. Conclusions: The use of generic drugs has reduced expenditure on ACEi and the mean weighted price of the subgroup. However, the increased use of generic drugs has not produced the expected savings for the Department of Health. This could be due to deviation of prescription scores toward drugs not affected by substitution by the pharmacy.

  13. Different initiatives across Europe to enhance losartan utilization post generics: impact and implications

    Science.gov (United States)

    Moon, James C.; Godman, Brian; Petzold, Max; Alvarez-Madrazo, Samantha; Bennett, Kathleen; Bishop, Iain; Bucsics, Anna; Hesse, Ulrik; Martin, Andrew; Simoens, Steven; Zara, Corinne; Malmström, Rickard E.

    2014-01-01

    Introduction: There is an urgent need for health authorities across Europe to fully realize potential savings from increased use of generics to sustain their healthcare systems. A variety of strategies were used across Europe following the availability of generic losartan, the first angiotensin receptor blocker (ARB) to be approved and marketed, to enhance its prescribing vs. single-sourced drugs in the class. Demand-side strategies ranged from 100% co-payment for single-sourced ARBs in Denmark to no specific measures. We hypothesized this heterogeneity of approaches would provide opportunities to explore prescribing in a class following patent expiry. Objective: Contrast the impact of the different approaches among European countries and regions to the availability of generic losartan to provide future guidance. Methodology: Retrospective segmented regression analyses applying linear random coefficient models with country specific intercepts and slopes were used to assess the impact of the various initiatives across Europe following the availability of generic losartan. Utilization measured in defined daily doses (DDDs). Price reductions for generic losartan were also measured. Results: Utilization of losartan was over 90% of all ARBs in Denmark by the study end. Multiple measures in Sweden and one English primary care group also appreciably enhanced losartan utilization. Losartan utilization actually fell in some countries with no specific demand-side measures. Considerable differences were seen in the prices of generic losartan. Conclusion: Delisting single-sourced ARBs produced the greatest increase in losartan utilization. Overall, multiple demand-side measures are needed to change physician prescribing habits to fully realize savings from generics. There is no apparent “spill over” effect from one class to another to influence future prescribing patterns even if these are closely related. PMID:25339902

  14. Drug Policy in Croatia.

    Science.gov (United States)

    Culig, Josip; Antolic, Sinisa; Szkultecka-Dębek, Monika

    2017-09-01

    We presented a general overview of the health care system as well as the pricing and reimbursement environment in Croatia. In Croatia, most of the public funding for health care is collected from employers, through mandatory health care contributions for all the employed citizens. This contribution is a dedicated tax reserved for the health care system derived from employees' salaries. The rest of the public funds is mainly from taxes used by the Ministry of Finance to complement the overall health budget each year. The population is covered by a basic health insurance plan provided by statute and optional insurance, administered by the Croatian Health Insurance Fund. Reimbursement decisions are based on the Ordinance of Ministry of Health issued in 2013, which is an ordinance establishing the criteria for inclusion of medicinal products in the Croatian Health Insurance Fund basic and supplementary drug lists. A health technology assessment agency was established in 2007 as a legal, public, independent, nonprofit institution under the Act on Quality of Health Care. Budget impact analysis is obligatory, and cost-effectiveness analysis is beneficial. Two reimbursement lists exist: the basic (100% drug coverage) and the supplementary (co-payment from 10% to 90%) lists. The basic list covers both hospital and retail drugs. There is also a special drug list for expensive drugs (mainly hospital drugs). International reference pricing is also in place. List updates are done on an yearly basis. Real-world evidence can be required for health technology assessment as evidence for the budget impact models and cost-effective analysis; it is, however, not mandatory. Copyright © 2017. Published by Elsevier Inc.

  15. Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine.

