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Sample records for generic medicines market

  1. Analysis of French generic medicines retail market: why the use of generic medicines is limited.

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Simoens, Steven

    2014-12-01

    The market share of generic medicines in France is low compared to other European countries. This perspective paper provides an overview of the generic medicines retail market in France and how the current policy environment may affect the long-term sustainability. Looking at the French generic medicines retail market and the surrounding regulatory framework, all conditions seem to be in place to create a healthy generic medicines market: the country has well-respected regulatory authorities, generic medicines enter the market in a timely manner and prices of generic medicines are competitive compared with other European countries. Despite the success of the demand-side policies targeted at pharmacists and patients, those targeted at physicians were less successful due to a lack of enforcement and a lack of trust in generic medicines by French physicians. Recommendations to increase the use of generic medicines in France round off this perspective paper.

  2. 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.

  3. Does the market share of generic medicines influence the price level?: a European analysis.

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    Dylst, Pieter; Simoens, Steven

    2011-10-01

    After the expiry of patents for originator medicines, generic medicines can enter the market, and price competition may occur. This process generates savings to the healthcare payer and to patients, but knowledge about the factors affecting price competition in the pharmaceutical market following patent expiry is still limited. This study aimed to investigate the relationship between the market share of generic medicines and the change of the medicine price level in European off-patent markets. Data on medicine volumes and values for 35 active substances were purchased from IMS Health. Ex-manufacturer prices were used, and the analysis was limited to medicines in immediate-release, oral, solid dosage forms. Countries included were Austria, Belgium, Denmark, Germany, France, Italy, the Netherlands, Spain, Sweden and the UK, which constitute a mix of countries with low and high generic medicines market shares. Data were available from June 2002 until March 2007. Market volume has risen in both high and low generic market share countries (+29.27% and +27.40%, respectively), but the cause of the rise is different for the two markets. In low generic market share countries, the rise was caused by the increased use of generic medicines, while in high market share countries, the rise was driven by the increased use of generic medicines and a shift of use from originator to generic medicines. Market value was substantially decreased in high generic market share countries (-26.6%), while the decrease in low generic market share countries was limited (-0.06%). In high generic market share countries, medicine prices dropped by -43.18% versus -21.56% in low market share countries. The extent to which price competition from generic medicines leads to price reductions appears to vary according to the market share of generic medicines. High generic market share countries have seen a larger decrease in medicine prices than low market share countries.

  4. Consumer choice between common generic and brand medicines in a country with a small generic market.

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    Fraeyman, Jessica; Peeters, Lies; Van Hal, Guido; Beutels, Philippe; De Meyer, Guido R Y; De Loof, Hans

    2015-04-01

    Generic medicines offer an opportunity for governments to contain pharmaceutical expenditures, since generics are generally 10%-80% lower in price than brand medicines. Belgium has a small generic market that takes up 15% of the total pharmaceutical market in packages sold. To determine the knowledge of consumers about the different available packages of a common over-the-counter medicine (acetaminophen) with regard to price advantage, quality, and effectiveness in a country with a small generic market. We conducted an online survey in the general Flemish population using a questionnaire with 25 statements. The questionnaire also contained 2 informative interventions. First, we showed the price per package and per tablet that the patient would pay in the pharmacy. Second, we provided the respondent with general information about generic medication (equivalence, effectiveness, price, and recognition). Before and after the interventions, we probed for preferences and knowledge about the different packages. Multivariate logistic models were used to examine the independent effects of consumer characteristics on responses to the survey statements. We obtained a sample of 1,636 respondents. The general attitude towards generic medication was positive-only 5% would rather not use a generic. Nevertheless, only 17% of the respondents were able to recognize a generic medicine. Older consumers (aged 60 years and above) were more often confused about the different packages (OR = 2.59, 95% CI = 1.76-3.80, P ≤ 0.001). Consumers without a higher education degree tended to be more doubtful about the difference in effectiveness and quality between the different brands (OR = 0.59, 95% CI = 0.44-0.79, P ≤ 0.001). Consumer recognition of the name of the active substance of acetaminophen was poor. When different brands were displayed, possible price advantage seemed to be an important motive to switch to a cheaper brand. Consumers generally found medicines

  5. 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.

  6. The Market Dynamics of Generic Medicines in the Private Sector of 19 Low and Middle Income Countries between 2001 and 2011: A Descriptive Time Series Analysis

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    Kaplan, Warren A.; Wirtz, Veronika J.; Stephens, Peter

    2013-01-01

    This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive “switching” to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly

  7. The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: a descriptive time series analysis.

    Directory of Open Access Journals (Sweden)

    Warren A Kaplan

    Full Text Available This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been

  8. The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: a descriptive time series analysis.

    Science.gov (United States)

    Kaplan, Warren A; Wirtz, Veronika J; Stephens, Peter

    2013-01-01

    This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted.

  9. Generic Market Models

    NARCIS (Netherlands)

    R. Pietersz (Raoul); M. van Regenmortel

    2005-01-01

    textabstractCurrently, there are two market models for valuation and risk management of interest rate derivatives, the LIBOR and swap market models. In this paper, we introduce arbitrage-free constant maturity swap (CMS) market models and generic market models featuring forward rates that span perio

  10. Generic medicines: issues and relevance for global health.

    Science.gov (United States)

    Rana, Proteesh; Roy, Vandana

    2015-12-01

    Generic medicine is a pharmaceutical product which is bioequivalent to the innovator product in terms of dosage form, strength, route of administration, quality, safety, performance characteristics, and intended use. Generic medicines are a cornerstone for providing affordable medicines to patients. The major generic markets in the world include United States of America followed by European Union, Canada, Japan, and Australia. The major suppliers of generic medicines China and India are showing tremendous growth in the generic medicine sector. There are many legal and regulatory issues along with quality concerns associated with the use of the generic products. Lately, bilateral international agreements called free trade agreements, delaying tactics by originator companies like strategic patenting and litigations on generic manufacturers, have been a major setback for the generic medicine industry. These issues need to be addressed to optimize the use of generic medicines. The sustainability of generic medicine sector is crucial for improving access to essential medicines for the worldwide. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  11. Generic medicine pricing in Europe: current issues and future perspective.

    Science.gov (United States)

    Simoens, Steven

    2008-01-01

    This editorial discusses a number of trends affecting the pricing of generic medicines in Europe. With respect to pricing, recent evidence has emerged that European generic medicine manufacturers face competition from Indian manufacturers; that the price level of generic medicines varies substantially between European countries; and that generic medicine manufacturers engage in competition by discount rather than price competition in France, The Netherlands and the UK. These trends suggest that there may be scope for further reducing the prices of generic medicines in several countries. In relation to reference pricing, most European countries have incorporated market incentives within reference pricing systems with a view to promoting price competition. The European experience indicates that the generic medicines industry delivers competitive prices under a reference pricing system if demand-side policies are in place that stimulate physicians, pharmacists and patients to use generic medicines. Finally, caution needs to be exercised when focusing on the drivers of generic medicine pricing as these drivers not only vary between countries, but may also vary within a country. Manufacturers of originator and generic medicines do not take a single pricing approach following patent expiry, but vary their pricing strategy from molecule to molecule.

  12. Quality of generic medicines in South Africa

    DEFF Research Database (Denmark)

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

    2012-01-01

    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...

  13. An observational comparative study of cost between branded medicines and generic medicines

    Directory of Open Access Journals (Sweden)

    Meenu Pichholiya

    2015-04-01

    Conclusions: Most of the drugs available in the market have brand names whether they are branded or generic medicines. Hence, doctor should write a cheapest known brand with the name of the generic salt in bracket so that the patient can buy another if that brand is not available. Furthermore, the Drug Controller of India should release a website where every doctor should be able to find the cheapest and approved drugs in the market. [Int J Basic Clin Pharmacol 2015; 4(2.000: 269-272

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

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    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.

  15. The Market for Hospital Medicine in Denmark

    DEFF Research Database (Denmark)

    Hostenkamp, Gisela

    2012-01-01

    increases and use summary statistics to compare market performance in both sectors. The market for hospital medicine is more concentrated than the pharmaceutical retail sector and the share of generics and parallel imported products is significantly lower. Between 2005 and 2009 expenditures for hospital...... for hospital medicines and their procurement are still poorly understood. The present paper characterises the market for hospital medicines in Denmark in terms of its organisation and developments between 2005 and 2009. In Denmark hospital medicines are publicly financed and procurement is centrally organised....... 98% of all medicines administered at Danish public hospitals are purchased through a public procurement agency by means of public tenders. Using data on actual contract prices we decompose pharmaceutical expenditure growth into the contributions from newly introduced medicines, price and volume...

  16. 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...

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

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    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.

  18. How can pharmacist remuneration systems in Europe contribute to generic medicine dispensing?

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    Dylst P

    2012-03-01

    Full Text Available Generic medicines can generate larger savings to health care budgets when their use is supported by incentives on both the supply-side and the demand-side. Pharmacists’ remuneration is one factor influencing the dispensing of generic medicines.Objective: The aim of this article is to provide an overview of different pharmacist remuneration systems for generic medicines in Europe, with a view to exploring how pharmacist remuneration systems can contribute to generic medicine dispensing.Methods: Data were obtained from a literature review, a Master thesis in Pharmaceutical Care at the Catholic University of Leuven and a mailing sent to all members of the Pharmaceutical Group of the European Union with a request for information about the local remuneration systems of community pharmacists and the possible existence of reports on discounting practices.Results: Pharmacists remuneration in most European countries consists of the combination of a fixed fee per item and a certain percentage of the acquisition cost or the delivery price of the medicines. This percentage component can be fixed, regressive or capped for very high-cost medicines and acts as a disincentive for dispensing generic medicines. Discounting for generic medicines is common practice in several European countries but information on this practice tends to be confidential. Nevertheless, data for Belgium, France, the Netherlands and United Kingdom indicated that discounting percentages varied from 10% to 70% of the wholesale selling price.Conclusion: Pharmacists can play an important role in the development of a generic medicines market. Pharmacists should not be financially penalized for dispensing generic medicines. Therefore, their remuneration should move towards a fee-for-performance remuneration instead of a price-dependent reimbursement which is currently used in many European countries. Such a fee-for-performance remuneration system provides a stimulus for generic medicines

  19. The market for hospital medicine in Denmark

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    Gisela Hostenkamp

    2011-11-01

    Full Text Available Pharmaceutical expenditure growth has outpaced GDP and healthcare expenditure growth rates in Denmark as in most OECD countries for the last decade. A major part of this increase was due to high growth rates in specialist areas that are typically located in hospital settings. Yet the market for hospital medicines and their procurement are still poorly understood. The present paper characterises the market for hospital medicines in Denmark in terms of its organisation and developments between 2005 and 2009. In Denmark hospital medicines are publicly financed and procurement is centrally organised. 98% of all medicines administered at Danish public hospitals are purchased through a public procurement agency by means of public tenders. Using data on actual contract prices we decompose pharmaceutical expenditure growth into the contributions from newly introduced medicines, price and volume increases and use summary statistics to compare market performance in both sectors. The market for hospital medicine is more concentrated than the pharmaceutical retail sector and the share of generics and parallel imported products is significantly lower. Between 2005 and 2009 expenditures for hospital medicines more than doubled -accounting for almost 40% of the total Danish pharmaceutical market in 2009. Price increases however - although positive and higher than in the pharmaceutical retail sector - were only moderate. The majority of the expenditure growth was due to an increase in utilisation and the introduction of new medicines in the hospital sector. Centralised tendering may therefore have important implications for competition and industry structure in the long run.

  20. Generic Drugs: The Same Medicine for Less Money

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    Generic Drugs: The Same Medicine for Less Money What is a generic drug? A generic is a copy of a brand-name drug. A brand- name drug has a patent. When ... benefit to your health, and you will save money. 7KH IHGHUDO )RRG DQG 'UXJ $GPLQLVWUDWLRQ )'$ UHJXODWHV ERWK ...

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    . 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......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...

  2. Pharmaceutical meaning-making beyond marketing: racialized subjects of generic thiazide.

    Science.gov (United States)

    Pollock, Anne

    2008-01-01

    In contrast to discussions of BiDil, this paper explores racial meaning-making processes around an old generic hypertension drug. By unpacking a vignette about race and thiazide outside marketing or medicine, it shows that racialization of drugs exceeds those spheres and moves in unpredictable ways.

  3. Are generic drugs really inferior medicines?

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    Moore, N; Berdaï, D; Bégaud, B

    2010-09-01

    In this issue Gagne et al. report an elegant case-crossover study of seizures in patients on antiepileptic drugs. They found that a dispensation episode approximately triples the risk of having a seizure within 21 days, but the risk is not statistically different whether the dispensation was of the same brand-name or generic drug as previously used or a switch from brand-name to a generic or from a generic to a brand name. The cause of the seizure might be a delay in taking medication or late redispensation, among others, but apparently the nature of the product dispensed is not relevant in this study; this may alleviate some of the concerns about generic drugs and epilepsy.

  4. The impact of the Medicines Control Council backlog and fast-track review system on access to innovative and new generic and biosimilar medicines of public health importance in South Africa.

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    Leng, Henry Martin John; Pollock, Allyson M; Sanders, David

    2016-03-17

    The fast-track registration policy of the South African National Department of Health allows for rapid registration of new medicines of public health importance and of all medicines on the Essential Medicines List, most of which are generics. No limit is placed on the number of generic brands of a medicine that can be submitted for fast-track registration. This, together with resource constraints at the regulator, may delay access to important new medicines, new fixed-dose combinations of critical medicines or affordable versions of biological medicines (biosimilars). One reason for not limiting the number of fast-track generic applications was to promote price competition among generic brands. We found this not to be valid, since market share correlated poorly with price. Generic brands with high market share were, mostly, those that were registered first. We propose that the number of generic brands accepted for fast-tracking be limited to not more than seven per medicine.

  5. The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use

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    Hassali, Mohamed Azmi; Alrasheedy, Alian A.; McLachlan, Andrew; Nguyen, Tuan Anh; AL-Tamimi, Saleh Karamah; Ibrahim, Mohamed Izham Mohamed; Aljadhey, Hisham

    2013-01-01

    Generic medicines are clinically interchangeable with original brand medicines and have the same quality, efficacy and safety profiles. They are, nevertheless, much cheaper in price. Thus, while providing the same therapeutic outcomes, generic medicines lead to substantial savings for healthcare systems. Therefore, the quality use of generic medicines is promoted in many countries. In this paper, we reviewed the role of generic medicines in healthcare systems and the experiences of promoting the use of generic medicines in eight selected countries, namely the United States (US), the United Kingdom (UK), Sweden, Finland, Australia, Japan, Malaysia and Thailand. The review showed that there are different main policies adopted to promote generic medicines such as generic substitution in the US, generic prescribing in the UK and mandatory generic substitution in Sweden and Finland. To effectively and successfully implement the main policy, different complementary policies and initiatives were necessarily introduced. Barriers to generic medicine use varied between countries from negative perceptions about generic medicines to lack of a coherent generic medicine policy, while facilitators included availability of information about generic medicines to both healthcare professionals and patients, brand interchangeability guidelines, regulations that support generic substitution by pharmacists, and incentives to both healthcare professionals and patients. PMID:25561861

  6. A price and use comparison of generic versus originator cardiovascular medicines: a hospital study in Chongqing, China.

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    Zeng, Wenjie

    2013-10-05

    Developed countries use generic competition to contain pharmaceutical expenditure. China, as a developing and transitional country, has not yet deemed an increase in the use of generic products as important; otherwise, much effort has been made to decrease the drug prices. This paper aims to explore dynamically the price and use comparison of generic and originator drugs in China, and estimate the potential savings of patients from switching originator drugs to generics. A typical hospital in Chongqing, China, was selected to examine the price and use comparisons of 12 cardiovascular drugs from 2006 to 2011. The market share of the 12 generic medicines studied in this paper was 34.37% for volume and 31.33% for value in the second half of 2011. The price ratio of generic to originator drugs was between 0.34 and 0.98, and the volume price index of originators to generics was 1.63. The potential savings of patients from switching originator drugs to generics is 65%. The market share of the generics was lowering and the weighted mean price kept increasing in face of the strict price control. Under the background of hospitals both prescribing and dispensing medicines, China's comprehensive healthcare policy makers should take measures from supply and demand sides to promote the consumption of generic medicines.

  7. 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.

  8. Price regulation and generic competition in the pharmaceutical market.

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    Dalen, Dag Morten; Strøm, Steinar; Haabeth, Tonje

    2006-09-01

    In March 2003 the Norwegian government implemented yardstick-based price regulation schemes on a selection of drugs subjected to generic competition. The retail price cap, termed the "index price," on a drug (chemical substance) was set equal to the average of the three lowest producer prices on that drug, plus a fixed wholesale and retail margin. This is supposed to lower barriers of entry for generic drugs and to trigger price competition. Using monthly data over the period 1998-2004 for the six drugs (chemical entities) included in the index price system, we estimate a structural model enabling us to examine the impact of the reform on both demand and market power. Our results suggest that the index price helped to increase the market shares of generic drugs and succeeded in triggering price competition.

  9. Use of generic medicines by the Brazilian population: an evaluation of PNAUM 2014

    Science.gov (United States)

    Bertoldi, Andréa Dâmaso; Arrais, Paulo Sergio Dourado; Tavares, Noemia Urruth Leão; Ramos, Luiz Roberto; Luiza, Vera Lucia; Mengue, Sotero Serrate; Dal-Pizzol, Tatiane da Silva; Farias, Mareni Rocha; Oliveira, Maria Auxiliadora

    2016-01-01

    ABSTRACT OBJECTIVE To analyze the existence of differences in the use of generic medicines in Brazil according to demographic and socioeconomic variables and acquisition sources of the medicines. METHODS Population-based cross-sectional study, conducted with data from the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines). Data collection took place between September, 2013 and February, 2014 in homes of Brazilian cities (urban area). The use of medicines has been investigated in relation to the treatment of chronic diseases and, in the case of acute events, regarding use over the previous 15 days. Generics were identified by visualization of packaging presented by the users of the medicines. The independent variables used were sex, age, education level, economic class, and region of the Country. The statistical significance of differences between the groups was evaluated by Pearson’s Chi-squared test, considering a 5% significance level. RESULTS The prevalence of generic medicines use was 45.5% (95%CI 43.7–47.3). There was no difference considering education level. The prevalence was higher in females (47.0%; 95%CI 44.9–49.0) than in males (43.1%; 95%CI 40.5–45.8), and were higher with increasing age. Generic medicines were more used in the economic class C (47.0%; 95%CI 44.9–49.1) and in the South (50.6%; 95%CI 46.6–54.6) and Southeast (49.9%; 95%CI 46.8–53.0) regions. Generics accounted for 37.3% of the medicines provided by the Brazilian Unified Health System. CONCLUSIONS Currently, there is a choice of purchase or free provision by the Brazilian Unified Health System, characterized by quality assurance and reduced price regarding branded medicines considered as reference. In the private market, a considerable part of the population is choosing generic medicines thanks to the availability of this option for virtually all

  10. The generic drug market in Japan: will it finally take off?

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    Iizuka, Toshiaki; Kubo, Kensuke

    2011-07-01

    Historically, brand-name pharmaceuticals have enjoyed long periods of market exclusivity in Japan, given the limited use of generics after patent expiration. To improve the efficiency of the health-care system, however, the government has recently implemented various policies aimed at increasing generic substitution. Although this has created expectations that the Japanese generic drug market may finally take off, to date, generic usage has increased only modestly. After reviewing the incentives of key market participants to choose generics, we argue that previous government policies did not provide proper incentives for pharmacies to boost generic substitution. We offer some recommendations that may help to increase generic usage.

  11. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study.

    Science.gov (United States)

    Dunne, Suzanne; Shannon, Bill; Dunne, Colum; Cullen, Walter

    2013-01-05

    Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of medicines in the world's two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing. This article refers to this situation as an exemplar of a national system on the cusp of significant health policy change, and specifically details Ireland's history with usage of generic medicines and how the proposed changes could affect healthcare provision.

  12. 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

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

    Directory of Open Access Journals (Sweden)

    Mohamed Azmi Hassali

    2014-11-01

    Full Text Available 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.

  14. 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

    Indian manufacturers of generic antiretroviral (ARV) medicines facilitated the rapid scale up of HIV/AIDS treatment in developing countries though provision of low-priced, quality-assured medicines. The legal framework in India that facilitated such production, however, is changing with implementation of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights, and intellectual property measures being discussed in regional and bilateral free trade agreement negotiations. Reliable quantitative estimates of the Indian role in generic global ARV supply are needed to understand potential impacts of such measures on HIV/AIDS treatment in developing countries. We utilized transactional data containing 17,646 donor-funded purchases of ARV tablets made by 115 low- and middle-income countries from 2003 to 2008 to measure market share, purchase trends and prices of Indian-produced generic ARVs compared with those of non-Indian generic and brand ARVs. Indian generic manufacturers dominate the ARV market, accounting for more than 80% of annual purchase volumes. Among paediatric ARV and adult nucleoside and non-nucleoside reverse transcriptase inhibitor markets, Indian-produced generics accounted for 91% and 89% of 2008 global purchase volumes, respectively. From 2003 to 2008, the number of Indian generic manufactures supplying ARVs increased from four to 10 while the number of Indian-manufactured generic products increased from 14 to 53. Ninety-six of 100 countries purchased Indian generic ARVs in 2008, including high HIV-burden sub-Saharan African countries. Indian-produced generic ARVs used in first-line regimens were consistently and considerably less expensive than non-Indian generic and innovator ARVs. Key ARVs newly recommended by the World Health Organization are three to four times more expensive than older regimens. Indian generic producers supply the majority of ARVs in developing countries. Future scale up using newly

  15. A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries

    Directory of Open Access Journals (Sweden)

    Waning Brenda

    2010-09-01

    Full Text Available Abstract Background Indian manufacturers of generic antiretroviral (ARV medicines facilitated the rapid scale up of HIV/AIDS treatment in developing countries though provision of low-priced, quality-assured medicines. The legal framework in India that facilitated such production, however, is changing with implementation of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights, and intellectual property measures being discussed in regional and bilateral free trade agreement negotiations. Reliable quantitative estimates of the Indian role in generic global ARV supply are needed to understand potential impacts of such measures on HIV/AIDS treatment in developing countries. Methods We utilized transactional data containing 17,646 donor-funded purchases of ARV tablets made by 115 low- and middle-income countries from 2003 to 2008 to measure market share, purchase trends and prices of Indian-produced generic ARVs compared with those of non-Indian generic and brand ARVs. Results Indian generic manufacturers dominate the ARV market, accounting for more than 80% of annual purchase volumes. Among paediatric ARV and adult nucleoside and non-nucleoside reverse transcriptase inhibitor markets, Indian-produced generics accounted for 91% and 89% of 2008 global purchase volumes, respectively. From 2003 to 2008, the number of Indian generic manufactures supplying ARVs increased from four to 10 while the number of Indian-manufactured generic products increased from 14 to 53. Ninety-six of 100 countries purchased Indian generic ARVs in 2008, including high HIV-burden sub-Saharan African countries. Indian-produced generic ARVs used in first-line regimens were consistently and considerably less expensive than non-Indian generic and innovator ARVs. Key ARVs newly recommended by the World Health Organization are three to four times more expensive than older regimens. Conclusions Indian generic producers supply the majority of

  16. The consequences of generic marketing on antibiotic consumption and the spread of microbial resistance: the need for new antibiotics.

    Science.gov (United States)

    Toutain, P-L; Bousquet-Melou, A

    2013-10-01

    In both human and veterinary medicine, it has been shown that flooding the market with different generics and/or 'me-too' branded drugs has increased overall antibiotic consumption correlating with the emergence and spread of bacterial resistance to antibiotics. Another possible undesirable consequence of the promotion of generics is the promotion of an economic incentive that encourages the use of old drug products with very poor oral bioavailability, marketed with historical dosage regimens and extensively excreted in the environment. What veterinary medicine rather needs is new innovative and 'ecofriendly' antibiotics to actually enforce a more prudent use of antibiotics. For a pharmaceutical company, generics are inexpensive to manufacture and on a short-term basis, the generic market is very appealing. However, on a long-term basis, this marketing orientation provides a disincentive to the development of new and innovative products that will be required to meet the therapeutic needs of the veterinary community while being consistent with public health concerns. Indeed, for veterinary medicine, the key issue surrounding antibiotics is public health. It is the opinion of the authors that veterinary antibiotics and/or veterinary drug formulations should be innovative in terms of selectivity (no or minimal impact on the commensal gut flora), biodegradable (with minimal environmental disruption), and more expensive, with a strictly regulated market rather than unselective, cheap, and freely available drugs.

  17. Investigation into the interchangeability of generic formulations using immunosuppressants and a broad selection of medicines

    NARCIS (Netherlands)

    Yu, Y.; Teerenstra, S.; Neef, C.; Burger, D.M.; Maliepaard, M.

    2015-01-01

    PURPOSE: To date, the interchangeability of generic drugs has only been investigated for a limited number of medicines. The objective of this study was to investigate generic-generic drug interchangeability in a large subset of generic formulations in order to cover a broad spectrum of drugs. METHOD

  18. Is there a need for a formulary of clinically interchangeable medicines to guide generic substitution in Saudi Arabia?

    Science.gov (United States)

    Alrasheedy, Alian A; Hassali, Mohamed Azmi; Aljadhey, Hisham; Ibrahim, Mohamed Izham Mohamed; Al-Tamimi, Saleh Karamah

    2013-06-01

    The escalating healthcare expenditure is a major challenge to sustainability of the healthcare systems. To confront the escalating health expenditure in general and medicines expenditure in particular, many countries promoted the use of generic medicines. To promote generic medicines, many countries have adopted a generic substitution (GS) policy and generic prescribing. To effectively implement the GS policy, it is evident in the literature that it is essential to have an evidence-based guide on therapeutic equivalence and formulary of interchangeable medicines to guide responsible GS. In Saudi Arabia, GS is permissive and pharmacists are given the right to perform GS. While the prescriber's approval is not a requirement, patient consent is required when performing GS. Although there are some general drug references, such as the Saudi National Formulary (SNF) and list of registered medicines in the Saudi market, but there is currently no information available to healthcare professionals that documents the therapeutic and bioequivalence between medicines. Thus, it is essential to have a formulary of interchangeable medicines to guide appropriate GS or at least to include such vital information regarding therapeutic equivalence and brand interchangeability as part of the SNF. That, in turn, will not only make healthcare professionals more confident when providing GS, but will also enable the avoidance of situations where GS is inappropriate.

  19. Analysis of Knowledge Level and Perception on Singkawang City Community towards Generic Medicines

    Directory of Open Access Journals (Sweden)

    Forid Morison

    2015-03-01

    Full Text Available Survey data show that the use of generic medicines in Indonesia is relatively very small, which only amounted 7%. This is due to lack of knowledge and poor perceptions towards generic medicines. Knowledge level and perceptions towards generic medicines are inflenced by community characteristics and information resource regarding generic medicines. The aim of this study was to determine the association between community characteristic and information resources with knowledge level and perception towards generic medicines. This study was an analytical survey with cross-sectional descriptive approach on 142 selected respondents who were fulfi inclusion and exclusion criteria. This study was conducted in June 2014 at several randomly selected locations on Singkawang City. The study show that 76 respondents (53.5% had inadequate knowledge and 123 respondents (86.6% had a good perception towards generic medicines. There is signifiant relationship between ethnicity (p=0.000 and information resources (p=0.009 with knowledge level regarding generic medicines at signifiance level of p<0.05. Although good perceptions were noted among the respondents, widespread dissemination of information regarding generic medicines should be continued to increase generic medicines used.

  20. Patient knowledge, perceptions, and acceptance of generic medicines: a comprehensive review of the current literature

    Directory of Open Access Journals (Sweden)

    Alrasheedy AA

    2014-04-01

    Full Text Available Alian A Alrasheedy,1 Mohamed Azmi Hassali,1 Kay Stewart,2 David CM Kong,2 Hisham Aljadhey,3 Mohamed Izham Mohamed Ibrahim,4 Saleh Karamah Al-Tamimi1 1Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia; 2Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, VIC, Australia; 3Medication Safety Research Chair, Clinical Pharmacy Department, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia; 4College of Pharmacy, Qatar University, Doha, Qatar Background: Generic medicines have the same quality, safety, and efficacy as their counterpart original brand medicines. Generic medicines provide the same therapeutic outcomes but at a much cheaper cost, so are promoted in many countries to contain pharmaceutical expenditure and sustain the health care system. Thus, the perspective of patients and medicine consumers as end users of these medicines is an important factor to enhance the use and utilization of generic medicines. The objective of this paper is to review patients’ and consumers’ knowledge, perceptions, acceptance, and views of generic medicines in the current literature. Methods: An extensive literature search was performed in several databases, namely Scopus, PubMed, ISI Web of Knowledge, Proquest, and the Wiley online library, to identify relevant studies published in the English literature for the period 1990–2013. Results: A total of 53 studies were included in the review, comprising 24 studies from Europe, ten from North America, six from Asia, five from Australia and New Zealand, five from the Middle East, one from Africa, one from Latin America, and one from the Caribbean region. A large body of literature has reported misconceptions and negative perceptions about generic medicines on the part of patients and medicine consumers. Moreover, although it is reported in almost all countries, the percentage of consumers who had

  1. Marketing and medicine: a questionable mix.

    Science.gov (United States)

    Moran, Michael E; Baum, Neil H

    2012-01-01

    Historically, medicine has been an evolving art and science. It never remains the same. Only in the past few decades has it been acceptable for doctors to market and promote their practices. This article will review the history of medical marketing and provide ethical examples of marketing that might be available to any physician, in any practice, and in any geographic location.

  2. Physical characterization and in vitro evaluation of some generic medications available in pharma market of United Arab Emirates (UAE)

    OpenAIRE

    Abdul Rasool, Bazigha K; Khan, Saeed A.; Shamsueldin, Eiman; Sadik, Raghad

    2011-01-01

    This study is the first attempt in UAE to prove the trustworthiness of the in vitro evaluation to assess the reliability of the generic medications comparing to the brand name. Five generic medicines, two Local (codes: L1, L2), three Arabic (codes: A1, A2 and A3) and the International brand (code: I1) of diclofenac sodium (DS) sustained release tablets, as a model product, was collected randomly from the UAE pharma market. The products were characterized by physical parameters including weigh...

  3. Marketing Approval of Ethical Kampo Medicines.

    Science.gov (United States)

    Hakamatsuka, Takashi

    2017-01-01

     Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

  4. Evolutions in both co-payment and generic market share for common medication in the Belgian reference pricing system.

    Science.gov (United States)

    Fraeyman, Jessica; Verbelen, Moira; Hens, Niel; Van Hal, Guido; De Loof, Hans; Beutels, Philippe

    2013-10-01

    In Belgium, a co-insurance system is applied in which patients pay a portion of the cost for medicines, called co-payment. Co-payment is intended to make pharmaceutical consumers more responsible, increase solidarity, and avoid or reduce moral hazards. Our objective was to study the possible influence of co-payment on sales volume and generic market share in two commonly used medicine groups: cholesterol-lowering medication [statins (HMG-CoA reductase inhibitors) and fibrates] and acid-blocking agents (proton pump inhibitors and histamine H2 receptor antagonists). The data were extracted from the Pharmanet database, which covers pharmaceutical consumption in all Belgian ambulatory pharmacies. First, the proportion of sales volume and costs of generic products were modelled over time for the two medicine groups. Second, we investigated the relation between co-payment and contribution by the national insurance agency using change-point linear mixed models. The change-point analysis suggested several influential events. First, the generic market share in total sales volume was negatively influenced by the abolishment of the distinction in the maximum co-payment level for name brands and generics in 2001. Second, relaxation of the reimbursement conditions for generic omeprazole stimulated generic sales volume in 2004. Finally, an increase in co-payment for generic omeprazole was associated with a significant decrease in omeprazole sales volume in 2005. The observational analysis demonstrated several changes over time. First, the co-payment amounts for name-brand and generic drugs converged in the observed time period for both medicine groups under study. Second, the proportion of co-payment for the total cost of simvastatin and omeprazole increased over time for small packages, and more so for generic than for name-brand products. For omeprazole, both the proportion and the amount of co-payment increased over time. Third, over time the prescription of small packages

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

    Science.gov (United States)

    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

  6. 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.

  7. Knowledge and perception of senior year pharmacy students about generic medicines in public Universities of Malaysia

    Directory of Open Access Journals (Sweden)

    Shi Wei Lee

    2014-01-01

    Conclusion: The findings highlight that pharmacy students needs a better understanding of the principles and concepts of bioavailability and bioequivalence if they are to contribute appropriately to generic medicine use.

  8. Medicinal plant markets and trade in Maputo, Mozambique

    DEFF Research Database (Denmark)

    Krog, Mogens Pedersen; Falcâo, Mario P.; Olsen, Carsten Smith

    Medicinal plants and traditional medicine are important to urban and rural livelihoods in Mozambique. This study presents a preliminary investigation of the structure and conduct of medicinal plant markets in Maputo.......Medicinal plants and traditional medicine are important to urban and rural livelihoods in Mozambique. This study presents a preliminary investigation of the structure and conduct of medicinal plant markets in Maputo....

  9. A method for understanding generic procurement of HIV medicines by developing countries with patent protection.

    Science.gov (United States)

    Beall, Reed F; Attaran, Amir

    2017-07-01

    Patent protection on medicines may frustrate access by blocking generic competition. Nevertheless, circumstances may still allow for generic procurement to occur anyway, especially for humanitarian cause. But to what extent does this occur? And which legal flexibilities may facilitate such procurement? We attempted to design a replicable methodology that involved linking antiretroviral (ARV) patent data (1260 patents for 12 medicines) from a World Intellectual Property Organization patent study on the 2013 World Health Organization's (WHO) Model List of Essential Medicines to all available matching procurement records in the WHO's Global Price Reporting Mechanism. We then cross-referenced these with lists of legal flexibilities which facilitate generic access where patents have been granted (e.g., supplier companies' patent non-enforcement policies, voluntary and compulsory licenses) to estimate plausible relevance. The patent data corresponded to 1924 generic procurement transactions (1.34 billion units) from 85 countries. While patents were relatively less common in these countries (the median coverage was 20%), over half (53%) of the generic procurements nevertheless aligned with patent protection in the exporting and/or importing country. The disproportionately high relevance of patents despite their lower numbers can be explained by their presence in key medicine-exporting countries and/or those with larger populations. We noted, however, that developing countries still seemed able to buy generic versions of these essential ARVs. A combination of legal flexibilities may have played important roles, but voluntary licensing agreements (VLs) between originator companies and generic ones appeared to align with the largest volumes of generic procurement where we estimated patent protection. If true, VLs may warrant proportionate attention from observers as a heavily relied upon international mechanism for facilitating generic access so that the implications can be

  10. Patients' Preferences for Generic and Branded Over-the-Counter Medicines: An Adaptive Conjoint Analysis Approach.

    Science.gov (United States)

    Halme, Merja; Linden, Kari; Kääriä, Kimmo

    2009-12-01

    : Despite increased use of generic medicines, little is known about either the attitudes of patients towards them or the decision-making process surrounding them. Young adults use over-the-counter (OTC) analgesics relatively often. : To assess the preferences of patients for generic and branded OTC pain medicines, to identify clusters with different preference structures, and to estimate the price elasticity of a generic alternative among university students. : Finnish university students (n = 256; students in courses at the Helsinki School of Economics) responded to an adaptive conjoint analysis (ACA) questionnaire on the choice between branded and generic OTC ibuprofen products. Product attributes of price, brand, onset time of effect, place of purchase and source of information were included in the questionnaire on the basis of the literature, a focus group and a previous pilot study. Several socioeconomic and health behavior descriptors were employed. Individual-level utility functions were estimated, preference clusters were identified, and the price elasticity of the generic medicine was assessed. : Five clusters with characteristic individual-level preferences and price elasticity but few differences in socioeconomic background were detected. Approximately half of the respondents were strongly price sensitive while the others had other preferences such as brand or an opportunity to buy the medicine at a pharmacy or to have a physician or a pharmacist as an information source. : The study provided new information on the concomitant effects of brand, price and other essential product attributes on the choice by patients between branded and generic medicines.

  11. Use of generic medicines by the Brazilian population: an evaluation of PNAUM 2014.

    Science.gov (United States)

    Bertoldi, Andréa Dâmaso; Arrais, Paulo Sergio Dourado; Tavares, Noemia Urruth Leão; Ramos, Luiz Roberto; Luiza, Vera Lucia; Mengue, Sotero Serrate; Dal-Pizzol, Tatiane da Silva; Farias, Mareni Rocha; Oliveira, Maria Auxiliadora

    2016-12-01

    To analyze the existence of differences in the use of generic medicines in Brazil according to demographic and socioeconomic variables and acquisition sources of the medicines. Population-based cross-sectional study, conducted with data from the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines). Data collection took place between September, 2013 and February, 2014 in homes of Brazilian cities (urban area). The use of medicines has been investigated in relation to the treatment of chronic diseases and, in the case of acute events, regarding use over the previous 15 days. Generics were identified by visualization of packaging presented by the users of the medicines. The independent variables used were sex, age, education level, economic class, and region of the Country. The statistical significance of differences between the groups was evaluated by Pearson's Chi-squared test, considering a 5% significance level. The prevalence of generic medicines use was 45.5% (95%CI 43.7-47.3). There was no difference considering education level. The prevalence was higher in females (47.0%; 95%CI 44.9-49.0) than in males (43.1%; 95%CI 40.5-45.8), and were higher with increasing age. Generic medicines were more used in the economic class C (47.0%; 95%CI 44.9-49.1) and in the South (50.6%; 95%CI 46.6-54.6) and Southeast (49.9%; 95%CI 46.8-53.0) regions. Generics accounted for 37.3% of the medicines provided by the Brazilian Unified Health System. Currently, there is a choice of purchase or free provision by the Brazilian Unified Health System, characterized by quality assurance and reduced price regarding branded medicines considered as reference. In the private market, a considerable part of the population is choosing generic medicines thanks to the availability of this option for virtually all medicines most used by the population. Analisar se há diferença no

  12. A survey exploring the knowledge and perceptions of senior medical students in Nepal toward generic medicines

    Directory of Open Access Journals (Sweden)

    Sudesh Gyawali

    2016-08-01

    Full Text Available Background: The accurate knowledge of generic medicine issues among future prescribers will enhance the prescribing of cost-effective medicines. This study aimed to explore the knowledge and perception of senior medical students about the generic medicines. Methodology: A cross-sectional study was conducted among 237 senior medical students (final year students and interns using a validated self-administered questionnaire. The collected data were analyzed using Statistical Package for the Social Sciences version 20 for windows and comparison of difference was done using linear by linear association. A p value of less than 0.05 was taken as statistically significant. Results: The average age (standard deviation of the respondents was 23.54 (1.39 years. Almost 5% of respondents correctly answered the question regarding the regulatory limits for bioequivalence. Almost two-thirds of respondents correctly agreed that generic medicine is bioequivalent to a brand-name medicine, and 79.3% and 72.5% of respondents correctly agreed that the medicine should be present in the same dosage form and same dose, respectively, as the brand-name medicines. However, almost half of the respondents had impression that brand-name medicines are required to meet higher safety standard than generic medicines. Almost 90% of respondents felt that advertisement by the drug companies would influence the use of brand-name medicine and they need more information about generic medicine. Conclusion: This study highlights the negative perception and knowledge deficit among the respondents. The students’ responses to almost all the statements were almost similar to the respondents’ academic year (final year students and interns, gender and nationality.

  13. A survey exploring the knowledge and perceptions of senior medical students in Nepal toward generic medicines

    Science.gov (United States)

    Gyawali, Sudesh; Hassali, Mohamed Azmi; Saha, Archana

    2016-01-01

    Background: The accurate knowledge of generic medicine issues among future prescribers will enhance the prescribing of cost-effective medicines. This study aimed to explore the knowledge and perception of senior medical students about the generic medicines. Methodology: A cross-sectional study was conducted among 237 senior medical students (final year students and interns) using a validated self-administered questionnaire. The collected data were analyzed using Statistical Package for the Social Sciences version 20 for windows and comparison of difference was done using linear by linear association. A p value of less than 0.05 was taken as statistically significant. Results: The average age (standard deviation) of the respondents was 23.54 (1.39) years. Almost 5% of respondents correctly answered the question regarding the regulatory limits for bioequivalence. Almost two-thirds of respondents correctly agreed that generic medicine is bioequivalent to a brand-name medicine, and 79.3% and 72.5% of respondents correctly agreed that the medicine should be present in the same dosage form and same dose, respectively, as the brand-name medicines. However, almost half of the respondents had impression that brand-name medicines are required to meet higher safety standard than generic medicines. Almost 90% of respondents felt that advertisement by the drug companies would influence the use of brand-name medicine and they need more information about generic medicine. Conclusion: This study highlights the negative perception and knowledge deficit among the respondents. The students’ responses to almost all the statements were almost similar to the respondents’ academic year (final year students and interns), gender and nationality. PMID:27551423

  14. Price regulation and generic competition in the pharmaceutical market

    OpenAIRE

    Dalen, Dag Morten; Strøm, Steinar; Haabeth, Tonje

    2009-01-01

    In March 2003 the Norwegian government implemented yardstick based price regulation schemes on a selection of drugs experiencing generic competition. The retail price cap, termed “index price”, on a drug (chemical substance) was set equal to the average of the three lowest producer prices on that drug, plus a fixed wholesale and retail margin. This is supposed to lower barriers of entry for generic drugs and to trigger price competition. Using monthly data over the period 1998-2004 for the 6 ...

  15. Switching to generic anti-epileptic medicines : A regulatory perspective

    NARCIS (Netherlands)

    Maliepaard, Marc; Hekster, Yechiel A.; Kappelle, Arnoud; Van Puijenbroek, Eugène P.; Elferink, André J.; Welink, Jan; Gispen-de Wied, Christine C.; Lekkerkerker, Frits J.F.

    2010-01-01

    Introduction: Currently, there is a lot of discussion about whether generic substitution of anti-epileptic drugs (AEDs) with the same active moiety but from different manufacturers can take place safely. Many AEDs are considered to have a narrow therapeutic index, and the consequences of an epilepti

  16. Assessment of knowledge and perceptions toward generic medicines among basic science undergraduate medical students at Aruba

    Science.gov (United States)

    Shankar, P. Ravi; Herz, Burton L.; Dubey, Arun K.; Hassali, Mohamed A.

    2016-01-01

    Objective: Use of generic medicines is important to reduce rising health-care costs. Proper knowledge and perception of medical students and doctors toward generic medicines are important. Xavier University School of Medicine in Aruba admits students from the United States, Canada, and other countries to the undergraduate medical (MD) program. The present study was conducted to study the knowledge and perception about generic medicines among basic science MD students. Materials and Methods: The cross-sectional study was conducted among first to fifth semester students during February 2015. A previously developed instrument was used. Basic demographic information was collected. Respondent’s agreement with a set of statements was noted using a Likert-type scale. The calculated total score was compared among subgroups of respondents. One sample Kolmogorov–Smirnov test was used to study the normality of distribution, Independent samples t-test to compare the total score for dichotomous variables, and analysis of variance for others were used for statistical analysis. Results: Fifty-six of the 85 students (65.8%) participated. Around 55% of respondents were between 20 and 25 years of age and of American nationality. Only three respondents (5.3%) provided the correct value of the regulatory bioequivalence limits. The mean total score was 43.41 (maximum 60). There was no significant difference in scores among subgroups. Conclusions: There was a significant knowledge gap with regard to the regulatory bioequivalence limits for generic medicines. Respondents’ level of knowledge about other aspects of generic medicines was good but could be improved. Studies among clinical students in the institution and in other Caribbean medical schools are required. Deficiencies were noted and we have strengthened learning about generic medicines during the basic science years. PMID:28031604

  17. Assessment of knowledge and perceptions toward generic medicines among basic science undergraduate medical students at Aruba.

    Science.gov (United States)

    Shankar, P Ravi; Herz, Burton L; Dubey, Arun K; Hassali, Mohamed A

    2016-10-01

    Use of generic medicines is important to reduce rising health-care costs. Proper knowledge and perception of medical students and doctors toward generic medicines are important. Xavier University School of Medicine in Aruba admits students from the United States, Canada, and other countries to the undergraduate medical (MD) program. The present study was conducted to study the knowledge and perception about generic medicines among basic science MD students. The cross-sectional study was conducted among first to fifth semester students during February 2015. A previously developed instrument was used. Basic demographic information was collected. Respondent's agreement with a set of statements was noted using a Likert-type scale. The calculated total score was compared among subgroups of respondents. One sample Kolmogorov-Smirnov test was used to study the normality of distribution, Independent samples t-test to compare the total score for dichotomous variables, and analysis of variance for others were used for statistical analysis. Fifty-six of the 85 students (65.8%) participated. Around 55% of respondents were between 20 and 25 years of age and of American nationality. Only three respondents (5.3%) provided the correct value of the regulatory bioequivalence limits. The mean total score was 43.41 (maximum 60). There was no significant difference in scores among subgroups. There was a significant knowledge gap with regard to the regulatory bioequivalence limits for generic medicines. Respondents' level of knowledge about other aspects of generic medicines was good but could be improved. Studies among clinical students in the institution and in other Caribbean medical schools are required. Deficiencies were noted and we have strengthened learning about generic medicines during the basic science years.

  18. Does Reference Pricing Drive Out Generic Competition in Pharmaceutical Markets? Evidence from a Policy Reform

    OpenAIRE

    Kurt R. Brekke; Canta, Chiara; Straume, Odd Rune

    2015-01-01

    In this paper we study the impact of reference pricing (RP) on entry of generic firms in the pharmaceutical market. For given prices, RP increases generic firms' expected profit, but since RP also stimulates price competition, the impact on generic entry is theoretically ambiguous. In order to empirically test the effects of RP, we exploit a policy reform in Norway in 2005 that exposed a subset of drugs to RP. Having detailed product-level data for a wide set of substances from 2003 to 2013,...

  19. 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

  20. [Anti-aging medicine: science or marketing ?].

    Science.gov (United States)

    Cogan, E

    2015-09-01

    Anti-aging medicine is self defined as a preventive medicine, combining nutritional recommendations, dietary supplements, prescriptions for hormones and various aesthetic techniques. The essential aim is to reduce the risk of aging, both psychically, physically and aesthetically. Although many scientific studies in animals or in vitro models have demonstrated the deleterious role of oxidative stress and of hormonal, vitamin or trace elements deficiencies, the transposition to humans of these findings is marginal and does not justify the therapeutic proposals advocated by the anti aging medicine. These practices are mostly not based on any scientific basis both in the diagnostic and therapeutic fields. These approaches are particularly costly for gullible patients in search of well being and abused by a carefully organized marketing involving tacit complicity of doctors, laboratories and firms producing hormones and dietary supplements and various substances devoted for aesthetic purposes.

  1. 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.

  2. [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.

  3. Volume, value and floristic diversity of Gabon's medicinal plant markets

    NARCIS (Netherlands)

    Towns, A.M.; Quiroz Villarreal, D.K.; Guinee, L.; Boer, H.; Andel, van T.

    2014-01-01

    Ethnopharmacological relevance - African medicinal plant markets offer insight into commercially important species, salient health concerns in the region, and possible conservation priorities. Still, little quantitative data is available on the trade in herbal medicine in Central Africa. The aim of

  4. Volume, value and floristic diversity of Gabon's medicinal plant markets

    NARCIS (Netherlands)

    Towns, A.M.; Quiroz Villarreal, D.K.; Guinee, L.; Boer, H.; Andel, van T.

    2014-01-01

    Ethnopharmacological relevance - African medicinal plant markets offer insight into commercially important species, salient health concerns in the region, and possible conservation priorities. Still, little quantitative data is available on the trade in herbal medicine in Central Africa. The aim of

  5. Understanding and fighting the medicine counterfeit market.

    Science.gov (United States)

    Dégardin, Klara; Roggo, Yves; Margot, Pierre

    2014-01-01

    Medicine counterfeiting is a serious worldwide issue, involving networks of manufacture and distribution that are an integral part of industrialized organized crime. Despite the potentially devastating health repercussions involved, legal sanctions are often inappropriate or simply not applied. The difficulty in agreeing on a definition of counterfeiting, the huge profits made by the counterfeiters and the complexity of the market are the other main reasons for the extent of the phenomenon. Above all, international cooperation is needed to thwart the spread of counterfeiting. Moreover effort is urgently required on the legal, enforcement and scientific levels. Pharmaceutical companies and agencies have developed measures to protect the medicines and allow fast and reliable analysis of the suspect products. Several means, essentially based on chromatography and spectroscopy, are now at the disposal of the analysts to enable the distinction between genuine and counterfeit products. However the determination of the components and the use of analytical data for forensic purposes still constitute a challenge. The aim of this review article is therefore to point out the intricacy of medicine counterfeiting so that a better understanding can provide solutions to fight more efficiently against it.

  6. Identifying internet marketing principles relevant to generic marketers / Ayesha Lian Bevan-Dye

    OpenAIRE

    Bevan-Dye, Ayesha Lian

    2005-01-01

    To deliver the type of marketing graduate that meets industry demand necessitates that marketing curricula content be continuously updated to keep pace with the dynamic marketing environment. One of the major trends influencing the twenty-first century marketing environment is the advent of the Internet and substantial growth in Internet usage and Internet-based commerce. Not only is the Internet driving major marketing environmental change, it is also emerging as a new marketing tool of sign...

  7. Understanding and perceptions of final-year Doctor of Pharmacy students about generic medicines in Karachi, Pakistan: a quantitative insight

    Directory of Open Access Journals (Sweden)

    Jamshed SQ

    2015-05-01

    Full Text Available Shazia Qasim Jamshed,1 Mohamad Izham Mohamad Ibrahim,2 Mohamad Azmi Hassali,3 Adheed Khalid Sharrad,4 Asrul Akmal Shafie,3 Zaheer-Ud-Din Babar5 1Pharmacy Practice, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan Campus, Pahang, Malaysia; 2College of Pharmacy, Qatar University, Doha, Qatar; 3Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Penang, Malaysia; 4College of Pharmacy, University of Basra, Basra, Iraq; 5School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand General objective: To evaluate the understanding and perceptions of generic medicines among final-year Doctor of Pharmacy students in Karachi, Pakistan. Methods: A 23-item survey instrument that included a question on the bioequivalence limits and Likert-type scale questions regarding the understanding and perceptions of generic medicines among the students was executed. Cronbach’s alpha was found to be 0.62. Results: Responses were obtained from 236 final-year Doctor of Pharmacy students (n=85 from a publicly funded institute; n=151 from a privately funded institute. When comparing a brand-name medicine to a generic medicine, pharmacy students scored poorly on bioequivalence limits. More than 80% of the students incorrectly answered that all the products that are rated as generic equivalents are therapeutically equivalent to each other (P<0.04. Half of the students agreed that a generic medicine is bioequivalent to the brand-name medicine (P<0.001. With regard to quality, effectiveness, and safety, more than 75% of the students disagreed that generic medicines are of inferior quality and are less effective than brand-name medicines (P<0.001. More than 50% of the students disagreed that generic medicines produce more side effects than brand-name medicines (P<0.001. Conclusion: The current study identified a positive perception toward generic medicines but also gaps in

  8. 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

    of confidence in the identical effect of the substitutable medicines. Several studies have focused on one specific drug group such as antihypertensive drugs. However, the influence of generic switching may affect concerns about medicine differently, depending on drug categories. Research on generic substitution...... reduced persistence. So far, studies of the effect of generic drug substitution on drug continuation have not focused on patients' overall experience of generic switches within one specific drug. AIMS: To analyse associations between generic substitution and patient characteristics as well as patients......' views on generic medicines, confidence in the healthcare system, beliefs about medicine, and experience with earlier generic substitution. To investigate the possible association between a specific generic switch and patients' concerns about their medicine. To examine how generic switch influences...

  9. Generic switching and non-persistence among medicine users: a combined population-based questionnaire and register study.

    Directory of Open Access Journals (Sweden)

    Jette Rathe

    Full Text Available 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.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' attitudes towards generic medicines and concerns about their medicine.Patients who experience their first-time switch of a specific drug were at higher risk of non-persistence, Hazard Ratio 2.98, 95% CI (1.81;4.89 versus those who have never switched, and 35.7% became non-persistent during the first year of follow-up. Generic switching did not influence persistence considerably in those having previous experience with generic switching of the specific drug. Stratified analyses on users of antidepressants and antiepileptics underpin the results, showing higher risk of non-persistence for first-time switchers for both drug categories.In conclusion, patients who are first-time switchers of a specific drug were at higher risk of non-persistence compared to never switchers and those having experienced previous generic switching.

  10. The role of generic medicines and biosimilars in oncology in low-income countries.

    Science.gov (United States)

    Renner, L; Nkansah, F A; Dodoo, A N O

    2013-09-01

    Cancer cases are rising in developing countries which are already grappling with high levels of infectious diseases including human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), tuberculosis (TB) and malaria. The United Nations (UN) including the World Health Organisation (WHO) have called on member states to establish strategies to deal with the increasing burden of non-communicable diseases, including cancer, in developing countries. The complexity of cancer care and management calls for innovative approaches in low resource settings especially since these settings are already grappling with huge challenges in healthcare including lack of funds, weak human resource base and lack of treatment guidelines. Whilst the cost of medications is by no means the only high cost in cancer care, the availability of affordable anti-cancer generic drugs and biologically similar therapeutic agents (biosimilars) will go a long way to reduce overall cost of cancer care. The high cost of anticancer medicines has been cited among the reasons whilst patients default in treatment. Non-proprietary anti-cancer agents--generics and biosimilars--often cost several times lower than their innovator branded counterparts. They can reduce the cost of care significantly and their multi-source origin often provide guarantee in supply. The use of generic and biosimilar products is hinged on the assumption that they are of assured quality and of the same pharmaceutical integrity as their innovator counterparts. The use of these products however is associated with challenges that must be understood and addressed. The quality of all generics and biosimilars should be rigorously controlled and assured. Measures to prevent counterfeit and sub-standard generics and biosimilars should be developed and the cold-chain must be maintained for all biosimilars. In addition to these, the WHO is encouraged to develop a prequalification scheme to assist countries without strong regulatory

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

    OpenAIRE

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

    2015-01-01

    Objectives Generic medicine prescribing has become a common practice in public hospitals. However, the trend in private medical centres seems to be different. The objective of this study was to investigate knowledge, perceptions and behavior of physicians from private medical centres in Malaysia regarding generic medicines. Methods This study was a cross-sectional nationwide survey targeting physicians from private medical centres in Malaysia. The survey was conducted using questionnaire havi...

  12. 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

    Generic medicine prescribing has become a common practice in public hospitals. However, the trend in private medical centres seems to be different. The objective of this study was to investigate knowledge, perceptions and behavior of physicians from private medical centres in Malaysia regarding generic medicines. This study was a cross-sectional nationwide survey targeting physicians from private medical centres in Malaysia. The survey was conducted using questionnaire having (i) background and demographic data of the physicians, volume of prescription in a day, stock of generic medicines in their hospital pharmacy etc. (ii) their knowledge about bioequivalence (iii) prescribing behavior (iv) physicians' knowledge of quality, safety and efficacy of generic medicines, and their cost (v) perceptions of physicians towards issues pertaining to generic medicines utilization. A total of 263 questionnaires out of 735 were received, giving a response rate of 35.8%. Of the respondents, 214 (81.4%) were male and 49 (18.6%) were females. The majority of the participants were in the age range of 41-50 years and comprised 49.0% of the respondents. Only 2.3% of physicians were aware of the regulatory limits of bioequivalence standards in Malaysia. Of the respondents, 23.2% agreed that they 'always' write their prescriptions using originator product name whereas 50.2% do it 'usually'. A number of significant associations were found between their knowledge, perceptions about generic medicines and their demographic characteristics. The majority of the physicians from private medical centres in Malaysia had negative perceptions about safety, quality and the efficacy of generic medicines. These negative perceptions could be the cause of the limited use of generic medicines in the private medical centres. Therefore, in order to facilitate their use, it is recommended that the physicians need to be reassured and educated about the drug regulatory authority approval system of generic

  13. COMPARATIVE EFFICACY AND SAFETY OF HYPOLIPIDEMIC THERAPY WITH GENERIC AND ORIGINAL MEDICINAL PRODUCTS OF SIMVASTATIN

    Directory of Open Access Journals (Sweden)

    E. I. Tarlovskaya

    2011-01-01

    Full Text Available Aim. To compare efficacy , safety and pharmacoeconomical characteristics of generic and original medicinal products of simvastatin in achievement of cholesterol and low density lipoprotein target levels. Material and methods. 38 patients with arterial hypertension accompanied by type 2 diabetes with dyslipidemia were included into the study. They had no clinically obvious ischemic heart disease and did not receive hypolipidemic pharmacotherapy for a month before the study start. The patients were randomized into group A or group B. Patients of group A (n=18 received original simvastatin, patients of group B (n=20 received generic simvastatin. Initial simvastatin dose was 20 mg daily. Lipid plasma profile, liver enzymes, creatine phosphokinase were evaluated every 4 weeks. Cost-effectiveness ratio was calculated. Results. 11 patients (61% in group A and only 5 patients (25% in group B (χ2=5.05; р<0.05 achieved cholesterol target level with simvastatin in dose of 20 mg daily in 3 months of the treatment. Creatine phosphokinase blood level did not increase significantly. Achievement of cholesterol target level cost 814 and 952 RUB per patient in groups A and B, respectively , in 1 month of simvastatin treatment. These costs were 643 and 417 RUB per patient in groups A and B, respectively , in 3 months of treatment. Conclusion. The original simvastatin in comparison with generic one has advantages in hypolipidemic effect. Safety profile is similar for both medications. Original simvastatin therapy has lower cost than this for generic simvastatin therapy in achievement of cholesterol target level in 1 month of treatment. In 3 months the cost of treatment per patient is 227 RUB higher for original medication in comparison with this for generic medication.

  14. Medicinal plants sold at traditional markets in southern Ecuador.

    Science.gov (United States)

    Tinitana, Fani; Rios, Montserrat; Romero-Benavides, Juan Carlos; de la Cruz Rot, Marcelino; Pardo-de-Santayana, Manuel

    2016-07-05

    The traditional markets in southern Ecuador and within the Andean region are especially important for plant resource trading among local people, even since before Spanish colonization; therefore, ethnobotanical studies are currently necessary and important. These strategic spaces persist for the traditional medicine cultural value reflected in the higher consumption of medicinal plants, which span all socioeconomic levels of rural and urban people. The purpose of this study includes the following: 1) to create a novel list of medicinal plants sold at 33 traditional markets; 2) to establish medicinal plant use agreement amongst vendors with the Factor of Informant Consensus (FIC); and 3) to determine the most sold medicinal plant species using the Fidelity Level (FL). This study focus on traditional markets ethnobotany utilizes the largest sample of medicinal plants market vendors up to date in Ecuador, interviewing them at 33 traditional markets, located within the Loja province. In order to determine the most sold medicinal plants and their ethnobotanical information, structured questionnaires and personal conversations were conducted with 196 medicinal plant vendors, and voucher specimens were created. Agreement among vendors about the therapeutic use of medicinal plants was measured using the FIC, and the most sold medicinal plant species were assessed with the FL. This research registered 160 medicinal plant species, grouped in 126 genera and 57 families that were sold in 33 traditional markets. The uses of medicinal plants in southern Ecuador are related to a long history of traditional medicine health practices that has persisted until today as well as high plant diversity. The 53 therapeutic uses recorded were grouped into 12 medical categories that were adapted from the World Health Organization. Three medical categories shared the highest value for FIC = 0.92, which showed a high level of agreement of market vendors for 57 medicinal plant species sold

  15. Does Sports Medicine Fit in the New Health Care Market?

    Science.gov (United States)

    Rogers, C C

    1985-01-01

    Physicians are being forced to compete for their share of a changing health care market. Two traditional concerns of sports medicine-fitness and preventive care-may help some physicians keep their practice healthy.

  16. Impact of the introduction of mandatory generic substitution in South Africa: private sector sales of generic and originator medicines for chronic diseases.

    Science.gov (United States)

    Gray, Andrew Lofts; Santa-Ana-Tellez, Yared; J Wirtz, Veronika

    2016-12-01

    To assess the impact of mandatory offer of generic substitution, introduced in South Africa in May 2003, on private sector sales of generic and originator medicines for chronic diseases. Private sector sales data (June 2001 to May 2005) were obtained from IMS Health for proton pump inhibitors (PPIs; ATC code A02BC), HMG-CoA reductase inhibitors (statins; C10AA), dihydropyridine calcium antagonists (C08CA), angiotensin-converting enzyme inhibitors (ACE-I; C09AA) and selective serotonin reuptake inhibitors (SSRIs; N06AB). Monthly sales were expressed as defined daily doses per 1000 insured population per month (DDD/TIM). Interrupted time-series models were used to estimate the changes in slope and level of medicines use after the policy change. ARIMA models were used to correct for autocorrelation and stationarity. Only the SSRIs saw a significant rise in level of generic utilisation (0.2 DDD/TIM; P increase in slope (0.01 DDD/TIM, P = 0.016; 0.02 DDD/TIM, P < 0.001), while the originators showed a decrease in slope (-0.003 DDD/TIM, P = 0.046; -0.01 DDD/TIM, P < 0.001). There were insufficient data on generic statin use before the policy change to allow for analysis. The mandatory offer of generic substitution appeared to have had a quantifiable effect on utilisation patterns in the 2 years after May 2003. Managed care interventions that were already in place before the intervention may have blunted the extent of the changes seen in this period. Generic policies are an important enabling provision for cost-containment efforts. However, decisions taken outside of official policy may anticipate or differ from that policy, with important consequences. © 2016 John Wiley & Sons Ltd.

  17. Generic Virtual Power Plants: Management of Distributed Energy Resources under Liberalized Electricity Market

    DEFF Research Database (Denmark)

    You, Shi; Træholt, Chresten; Poulsen, Bjarne

    2009-01-01

    The emergence of Virtual Power Plant (VPP) can be attributed to the major boost of distributed energy resources (DER), which satisfies the changing needs of modern society on energy industry. Based on this concept, DER units disregarding the differences in each individualtechnology are loosely...... that are necessary for the efficient operation of GVPP. By applying with the function-based design (FBD) method, GVPP developers with different system requirements are able to get the most flexibility out of the GVPP model. This is demonstrated in a case study wherein different GVPP scenarios are employed. Tools...... aggregated with a unique interface to the external grid and energy market. This paper gives a broad overview of state-of-the-art VPP concepts and proposes a detailed generic VPP (GVPP) model running in liberalized electricity market environment. An attempt is made to provide an outline of the main functions...

  18. Medicinal plants sold at the El Rio Market, Camaguey, Cuba

    NARCIS (Netherlands)

    Godinez-Caraballo, D.; Volpato, G.

    2008-01-01

    Information regarding medicinal plants sold in the El Rio Market, Camaguey, Cuba, revealed 184 species belonging to 69 vascular plant families. The most important family was Fabaceae s.l. with 13 species, followed by Lamiaceae with 12, and Asteraceae with 8. More than 90 general medicinal indication

  19. Medicinal plants sold at the El Rio Market, Camaguey, Cuba

    NARCIS (Netherlands)

    Godinez-Caraballo, D.; Volpato, G.

    2008-01-01

    Information regarding medicinal plants sold in the El Rio Market, Camaguey, Cuba, revealed 184 species belonging to 69 vascular plant families. The most important family was Fabaceae s.l. with 13 species, followed by Lamiaceae with 12, and Asteraceae with 8. More than 90 general medicinal

  20. A survey exploring knowledge and perceptions of general practitioners towards the use of generic medicines in the northern state of Malaysia.

    Science.gov (United States)

    Chua, Gin Nie; Hassali, Mohamed Azmi; Shafie, Asrul Akmal; Awaisu, Ahmed

    2010-05-01

    The objective of this study was to evaluate the general practitioners' (GPs') knowledge and perceptions towards generic medicines in a northern state of Malaysia. A postal cross-sectional survey involving registered GPs in Penang, Malaysia was undertaken. A 23-item questionnaire was developed, validated and administered on the GPs. Eighty-seven GPs responded to the survey (response rate 26.8%). The majority of the respondents (85.1%) claimed that they actively prescribed generic medicines in their practice. On the other hand, only 4.6% of the respondents correctly identified the Malaysia's National Pharmaceutical Control Bureau's bioequivalence standard for generic products. There were misconceptions among the respondents about the concepts of "bioequivalence", "efficacy", "safety", and "manufacturing standards" of generic medicines. GPs in this survey believed that a standard guideline on brand substitution process, collaboration with pharmacists, patient education and information on safety and efficacy of generic medicines were necessary to ensure quality use of generics. Furthermore, advertisements and product bonuses offered by pharmaceutical companies, patient's socio-economic factors as well as credibility of manufacturers were factors reported to influence their choice of medicine. Although it appeared that GPs have largely accepted the use of generic medicines, they still have concerns regarding the reliability and quality of such products. GPs need to be educated and reassured about generic products approval system in Malaysia concerning bioequivalence, quality, and safety. The current findings have important implications in establishing generic medicines policy in Malaysia. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.

  1. State Medicaid programs missed $220 million in uncaptured savings as generic fluoxetine came to market, 2001-05.

    Science.gov (United States)

    Kelton, Christina M L; Chang, Lenisa V; Kreling, David H

    2013-07-01

    Patent expiration of brand-name pharmaceuticals creates opportunities for large savings for state Medicaid programs because generic versions of medications frequently represent a lower-cost alternative. State Medicaid programs that quickly recognize the availability of generics and adjust their drug payments in response to falling market prices can obtain the greatest benefit. We examined one such case: the movement to generic fluoxetine following patent expiration for Prozac, a widely prescribed antidepressant and an expensive drug for Medicaid. We found large differences in states' responses to generic availability. States took between two and ten calendar quarters to reach 90 percent use of generic rather than brand-name fluoxetine and four to eight quarters to achieve a 50 percent decrease in reimbursement per pill. We estimated that states failed to realize $220 million in uncaptured savings during 2001-05. By coordinating their efforts, perhaps with federal help, states could gain access in a more timely way to market prices for generic drugs and, hence, take greater advantage of the savings that those drugs offer.

  2. Can NGOs regulate medicines markets? Social enterprise in wholesaling, and access to essential medicines

    Science.gov (United States)

    2011-01-01

    Background Citizens of high income countries rely on highly regulated medicines markets. However low income countries' impoverished populations generally struggle for access to essential medicines through out-of-pocket purchase on poorly regulated markets; results include ill health, drug resistance and further impoverishment. While the role of health facilities owned by non-governmental organisations (NGOs) in low income countries is well documented, national and international wholesaling of essential medicines by NGOs is largely unstudied. This article describes and assesses the activity of NGOs and social enterprise in essential medicines wholesaling. Methods The article is based on a set of interviews conducted in 2006-8 with trading NGOs and social enterprises operating in Europe, India and Tanzania. The analysis applies socio-legal and economic perspectives on social enterprise and market regulation. Results Trading NGOs can resist the perverse incentives inherent in medicines wholesaling and improve access to essential medicines; they can also, in definable circumstances, exercise a broader regulatory influence over their markets by influencing the behaviour of competitors. We explore reasons for success and failure of social enterprise in essential medicines wholesaling, including commercial manufacturers' market response; social enterprise traders' own market strategies; and patterns of market advantage, market segmentation and subsidy generated by donors. Conclusions We conclude that, in the absence of effective governmental activity and regulation, social enterprise wholesaling can improve access to good quality essential medicines. This role should be valued and where appropriate supported in international health policy design. NGO regulatory impact can complement but should not replace state action. PMID:21356076

  3. Can NGOs regulate medicines markets? Social enterprise in wholesaling, and access to essential medicines

    Directory of Open Access Journals (Sweden)

    Chaudhuri Sudip

    2011-02-01

    Full Text Available Abstract Background Citizens of high income countries rely on highly regulated medicines markets. However low income countries' impoverished populations generally struggle for access to essential medicines through out-of-pocket purchase on poorly regulated markets; results include ill health, drug resistance and further impoverishment. While the role of health facilities owned by non-governmental organisations (NGOs in low income countries is well documented, national and international wholesaling of essential medicines by NGOs is largely unstudied. This article describes and assesses the activity of NGOs and social enterprise in essential medicines wholesaling. Methods The article is based on a set of interviews conducted in 2006-8 with trading NGOs and social enterprises operating in Europe, India and Tanzania. The analysis applies socio-legal and economic perspectives on social enterprise and market regulation. Results Trading NGOs can resist the perverse incentives inherent in medicines wholesaling and improve access to essential medicines; they can also, in definable circumstances, exercise a broader regulatory influence over their markets by influencing the behaviour of competitors. We explore reasons for success and failure of social enterprise in essential medicines wholesaling, including commercial manufacturers' market response; social enterprise traders' own market strategies; and patterns of market advantage, market segmentation and subsidy generated by donors. Conclusions We conclude that, in the absence of effective governmental activity and regulation, social enterprise wholesaling can improve access to good quality essential medicines. This role should be valued and where appropriate supported in international health policy design. NGO regulatory impact can complement but should not replace state action.

  4. 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.

  5. [History of the evaluation of medicines aiming for marketing authorization].

    Science.gov (United States)

    Caulin, C

    2008-01-01

    The European Directive on Medicines Evaluation and Marketing Authorization were issued in 1975. For more than 30 years, Marketing Authorization criteria have been defined as pharmaceutical and biological quality, therapeutic efficacy, and safety. The application comes from the pharmaceutical company and must include the full data on drug development. French procedures have always included practical assessment of the drug by health practitioners: clinicians, pharmacists, biologists, and specialists in biostatistics.

  6. Intervening in global markets to improve access to HIV/AIDS treatment: an analysis of international policies and the dynamics of global antiretroviral medicines markets

    Directory of Open Access Journals (Sweden)

    Hochstadt Jenny

    2010-05-01

    Full Text Available Abstract Background Universal access to antiretroviral therapy (ART in low- and middle-income countries faces numerous challenges: increasing numbers of people needing ART, new guidelines recommending more expensive antiretroviral (ARV medicines, limited financing, and few fixed-dose combination (FDC products. Global initiatives aim to promote efficient global ARV markets, yet little is known about market dynamics and the impact of global policy interventions. Methods We utilize several data sources, including 12,958 donor-funded, adult first-line ARV purchase transactions, to describe the market from 2002-2008. We examine relationships between market trends and: World Health Organization (WHO HIV/AIDS treatment guidelines; WHO Prequalification Programme (WHO Prequal and United States (US Food and Drug Administration (FDA approvals; and procurement policies of the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM, US President's Emergency Plan for AIDS Relief (PEPFAR and UNITAID. Results WHO recommended 7, 4, 24, and 6 first-line regimens in 2002, 2003, 2006 and 2009 guidelines, respectively. 2009 guidelines replaced a stavudine-based regimen ($88/person/year with more expensive zidovudine- ($154-260/person/year or tenofovir-based ($244-465/person/year regimens. Purchase volumes for ARVs newly-recommended in 2006 (emtricitabine, tenofovir increased >15-fold from 2006 to 2008. Twenty-four generic FDCs were quality-approved for older regimens but only four for newer regimens. Generic FDCs were available to GFATM recipients in 2004 but to PEPFAR recipients only after FDA approval in 2006. Price trends for single-component generic medicines mirrored generic FDC prices. Two large-scale purchasers, PEPFAR and UNITAID, together accounted for 53%, 84%, and 77% of market volume for abacavir, emtricitabine, and tenofovir, respectively, in 2008. PEPFAR and UNITAID purchases were often split across two manufacturers. Conclusions Global initiatives

  7. [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.

  8. [Innovative medicines and market access agreements].

    Science.gov (United States)

    Toumi, M; Zard, J; Duvillard, R; Jommi, C

    2013-09-01

    Market Access Agreements (MAA) for drugs have emerged in response to the need to control health expenditures, as well as to the uncertainty about the true benefit of a drug. It is possible to group MAA in two types of agreements: financial agreements and outcome-based agreements. MAA is a growing trend and is shifting towards conditional access. However, the willingness to use these contracts and their implementation differ across countries, and some are still resistant to put them in place. The MAA challenges to overcome encompass the complexity of the schemes, the administrative burden and the difficulty of evaluating MAA. It is likely that these agreements might experience further evolution in the future to become a faster pathway for therapeutic innovations, at a fair price.

  9. Consumer behavior in OTC medicines market.

    Science.gov (United States)

    Woźniak-Holecka, Joanna; Grajek, Mateusz; Siwozad, Karolina; Mazgaj, Kamila; Czech, Elzbieta

    2012-01-01

    Over-the-counter (OTC) drugs are pharmaceuticals sold without a medical prescription. The goal of the paper was to evaluate the awareness in the studied group of people concerning purchasing and usage of the OTC drugs. The essence of the research was to determine whether factors as: education, income, type and place of work influence purchase and use of OTC drugs. Four equal groups (100 people each) were studied by an anonymous questionnaire. Two occupational groups: nurses and people working outside the medical sector, and also 2 student groups--from medical and non-medical schools living in Silesia. Respondents answered 47 questions. Data received from the questionnaire were statistically analyzed by means of the Chi2 test (p < 0.05). More than half of the respondents use OTC drugs. The respondents mainly buy the medicines in pharmacies. People connected with medical sector more often take pharmacists' advice and opinion than people from non-medical sector. The majority of the respondents are not familiar with chemical composition of the OTC drugs they take. Among them medical staff and medical schools students are to be found.

  10. Solid-state characterization fluconazol generic products and impurities determination of marketed in Morocco

    Institute of Scientific and Technical Information of China (English)

    Houda Bourichi; Youness Brik; Philipe Hubert; Yahia Cherrah; Abdelaziz Bouklouze

    2012-01-01

    In this paper, we report the results of quality control based in pbysicochemical characteriza- tion and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These samples were supplied by different pharmaceuticals companies. The sample A, as the discovered product, was supplied by Pfizer, while samples B and C (generics), were manufactured by two different Indian industries. Solid-state characterization of the three samples was realized with different physicochemical methods as: X-ray powder diffraction, Fourier-transformation infrared spectroscopy, differential scanning calorimetry. High performance liquid chromatography was used to quantify the impurities in the different samples. The results from the physicochemical methods cited above, showed difference in polymorph structure of the three drug substances. Sample A consisted in pure polymorph II1, sample B consisted in pure polymorph I1, sample C consisted in a mixture of fluconazole Form Ili, form II and the monohydrate. This result was confirmed by differential scanning calorimetry. Also it was demonstrated that solvents used during the re-crystallization step were among the origins of these differences in the structure form. On the other hand, the result of the stability study under humidity and temperature showed that fluconazole polymorphic transformation could be owed to the no compliance with the conditions of storage. The HPLC analysis of these compounds showed the presence of specific

  11. Estimated generic prices of cancer medicines deemed cost-ineffective in England: a cost estimation analysis

    National Research Council Canada - National Science Library

    Hill, Andrew; Redd, Christopher; Gotham, Dzintars; Erbacher, Isabelle; Meldrum, Jonathan; Harada, Ryo

    2017-01-01

    ...: bortezomib, dasatinib, everolimus and gefitinib. These medications were selected according to their clinical importance, novel pharmaceutical actions and the availability of generic price data...

  12. Nanotechnology in medicine: from inception to market domination.

    Science.gov (United States)

    Morigi, Valentina; Tocchio, Alessandro; Bellavite Pellegrini, Carlo; Sakamoto, Jason H; Arnone, Marco; Tasciotti, Ennio

    2012-01-01

    Born from the marriage of nanotechnology and medicine, nanomedicine is set to bring advantages in the fight against unmet diseases. The field is recognized as a global challenge, and countless worldwide research and business initiatives are in place to obtain a significant market position. However, nanomedicine belongs to those emerging sectors in which business development methods have not been established yet. Open issues include which type of business model best fits these companies and which strategies would lead them to sustained growth. This paper describes the financial and strategic decisions by nanomedicine start-ups to reach the market successfully, obtain a satisfactory market share, and build and maintain a competitive defendable advantage. Walking nanomedicine-product from the hands of the inventor to those of the doctor, we explored the technological transfer process, which connects laboratories or research institutions to the marketplace. The process involves detailed analysis to evaluate the potentials of end-products, and researches to identify market segment, size, structure, and competitors, to ponder a possible market entry and the market share that managers can realistically achieve at different time horizons. Attracting funds is crucial but challenging. However, investors are starting to visualize the potentials of this field, magnetized by the business of "nano."

  13. Nanotechnology in Medicine: From Inception to Market Domination

    Science.gov (United States)

    Morigi, Valentina; Tocchio, Alessandro; Bellavite Pellegrini, Carlo; Sakamoto, Jason H.; Arnone, Marco; Tasciotti, Ennio

    2012-01-01

    Born from the marriage of nanotechnology and medicine, nanomedicine is set to bring advantages in the fight against unmet diseases. The field is recognized as a global challenge, and countless worldwide research and business initiatives are in place to obtain a significant market position. However, nanomedicine belongs to those emerging sectors in which business development methods have not been established yet. Open issues include which type of business model best fits these companies and which strategies would lead them to sustained growth. This paper describes the financial and strategic decisions by nanomedicine start-ups to reach the market successfully, obtain a satisfactory market share, and build and maintain a competitive defendable advantage. Walking nanomedicine-product from the hands of the inventor to those of the doctor, we explored the technological transfer process, which connects laboratories or research institutions to the marketplace. The process involves detailed analysis to evaluate the potentials of end-products, and researches to identify market segment, size, structure, and competitors, to ponder a possible market entry and the market share that managers can realistically achieve at different time horizons. Attracting funds is crucial but challenging. However, investors are starting to visualize the potentials of this field, magnetized by the business of “nano.” PMID:22506121

  14. Nanotechnology in Medicine: From Inception to Market Domination

    Directory of Open Access Journals (Sweden)

    Valentina Morigi

    2012-01-01

    Full Text Available Born from the marriage of nanotechnology and medicine, nanomedicine is set to bring advantages in the fight against unmet diseases. The field is recognized as a global challenge, and countless worldwide research and business initiatives are in place to obtain a significant market position. However, nanomedicine belongs to those emerging sectors in which business development methods have not been established yet. Open issues include which type of business model best fits these companies and which strategies would lead them to sustained growth. This paper describes the financial and strategic decisions by nanomedicine start-ups to reach the market successfully, obtain a satisfactory market share, and build and maintain a competitive defendable advantage. Walking nanomedicine-product from the hands of the inventor to those of the doctor, we explored the technological transfer process, which connects laboratories or research institutions to the marketplace. The process involves detailed analysis to evaluate the potentials of end-products, and researches to identify market segment, size, structure, and competitors, to ponder a possible market entry and the market share that managers can realistically achieve at different time horizons. Attracting funds is crucial but challenging. However, investors are starting to visualize the potentials of this field, magnetized by the business of “nano.”

  15. Diferenças de preços entre medicamentos genéricos e de referência no Brasil Price differences between generic and innovator medicines in Brazil

    Directory of Open Access Journals (Sweden)

    Fabiola Sulpino Vieira

    2006-06-01

    Full Text Available OBJETIVO: Verificar a magnitude da diferença de preço entre os medicamentos genéricos e os respectivos medicamentos de referência, além de avaliar o efeito da concorrência entre eles quanto aos seus preços. MÉTODOS: De janeiro de 2000 a junho de 2004, foram acompanhadas 135 apresentações de medicamentos genéricos e seus respectivos medicamentos de referência por um período de até quatro anos. Os preços foram extraídos de publicações específicas voltadas para o comércio farmacêutico, e foram anotados os preços para ambos os medicamentos, desde o lançamento do genérico e durante período de comercialização posterior. RESULTADOS: Os genéricos foram introduzidos, em média, com preços 40% menores do que os medicamentos de referência e esta diferença tendeu a aumentar ao longo do tempo. Comparando a diferença de preço do genérico em relação ao seu medicamento de referência observou-se aumento de 68% nos quatro anos seguintes ao seu lançamento. CONCLUSÕES: A introdução de medicamentos genéricos no mercado farmacêutico brasileiro contribuiu para a oferta de medicamentos a preços menores. Entretanto, a procura dos medicamentos genéricos não provocou redução dos preços da maioria dos medicamentos de referência.OBJECTIVE: To assess the magnitude of price difference between generic and innovator medicines and to evaluate the effect of the price competition between them. METHODS: From January 2000 to June 2004, 135 generic medicines and their respective innovator medicines were followed up for a period of up to four years. Prices were extracted from pharmaceutical market specific publications and recorded from the launching of generics and during their marketing period. RESULTS: The generic medicines were introduced on average at prices 40% lower than the innovator ones and this difference tended to increase over the years. The price difference between generic and innovator medicines increased in the

  16. The attractions of medicine: the generic motivations of medical school applicants in relation to demography, personality and achievement.

    Science.gov (United States)

    McManus, I C; Livingston, G; Katona, Cornelius

    2006-02-21

    The motivational and other factors used by medical students in making their career choices for specific medical specialities have been looked at in a number of studies in the literature. There are however few studies that assess the generic factors which make medicine itself of interest to medical students and to potential medical students. This study describes a novel questionnaire that assesses the interests and attractions of different aspects of medical practice in a varied range of medical scenarios, and relates them to demographic, academic, personality and learning style measures in a large group of individuals considering applying to medical school. A questionnaire study was conducted among those attending Medlink, a two-day conference for individuals considering applying to medical school for a career in medicine. The main outcome measure was the Medical Situations Questionnaire, in which individuals ranked the attraction of three different aspects of medical practise in each of nine detailed, realistic medical scenarios in a wide range of medical specialities. As well as requiring clear choices, the questionnaire was also designed so that all of the possible answers were attractive and positive, thereby helping to eliminate social demand characteristics. Factor analysis of the responses found four generic motivational dimensions, which we labelled Indispensability, Helping People, Respect and Science. Background factors assessed included sex, ethnicity, class, medical parents, GCSE academic achievement, the 'Big Five' personality factors, empathy, learning styles, and a social desirability scale. 2867 individuals, broadly representative of applicants to medical schools, completed the questionnaire. The four generic motivational factors correlated with a range of background factors. These correlations were explored by multiple regression, and by path analysis, using LISREL to assess direct and indirect effects upon the factors. Helping People was

  17. The attractions of medicine: the generic motivations of medical school applicants in relation to demography, personality and achievement

    Directory of Open Access Journals (Sweden)

    Katona Cornelius

    2006-02-01

    Full Text Available Abstract Background The motivational and other factors used by medical students in making their career choices for specific medical specialities have been looked at in a number of studies in the literature. There are however few studies that assess the generic factors which make medicine itself of interest to medical students and to potential medical students. This study describes a novel questionnaire that assesses the interests and attractions of different aspects of medical practice in a varied range of medical scenarios, and relates them to demographic, academic, personality and learning style measures in a large group of individuals considering applying to medical school. Methods A questionnaire study was conducted among those attending Medlink, a two-day conference for individuals considering applying to medical school for a career in medicine. The main outcome measure was the Medical Situations Questionnaire, in which individuals ranked the attraction of three different aspects of medical practise in each of nine detailed, realistic medical scenarios in a wide range of medical specialities. As well as requiring clear choices, the questionnaire was also designed so that all of the possible answers were attractive and positive, thereby helping to eliminate social demand characteristics. Factor analysis of the responses found four generic motivational dimensions, which we labelled Indispensability, Helping People, Respect and Science. Background factors assessed included sex, ethnicity, class, medical parents, GCSE academic achievement, the 'Big Five' personality factors, empathy, learning styles, and a social desirability scale. Results 2867 individuals, broadly representative of applicants to medical schools, completed the questionnaire. The four generic motivational factors correlated with a range of background factors. These correlations were explored by multiple regression, and by path analysis, using LISREL to assess direct and

  18. Seeking to understand: using generic qualitative research to explore access to medicines and pharmacy services among resettled refugees.