    Science.gov (United States)

    Capati, Vincent C; Kesselheim, Aaron S

    2016-04-01

    A "product hop" involves the substitution of a new formulation of a prescription drug by a pharmaceutical manufacturer for an old version to forestall generic competition. In 2015, for example, Forest Laboratories, the brand-name drug manufacturer of memantine, an Alzheimer's disease treatment, introduced an extended-release version and tried to restrict patient access to the previous version. Product hops can lead to useful incremental innovation but can also have major public health implications by disrupting patients on stable treatment regimens and increasing costs for patients and payers. This commentary reviews alleged anticompetitive product hopping in the case of memantine, which involved proposed conduct that would have left Alzheimer's disease patients with no effective choice but to transition to memantine XR. Policy solutions that can limit anticompetitive product hops include raising the bar for obtaining patents on new drug product formulations and changing automatic generic substitution laws. No outside funding supported this research. To support his work at PORTAL in the summer of 2015, Capati was the recipient of the University of New Hampshire School of Law Rudman Center Public Service Fellowship. Kesselheim's research was supported by Greenwall Faculty Scholars program, the Laura and John Arnold Foundation, and the Harvard Program in Therapeutic Science. In 2013, Kesselheim served as an expert on behalf of a class of individual plaintiffs against Warner Chilcott regarding potential antitrust violations Kesselheim was responsible for concept and design of this commentary. Capati took the lead in data collection and analysis, along with Kesselheim. Capati wrote the manuscript, which was revised by primarily by Kesselheim, along with Capati.

  16. The impact of reference pricing of nonsteroidal anti-inflammatory agents on the use and costs of analgesic drugs.

    Science.gov (United States)

    Grootendorst, Paul V; Marshall, John K; Holbrook, Anne M; Dolovich, Lisa R; O'Brien, Bernie J; Levy, Adrian R

    2005-10-01

    To estimate the effect of reference pricing (RP) of nonsteroidal anti-inflammatory drugs (NSAIDs) on drug subsidy program and beneficiary expenditures on analgesic drugs. Monthly claims data from Pharmacare, the public drug subsidy program for seniors in British Columbia, Canada, over the period of February 1993 to June 2001. RP limits drug plan reimbursement of interchangeable medicines to a reference price, which is typically equal to the price of the lowest cost interchangeable drug; any cost above that is borne by the patient. Pharmacare introduced two different forms of RP to the NSAIDs, Type 1 in April 1994 and Type 2 in November 1995. Under Type 1 RP, generic and brand versions of the same NSAID are considered interchangeable, whereas under Type 2 RP different NSAIDs are considered interchangeable. We extrapolated average reimbursement per day of NSAID therapy over the months before RP to estimate what expenditures would have been without the policies. These counterfactual predictions were compared with actual values to estimate the impact of the policies; the estimated impacts on reimbursement rates were multiplied by the postpolicy volume of NSAIDS dispensed, which appeared unaffected by the policies, to estimate expenditure changes. After Type 2 RP, program expenditures declined by $22.7 million (CAN), or $4 million (CAN), annually cutting expenditure by about half. Most savings accrued from the substitution of low-cost NSAIDs for more costly alternatives. About 20 percent of savings represented expenditures by seniors who elected to pay for partially reimbursed drugs. Type 1 RP produced one-quarter the savings of type 2 RP. Type 2 RP of NSAIDs achieved its goal of reducing drug expenditures and was more effective than Type 1 RP. The effects of RP on patient health and associated health care costs remain to be investigated.

  17. NET 40 Generics Beginner's Guide

    CERN Document Server

    Mukherjee, Sudipta

    2012-01-01

    This is a concise, practical guide that will help you learn Generics in .NET, with lots of real world and fun-to-build examples and clear explanations. It is packed with screenshots to aid your understanding of the process. This book is aimed at beginners in Generics. It assumes some working knowledge of C# , but it isn't mandatory. The following would get the most use out of the book: Newbie C# developers struggling with Generics. Experienced C++ and Java Programmers who are migrating to C# and looking for an alternative to other generic frameworks like STL and JCF would find this book handy.

  18. An Optimization Model for Expired Drug Recycling Logistics Networks and Government Subsidy Policy Design Based on Tri-level Programming

    Directory of Open Access Journals (Sweden)

    Hui Huang

    2015-07-01

    Full Text Available In order to recycle and dispose of all people’s expired drugs, the government should design a subsidy policy to stimulate users to return their expired drugs, and drug-stores should take the responsibility of recycling expired drugs, in other words, to be recycling stations. For this purpose it is necessary for the government to select the right recycling stations and treatment stations to optimize the expired drug recycling logistics network and minimize the total costs of recycling and disposal. This paper establishes a tri-level programming model to study how the government can optimize an expired drug recycling logistics network and the appropriate subsidy policies. Furthermore, a Hybrid Genetic Simulated Annealing Algorithm (HGSAA is proposed to search for the optimal solution of the model. An experiment is discussed to illustrate the good quality of the recycling logistics network and government subsides obtained by the HGSAA. The HGSAA is proven to have the ability to converge on the global optimal solution, and to act as an effective algorithm for solving the optimization problem of expired drug recycling logistics network and government subsidies.

  19. Research and development in drug innovation: reflections from the 2013 bioeconomy conference in China, lessons learned and future perspectives.

    Science.gov (United States)

    Liu, Changxiao; Constantinides, Panayiotis P; Li, Yazhuo

    2014-04-01

    The enormous progress biotechnology, bioinformatics and nanotechnology made in recent years provides opportunities and scientific framework for development of biomedicine and constitutes a paradigm shift in pharmaceutical R&D and drug innovation. By analyzing the data and related information at R&D level over the past decades, developmental tendency and R&D patterns were summarized. We found that a growing number of biologics in the pipeline of pharma companies with successful products already in the market though, small molecular entities have primarily dominated drug innovation. Additionally, small/medium size companies will continue to play a key role in the development of small molecule drugs and biologics in a multi-channel integrated process. More importantly, modern and effective R&D strategies in biomedicine development to predict and evaluate efficacy and/or safety of 21st century therapeutics are urgently needed. To face new challenges, developmental strategies were proposed, in terms of molecular targeted medicine, generic drugs, new drug delivery system and protein-based drugs. Under the current circumstances, interdisciplinary cooperation mode and policy related to drug innovation in China were deeply discussed as well.

  20. The drugging of the Third World.

    Science.gov (United States)

    Silverman, M; Lee, P R; Lydecker, M

    1982-01-01

    This article reports an investigation of the promotion of more than 500 products marketed by over 150 pharmaceutical companies in the United States, Great Britain, Latin America, Africa, and Asia. In contrast to the promotional material provided to physicians in the United States and Great Britain, material presented to physicians in Third World countries was found to be marked by gross exaggeration of product effectiveness and minimized or completely omitted potential hazards. No substantial differences could be found between multinational and domestic companies, brand-name and generic firms, or companies based in capitalist nations and those in socialist or communist-bloc countries in terms of the adequacy and accuracy of their promotion. Little evidence was found to support industry claims that the discrepancies in promotion reflect the different policies of various drug regulatory agencies. Much of the promotion concerned "luxury products," including costly tonics and appetite stimulants marketed in poor countries where the pressing need is for food. Bribery of influential physicians and key governmental officials may play an important role in irrational drug promotion and use in the Third World. Some of the proposed corrective approaches to this problem are examined.

  1. Plenary III–04: Responses to Drug Costs: Year Three of the Medicare Part D Program

    OpenAIRE

    Fung, Vicki; Reed, Mary; Hsu, John

    2010-01-01

    Background/Aims: Many Medicare Part D beneficiaries face substantial prescription drug cost-sharing. In the first year of the program, many beneficiaries reported substantial drug use changes in response to the coverage gap. In response, an increasing number of plans offer generic drug coverage during the gap. We compared responses to Part D costs among beneficiaries with generic-only gap coverage and full gap coverage in 2008, the third year of the Part D program.

  2. [Family and acquaintances of illicit drug users: community perspectives on laws and public policies in Western Rio de Janeiro, Brazil].

    Science.gov (United States)

    Silva, Jaqueline da; Brands, Bruna; Adlaf, Edward; Giesbrecht, Norman; Simich, Laura; Wright, Maria da Gloria Miotto

    2009-01-01

    This article is part of the study 'Illicit Drug Use in Seven Latin American Countries and Canada: Critical Perspectives of Family and Familiars' (7LACC), which investigated four domains: protective and risk factors; preventive initiatives; treatment facilities; and laws and policies. The article presents a section of the results based on four items of the laws and policies domain--as perceived by the family and acquaintances of illicit drug users living in the community. Participants were recruited in urban primary health care units located in Western Rio de Janeiro (city), Brazil. This multi-method, cross-temporal study performed interviews with 100 adults (18 years of age or older), all cognitively healthy. Results and key conclusions included non-compliance with the fundamental principles of the Unique Health System Legislation / Law 8.080/90 and the erroneous implementation of laws and public policies on illicit drug.