    Science.gov (United States)

    Bellamy, Kim; Ostini, Remo; Martini, Nataly; Kairuz, Therese

    2016-06-01

    Introduction There are challenges associated with selecting a qualitative research approach. In a field abundant with terminology and theories, it may be difficult for a pharmacist to know where and how to begin a qualitative research journey. The purpose of this paper is to provide insight into generic qualitative research and to describe the journey of data collection of a novice qualitative researcher in the quest to answer her research question: 'What are the barriers to accessing medicines and pharmacy services for resettled refugees in Queensland, Australia?' Methodology Generic qualitative research draws on the strengths of one or more qualitative approaches. The aim is to draw out participants' ideas about things that are 'outside themselves'; rather than focussing on their inner feelings the research seeks to understand a phenomenon, a process, or the perspectives of participants. Sampling is designed to obtain a broad range of opinions about events and experiences and data collection includes interviews, questionnaires or surveys; thematic analysis is often used to analyse data. When to use Generic qualitative research provides an opportunity to develop research designs that fit researchers' epistemological stance and discipline, with research choices, including methodology and methods, being informed by the research question. Limitations Generic qualitative research is one of many methodologies that may be used to answer a research question and there is a paucity of literature about how to do it well. There is also debate about its validity as a qualitative methodology.

  19. Buddhism, science, and market: The globalisation of Tibetan medicine.

    Science.gov (United States)

    Janes, Craig R

    2002-01-01

    In this paper I discuss the processes by which Tibetan medicine has become globalised, and the ways in which these have come to determine, constrain, and, ultimately, transform local practices of healing in both Tibet and the West. I examine the degree to which globalisation, in particular international market capitalism, operating in this case through the Chinese state, structures the content of primary medical resources, confers legitimacy to certain technologies, and sets the ground rules by which the healers in charge of deploying such technologies are set into conversation with one another. I also argue that the cultural dimensions of globalisation enter the local context through the multiple-stranded flows of people, images, and ideas, and contribute to redefinitions of identity, suffering, and body praxis among patients/consumers in diverse local contexts. I proceed within two registers of analysis. In the first, I analyse these movements in the context of Tibetan medicine as it has been transformed, practised, and used, in the Tibet Autonomous Region of China. In the second, the analytic lens shifts to a focus on Tibetan medicine as a 'global' alternative medicine in North America and Europe. The focus throughout is on the global-local dialectic: how Tibetan medicine is both produced as global commodity and consumed as 'local' tradition.

  20. 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

    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...... Odense PharmacoEpidemiologic Database (OPED). The purpose of the questionnaire survey was to elucidate patients' experience with medicine, combined with information from OPED on a single well-defined generic switch of the index drug. The questionnaire was adapted to the individual subject with reference...

  1. 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

    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...... Odense PharmacoEpidemiologic Database (OPED). The purpose of the questionnaire survey was to elucidate patients’ experience with medicine, combined with information from OPED on a single well-defined generic switch of the index drug. The questionnaire was adapted to the individual subject with reference...

  2. [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.

  3. [Technical specifications for post-marketing pharmacoeconomic evaluation of Chinese medicine (draft version for comments)].

    Science.gov (United States)

    Xie, Yan-Ming; Wang, Xin; Wang, Nuo; Chang, Yan-Peng

    2013-09-01

    Pharmacoeconomics is an important part of the post-marketing evaluation of Chinese medicine, post-marketing pharmacoeconomic evaluation can better reflect the clinical and market value of Chinese medicine, the purpose of establishing the technical specifications for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines more scientific and fair. Every country's technical specifications for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the technical specifications which take into account the special characteristics of Chinese medicine; these are in preparation for post-marketing pharmacoeconomic evaluation Chinese medicine.

  4. Medicinal plants, traditional medicine, markets and management in far-west Nepal.

    Science.gov (United States)

    Kunwar, Ripu M; Mahat, Laxmi; Acharya, Ram P; Bussmann, Rainer W

    2013-04-12

    Modern therapeutic medicine is historically based on indigenous therapies and ethnopharmacological uses, which have become recognized tools in the search for new sources of pharmaceuticals. Globalization of herbal medicine along with uncontrolled exploitative practices and lack of concerted conservation efforts, have pushed many of Nepal's medicinal plants to the verge of extinction. Sustainable utilization and management of medicinal plants, based on traditional knowledge, is therefore necessary. After establishing verbal informed consent with participating communities, five field surveys, roughly 20 days in duration, were carried out. In all, 176 schedules were surveyed, and 52 participants were consulted through focus group discussions and informal meetings. Altogether, 24 key informants were surveyed to verify and validate the data. A total of 252 individuals, representing non-timber forest product (NTFP) collectors, cultivators, traders, traditional healers (Baidhya), community members, etc. participated in study. Medicinal plants were free-listed and their vernacular names and folk uses were collected, recorded, and applied to assess agreement among respondents about traditional medicines, markets and management. Within the study area, medicinal herbs were the main ingredients of traditional therapies, and they were considered a main lifeline and frequently were the first choice. About 55% plants were ethnomedicinal, and about 37% of ethnomedicinal plants possessed the highest informant consensus value (0.86-1.00). Use of Cordyceps sinensis as an aphrodisiac, Berberis asiatica for eye problems, Bergenia ciliata for disintegration of calculi, Sapindus mukorossi for dandruff, and Zanthoxylum armatum for toothache were the most frequently mentioned. These species possess potential for pharmacology. Medicinal plants are inseparable from local livelihoods because they have long been collected, consumed, and managed through local customs and knowledge. Management

  5. The market of biopharmaceutical medicines: A snapshot of a diverse industrial landscape

    NARCIS (Netherlands)

    Moorkens, E. (Evelien); Meuwissen, N. (Nicolas); Huys, I. (Isabelle); P.J. Declerck (Paul); A.G. Vulto (Arnold); S. Simoens (Steven)

    2017-01-01

    textabstractBackground: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market. Objectives: This study aims to identify

  6. Procedures and Applications for Marketing Authorisation of Medicinal Products in European Union

    National Research Council Canada - National Science Library

    N Jawahar; Nishit Shrivastava; A Ramachandran; Baviya R Priyadharshini

    2015-01-01

    .... Keywords: EMA, European Union, Marketing procedure, CP, DCP, MRP, Marketing applications. INTRODUCTION: Every country has its basic legislation concerning medicinal product for human use. The marketing authorisation of the product is granted by the competent health authority. The marketing authorisation of the respective drug is granted and renewed o...

  7. [Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

  8. Medicamentos genéricos: uma alternativa para o mercado brasileiro Generic drugs: an alternative for the Brazilian market

    Directory of Open Access Journals (Sweden)

    Jorge Bermudez

    1994-09-01

    Full Text Available A análise das características da indústria farmacêutica no mundo e os aspectos mercadológicos desse segmento no Brasil deixam evidentes a dependência externa e a oligopolização, com predomínio de empresas de caráter mutinacional, refletindo uma tendência mundial. As iniciativas governamentais recentes no Brasil, com o objetivo de diminuir essa dependência, aliadas à gravidade da questão dos preços e custos de medicamentos no Brasil, comparados a preços mundiais, fundamentam a proposta de avaliar os medicamentos genéricos como uma alternativa viável para o mercado brasileiro. Um dos aspectos mais alarmantes é a verificação do superfaturamento de matérias-primas evidenciada pelos denominados "preços de transferência", prática constatada em diversos países. Analisando os conceitos internacionais sobre medicamentos genéricos, denominação genérica e equivalência farmacêutica, com base ainda em recomendações da Organização Mundial da Saúde e avaliando as experiências de diversos países, são propostas uma série de medidas destinadas a implementar, gradativamente, uma política de medicamentos genéricos bioequivalentes e intercambiáveis como um dos mecanismos de regulação do mercado brasileiro.The analysis of the main characteristics of the pharmaceutical industry worldwide and market aspects of that industry in Brazil leads us to consider a high share of external dependency and oligopolization. This situation is not peculiar to our country, but is rather a global trend. Recent Government initiatives in Brazil, aiming at reducing that dependency, associated with the critical aspects regarding the prices and costs of drugs as compared to international prices, are the background that support the proposal of evaluating generic drugs as an alternative for Brazilian market. One of the most striking aspect is the verification of overpricing of raw materials as demonstrated by "transfer prices", a practice that has

  9. 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

    2017-01-01

    Objectives 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. Setting This research was carried out in a non-clinical research setting using secondary data. Participants 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. Primary and secondary outcome measures 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. Results 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. Conclusions 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. PMID:28110283

  10. Right to health encompasses right to access essential generic medicines: challenging the 2008 Anti-Counterfeit Act in Kenya.

    Science.gov (United States)

    Maleche, Allan; Day, Emma

    2014-12-11

    To what extent has the right to access generic HIV medication been implemented in Kenya for the 1.6 million people living with HIV? How does this relate to the right to health under international and national law? This paper examines a constitutional challenge brought to the High Court of Kenya in 2009 (the "Anti-Counterfeit Case") against the Anti-Counterfeit Act of 2008, which the petitioners, all of whom were living with HIV, argued would affect their ability to access affordable and generic antiretroviral medication. They argued that this would amount to a violation of their right to life, dignity, and health. This case is particularly interesting because the new Kenyan Constitution came into force in 2010, after the case had been filed, and specifically provided for the right to health for all of Kenya's citizens, as well as giving direct effect to all international laws ratified by the Kenyan government. This paper follows the Anti-Counterfeit Case, which includes amendments filed by the petitioners following the new constitutional changes, the arguments by the different parties in the case, and the inappropriateness of counterfeit laws as measures to control substandard and falsified medicine. The case has resulted in the suspension of significant parts of the Anti-Counterfeit Act that would pose a challenge to parallel importation, and to the court issuing a directive that the sections be amended. The judgment is examined in detail, as are the broader implications of this case for other countries in Eastern Africa.

  11. Translational research: precision medicine, personalized medicine, targeted therapies: marketing or science?

    Science.gov (United States)

    Marquet, Pierre; Longeray, Pierre-Henry; Barlesi, Fabrice; Ameye, Véronique; Augé, Pascale; Cazeneuve, Béatrice; Chatelut, Etienne; Diaz, Isabelle; Diviné, Marine; Froguel, Philippe; Goni, Sylvia; Gueyffier, François; Hoog-Labouret, Natalie; Mourah, Samia; Morin-Surroca, Michèle; Perche, Olivier; Perin-Dureau, Florent; Pigeon, Martine; Tisseau, Anne; Verstuyft, Céline

    2015-01-01

    Personalized medicine is based on: 1) improved clinical or non-clinical methods (including biomarkers) for a more discriminating and precise diagnosis of diseases; 2) targeted therapies of the choice or the best drug for each patient among those available; 3) dose adjustment methods to optimize the benefit-risk ratio of the drugs chosen; 4) biomarkers of efficacy, toxicity, treatment discontinuation, relapse, etc. Unfortunately, it is still too often a theoretical concept because of the lack of convenient diagnostic methods or treatments, particularly of drugs corresponding to each subtype of pathology, hence to each patient. Stratified medicine is a component of personalized medicine employing biomarkers and companion diagnostics to target the patients likely to present the best benefit-risk balance for a given active compound. The concept of targeted therapy, mostly used in cancer treatment, relies on the existence of a defined molecular target, involved or not in the pathological process, and/or on the existence of a biomarker able to identify the target population, which should logically be small as compared to the population presenting the disease considered. Targeted therapies and biomarkers represent important stakes for the pharmaceutical industry, in terms of market access, of return on investment and of image among the prescribers. At the same time, they probably represent only the first generation of products resulting from the combination of clinical, pathophysiological and molecular research, i.e. of translational research.

  12. Generic features of the wealth distribution in ideal-gas-like markets.

    Science.gov (United States)

    Mohanty, P K

    2006-07-01

    We provide an exact solution to the ideal-gas-like models studied in econophysics to understand the microscopic origin of Pareto law. In these classes of models the key ingredient necessary for having a self-organized scale-free steady-state distribution is the trading or collision rule where agents or particles save a definite fraction of their wealth or energy and invest the rest for trading. Using a Gibbs ensemble approach we could obtain the exact distribution of wealth in this model. Moreover we show that in this model (a) good savers are always rich and (b) every agent poor or rich invests the same amount for trading. Nonlinear trading rules could alter the generic scenario observed here.

  13. Matching of Developed Generic Competences of Graduates in Higher Education with Labour Market Needs

    Science.gov (United States)

    Pukelis, Kestutis; Pileicikiene, Nora

    2012-01-01

    Higher education provides graduates with both monetary and non-monetary benefits. Globalization and technological developments foster utilitarian approach, therefore the transmission of competences that are relevant in labour market is an important target for higher education institutions. The paper presents findings of research on the match of…

  14. From Service Markets to Service Economies - An infrastructure for protocol-generic SLA negotiations

    Science.gov (United States)

    Hudert, Sebastian

    Visions of 21st century's information systems show highly specialized digital services and resources, interacting continuously and with a global reach. For a broad adoption of this vision in a commercial context it is crucial to have a mechanism in place to guarantee quality of service and to decentrally coordinate the involved resources. Current service infrastructures try to tackle these problems by applying socioeconomic mechanisms such as electronic negotiations and service level agreements. Such technologies allow for the implementation of electronic service markets in analogy to real-world markets for everyday goods. However, economic theory claims that different market situations and negotiated products (i.e. SLAs) demand different negotiation protocols in order to reach the highest-possible overall efficiency of the system. Thus we argue that next generation service infrastructures will be based on a global service economy where several different service markets and thus protocols are present at any given point in time. In this paper we present a novel approach for such an infrastructure, based on structured protocol descriptions and software-agent technology.

  15. 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.

  16. [Effect of the brand and generic medicine of pravastatin on dyslipidemia in rabbits fed a high cholesterol diet].

    Science.gov (United States)

    Kano, Seiichiro; Taguchi, Mutsumi; Hayase, Nobumasa; Kaneta, Shigeru; Takaguri, Akira; Ichihara, Kazuo; Satoh, Kumi

    2009-01-01

    Mevalotin containing pravastatin, a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, is the brand medicine and well known to be effective for patients with dyslipidemia. Now, more than 20 generic pravastatins are available for clinical therapy. We compared pharmaceutical property of Mevan,a generic pravastatin, with that of Mevalotin.According to the definition of the Japanese Pharmacopoeia, Mevalotin 10 mg tablets were uniform in pravastatin content, whereas 5 mg tablets were rather variable. Variation in pravastatin content of Mevan 5 mg tablets was the same as Mevalotin 5 mg, whereas that of 10 mg tablets was very variable. The plasma concentration of pravastatin in the normal rabbits continuously increased until 180 min after oral administration of 30 mg Mevan, whereas it increased in a biphasic pattern after 30 mg Mevalotin.All rabbits were fed 0.2% cholesterol diet throughout the experiment. After 8 weeks, oral administration of either Mevalotin or Mevan was started at the dose of 30 mg pravastatin/day for 16 weeks. After a transient increase for a few weeks, the plasma levels of total- and LDL-cholesterol gradually decreased in Mevalotingroup, whereas these levels did not significantly changed in Mevan group within 16 weeks. The level of HDL-cholesterol in Mevan group tended to increase but not in Mevalotin group. The triglyceride level in Mevan group changed as well as that in Mevalotin group until 10 weeks after administration, and then gradually increased. The present results suggest that pharmaceutical properties of Mevan are not always identical with those of Mevalotin.

  17. [Generic drugs: quality, efficacy, safety and interchangeability].

    Science.gov (United States)

    Tschabitscher, Doris; Platzer, Peter; Baumgärtel, Christoph; Müllner, Marcus

    2008-01-01

    Since the introduction of generic drugs to the pharmaceutical market a sometimes emotional debate exists whether they are well-investigated and of high quality. There is some uncertainty about whether evidence of bioequivalence is enough to guarantee efficacy and safety of generic drugs. Some physicians ask the question if competent authorities are able to ascertain that the pharmaceutical quality of generics is acceptable. Doctors and patients sometimes are ill at ease about the interchangeability of innovator and generic products. This article describes how the European Union legislation ensures that a generic drug is only approved if its risk-benefit relationship is favourable and that it is essentially similar to the innovator product. In this context pharmacokinetic parameters are accepted as surrogates for clinical results because bioequivalence means therapeutic equivalence as well. For most drugs, current bioequivalence testing generally enables clinicians to routinely substitute generic for innovator products. Published findings, however, suggest that particular drugs may not be ideally suited for generic substitution when a patient is already on that drug. These are the so called critical dose medicinal products (drugs with a narrow therapeutic range). When starting a new therapy with any generic drug, however, its similarity to the innovator drug in terms of efficacy, safety and quality is guaranteed.

  18. A price and use comparison of generic versus originator cardiovascular medicines: a hospital study in Chongqing, China

    OpenAIRE

    Zeng, Wenjie

    2013-01-01

    Background Developed countries use generic competition to contain pharmaceutical expenditure. China, as a developing and transitional country, has not yet deemed an increase in the use of generic products as important; otherwise, much effort has been made to decrease the drug prices. This paper aims to explore dynamically the price and use comparison of generic and originator drugs in China, and estimate the potential savings of patients from switching originator drugs to generics. Methods A ...

  19. Use of the conditional marketing authorization pathway for oncology medicines in Europe.

    Science.gov (United States)

    Hoekman, J; Boon, W P C; Bouvy, J C; Ebbers, H C; de Jong, J P; De Bruin, M L

    2015-11-01

    Conditional marketing authorization (CMA) in the European Union (EU) is an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. Using a mixed quantitative-qualitative research design, we evaluated how CMA has been used in marketing authorization of oncology medicines in the period 2006 to 2013. We show that compared to full marketing authorization, CMA is granted based on less comprehensive data. However, this is accompanied by significantly longer assessment times and less consensus among regulators about marketing authorization. Moreover, development time from first-in-human testing to marketing authorization did not differ between full marketing authorization and CMA, but was significantly longer for CMA compared to accelerated approved products in the United States (US). Results indicate that CMA is not used by companies as a prospectively planned pathway to obtain early access, but as a "rescue option" when submitted data are not strong enough to justify full marketing authorization.

  20. Marketing and medicine. A basic guide for PAs.

    Science.gov (United States)

    Blessing, J D; Davis, N L

    1988-07-01

    Marketing is a conscious plan to influence the behavior of others. Physician assistants can use marketing techniques to promote themselves and their profession as well as to help build a practice and improve patient services. Basic components of a marketing strategy include analysis, planning, implementation, and monitoring. Marketing tools easily accessible to PAs are the telephone (call to check on compliance); a photocopy machine (patient handouts and practice newsletters); and the mail (postcard to remind of follow-up visit).

  1. Reptiles sold as traditional medicine in Xipamanine and Xiquelene Markets (Maputo, Mozambique

    Directory of Open Access Journals (Sweden)

    Vivienne L. Williams

    2016-07-01

    Full Text Available Zootherapy plays a role in healing practices in Mozambican society. Although several studies have focused on ethnobotany and traditional medicine in the country, little research has been conducted on the use of reptiles in zootherapy. The aim of this study was therefore to fill this gap by assessing the reptile species traded for traditional medicine in the Xipamanine and Xiquelene Markets in Maputo, Mozambique. We found that few reptile species are traded domestically for traditional medicine and that their use appears to be in decline in Mozambique. Our findings also suggest that the domestic trade of reptiles for traditional medicines in Maputo markets is unlikely to have a significant impact on the conservation of reptiles in Mozambique. However, we suggest that international trade with South Africa is likely having a larger impact, given observations of Mozambican nationals selling a diverse range of fauna in urban traditional medicine markets in Johannesburg and Durban.

  2. Knowledge and attitudes of physicians and pharmacists towards the use of generic medicines in Bosnia and Herzegovina.

    Science.gov (United States)

    Čatić, Tarik; Avdagić, Lejla; Martinović, Igor

    2017-02-01

    Aim To investigate and assess knowledge and attitudes of pharmacists and physicians towards generic drugs prescription in order to evaluate current trends, obstacles to prescribe/dispense generics and suggest possible improvements of rational and economic prescribing having in mind scarce public budgets for drugs. Methods A cross-sectional survey among 450 primary care physicians (prescribers) and pharmacists in four major cities in Bosnia and Herzegovina (Sarajevo, Banja Luka, Tuzla and Mostar) during the period between January and March 2016 was conducted. The survey (questionnaire) was developed and physicians' and pharmacists' perception was examined using the 5-point Likert scale. Descriptive statistics was used to examine respondents' characteristics and their responses to survey questions. The respondents perception based on different characteristics was assessed using ordinal logistic regression. Results Generally, positive attitudes towards generic drugs were found. Majority of respondents, 392 (87.0%) considered generic drugs the same as originators and they could be mutually substituted. Physicians were more likely to prescribe branded drugs, 297 (66.6%), even 391 (86.8%) were aware of generic alternatives. Respondents believed that patients considered generic drugs less effective, 204 (45.4%), and 221 (49.0%) disapproved generic substitution. Conclusion Our findings suggest that further education and more information about benefits of generic drugs should be provided to key stakeholders including patients. Also, clearer generic drugs policies should be introduced in order to improve generic prescribing and potentially improve access and optimize pharmaceutical public expenditures.

  3. [Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

    Science.gov (United States)

    Liu, Huan; Xie, Yanming

    2011-10-01

    The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

  4. Marketing authorisation of new medicines in the EU: towards evidence-based improvement

    NARCIS (Netherlands)

    Putzeist, M.

    2013-01-01

    The relevance of continuous development of new medicines is publicly recognized, but the development of new medicines requires increasing efforts and costs. Despite regulatory initiatives to enhance marketing authorisation such as the orphan regulation and the scientific advice procedure, current no

  5. Intervening in global markets to improve access to HIV/AIDS treatment: an analysis of international policies and the dynamics of global antiretroviral medicines markets

    National Research Council Canada - National Science Library

    Waning, Brenda; Kyle, Margaret; Diedrichsen, Ellen; Soucy, Lyne; Hochstadt, Jenny; Bärnighausen, Till; Moon, Suerie

    2010-01-01

    ...) medicines, limited financing, and few fixed-dose combination (FDC) products. Global initiatives aim to promote efficient global ARV markets, yet little is known about market dynamics and the impact of global policy interventions...

  6. [Study on status of criteria for formulating specification and grade of Chinese medicinal materials based on filed survey in medicine market].

    Science.gov (United States)

    Yang, Guang; Wang, Nuo; Zhan, Zhi-Lai; Wang, Hai-Yang; Jin, Yan

    2016-03-01

    The commodity specification and grade is an important factor affecting the price of Chinese medicinal materials. Specification and grade standard play an important role in transferring quality information in Chinese medicinal market, which is characterized by highly information asymmetry. This paper analyses and expounds six classification methods of commodity specification and grade of Chinese medicinal materials based on the market investigation carried out in the medicine markets in Anguo, Bozhou, Yulin, Chengdu and so on. This study proposes that to formulate the commodity specification and grade standard of Chinese medicinal materials, their efficacy, inspection, purity and beauty should be taken into account orderly. Copyright© by the Chinese Pharmaceutical Association.

  7. Targeting the American Market for Medicines, ca. 1950s–1970s:

    Science.gov (United States)

    Quirke, Viviane

    2014-01-01

    summary The forces that have shaped American medicine include a wide set of interrelated changes, among them the changing research, development, and marketing practices of the pharmaceutical industry. This article compares the research and development (R&D) and marketing strategies of the British group Imperial Chemical Industries (ICI, whose Pharmaceutical Division was spun off and merged with the Swedish company Astra to form AstraZeneca) and its French counterpart Rhône-Poulenc (now part of Sanofi-Aventis) in dealing with the American medical market. It examines how, in the process, the relationship between R&D and marketing was altered, and the firms themselves were transformed. The article also questions the extent to which their approaches to this market, one of the most significant markets for drugs in general, and for anticancer drugs in particular, became standardized in the period of “scientific marketing.” PMID:25557515

  8. Reflections on market access for personalized medicine: recommendations for Europe.

    Science.gov (United States)

    Payne, Katherine; Annemans, Lieven

    2013-01-01

    This article aims to provide an overview of the current literature focusing on the reimbursement of personalized medicine across the European Union. The article starts by describing types of perspectives that are possible (general public, patient, payer, provider, service commissioner, and policymaker). The description of perspectives also explains the importance of understanding the different possible decision criteria and processes from the various perspectives by taking into account budget constraints. The article then focuses on an example of personalized medicine, namely, the use of companion diagnostic-medicine combinations, to describe the role of reimbursement/payer agencies across the European Union to control the introduction and coverage of such companion diagnostic-medicine technologies. The article touches on the strategic challenges and the use of economic evidence to introduce personalized medicine from a health policy perspective. The article also draws on empirical studies that have explored patients' and clinicians' views of examples of personalized medicine to illustrate the challenges for developing patient-centered and timely health care services.

  9. Analysis of Marketing Strategy for Food Supplements and Over-The-Counter Medicines.

    Science.gov (United States)

    Dzeparoski, Marjan; Trajkovic-Jolevska, Suzana

    2016-09-15

    Marketing strategy is correlated with the regulations for the corresponding product category. Accordingly, there is a big difference in the marketing strategy of food supplements and over-the-counter medicines. In this paper are presented 2 different marketing strategies of a new small pharmaceutical company in two studies. The findings of studies analysis can be used for developing marketing strategies in the wider sense and other products, for other small to medium sized companies in other countries of interest with similar regulations and help them understand how to position and promote themselves and their products.

  10. Analysis of Marketing Strategy for Food Supplements and Over-The-Counter Medicines

    Directory of Open Access Journals (Sweden)

    Marjan Dzeparoski

    2016-07-01

    Full Text Available Marketing strategy is correlated with the regulations for the corresponding product category. Accordingly, there is a big difference in the marketing strategy of food supplements and over-the-counter medicines. In this paper are presented 2 different marketing strategies of a new small pharmaceutical company in two studies. The findings of studies analysis can be used for developing marketing strategies in the wider sense and other products, for other small to medium sized companies in other countries of interest with similar regulations and help them understand how to position and promote themselves and their products.

  11. Structure, control and regulation of the formal market for medicinal plants' products in Nigeria.

    Science.gov (United States)

    Oguntade, Adegboyega E; Oluwalana, Isaac B

    2011-01-01

    There are informal and formal markets for medicinal plants' products in Nigeria. The formal market is subject to the national regulatory framework for Food and Drug Administration and Control. It is relatively new and underdeveloped. This study was designed to appraise this market with special emphasis on the market participants, market structure, marketing functions performed, conduct of sellers in the market and; standards and regulations to which the market is subject. Information used for this study was collected through personal interviews and interactions with key participants in the market; especially the officials of regulatory agency. The market structure was analysed in terms of the share of market controlled by participants and product types. Concentration Ratios (CR2 and CR4) were used to assess the market share. Marketing functions being performed were described in terms of the exchange, physical and facilitating functions while the conduct was described in terms of pricing and promotional strategies. The regulatory framework under which the market operates was appraised. The market was highly concentrated with a CR2 and CR4 of 58.5% and 80.8 %; respectively. Imported products accounted for only 12.3% of the market. The predominant modes of presentation of the product were capsule (41.6%) and liquid (36.2%). About 20.77% of the products were classified as multivitamins, 13.85% were antibiotics while 10.77% addressed sexual dysfunctional problems. These products were regulated under the Food and Drug Administration and Control (NAFDAC) decrees, 1993-1999. Only 2.3% of the products have received full registration status while the others were only listed.

  12. Generic drugs: Review and experiences from South India.

    Science.gov (United States)

    Mathew, Philip

    2015-01-01

    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.

  13. Post-Marketing Regulation of Medicines Withdrawn from the Market Because of Drug-Attributed Deaths: An Analysis of Justification.

    Science.gov (United States)

    Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

    2017-05-01

    Several medicinal products have been withdrawn from the market because of drug-attributed deaths. However, there has been no investigation of whether such withdrawals were justified, and the extent to which confirmatory studies are used to investigate drug-adverse event relationships when deaths are reported is uncertain. We documented medicinal products withdrawn from the market because of drug-attributed deaths, identified confirmatory studies investigating the drug-adverse event relationships, examined whether withdrawals of medicinal products because of drug-attributed deaths after marketing were justified based on a mechanistic analysis, and examined the trends over time. We searched electronic and non-electronic sources to identify medicinal products that were withdrawn because of drug-attributed deaths. We used a previously published algorithm to examine whether the withdrawals of products were justified. We then searched PubMed and Google Scholar to identify studies investigating the drug-adverse event relationships, used the Oxford Centre for Evidence-Based Medicine criteria to document the levels of evidence, and assessed whether the evidence of an association was confirmed. We included 83 medicinal products. The reasons for withdrawal appeared to have been justified in 80 cases (96%). The median interval between the first reported adverse reaction that was related to the cause of death and the first reported death was 1 year (interquartile range = 1-3); products were withdrawn sooner when the interval between the first reported relevant adverse reaction and the first death was shorter. Confirmatory studies were conducted in 57 instances (69%), and there was evidence of an association in 52 cases (63%). Four products (5%) were re-introduced after initial withdrawal. Regulatory authorities have been justified in making withdrawal decisions when deaths have been attributed to medicinal products, using the precautionary principle when alternative decisions

  14. Managed care or managed inequality? A call for critiques of market-based medicine.

    Science.gov (United States)

    Rylko-Bauer, Barbara; Farmer, Paul

    2002-12-01

    This review article critiques the growing dominance of market-based medicine in the United States against the background of existing problems with quality of care, rising costs, devaluation of doctor-patient relationships, and, especially, persistent inequalities of access and outcomes. It summarizes the present state of health care delivery by focusing on the concurrent trends of growth in managed care, expanding profits, increasing proportion of those uninsured, and widening racial, ethnic, and class disparities in access to care. Allowing market forces to dictate the shape of health care delivery in this country ensures that inequalities will continue to grow and modern medicine will become increasingly adept at managing inequality rather than managing (providing) care. The article challenges anthropology to become more involved in critiquing these developments and suggests how anthropologists can expand on and contextualize debates surrounding the market's role in medicine, here and abroad.

  15. Quantifying the domestic market in herbal medicine in Benin, West Africa.

    Science.gov (United States)

    Quiroz, Diana; Towns, Alexandra; Legba, Sènan Ingrid; Swier, Jorik; Brière, Solène; Sosef, Marc; van Andel, Tinde

    2014-02-12

    Herbal medicine markets are essential in understanding the importance of medicinal plants amongst a country's inhabitants. They are also instrumental in identifying plant species with resource management priorities. To document the diversity of the medicinal plant market in Benin (West Africa), to quantify the weight of traded species in order to evaluate their economic value, and to make a first assessment of their vulnerability for commercial extraction. We quantitatively surveyed 22 market stalls of 16 markets in the country's eight largest urban areas. We collected all plant (parts) following standard botanical methods and recorded uses, prices and local names, and weighed and counted the numbers of sales units. We recorded 307 medicinal products corresponding to ca. 283 species. Thirty-five species were encountered in at least 25% of the surveyed stalls, from which ten are locally endangered or red-listed by the IUCN. Examples of vulnerable species included Caesalpinia bonduc, which has been declared extinct in the wild but is largely cultivated in home gardens, and was exploited for its seeds, roots, and leaves, and Zanthoxylum zanthoxyloides which was harvested for its bark, roots, and leaves. Other top-selling fruits and seeds included red-listed species: Monodora myristica, Xylopia aethiopica, and Schrebera arborea. Top-selling woody plant parts included the roots of Sarcocephalus latifolius, Mondia whitei, and the barks of Khaya senegalensis and Pteleopsis suberosa. All but Sarcocephalus latifolius and Pteleopsis subersosa were species with some threat status. Plants sold at the market were mainly used for ritual purposes, women's health, and to treat malaria and its symptoms. Our results suggest that the domestic medicinal plant market in Benin is of substantial economic importance. A volume of approximately 655 metric tons worth 2.7 million USD is offered for sale annually. Traditional spiritual beliefs seem to be a major driving force behind the trade

  16. Strategic development on generic anti-cancer drugs Bevacizumab and Erlotinib Hydrochloride for Harbin Pharmaceutical Group

    Institute of Scientific and Technical Information of China (English)

    Cheung Fat Ping

    2011-01-01

    @@ With improved economy, changing life styles, aging population and health care reform, China had a very potential anti-cancer drug market.The patents of popular anti-cancer drugs Avastin and Tarceva would expire in few years.Generic versions of Avastin and Tarceva were Bevacizumab and Erlotinib Hydrochloride respectively.Harbin Pharmaceutical Group was proposed to develop strategically both generic medicines to enter the high-end anti-cancer drug market for targeted cancer therapies.The vital to success of developing the generic drugs were discussed.

  17. [Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

    2014-09-01

    Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

  18. [Exploration of how to formulate guidelines on post-marketing traditional Chinese medicine surveillance].

    Science.gov (United States)

    Zhang, Wen; Xie, Yan-Ming; Yu, Wen-Ya

    2013-09-01

    Combining the world health organization's (WHO), the United States and the European union's relevant laws and guidelines on post-marketing drug surveillance to judge the status of post-marketing surveillance of traditional Chinese medicine(TCM) in China. We found that due to the late start of post-marketing surveillance of traditional Chinese medicine, the appropriate guidelines are yet to be developed. Hence, hospitals, enterprises and research institutions do not have a shared foundation from which to compare their research results. Therefore there is an urgent need to formulate such post-marketing surveillance guidelines. This paper has used as guidance various technical documents such as, "procedures to formulate national standards" and "testing methods of management in formulating traditional Chinese medicine standards" and has combined these to produce a version of post-marketing surveillance particular to Chinese medicine in China. How to formulate these guidelines is discussed and procedures and methods to formulate technical specifications are introduced. These provide a reference for future technical specifications and will assist in the development of TCM.

  19. Non-timber forest products marketing systems and market players in southwest Virginia: crafts, medicinal and herbal, and specialty wood products

    Science.gov (United States)

    S.M. Greene; A.L. Hammett; S. Kant

    2000-01-01

    Non-timber forest products (NTFPs) are important in rural southwest Virginia as a source of household income. Marketing system of crafts, medicinal and herbal, and specialty wood products are studied using exploratory and qualitative research methods. Fifty market players at various levels in marketing chains are interviewed to get the information on elements of...

  20. Marketing Strategies Used to Promote Children's Medicine Sold on Internet Sites of Pharmaceutical Stores.

    Science.gov (United States)

    Basch, Corey H; Roberts, Katherine J; Zagnit, Emily A; Martinez, Amairany

    2016-12-01

    Retail sales of over the counter (OTC) medications have risen steadily over the years; however, these products are not without potential risk. The aim of this study was to describe the marketing strategies used to promote OTC medicines to children and their parents. Data were collected from 187 product packaging of fever reducer, allergy, and cough medicines posted on the Internet sites of three of the largest pharmacies in the United States. Specific marketing information was collected related to flavorings and pictures appearing on the packaging. There was no significant difference between the type of medicine and whether they were flavored or not, as almost every product (95.7 %) indicated that it resembles a food flavoring. On almost all the packaging (92.5 %) the flavor was also indicated by words in different font sizes. Most of the products (83.4 %) showed a picture of a food product on their packaging. There was a significant difference between the medicine types by picture, with fever medicines having more pictures of food than either cough or allergy medicine. Stronger regulations of marketing strategies of these products are needed.

  1. Ethnobotanical investigation of traditional medicinal plants commercialized in the markets of Mashhad, Iran

    Directory of Open Access Journals (Sweden)

    Mohammad Sadegh Amiri

    2013-05-01

    Full Text Available Objective: An ethnobotanical survey on the medicinal plant species marketed in Mashhad city, northeastern Iran, was conducted in order to document traditional medicinal knowledge and application of medicinal plants. Materials and Methods: This study was undertaken between 2011 and 2012. The indigenous knowledge of traditional healers used for medicinal purposes were collected through questionnaire and personal interviews during field trips. Ethnobotanical data was arranged alphabetically by family name followed by botanical name, vernacular name, part used, folk use, and recipe. Correct identification was made with the help of the various Floras and different herbal literature at the Ferdowsi University of Mashhad Herbarium (FUMH. Results: The present investigation reported medicinal information for about 269 species, belonging to 87 vascular plant families and one fungus family. The most important family was Lamiaceae with 26 species, followed by Asteraceae with 23, Fabaceae with 20, and Apiaceae with 19. Herbal medicine uses reported by herbalists was classified into 132 different uses which show significant results to treat a wide spectrum of human ailments. Plants sold at the market were mostly used for digestive system disorders, respiratory problems, urological troubles, nervous system disorders, skin problems, and gynecological ailments. Conclusion: This survey showed that although people in study area have access to modern medical facilities,  a lot of them still continue to depend on medicinal plants for the treatment of healthcare problems. The present paper represents significant ethnobotanical information on medical plants which provides baseline data for future pharmacological and phytochemical studies.

  2. [Several common types of counterfeit and inferior drugs in Chinese medicinal materials market].

    Science.gov (United States)

    Liu, Yimei; Chen, Keli

    2012-04-01

    Though there are many species of counterfeit and inferior drugs of Chinese Medicinal Materials in the market, the means of fabrication is common. According to our investigating and reports in the literature it is found that the counterfeits and inferior drugs exist in 4 styles: counterfeits, reused medicinal materials and their slices which have been extracted by boiling water or ethanol, medicinal materials and their slices which have been added with non-medicinal parts or chemicals, medicinal materials which have no enough growth time or have been reserved for a long time. Through summarizing the styles and their common characteristics of the counterfeits and inferior drugs,it is helpful to raise vigilance and detect them.

  3. Use of the conditional marketing authorization pathway for oncology medicines in Europe

    DEFF Research Database (Denmark)

    Hoekman, J; Boon, W P C; Bouvy, J C

    2015-01-01

    Conditional marketing authorization (CMA) in the European Union (EU) is an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. Using a mixed quantitative-qualitative research design, we evaluated how CMA has been used in ...

  4. Use of the conditional marketing authorization pathway for oncology medicines in Europe

    NARCIS (Netherlands)

    Hoekman, J; Boon, Wouter; Bouvy, J C; Ebbers, H C; de Jong, J P; De Bruin, M L

    2015-01-01

    Conditional marketing authorization (CMA) in the European Union (EU) is an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. Using a mixed quantitative-qualitative research design, we evaluated how CMA has been used in mar

  5. [Macroscopic analysis on production and marketing of medicinal material resources for sustainable development].

    Science.gov (United States)

    Xiao, Peigen; Zhao, Runhuai; Long, Xingehao; Guo, Baolin

    2009-09-01

    In this paper, the production and marketing of medicinal materials of plant origin are sorted and analyzed. The total annual yield and total output value are presented. The resources sustainable development is discussed by three aspects, i.e., the yield Top 60 items, rare and endangered species and several wild drugs should be deeply concerned. Relevant measures and implementation are recommended respectively.

  6. [GENERIC DRUGS: IS BIOEQUIVALENCE SUFFICIENT TO ENSURE QUALITY, EFFICACY AND SAFETY?].

    Science.gov (United States)

    Carrillo Norte, Juan Antonio; Postigo Mota, Salvador

    2015-05-01

    This article is focusing on the current debate that prescription of generic drugs is producing among patients and healthcare professionals. Following European Medicine Agency (EMA) recommendations, a number of generic medicines have recently been withdrawn from the market in Spain. The authorization for these generic drugs was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India. The EMA inspection of GVK revealed data manipulation of electrocardiograms during the development of some studies of generic medicines. These manipulations had taken place over a period of at least five years. The article is also dealing with the consideration that bioavailability and bioequivalence studies receive as a cornerstone to approve generic drugs, and the discrepancies between the national regulatory agencies of medicines to implement guidelines of approval. Likewise, in the last few years, the rapid expansion of clinical trial activity regarding generic medicines and other drugs in emerging markets, is often leading to doubt on the integrity of the way trials were performed and on the reliability of data obtained from these studies.

  7. Potential markets for application of space medicine achievements

    Science.gov (United States)

    Orlov, Oleg; Belakovskiy, Mark; Kussmaul, Anna

    2014-11-01

    The Institute of Biomedical Problems (IBMP) is the lead institution of the Russian Federation in the area of space biology and medicine. It has successfully implemented a set of innovation-based activities and projects to develop and introduce promising space products and technologies into the practices of Earth health care. To this end, various investigative methods developed for the medical selection of cosmonauts have been successfully applied in ophthalmology, gastroenterology, and cardiology. Axial loading “Regent” suits and soil simulators of bearing load have proved their efficiency in rehabilitating patients with motor disorders. Developmental prototypes of versatile training devices and technologies of their application are used for rehabilitation and purposeful development of physical status in people of various age groups. The application of telemedicine technologies allows one to diagnose and treat diseases in people who are in remote locations from medical centers or happen to be in extreme conditions. In cooperation with leading national medical institutions, other developments by the Institute have been also introduced into clinical practice: for example, the method of assessing the human functional state on the basis of computerized analysis of cardiac rhythm indices; methods of diagnosing, treating and preventing osteoporosis and metabolic osteopathias; methods of treating cardiorespiratory diseases using warmed-up heliox mixtures; methods of prophylactic examination and assessing the physical health status of the population; methods of monitoring the functional state and enhancing the physical capacity of athletes; developmental models of devices for simulating the effects of artificial gravity for refining methods of treatment and rehabilitation of patients; and systems of IV anesthesia with an option of a remote control. The effective management of innovation-based activities and the issues of commercialization of promising developments and

  8. Partnerships to provide care and medicine for chronic diseases: a model for emerging markets.

    Science.gov (United States)

    Goroff, Michael; Reich, Michael R

    2010-12-01

    The challenge of expanding access to treatment and medicine for chronic diseases in emerging markets is both a public health imperative and a commercial opportunity. Cross-sector partnerships-involving a pharmaceutical manufacturer; a local health care provider; and other private, public, and nonprofit entities-could address this challenge. Such partnerships would provide integrated, comprehensive care and medicines for a specific chronic disease, with medicines directly supplied to the partnership at preferential prices by the manufacturer. The model discussed here requires additional specification, using real numbers and specific contexts, to assess its feasibility. Still, we believe that this model has the potential for public health and private business to cooperate in addressing the rising problem of chronic diseases in emerging markets.