  3. Excipient Usage Technical Risk Assessment for Generic Solid Dose Products

    Directory of Open Access Journals (Sweden)

    Ajay Babu Pazhayattil

    2017-09-01

    Full Text Available This paper proposes an assessment methodology for solid dose generic small molecule drug products. It addresses the ‘usage of the excipient’ portion of the trinomial by utilizing the systematic approach of Risk Identification, Risk Analysis and Risk Evaluation as per ICH Q9 Quality Risk Management outlined for developing risk control strategies. The assessment and maintenance of excipient risk profile is essential to minimize any potential risk associated to excipients impacting patients.

  4. 'Social evils' and harm reduction: the evolving policy environment for human immunodeficiency virus prevention among injection drug users in China and Vietnam.

    Science.gov (United States)

    Hammett, Theodore M; Wu, Zunyou; Duc, Tran Tien; Stephens, David; Sullivan, Sheena; Liu, Wei; Chen, Yi; Ngu, Doan; Des Jarlais, Don C

    2008-01-01

    This paper reviews the evolution of government policies in China and Vietnam regarding harm reduction interventions for human immunodeficiency virus (HIV) prevention, such as needle/syringe provision and opioid substitution treatment. The work is based upon the authors' experiences in and observations of these policy developments, as well as relevant government policy documents and legislation. Both countries are experiencing HIV epidemics driven by injection drug use and have maintained generally severe policies towards injection drug users (IDUs). In recent years, however, they have also officially endorsed harm reduction. We sought to understand how and why this apparently surprising policy evolution took place. Factors associated with growing support for harm reduction were similar but not identical in China and Vietnam. These included the emergence of effective 'champions' for such policies, an ethos of pragmatism and receptivity to evidence, growing collaboration across public health, police and other sectors, the influence of contingent events such as the severe acute respiratory syndrome (SARS) epidemic and pressure from donors and international organizations to adopt best practice in HIV prevention. Ongoing challenges and lessons learned include the persistence of tensions between drug control and harm reduction that may have negative effects on programs until a fully harmonized policy environment is established. Excessive reliance on law enforcement and forced detoxification will not solve the problems of substance abuse or of HIV among drug users. Ongoing evaluation of harm reduction programs, as well as increased levels of multi-sectoral training, collaboration and support are also needed.

  5. Canada's implementation of the Paragraph 6 Decision: is it sustainable public policy?

    Directory of Open Access Journals (Sweden)

    Cosio Andre

    2007-12-01

    Full Text Available Abstract Background Following the Implementation of Paragraph 6 of the Doha Declaration on TRIPS and Public Health, Canada was among the first countries globally to amend its patent law, which resulted in Canada's Access to Medicines Regime (CAMR. CAMR allows the production and export of generic drugs to developing countries without the requisite manufacturing capacity to undertake a domestic compulsory license. CAMR has been the subject of much criticism lodged at its inability to ensure fast access to urgent medicines for least developing and developing countries in need. Only recently did the Canadian government grant Apotex the compulsory licenses required under CAMR to produce and export antiretroviral therapy to Rwanda's population. Methods The objective of this research is to investigate whether the CAMR can feasibly achieve its humanitarian objectives given the political interests embedded in the crafting of the legislation. We used a political economy framework to analyze the effect of varied institutions, political processes, and economic interests on public policy outcomes. In-depth, semi-structured interviews were conducted with nineteen key stakeholders from government, civil society and industry. Qualitative data analysis was performed using open-coding for themes, analyzing by stakeholder group. Results CAMR is removed from the realities of developing countries and the pharmaceutical market. The legislation needs to include commercial incentives to galvanize the generic drug industry to make use of this legislation. CAMR assumes that developing country governments have the requisite knowledge and human resource capacity to make use of the regime, which is not the case. The legislation does not offer sufficient incentives for countries to turn to Canada when needed drugs may be procured cheaply from countries such as India. In the long term, developing and least developing countries seek sustainable solutions to meet the health

  6. [Laws and policies on illicit drugs in Brazil and the perspective of drug users' family members and acquaintances: a study in the City of Ribeirão Preto, São Paulo, Brazil].

    Science.gov (United States)

    Ventura, Carla Aparecida Arena; Brands, Bruna; Adlaf, Edward; Giesbrecht, Norman; Simich, Laura; Wright, Maria da Gloria Miotto; Ferreira, Paulo Sérgio

    2009-01-01

    Brazilian drugs legislation has evolved from a prohibitionist system to a less repressive one in terms of drug users. The objective of this study was to identify the perception of relatives and acquaintances of drug users living in Ribeirão Preto, São Paulo, Brazil, about the country's laws and policies on drugs. Data collection was performed using a structured questionnaire. The sample consisted of 100 drug users' relatives or acquaintances, selected at a public health service. Respondents' relationships with the drug user were as follows: 31% friend, 23% sibling, 15% child and 7% spouse. Most users (78%) were men, with an average age of 26 years. Results confirm that national laws and policies have a direct effect on individuals' attitude and behaviors. There is a lack of trust in the police and a general perception that, despite recent chances that favor user rehabilitation, the laws on drugs do not respect users' human rights.

  7. The Impact of the National Essential Medicines Policy on Rational Drug Use in Primary Care Institutions in Jiangsu Province of China.

    Science.gov (United States)

    Chao, Jianqian; Gu, Jiangyi; Zhang, Hua; Chen, Huanghui; Wu, Zhenchun

    2018-01-01

    Essential medicine policy is a successful global health policy to promote rational drug use. The aim of this study was to evaluate the impact of the National Essential Medicines Policy (NEMP) on the rational drug use in primary care institutions in Jiangsu Province of China. In this exploratory study, a multistage, stratified, random sampling was used to select 3400 prescriptions from 17 primary care institutions who implemented the NEMP before (Jan 2010) and after the implementation of the NEMP (Jan 2014). The analyses were performed in SPSS 18.0 and SPSS Clementine client. After the implementation of the NEMP, the percentage of prescribed EML (Essential Medicines List) drugs rose significantly, the average number of drugs per prescription and average cost per prescription were declined significantly, while the differences of the prescription proportion of antibiotics and injection were not statistically significant. BP (Back Propagation) neural network analysis showed that the average number of drugs per prescription, the number of using antibiotics and hormone, regional differences, size of institutions, sponsorship, financial income of institutions, doctor degree, outpatient and emergency visits person times were important factors affecting the prescription costs, among these the average number of drugs per prescription has the greatest effect. The NEMP can promote the rational use of drugs in some degree, but its role is limited. We should not focus only on the EML but also make comprehensive NEMP.

  8. Efficient Generic Functional Programming

    NARCIS (Netherlands)

    Alimarine, A.; Smetsers, J.E.W.

    2005-01-01

    Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular data type. An instance on a specific type is generated by interpretation of the type's structure. A

  9. An Optimization Model for Expired Drug Recycling Logistics Networks and Government Subsidy Policy Design Based on Tri-level Programming

    OpenAIRE

    Huang, Hui; Li, Yuyu; Huang, Bo; Pi, Xing

    2015-01-01

    In order to recycle and dispose of all people’s expired drugs, the government should design a subsidy policy to stimulate users to return their expired drugs, and drug-stores should take the responsibility of recycling expired drugs, in other words, to be recycling stations. For this purpose it is necessary for the government to select the right recycling stations and treatment stations to optimize the expired drug recycling logistics network and minimize the total costs of recycling and disp...

  10. Generic robot architecture

    Science.gov (United States)

    Bruemmer, David J [Idaho Falls, ID; Few, Douglas A [Idaho Falls, ID

    2010-09-21

    The present invention provides methods, computer readable media, and apparatuses for a generic robot architecture providing a framework that is easily portable to a variety of robot platforms and is configured to provide hardware abstractions, abstractions for generic robot attributes, environment abstractions, and robot behaviors. The generic robot architecture includes a hardware abstraction level and a robot abstraction level. The hardware abstraction level is configured for developing hardware abstractions that define, monitor, and control hardware modules available on a robot platform. The robot abstraction level is configured for defining robot attributes and provides a software framework for building robot behaviors from the robot attributes. Each of the robot attributes includes hardware information from at least one hardware abstraction. In addition, each robot attribute is configured to substantially isolate the robot behaviors from the at least one hardware abstraction.