  9. A single European pharmaceutical market: Does maximum harmonization enhance medicinal product innovation?

    DEFF Research Database (Denmark)

    Faeh, Andrea Beata

    2013-01-01

    – Innovation Union’ – market fragmentation to be one of the major causes of the lack of innovation. In order to establish if maximum harmonization benefits innovation, two distinct legal regimes in the pharmaceutical sector will be compared. The general rules for medicinal products are weighed against......The pharmaceutical sector in the European Union is innovative, but not innovative enough to compete on the world market. This article addresses this issue from the perspective of market harmonization, since the European Commission perceives – according to the ‘European 2020 Flagship Initiative...... the orphan medicinal products scheme. The latter is subject to uniform Union rules specifically introduced to stimulate research and development and has led to the development of a number of new products. The article shows that the most radical positive integration depends to a large extent on the prospect...

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

    Science.gov (United States)

    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.

  11. A Visual-Based Approach to the Mapping of Generic Skills: Its Application to a Marketing Degree

    Science.gov (United States)

    Ang, Lawrence; D'Alessandro, Steven; Winzar, Hume

    2014-01-01

    With increasing complexity in the world, universities continue to face pressure to demonstrate that their graduates have acquired skills beyond discipline-based knowledge. These are generic skills like critical thinking, intellectual curiosity, problem-solving and so forth. In order to demonstrate this, universities have to show how their teaching…

  12. National post-market surveillance assessment of veterinary medicines in Korea during the past decade.

    Science.gov (United States)

    Kang, JeongWoo; Park, Hae-Chul; Jang, Yang Ho; Hossain, Md Akil; Jeong, Kyunghun; Jeong, Mi Young; Yun, Seon-Jong; Park, Sung-Won; Kim, Dae Gyun; Lee, Kwang-Jick

    2017-05-22

    Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine. In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the "national post-market surveillance (NPMS) system" over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A. The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good

  13. [Should modern medicine become a service industry? An ethical appraisal of a market-oriented medicine].

    Science.gov (United States)

    Maio, Giovanni

    2009-08-01

    Currently, modern medicine is undergoing fundamental transformation. Care for the patient has transformed into a client service delivery where patients are perceived as customers. It's not just simple semantics. Rather, such changes reflect a fundamental shift in human and social values and, in particular, in human self-awareness. Health has become the absolute and natural human condition which can and must be claimed and it has become the epitome of an individual's potential. In turn, these changes have a sensitively responding addressee. They affect the moral values and the sense of identity of health care workers and especially of physicians. Thus, it is a network of interlinked external and internal factors that are reshaping the core values and professional identity of medicine. In these times of change it is pivotal to ponder about the basic task of medicine and what medicine is actually meant to be. Replacing health care providers for patients by economically focused traders serving the needs of demanding clients constitutes a shift in paradigm. It is medicine as a health care profession and the specific needs of suffering patients and disabled individuals what is at stake here.

  14. Controlling South Africa's private health care expenditures : the perceptions and experiences of private health care providers about generic medicines in the Mafikeng district, North West Province, South Africa / Patience Elizabeth Kerotse Seodi

    OpenAIRE

    Seodi, Patience Elizabeth Kerotse

    2004-01-01

    This was a study which sought to investigate the perceptions and experiences of private health care providers in Mafikeng, North West Province about generic medicines. The escalating cost of medicine in South Africa and elsewhere in the world has necessitated government intervention to come up with strategies to make health care accessible and affordable to the majority of the people. In South Africa, the Medicine and Related Substances Control Amendment Act (Act I0I of 1965...

  15. Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world

    Directory of Open Access Journals (Sweden)

    Roberto Nardi

    2014-05-01

    Full Text Available A lot of issues have been raised to argue that equivalent drugs may not work as well or at least the same as what the drug industry likes to call innovator products. Many doubts and biases are also reported in connection with the use of generic drugs. Doctors are mostly concerned about their efficacy, their tolerability, the quality and amount of active ingredients, their formulation or excipients, their packaging, their pharmaceutical form and their palatability. We describe the differences between prescribability (equivalence when prescribing a drug to a patient for the first time and switchability (interchangeability of drugs for a patient already in treatment considering the notions of average bioequivalence, population bioequivalence and individual bioequivalence as well as the usefulness of the U.S. Orange Book in the assessment of bioequivalence. Other key issues deserve attention, such as: duplicate applications for medicinal products, different salt forms, formulations used in the development of each medicinal product and excipients, product quality. Clinicians in collaboration with pharmacists and research pharmacologists have to find solutions for unanswered questions and unsolved doubts, by developing targeted studies, communication tools and shared guidelines.

  16. An authenticity survey of herbal medicines from markets in China using DNA barcoding.

    Science.gov (United States)

    Han, Jianping; Pang, Xiaohui; Liao, Baosheng; Yao, Hui; Song, Jingyuan; Chen, Shilin

    2016-01-07

    Adulterant herbal materials are a threat to consumer safety. In this study, we used DNA barcoding to investigate the proportions and varieties of adulterant species in traditional Chinese medicine (TCM) markets. We used a DNA barcode database of TCM (TCMD) that was established by our group to investigate 1436 samples representing 295 medicinal species from 7 primary TCM markets in China. The results indicate that ITS2 barcodes could be generated for most of the samples (87.7%) using a standard protocol. Of the 1260 samples, approximately 4.2% were identified as adulterants. The adulterant focused on medicinal species such as Ginseng Radix et Rhizoma (Renshen), Radix Rubi Parvifolii (Maomeigen), Dalbergiae odoriferae Lignum (Jiangxiang), Acori Tatarinowii Rhizoma (Shichangpu), Inulae Flos (Xuanfuhua), Lonicerae Japonicae Flos (Jinyinhua), Acanthopanacis Cortex (Wujiapi) and Bupleuri Radix (Chaihu). The survey revealed that adulterant species are present in the Chinese market, and these adulterants pose a risk to consumer health. Thus, regulatory measures should be adopted immediately. We suggest that a traceable platform based on DNA barcode sequences be established for TCM market supervision.

  17. 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 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..

  18. Generic drugs for hypertension: are they really equivalent?

    Science.gov (United States)

    Cooper-DeHoff, Rhonda M; Elliott, William J

    2013-08-01

    Many antihypertensive drugs are now available in generic formulations at fractions of the cost of their branded counterparts. In the United States, marketing approval for generic medications is usually granted by the Food and Drug Administration on the basis of two simple studies involving dissolution rates and bioavailability in 24 - 36 healthy people, without data regarding antihypertensive efficacy, safety, or long-term outcomes. This process leaves many true disciples of "Evidence-Based Medicine" in a quandary: prescribe only brand-name medications that have been demonstrated in clinical trials to both lower blood pressure and prevent cardiovascular events, or instead recommend lower-priced generic agents that are usually supported by no such data. This review summarizes the current evidence that generic antihypertensive drugs are likely to be safe and effective, may increase the probability of medication availability and adherence for many patients, but, by law, must have a different physical appearance than the original product.

  19. 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.

  20. Marketing research on the angiotensin-converting enzyme inhibitors antihypertensive medicines

    Science.gov (United States)

    BOBOIA, ANAMARIA; GRIGORESCU, MARIUS RAREŞ; TURCU - ŞTIOLICĂ, ADINA

    2017-01-01

    Background and aims The research aimed at investigating sales trends of angiotensin-converting enzyme inhibitors antihypertensive medicines, both in terms of quantity and value, in ten community pharmacies, for a period of three years. The research on the antihypertensive medicines consumption is important for highlighting the ever increasing impact of hypertension among the population. Methods The methods used in this research were the following: marketing research, method of sampling, descriptive methods, retrospective analysis, method of comparison. Results The results showed that the drugs containing the active substances of the angiotensin converting enzyme inhibitors class had had significant increases in quantitative and value sales, bringing substantial revenues to pharmacies. From the quantitative perspective, the best-selling products were those containing Enalaprilum, while in terms of value, the best-selling medicines were those containing Perindoprilum. We evidenced that spectacular sales were also achieved for products that have Lisinoprilum, respectively Captoprilum, as active substances. The largest quantities were marketed for the Captopril Terapia® product and the highest earnings were recorded for the Prestarium® medicine. Conclusion This paper approaches an interesting and topical issue, which can be helpful to professionals (pharmacists, doctors) and other categories, such as economists, statisticians, representatives of companies manufacturing medicines, as well as to hypertensive patients, as it could be used to warn population regarding the incidence of cardiovascular diseases, and, at the same time, trace sales trends in order to accomplish profitable business plans. PMID:28246502

  1. Off-patent generic medicines vs. off-patent brand medicines for six reference drugs: a retrospective claims data study from five local healthcare units in the Lombardy Region of Italy.

    Directory of Open Access Journals (Sweden)

    Giorgio L Colombo

    Full Text Available The scientific documentation supporting the potential clinical and economic benefits of a growing use of off-patent generic drugs in clinical practice seems to be limited in Italy as yet.We compared differences in outcomes between off-patent generic drugs and off-patent brand drugs in real clinical practice. The outcomes were: persistence and compliance with therapy, mortality, and other health resources consumption (hospitalizations, specialist examinations, other drugs and total costs. Retrospective analysis was carried out by using the administrative databases of five Local Healthcare Units (ASLs - Aziende Sanitarie Locali in the Lombardy Region of Italy. Data from the five ASLs were aggregated through a meta-analysis, which produced an estimate indicator of the mean or percentage difference between the two groups (branded vs. generic and their respective significance tests. The therapeutic areas and studied drugs were: diabetes: metformin - A10BA02; hypertension: amlodipine - C08CA01; dyslipidemia: simvastatin - C10AA01; psychiatry: sertraline - N06AB06; cardiology: propafenone - C01BC03; osteoporosis: alendronate - M05BA04.The 5 Local Healthcare Units (ASL represent a population of 3,847,004 inhabitants. The selected sample included 347,073 patients, or 9.02% of the total ASL population; 67% of the patients were treated with off-patent brand drugs. The average age was 68 years, with no difference between the two groups. After 34 months of observation, compliance and persistence were in favor to generic drugs in all therapeutic areas and statistically significant in the metformin, amlodipine, simvastatin, and sertraline groups. The clinical outcomes (hospitalizations, mortality, and other health costs show no statistically significant differences between off-patent generic vs. off-patent brand medicines.Off-patent generic drugs appear to be a therapy option of choice in Italy as well, based on clinical outcomes and economic consequences

  2. Off-patent generic medicines vs. off-patent brand medicines for six reference drugs: a retrospective claims data study from five local healthcare units in the Lombardy Region of Italy.

    Science.gov (United States)

    Colombo, Giorgio L; Agabiti-Rosei, Enrico; Margonato, Alberto; Mencacci, Claudio; Montecucco, Carlo Maurizio; Trevisan, Roberto

    2013-01-01

    The scientific documentation supporting the potential clinical and economic benefits of a growing use of off-patent generic drugs in clinical practice seems to be limited in Italy as yet. We compared differences in outcomes between off-patent generic drugs and off-patent brand drugs in real clinical practice. The outcomes were: persistence and compliance with therapy, mortality, and other health resources consumption (hospitalizations, specialist examinations, other drugs) and total costs. Retrospective analysis was carried out by using the administrative databases of five Local Healthcare Units (ASLs - Aziende Sanitarie Locali) in the Lombardy Region of Italy. Data from the five ASLs were aggregated through a meta-analysis, which produced an estimate indicator of the mean or percentage difference between the two groups (branded vs. generic) and their respective significance tests. The therapeutic areas and studied drugs were: diabetes: metformin - A10BA02; hypertension: amlodipine - C08CA01; dyslipidemia: simvastatin - C10AA01; psychiatry: sertraline - N06AB06; cardiology: propafenone - C01BC03; osteoporosis: alendronate - M05BA04. The 5 Local Healthcare Units (ASL) represent a population of 3,847,004 inhabitants. The selected sample included 347,073 patients, or 9.02% of the total ASL population; 67% of the patients were treated with off-patent brand drugs. The average age was 68 years, with no difference between the two groups. After 34 months of observation, compliance and persistence were in favor to generic drugs in all therapeutic areas and statistically significant in the metformin, amlodipine, simvastatin, and sertraline groups. The clinical outcomes (hospitalizations, mortality, and other health costs) show no statistically significant differences between off-patent generic vs. off-patent brand medicines. Off-patent generic drugs appear to be a therapy option of choice in Italy as well, based on clinical outcomes and economic consequences, both for the

  3. [Significance of the German Act on the Reform of the Market for Medicinal Products for psychopharmacotherapy].

    Science.gov (United States)

    Gründer, G

    2016-04-01

    The German Act on the Reform of the Market for Medicinal Products (AMNOG) will lead to rapid disappearance of many new psychotropic drugs from the market in Germany over the next few years or their not being introduced in the first place. This article lists the reasons and discusses possible solutions. In the long term, the AMNOG could not only lead to an improvement of psychopharmacology but also contribute to the development of psychiatry as a whole, especially if its standards become an international reference.

  4. From non-aligned medicines to market-based herbals: China's relationship to the shifting politics of traditional medicine in Tanzania.

    Science.gov (United States)

    Langwick, Stacey

    2010-01-01

    The institutionalization of traditional medicine in Tanzania reveals how strategies for socialist liberation are morphing into strategies for neoliberalization. In the 1960s and 1970s, traditional medicine promised the raw material for the scientific development of an indigenous pharmaceutical industry. At the turn of the millennium, however, traditional medicine has re-emerged in Tanzania as a new path into the fast-growing global herbals market. Tanzania's relationship with China has been central to these dynamics. Development programs rooted in socialist friendship trained Tanzanian doctors in China throughout the 1970s and into the 1980s. These practitioners forged Tanzanian efforts to develop and modernize traditional medicine. In this article, I look with particular detail at one woman who was chosen to start the Office of Traditional Medicine in the Ministry of Health in Tanzania, in order to elaborate the continuities and discontinuities central to the emerging field of market-based traditional medicines.

  5. Bioequivalence of generic drugs.

    Science.gov (United States)

    Andrade, Chittaranjan

    2015-09-01

    Generic drugs are bioequivalent to the original brand; this is a prerequisite for marketing approval. It is theoretically possible that one generic drug may overestimate the pharmacokinetic (PK) parameters of the original and another generic may underestimate these PK parameters; in consequence, these 2 generics may not be bioequivalent between themselves. The result could be loss of efficacy or development of drug-related adverse effects if these generics are interchanged in stable patients. In a recent study involving 292 indirect comparisons of generic formulations of 9 different drugs, mathematical modeling showed that in most cases (87.0% for maximum concentration, 90.1% for area under the curve, and 80.5% for both) generic drugs are bioequivalent to each other. These reassuring findings notwithstanding, prudence dictates that, in stable patients, generic drugs should be interchanged only if there is a good reason for it. This is because bioequivalent brands of drugs may differ in their excipient content, and this can result in variations in safety profiles.

  6. 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.

  7. Definition and Classification of Generic Drugs Across the World.

    Science.gov (United States)

    Alfonso-Cristancho, Rafael; Andia, Tatiana; Barbosa, Tatiana; Watanabe, Jonathan H

    2015-08-01

    Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30% of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.

  8. Research and Development for Botanical Products in Medicinals and Food Supplements Market

    Directory of Open Access Journals (Sweden)

    Marco Miroddi

    2013-01-01

    Full Text Available Botanical products sold in the health area are generally intended as drugs, medicinal products, food supplements or substances for therapeutic use. Use of botanicals for improving or to care human health has evolved independently in different countries worldwide. Regulatory issues regarding botanical products designed for the food supplements or medicinal market and their influence on research and development are discussed. European Union (EU and United States (US policies regulating these products are focused with comments on the legislations delivered during the last ten years and differences existing in rules between these countries are emphasized. Research and development on botanical products nowdays strongly influenced by the product destination in the market. Addressed and differentiated research for either food supplements or medicinal markets is necessary to purchase data really useful for assessment of safe and effective use for both the categories. The main objective is to catalyze interest of academic and companies' researchers on crucial aspects to be taken into account in the research for the development of botanical products.

  9. Restrictions on the reimbursement policy with regard to retail marketing of medicinal products in Poland.

    Science.gov (United States)

    Zimmermann, Agnieszka

    2013-01-01

    On January 1, 2012, the law of 12 May 2011 on the reimbursement of medicines, food products of special nutritional purpose and medicinal products, intended to tighten up the reimbursement system, came into force in Poland. The new legislative act has significantly altered the previous principles of retail marketing of products subject to publicly financed reimbursement. First of all, the prices of reimbursed products have been unified through the introduction of fixed margins and prices and a ban--completely unknown until now--on using free market sales practices. These regulations are intended to lead to the abolition of price competition and its replacement with competition as to the quality of services provided by pharmacies. At the same time, entities engaged in retail marketing of medicinal products have been imposed a number of new obligations and highly repressive penalties for failure to fulfill them. The paper analyzes the legislative changes and points out the consequences, both those which can already be seen and the predictable ones. The assumed priority and criterion of evaluation of the reimbursement policy in question is its impact on the functioning of pharmacies which, according to the premises of Polish pharmaceutical law, should play the role of public health protection institutions.

  10. Investigating the Impact of Herbal Medicines Marketing Mix and Physicians' Product Involvement on Prescription of these Drugs

    Directory of Open Access Journals (Sweden)

    Bahram Ranjbarian

    2013-11-01

    Full Text Available Although the main side effects of chemical medicines have been discovered, the level of using herbal medicines is still low in Iran. Today prescribing herbal medicines along with chemical ones have different kinds of advantages including: increased health rate in society and developed job opportunities in the fields of agriculture, medicine industry and all of related processes. In our country there are few researches in which the important factors influencing the prescription of herbal medicines have been investigated. Thus to fill this gap the main purpose of this paper is to study the impact of marketing mix of herbal medicines and physicians’ involvement about these drugs on prescribing them. Thus to develop this research 253 doctors in Isfahan were evaluated. In order to examine the main hypotheses Spss19, Structural Equation Modeling (SEM and Amos graphic have been used. Results showed that marketing mix and all of its components and also physicians' product Involvement affect prescribing of herbal medicines.

  11. Challenges in the clinical development requirements for the marketing authorization of new medicines in southeast Asia.

    Science.gov (United States)

    Kudrin, Alex

    2009-03-01

    A rapid growth of investment into clinical research and new drug development has manifested itself by an exponential increase of new products coming onto the worldwide market. The emerging pharmaceutical and biotech markets in Southeast Asia are believed to be extremely promising from a commercial point of view in the next decade. The unique position of the Asian market and the diversity in clinical research initiatives are linked with diverse regulatory requirements for clinical development and registration of new medicines. Some of these differences have an impact on timelines for marketing authorizations in South Korea, China, Thailand, Japan, Singapore, and other countries. One of the approaches to streamlining regulatory strategy in different countries is the initiation of multicountry international clinical trials trying to address requirements and allowing registration in several regional countries simultaneously. Increasing cooperation between South Asian countries in relation to regulatory requirements and clinical development will facilitate the registration of innovative medicines in this rapidly developing region of the world and enable improved cohesiveness between countries in a drug safety framework.

  12. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents

    Directory of Open Access Journals (Sweden)

    J.B. Calixto

    2000-02-01

    Full Text Available This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs. Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

  13. [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.

  14. Changes in the trade in native medicinal plants in Brazilian public markets.

    Science.gov (United States)

    Brandão, Maria das Graças Lins; Cosenza, Gustavo Pereira; Pereira, Flávia Liparini; Vasconcelos, Ariela Silva; Fagg, Christopher William

    2013-08-01

    Plants continue to be an important source of new bioactive substances. Brazil is one of the world's mega-diverse countries, with 20 % of the world's flora. However, the accelerated destruction of botanically rich ecosystems has contributed to a gradual loss of native medicinal species. In previous study, we have observed a fast and intensive change in trade of medicinal plants in an area of Amazon, where human occupation took place. In this study, we surveyed 15 public markets in different parts of Brazil in search of samples of 40 plants used in traditional medicine and present in first edition of Brazilian Official Pharmacopoeia (FBRAS), published in 1926. Samples of plants commercialized as the same vernacular name as in Pharmacopoeia were acquired and submitted to analysis for authentication. A total of 252 plant samples were purchased, but the laboratory analyses showed that only one-half of the samples (126, 50.2 %) were confirmed as the same plant species so named in FBRAS. The high number of unauthenticated samples demonstrates a loss of knowledge of the original native species. The proximity of the market from areas in which the plant occurs does not guarantee that trade of false samples occurs. The impact of the commerce of the substitute species on their conservation and in public health is worrying. Strategies are necessary to promote the better use and conservation of this rich heritage offered by Brazilian biodiversity.

  15. International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

    OpenAIRE

    Davit, Barbara; Braddy, April C.; Conner, Dale P.; Yu, Lawrence X.

    2013-01-01

    The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused on the 13 jurisdictions and organizations participating in the International Generic Drug Regulators Pilot. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Assoc...

  16. Determinants for successful marketing authorisation of orphan medicinal products in the EU.

    Science.gov (United States)

    Putzeist, Michelle; Heemstra, Harald E; Garcia, Jordi Llinares; Mantel-Teeuwisse, Aukje K; Gispen-De Wied, Christine C; Hoes, Arno W; Leufkens, Hubert G M

    2012-04-01

    In 2010, the European Regulation for Orphan Medicinal Products (OMPs) was in force for ten years. In this study we assessed possible determinants of applications for OMPs in the EU since 2000 that are associated with a successful marketing authorisation. Our analysis shows that clinical trial characteristics such as demonstrating convincing evidence of a beneficial effect on the primary endpoint, the selection of a clinically relevant endpoint, providing RCT data as pivotal study evidence and the submission of sound dose finding data are critical success factors. In addition, high medical need seems to counterweigh uncertainties about the scientific evidence in the benefit-risk assessment of OMPs.

  17. [Marketing of medicinal products in the European Community. The Mutual Recognition and Decentralised Procedures].

    Science.gov (United States)

    Bachmann, Peter

    2008-07-01

    The Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP), which were first established in late 2005, can be regarded as the backbone for marketing authorisation of medicinal products in the European Community (EC) and the European Economic Area (EEA). Both procedures are compared and advantages and disadvantages are discussed. However, the focus is more related to current developments than the detailed comparison of both procedures. The role of the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMD(h)) and the decision making process in relation to the MRP and DCP is also discussed.

  18. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

    Science.gov (United States)

    Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

    2015-01-01

    With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

  19. Generic variation?

    DEFF Research Database (Denmark)

    Jensen, Torben Juel

    2009-01-01

    Abstract In modern Danish, a handful of pronouns may be used to refer to a generic referent. In recent decades, the second person singular pronoun du has gained ground, apparently in parallel to similar recent developments in other languages. Even though generic du may not be as old as the tradit...

  20. Targeting the American market for medicines, ca. 1950s-1970s: ICI and Rhône-Poulenc compared.

    Science.gov (United States)

    Quirke, Viviane

    2014-01-01

    The forces that have shaped American medicine include a wide set of interrelated changes, among them the changing research, development, and marketing practices of the pharmaceutical industry. This article compares the research and development (R&D) and marketing strategies of the British group Imperial Chemical Industries (ICI, whose Pharmaceutical Division was spun off and merged with the Swedish company Astra to form AstraZeneca) and its French counterpart Rhône-Poulenc (now part of Sanofi-Aventis) in dealing with the American medical market. It examines how, in the process, the relationship between R&D and marketing was altered, and the firms themselves were transformed. The article also questions the extent to which their approaches to this market, one of the most significant markets for drugs in general, and for anticancer drugs in particular, became standardized in the period of "scientific marketing."

  1. Comparators (medicinal and non medicinal) for marketing authorization, for public health, for payers and at the European level.

    Science.gov (United States)

    Berdaï, Driss; Hotton, Jean-Michel; Lechat, Philippe

    2010-01-01

    Drug evaluation is based on comparison. Thus, the choice of the comparator for any new treatment becomes a key issue, especially when there are great differences in medical practice and of use conditions of the comparators depending on the geographical zones and their evolution with time. The choice of the comparators must satisfy sometimes different expectations from the registration authorities and for insurance coverage. The universal comparator that allows answering all the clinical assessment questions does not exist. Placebo, when it can be used, remains a reference for the MA (marketing authorisation) application, but does not exclude the use of the reference drug available on the market and prescribed under optimal efficacy conditions. The reference treatment is sometimes a difficult choice due to the absence of validated therapeutic recommendations or if the recommendations vary depending on the countries. The expansion and international harmonization of prescription guidelines (clinical practice guidelines) would reinforce the robustness and efficiency of clinical research efforts with respect to the relevance of the comparison to reference treatments. This principle also applies to the use of a non-drug comparator when it has been recognized as the reference comparator in the treatment of the pathology in question. In as much as possible, the search for a consensus must also aim at defining in the clinical development recommendations significant thresholds for the size of evaluated effects. Optimization of the information made available after clinical trials could also be helped by the development of use of methodologies that allow assessing superiority on secondary criteria during a non-inferiority study on the main criterion. Finally, the development of early scientific consultations by the Haute Autorité de Santé (HAS, French Health Authority) would contribute to adapt phase III clinical trials better to questions concerning the assessment of the

  2. The diffusion of generics after patent expiry in Germany.

    Science.gov (United States)

    Fischer, Katharina Elisabeth; Stargardt, Tom

    2016-11-01

    To identify the influences on the diffusion of generics after patent expiry, we analyzed 65 generic entries using prescription data of a large German sickness fund between 2007 and 2012 in a sales model. According to theory, several elements are responsible for technology diffusion: (1) time reflecting the rate of adaption within the social system, (2) communication channels, and (3) the degree of incremental innovation, e.g., the modifications of existing active ingredient's strength. We investigated diffusion in two ways: (1) generic market share (percentage of generic prescriptions of all prescriptions of a substance) and, (2) generic sales quantity (number of units sold) over time. We specified mixed regression models. Generic diffusion takes considerable time. An average generic market share of about 75 % was achieved not until 48 months. There was a positive effect of time since generic entry on generic market share (p innovation influenced generic market share (mostly p < 0.001), but not generic sales quantity. Market structure, e.g., the number of generic manufacturers (p < 0.001) and prices influenced both generic market share and sales. Imperfections in generic uptake through informational cascades seem to be largely present. Third-party payers could enhance means to promote generic diffusion to amplify savings through generic entry.

  3. Advanced therapy medicinal products : How to bring cell-based medicinal products successfully to the market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014

    NARCIS (Netherlands)

    Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A.; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

    2015-01-01

    On September 11, 2014, a workshop entitled 'Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market' was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicine

  4. Medicines informal market in Congo, Burundi and Angola: counterfeit and sub-standard antimalarials

    Directory of Open Access Journals (Sweden)

    Bertocchi Paola

    2007-02-01

    Full Text Available Abstract Background The presence of counterfeits and sub-standards in African medicines market is a dramatic problem that causes many deaths each year. The increase of the phenomenon of pharmaceutical counterfeiting is due to the rise of the illegal market and to the impossibility to purchase branded high cost medicines. Methods In this paper the results of a quality control on antimalarial tablet samples purchased in the informal market in Congo, Burundi and Angola are reported. The quality control consisted in the assay of active substance by means of validated liquid chromatographic methods, uniformity of mass determination, disintegration and dissolution tests. Moreover, a general evaluation on label and packaging characteristics was performed. Results The results obtained on thirty antimalarial tablet samples containing chloroquine, quinine, mefloquine, sulphadoxine and pyrimethamine showed the presence of different kinds of problems: a general problem concerning the packaging (loose tablets, packaging without Producer name, Producer Country and sometimes without expiry date; low content of active substance (in one sample; different, non-declared, active substance (in one sample; sub-standard technological properties and very low dissolution profiles (in about 50% of samples. This last property could affect the bioavailability and bioequivalence in comparison with branded products and could be related to the use of different excipients in formulation or bad storage conditions. Conclusion This paper evidences that the most common quality problem in the analysed samples appears to be the low dissolution profile. Here it is remarked that the presence of the right active substance in the right quantity is not a sufficient condition for a good quality drug. Dissolution test is not less important in a quality control and often evidences in vitro possible differences in therapeutic efficacy among drugs with the same active content. Dissolution

  5. Suitable DNA Barcoding for Identification and Supervision of Piper kadsura in Chinese Medicine Markets.

    Science.gov (United States)

    Yu, Ning; Gu, Hong; Wei, Yulong; Zhu, Ning; Wang, Yanli; Zhang, Haiping; Zhu, Yue; Zhang, Xin; Ma, Chao; Sun, Aidong

    2016-09-12

    Piper kadsura is a vine-like medicinal plant which is widely used in clinical treatment. However, P. kadsura is often substituted by other materials in the markets, thereby causing health risks. In this study, 38 P. kadsura samples and eight sequences from GenBank, including a closely-related species and common adulterants were collected. This study aimed to identify an effective DNA barcode from four popular DNA loci for P. kadsura authentication. The success rates of PCR amplification, sequencing, and sequence acquisition of matK were 10.5%, 75%, and 7.9%, respectively; for rbcL they were 89.5%, 8.8%, and 7.9%, respectively; ITS2 rates were 86.8%, 3.0%, and 2.6%, respectively, while for psbA-trnH they were all 100%, which is much higher than for the other three loci. The sequences were aligned using Muscle, genetic distances were computed using MEGA 5.2.2, and barcoding gap was performed using TAXON DNA. Phylogenetic analysis showed that psbA-trnH could clearly distinguish P. kadsura from its closely related species and the common adulterant. psbA-trnH was then used to evaluate the fake proportions of P. kadsura. Results showed that 18.4% of P. kadsura samples were fake, indicating that adulterant species exist in the Chinese markets. Two-dimensional DNA barcoding imaging of P. kadsura was conducted, which was beneficial to the management of P. kadsura. We conclude that the psbA-trnH region is a powerful tool for P. kadsura identification and supervision in the current medicine markets.

  6. Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

    Science.gov (United States)

    Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

    2010-01-01

    The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

  7. The Market of Biopharmaceutical Medicines: A Snapshot of a Diverse Industrial Landscape.

    Science.gov (United States)

    Moorkens, Evelien; Meuwissen, Nicolas; Huys, Isabelle; Declerck, Paul; Vulto, Arnold G; Simoens, Steven

    2017-01-01

    Background: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market. Objectives: This study aims to identify and document which investment and development strategies are adopted by industrial players in the global biopharmaceutical market. Methods: A descriptive analysis was undertaken of the investment and development strategies of the top 25 pharmaceutical companies according to 2015 worldwide prescription drug sales. Strategies were documented by collecting data on manufacturing plans, development programs, acquisition and collaboration agreements, the portfolio and pipeline of biosimilar, originator and next-generation biopharmaceutical products. Data were extracted from publicly available sources. Results: Various investment and development strategies can be identified in the global biopharmaceutical market: (a) development of originator biopharmaceuticals, (b) investment in biotechnology, (c) development of next-generation biopharmaceuticals, (d) development of biosimilars, (e) investment in emerging countries, and (f) collaboration between companies. In the top 25 pharmaceutical companies almost every company invests in originator biopharmaceuticals and in biotechnology in general, but only half of them develops next-generation biopharmaceuticals. Furthermore, only half of them invest in development of biosimilars. The companies' biosimilar pipeline is mainly focused on development of biosimilar monoclonal antibodies and to some extent on biosimilar insulins. A common strategy is collaboration between companies and investment in emerging countries. Conclusions: A snapshot of investment and development strategies used by industrial players in the global biopharmaceutical market shows that all top 25 pharmaceutical companies are engaged in the biopharmaceutical market and that this

  8. The Market of Biopharmaceutical Medicines: A Snapshot of a Diverse Industrial Landscape

    Directory of Open Access Journals (Sweden)

    Evelien Moorkens

    2017-06-01

    Full Text Available Background: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market.Objectives: This study aims to identify and document which investment and development strategies are adopted by industrial players in the global biopharmaceutical market.Methods: A descriptive analysis was undertaken of the investment and development strategies of the top 25 pharmaceutical companies according to 2015 worldwide prescription drug sales. Strategies were documented by collecting data on manufacturing plans, development programs, acquisition and collaboration agreements, the portfolio and pipeline of biosimilar, originator and next-generation biopharmaceutical products. Data were extracted from publicly available sources.Results: Various investment and development strategies can be identified in the global biopharmaceutical market: (a development of originator biopharmaceuticals, (b investment in biotechnology, (c development of next-generation biopharmaceuticals, (d development of biosimilars, (e investment in emerging countries, and (f collaboration between companies. In the top 25 pharmaceutical companies almost every company invests in originator biopharmaceuticals and in biotechnology in general, but only half of them develops next-generation biopharmaceuticals. Furthermore, only half of them invest in development of biosimilars. The companies' biosimilar pipeline is mainly focused on development of biosimilar monoclonal antibodies and to some extent on biosimilar insulins. A common strategy is collaboration between companies and investment in emerging countries.Conclusions: A snapshot of investment and development strategies used by industrial players in the global biopharmaceutical market shows that all top 25 pharmaceutical companies are engaged in the biopharmaceutical market and

  9. The Disposable Author: How Pharmaceutical Marketing Is Embraced within Medicine's Scholarly Literature.

    Science.gov (United States)

    Matheson, Alastair

    2016-07-01

    The best studies on the relationship between pharmaceutical corporations and medicine have recognized that it is an ambiguous one. Yet most scholarship has pursued a simpler, more saleable narrative in which pharma is a scheming villain and medicine its maidenly victim. In this article, I argue that such crude moral framing blunts understanding of the murky realities of medicine's relationship with pharma and, in consequence, holds back reform. My goal is to put matters right in respect to one critical area of scholarly interest, the medical journal publication. Pharma relies on peer advocacy to sell its wares to prescribing doctors. This is an arrangement in which clinicians' qualified colleagues, including "key opinion leaders," are recruited by pharmaceutical corporations and marketing agencies to deliver commercially expedient content to their professional fellows. Precisely how this practice works in the setting of publications is not well understood because ethicists studying the problem have made too much of the narrative of corporate villainy and medical victimhood. Accordingly, criticism of industry publications has been preoccupied with the crudely dishonest practices of ghostwriting, ghost authorship, and "ghost management," vices condemned as "dirty little secrets" perpetrated from "behind the scenes" with the connivance of academic "shills" or "guest authors," in contempt of standards set by the International Committee of Medical Journal Editors. This account is appealing, and yet it is wrong or, at the very least, seriously incomplete, with only limited relevance to the actualities of contemporary industry practices. In truth, many commercial publications are not developed in secret but fashioned within a culture of open collaboration, where academic authors make substantial, independent contributions; pharmaceutical companies are showcased rather than hidden; and medicine's editorial standards assist rather than impede the workings of commerce.

  10. Negotiating the boundary between medicine and consumer culture: online marketing of nutrigenetic tests.

    Science.gov (United States)

    Saukko, Paula M; Reed, Matthew; Britten, Nicky; Hogarth, Stuart

    2010-03-01

    Genomics researchers and policy makers have accused nutrigenetic testing companies--which provide DNA-based nutritional advice online--of misleading the public. The UK and USA regulation of the tests has hinged on whether they are classed as "medical" devices, and alternative regulatory categories for "lifestyle" and less-serious genetic tests have been proposed. This article presents the findings of a qualitative thematic analysis of the webpages of nine nutrigenetic testing companies. We argue that the companies, mirroring and negotiating the regulatory debates, were creating a new social space for products between medicine and consumer culture. This space was articulated through three themes: (i) how "genes" and tests were framed, (ii) how the individual was imagined vis a vis health information, and (iii) the advice and treatments offered. The themes mapped onto four frames or models for genetic testing: (i) clinical genetics, (ii) medicine, (iii) intermediate, and (iv) lifestyle. We suggest that the genomics researchers and policy makers appeared to perform what Gieryn (Gieryn, T.F. (1983). Boundary-work and the demarcation of science from non-science: strains and interests in professional ideologies of scientists. American Sociological Review, 48, 781-795.) has termed "boundary work", i.e., to delegitimize the tests as outside proper medicine and science. Yet, they legitimated them, though in a different way, by defining them as lifestyle, and we contend that the transformation of the boundaries of science into a creation of such hybrid or compromise categories is symptomatic of current historical times. Social scientists studying medicine have referred to the emergence of "lifestyle" products. This article contributes to this literature by examining the historical, regulatory and marketing processes through which certain goods and services become defined this way.

  11. 我国某省原研药与仿制药价格差异与市场份额实证研究%Empirical research of price difference and market share between brand-name drugs and generics in one province in China

    Institute of Scientific and Technical Information of China (English)

    李晗; 管晓东; 许立平; 刘洋; 韩晟; 史录文

    2012-01-01

    Objective: To provide scientific reference for the country's price management of brand-name drugs and generics. Methods:We analyzed price comparison and market share between brand-name drugs and generics in a province with the data from the database of medicine bidding and purchase center in the province. Results: The average price ratio of the 198 samples between brand-name drugs and generics was 3.6 in the province. This was higher than the price difference rate as required by the Governmental Pricing Method for the Pharmaceuticals in China. Conclusion:The price difference between brand-name drugs and generics is bigger than the one the government required.%目的:为完善国家原研药与仿制药管理工作提供科学参考.方法:根据某省药品招标采购中心数据库的数据,分析该省原研药与仿制药的价格差异与市场份额.结果:该省198个样本药品中,原研药与仿制药的价格差异倍数的均值为3.6倍,高于《药品政府定价办法》规定的差价率.结论:我国原研药与仿制药的价格差异高于国家规定.

  12. Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or knowledge? Part 1. Pharmacological issues

    OpenAIRE

    Roberto Nardi; Marco Masina; Giorgio Cioni; Paolo Leandri; Paola Zuccheri

    2014-01-01

    Despite compelling evidence and guidelines, in Italy, generic/equivalent drugs are still underused. The failure to adopt existing generic drugs may result into a missed opportunity to further reduce healthcare costs. Equivalent drugs are approved based on data deriving from bioequivalence studies. In the first part of the article, the concepts of generic/equivalent drugs are defined, emphasizing the differences between pharmaceutical equivalence, therapeutic equivalence, bioequivalence and bi...

  13. Analysis on Ga-Rak market workers' disease and treatment of Traditional Korean Medicine(TKM) (pilot study)

    OpenAIRE

    Yoo, Jae Ryong; Song, Ho Sueb

    2004-01-01

    Objective : To broaden our understanding on occupational disease of market workers and to evaluate the effect of TKM treatment focusing on acupuncture and herb medicine and to promote base studies and clinical trials on occupational disease. Materials and Methods : Analysis was done on 33 Ga-Rak market workers' chart which had been selected through investigation of 1508 outpatient's chart of Kyung Won University Hospital from Jun. 1st, 2002 to May. 31th, 2003. Results : 1. Out of 33 p...

  14. Medicinal Plants of the markets of Izúcar de Matamoros and Acatlán de Osorio, Puebla

    Directory of Open Access Journals (Sweden)

    David Martínez Moreno

    2016-03-01

    Full Text Available In Mexico the traditional markets are places that reflect the interaction between people and plants, so they come to define the identity in the area where they are. Theobjective of the present study was to record marketing, use, and source of medicinal plants as well as the comparison between the markets of Izúcar de Matamoros and Acatlán de Osorio, in the State of Puebla. In order to achieve the proposed objective 6 visits to the 'Revolution' of Izúcar de Matamoros market and 24 to the "General Rafael Sanchez Taboada" market at of Acatlán de Osorio were made. Structured Interviews were made to people who sell the plants, in order to record their common name, use, preparation, route of administration, the kind of disease they cure, healing, cost per sample, origin of species, time in collecting them and, if they are indirectly bought, how much sellers pay for each one and how they learned the use of medicinal plants. The collection of the botanical material was conducted through the acquisition of samples in fresh and dry, for subsequent identification. The results showed that in the Izúcar de Matamoros market 1133 stands were recorded; in 0.71% of them medicinal plantsare sold; the number of registered species was 49 -49genera and 35 families- being the family Asteraceae the most outstanding, with 12 genera. As for its origin, 43 of these species are wild and 11 are grown, some of them have double performance. In the Acatlán de Osorio market 641 stands were registered, where the 1.71% are of medicinal plants; the number of medicinal species was 144, with 122 genera and 71 families. The most outstanding families were Asteraceae, Lamiaceae, and Fabaceae. From all the registered species of medicinal plants we found that 61 are introduced, 73 native and the origin of 10 of them is unknown. We also registered, according to the surveys applied to sellers, that 110 species are wild and 33 cultivated, all of which are sold both fresh and dry. The

  15. Marketing.

    Science.gov (United States)

    Doyle, Peter

    1987-01-01

    Explores the role of marketing in the modern firm and the key tasks of marketing management. Defines the term "marketing" and discusses it as an economic concept. Discusses three key marketing principals. (RKM)

  16. Generic drug names and social welfare.

    Science.gov (United States)

    Lobo, Félix; Feldman, Roger

    2013-06-01

    This article studies how well International Nonproprietary Names (INNs), the "generic" names for pharmaceuticals, address the problems of imperfect information. Left in private hands, the identification of medicines leads to confusion and errors. Developed in the 1950s by the World Health Organization, INNs are a common, global, scientific nomenclature designed to overcome this failure. Taking stock after sixty years, we argue that the contribution of INNs to social welfare is paramount. They enhance public health by reducing errors and improving patient safety. They also contribute to economic efficiency by creating transparency as the foundation of competitive generic drug markets, reducing transaction costs, and favoring trade. The law in most countries requires manufacturers to designate pharmaceuticals with INNs in labeling and advertising. Generic substitution is also permitted or mandatory in many countries. But not all the benefits of INNs are fully realized because prescribers may not use them. We advocate strong incentives or even legally binding provisions to extend the use of INNs by prescribing physicians and dispensing pharmacists, but we do not recommend replacing brand names entirely with INNs. Instead, we propose dual use of brand names and INNs in prescribing, as in drug labeling.