  11. Racial and ethnic disparities in antidepressant drug use.

    Science.gov (United States)

    Chen, Jie; Rizzo, John A

    2008-12-01

    Little is known about racial and ethnic disparities in health care utilization, expenditures and drug choice in the antidepressant market. This study investigates factors associated with the racial and ethnic disparities in antidepressant drug use. We seek to determine the extent to which disparities reflect differences in observable population characteristics versus heterogeneity across racial and ethnic groups. Among the population characteristics, we are interested in identifying which factors are most important in accounting for racial and ethnic disparities in antidepressant drug use. Using Medical Expenditure Panel Survey (MEPS) data from 1996-2003, we have an available sample of 10,416 Caucasian, 1,089 African American and 1,539 Hispanic antidepressant drug users aged 18 to 64 years. We estimate individual out-of-pocket payments, total prescription drug expenditures, drug utilization, the probability of taking generic versus brand name antidepressants, and the share of drugs that are older types of antidepressants (e.g., TCAs and MAOIs) for these individuals during a calendar year. Blinder-Oaxaca decomposition techniques are employed to determine the extent to which disparities reflect differences in observable population characteristics versus unobserved heterogeneity across racial and ethnic groups. Caucasians have the highest antidepressant drug expenditures and utilization. African-Americans have the lowest drug expenditures and Hispanics have the lowest drug utilization. Relative to Caucasians and Hispanics, African-Americans are more likely to purchase generics and use a higher share of older drugs (e.g., TCAs and MAOIs). Differences in observable characteristics explain most of the racial/ethnic differences in these outcomes, with the exception of drug utilization. Differences in health insurance and education levels are particularly important factors in explaining disparities. In contrast, differences in drug utilization largely reflect unobserved

  12. Measuring performance in off-patent drug markets: a methodological framework and empirical evidence from twelve EU Member States.

    Science.gov (United States)

    Kanavos, Panos

    2014-11-01

    This paper develops a methodological framework to help evaluate the performance of generic pharmaceutical policies post-patent expiry or after loss of exclusivity in non-tendering settings, comprising five indicators (generic availability, time delay to and speed of generic entry, number of generic competitors, price developments, and generic volume share evolution) and proposes a series of metrics to evaluate performance. The paper subsequently tests this framework across twelve EU Member States (MS) by using IMS data on 101 patent expired molecules over the 1998-2010 period. Results indicate that significant variation exists in generic market entry, price competition and generic penetration across the study countries. Size of a geographical market is not a predictor of generic market entry intensity or price decline. Regardless of geographic or product market size, many off patent molecules lack generic competitors two years after loss of exclusivity. The ranges in each of the five proposed indicators suggest, first, that there are numerous factors--including institutional ones--contributing to the success of generic entry, price decline and market penetration and, second, MS should seek a combination of supply and demand-side policies in order to maximise cost-savings from generics. Overall, there seems to be considerable potential for faster generic entry, uptake and greater generic competition, particularly for molecules at the lower end of the market. Copyright © 2014. Published by Elsevier Ireland Ltd.

  13. The Effect of Florida Medicaid's State-Mandated Formulary Provision on Prescription Drug Use and Health Plan Costs in a Medicaid Managed Care Plan.

    Science.gov (United States)

    Munshi, Kiraat D; Mager, Douglas; Ward, Krista M; Mischel, Brian; Henderson, Rochelle R

    2018-02-01

    Formulary or preferred drug list (PDL) management is an effective strategy to ensure clinically efficient prescription drug management by managed care organizations (MCOs). Medicaid MCOs participating in Florida's Medicaid program were required to use a state-mandated PDL between May and August 2014. To examine differences in prescription drug use and plan costs between a single Florida Medicaid managed care (MMC) health plan that implemented a state-mandated PDL policy on July 1, 2014, and a comparable MMC health plan in another state without a state-mandated PDL, controlling for sociodemographic confounders. A retrospective analysis with a pre-post design was conducted using deidentified administrative claims data from a large pharmacy benefit manager. The prepolicy evaluation period was January 1 through June 30, 2014, and the postpolicy period was January 1 through June 30, 2015. Continuously eligible Florida MMC plan members were matched on sociodemographic and health characteristics to their counterparts enrolled in a comparable MMC health plan in another state without a state-mandated formulary. Outcomes were drug use, measured as the number of 30-day adjusted nonspecialty drug prescriptions per member per period, and total drug plan costs per member per period for all drugs, with separate measures for generic and brand drugs. Bivariate comparisons were conducted using t-tests. Employing a difference-in-differences (DID) analytic approach, multivariate negative binomial regression and generalized estimating equation models were used to analyze prescription drug use and costs. The final analytical sample consisted of 18,372 enrollees, evenly divided between the 2 groups. In the postpolicy evaluation period, overall and generic use declined, while brand use increased for members in the Florida health plan. Drug costs, especially for brands, significantly increased for Florida health plan members. No significant changes were observed over the same time period

  14. Dose uniformity of loteprednol etabonate ophthalmic gel (0.5%) compared with branded and generic prednisolone acetate ophthalmic suspension (1%).

    Science.gov (United States)

    Marlowe, Zora T; Davio, Stephen R

    2014-01-01

    Loteprednol etabonate (LE) ophthalmic gel 0.5% (Lotemax®) is a new polycarbophil-based, nonsettling topical ophthalmic formulation. The formulation is a semisolid gel at rest and a shear thinning fluid when expressed through a dropper tip. The present study was undertaken to determine how the nonsettling character of LE ophthalmic gel affects dose uniformity. Prednisolone acetate ophthalmic suspension 1% (Pred Forte®) and a generic prednisolone acetate suspension 1% were used as comparators. Drug concentrations of LE ophthalmic gel, Pred Forte, and a generic prednisolone acetate suspension were determined following simulated dosing - consisting of 2 drops, expressed four times daily for 2 weeks, with bottles that were shaken or not shaken immediately prior to expressing the drops. Drug concentrations were determined using a reverse-phase high-performance liquid chromatography (HPLC) method and reported as a percentage of the declared (labeled) concentration. Comparative kinetics of drug particle sedimentation were also determined for each formulation, using dispersion analysis under gravity. Mean drug concentrations in drops of all three formulations were within a few percentage points of the declared concentration when the bottles were shaken for 5 seconds prior to dispensing. Only LE ophthalmic gel showed consistent and on-target concentrations when the bottles were unshaken prior to dispensing, with a mean (standard deviation [SD]) percent declared concentration of 102% (1.92%) over the 2-week dosing regimen. Drug concentrations for the branded and generic prednisolone acetate suspensions following expression from unshaken bottles were highly variable (overall relative SDs of 16.8% and 20.3%, respectively), with mean concentrations for both falling significantly below the declared concentration for drops expressed at the beginning of the 2-week dosing regimen and significantly above the declared concentration for drops expressed near the end of the dosing

  15. A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries.

    Science.gov (United States)

    Waning, Brenda; Diedrichsen, Ellen; Moon, Suerie

    2010-09-14

    recommended ARVs will likely be hampered until Indian generic producers can provide the dramatic price reductions and improved formulations observed in the past. Rather than agreeing to inappropriate intellectual property obligations through free trade agreements, India and its trade partners--plus international organizations, donors, civil society and pharmaceutical manufacturers--should ensure that there is sufficient policy space for Indian pharmaceutical manufacturers to continue their central role in supplying developing countries with low-priced, quality-assured generic medicines.

  16. Development and optimisation of generic decommissioning strategies for civil Magnox reactors

    International Nuclear Information System (INIS)

    Carpenter, G.; Hebditch, D.; Meek, N.; Patel, A.; Reeve, P.

    2004-01-01

    BNFL Environmental Services has formulated updated proposals for the use of decision analysis in the development of decommissioning strategy. The proposals are based on the Department of Transport, Local Government and the Regions manual for practitioners on multi-criteria analysis, specifically multi-criteria decision analysis, as suited to complex problems with a mixture of monetary and non-monetary objectives. They take account of up-to-date academic methodology, the newly issued BNFL decision analysis framework for environmental decisions and a wide variety of other engineering, optioneering and optimisation processes. The paper also summarises legislative and company policy areas of importance to decommissioning strategy development. Higher-level generic reactor and site remediation strategies already exist. At the lower level, various generic decommissioning reference processes and project options need development. For the past year, Environmental Services has held responsibility to respond to the Nuclear Installations Inspectorates' quinquennial review, develop and maintain up-to-date strategies, institute the review of a selected number of key strategies, and respond to changing circumstances including stakeholder views. Environmental Services is performing a range of generic studies for selection of strategies and end-points as used for a variety of waste management and site care and maintenance preparations. (author)