  17. Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization.

    NARCIS (Netherlands)

    Luijn, J.C.F. van; Gribnau, F.W.J.; Leufkens, H.G.

    2007-01-01

    AIMS: To investigate the availability of information about premarketing randomized active-control trials (RaCTs) involving medicines with a new active substance at the moment of market authorization in the European Union. METHODS: Information was obtained from the EMEA European Public Assessment Rep

  18. Exposing the illegal trade in cycad species (Cycadophyta: Encephalartos) at two traditional medicine markets in South Africa using DNA barcoding.

    Science.gov (United States)

    Williamson, J; Maurin, O; Shiba, S N S; van der Bank, H; Pfab, M; Pilusa, M; Kabongo, R M; van der Bank, M

    2016-09-01

    Species in the cycad genus Encephalartos are listed in CITES Appendix I and as Threatened or Protected Species in terms of South Africa's National Environmental Management: Biodiversity Act (NEM:BA) of 2004. Despite regulations, illegal plant harvesting for medicinal trade has continued in South Africa and resulted in declines in cycad populations and even complete loss of sub-populations. Encephalartos is traded at traditional medicine markets in South Africa in the form of bark strips and stem sections; thus, determining the species traded presents a major challenge due to a lack of characteristic plant parts. Here, a case study is presented on the use of DNA barcoding to identify cycads sold at the Faraday and Warwick traditional medicine markets in Johannesburg and Durban, respectively. Market samples were sequenced for the core DNA barcodes (rbcLa and matK) as well as two additional regions: nrITS and trnH-psbA. The barcoding database for cycads at the University of Johannesburg was utilized to assign query samples to known species. Three approaches were followed: tree-based, similarity-based, and character-based (BRONX) methods. Market samples identified were Encephalartos ferox (Near Threatened), Encephalartos lebomboensis (Endangered), Encephalartos natalensis (Near Threatened), Encephalartos senticosus (Vulnerable), and Encephalartos villosus (Least Concern). Results from this study are crucial for making appropriate assessments and decisions on how to manage these markets.

  19. Pharmaceutical policy regarding generic drugs in Belgium.

    Science.gov (United States)

    Simoens, Steven; De Bruyn, Kristien; Bogaert, Marc; Laekeman, Gert

    2005-01-01

    Pressure to control pharmaceutical expenditure and price competition among pharmaceutical companies are fuelling the development of generic drug markets in EU countries. However, in Belgium, the market for generic drugs is underdeveloped compared with other countries. To promote the use of generic drugs, the government introduced a reference pricing (RP) scheme in 2001. The aim of this paper is to discuss Belgian pharmaceutical policy regarding generic drugs and to analyse how the Belgian drug market has evolved following initiation of the RP scheme. The market share held by generic drugs increased following implementation of the RP scheme. Focusing on volume, average market share (by semester) for generic drugs amounted to 2.05% of the total pharmaceutical market from January 1998 to June 2001, compared with 6.11% from July 2001 to December 2003. As new generic drugs are introduced, their market share tends to increase in the first couple of months, after which it levels off. Faced with increasing generic competition, some manufacturers have launched new variants of their original drug, thereby effectively extending the period of patent protection. Strategies consisting of price reductions in return for the abolition of prescribing conditions and the launch of new dosages or formulations appear to have been successful in maintaining the market share of original drugs. Nevertheless, the introduction of the RP scheme was associated with savings amounting to 1.8% of pharmaceutical expenditure by the third-party payer in 2001 and 2.1% in 2002. The findings of this paper indicate that the RP scheme has stimulated the Belgian generic drug market. However, existing policy has largely failed to take into account the role that physicians and pharmacists can play in stimulating generic drug use. Therefore, further development of the Belgian generic drug market seems to hinge on the creation of appropriate incentives for physicians to prescribe, and for pharmacists to

  20. Family Genericity

    DEFF Research Database (Denmark)

    Ernst, Erik

    2006-01-01

    Type abstraction in object-oriented languages embody two techniques, each with its own strenghts and weaknesses. The first technique is extension, yielding abstraction mechanisms with good support for gradual specification. The prime example is inheritance. The second technique is functional abst...... the result as family genericity. The presented language design has been implemented....

  1. Family Genericity

    DEFF Research Database (Denmark)

    Ernst, Erik

    2006-01-01

    Type abstraction in object-oriented languages embody two techniques, each with its own strenghts and weaknesses. The first technique is extension, yielding abstraction mechanisms with good support for gradual specification. The prime example is inheritance. The second technique is functional abst...... the result as family genericity. The presented language design has been implemented....

  2. Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or knowledge? Part 1. Pharmacological issues

    Directory of Open Access Journals (Sweden)

    Roberto Nardi

    2014-05-01

    Full Text Available Despite compelling evidence and guidelines, in Italy, generic/equivalent drugs are still underused. The failure to adopt existing generic drugs may result into a missed opportunity to further reduce healthcare costs. Equivalent drugs are approved based on data deriving from bioequivalence studies. In the first part of the article, the concepts of generic/equivalent drugs are defined, emphasizing the differences between pharmaceutical equivalence, therapeutic equivalence, bioequivalence and bioavailability. A summary of the methods adopted to define bioequivalence (pharmacokinetic studies; pharmacodynamic studies; comparative clinical trials; in vitro studies is also included.

  3. Generic drugs in Brazil: known by many, used by few.

    Science.gov (United States)

    Bertoldi, Andréa D; Barros, Aluísio J D; Hallal, Pedro C

    2005-01-01

    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.

  4. High-cost generic drugs--implications for patients and policymakers.

    Science.gov (United States)

    Alpern, Jonathan D; Stauffer, William M; Kesselheim, Aaron S

    2014-11-13

    Some older generic drugs have become very expensive, owing to factors including drug shortages, supply disruptions, and consolidations in the generic-drug industry. But generics manufacturers that legally obtain a market monopoly can also unilaterally raise prices.

  5. [Internationalization, science and health: global regenerative medicine and the parallel markets].

    Science.gov (United States)

    Acero, Liliana

    2015-02-01

    Regenerative medicine involves a paradigm change due to organism regeneration at cellular and tissue level - a controversial contemporary issue and difficult to regulate. This article presents a summary of the main scientific, economic, social and regulatory global trends, analyzed according to relevant theoretical dilemmas in medical anthropology and in the sociology of science and health. This is especially true of the construction of a 'collective frame of reference' on the new biological and ontological entities, the shaping of biological citizenship, and governance through uncertainty. Empirical evidence is also presented on a key aspect in regulation and governance, namely the emergence of a new transnational demand in health research through the establishment of parallel markets for ova and experimental cellular therapies. Qualitative data collected for a broader research paper is analyzed, as well as journal reviews and information gathered during interviews with international leaders. The paper concludes with a discussion on the importance on international governance of clinical trials and on further exploration, towards a multilevel harmonization of a diversity of normative practices.

  6. Reading baby books: medicine, marketing, money and the lives of American infants.

    Science.gov (United States)

    Golden, Janet; Weiner, Lynn

    2011-01-01

    This article examines American baby books from the late nineteenth through the twentieth century. Baby books are ephemeral publications—formatted with one or more printed pages for recording developmental, health, and social information about infants and often including personal observations, artifacts such as photographs or palm prints, medical and other prescriptive advice, and advertisements. For historians they serve as records of the changing social and cultural worlds of infancy, offering insights into the interplay of childrearing practices and larger social movements.Baby books are a significant historical source both challenging and supporting current historiography, and they illustrate how medical, market and cultural forces shaped the ways babies were cared for and in turn how their won behavior shaped family lives. A typology of baby books includes the lavishly illustrated keepsake books of the late nineteenth century, commercial and public health books of the twentieth century, and on-line records of the present day. Themes that emerge over time include those of scientific medicine and infant psychology, religion and consumerism. The article relies on secondary literature and on archival sources including the collections of the UCLA Louise M. Darling Biomedical Library as well as privately held baby books.

  7. Farmácia Popular Program: pharmaceutical market analysis of antihypertensive acting on the renin-angiotensin system medicines.

    Science.gov (United States)

    Silva, Rondineli Mendes da; Chaves, Gabriela Costa; Chaves, Luisa Arueira; Campos, Mônica Rodrigues; Luiza, Vera Lucia; Bertoldi, Andréa Dâmaso; Ross-Degnan, Dennis; Emmerick, Isabel Cristina Martins

    2017-08-01

    This paper aims to analyse changes in the retail pharmaceutical market following policy changes in the Farmácia Popular Program (FP), a medicines subsidy program in Brazil. The retrospective longitudinal analyses focus on therapeutic class of agents acting on the renin-angiotensin system. Data obtained from QuintilesIMS (formerly IMS Health) included private retail pharmacy sales volume (pharmaceutical units) and sales values from 2002 to 2013. Analyses evaluated changes in market share following key FP policy changes. The therapeutic class was selected due to its relevance to hypertension treatment. Market share was analysed by therapeutic sub-classes and by individual company. Losartan as a single product accounted for the highest market share among angiotensin II antagonists. National companies had higher sales volume during the study period, while multinational companies had higher sales value. Changes in pharmaceutical market share coincided with the inclusion of specific products in the list of medicines covered by FP and with increases in or exemption from patient copayment.

  8. Alienating evidence based medicine vs. innovative medical device marketing: a report on the evidence debate at a Wounds conference.

    Science.gov (United States)

    Madden, Mary

    2012-06-01

    Wound care management is one of the largest segments of the UK medical technology sector with a turnover exceeding £1bn in 2009 (BIS, 2010). Using data derived from participant observation, this article examines the antagonistic relationship expressed by wound care clinicians towards evidence based medicine in the context of the 2010 United Kingdom (UK) Wounds UK conference/trade show, where evidence based medicine is positioned in opposition to clinical knowledge, as an obstacle to innovation and as a remover of solutions rather than a provider of them. The article is written in the context of the trend towards increasing marketization and privatization in the UK National Health Service (NHS).

  9. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  10. 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.

  11. [Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection].

    Science.gov (United States)

    Xiao, Ying; Zhao, Yubin; Xie, Yanming

    2011-10-01

    The nested case-control study design (or the case-control in a cohort study) is described here as a new study design used in safe evaluation of post-marketing traditional Chinese medicine injection. In the nested case-control study, cases of a disease that occur in a defined cohort are identified and, for each, a specified number of matched controls is selected from among those in the cohort who have not developed the disease by the time of disease occurrence in the case. For many research questions, the nested case-control design potentially offers impressive reductions in costs and efforts of data collection and analysis compared with the full cohort approach, with relatively minor loss in statistical efficiency. The nested case-control design is particularly advantageous for studies in safe evaluation of post-marketing traditional Chinese medicine injection. Some examples of the application of nested case-control study were given.

  12. Generic medications in ophthalmology.

    Science.gov (United States)

    Zore, Matt; Harris, Alon; Tobe, Leslie Abrams; Siesky, Brent; Januleviciene, Ingrida; Behzadi, Jennifer; Amireskandari, Annahita; Egan, Patrick; Garff, Kevin; Wirostko, Barbara

    2013-03-01

    The purpose of this review is to discuss the process of genericisation of medications in the US and Europe with a focus on ophthalmic drugs. Regulatory guidelines of the US Food and Drug Administration and the European Medicines Agency will be discussed, and the advantages and concerns of genericisation will be explored. We will look at various studies concerning the safety and efficacy of generic drugs compared to their branded counterparts. In particular, the challenges of assuring bioequivalence and therapeutic equivalence in topical ophthalmic drugs will be examined.

  13. Analysis on Ga-Rak market workers' disease and treatment of Traditional Korean Medicine(TKM (pilot study

    Directory of Open Access Journals (Sweden)

    Yoo, Jae Ryong

    2004-06-01

    Full Text Available Objective : To broaden our understanding on occupational disease of market workers and to evaluate the effect of TKM treatment focusing on acupuncture and herb medicine and to promote base studies and clinical trials on occupational disease. Materials and Methods : Analysis was done on 33 Ga-Rak market workers' chart which had been selected through investigation of 1508 outpatient's chart of Kyung Won University Hospital from Jun. 1st, 2002 to May. 31th, 2003. Results : 1. Out of 33 patients, Men had more occupational diseases than women had and Most people were in their forties. 2. Major cause of the disease include repetitve bending, heavy weight lifting and overwork. 3. Past History of patients mostly include frequent lumbar sprain, periarthritis of shoulder, lumbar HNP. 4. The patients with occupational disease were diagnosed as lumbar sprain, periarthritis of shoulder, lumbar HNP, degenerative spondylosis, spinal stenosis and their chief complaints were low back pain, omalgia, back pain with radicular pain. 5. The duration of treatment was mostly within a week. 6. Acupuncture, Bee Venom Acupuncture, moxibustion, Herb-medicine, extract, taping therapy, physical therapy were used as treatment methods. 7. Applied herb medicine were composed of 8 kinds of prescriptions and extract were made up of 6 prescriptions 8. Applied acupoints belonged mainly to 14 meridians 9. The treatment of herb medicine combined with acupuncture proved effective in treating the ocupational disease. conclusions : The occupational disease of patients working in Ga-Rak market were closely related with overwork, especially with repetitive bending and heavy weight lifting and TKM treatment focusing on acupuncture combined with herb medicine was effective in treating occupational disease.

  14. Bioequivalence studies: need for the reability of generic drugs

    OpenAIRE

    Laosa, Olga; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Guerra, Pedro; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; López-Durán, Jose Luis; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Mosquera, Beatriz; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Licenciada en Ciencias Químicas.; Frías, Jesús; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Servicio de Farmacología Clínica, Hospital Universitario la Paz. Madrid, España. Médico especialista en Farmacología Clínica.

    2009-01-01

    A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. The clinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the United States g...

  15. Bioequivalence studies: need for the reability of generic drugs

    OpenAIRE

    Laosa, Olga; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Guerra, Pedro; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; López-Durán, Jose Luis; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Mosquera, Beatriz; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Licenciada en Ciencias Químicas.; Frías, Jesús; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Servicio de Farmacología Clínica, Hospital Universitario la Paz. Madrid, España. Médico especialista en Farmacología Clínica.

    2009-01-01

    A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. The clinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the United States g...

  16. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    Science.gov (United States)

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  17. 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...

  18. Associations between generic substitution and patient-related factors

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette

    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...... was made on beliefs about medicine, views on generic medicine and confidence in the health care system. The study comprised 2476 patients (736 users of antidepressants, 795 users of antiepileptics and 945 users of other substitutable drugs). For each patient we focused on one purchase of a generically...

  19. 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

  20. Medicinal plants and finished marketed herbal products used in the treatment of malaria in the Ashanti region, Ghana.

    Science.gov (United States)

    Komlaga, Gustav; Agyare, Christian; Dickson, Rita Akosua; Mensah, Merlin Lincoln Kwao; Annan, Kofi; Loiseau, Philippe M; Champy, Pierre

    2015-08-22

    Ethnobotanical survey was performed to document medicinal plants employed in the management of malaria in the Bosomtwe and Sekyere East Districts of the Ashanti Region (Ghana), in comparison with the plant ingredients in herbal antimalarial remedies registered by the Ghana Food and Drug Administration. Two hundred and three (203) herbalists from 33 communities within the two districts were interviewed on medicinal plants they use to manage malaria. A literature search was made to determine already documented plants. In addition, 23 finished marketed herbal products indicated for the management of malaria were identified and their labels examined to find out which of the plants mentioned in our survey were listed as ingredients and whether these products are in anyway regulated. Ninety-eight (98) species of plants were cited for the management of malaria. In comparison with literature citations, 12 (12.2%) species were reported for the management of malaria for the first time and 20 (20.4%) others for the first time in Ghana. Twenty-three (23) finished marketed herbal antimalarial products examined contained aerial or underground parts of 29 of the plants cited in our survey as ingredients. Twenty-two (22) of these products have been registered by the Ghana Food and Drugs Authority, four (4) of which were included in the recommended herbal medicine list for treating malaria in Ghana. This study provides new additions to the inventory of medicinal plants used for the management of malaria and reports the commercial availability and regulation of finished marketed labelled herbal products intended for the treatment of malaria in Ghana. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  1. Reference pricing with endogenous generic entry.

    OpenAIRE

    Kurt R. Brekke; Canta, Chiara; Straume, Odd Rune

    2015-01-01

    In this paper we study the effect of reference pricing on pharmaceutical prices and ex-penditures when generic entry is endogenously determined. We develop a Salop-type model where a brand-name producer competes with generic producers in terms of prices. In the market there are two types of consumers: (i) brand biased consumers who choose between brand-name and generic drugs, and (ii) brand neutral consumers who choose between the different generic drugs. We find that, for a given number of ...

  2. "Generic Entry and the Pricing of Pharmaceuticals"

    OpenAIRE

    Frank, Richard G.; David S. Salkever

    1995-01-01

    During the 1980s the share of prescriptions sold by retail pharmacies that was accounted for by generic products roughly doubled. The price response to generic entry of brand-name products has been a source of controversy. In this paper we estimate models of price responses to generic entry in the market for brand-name and generic drugs. We study a sample of 32 drugs that lost patent protection during the early to mid-1980s. Our results provide strong evidence that brand-name prices increase ...

  3. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    Science.gov (United States)

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

  4. Quali-quantitative analysis of best selling drugs from pharmacy, street market and traditional herbal medicine: a pilot study of market surveillance in Senegal.

    Science.gov (United States)

    Pichini, Simona; Rotolo, Maria Concetta; Bellotti, Pasquale; Minutillo, Adele; Mastrobattista, Luisa; Pacifici, Roberta

    2015-02-01

    A pilot study of market surveillance in Senegal has been performed analyzing best selling drugs from an official pharmacy and a street market in two principal cities of Senegal and some traditional preparations from herbal medicine from the same market. A simple and rapid gas chromatography method with mass spectrometry detection has been applied after a liquid-liquid extraction of pharmaceutical products and traditional preparations at acidic, neutral and basic pH with chloroform-isopropanol (9:1, v/v). The assay was validated in the range from 10mg to 250 mg/g powder preparations with good determination coefficients (r(2)≥ 0.99) for the calibration curves. At three concentrations spanning the linear dynamic ranges of the calibration curves, mean recoveries of substances under investigation were always higher than 90% and intra-assay and inter-assay precision and accuracy were always better than 15%. The four best selling drugs purchased from a Dakar local pharmacy exactly contained the amount of active principles reported in the respective labels while the best selling drugs freely purchased from Kaolack market contained an amount of active ingredients lower than that declared on the label. No pharmacological active compound, but salicylic acid was found in one of the traditional herbal preparations. This pilot study showed that whereas official drugs sold in pharmacies at prices accessible for a very few portion of the population contained the amount of active principles as reported in the labels, those from street market bought by the majority of population contained an amount of active ingredients lower than that declared on the label and finally traditional herbal preparations seldom contain pharmacological active principles.

  5. [Competition and prices in the Mexican pharmaceutical market].

    Science.gov (United States)

    Molina-Salazar, Raúl E; González-Marín, Eloy; Carbajal-de Nova, Carolina

    2008-01-01

    The forms of market competition define prices. The pharmaceutical market contains submarkets with different levels of competition; on the one hand are the innovating products with patents, and on the other, generic products with or without trade names. Innovating medicines generally have monopolistic prices, but when the patents expire prices drop because of competition from therapeutic alternatives. The trade name makes it easier to maintain monopolistic prices. In Mexico, medicine prices in the private market are high--according to aggregated estimates and prices for specific medicines--which reflect the limitations of pharmaceutical market competition and the power of the trade name. The public segment enjoys competitive prices using the WHO strategy for essential medicines on the basis of the Essential List.

  6. Generics, Supergenerics and Patent Strategies--SMi's 13th Annual Meeting.

    Science.gov (United States)

    Edwards, Catherine

    2010-07-01

    SMi's 13th Annual Meeting on Generics, Supergenerics and Patent Strategies, held in London, included topics covering new trends in the generics field, the difficulties faced by companies in entering the generics market and recent developments in IP. This conference report highlights selected presentations on generics in India, protecting pharmaceutical products in China, changes in generics law and litigation in the US and Europe, challenges for market selection and entry for generics companies, the influence of changes in the healthcare market on the generics industry, supergenerics, and biosimilars.

  7. Ethnobotanical survey of medicinal plants marketed in the municipality of Uruará, Pará, Brazil

    Directory of Open Access Journals (Sweden)

    Reinaldo Lucas Cajaiba

    2016-02-01

    Full Text Available The present study aimed to perform an ethnobotanical survey of medicinal plants marketed by the population of the municipality of Uruará, Pará, and its main districts. The respondents mentioned 63 species distributed in 36 botanical families. The most representative families were Lamiaceae, Asteraceae, Fabaceae and Rutaceae. The species with the highest Use Value were capim cidreira (Cymbopogon citratus, UV = 0.90, mastruz (Chenopodium ambrosioides, UV = 0.83 and hortelã (Mentha sp., UV = 0.79, while capim cidreira (Cymbopogon citratus and picão (Bidens pilosa had a higher indicator value, and were indicated as a tranquilizer/painkiller and for treating kidney disease, respectively. Among the main disorders treated with medicinal plants, diseases of the digestive system, infections/inflammations, colds and respiratory system diseases were the most cited. There was no significant difference between the number of species mentioned and the number of individuals per family or the distance of households to the urban zone. There was also no difference between the number of species mentioned and education level. Most medicinal plants marketed in the municipality are herbs, leaves are the most used parts and the most common form of preparation is tea.

  8. Skin rash during treatment with generic itraconazole

    Directory of Open Access Journals (Sweden)

    Antonio De Vuono

    2014-01-01

    Full Text Available 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.

  9. Regulatory and clinical aspects of psychotropic medicinal products bioequivalence.

    Science.gov (United States)

    Bałkowiec-Iskra, Ewa; Cessak, Grzegorz; Kuzawińska, Olga; Sejbuk-Rozbicka, Katarzyna; Rokita, Konrad; Mirowska-Guzel, Dagmara

    2015-07-01

    Introduction of generic medicinal products to the market has increased access to modern therapies but also enabled significant reduction in their cost, leading to containment of public expenditures on medicinal products reimbursement. The critical assessment of bioequivalence of any reference medicinal product and its counterpart is based on comparison of their rate and extent of absorption. It is assumed that two medicinal products are bioequivalent when their rate and extent of absorption do not show significant differences when administered at the same dose under similar experimental conditions. Bioequivalent medicinal products are declared to be also therapeutically equivalent and can be used interchangeably. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of this article is to provide a description of rules that guide registration of generic medicinal products in the European Union and to analyze specific examples from the scientific literature concerning therapeutic equivalence of reference and generic antidepressant and antipsychotic medicinal products.

  10. Marketing.

    Science.gov (United States)

    Chambers, David W

    2010-01-01

    There is not enough marketing of dentistry; but there certainly is too much selling of poor quality service that is being passed off as dentistry. The marketing concept makes the patient and the patients' needs the ultimate criteria of marketing efforts. Myths and good practices for effective marketing that will promote oral health are described under the traditional four "Ps" categories of "product" (best dental care), "place" (availability), "promotion" (advertising and other forms of making patients aware of available services and how to use them), and "price" (the total cost to patients of receiving care).

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

    African Journals Online (AJOL)

    D. Husselmann

    Background: Schizophrenia is a costly illness to treat, especially during a time of escalating medicine ... suffer from common mental disorders, including, inter alia, ...... delusional or even hostile when changing their medicine to a generic ...

  12. Anthranoid-containing medicines and food supplements on the Belgian market: a comparative study.

    Science.gov (United States)

    Fierens, C; Corthout, J

    2014-06-01

    Medicines and food supplements containing anthranoid herbal drug preparations were verified on identity of the herbal substance, content of total hydroxyanthracene glycosides and microbiological quality. All examined medicines complied with the fixed requirements whereas all food supplements deviated from 1 or more of the criteria. The food supplements showed a large variability in quality and content.

  13. Políticas de fomento de la competencia en precios en el mercado de genéricos: lecciones de la experiencia europea Policies encouraging price competition in the generic drug market: Lessons from the European experience

    Directory of Open Access Journals (Sweden)

    Jaume Puig-Junoy

    2010-06-01

    Full Text Available Objetivos: Describir políticas alternativas para el fomento de la competencia en precios en el mercado de medicamentos genéricos de países altamente regulados, y presentar algunos casos de estudio de la experiencia europea. Métodos: Revisión sistemática de artículos e informes técnicos posteriores a 1999. Resultados: Las limitaciones a la competencia de precios de venta al público de los genéricos observadas en varios países europeos, entre los que se incluye España, se pueden mitigar mediante reformas de las políticas de reembolso o financiación pública que se pueden clasificar en tres grandes grupos: medidas de mejora y profundización del diseño de los sistemas vigentes de fijación del reembolso máximo; medidas de seguimiento de los precios competitivos con la finalidad de reembolsar a las oficinas de farmacia sólo los costes reales de adquisición; y medidas de fomento de la competencia de precios en las adquisiciones públicas basadas en instrumentos de mercado como las subastas competitivas. La experiencia de las medidas adoptadas en los últimos años en Alemania, Bélgica, Holanda, Noruega y Suecia resulta una referencia útil para los países altamente regulados, como España, caracterizados por una limitada competencia de precios de venta al público y elevados descuentos a las oficinas de farmacia. Conclusiones: Resulta posible adoptar medidas efectivas de fomento de la competencia de precios de venta al público en los mercados de medicamentos genéricos en los países con una regulación directa de los precios o sistemas de precios de referencia como instrumento privilegiado para reducir el precio de los genéricos.Objectives: 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. Methods: Systematic literature review of articles and technical reports published

  14. 中国制药企业在美国市场中应对授权仿制药竞争的策略研究%Research on Strategy of China Pharmaceutical Companies Coping with Competition of Authorized Generics in American Drug Market

    Institute of Scientific and Technical Information of China (English)

    刘立春; 朱雪忠

    2013-01-01

    OBJECTIVE To study the principle,feature and impact of the authorized generics strategy in American drug market,thus to provide some references for Chinese scholars who research the authorized generics strategy and for China pharmaceutical companies that would face competition in American pharmaceutical market.METHODS By case study and policies analysis,the ways how the brand-name companies used the authorized generics in American drug market were summarized.RESULTS AND CONCLUSION Successful authorized generics strategy can maintain a large market share of the brand-name companies'products.In American drug market,there are some particularities about the authorize generics strategy due to the features of American drug policies and regulations.China pharmaceutical companies should implement different authorized generics strategy according to their own conditions in American drug market at present.%目的 通过对美国授权仿制药战略原理、特点以及影响进行研究,为中国学者探讨授权仿制药战略以及中国制药企业在美国市场面临授权仿制药竞争时提供借鉴.方法 通过案例分析和政策解析,总结品牌药厂商在美国市场中使用授权仿制药策略的特点.结论与结果 成功的授权仿制药战略能够使品牌药厂商的产品在专利到期后仍能后维持较大的市场份额.中国制药企业需要根据自身的情况在美国市场选择不同的授权仿制药策略.

  15. The Marketing Strategy of Traditional Chinese Medicine in the International Market%中药国际市场营销策略研究

    Institute of Scientific and Technical Information of China (English)

    刘爽

    2015-01-01

    自全球金融危机以来,中药进出口额不断降低。依据对中药国际市场营销的SWOT分析显示,我国中医药悠久历史,资源丰富,中药产业已初具规模,世界人口的增长及老龄化趋势,人类疾病谱的变化以及宽松的法律环境有利于中药市场的发展。但产品质量难以保证,出口产品结构不合理,知识产权保护意识淡薄,国际贸易壁垒,“洋中药”的冲击以及文化的差异降低中药的出口额。我国应增强对中医药的文化传播,注重中药知识产权的保护,提高产品质量并加强剂型开发;中医药企业应保持自身优势,积极改革创新,积极开拓国际市场,不断提升我国中医药的国际竞争力。%Since the global financial crisis, the import and export amount of Traditional Chinese Medicine (TCM) has increasingly reduced. According to the SWOT analysis, TCM has a long history and rich resources. TCM industry has begun to take shape. And it is conducive to the development of TCM market with world population growth, aging population trend, changes in human disease spectrum and loose legal environment. But exports of TCM are decreasing as it is difficult to guarantee the quality of products, the structure of export products is ir-rational, and the awareness of intellectual property protection is weak. Other factors include international trade barriers, the impact of Chi-nese herbal medicine made in foreign countries and cultural differences. China should enhance the dissemination of the culture of Chinese herbal medicine, pay attention to the protection of intellectual property of TCM, improve the quality of products and strengthen dosage form development. Chinese medicine enterprises should maintain its own advantages, proactively make reforms and innovations, explore the in-ternational market, and improve the international competitiveness of TCM.

  16. Methods for implementing a medicine outlet survey: lessons from the anti-malarial market

    National Research Council Canada - National Science Library

    O'Connell, Kathryn A; Poyer, Stephen; Solomon, Tsione; Munroe, Erik; Patouillard, Edith; Njogu, Julius; Evance, Illah; Hanson, Kara; Shewchuk, Tanya; Goodman, Catherine

    2013-01-01

    In recent years an increasing number of public investments and policy changes have been made to improve the availability, affordability and quality of medicines available to consumers in developing...

  17. [Prudent use price controls in Chinese medicines market: based on statistical data analysis].

    Science.gov (United States)

    Yang, Guang; Wang, Nuo; Huang, Lu-Qi; Qiu, Hong-Yan; Guo, Lan-Ping

    2014-01-01

    A dispute about the decreasing-price problem of traditional Chinese medicine (TCM) has recently arisen. This article analyzes the statistical data of 1995-2011 in China, the results showed that the main responsibility of expensive health care has no direct relationship with the drug price. The price index of TCM rose significantly slower than the medicine prices, the production margins of TCM affected by the material prices has been diminishing since 1995, continuous price reduction will further depress profits of the TCM industry. Considering the pros and cons of raw materials vary greatly in price, decreasing medicine price behavior will force enterprises to use inferior materials in order to maintain corporate profits. The results have the guiding meaning to medicine price management.

  18. European Medicines Agency Perspective on Oncology Study Design for Marketing Authorization and Beyond.

    Science.gov (United States)

    Jonsson, B; Martinalbo, J; Pignatti, F

    2017-05-01

    In the development of highly active anticancer drugs, the European situation may be viewed as paradoxical. Limited data may support marketing authorization, but may be insufficient for the health economic appraisal needed for reimbursement and market uptake. To achieve this, conventional confirmatory studies may be needed. For products of special interest, studies aimed at optimizing cost-effectiveness may be warranted. Efficient designs of studies to meet these objectives constitute challenges to all stakeholders. © 2017 ASCPT.

  19. Patients' attitude about generics –Bulgarian perspective

    Directory of Open Access Journals (Sweden)

    Hristina Lebanova

    2012-01-01

    Full Text Available OBJECTIVE: The aim of the present study is to investigate (1 what is the patients' attitude towards and (2 preferences to use generic medicines in Bulgaria and (3 which are the main factors influencing their opinion.METHODS: Using pseudo-randomization we select a sample of 225 participants, men and women from general population, patients in community pharmacies. For our survey we used a standardized self-questionnaire of ten points. The influence of sex, age, education, medical history, knowledge of generic drugs and experience with generic substitution and medicines was examined through Chi-square tests.RESULTS: The results show that 74% of the participants seemed not to be informed on generic drugs and 26% received valuable and relevant information from their general practitioner or pharmacist. 94% believed that generic medicines are inferior to brand medicines on quality, safety and efficacy.CONCLUSIONS: The main reason for almost all the participants (94% to prefer original medicines, over generics is the insufficient information, they have. The core factors forming patients' opinion and expectations for generic drugs are medical professionals' recommendation and previous experience. The main advantages of the generics according to the participants in the study are the lower price and better accessibility. The results raise the issue of the awareness and level knowledge about generic medicines and the rational drug use in the general population.

  20. The impact of generic substitution on the activities of pharmaceutical companies - a survey from the companies' perspective one year and five years after the introduction of generic substitution in finland

    Science.gov (United States)

    2010-01-01

    Background Mandatory generic substitution (GS) was introduced in Finland on 1 April 2003. The aim of this study was to explore and compare the impacts of GS on the activities of pharmaceutical companies representing mainly original or generic pharmaceutical products in Finland. The self-reported impact of GS from pharmaceutical companies' perspective was explored with a focus on the number of employees, the range of sales packages on the market, the marketing activities, the research and development of new pharmaceutical products and storage of pharmaceuticals. Methods A cross-sectional postal survey was conducted among pharmaceutical companies with an office in Finland and substitutable medicines in the Finnish pharmaceutical market one year (2004) and five years (2008) after the introduction of GS. Completed questionnaires were returned by 16 original and 7 generic product companies in 2004 (response rate 56%, n = 41) and by 16 original and 6 generic product companies in 2008 (response rate 56%, n = 39). Descriptive statistical analyses were performed. Results The number of employees (2004: n = 6/16, 2008: n = 7/16) and the amount of prescription medicine marketing (2004: n = 7/16, 2008: n = 8/16) decreased in many of the original product companies after the introduction of GS. GS resulted in problems related to the storage of pharmaceuticals in the original product companies shortly after GS was introduced (p = 0.032 between 2004 and 2008). In the generic product companies, the prescription medicine representatives' visits to pharmacies increased at the beginning of GS (p = 0.021 between 2004 and 2008). In addition, GS caused problems with the storage of pharmaceuticals one year and five years after the reform (2004: n = 4/7, 2008: n = 3/6). The differences between original and generic product companies regarding the impacts of GS were not, however, statistically significant. GS did not affect on the range of sales packages on the market or the research

  1. HIV/AIDS treatment and physicochemical quality control of medicines: evaluation of non-generic lamivudine + zidovudine tablets manufactured in Brazil

    Directory of Open Access Journals (Sweden)

    Ruy Carlos Ruver Beck

    Full Text Available In this work it was evaluated the physicochemical quality of lamivudine + zidovudine tablets, whose association belongs to the list of drugs distributed by the Brazil's National Program on Sexually Transmitted Diseases and AIDS. Four non-generic products (lamivudine + zidovudine tablets were analyzed. They were obtained from different Brazilian manufacturers, besides a reference product. The quality was evaluated by physicochemical tests described in the official codes. A validated reversed-phase high performance liquid chromatography (HPLC method was used for the assay of the active substances. All samples were in accordance to the requisites in relation to their physicochemical characteristics. Dissolution studies showed similar drug percentual dissolved among all samples. The results reflect the interest of the national pharmaceutical industry to ensure the delivery of safer and cheaper drugs to the Brazilian people, with particular importance in the National Program on Sexually Transmitted Diseases and AIDS.

  2. HIV/AIDS treatment and physicochemical quality control of medicines: evaluation of non-generic lamivudine + zidovudine tablets manufactured in Brazil.

    Science.gov (United States)

    Beck, Ruy Carlos Ruver; Athayde, Margareth Linde; Cardoso, Simone Gonçalves

    2007-12-01

    In this work it was evaluated the physicochemical quality of lamivudine + zidovudine tablets, whose association belongs to the list of drugs distributed by the Brazil's National Program on Sexually Transmitted Diseases and AIDS. Four non-generic products (lamivudine + zidovudine tablets) were analyzed. They were obtained from different Brazilian manufacturers, besides a reference product. The quality was evaluated by physicochemical tests described in the official codes. A validated reversed-phase high performance liquid chromatography (HPLC) method was used for the assay of the active substances. All samples were in accordance to the requisites in relation to their physicochemical characteristics. Dissolution studies showed similar drug percentual dissolved among all samples. The results reflect the interest of the national pharmaceutical industry to ensure the delivery of safer and cheaper drugs to the Brazilian people, with particular importance in the National Program on Sexually Transmitted Diseases and AIDS.

  3. New National Drug Policy in Iran leading to Expanded Pharma¬ceutical Market and Extended Access of Public to Medicines

    Directory of Open Access Journals (Sweden)

    R Dinarvand

    2009-03-01

    Full Text Available "nPharmaceutical market in Iran has been expanding since 2001 when the new development act was approved in the parlia­ment of the Islamic republic of Iran. The pharma market size has annually increased 6.8% in terms of volume and 18.5% in terms of value.  However, the growth rate of imported items has been greater than locally produced items both in terms of value and volume. This may be mainly due to the introduction of free market regulations at macroeconomic point of view that has influenced the pharmaceutical market as well. The expansion of pharmaceutical market is welcomed by the industry which is investing heavily in the manufacturing and research and development capacity of pharma sector in Iran. However it does also mean greater access of the public to essential and vital medicines. In the same situation the presence of extra choices in the market may be a challenge for the local industry as the demand for higher quality medicines grows. Market forces are always a challenge for the advocacy of rational prescription and use of medicines.

  4. Where is industry getting it wrong? A review of quality concerns raised at Day 120 by the Committee For Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products.

    Science.gov (United States)

    Borg, John Joseph; Robert, Jean-Louis; Wade, George; Aislaitner, George; Pirozynski, Michal; Abadie, Eric; Salmonson, Tomas; Vella Bonanno, Patricia

    2009-01-01

    The aim of this study was to identify common trends in the deficiencies identified in the quality part of the dossier during the evaluation of marketing authorisation applications for medicinal products for human use submitted through the EU's centralised procedure. We analysed all the adopted Day 120 list of questions on the quality module of 52 marketing authorisation applications for chemical entity medicinal products submitted to the European Medicines Agency and evaluated by the Committee for Medicinal Products for Human Use (CHMP), during 12 consecutive plenary meetings held in 2007 and 2008. Subsequently we calculated the frequency of common deficiencies identified across these applications. Frequencies and trends on quality deficiencies have been recorded and presented for 52 marketing authorisation applications. 32 "Major Objections" originated from 13 marketing authorisation applications. 13 concerned were raised regarding drug substances and 19 for drug products. Furthermore, 905 concerns on drug substance and 1,054 on drug product were also adopted. The impact of the frequencies and trends in quality deficiencies that were identified are discussed from a regulatory point of view. It is expected that the results of this study will not only be of interest to pharmaceutical companies but will also aid regulators' in obtaining consistent information on drug products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

  5. 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.

  6. Personalized Medicine: how to Switch from the Concept to the Integration into the Clinical Development Plan to Obtain Marketing Authorization.

    Science.gov (United States)

    Becquemont, Laurent; Bordet, Régis; Cellier, Dominic

    2012-01-01

    One of the challenges of the coming years is to personalize medicine in order to provide each patient with an individualized treatment plan. The three objectives of personalized medicine are to refine diagnosis, rationalize treatment and engage patients in a preventive approach. Personalization can be characterized by various descriptors whether related to the field, biology, imaging, type of lesion of the entity to be treated, comorbidity factors, coprescriptions or the environment As part of personalized medicine focused on biological markers including genetics or genomics, the integration of the clinical development plan to obtain marketing authorization may be segmented in 3 stages with a known descriptor identified before clinical development, a known descriptor discovered during clinical development or a known descriptor known after clinical development. For each stage, it is important to clearly define the technical optimization elements, to specify the expectations and objectives, to examine the methodological aspects of each clinical development phase and finally to consider the fast changing regulatory requirements in view of the few registered therapeutics complying with the definition of personalized medicine as well as the significant technological breakthroughs according to the screened and selected biomarkers. These considerations should be integrated in view of the time required for clinical development from early phase to MA, i.e. more than 10 years. Moreover, business models related to the economic environment should be taken into account when deciding whether or not to retain a biomarker allowing the selection of target populations in a general population. © 2012 Société Française de Pharmacologie et de Thérapeutique.

  7. [Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming; Fu, Yingkun

    2011-10-01

    Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.

  8. In silico regenerative medicine: how computational tools allow regulatory and financial challenges to be addressed in a volatile market.

    Science.gov (United States)

    Geris, L; Guyot, Y; Schrooten, J; Papantoniou, I

    2016-04-06

    The cell therapy market is a highly volatile one, due to the use of disruptive technologies, the current economic situation and the small size of the market. In such a market, companies as well as academic research institutes are in need of tools to advance their understanding and, at the same time, reduce their R&D costs, increase product quality and productivity, and reduce the time to market. An additional difficulty is the regulatory path that needs to be followed, which is challenging in the case of cell-based therapeutic products and should rely on the implementation of quality by design (QbD) principles. In silico modelling is a tool that allows the above-mentioned challenges to be addressed in the field of regenerative medicine. This review discusses such in silico models and focuses more specifically on the bioprocess. Three (clusters of) examples related to this subject are discussed. The first example comes from the pharmaceutical engineering field where QbD principles and their implementation through the use of in silico models are both a regulatory and economic necessity. The second example is related to the production of red blood cells. The described in silico model is mainly used to investigate the manufacturing process of the cell-therapeutic product, and pays special attention to the economic viability of the process. Finally, we describe the set-up of a model capturing essential events in the development of a tissue-engineered combination product in the context of bone tissue engineering. For each of the examples, a short introduction to some economic aspects is given, followed by a description of the in silico tool or tools that have been developed to allow the implementation of QbD principles and optimal design.

  9. Medicinal plants traded in the open-air markets in the State of Rio de Janeiro, Brazil: an overview on their botanical diversity and toxicological potential

    OpenAIRE

    Fernanda Leitão; Suzana Guimarães Leitão; Viviane Stern da Fonseca-Kruel; Ines Machline Silva; Karine Martins

    2014-01-01

    Medicinal plants have been used for many years and are the source of new active substances and new drugs of pharmaceutical interest. The popular knowledge contained in the open-air markets is studied through urban ethnobotany, and is a good source of information for ethnobotanical research. In this context, we surveyed the literature on works concerning open-air markets in the State of Rio de Janeiro to gather knowledge of the commercialized plants therein. A literature search resulted in ten...

  10. Potential metal impurities in active pharmaceutical substances and finished medicinal products - A market surveillance study.

    Science.gov (United States)

    Wollein, Uwe; Bauer, Bettina; Habernegg, Renate; Schramek, Nicholas

    2015-09-18

    A market surveillance study has been established by using different atomic spectrometric methods for the determination of selected elemental impurities of particular interest, to gain an overview about the quality of presently marketed drug products and their bulk drug substances. The limit tests were carried out with respect to the existing EMA guideline on the specification limits for residuals of metal catalysts or metal reagents. Also attention was given to the future implementation of two new chapters of the United States Pharmacopoeia (USP) stating limit concentrations of elemental impurities. The methods used for determination of metal residues were inductively coupled plasma-mass spectrometry (ICP-MS), inductively coupled plasma-optical emission spectrometry (ICP-OES), and atomic absorption spectrometry technologies (GFAAS, CVAAS, HGAAS). This article presents the development and validation of the methods used for the determination of 21 selected metals in 113 samples from drug products and their active pharmaceutical ingredients.

  11. Perceptions and patterns of use of generic drugs among Italian family pediatricians: first round results of a web survey.

    Science.gov (United States)

    Fabiano, Valentina; Mameli, Chiara; Cattaneo, Dario; Delle Fave, Antonella; Preziosa, Alessandra; Mele, Giuseppe; Clementi, Emilio; Zuccotti, Gian Vincenzo

    2012-03-01

    Prescription of generic medicines represents an efficacious healthcare cost containment strategy. In some European countries and in the US, generic medicines are largely prescribed. In Italy, generic drugs prescription rate is lower. General Practitioners and Family Pediatricians may be less confident in prescribing generic equivalents instead of "branded" medicines. There are currently no data about Italian Family Pediatricians' perceptions and patterns of use of generic drugs. This is a first nationwide web survey conducted with the aim to evaluate generic medicines knowledge and prescribing habits of Italian Family Pediatricians. 303 Family Pediatricians completed the online questionnaire. 37.2% and 32.6% of them declared to have a sufficient or fairly good knowledge of generic medicines, respectively, and the majority of them believed that efficacy of generic medicines was sufficient (33.6%) or good (45.2%). Nevertheless, Italian Family Pediatricians are still prone to prescribe trade medicines more frequently, since only 13.5% of them declared that more than a half of their patients were treated with generic medicines. Major issues related with generic medicines prescriptions by Italian Family Pediatricians seem to be represented by diffuse scepticism about reliability of bioequivalence tests and safety of switchability from branded to generic equivalents. More information about generic drugs and more research in the field of pediatric pharmacology are needed for increasing generic medicines prescription rate among Italian Family Pediatricians.

  12. Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.

    Science.gov (United States)

    Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

    2015-05-01

    On September 11, 2014, a workshop entitled 'Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market' was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT.

  13. GENERIC DRUG USER FEE: AN OVERVIEW

    Directory of Open Access Journals (Sweden)

    Darshit S. Patel*, Abhishek R. Patel and Narendra A. Patel

    2012-09-01

    Full Text Available The globalization of generic drug manufacturing, supply and testing, and a growing workload that has far outpaced USFDA’s resources has created new challenges. USFDA & Industry propose generic drug user fee to address the need for globalization of the inspection process, and to speed the timely review of generic product applications. The Generic Drug User Fee (GDUF proposal is agreed by generic industry & USFDA and is focused on three key aims: safety, access, and transparency. Under the program, USFDA will receive nearly $1.5 billion over five years in supplemental funding through generic industry user fees in order to help the agency expedite access to generic drugs, enhance drug quality and safety and ensure inspection parity of both foreign and domestic manufacturing sites. GDUF also will help accelerate the market entry of additional manufacturers of drugs currently in short supply and improve quality, consistency, and availability within the supply chain, further helping to mitigate drug shortages. The GDUF new legislation is a milestone for the generic giants and a major win for American health care consumers.

  14. [Skin test: guide of post-marketed re-evaluation of clinical safety in traditional Chinese medicine injection].

    Science.gov (United States)

    Wei, Xu; Xie, Yanming; Wang, Yongyan

    2011-10-01

    Anaphylaxis is the most common adverse reaction caused by traditional Chinese medicine (TCM) injection, the most serious of which is type I, so post-marketed safety re-evaluation is necessary. Skin test can be used to screen type I allergy reaction, which is of great significance for TCM injection safe use. Skin test is not only able to find the population sensitization situation of TCM injection, but also is a way of understanding the mechanism of allergy reaction. TCM injection varieties that often occur type I anaphylaxis are applicable to skin test, and study population include healthy volunteers and patients whose disease is listed in the drug specification, intracutaneous test and prick test are the alternative method. The concentration of skin-test solution may influence the positive rate of skin test, penicillin skin-test solution preparation method can be used as the reference in TCM injection. Different doses of TCM injection skin-test solution,glucose injection and normal saline, histamine hydrochloride are comprised in comparison. Given the characteristics of type I allergy reaction,we should be pay close attention to skin test reaction in half an hour, and observation index need be designed based on post-marketed re-evaluation of clinical safety.

  15. Finding generically stable measures

    CERN Document Server

    Simon, Pierre

    2010-01-01

    We discuss two constructions for obtaining generically stable Keisler measures in an NIP theory. First, we show how to symmetrize an arbitrary invariant measure to obtain a generically stable one from it. Next, we show that suitable sigma-additive probability measures give rise to generically stable measures. Also included is a proof that generically stable measures over o-minimal theories and the p-adics are smooth.

  16. [Key elements of design about PPK of Chinese medicine after marketing].

    Science.gov (United States)

    Wang, Jiannong; Jiang, Junjie; Xie, Yanming

    2011-10-01

    PPK is a discipline that quantitative investigates the determinants of drug concentration in patient groups. Developing reasonable PPK design of experiment can provides the real objective data for clinical medicationand then promotes the formulating of clinical individualized medication regimens. This paper referenced over all years literatures, and combined with practical work experience. Summarizes of the main points of PPK design of experiment focused on traditional Chinese medicine. The content mainly included choosing research objects, selecting items, designing sample collection steps, blood sample analysis experiments and data analysis schemes.

  17. 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 invo

  18. Macro- and Trace metals in three Medicinal Herbs Collected from Baghdad, Iraq Market.

    Directory of Open Access Journals (Sweden)

    Abdul Latif Mohammed Raouf

    2014-11-01

    Full Text Available Several metals (Ca, Mg, Zn, Fe, Pb, Cd, Cr, Mn, Ni, and Co were determined in three medicinal herbs (Feverfew (Tanacetum parthenium, Rosemary (Rosmarinus officinalis, Chamomile or camomile (Matricaria chamomilla by applying Flame Atomic Absorption Spectrophotometer. The obtained results showed that Calcium content in tested herb was ranged (1-3.675 ppm. Magnesium maximum content (4247.5 ppm presented in rosemary was higher and with this content kidney stone may be formed easily with other affected factors. Zinc concentration varied from (4.8-35.5 ppm reflecting type of plant effect on element transfer and accumulation in plant. Iron was with higher content (32-490 ppm compared with WHO recommendations. Lead content (3 ppm in all tested herbs was less than the WHO highest limits but higher than Germany limits. Cadmium content found (0.575 ppm only in Rosemary among three tested herbs which is more than WHO and Germany limitations. Chromium ranged (6-12 ppm that may be a result of its low solubility water and plant uptake. Manganese - Chamomile was below WHO maximum limit (200 ppm in medicinal plants with the lowest concentration (10.25 ppm while rosemary and feverfew had (27.75 and 12.375 ppm respectively. Nickel content ranged (8.8125-10.25 ppm was higher than WHO limitations. Cobalt was found in rosemary herb (1.85 ppm while feverfew and chamomile were with the same content (0.5 ppm.

  19. Market reforms in English primary medical care: medicine, habitus and the public sphere.

    Science.gov (United States)

    McDonald, Ruth

    2009-07-01

    Drawing on interviews with English primary care doctors (GPs), this paper examines GP responses to reforms intended to introduce a market in primary health care. GPs' reactions are conceptualised in terms of a GP habitus, which takes for granted the superiority of 'public' providers (i.e. GP partnerships) in the provision of care. GPs are actively involved in the defence of the public sphere, which is neither a neo-liberal minimalist market state, nor a wholly altruistic state, responding to consumers' wants. The public sphere they defend is one in which boundaries are drawn about entitlements and GPs are actively engaged in defining and policing these boundaries. The GP habitus can be seen as shaping responses in ways which serve GP interests. In the context of struggles involving various social actors (e.g. private providers, third-party payers, patients) with different stakes in the field of general medical practice; this public service orientation may enable GPs to reap cultural capital. At the same time, the habitus constrains action in a way which limits resistance to reforms threatening GPs' interests, with GPs responding by coping, rather than downing tools or engaging in active confrontation.

  20. Changes in prescription habits with the introduction of generic fluoxetine.

    Science.gov (United States)

    McLay, Robert; Klinski, Angelica

    2008-01-01

    When the patent on fluoxetine expired in 2001, prices for it fell sharply and marketing decreased. We investigated how market share for fluoxetine changed with the introduction of the generic. Prescribing information was tracked at a military hospital where providers knew the cost of medication, but were not compelled to use the cheaper form. Market share for fluoxetine among selective serotonin reuptake inhibitors was observed for the 64 months surrounding the introduction, and changes were examined by linear regression analysis. Results showed that in the 32 months before the introduction of the generic, fluoxetine maintained a relatively steady share of prescriptions. After the introduction of the generic, fluoxetine steadily lost market share over time. No significant relationship could be seen between drug company visits and gains for their individual products. Examination of all Department of Defense prescriptions for the 16 months surrounding the introduction of generic fluoxetine showed a similar drop in its market share.

  1. Prepsychotic treatment for schizophrenia: preventive medicine, social control, or drug marketing strategy?

    Science.gov (United States)

    Gosden, R

    1999-01-01

    The definition of schizophrenia is currently being extended to include a "prepsychotic" phase. Prepsychosis detection and intervention programs have already been established in Australia. These are intended to identify people "at-risk" for schizophrenia and treat them to prevent their transition into psychosis. However, analysis of leading research in this field shows high levels of arbitrariness in the selection of diagnostic indicators and a lack of convincing evidence about the efficacy of treatments. The favored prophylactic treatment is atypical neuroleptic medication, and sponsorship of research is providing manufacturers of these drugs with a ubiquitous presence in the field. Many risks are associated with atypical neuroleptics and adverse reactions include psychosis. Taken together these factors suggest that prepsychotic intervention may be more concerned with expanding the market for atypical neuroleptics than with preventing schizophrenia.

  2. Adverse event reporting for herbal medicines: a result of market forces.

    Science.gov (United States)

    Walji, Rishma; Boon, Heather; Barnes, Joanne; Austin, Zubin; Baker, G Ross; Welsh, Sandy

    2009-05-01

    Herbal products are readily available over the counter in health food stores and are often perceived to be without risk. The current Canadian adverse event reporting system suffers from severe underreporting, resulting in a scarcity of safety data on herbal products. Twelve health food store personnel in the Greater Toronto Area were interviewed about their responses to herbal product-related adverse reactions. They generally fostered customer loyalty by offering generous return policies, which included collecting contact information to be sent to the manufacturers with the returned product. Thus, despite the public's lack of knowledge about the formal reporting system, adverse reaction information was directed to manufacturers whenever it resulted in a product return. The relationship between health food stores, industry and Health Canada provides a new opportunity to facilitate adverse event reporting. Additional information could be collected during the return process, and educational initiatives could be implemented to augment current post-market surveillance procedures for herbal products.

  3. Heavy Metals (Lead and Cadmium in some Medicinal Herbal Products in Iranian Market

    Directory of Open Access Journals (Sweden)

    Zahra Mousavi

    2014-03-01

    Full Text Available Background: The use of herbal or medicinal plants in various forms has been popular for thousands of years. It is estimated that about 70–80% of the world’s population relies on alternative medicine, mainly of herbal origin. However, due to the nature and sources of these plants, they are sometimes contaminated with toxic heavy metals, which pose serious health risks to consumers. Herbal formulations, especially those used in the treatment of diseases such as hypertension, diabetes, and weight loss may require long-term usage and the patient might be at risk of heavy metal poisoning. In this study, the levels of toxic heavy metals (Pb, Cd were evaluated in 11 Iranian common herbal drugs for their health implications. Methods: In this investigation, concentrations of lead and cadmium were quantitatively determined in Iranian herbal drugs sampled from pharmacies in Tehran, Iran, using atomic absorption spectrophotometry (wet digestion. Results: The results indicated that lead and cadmium were present in all investigated herbal drugs. The concentrations of metals in drugs ranged from 0.19 to 1.75 µg/g for Cd and 9.61 to 52.74 µg/g for Pb. Conclusion: The concentrations of lead and cadmium were higher than the maximum permissible daily levels in the majority of these herbal drugs, whereas the quantities of Pb and Cd were well below provisional tolerable weekly intake (PTWI. Daily total intake of these metals is considered in accord with the recommended daily intake of their corresponding formulations.

  4. Prevention is still the best medicine. Condom social marketing campaign changes attitudes and actions in Guinea.

    Science.gov (United States)

    Hess, L L

    1993-09-01

    In Guinea, jingles promoting Prudence condoms are heard on radio and television in 4 different national languages 5 times a day. This has produced an attitudinal change through an intense national media campaign orchestrated by the USAID-financed Social Marketing of Contraceptives Project carried out by Population Services International (PSI), which provides family planning information, products and services through public and private outlets for 500,000 sexually active couples. PSI's paid media campaign has sponsored call-in talk shows on women and AIDS and religion and AIDS at the rural radio station in Labe. Billboards placed in key locations remind people that using condoms helps prevent AIDS. PSI organized a team of 10 Prudence condom marketing agents in March 1992 to establish 400 nontraditional retail and 50 traditional retail and wholesale outlets for condoms. Outlets include pharmacies, restaurants, hotels, grocery stores, and nightclubs. The distributors sell the condoms at a profit. In the first 6 months, PSI distributed 2.3 million condoms. Young women want to space their children and limit the number of children, said the chief midwife for the Guinean Association for Family Well Being clinic in Conakry. Guinea's population growth rate is 2.8%, which will result in a doubling of the population in 25 years. In May 1992, Guinea's government ratified a national population policy supporting family planning. One of the primary goals is to increase contraceptive use to 25% of all couples. PSI works with the Ministry of Health and the Guinean Association for Family Well Being to integrate family planning and sexually transmitted disease prevention activities into 32 primary health care centers in Guinea's Forest Region. To combat the spread of HIV infection, PSI provides technical assistance to the National AIDS Committee to carry out AIDS information activities throughout the country, targeting the military, police, truck drivers, and students.

  5. Prices of Generic Heart Failure Drugs Vary Widely

    Science.gov (United States)

    ... medlineplus.gov/news/fullstory_162035.html Prices of Generic Heart Failure Drugs Vary Widely Patients can spend from $12 to $ ... Nov. 15, 2016 (HealthDay News) -- Cash prices of generic medicines to treat heart failure vary so widely that ...

  6. Resisting market-inspired reform in healthcare: the role of professional subcultures in medicine.

    Science.gov (United States)

    Martinussen, Pål Erling; Magnussen, Jon

    2011-07-01

    The reorganisation efforts of the hospital sector in many Western countries in recent decades have challenged the role, identity and autonomy of medical professionals. This has led to increased focus on the role and impact of physicians who are also managers and on the unique discourse being formed through the integration of medical and managerial knowledge. Following the line of studies addressing the professional subcultures in medicine, we investigated whether assessments of health reform differ between medical doctors with managerial responsibilities and their colleagues at the clinical level as well as between those involved in direct patient care and those who are not. The analysis was performed within the context of the Norwegian hospital sector, where a major reform was implemented in 2002, and it was based on a survey of a representative sample of hospital physicians in 2006. The analysis focused on how the respondents viewed the overall effect of the reform and on the reform's effect on three central health policy goals: equity, quality and productivity. Combining data from the survey with organisational and financial data from the hospitals, we employed multilevel techniques to control for a number of individual and hospital-specific factors that could explain the physicians' views. As expected, respondents with managerial responsibilities were more positive in their evaluations of the reform, whereas respondents who spent time on direct patient-related work showed the opposite pattern. Of the hospital-specific factors of interest, the share of department managers with medical backgrounds and the economic situation positively affected the evaluations. Our findings support the view that, rather than managerialist values colonising the medical profession through a process of hybridisation, there is heterogeneity within the profession: some physician managers are adopting management values and tools, whereas others remain alienated from them. Copyright

  7. Comparison of outcomes following a switch from a brand to an authorized vs. independent generic drug.

    Science.gov (United States)

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

    2016-12-16

    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 1999-2014, 5,234 unique patients were on brand drug 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 visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparator. This article is protected by copyright. All rights reserved.

  8. Medicinal Product Regulation: Portugal׳s Framework.

    Science.gov (United States)

    Herdeiro, Maria Teresa; Bastos, Paulo D; Teixeira-Rodrigues, António; Roque, Fátima

    2016-09-01

    The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED). From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required. In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety. The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

  9. Pharmacopoieal quality of non-expired and expired nifedipine formulations from Estonian and Russian Federation medicinal products market.

    Science.gov (United States)

    Teder, Kersti; Pepeloshev, Andrei; Matto, Vallo; Meos, Andres

    2013-01-01

    The pharmacopoeial quality of non-expired and expired nifedipine tablets of the same batches purchased from the Estonian and Russian Federation medicinal product markets was evaluated. The IR spectroscopy, HPLC analysis for quantitative content and purity of the active pharmaceutical ingredient (API), and dissolution test techniques were applied. In the experiments with non-expired nifedipine tablets, in all Estonian (n = 8, label claims 10, 20, and 40 mg) and Russian Federation (n = 4, label claim 10 mg) registered formulations the API was identified and quantified as nifedipine in amounts set by the European Pharmacopoeia and without exceeding the tolerance limits for the impurities. The dissolution rate was variable but all 10 and 20 mg non-expired nifedipine tablets released at least 80% of API in 12 h. The expiration of the nifedipine tablets led to somewhat increased dissolution rate while only traces of the nifedipine degradation products were discovered in the dissolution medium. In conclusion, our present study shows that with minor variations the Estonian and Russian Federation registered nifedipine tablets are comparable, the API preserves well beyond the expiration date but the expired nifedipine tablets may release the API faster than the non-expired tablets.

  10. [Counterfeit medicines: a growing threat].

    Science.gov (United States)

    Barbereau, S

    2006-12-01

    The medical drug market has undergone considerable transformation in recent years. Like other products, medicines have been affected by globalization. Free trade policies have had a number of negative effects including a reduction in quality control not only for some products but also for raw materials and finished products. The global environment has also created conditions conducive to counterfeit medicines. The term counterfeit medicine is defined differently from one country to another in terms of quality, legality and fraudulent intent. This situation prompted the WHO to propose the following definition: "A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging." Weak pharmaceutical regulation often compounded by widespread corruption in developing countries has greatly facilitated the development of this illicit market with harmful and costly effects on public health. Due to the lack of pharmocovigilance accidents involving use of counterfeit drugs go unreported. For this reason it is not possible to measure the economic impact. While counterfeiting has become a major threat in developing countries, it also affects industrialized countries. Fraudulent behavior occurs all over the world.

  11. Generic Fortran Containers (GFC)

    Energy Technology Data Exchange (ETDEWEB)

    2016-09-01

    The Fortran language does not provide a standard library that implements generic containers, like linked lists, trees, dictionaries, etc. The GFC software provides an implementation of generic Fortran containers natively written in Fortran 2003/2008 language. The following containers are either already implemented or planned: Stack (done), Linked list (done), Tree (done), Dictionary (done), Queue (planned), Priority queue (planned).

  12. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

    Science.gov (United States)

    Regnstrom, Jan; Koenig, Franz; Aronsson, Bo; Reimer, Tatiana; Svendsen, Kristian; Tsigkos, Stelios; Flamion, Bruno; Eichler, Hans-Georg; Vamvakas, Spiros

    2010-01-01

    To identify factors associated with success of Market Authorisation Applications (MAAs) for pharmaceutical drugs submitted to the European Medicines Agency (EMEA), with an emphasis on the Scientific Advice (SA) given by the Committee for Human Medicinal Products (CHMP). MAAs with a CHMP decision (outcome) between 1 January 2004 and 31 December 2007 were included in the analysis. Factors evaluated were: company size, orphan drug (OD) status, product type, existence of SA, compliance with SA, therapeutic area and year of outcome. Compliance with SA was retrospectively assessed with reference to three critical clinical variables in pivotal studies: choice of primary endpoint, selection of control and statistical methods. Of 188 MAAs with an outcome, 137 (72.9%) were approved, whereas 51 (27.1%) were not approved or were withdrawn by the company. In the simple logistic regression analysis, company size [odds ratio (OR) 2.96, 95% confidence interval (CI) 1.92; 4.56, p analysis revealed that company size and SA compliance were independent predictors of outcome. The proportion of the MAAs that had received SA increased from 22% in 2004 to 47% in 2007. Company size and product type were associated with the frequency of requesting SA (26, 33 and 46% for small, medium-sized and large companies, respectively; 16, 39 and 48% for known chemical substances, new chemical substances and biologics, respectively). Factors related to compliance with SA were company size and OD status (25, 60 and 84% for small, medium-sized, and large companies, respectively; 77 and 38% for non-OD and OD status, respectively). The strong association between company size and outcome suggests that resources and experience in drug development and obtaining regulatory approval are critical factors for a successful MAA. In addition, obtaining and complying with SA appears to be a predictor of outcome. Based on this analysis, companies, particularly smaller ones and those developing orphan drugs, are

  13. 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.

  14. 中药产品印尼市场准入浅析%Analysis of Indonesian Market Access System of Traditional Chinese Medicine

    Institute of Scientific and Technical Information of China (English)

    刘艳玲; 高晶; 王海

    2014-01-01

    印尼作为中国中医药产品出口重要市场,在中药产品的市场准入方面具有独特特点。本文对印尼中药产品市场准入进行了解读,重点包括印尼中药的监管和注册,帮助中药企业突破技术贸易壁垒。%Indonesia, as the important export market of traditional Chinese medicine (TCM), has the TCM market access system with unique characteristics. The paper introduces the Indonesian TCM market access system, including the supervision and registration of TCM in Indonesia, assisting TCM enterprises in breaking the techncial barriers to trade.

  15. Patent indicators: a window to pharmaceutical market success.

    Science.gov (United States)

    Guo, Yang; Hu, Yuanjia; Zheng, Mingli; Wang, Yitao

    2013-07-01

    Pharmaceutical success in the market is the best reward for pharmaceutical investors undergoing the lengthy, costly and risky process of pharmaceutical Research and Development (R&D). Drugs with high market revenues trigger fierce competition between pharmaceutical enterprises, as is demonstrated by the increasing Mergers & Acquisitions (M&A) cases focusing on seizing the best-selling products. On the other hand, patents, as the best shield for innovative drugs against generic drugs, become a powerful weapon for pharmaceutical enterprises to win the substantial returns generated by market exclusivity. Patents seem to be directly responsible for the commercial success of new medicines. In this context, it is of great significance to find out the empirical associations between pharmaceutical commercial success and patents. By comprehensively analysing 127 drugs marketed in the USA and their 621 American patents, this article identifies the evidence to link various patent indicators with pharmaceutical sales in actual market.

  16. Examining the Quality of Medicines at Kenyan Healthcare Facilities: A Validation of an Alternative Post-Market Surveillance Model That Uses Standardized Patients.

    Science.gov (United States)

    Wafula, Francis; Dolinger, Amy; Daniels, Benjamin; Mwaura, Njeri; Bedoya, Guadalupe; Rogo, Khama; Goicoechea, Ana; Das, Jishnu; Olayo, Bernard

    2017-03-01

    Promoting access to medicines requires concurrent efforts to strengthen quality assurance for sustained impact. Although problems of substandard and falsified medicines have been documented in low- and middle-income countries, reliable information on quality is rarely available. The aim of this study was to validate an alternative post-market surveillance model to complement existing models. The study used standardized patients or mystery clients (people recruited from the local community and trained to pose as real patients) to collect medicine samples after presenting a pre-specified condition. The patients presented four standardized conditions to 42 blinded facilities in Nairobi, Kenya, resulting in 166 patient-clinician interactions and dispensing of 300 medicines at facilities or nearby retail pharmacies. The medicine samples obtained thus resemble those that would be given to real patients. Sixty samples were selected from the 300, and sent for analysis at the Kenya National Quality Control Laboratory. Of these, ten (17%) did not comply with monograph specifications (three ibuprofen, two cetirizine, two amoxicillin/clavulanic acid combinations, and one each for prednisone, salbutamol and zinc). Five of the ten samples that failed had been inappropriately prescribed to patients who had presented symptoms of unstable angina. There was no association between medicine quality and ownership, size or location of the facilities. The study shows that the standardized patient model can provide insights into multiple dimensions of care, thus helping to link primary care encounters with medicine quality. Furthermore, it makes it possible to obtain medicines from blinded sellers, thus minimizing the risk of obtaining biased samples.

  17. [Quality of medicines in least developed countries].

    Science.gov (United States)

    Videau, J Y

    2006-12-01

    Due to worsening economic conditions and poor enforcement of existing pharmaceutical and customs regulations, third world countries are faced with a growing threat from counterfeit and substandard medicines. With the expansion of illicit markets in urban areas, the sales of medicines of uncertain quality and origin are increasing. Most victims of this illicit trade are among the world's poorest populations that cannot afford to buy quality drugs through private-sector distribution channels. National pharmaceutical programs promoting universal access to essential generic medicines at reasonable cost are the key to curbing this problem. A system based on strict, rational pharmaceutical purchasing and distribution policies with quality assurance at every level of the supply chain is needed to guarantee that patients receive safe effective high quality healthcare products.

  18. What Is the Future of Generics in Transplantation?

    Science.gov (United States)

    van Gelder, Teun

    2015-11-01

    Generic immunosuppressive drugs are available in Europe, Canada, and the United States. Between countries, there are large differences in the market penetration of generic drugs in general, and for immunosuppressive drugs in particular. The registration criteria for generic immunosuppressive drugs are often criticized. However, it is unlikely that the criteria for registration of narrow therapeutic index drugs are going to change, and bioequivalence studies, performed in healthy volunteers, will remain the backbone of the registration process. It would be good if the registration authorities would demand that all generic variants of an innovator drug have the same pill appearance to reduce errors and promote drug adherence.To allow for safe substitution, a number of criteria need to be fulfilled. Generic substitution should not be taken out of the hands of the treating physicians. Generic substitution can only be done safely if initiated by the prescriber, and in well-informed and prepared patients. Payers should refrain from forcing pharmacists to dispense generic drugs in patients on maintenance treatment with innovator drug. Instead, together with transplant societies, they should design guidelines on how to implement generic immunosuppressive drugs into clinical practice. Substitutions must be followed by control visits to check if the patient is taking the medication correctly and if drug exposure remains stable. Inadvertent, uncontrolled substitutions from 1 generic to another, initiated outside the scope of the prescriber, must be avoided as they are unsafe. Repetitive subsequent generic substitutions result in minimal additional cost savings and have an inherent risk of medication errors.

  19. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks.

    Science.gov (United States)

    Gronde, Toon van der; Uyl-de Groot, Carin A; Pieters, Toine

    2017-01-01

    Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines. Changes in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies. Market failure in combination with high merger and acquisition activity in the sector have allowed price increases for even off-patent drugs. With market interventions and the introduction of QALY measures in health care, governments have tried to influence drug prices, but often encounter unintended consequences. Patent reform legislation, reference pricing, outcome-based pricing and incentivizing physicians and pharmacists to prescribe low-cost drugs are among the most promising short-term policy options. Due to the lack of systematic research on the effectiveness of policy measures, an increasing number of ad hoc decisions have been made with counterproductive effects on the availability of essential drugs. Future challenges demand new policies, for which recommendations are offered. A fertile ground for high-priced drugs has been created by changes in drug life-cycle dynamics, the unintended effects of patent legislation, government policy measures and orphan drug programs. There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines.

  20. Marketing marketing

    OpenAIRE

    Alsem, K.J.

    2013-01-01

    In deze installatierede betoogt Karel Jan Alsem dat marketing een grotere strategische rol in organisaties zou moeten krijgen. Want marketing is bij uitstek de verbinding tussen klantwensen en het DNA van een organisatie. Doordat merken gemiddeld voor mensen niet heel belangrijk zijn, is goede branding en onderscheidende zichtbaarheid juist van belang. Met de groei van big data en het belang van onbewust gedrag, zullen vooral die marketeers in de toekomst succesvol zijn die de consument het b...

  1. Practicing the Generic (City)

    DEFF Research Database (Denmark)

    Hansen, Lone Koefoed

    2010-01-01

    Flanagan proposes that most locative media artworks neglect the particularities of spaces, their historical and political layers. Koolhaas, on the other hand, states that all urban areas are alike, that we are facing a global Generic City. The paper analyses digital media artist Esther Polak......’s NomadicMILK project in light of the generic and particular properties of space as laid out by Flanagan and Koolhaas in order to discuss the possible reconfiguring practices of locative media....

  2. [Perception, knowledge, and use of generic drugs in southern Brazil: what changed from 2002 to 2012?].

    Science.gov (United States)

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

    2016-08-01

    This study compared the perception, knowledge, and use of generic drugs by adults in Pelotas, Rio Grande do Sul State, Brazil, using two cross-sectional population-based studies from 2002 and 2012. Study outcomes were: (a) prevalence of use of generics; (b) generics as a proportion of all medication; (c) users' perceptions of prices and quality; (d) users' knowledge of generics; and (e) strategies for acquisition of medicines. Prevalence of generics use increased from 3.6% (95%CI: 3.0-4.3) to 26.1% (95%CI: 24.5-27.7) in the 10-year period. Perceptions of prices and quality of generics remained stable, identification of characteristics that distinguish generics from other drugs improved (p generics. Between 2002 and 2012 there was an increase in knowledge and use of generics, while perception of lower prices and equivalent quality remained high.

  3. Marketing marketing

    NARCIS (Netherlands)

    Alsem, K.J.

    2013-01-01

    In deze installatierede betoogt Karel Jan Alsem dat marketing een grotere strategische rol in organisaties zou moeten krijgen. Want marketing is bij uitstek de verbinding tussen klantwensen en het DNA van een organisatie. Doordat merken gemiddeld voor mensen niet heel belangrijk zijn, is goede brand

  4. Prioritizing West African medicinal plants for conservation and sustainable extraction studies based on market surveys and species distribution models.

    NARCIS (Netherlands)

    Andel, van T.R.; Croft, S.; Loon, van E.E.; Quiroz Villarreal, D.K.; Towns, A.M.; Raes, N.

    2015-01-01

    Sub-Saharan African human populations rely heavily on wild-harvested medicinal plants for their health. The trade in herbal medicine provides an income for many West African people, but little is known about the effects of commercial extraction on wild plant populations. Detailed distribution maps

  5. Prioritizing West African medicinal plants for conservation and sustainable extraction studies based on market surveys and species distribution models

    NARCIS (Netherlands)

    van Andel, T.R.; Croft, S.; van Loon, E.E.; Quiroz, D.; Towns, A.M.; Raes, N.

    2015-01-01

    Sub-Saharan African human populations rely heavily on wild-harvested medicinal plants for their health. The trade in herbal medicine provides an income for many West African people, but little is known about the effects of commercial extraction on wild plant populations. Detailed distribution maps

  6. Prioritizing West African medicinal plants for conservation and sustainable extraction studies based on market surveys and species distribution models.

    NARCIS (Netherlands)

    Andel, van T.R.; Croft, S.; Loon, van E.E.; Quiroz Villarreal, D.K.; Towns, A.M.; Raes, N.

    2015-01-01

    Sub-Saharan African human populations rely heavily on wild-harvested medicinal plants for their health. The trade in herbal medicine provides an income for many West African people, but little is known about the effects of commercial extraction on wild plant populations. Detailed distribution maps a

  7. Prioritizing West African medicinal plants for conservation and sustainable extraction studies based on market surveys and species distribution models

    NARCIS (Netherlands)

    van Andel, T.R.; Croft, S.; van Loon, E.E.; Quiroz, D.; Towns, A.M.; Raes, N.

    2015-01-01

    Sub-Saharan African human populations rely heavily on wild-harvested medicinal plants for their health. The trade in herbal medicine provides an income for many West African people, but little is known about the effects of commercial extraction on wild plant populations. Detailed distribution maps a

  8. Are women appropriately represented and assessed in clinical trials submitted for marketing authorization? A review of the database of the European Medicines Agency.

    Science.gov (United States)

    Müllner, M; Vamvakas, S; Rietschel, M; van Zwieten-Boot, B J

    2007-09-01

    There is concern that patients included in trials do not represent the true patient population and women in particular may selectively be excluded. We looked at trial data submitted to the European Medicines Agency (EMEA) by drug companies to achieve marketing authorization in Europe between 2000 and 2003. We reviewed the EMEA database and included the main studies for the risk/benefit assessment (pivotal trials) submitted between 2000 and 2003. In pivotal trials submitted to the EMEA there was no, or generally clinically negligible, evidence for gender bias; however, women were underrepresented in hypertension, diabetes and hepatitis B trials, and overrepresented in rheumatoid arthritis and allergic conjunctivitis. In trials submitted for marketing authorization to the EMEA gender bias was not a serious problem.

  9. The shifting architectonics of pain medicine: toward ethical realignment of scientific, medical and market values for the emerging global community--groundwork for policy.

    Science.gov (United States)

    Giordano, James; Benedikter, Roland

    2011-03-01

    Following the Second Industrial Revolution, Western medicine has become an interwoven enterprise of humanitarian and technologic values. In this essay, we posited that rather than being seen as a means toward achieving the ends of providing technically right and morally sound pain care, the resources and goods of pain medicine have been subordinated to a market-based values system that regards these tools as ends unto themselves. We argued that this approach is 1) pragmatically inapt, in that it fails to acknowledge and provide those tools as rightly necessary for the "good" of pain medicine to be enacted; and is therefore 2) morally unsound, in that the good, while recognized, is not afforded, thereby disserving the fiduciary of science/technology, medicine, and economics. We framed these issues within 1) the context(s) and effects of postmodernism and 2) the increasing call for a globally relevant and applicable system of pain care. Toward this latter end, we addressed how policies can be created that accommodate differing social values, and still enable the execution of care in ways that are morally sound, yet economically viable. We posited that such policies need to be finely grained so as to 1) sustain research in pain diagnosis, assessment, treatment, and management; 2) translate research efforts into clinically relevant resources; 3) enable availability and just distribution of both low- and high-tech resources; and 4) prompt fiscal programs that support, allow, and reinforce responsible choice (of such resources) as socioculturally required, valued, and valid. Wiley Periodicals, Inc.

  10. [Discussion about relativity between post-marketed safety outcome and treatment course of traditional Chinese medicine drugs on basis of reinforced urn processes].

    Science.gov (United States)

    Zhong, Cheng-Liang; Hu, Si-Yuan; Xie, Yan-Ming; Wang, Yong-Yan

    2013-09-01

    Based on relevant research and development, the possibility of applying the reinforced urn processes (RUPs) statistical approach to traditional Chinese medicine(TCM) drugs safety research is discussed in this paper, primarily through theoretical discussion and simulations. Also introduced are work flows and the key points for the application of the RUPs approach. This potentially new approach has recently been applied to the target estimation of phase I human tolerance clinical trials. A traditional RUPs approach has also been widely applied in the precise point-estimation of allowable longest treatment courses, according to the particular safety outcomes of post-marketed TCM.

  11. Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.

    Science.gov (United States)

    Giannuzzi, Viviana; Landi, Annalisa; Bosone, Enrico; Giannuzzi, Floriana; Nicotri, Stefano; Torrent-Farnell, Josep; Bonifazi, Fedele; Felisi, Mariagrazia; Bonifazi, Donato; Ceci, Adriana

    2017-09-11

    The research and development process in the field of rare diseases is characterised by many well-known difficulties, and a large percentage of orphan medicinal products do not reach the marketing approval.This work aims at identifying orphan medicinal products that failed the developmental process and investigating reasons for and possible factors influencing failures. Drugs designated in Europe under Regulation (European Commission) 141/2000 in the period 2000-2012 were investigated in terms of the following failures: (1) marketing authorisation failures (refused or withdrawn) and (2) drugs abandoned by sponsors during development.Possible risk factors for failure were analysed using statistically validated methods. This study points out that 437 out of 788 designations are still under development, while 219 failed the developmental process. Among the latter, 34 failed the marketing authorisation process and 185 were abandoned during the developmental process. In the first group of drugs (marketing authorisation failures), 50% reached phase II, 47% reached phase III and 3% reached phase I, while in the second group (abandoned drugs), the majority of orphan medicinal products apparently never started the development process, since no data on 48.1% of them were published and the 3.2% did not progress beyond the non-clinical stage.The reasons for failures of marketing authorisation were: efficacy/safety issues (26), insufficient data (12), quality issues (7), regulatory issues on trials (4) and commercial reasons (1). The main causes for abandoned drugs were efficacy/safety issues (reported in 54 cases), inactive companies (25.4%), change of company strategy (8.1%) and drug competition (10.8%). No information concerning reasons for failure was available for 23.2% of the analysed products. This analysis shows that failures occurred in 27.8% of all designations granted in Europe, the main reasons being safety and efficacy issues. Moreover, the stage of development

  12. Generic Airspace Survey

    Science.gov (United States)

    Mogford, Richard H.; Bridges, Wayne; Gujarl, Vimmy; Lee, Paul U.; Preston, William

    2013-01-01

    This paper reports on an extension of generic airspace research to explore the amount of memorization and specialized skills required to manage sectors with specific characteristics or factors. Fifty-five retired controllers were given an electronic survey where they rated the amount of memorization or specialized skills needed for sixteen generic airspace factors. The results suggested similarities in the pattern of ratings between different areas of the US (East, Central, and West). The average of the ratings for each area also showed some differences between regions, with ratings being generally higher in the East area. All sixteen factors were rated as moderately to highly important and may be useful for future research on generic airspace, air traffic controller workload, etc.

  13. 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.

  14. 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.

  15. The Impact of Information on Doctors' Attitudes Toward Generic Drugs.

    Science.gov (United States)

    Tsaprantzi, Aggeliki V; Kostagiolas, Petros; Platis, Charalampos; Aggelidis, Vassilios P; Niakas, Dimitris

    2016-01-01

    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.

  16. [Generic drugs in Brazil: historical overview and legislation].

    Science.gov (United States)

    Araújo, Lorena Ulhôa; Albuquerque, Kemile Toledo de; Kato, Kelly Cristina; Silveira, Gleiciely Santos; Maciel, Náira Rezende; Spósito, Pollyanna Álvaro; Barcellos, Neila Márcia Silva; Souza, Jacqueline de; Bueno, Márcia; Storpirtis, Sílvia

    2010-12-01

    The Brazilian generic drugs policy was implemented in 1999 with the aim of stimulating competition in the market, improve the quality of drugs and improve the access of the population to drug treatment. The process of implementing this policy allowed the introduction and discussion of concepts that had never before been used in the context of drug registration in Brazil: bioavailability, bioequivalence, pharmaceutical equivalence, generic drugs, biopharmaceutical classification system, biowaiver. The present article provides definitions for these concepts in the context of Brazilian legislation as well as a historical and chronological description of the implementation of the generic drugs policy in Brazil, including a list of current generic drug legislation. This article contributes to the understanding of the Brazilian generic drugs policy and facilitates the search for information concerning the legal requirements for registration of drugs in Brazil.

  17. 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.

  18. Generic Kalman Filter Software

    Science.gov (United States)

    Lisano, Michael E., II; Crues, Edwin Z.