  17. NRC policy on future reactor designs

    International Nuclear Information System (INIS)

    1985-07-01

    On April 13, 1983, the US Nuclear Regulatory Commission issued for public comment a ''Proposed Commission Policy Statement on Severe Accidents and Related Views on Nuclear Reactor Regulation'' (48 FR 16014). This report presents and discusses the Commission's final version of that policy statement now entitled, ''Policy Statement on Severe Reactor Accidents Regarding Future Designs and Existing Plants.'' It provides an overview of comments received from the public and the Advisory Committee on Reactor Safeguards and the staff response to these. In addition to the Policy Statement, the report discusses how the policies of this statement relate to other NRC programs including the Severe Accident Research Program; the implementation of safety measures resulting from lessons learned in the accident at Three Mile Island; safety goal development; the resolution of Unresolved Safety Issues and other Generic Safety Issues; and possible revisions of rules or regulatory requirements resulting from the Severe Accident Source Term Program. Also discussed are the main features of a generic decision strategy for resolving Regulatory Questions and Technical Issues relating to severe accidents; the development and regulatory use of new safety information; the treatment of uncertainty in severe accident decision making; and the development and implementation of a Systems Reliability Program for both existing and future plants to ensure that the realized level of safety is commensurate with the safety analyses used in regulatory decisions

  18. Generic phytosanitary irradiation treatments

    International Nuclear Information System (INIS)

    Hallman, Guy J.

    2012-01-01

    The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies. - Highlights: ► The history of phytosanitary irradiation (PI) treatments is given. ► Generic PI treatments in use today are discussed. ► Suggestions for future research are presented. ► A dose of 250 Gy for most insects may suffice.

  19. Peter Bourne’s Drug Policy and the Perils of a Public Health Ethic, 1976–1978

    Science.gov (United States)

    Dufton, Emily

    2015-01-01

    As President Jimmy Carter’s advisor for health issues, Peter Bourne promoted a rational and comprehensive drug strategy that combined new supply-side efforts to prevent drug use with previously established demand-side addiction treatment programs. Using a public health ethic that allowed the impact of substances on overall population health to guide drug control, Bourne advocated for marijuana decriminalization as well as increased regulations for barbiturates. A hostile political climate, a series of rumors, and pressure from both drug legalizers and prohibitionists caused Bourne to resign in disgrace in 1978. We argue that Bourne’s critics used his own public health framework to challenge him, describe the health critiques that contributed to Bourne’s resignation, and present the story of his departure as a cautionary tale for today’s drug policy reformers. PMID:25521893

  20. Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved?

    Science.gov (United States)

    Cameron, Alexandra; Mantel-Teeuwisse, Aukje K; Leufkens, Hubert G M; Laing, Richard Ogilvie

    2012-01-01

    In low- and middle-income countries, patients and reimbursement agencies that purchase medicines in the private sector pay more for originator brands when generic equivalents exist. We estimated the savings that could be obtained from a hypothetical switch in medicine consumption from originator brands to lowest-priced generic equivalents for a selection of medicines in 17 countries. In this cost minimization analysis, the prices of originator brands and their lowest-priced generic equivalents were obtained from facility-based surveys conducted by using a standard methodology. Fourteen medicines most commonly included in the surveys, plus three statins, were included in the analysis. For each medicine, the volume of private sector consumption of the originator brand product was obtained from IMS Health, Inc. Volumes were applied to the median unit prices for both originator brands and their lowest-priced generics to estimate cost savings. Prices were adjusted to 2008 by using consumer price index data and were adjusted for purchasing power parity. For the medicines studied, an average of 9% to 89% could be saved by an individual country from a switch in private sector purchases from originator brands to lowest-priced generics. In public hospitals in China, US $ 370 million could be saved from switching only four medicines, saving an average of 65%. Across individual medicines, average potential savings ranged from 11% for beclometasone inhaler to 73% for ceftriaxone injection. Substantial savings could be achieved by switching private sector purchases from originator brand medicines to lowest-priced generic equivalents. Strategies to promote generic uptake, such as generic substitution by pharmacists and increasing confidence in generics by professionals and the public, should be included in national medicines policies. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.