    2005-01-01

    The Generic Kalman Filter (GKF) software provides a standard basis for the development of application-specific Kalman-filter programs. Historically, Kalman filters have been implemented by customized programs that must be written, coded, and debugged anew for each unique application, then tested and tuned with simulated or actual measurement data. Total development times for typical Kalman-filter application programs have ranged from months to weeks. The GKF software can simplify the development process and reduce the development time by eliminating the need to re-create the fundamental implementation of the Kalman filter for each new application. The GKF software is written in the ANSI C programming language. It contains a generic Kalman-filter-development directory that, in turn, contains a code for a generic Kalman filter function; more specifically, it contains a generically designed and generically coded implementation of linear, linearized, and extended Kalman filtering algorithms, including algorithms for state- and covariance-update and -propagation functions. The mathematical theory that underlies the algorithms is well known and has been reported extensively in the open technical literature. Also contained in the directory are a header file that defines generic Kalman-filter data structures and prototype functions and template versions of application-specific subfunction and calling navigation/estimation routine code and headers. Once the user has provided a calling routine and the required application-specific subfunctions, the application-specific Kalman-filter software can be compiled and executed immediately. During execution, the generic Kalman-filter function is called from a higher-level navigation or estimation routine that preprocesses measurement data and post-processes output data. The generic Kalman-filter function uses the aforementioned data structures and five implementation- specific subfunctions, which have been developed by the user on

  19. Using Service Oriented Architecture in a Generic Virtual Power Plant

    DEFF Research Database (Denmark)

    Andersen, Peter Bach; Poulsen, Bjarne; Træholt, Chresten;

    2009-01-01

    interesting properties that can influence the future shape of power markets. The concept holds many promises including cheaper power to the consumer, a more flexible and responsive power production and the support of a more environment-friendly development. In order to realize a software solution supporting...... the Generic Virtual Power Plant, an array of different software design principles, patterns and architectures must be applied. Especially Service Oriented Architecture (SOA) can aid in implementing the Generic Virtual Power Plant....

  20. Generic and Brand Advertising Strategies in a Dynamic Duopoly

    OpenAIRE

    Frank M. Bass; Anand Krishnamoorthy; Ashutosh Prasad; Suresh P. Sethi

    2005-01-01

    To increase the sales of their products through advertising, firms must integrate their brand-advertising strategy for capturing market share from competitors and their generic-advertising strategy for increasing primary demand for the category. This paper examines whether, when, and how much brand advertising versus generic advertising should be done. Using differential game theory, optimal advertising decisions are obtained for a dynamic duopoly with symmetric or asymmetric competitors. We ...

  1. Medicinal plants traded in the open-air markets in the State of Rio de Janeiro, Brazil: an overview on their botanical diversity and toxicological potential

    Directory of Open Access Journals (Sweden)

    Fernanda Leitão

    2014-04-01

    Full Text Available Medicinal plants have been used for many years and are the source of new active substances and new drugs of pharmaceutical interest. The popular knowledge contained in the open-air markets is studied through urban ethnobotany, and is a good source of information for ethnobotanical research. In this context, we surveyed the literature on works concerning open-air markets in the State of Rio de Janeiro to gather knowledge of the commercialized plants therein. A literature search resulted in ten studies with 376 listed species, distributed in 94 families and 273 genera. Asteraceae family had the greater representation, followed by Lamiaceae and Fabaceae. Solanum was the most frequent genus. Two hundred and twenty four species could be considered potentially toxic or potentially interact with other drugs/medicines. Eighteen species are referred as "not for use during pregnancy", and 3 "not for use while nursing". These results are a source of concern since in Brazil, as it is worldwide, there is the notion that plants can never be harmful. The results for the Sørensen Coefficient showed greater similarity between works performed in very close study areas. Other studies presented low similarity, mainly because of the difficulty in plant identification or a very specific focus in methodology.

  2. Toward better quality of anticancer generics in India

    Directory of Open Access Journals (Sweden)

    V S Gota

    2014-01-01

    Full Text Available Treatment of cancer is limited by affordability of patients in the many developing countries including India. Generic drug manufacturers have responded to this scenario by making drugs available at affordable costs, often at less than 10% the cost of the original brand. In our practice, it is found that there is a three-fold higher prescription of generic brands compared to innovator, accompanied by cost savings of up to 80% per prescription. Unfortunately, the regulatory environment prevailing in India is not geared to ensure satisfactory quality of generic products. The standards set by the regulatory agencies for establishing equivalence of generics vis-ΰ-vis the innovator product allow anticancer generics to enter markets without undergoing clinical evaluation. Many drug manufacturing units in India flout good manufacturing practice norms, which was evident during the center for drug evaluation and research classifications inspection in the year 2006. Inferior drugs have therefore, made their way into the Indian markets, compromising the quality of care. The system of drug manufacturing and marketing approval needs a major overhaul, including regular inspection of manufacturing facilities. Bioequivalence should be made mandatory for all oral formulations. Unless these measures are rigidly implemented, the benefits of generic substitution would be seriously undermined.

  3. Toward better quality of anticancer generics in India.

    Science.gov (United States)

    Gota, V S; Patial, P

    2014-01-01

    Treatment of cancer is limited by affordability of patients in the many developing countries including India. Generic drug manufacturers have responded to this scenario by making drugs available at affordable costs, often at less than 10% the cost of the original brand. In our practice, it is found that there is a three-fold higher prescription of generic brands compared to innovator, accompanied by cost savings of up to 80% per prescription. Unfortunately, the regulatory environment prevailing in India is not geared to ensure satisfactory quality of generic products. The standards set by the regulatory agencies for establishing equivalence of generics vis-ΰ-vis the innovator product allow anticancer generics to enter markets without undergoing clinical evaluation. Many drug manufacturing units in India flout good manufacturing practice norms, which was evident during the center for drug evaluation and research classifications inspection in the year 2006. Inferior drugs have therefore, made their way into the Indian markets, compromising the quality of care. The system of drug manufacturing and marketing approval needs a major overhaul, including regular inspection of manufacturing facilities. Bioequivalence should be made mandatory for all oral formulations. Unless these measures are rigidly implemented, the benefits of generic substitution would be seriously undermined.

  4. 4Ps Marketing Strategies for Traditional Chinese Medicine Tourism%中医药旅游的4Ps营销策略探讨

    Institute of Scientific and Technical Information of China (English)

    张群

    2012-01-01

    Traditional Chinese medicine tourism,as a new way of tourism,has not yet been generally accepted due to the fact that traditional Chinese medicine tourism lacks tourism overall planning, thus affecting the building, promotion and ascension of tourism image. Based on the traditional 4Ps marketing theory and the situation of the traditional Chinese medicine tourism,this paper applies the 4Ps marketing theory in Chinese medicine tourism marketing, namely, the use of products, channel, promotion, and price strategies. The products strategy should focus on the characteristics, paying attention to the culture cooperation and experiential product development~ the promotion strategy should focus on more contact and cooperation with the sales middlemen ; the channel strategy should focus on all kinds of means such as film and television,public relations and staff communication and the price strategy should focus on the principle of flexibility and rationality.%中医药旅游作为一种新型的旅游方式,尚未被社会普遍接受,其原因有很多,其中重要的一点是中医药旅游的产品营销缺乏整体规划,从而影响旅游形象的打造、推广与提升。借助传统的商品经济学的4Ps营销理论,针对中医药旅游的发展现状,对4Ps理论在中医药旅游市场营销中的运用,即产品、渠道、促销、价格等策略运用做出了一些初步的探讨。认为在产品策略方面应注重特色,注意挖掘文化内涵和体验性产品开发;在促销上多与中间商联系与合作;在渠道上运用影视、公共关系、人员等渠道进行传播;在价格上采用灵活性和合理性原则。

  5. Exploring Generic Haskell

    NARCIS (Netherlands)

    Löh, A.

    2004-01-01

    This thesis is an exploration -- an exploration of a language extension of the functional programming language Haskell. The extension is called Generic Haskell, albeit the name has been used to refer to different objects over the last several years: Many papers have described different proposals, fe

  6. Veterinary medicines update.

    Science.gov (United States)

    2017-03-11

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues.

  7. Projecting expenditure on medicines in the UK NHS.

    Science.gov (United States)

    O'Neill, Phill; Mestre-Ferrandiz, Jorge; Puig-Peiro, Ruth; Sussex, Jon

    2013-10-01

    Expenditure on medicines is a readily identifiable element of health service costs. It is the focus of much attention by payers, not least in the UK even though the cost of medicines represents less than 10 % of total UK National Health Service (NHS) expenditure. Projecting future medicines spending enables the likely cost pressure to be allowed for in planning the scale and allocation of NHS resources. Simple extrapolations of past trends in expenditure fail to account for changes in the rate and mix of new medicines becoming available and in the scope for windfall savings when some medicines lose their patent protection. The objective of this study is to develop and test an improved method to project NHS pharmaceutical expenditure in the UK for the period 2012-2015. We have adopted a product-by-product, bottom-up approach, which means that our projections are built up from individual products to the total market. Our projections of the impact of generic and biosimilars entry on prices and quantities of medicines sold, and of the rate of uptake of newly launched medicines, have been obtained from regression analysis of UK data. To address uncertainty, we have created a baseline and two other illustrative scenarios. We have compared our projections with actual expenditure for 2012. Our projections estimate that, between 2011 and 2015, with no change in policy or price regulation, the UK total medicines bill would increase at an average compound annual growth rate (CAGR) of between 3.1 and 4.1 %. Total NHS spending on branded medicines and total NHS spending on generics are projected to increase at average CAGRs of 0.5-1.8 and 10.0-11.0 %, respectively, over the same time period. For the total market, the actual growth rate for 2012 lay within our projected range. Our methodology provides a useful framework for projecting UK NHS medicines expenditure over the medium term and captures the impacts of existing medicines losing exclusivity and of new medicines being

  8. Needs-driven versus market-driven pharmaceutical innovation: the consortium for the development of a new medicine against malaria in Brazil.

    Science.gov (United States)

    Kameda, Koichi

    2014-08-01

    The prevailing model for encouraging innovation based on patents and market-oriented raises at least two economic and ethical issues: it imposes barriers on individuals and developing countries governments' access to medicines by defining prices that do not match their income, and the unavailability of new or appropriate products to address the health problems of these populations. In the last decade, this scenario has undergone some changes due to the emergence of new actors, the contribution of aid resources, the introduction to the market of new products against neglected diseases, the development of new governmental healthcare policies and research programs, etc. One example of such initiatives is the Fixed-Dose Artesunate Combination Therapy (FACT) project consortium, which brought together institutions with different natures from both the North and the South, for the development of two antimalarial fixed-dose combinations recommended by the WHO - artesunate-amodiaquine (ASAQ) and artesunate-mefloquine (ASMQ). This paper proposes to describe and analyze the ASMQ consortium, which is the result of a new pharmaceutical development approach, based on a different paradigm - needs-driven instead of market-driven -, collaborative, with strategic participation of institutions from the South, funded by alternative resources (public and philanthropic). Thus, it represents an interesting object of study for bioethical debates on intellectual property and innovation, and its analysis is justified in light of the current debate on ways of stimulating needs-driven pharmaceutical innovation.

  9. 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.

  10. 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.

  11. Temporary authorization for use: does the French patient access programme for unlicensed medicines impact market access after formal licensing?

    Science.gov (United States)

    Degrassat-Théas, Albane; Paubel, Pascal; Parent de Curzon, Olivier; Le Pen, Claude; Sinègre, Martine

    2013-04-01

    To reach the French market, a new drug requires a marketing authorization (MA) and price and reimbursement agreements. These hurdles could delay access to new and promising drugs. Since 1992, French law authorizes the use of unlicensed drugs on an exceptional and temporary basis through a compassionate-use programme, known as Temporary Authorization for Use (ATU). This programme was implemented to improve early access to drugs under development or authorized abroad. However, it is suspected to be inflationary, bypassing public bodies in charge of health technology assessment (HTA) and of pricing. The aim of this study is to observe the market access after the formal licensing of drugs that went through this compassionate-use programme. We included all ATUs that received an MA between 1 January 2005 and 30 June 2010. We first examined market access delays from these drugs using the standard administrative path. We positioned this result in relation to launch delays observed in France (for all outpatient drugs) and in other major European markets. Second, we assessed the bargaining power of a hospital purchaser after those drugs had obtained an MA by calculating the price growth rate after the approval. During the study period, 77 ATUs were formally licensed. The study concluded that, from the patient's perspective, licensing and public bodies' review time was shortened by a combined total of 36 months. The projected 11-month review time of public bodies may be longer than delays usually observed for outpatient drugs. Nonetheless, the study revealed significant benefits for French patient access based on comparable processing to launch time with those of other European countries with tight price control policies. In return, a 12 % premium, on average, is paid to pharmaceutical companies while drugs are under this status (sub-analysis on 56 drugs). In many instances, the ATU programme responds to a public health need by accelerating the availability of new drugs

  12. What happened to anti-malarial markets after the Affordable Medicines Facility-malaria pilot? Trends in ACT availability, price and market share from five African countries under continuation of the private sector co-payment mechanism.

    Science.gov (United States)

    Tougher, Sarah; Hanson, Kara; Goodman, Catherine

    2017-04-25

    The private sector supplies anti-malarial treatment for large proportions of patients in sub-Saharan Africa. Following the large-scale piloting of the Affordable Medicines Facility-malaria (AMFm) from 2010 to 2011, a private sector co-payment mechanism (CPM) provided continuation of private sector subsidies for quality-assured artemisinin combination therapies (QAACT). This article analyses for the first time the extent to which improvements in private sector QAACT supply and distribution observed during the AMFm were maintained or intensified during continuation of the CPM through 2015 in Kenya, Madagascar, Nigeria, Tanzania and Uganda using repeat cross-sectional outlet survey data. QAACT market share in all five countries increased during the AMFm period (p market share was maintained or improved post-AMFm in Nigeria, Tanzania and Uganda, but statistically significant declines were observed in Kenya and Madagascar. In 2014/5, QAACT market share was highest in Kenya and Uganda (48.2 and 47.5%, respectively) followed by Tanzania (39.2%), Nigeria (35.0%), and Madagascar (7.0%). Four of the five countries experienced significant decreases in median QAACT price during the AMFm period. Private sector QAACT prices were maintained or further reduced in Tanzania, Nigeria and Uganda, but prices increased significantly in Kenya and Madagascar. SP prices were consistently lower than those of QAACT in the AMFm period, with the exception of Kenya and Tanzania in 2011, where they were equal. In 2014/5 QAACT remained two to three times more expensive than the most popular non-artemisinin therapy in all countries except Tanzania. Results suggest that a private sector co-payment mechanism for QAACT implemented at national scale for 5 years was associated with positive and sustained improvements in QAACT availability, price and market share in Nigeria, Tanzania and Uganda, with more mixed results in Kenya, and few improvements in Madagascar. The subsidy mechanism as implemented

  13. Generic wormhole throats

    CERN Document Server

    Visser, M; Visser, Matt; Hochberg, David

    1997-01-01

    Wormholes and black holes have traditionally been treated a quite separate objects with relatively little overlap. The possibility of a connection arises in that wormholes, if they exist, might have profound influence on black holes, their event horizons, and their internal structure. After discussing some connections, we embark on an overview of what can generally be said about traversable wormhole throats. We discuss the violations of the energy conditions that typically occur at and near the throat of any traversable wormhole and emphasize the generic nature of this result. We discuss the original Morris-Thorne wormhole and its generalization to a spherically symmetric time-dependent wormhole, and also discuss spherically symmetric Brans-Dicke wormholes. We also discuss the relationship with the topological censorship theorem. Finally we turn to a rather general class of wormholes that permit explicit analysis: generic static traversable wormholes (without any symmetry). We define the wormhole throat in te...

  14. Generic safety documentation model

    Energy Technology Data Exchange (ETDEWEB)

    Mahn, J.A.

    1994-04-01

    This document is intended to be a resource for preparers of safety documentation for Sandia National Laboratories, New Mexico facilities. It provides standardized discussions of some topics that are generic to most, if not all, Sandia/NM facilities safety documents. The material provides a ``core`` upon which to develop facility-specific safety documentation. The use of the information in this document will reduce the cost of safety document preparation and improve consistency of information.

  15. Generic Network Location Service

    Directory of Open Access Journals (Sweden)

    Laban Mwansa

    2010-11-01

    Full Text Available This work presents the Generic Network Location Service based on the Chord implementation utilizing data structures called distributed hash tables (DHT or structured overlay networks, which are used to build scalable self-managing distributed systems. The provided algorithms guarantee resilience in the presence of dynamism: they guarantee consistent lookup results in the presence of nodes failing and leaving. Generic Network Location Service provides a Location Service system based on DHT technology, which is storing device location records in nodes within a Chord DHT. Location records are consisting of network device identification keys as attributes, which are used to create replicas of additional location records through established Chord hashing mechanisms. Storing device location records, in places address-able (using the DHT lookup by individual location record keys provides a simple way of implementing transla¬tion functions similar to well¬ known network services (e.g. ARP, DNS, ENUM. The generic network location ser¬vice presented in the paper is not supposed to be a substitu¬tion of the existing translation techniques (e.g. ARP, DNS, ENUM, but it is considered as an overlay service that uses data available in existing systems and provides some translations currently unavailable.

  16. Isolation and identification of toxigenic and non-toxigenic fungi in samples of medicinal plants from the market

    Directory of Open Access Journals (Sweden)

    C.G. PEREIRA

    2015-06-01

    Full Text Available ABSTRACT:The consumption of preparations of medicinal plants has been increasing during the last decades in occidental societies. The presence of toxigenic fungi in a plant product may represent a potential risk of contamination, because of aflatoxins and ochratoxins. In this study, 12 samples of medicinal plants were analyzed in relation to the level of fungal contamination, and the presence of producers of ochratoxin A and aflatoxins was assessed by visualization of fungi using a cromatovisor in coconut milk. Most of the species found belong to the genus Cladosporium, Fusarium, Aspergillus and Penicillium. Species producing ochratoxin A were present in 2 samples (16.7%, Melissa and Hibiscus. Species producing aflatoxin were found in samples of Jacaranda decurrens (8.33%. This study suggests that herbs, if stored improperly, can provide the growth of fungi and should be examined before consumption.

  17. 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.

  18. Strategies that delay or prevent the timely availability of affordable generic drugs in the United States.

    Science.gov (United States)

    Jones, Gregory H; Carrier, Michael A; Silver, Richard T; Kantarjian, Hagop

    2016-03-17

    High cancer drug prices are influenced by the availability of generic cancer drugs in a timely manner. Several strategies have been used to delay the availability of affordable generic drugs into the United States and world markets. These include reverse payment or pay-for-delay patent settlements, authorized generics, product hopping, lobbying against cross-border drug importation, buying out the competition, and others. In this forum, we detail these strategies and how they can be prevented.

  19. 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.

  20. Methodological approaches to developing and establishing the body of evidence on post-marketing Chinese medicine safety.

    Science.gov (United States)

    Liao, Xing; Robinson, Nicola

    2013-07-01

    Evidence based medicine demands the highest form of scientific evidence to demonstrate the efficacy and clinical effectiveness for any therapeutic intervention in order to provide best care. It is however accepted that in the absence of scientific evidence, personal experience and expert opinion together with professional judgement are critical. Obtaining evidence for drug safety, postmarketing surveillance (PMS) has focussed on follow up of observational cohorts exposed to a particular drug in order to estimate the incidence of adverse drug reactions (ADRs). Evidence on PMS of Chinese herbal products is still limited, in particular for herbal injections. The aim of this article is to suggest a new model of ascertaining the safety of Chinese medicine using a more comprehensive approach for collecting data. To collect safety data on the Chinese herbal injection, Kudiezi, a mixed methods approach is proposed using 18 hospital information systems to detect ADRs in order to prospectively observe 30,000 patients over 3 years. Evidence will also be collected using a questionnaire survey and through a sample of semi structured interviews. This information based on the expert opinion and the experience of clinicians will produce additional data on the frequency and types of side effects in clinical practice. Furthermore semi structured interviews with a random sample of patients receiving the injection will be carried out to ascertain any potential side effects missed. It is hoped that this comprehensive approach to data collection will accumulate wider evidence based on individual traditional Chinese medicine care and treatment and provide important feedback to the national data collection system to ensure completeness of ADR data recording, monitoring and any potential wider effects through developing improved ADR guidelines.

  1. 濒危野生动植物药材非法贸易调查%Survey on Illegal Trade in Endangered Medicinal Species in China’s Traditional Chinese Medicine Wholesale Markets

    Institute of Scientific and Technical Information of China (English)

    尹峰; 梦梦; 徐玲; 刘定震

    2015-01-01

    对10个药材市场上的沉香、冬虫夏草、肉苁蓉、蛤蚧、乌梢蛇、蕲蛇、金钱白花蛇、玳瑁、熊胆、麝香、虎骨、豹骨、犀牛角、羚羊角和穿山甲片等15种常用或曾用的濒危物种药材进行实地调查,结果表明:对国家明令禁止贸易的濒危物种药材公开摆卖现象并不突出,但其地下交易具有普遍性;虎豹骨和犀牛角的贸易已非常少见,仅0.8%和1.4%的药材经营者声称有售,而且他们都提及了贸易禁令,显示出从业人员较强的保护意识;“中国野生动物经营利用管理专用标识制度”的推行,在一定程度上遏制了标识物种药材的非法贸易;药市上部分濒危物种药材来自境外,走私现象依然存在。针对调查中存在的问题,建议修改和完善相应的法律法规、加大执法能力建设和打击力度、加强贸易和市场的监测、开展公众教育,以遏制药用濒危野生动植物药材的非法贸易。%In this survey,10 Traditional Chinese Medicine(TCM)wholesale markets in China were visi-ted and 15 endangered medicinal species were recorded.The species include Aquilaria Spp.,Cordyceps sinensis,Cistanche Spp,Gekko gecko,Zaocys dhumnades,Agkistrodon acutus,Bungarus multicinctus, Hawksbill (Eretmochelys imbricata)shell,Bear (Ursus thibetanus and U.arctos)bile,Musk (Moschus spp.),Tiger(Panthera tigris)bone,Leopard (Panthera pardus,Neofelis nebulosa and Uncia uncia,) bone,Rhino(Rhinoceros spp.)horn,Saiga(Saiga tatarica)horn and Pangolin(Manis spp.)scale.The investigation shows that the open illegal wildlife trade is not serious,however it is still common in black market.Very little tiger bone,leopard bone and rhino horn was found,only 0.8% and 1.4% dealers claimed to have tiger bone and rhino horn for sale,all of them mentioned the 1993 trade ban.The imple-mentation of Special Mark System of China Wildlife Management and Utilization has succeeded in de-creasing the

  2. Generic patch inference

    DEFF Research Database (Denmark)

    Andersen, Jesper; Lawall, Julia

    2010-01-01

    A key issue in maintaining Linux device drivers is the need to keep them up to date with respect to evolutions in Linux internal libraries. Currently, there is little tool support for performing and documenting such changes. In this paper we present a tool, spdiff, that identifies common changes...... developers can use it to extract an abstract representation of the set of changes that others have made. Our experiments on recent changes in Linux show that the inferred generic patches are more concise than the corresponding patches found in commits to the Linux source tree while being safe with respect...

  3. ASSESSMENT OF QUALITY OF GENERICS IN CARDIOLOGY: REALITY AND POSSIBILITIES

    Directory of Open Access Journals (Sweden)

    V. V. Yakusevich

    2005-01-01

    Full Text Available Wide presence of original drugs’ copies, the so-called “generics”, on the pharmaceutical market is analyzed. The positive side of this expansion is connected with the lower price of generics, which makes it possible to decrease the costs of treatment. From the other side with the advent of big number of copies of the original drugs it becomes more difficult to assess the quality of each particular generic. Russian legislation in the field of registration allows selling in the country almost all drugs, which have at least minimal similarity to the original. The problem of pre-registration studies of bioequivalency of original and analogue drugs, therapeutical equivalency is widely observed. Concrete proposals of how to prevent the overflow of the Russian market with the generics with the unproved efficacy and safety are considered.

  4. The Inculcation of Generic Skills among Juveniles through Technical and Vocational Education

    Science.gov (United States)

    Wan-Mohamed, Wan Azlinda; Yunus, Mohamed Hafis

    2009-01-01

    Generic skills are skills which contribute towards individual's effective and successful participation in the workplace. For juveniles, Technical and Vocational Education (TVE) is one of the platforms that provide them generic skills which enable them to compete for job market. The purpose of this study is to investigate the level of generic…

  5. Improvement of Generic Skills Development in Study Programmes of Higher Education: The Graduates' Viewpoint

    Science.gov (United States)

    Pukelis, Kestutis; Pileicikiene, Nora

    2010-01-01

    The article discusses the concept of generic skills, underlines the importance of their development in studies of higher education, introduces methodology and results of the research on the match between generic skills of Lithuanian universities' and colleges' graduates (N=1021) and labour market needs, as well as reviews potentialities for the…

  6. Comparing the biological impact of glatiramer acetate with the biological impact of a generic.

    Directory of Open Access Journals (Sweden)

    Fadi Towfic

    Full Text Available For decades, policies regarding generic medicines have sought to provide patients with economical access to safe and effective drugs, while encouraging the development of new therapies. This balance is becoming more challenging for physicians and regulators as biologics and non-biological complex drugs (NBCDs such as glatiramer acetate demonstrate remarkable efficacy, because generics for these medicines are more difficult to assess. We sought to develop computational methods that use transcriptional profiles to compare branded medicines to generics, robustly characterizing differences in biological impact. We combined multiple computational methods to determine whether differentially expressed genes result from random variation, or point to consistent differences in biological impact of the generic compared to the branded medicine. We applied these methods to analyze gene expression data from mouse splenocytes exposed to either branded glatiramer acetate or a generic. The computational methods identified extensive evidence that branded glatiramer acetate has a more consistent biological impact across batches than the generic, and has a distinct impact on regulatory T cells and myeloid lineage cells. In summary, we developed a computational pipeline that integrates multiple methods to compare two medicines in an innovative way. This pipeline, and the specific findings distinguishing branded glatiramer acetate from a generic, can help physicians and regulators take appropriate steps to ensure safety and efficacy.

  7. How to improve communication for the safe use of medicines?: Discussions on social marketing and patient-tailored approaches at the annual meetings of the WHO Programme for International Drug Monitoring.

    Science.gov (United States)

    Bahri, Priya; Harrison-Woolrych, Mira

    2012-12-01

    Over the past decade, the annual meetings of national centres participating in the WHO Programme for International Drug Monitoring have increasingly included discussions on how to improve communication between national pharmacovigilance centres, patients, healthcare professionals, policy makers and the general public, with the aim of promoting the safe use of medicines. At the most recent meetings, working groups were dedicated to discuss possible applications and implementation of social marketing and patient-tailored approaches. This article provides the history and a summary of the recent discussions and recommendations to support progress in this respect at national and global level. Recommendations are made to investigate and pilot these approaches in small-scale projects at national pharmacovigilance centres. Applying elements from the social marketing and patient-tailored approaches to support behaviours of safe medicines use in patients and healthcare professionals should give the pharmacovigilance community new tools to achieve their goal to minimize risks with medicines and improve patient safety.

  8. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences.

    Science.gov (United States)

    Davit, Barbara; Braddy, April C; Conner, Dale P; Yu, Lawrence X

    2013-10-01

    The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused on the 13 jurisdictions and organizations participating in the International Generic Drug Regulators Pilot. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Association, Japan, Mexico, Singapore, South Korea, Switzerland, the USA, and the World Health Organization. We began with a comparison of how the various jurisdictions and organizations define a generic product and its corresponding reference product. We then compared the following bioequivalence approaches: recommended bioequivalence study designs, method of pharmacokinetic calculations and bioequivalence acceptance limits, recommendations for modifying bioequivalence study designs and limits for highly variable drugs and narrow therapeutic index drugs, provisions for waiving bioequivalence study requirements (granting biowaivers), and implementation of the Biopharmaceutics Classification System. We observed that, overall, there are more similarities than differences in bioequivalence approaches among the regulatory authorities surveyed.

  9. 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.

  10. Affordability of adult HIV/AIDS treatment in developing countries: modelling price determinants for a better insight of the market functioning

    Directory of Open Access Journals (Sweden)

    Luis Sagaon-Teyssier

    2016-10-01

    Full Text Available Introduction: This study aims to provide a landscape of the global antiretroviral (ARV market by analyzing the transactional data on donor-funded ARV procurement between 2003 and 2015, and the ARV price determinants. Design: The data were obtained from the Global Price Reporting Mechanism (GPRM managed by the AIDS Medicines and Diagnostics Service of the WHO, and it consists of information that covers approximately 80% of the total donor-funded adult ARV transactions procurement. Methods: ExWorks prices and procured quantities were standardized according to the guidelines in terms of yearly doses. Descriptive statistics on quantities and prices show the main trends of the ARV market. Ordinary least squares estimation was carried out for the whole sample, then stratified according to the type of supplier (originator and generic and controlled for time and geographical fixed-effects. Given that analyses were carried out on a public dataset on ARV transactional prices from the GPRM, ethics are respected and consent was not necessary. Results: Originator medicines are on average the least expensive in the sub-Saharan Africa region, where at the same time, generic medicines are on average the most expensive. By contrast, originator medicines are the most expensive in Europe and Central Asia, and generic medicines are the least expensive. In fact, the data suggest mixed strategies by ARV suppliers to exploit opportunities for profit maximization and to adapt to the specific conditions of market competition in each region. Our results also suggest that the expiration of patents is not sufficient to boost additional developments in generic competition (at least in the ARV market and that formal or informal agreements between generic firms may de facto slow down or even reverse long-term trends towards price decreases. Conclusions: Our findings provide an improved understanding of the ARV market that can help countries strengthen policy measures to

  11. Affordability of adult HIV/AIDS treatment in developing countries: modelling price determinants for a better insight of the market functioning

    Science.gov (United States)

    Sagaon-Teyssier, Luis; Singh, Sauman; Dongmo-Nguimfack, Boniface; Moatti, Jean-Paul

    2016-01-01

    Introduction This study aims to provide a landscape of the global antiretroviral (ARV) market by analyzing the transactional data on donor-funded ARV procurement between 2003 and 2015, and the ARV price determinants. Design The data were obtained from the Global Price Reporting Mechanism (GPRM) managed by the AIDS Medicines and Diagnostics Service of the WHO, and it consists of information that covers approximately 80% of the total donor-funded adult ARV transactions procurement. Methods ExWorks prices and procured quantities were standardized according to the guidelines in terms of yearly doses. Descriptive statistics on quantities and prices show the main trends of the ARV market. Ordinary least squares estimation was carried out for the whole sample, then stratified according to the type of supplier (originator and generic) and controlled for time and geographical fixed-effects. Given that analyses were carried out on a public dataset on ARV transactional prices from the GPRM, ethics are respected and consent was not necessary. Results Originator medicines are on average the least expensive in the sub-Saharan Africa region, where at the same time, generic medicines are on average the most expensive. By contrast, originator medicines are the most expensive in Europe and Central Asia, and generic medicines are the least expensive. In fact, the data suggest mixed strategies by ARV suppliers to exploit opportunities for profit maximization and to adapt to the specific conditions of market competition in each region. Our results also suggest that the expiration of patents is not sufficient to boost additional developments in generic competition (at least in the ARV market) and that formal or informal agreements between generic firms may de facto slow down or even reverse long-term trends towards price decreases. Conclusions Our findings provide an improved understanding of the ARV market that can help countries strengthen policy measures to increase their bargaining

  12. 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.

  13. Generic Quantum Fourier Transforms

    CERN Document Server

    Moore, Cristopher; Russell, A; Moore, Cristopher; Rockmore, Daniel; Russell, Alexander

    2003-01-01

    The quantum Fourier transform (QFT) is the principal algorithmic tool underlying most efficient quantum algorithms. We present a generic framework for the construction of efficient quantum circuits for the QFT by ``quantizing'' the separation of variables technique that has been so successful in the study of classical Fourier transform computations. Specifically, this framework applies the existence of computable Bratteli diagrams, adapted factorizations, and Gel'fand-Tsetlin bases to offer efficient quantum circuits for the QFT over a wide variety a finite Abelian and non-Abelian groups, including all group families for which efficient QFTs are currently known and many new group families. Moreover, the method gives rise to the first subexponential-size quantum circuits for the QFT over the linear groups GL_k(q), SL_k(q), and the finite groups of Lie type, for any fixed prime power q.

  14. Dimensional regularization is generic

    CERN Document Server

    Fujikawa, Kazuo

    2016-01-01

    The absence of the quadratic divergence in the Higgs sector of the Standard Model in the dimensional regularization is usually regarded to be an exceptional property of a specific regularization. To understand what is going on in the dimensional regularization, we illustrate how to reproduce the results of the dimensional regularization for the $\\lambda\\phi^{4}$ theory in the more conventional regularization such as the higher derivative regularization; the basic postulate involved is that the quadratically divergent induced mass, which is independent of the scale change of the physical mass, is kinematical and unphysical. This is consistent with the derivation of the Callan-Symanzik equation, which is a comparison of two theories with slightly different masses, for the $\\lambda\\phi^{4}$ theory without encountering the quadratic divergence. We thus suggest that the dimensional regularization is generic in a bottom-up approach starting with a successful low-energy theory. We also define a modified version of t...

  15. Generic torus canards

    Science.gov (United States)

    Vo, Theodore

    2017-10-01

    Torus canards are special solutions of fast/slow systems that alternate between attracting and repelling manifolds of limit cycles of the fast subsystem. A relatively new dynamic phenomenon, torus canards have been found in neural applications to mediate the transition from tonic spiking to bursting via amplitude-modulated spiking. In R3, torus canards are degenerate: they require one-parameter families of 2-fast/1-slow systems in order to be observed and even then, they only occur on exponentially thin parameter intervals. The addition of a second slow variable unfolds the torus canard phenomenon, making it generic and robust. That is, torus canards in fast/slow systems with (at least) two slow variables occur on open parameter sets. So far, generic torus canards have only been studied numerically, and their behaviour has been inferred based on averaging and canard theory. This approach, however, has not been rigorously justified since the averaging method breaks down near a fold of periodics, which is exactly where torus canards originate. In this work, we combine techniques from Floquet theory, averaging theory, and geometric singular perturbation theory to show that the average of a torus canard is a folded singularity canard. In so doing, we devise an analytic scheme for the identification and topological classification of torus canards in fast/slow systems with two fast variables and k slow variables, for any positive integer k. We demonstrate the predictive power of our results in a model for intracellular calcium dynamics, where we explain the mechanisms underlying a novel class of elliptic bursting rhythms, called amplitude-modulated bursting, by constructing the torus canard analogues of mixed-mode oscillations. We also make explicit the connection between our results here with prior studies of torus canards and torus canard explosion in R3, and discuss how our methods can be extended to fast/slow systems of arbitrary (finite) dimension.

  16. Generic drugs for the treatment of ocular conditions: changing the treatment landscape.

    Science.gov (United States)

    Aref, Ahmad A

    2014-09-01

    As global spending on medicinal products continues to rise, the availability of lower-cost generic substitutes is increasingly driving health care decision-making. US FDA does not require strict demonstration of human bioequivalence and/or therapeutic studies for the approval of generic ophthalmic compounds. Bioequivalence between generic and innovator compounds is presumed on the basis of matching active and inactive ingredient profiles. Generic compounds may differ from innovator agents with regards to performance under environmental stress, relative acidity and bottle size/rigidity. Matching ingredient profiles may therefore not result in consistently comparable drug compositions and clinical effects.

  17. Prioritisation of Marketing Investments in Different Types of Marketing Functions

    DEFF Research Database (Denmark)

    Martensen, Anne; Mouritsen, Jan

    2015-01-01

    To elucidate how the marketing function's efforts influence the company's results, marketing functions are classified according to their role mix. The impact of the types is studied on the basis of an empirical study among 395 marketing managers. The study identifies four types of marketing...... functions based on the efforts they dedicate to seven generic marketing roles. The four types of marketing functions are denoted as follows: (1) the broadly-based; (2) the hesitant; (3) the traditional and (4) the market-creating marketing function. All four types of marketing functions directly influence...... the company's results, but there is considerable variation in the composition of the roles within each type of marketing function, their use and impact on the company's results. The findings of this study indicate that marketing functions are heterogeneous, and the effect achieved from investing in any given...

  18. Acceptability and confidence in antiretroviral generics of physicians and HIV-infected patients in France

    Directory of Open Access Journals (Sweden)

    Clotilde Allavena

    2014-11-01

    Full Text Available Introduction: 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. Materials and Methods: 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. Results: 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

  19. Typed combinators for generic traversal

    NARCIS (Netherlands)

    Lämmel, R.; Vonk, J.

    2001-01-01

    Lacking support for generic traversal, functional programming languages suffer from a scalability problem when applied to large-scale program transformation problems. As a solution, we introduce emph{functional strategies: typeful generic functions that not only can be applied to terms of any type,

  20. Article choice in plural generics

    NARCIS (Netherlands)

    Farkas, D.F.; Swart, Henriëtte de

    2007-01-01

    We discuss two groups of languages where article use contrasts in generic plural sentences but is otherwise essentially similar. The languages in the first group (English and Dutch) use bare plurals in the expression of kind reference (‘Dinosaurs are extinct’) and in generic generalizations (‘Dogs a

  1. From evidence-based to hope-based medicine? Ethical aspects on conditional market authorization of and early access to new cancer drugs.

    Science.gov (United States)

    Sandman, Lars; Liliemark, Jan

    2017-08-01

    There is a strong patient demand for early access to potentially beneficial cancer drugs. In line with this authorization agencies like the European Medicines Agency are providing drugs with conditional market authorisation based on positive interim analyses. This implies that drugs are used with insecure evidence of efficacy and adverse side-effects. Several authors have pointed to ethical problems with such a system but up to date no indepth ethical analysis of this system is found which is the aim of this article. Drawing of the four generally accepted principles of medical ethics: beneficence, nonmaleficence, respect for autonomy and justice the ethical pros and cons of conditional market authorisation are analysed. From the perspective of beneficence and non-maleficence it is found that the main problem is not risk of adverse side-effects to patients, but rather risk of less beneficial outcomes than what can be expected which could change incentives for patients' choice of treatment. This is also related to the extent to which patients might make an autonomous choice, especially taking into account problematic psychological attitudes and biases in medical decision-making. However, the main problem is related to justice and an equitable distribution of scarce health-care resources given the opportunity cost of drugs treatment. When using resources on cancer treatments which later might be found to be less efficacious than was first expected, other patients (in and outside the cancer field) are deprived of potentially more beneficial treatments even though their needs might be equally or more severe. At the same time, demanding more evidence has an ethical cost to patients in terms of depriving them of potential benefits in terms of reduced mortality and morbidity. In order to handle these ethical conflicts further research and analyses are required and it is suggested that pricing strategies and information requirements are alternatives to be further explored

  2. Got ACTs? Availability, price, market share and provider knowledge of anti-malarial medicines in public and private sector outlets in six malaria-endemic countries

    Directory of Open Access Journals (Sweden)

    O'Connell Kathryn A

    2011-10-01

    Full Text Available Abstract Background Artemisinin-based combination therapy (ACT is the first-line malaria treatment throughout most of the malaria-endemic world. Data on ACT availability, price and market share are needed to provide a firm evidence base from which to assess the current situation concerning quality-assured ACT supply. This paper presents supply side data from ACTwatch outlet surveys in Benin, the Democratic Republic of Congo (DRC, Madagascar, Nigeria, Uganda and Zambia. Methods Between March 2009 and June 2010, nationally representative surveys of outlets providing anti-malarials to consumers were conducted. A census of all outlets with the potential to provide anti-malarials was conducted in clusters sampled randomly. Results 28,263 outlets were censused, 51,158 anti-malarials were audited, and 9,118 providers interviewed. The proportion of public health facilities with at least one first-line quality-assured ACT in stock ranged between 43% and 85%. Among private sector outlets stocking at least one anti-malarial, non-artemisinin therapies, such as chloroquine and sulphadoxine-pyrimethamine, were widely available (> 95% of outlets as compared to first-line quality-assured ACT ( Conclusions These standardized, nationally representative results demonstrate the typically low availability, low market share and high prices of ACT, in the private sector where most anti-malarials are accessed, with some exceptions. The results confirm that there is substantial room to improve availability and affordability of ACT treatment in the surveyed countries. The data will also be useful for monitoring the impact of interventions such as the Affordable Medicines Facility for malaria.

  3. 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.

  4. Generic entry, reformulations and promotion of SSRIs in the US.

    Science.gov (United States)

    Huskamp, Haiden A; Donohue, Julie M; Koss, Catherine; Berndt, Ernst R; Frank, Richard G

    2008-01-01

    Previous research has shown that a manufacturer's promotional strategy for a brand name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion. To examine the relationships among promotional expenditures, generic entry, reformulation entry and new indication approval. We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising [DTCA], and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997-2004. We estimated econometric models of detailing, DTCA and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations and US FDA approval for new clinical indications for existing medications in the SSRI class. Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications was the main outcome measure. Over the period 1997-2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil and Zoloft

  5. Comparison of Medicinal Material Markets in“South Zhang and North Qi”After the Ming and Qing Dynasties%明清以降“南樟北祁”药市之比较

    Institute of Scientific and Technical Information of China (English)

    王中良; 杨小敏

    2014-01-01

    中国古代药市,自唐宋时期初步发展至明清时期日益繁盛,是传统中药材交流与贸易必不可少的市场载体。明清以后,全国陆续出现许多颇具影响的地方药市,其中“南樟北祁”(江西樟树药市、河北祁州药市)作为地区甚至全国性药材交易的典型代表影响甚大,一直颇受各界关注。两个药市的发展之路,有相同之处,亦有各自特色。特别是在清末民初应对传统经济向近代经济转型变化时,“南樟北祁”结合各自实际作出了适时适当的抉择与变化,实现了在新的历史环境下的发展与整合。%The medicinal material market, preliminary development since the Tang and Song Dynasties to the Ming and Qing Dy-nasties to flourish. They play an essential part of traditional Chinese medicinal materials exchanges and trade market. After the Ming and Qing Dynasties, the national have many influential local medicinal material markets, the“South Zhang and North Qi”(Jiangxi Zhangshu, Hebei Qizhou) as a regional and even national medicine market representative, has been praised by people from all walks of life. Com-parison of“South Zhang and North Qi” medicinal material market, both have in common, also have respective characteristics. In the late Qing Dynasty and the early Republic of China period, to deal with traditional economy to modern economic transition change,“South Zhang and North Qi” combining the reality of their medicinal material markets made timely appropriate choice and change, implements in the new historical environment of development and integration.

  6. [Marketing for hospitals--an issue?].

    Science.gov (United States)

    Schindler, Achim W; Schindler, Nicola; Vagts, Dierk

    2007-09-01

    Since economization of medicine continues, marketing is becoming more and more important. To shape marketing activities in correspondence with their professional ethics, physicians need some basic knowledge about marketing. The process of marketing consists of SWOT-analysis, market segmentation, market differentiation, positioning and the marketing-mix with ist most important component, the marketing communication. Specific aspects in the marketing of medical services derive from their nature as a service and the determinants of perceived service quality.

  7. 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.

  8. A Generic Dynamic Emulator

    CERN Document Server

    Albert, Carlo

    2011-01-01

    In applied sciences, we often deal with deterministic simulation models that are too slow for simulation-intensive tasks such as calibration or real-time control. In this paper, an emulator for a generic dynamic model, given by a system of ordinary non-linear differential equations, is developed. The non-linear differential equations are linearized and Gaussian white noise is added to account for the non-linearities. The resulting linear stochastic system is conditioned on a set of solutions of the non-linear equations that have been calculated prior to the emulation. A path-integral approach is used to derive the Gaussian distribution of the emulated solution. The solution reveals that most of the computational burden can be shifted to the conditioning phase of the emulator and the complexity of the actual emulation step only scales like $\\mathcal O(Nnm^2)$, where $N$ is the number of time-points at which the solution is to be emulated, $n$ the number of solutions the emulator is conditioned on and $m$ the n...

  9. Generic substitution - comparing the clinical efficacy of a generic ...

    African Journals Online (AJOL)

    1998-03-03

    Mar 3, 1998 ... Departments of Psychiatry and Biostatistics, University of the. Orange Free State ... industry has expanded rapidly during the last 2 decades! The need to contain the ... Substitution of a generic drug product for an innovator.

  10. Got ACTs? Availability, price, market share and provider knowledge of anti-malarial medicines in public and private sector outlets in six malaria-endemic countries.

    Science.gov (United States)

    O'Connell, Kathryn A; Gatakaa, Hellen; Poyer, Stephen; Njogu, Julius; Evance, Illah; Munroe, Erik; Solomon, Tsione; Goodman, Catherine; Hanson, Kara; Zinsou, Cyprien; Akulayi, Louis; Raharinjatovo, Jacky; Arogundade, Ekundayo; Buyungo, Peter; Mpasela, Felton; Adjibabi, Chérifatou Bello; Agbango, Jean Angbalu; Ramarosandratana, Benjamin Fanomezana; Coker, Babajide; Rubahika, Denis; Hamainza, Busiku; Chapman, Steven; Shewchuk, Tanya; Chavasse, Desmond

    2011-10-31

    comprised non-artemisinin therapies, and in the DRC and Nigeria, oral artemisinin monotherapies. Provider knowledge of the first-line treatment was significantly lower in the private sector than in the public/not-for-profit sector. These standardized, nationally representative results demonstrate the typically low availability, low market share and high prices of ACT, in the private sector where most anti-malarials are accessed, with some exceptions. The results confirm that there is substantial room to improve availability and affordability of ACT treatment in the surveyed countries. The data will also be useful for monitoring the impact of interventions such as the Affordable Medicines Facility for malaria.

  11. Got ACTs? Availability, price, market share and provider knowledge of anti-malarial medicines in public and private sector outlets in six malaria-endemic countries

    Science.gov (United States)

    2011-01-01

    . Most anti-malarials were distributed through the private sector, but often comprised non-artemisinin therapies, and in the DRC and Nigeria, oral artemisinin monotherapies. Provider knowledge of the first-line treatment was significantly lower in the private sector than in the public/not-for-profit sector. Conclusions These standardized, nationally representative results demonstrate the typically low availability, low market share and high prices of ACT, in the private sector where most anti-malarials are accessed, with some exceptions. The results confirm that there is substantial room to improve availability and affordability of ACT treatment in the surveyed countries. The data will also be useful for monitoring the impact of interventions such as the Affordable Medicines Facility for malaria. PMID:22039838

  12. Principles of marketing: Setting goals and marketing strategies

    OpenAIRE

    Marjanova Jovanov, Tamara

    2015-01-01

    Presented material to the students: 6.1. The mission of the organization and corporate goals 6.2. Marketing goals 6.3. Classification of marketing strategies 6.4. Generic marketing strategies regarding the wanted competitive advantage. 6.5. Competitive strategies in relation to the competitors and in relation to the environment. 6.6. Growth strategies or investment (intensive growth and integration / diversification) and maintenance strategies or divest (maintenance, harvest...

  13. Principles of marketing: Setting goals and marketing strategies

    OpenAIRE

    Marjanova Jovanov, Tamara

    2015-01-01

    Presented material to the students: 6.1. The mission of the organization and corporate goals 6.2. Marketing goals 6.3. Classification of marketing strategies 6.4. Generic marketing strategies regarding the wanted competitive advantage. 6.5. Competitive strategies in relation to the competitors and in relation to the environment. 6.6. Growth strategies or investment (intensive growth and integration / diversification) and maintenance strategies or divest (maintenance, harvest...

  14. Strategic business planning for internal medicine.

    Science.gov (United States)

    Ervin, F R

    1996-07-01

    The internal medicine generalist is at market risk with expansion of managed care. The cottage industry of Academic Departments of internal medicine should apply more business tools to the internal medicine business problem. A strength, weakness, opportunity, threat (SWOT) analysis demonstrates high vulnerability to the internal medicine generalist initiative. Recommitment to the professional values of internal medicine and enhanced focus on the master clinician as the competitive core competency of internal medicine will be necessary to retain image and market share.

  15. Generic interpreters and microprocessor verification

    Science.gov (United States)

    Windley, Phillip J.

    1990-01-01

    The following topics are covered in viewgraph form: (1) generic interpreters; (2) Viper microprocessors; (3) microprocessor verification; (4) determining correctness; (5) hierarchical decomposition; (6) interpreter theory; (7) AVM-1; (8) phase-level specification; and future work.

  16. Generic ISIS Transport Module Project

    Data.gov (United States)

    National Aeronautics and Space Administration — The purpose of the Generic ISIS Transport Module is to provide a means to bring living specimens to and from orbit. In addition to living specimens, the module can...

  17. Value added medicines: what value repurposed medicines might bring to society?

    Science.gov (United States)

    Toumi, Mondher; Rémuzat, Cécile

    2017-01-01

    ) to improve healthcare system efficiency; and (3) to contribute to sustainability of healthcare systems through economic advantages. Current HTA framework, generic stigma, and pricing rules, such as internal reference pricing or tendering processes in place in some countries, were reported as the current key hurdles preventing the full recognition of value added medicines' benefits, discouraging manufacturers from bringing such products to the market. Discussion & conclusions: There is currently a gap between increasing regulatory authority interest in capturing value added medicines' benefits and the resistance of HTA bodies/payers, who tend to ignore this important segment of the pharmaceutical field. This situation calls for policy changes to foster appropriate incentives to enhance value recognition of value added medicines and deliver the expected benefit to society. Policy changes from HTA perspective should include: absence of any legislative barriers preventing companies from pursuing HTA; HTA requirements proportionate to potential reward; HTA decision-making framework taking into account the specific characteristics of value added medicines; eligibility for early HTA dialogues; Policy changes from pricing perspective should encompass: tenders/procurement policies allowing differentiation from generic medicines; eligibility for early entry agreement; non-systematic implementation of external and internal reference pricing policies; recognition of indication-specific pricing. At the same time, the pharmaceutical industry should engage all the stakeholders (patients, healthcare providers, HTA bodies/payers) in early dialogues to identify their expectations and to ensure the developed value added medicines address their needs.

  18. Generic Advertising Optimum Budget for Iran’s Milk Industry

    Directory of Open Access Journals (Sweden)

    H. Shahbazi

    2016-05-01

    Full Text Available Introduction One of the main targets of planners, decision makers and governments is increasing society health with promotion and production of suitable and healthy food. One of the basic commodities that have important role in satisfaction of required human food is milk. So, some part of government and producer healthy budget allocate to milk consumption promotion by using generic advertising. If effectiveness of advertising budget on profitability is more, producer will have more willing to spend for advertising. Determination of optimal generic advertising budget is one of important problem in managerial decision making in producing firm as well as increase in consumption and profit and decrease in wasting and non-optimality of budget. Materials and Methods: In this study, optimal generic advertising budget intensity index (advertising budget share of production cost was estimated under two different scenarios by using equilibrium replacement model. In equilibrium replacement model, producer surplus are maximized in respect to generic advertising in retail level. According to market where two levels of farm and processing before retail exist and there is trade in farm and retail level, we present different models. Fixed and variable proportion hypothesis is another one. Finally, eight relations are presented for determination of milk generic advertising optimum budget. So, we use data from several resources such as previous studies, national (Iran Static center and international institute (Fao formal data and own estimation. Because there are several estimations in previous studies, we identify some scenarios (in two general scenarios for calculation of milk generic advertising optimum budget. Results and Discussion: Estimation of milk generic advertising optimum budget in scenario 1 shows that in case of one market level, fixed supplies and no trade, optimum budget is 0.4672539 percent. In case of one market level and no trade, optimum

  19. Hanford Generic Interim Safety Basis

    Energy Technology Data Exchange (ETDEWEB)

    Lavender, J.C.

    1994-09-09

    The purpose of this document is to identify WHC programs and requirements that are an integral part of the authorization basis for nuclear facilities that are generic to all WHC-managed facilities. The purpose of these programs is to implement the DOE Orders, as WHC becomes contractually obligated to implement them. The Hanford Generic ISB focuses on the institutional controls and safety requirements identified in DOE Order 5480.23, Nuclear Safety Analysis Reports.

  20. The Generic Data Capture Facility

    Science.gov (United States)

    Connell, Edward B.; Barnes, William P.; Stallings, William H.

    The Generic Data Capture Facility, which can provide data capture support for a variety of different types of spacecraft while enabling operations costs to be carefully controlled, is discussed. The data capture functions, data protection, isolation of users from data acquisition problems, data reconstruction, and quality and accounting are addressed. The TDM and packet data formats utilized by the system are described, and the development of generic facilities is considered.

  1. Knowledge Development Generic Framework Concept

    Science.gov (United States)

    2008-12-18

    Branch This is the final MNE 5 document on Knowledge Development. Contact ZTransfBw Abt II CDE@bundeswehr.org for inquiries regarding...subsequent updates beyond MNE 5 efforts. VERSION 1.30 18. December 2008 Knowledge Development Generic Framework Concept Draft Report...2. REPORT TYPE Final 3. DATES COVERED - 4. TITLE AND SUBTITLE Knowledge Development Generic Framework Concept 5a. CONTRACT NUMBER 5b

  2. Generic Planning and Control of Automated Material Handling Systems: Practical Requirements Versus Existing Theory

    NARCIS (Netherlands)

    Haneyah, Sameh; Zijm, Henk; Schutten, Marco; Schuur, Peter

    2011-01-01

    This paper discusses the problem of generic planning and control of Automated Material Handling Systems (AMHSs). The paper illustrates the relevance of this research direction, and then addresses three different market sectors where AMHSs are used. These market sectors are: baggage handling, distrib

  3. High Cholesterol: Medicines to Help You

    Science.gov (United States)

    ... Consumers Consumer Information by Audience For Women High Cholesterol--Medicines To Help You Share Tweet Linkedin Pin ... side effects for each drug, check Drugs@FDA . Cholesterol Absorption Inhibitors Brand Name Generic Name Zetia Ezetimibe ...

  4. 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.

  5. 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.

  6. [Generics: similarities, bioequivalence but no conformity].

    Science.gov (United States)

    Even-Adin, D; De Muylder, J A; Sternon, J

    2002-01-01

    The using of generic forms (GF) is presented as a potential source of budgetary "saving of money" in the field of pharmaceutical expenses. Not frequently prescribed in Belgium, they win a new interest thanks to the recent making use of the "reference repayment". Sale's authorization of GF is controlled by european rules, but some questions about their identity to original medications remain. Do similarities based only upon qualitative and quantitative composition in active molecules, pharmaceutical forms and biodisponibility give us all requested guaranties? Several cases of discordances can appear; the major elements of non conformity are the nature of excipients, notice's contents and the value of biodisponibility studies. However, in term of economy, in the drug market, development of GF appears to constitute an unavoidable phenomenon.

  7. Long-term Medicaid excess payments from alleged price manipulation of generic lorazepam.

    Science.gov (United States)

    Bian, Boyang; Gorevski, Elizabeth; Kelton, Christina M L; Guo, Jeff J; Martin Boone, Jill E

    2012-09-01

    Cost savings from the use of generic drugs versus brand-name drugs are well known. Both private and public prescription drug plans encourage the use of generic drugs through a variety of mechanisms. The magnitude of cost savings for a given generic drug is dependent on the degree to which the generic market is competitive. Should the competitive structure become compromised, higher prices and reduced cost savings may result. An alleged conspiracy between Mylan Laboratories and its active-ingredient suppliers in 1997 was associated with an increase in seller concentration in the generic lorazepam market. The Federal Trade Commission (FTC) alleged that Mylan raised costs to consumers by $120 million because of price increases for generic lorazepam from March through December 1998 and for generic clorazepate from January through December 1998. In November 2002, a settlement with Mylan was approved by the FTC, and a federal district court required Mylan to pay $147 million, including $28.2 million to state agencies including Medicaid. To (a) describe the seller concentration in the national Medicaid generic lorazepam market over a 19-year period from January 1991 through December 2009, (b) estimate the excess payments for generic lorazepam by Medicaid between 1998 and 2009, and (c) investigate potentially increased utilization and prices of 2 substitute pharmaceuticals: branded lorazepam (Ativan) and generic alprazolam (another widely used intermediate-acting benzodiazepine). Using Medicaid State Drug Utilization Data from the Centers for Medicare Medicaid Services, we calculated the 4-firm concentration ratio (CR₄) and the Herfindahl-Hirschman Index (HHI) for the Medicaid generic lorazepam market, along with pre-rebate reimbursement for pharmacy claims, number of claims (utilization), and average pre-rebate reimbursement per claim (average "price") for generic lorazepam, from 1991 through 2009. Medicaid's excess payments were estimated under 2 different assumptions

  8. HOW IS CURRENT PHARMACEUTICALS PRICING POLICY ON GENERICS PERFORMING IN TURKEY REGARDING PRICE EROSION?

    Directory of Open Access Journals (Sweden)

    Kadir GÜRSOY

    2017-02-01

    Full Text Available Generics are commonly accepted to contribute significantly to treating disease by improving the affordability of pharmaceuticals. Once the patent expires for an originator brand, generics erode prices through creating fierce competition. The objective of this study is to investigate on Turkish pharmaceutical policies over generics through measuring how much they lower the prices, and then develop alternative strategies to maintain higher level of price reduction, and hence saving. Claims data from Turkish Social Security Institution (SSI for all ambulatory care drugs reimbursed were collected monthly in the period of January 2009 to December 2013 and for selected 12 equivalent groups price erosion and saving impacts due to generic entry be computed. Moreover, the price erosion for 15 generics entering the reimbursement list in 2012 as first generics was measured. For 12 equivalent groups constituting nearly 7% of SSI drug spending, the price erosion was nearly 41% ranging from 8% to 74%. In the first year of the first generic entry, on average the prices were only shrank by 39% with an increase of 41% in units sold. As a result of those analyses, it is concluded that Turkey is not maximizing its full potential with respect to generic medicines. Therefore, it is of great importance that policies such as therapeutic equivalence, tendering, and aggressive generic pricing policy to stimulate higher savings need to be introduced in the near future.

  9. Newest generic OC manufacturer issues recall after packaging snafu.

    Science.gov (United States)

    1987-04-01

    Due to a packaging error that left white placebo pills in place of active pills, Gynex Inc. has had to recall 325,000 packages of generic oral contraceptives (OC), a mistake that the company insists has not affected consumers. Company vice president Stephen M. Simes says that although the majority of the defective packages remain in the possession of wholesalers and chain store warehouses, some had been shipped to pharmacies. But presently, it seems that none have reached consumers. Recently entering the generic OC market, the company's packaging error involved its first shipment of Gynex 1/35E and Gynex 0.5/35 in 28-day packs. These two generics are copy products on ON 1/35, made by Ortho Pharmaceutical, Modicon/Brevicon, made by Ortho Pharmaceutical and Syntex Laboratories--two widely used OCs. While the company is still investigating the incident, Simes explains that the company is enacting changes in the packaging procedures and is considering alterations in machinery and in quality control. The error will probably represent a financial loss for the company, and it will delay Gynex's entry into the contraceptive market. But the California-based company plans to press ahead, having already filed marketing applications for 5 additional low-dose OC formulations.

  10. Raising the Barriers to Access to Medicines in the Developing World - The Relentless Push for Data Exclusivity.

    Science.gov (United States)

    Diependaele, Lisa; Cockbain, Julian; Sterckx, Sigrid

    2017-04-01

    Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional 'regulatory' protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from 'free-riding' encounters some important problems: Neither legitimize excluding all others.

  11. Value added medicines: what value repurposed medicines might bring to society?

    Science.gov (United States)

    Toumi, Mondher; Rémuzat, Cécile

    2017-01-01

    access; (2) to improve healthcare system efficiency; and (3) to contribute to sustainability of healthcare systems through economic advantages. Current HTA framework, generic stigma, and pricing rules, such as internal reference pricing or tendering processes in place in some countries, were reported as the current key hurdles preventing the full recognition of value added medicines’ benefits, discouraging manufacturers from bringing such products to the market. Discussion & conclusions: There is currently a gap between increasing regulatory authority interest in capturing value added medicines’ benefits and the resistance of HTA bodies/payers, who tend to ignore this important segment of the pharmaceutical field. This situation calls for policy changes to foster appropriate incentives to enhance value recognition of value added medicines and deliver the expected benefit to society. Policy changes from HTA perspective should include: absence of any legislative barriers preventing companies from pursuing HTA; HTA requirements proportionate to potential reward; HTA decision-making framework taking into account the specific characteristics of value added medicines; eligibility for early HTA dialogues; Policy changes from pricing perspective should encompass: tenders/procurement policies allowing differentiation from generic medicines; eligibility for early entry agreement; non-systematic implementation of external and internal reference pricing policies; recognition of indication-specific pricing. At the same time, the pharmaceutical industry should engage all the stakeholders (patients, healthcare providers, HTA bodies/payers) in early dialogues to identify their expectations and to ensure the developed value added medicines address their needs. PMID:28265347

  12. 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.

  13. The future of medicine.

    Science.gov (United States)

    Ray, Russ

    2012-03-01

    The recent innovation of prediction markets is examined, and their significant applications to the science of medicine are demonstrated. According to one comprehensive study, these markets make "uncannily accurate" predictions of every type of event. In the medical field, being able to predict cures, epidemics, medical discoveries, and myriad other medical variables can greatly further the advances of medical science and its clinical applications.

  14. New European commission regulation on variations to the terms of marketing authorization for medicinal products and its impact on Croatian legislation.

    Science.gov (United States)

    Martinac, Adrijana Ilić; Tomić, Sinisa; Simicić, Mirna

    2010-09-01

    Variations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product. Croatian Medicinal Products Act and accompanying ordinances are largely aligned with the EU regulations. The EU has now tried to simplify the issue of variations with a new Regulation, creating differences in the definition of and approach to resolving certain types of variations between Croatia and the EU. These differences could hinder the approval procedure for variations in Croatia, particularly for medicines already approved in the EU. Amending the Croatian Ordinance on medicines already authorised in the EU would be one way of maintaining the efficiency of the Croatian regulatory system.

  15. MIIT Issued Industrial Key Generic Technology Development Guidelines (2011)

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    In order to make full use of social resources, guide conducts of market subject, lead the developing direction of industrial key generic technology, promote industrial technology advance and realize transformation, upgrading and structural optimization of industry and communications industry, on July 1, the Ministry of Industry and Information Technology (MIIT) issued Industrial Key Generic Technology Development Guidelines (2011) (Gong Xin Bu Ke [2011] No.320),

  16. 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.

  17. 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

  18. Rectification of two generic names

    NARCIS (Netherlands)

    Büttikofer, J.

    1896-01-01

    I am sorry to say that amongst the new generic names, occurring in my recent paper on the genus Pycnonotus and some allied Genera (N. L. M. XVII), Centrolophus and Gymnocrotaphus are already preoccupied among the Fishes, the first being used by Lacépède, the second by Günther. I propose, therefore,

  19. GENERIC model for multiphase systems

    NARCIS (Netherlands)

    Sagis, L.M.C.

    2010-01-01

    GENERIC is a nonequilibrium thermodynamic formalism in which the dynamic behavior of a system is described by a single compact equation involving two types of brackets: a Poisson bracket and a dissipative bracket. This formalism has proved to be a very powerful instrument to model the dynamic behavi

  20. Generic Hurricane Extreme Seas State

    DEFF Research Database (Denmark)

    Wehmeyer, Christof; Skourup, Jesper; Frigaard, Peter

    2012-01-01

    the US east coast and the Gulf of Mexico (1851 - 2009) and Japanese east coast (1951 -2009) form the basis for Weibull extreme value analyses to determine return period respective maximum wind speeds. Unidirectional generic sea state spectra are obtained by application of the empirical models...

  1. Generic Software Architecture for Launchers

    Science.gov (United States)

    Carre, Emilien; Gast, Philippe; Hiron, Emmanuel; Leblanc, Alain; Lesens, David; Mescam, Emmanuelle; Moro, Pierre

    2015-09-01

    The definition and reuse of generic software architecture for launchers is not so usual for several reasons: the number of European launcher families is very small (Ariane 5 and Vega for these last decades); the real time constraints (reactivity and determinism needs) are very hard; low levels of versatility are required (implying often an ad hoc development of the launcher mission). In comparison, satellites are often built on a generic platform made up of reusable hardware building blocks (processors, star-trackers, gyroscopes, etc.) and reusable software building blocks (middleware, TM/TC, On Board Control Procedure, etc.). If some of these reasons are still valid (e.g. the limited number of development), the increase of the available CPU power makes today an approach based on a generic time triggered middleware (ensuring the full determinism of the system) and a centralised mission and vehicle management (offering more flexibility in the design and facilitating the long term maintenance) achievable. This paper presents an example of generic software architecture which could be envisaged for future launchers, based on the previously described principles and supported by model driven engineering and automatic code generation.

  2. Exploring factors underlying the attitude of community pharmacists to generic substitution: a nationwide study from Poland.

    Science.gov (United States)

    Drozdowska, Aleksandra; Hermanowski, Tomasz

    2016-02-01

    Generic uptake will increasingly be promoted by governments in the face of increasing healthcare costs and global economic uncertainties. The purpose of this study was to investigate attitudes towards generic substitution among community pharmacists, with a focus on the perception of the efficacy, knowledge of the generics characteristics, as well as the willingness to recommend generic substitution. Community pharmacies in Poland. The survey was conducted in 2013 by telephone interviews with 802 holders of an MSc degree in pharmacy working as community pharmacists. Stratified sampling was implemented to make the study representative in geographic terms. Pharmacists' attitudes towards generics drugs. The study showed that only 40 % of pharmacists always inform patients about their right to choose a generic substitute. It was also shown that the less time a pharmacist has been practising, the less likely they are to invite consumers to choose between generic and innovator products. The likelihood of informing was not affected by pharmacist's sex or age, or by pharmacy location or status (chain vs. independent pharmacy) (p > 0.05). Pharmacists varied in their approach to their statutory obligation to inform about a generic; a more or less equal share of respondents were either in favour or against it. Approximately 60 % pharmacists were shown to be familiar with the definition of a generic medicine. Pharmacists with shorter time of practice proved to know more about generics. However, more than 30 % respondents failed to choose the correct statement on generic versus reference medicine dosage. The majority of respondents (67 %) believed there are no differences in efficacy between generics and innovator drugs, whereas 31 % claimed that original brands could be more effective. A significant correlation was demonstrated between the views of pharmacists on the therapeutic efficacy and their willingness to substitute for generics whenever permitted by a physician. It is

  3. Nonbioequivalent prescription drug interchangeability, concerns on patient safety and drug market dynamics in Brazil.

    Science.gov (United States)

    Paumgartten, Francisco José Roma; Oliveira, Ana Cecilia Amado Xavier de

    2017-08-01

    Since the enforcement of Generics Act (1999), three types of pharmaceutically equivalent products are marketed in Brazil: innovative reference (REF), "similar" (S) and generic (G) drugs. The S (brand name) and G (generic name) borrow from REF (brand name) clinical data on safety and efficacy and dosage regimen. G (but not S) is bioequivalent to and interchangeable with REF. Starting in 2003, Brazilian Sanitary Surveillance Agency (Anvisa) has required data on relative bioavailability tests (with REF) to approve (or renew registration of) S drugs. In 2014, Anvisa extended interchangeability notion to similar drugs with a "comparable" bioavailability, i.e., an "equivalent" similar drug (EQ). Drugs for chronic diseases and "critical dose medicines" are listed among the EQ drugs approved. Interchangeability of nonbioequivalent medicines raises deep concerns regarding therapeutic failures and adverse events. Concerns are even more worrisome if patients switch from one drug to another during an ongoing treatment for illnesses such as epilepsy, congestive heart failure, hypertension, diabetes and/or substitutable drugs have a narrow therapeutic index.

  4. 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 …

  5. Mylan to Offer Generic EpiPen

    Science.gov (United States)

    ... news/fullstory_160669.html Mylan to Offer Generic EpiPen Manufacturer responds to mounting criticism about price hikes ... cheaper generic version of the emergency allergy treatment EpiPen will be made available within the next few ...

  6. Study on Database Construction Scheme of Market Ontology for Internet Medicine Enterprises%互联网药品经营企业市场本体数据库建设研究

    Institute of Scientific and Technical Information of China (English)

    陆颖; 顿彬; 陈锋; 陆明

    2011-01-01

    The ontology information management platform of intemet medicine market is the basis of the secure and stable development for internet medicine market. Meanwhile, it is also the important carrier of the government' s effective supervision. Moreover, the database of market ontology is the core of the platform. The market ontology has the characteristics of complexity, magnanimity, dynamic, multi-resource, multi-relationship and multi- metrics. According to the developing idea of the platform and the developing tools, also through the database design theory and method, we particularly construct the database based on the ontology information management platform of intemet medicine market and design the communication mechanism among the database and the related functional organizations' databases.%互联网药品市场本体信息管理平台是互联网药品市场安全、稳定发展的基础,同时也是政府部门对互联网药品市场进行有效监管的重要载体,而互联网药品经营企业的市场本体数据库正是此载体的核心.这些市场本体数据具有复杂性、海量性和动态性及多源、多关联和多尺度特征.利用互联网药品市场本体信息管理平台的开发思想与工具,依托数据库设计理论与方法,详细分析并构建了基于互联网药品经营企业信息平台的数据库,设计了互联网药品经营企业信息平台数据库与相关职能机构数据库的通信机制.

  7. Evaluation of a Generic Virtual Power Plant Framework Using Service Oriented Architecture

    DEFF Research Database (Denmark)

    Andersen, Peter Bach; Poulsen, Bjarne; Decker, Morten

    2008-01-01

    interesting properties that can influence the future shape of power markets. The concept holds many promises including cheaper power to the consumer, a more flexible and responsive power production and the support of a more environment- friendly development. In order to realize a software solution supporting...... the generic virtual power plant, an array of different software design principles, patterns and architectures must be applied. Especially Service Oriented Architecture (SOA) can aid in implementing the generic virtual power plant. An analysis of the Nordic power market has been carried out in order...

  8. Compositional Design of a Generic Design Agent

    NARCIS (Netherlands)

    Brazier, F.M.T.; Jonker, C.M.; Treur, J.; Wijngaards, N.J.E.

    2001-01-01

    This paper presents a generic architecture for a design agent, to be used in an Internet environment. The design agent is based on an existing generic agent model, and includes a refinement of a generic model for design, in which strategic reasoning

  9. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2007-01-01

    The last decade has seen a number of approaches to data- type-generic programming: PolyP, Functorial ML, `Scrap Your Boiler- plate', Generic Haskell, `Generics for the Masses', etc. The approaches vary in sophistication and target audience: some propose full-blown pro- gramming languages, some sugge

  10. Fluorine in medicinal chemistry.

    Science.gov (United States)

    Swallow, Steven

    2015-01-01

    Since its first use in the steroid field in the late 1950s, the use of fluorine in medicinal chemistry has become commonplace, with the small electronegative fluorine atom being a key part of the medicinal chemist's repertoire of substitutions used to modulate all aspects of molecular properties including potency, physical chemistry and pharmacokinetics. This review will highlight the special nature of fluorine, drawing from a survey of marketed fluorinated pharmaceuticals and the medicinal chemistry literature, to illustrate key concepts exploited by medicinal chemists in their attempts to optimize drug molecules. Some of the potential pitfalls in the use of fluorine will also be highlighted.

  11. Quality evaluation of medicinal products and health foods containing chaste berry (Vitex agnus-castus) in Japanese, European and American markets.

    Science.gov (United States)

    Fukahori, Masahiro; Kobayashi, Shojiro; Naraki, Yoko; Sasaki, Takahiro; Oka, Hideki; Seki, Masaharu; Masada-Atsumi, Sayaka; Hakamatsuka, Takashi; Goda, Yukihiro

    2014-01-01

    The aim of present study was to evaluate the qualities of chaste berry (fruit of Vitex agnus-castus L.) preparations using HPLC fingerprint analysis. Seven medicinal products 1 from Japan and 6 from Europe, and 17 health foods, 6 from Japan and 11 from the United States were analyzed. HPLC profile and 26 authentic peaks were compared medicinal products and health foods. Whereas medicinal products had similar HPLC profiles, health foods had various profiles and each peak was also greatly different. The measured amounts of two markers in 5 traditional medicinal products, agnuside and casticin specified in the European Pharmacopoeia (EP), the U.S. Pharmacopoeia (USP) or the WHO monographs of chaste berry, were much lower than those in 2 medicinal products defined as "well-established use" by the European Medicines Agency. The amounts of two markers for 17 health foods differed in a great deal from 14-5054% and 3-1272%, respectively. Furthermore the amount ratios of two markers, agnuside/casticin, in about half of the health foods were remarkably larger than the standard crude drug and the ratios were closer to one of the related Chinese herbs, Vitex negundo L. It is concluded that a combination of HPLC fingerprints and the amount ratios of the marker compounds of chaste berry preparations serves as a useful tool to evaluate the qualities of these preparations.

  12. Enhancing Safety through Generic Competencies

    Directory of Open Access Journals (Sweden)

    S. Mockel

    2014-03-01

    Full Text Available This article provides insights into proactive safety management and mitigation. An analysis of accident reports reveals categories of supervening causes of accidents which can be directly linked to the concept of generic competencies (information management, communication and coordination, problem solving, and effect control. These findings strongly suggest adding the human element as another safety-constituting pillar to the concept of ship safety next to technology and regulation. We argue that the human element has unique abilities in dealing with critical and highly dynamic situations which can contribute to the system's recovery from non-routine or critical situations. By educating seafarers in generic competencies we claim to enable the people onboard to successfully deal with critical situations.

  13. Efficient Generation of Generic Entanglement

    CERN Document Server

    Oliveira, R; Plenio, M B

    2006-01-01

    We find that generic entanglement is physical, in the sense that it can be generated in polynomial time from two-qubit gates picked at random. We prove as the main result that such a process generates the average entanglement of the uniform (Haar) measure in at most $O(N^3)$ steps for $N$ qubits. This is despite an exponentially growing number of such gates being necessary for generating that measure fully on the state space. Numerics furthermore show a variation cut-off allowing one to associate a specific time with the achievement of the uniform measure entanglement distribution. Various extensions of this work are discussed. The results are relevant to entanglement theory and to protocols that assume generic entanglement can be achieved efficiently.

  14. Access to essential medicines for sexual and reproductive health care: the role of the pharmaceutical industry and international regulation.

    Science.gov (United States)

    Cottingham, Jane; Berer, Marge

    2011-11-01

    The range of medicines and technologies that are essential for sexual and reproductive health care is well established, but access to them is far from universally assured, particularly in less developed countries. This paper shows how the pharmaceutical industry plays a major role in the lack of access to essential medicines for sexual and reproductive health care, by a) investing in products for profit-making reasons despite their negative health impact (e.g. hormone replacement therapy), b) marketing new essential medicines at prices beyond the reach of countries that most need them (e.g. HPV vaccines), and c) failing to invest in the development of new products (e.g. microbicides and medical abortion pills). Small companies, some of them non-profit-making, struggle to fill some of that demand (e.g. for female condoms). International patent protection contributes to high prices of medicines, and while international agreements such as compulsory licensing under TRIPS and the Medicines Patent Pool allow for mechanisms to enable poorer countries to get access to essential medicines, the obstacles created by "big pharma" are daunting. All these barriers have fostered a market in sub-standard medicines (e.g. fake medical abortion pills sold over the internet). An agenda driven by sexual and reproductive health needs, based on the right to health, must focus on universal access to essential medicines at prices developing countries can afford. We call for greater public investment in essential medicines, expanded production of affordable generic drugs, and the development of broad strategic plans, that include affordable medicines and technologies, for addressing identified public health problems, such as cervical cancer.

  15. An introduction to InP-based generic integration technology

    Science.gov (United States)

    Smit, Meint; Leijtens, Xaveer; Ambrosius, Huub; Bente, Erwin; van der Tol, Jos; Smalbrugge, Barry; de Vries, Tjibbe; Geluk, Erik-Jan; Bolk, Jeroen; van Veldhoven, Rene; Augustin, Luc; Thijs, Peter; D'Agostino, Domenico; Rabbani, Hadi; Lawniczuk, Katarzyna; Stopinski, Stanislaw; Tahvili, Saeed; Corradi, Antonio; Kleijn, Emil; Dzibrou, Dzmitry; Felicetti, Manuela; Bitincka, Elton; Moskalenko, Valentina; Zhao, Jing; Santos, Rui; Gilardi, Giovanni; Yao, Weiming; Williams, Kevin; Stabile, Patty; Kuindersma, Piet; Pello, Josselin; Bhat, Srivathsa; Jiao, Yuqing; Heiss, Dominik; Roelkens, Gunther; Wale, Mike; Firth, Paul; Soares, Francisco; Grote, Norbert; Schell, Martin; Debregeas, Helene; Achouche, Mohand; Gentner, Jean-Louis; Bakker, Arjen; Korthorst, Twan; Gallagher, Dominic; Dabbs, Andrew; Melloni, Andrea; Morichetti, Francesco; Melati, Daniele; Wonfor, Adrian; Penty, Richard; Broeke, Ronald; Musk, Bob; Robbins, Dave

    2014-06-01

    Photonic integrated circuits (PICs) are considered as the way to make photonic systems or subsystems cheap and ubiquitous. PICs still are several orders of magnitude more expensive than their microelectronic counterparts, which has restricted their application to a few niche markets. Recently, a novel approach in photonic integration is emerging which will reduce the R&D and prototyping costs and the throughput time of PICs by more than an order of magnitude. It will bring the application of PICs that integrate complex and advanced photonic functionality on a single chip within reach for a large number of small and larger companies and initiate a breakthrough in the application of Photonic ICs. The paper explains the concept of generic photonic integration technology using the technology developed by the COBRA research institute of TU Eindhoven as an example, and it describes the current status and prospects of generic InP-based integration technology.

  16. Nuclear Medicine

    Science.gov (United States)

    ... for Parents/Teachers Resource Links for Students Glossary Nuclear Medicine What is nuclear medicine? What are radioactive ... NIBIB-funded researchers advancing nuclear medicine? What is nuclear medicine? Nuclear medicine is a medical specialty that ...

  17. Involve physicians in marketing.

    Science.gov (United States)

    Randolph, G T; Baker, K M; Laubach, C A

    1984-01-01

    Many everyday problems in medical group practice can be attacked by a marketing approach. To be successful, however, this kind of approach must have the full support of those involved, especially the physicians, since they are the principal providers of healthcare services. When marketing is presented in a broad context, including elements such as patient mix, population distribution, and research, physicians are more likely to be interested and supportive. The members of Geisinger Medical Center's Department of Cardiovascular Medicine addressed their patient appointment backlog problem with a marketing approach. Their method is chronicled here and serves as a fine example of how physician involvement in marketing can lead to a positive outcome.

  18. Building up Evidence Body for Post-marketing Chinese Medicines Research%构建中药上市后安全性评价证据体的思考

    Institute of Scientific and Technical Information of China (English)

    廖星; 谢雁鸣

    2014-01-01

    Safety surveillance is the most important aspect for post-marketing research of Chinese medicine.However,passive monito-ring systems or phase four clinical trials or large sample epidemiology studies were historically the common ways of surveillance of post-marketing Chinese medicine.However those studies can no longer meet the expectations,and there are many more evidence sources for post-marketing Chinese medicine safety evaluation,eg.active surveillance from observational cohort study and study on hospital informa-tion system.These data and study can provide adequate source data for post-marketing Chinese medicine research.The most prominent problem is how to integrate different evidences from multiple sources.This article suggests we should build an evidence-based system to evaluate post-marketing Chinese medicines safety.%中药上市后安全性评价关乎用药患者在临床应用中的生命安全,关系着国家医疗卫生政策的导向,以及药厂对药品开发规划设计。上市后药品的安全监测无疑是所有上市后药品的重要内容,而监测主要关注药品在上市前未曾发现的那些潜在的不良反应/事件。既往,上市后药物监测习惯以被动监测模式或者是四期的临床试验或者是大型的流行病学调查,这些统被称之为安全性监测或药物警戒研究。现今,研究者们发现这些方法或方式远远不能满足当下对于上市后药品安全性评价的证据需求。为此,为了能够弥补这些证据积累的不足,目前亟需发展新的证据研究模式,比如转向大样本大范围的主动监测,采用队列观察性研究方法,基于真实世界医疗电子数据库等等。本文基于上市后中药的特点,从循证医学证据理念出发,提出构建中药上市后安全性评价证据体的设想来对未来中药上市后安全性评价研究提供参考。

  19. 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.

  20. Generic drugs in dermatology: part II.

    Science.gov (United States)

    Payette, Michael; Grant-Kels, Jane M

    2012-03-01

    In part I, we discussed new drug development, reviewed the history of the generic drug industry, described how generic drugs are approved by the US Food and Drug Administration, and defined the concepts of bioequivalence and therapeutic equivalence. Herein, we explore various factors impacting generic drug use across the different parties involved: the prescriber, the pharmacist, the patient, and the payer. We also include original cost analysis of dermatologic brand name and generic drugs and show the potential cost savings that can be achieved through generic substitution. We conclude with a review of the data addressing potential differences in the effectiveness of brand name versus generic drugs in dermatology. The cost of brand name and generic medications is highly variable by pharmacy, state, and payer. We used one source (www.drugstore.com) as an example and for consistency across all medications discussed herein. Prices included here may not reflect actual retail prices across the United States.

  1. Potential cost savings from generic medicines – protecting the ...

    African Journals Online (AJOL)

    reconsider these requirements in order to increase the affordability of medical ... site of the Pharmaceutical Blue Book and the cost per defined daily dose for one ... There were examples of high-cost differentials in highly competitive areas of.

  2. [Generic drugs: we must cut pharmaceutical spending but undertaking drug quality].

    Science.gov (United States)

    Carrillo Norte, Juan Antonio; Postigo Mota, Salvador

    2012-02-01

    The World Health Organization and all drug regulatory agencies (DRA) support the commercialization of generic medicines because they control costs and are irreplaceable therapeutic options in countries lacking the innovator product. Generic drugs are widely considered to be cost-efficient substitutes for brand-name medications. They make up about 20% of the total number of prescriptions in Spain, a figure that is still far from the use of generic drugs in USA and other European countries. Despite economical interest in this issue, in this article we review the interest of generic drugs from a pharmacological and clinical perspective that must undertake drug quality to ensure drug efficacy and safety of the patients. A generic drug (generic drugs, short: generics) is defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use". Both the reference drug and the generic drug have to demonstrate previously they are therapeutically equivalent. With the exception of parenteral drugs, two products have demonstrated to be therapeutically equivalent if after administration in the same molar dose, their effects with respect to both efficacy and safety are essentially the same, as determined from bioequivalence studies in terms of comparison of appropriate pharmacokinetic parameters and bioavailability. Parenteral formulations, however, are not required to demonstrate therapeutic equivalence because it may be considered self-evident. Such assumptions have never been challenged, but there are reasons to do so for parenteral antimicrobials. It is interesting to highlight that although brand-name drugs and generic drugs are both approved by DRA and may be interchangeable with respect to their clinical effects, they can differ substantially in their appearance. Consumers of brand-name medications receive identical-appearing batches of pills with

  3. The Influence of Event Marketing Activity of Medicine and Health Products on Purcha-sing Behavior among Residents%活动营销对居民购买医药保健品行为影响的研究

    Institute of Scientific and Technical Information of China (English)

    那军; 李爽; 礼彦侠; 穆慧娟; 马尉瑶; 刘莉

    2016-01-01

    Objectives To explore the characteristic and the influence factors of joining in the event marketing ac-tivity and purchasing medicine and health care products among residents in Liaoning province.Methods 2 901 sub-jects were randomly selected from 1 1 cities (area under administration)by stratified multi-stage sampling meth-od.Results Among the interviewees,1 1.62% had joined in event marketing activity,among whom 48.97% had pur-chased medicine and health care products.Persons above 60 years older who paid attention to health information, trusted in advertisement and joined in the event marking activity would tend to purchase products mostly,and joining marketing event activity was the most important influence factor(OR =6.60,95%CI =4.67 ~9.33).Conclusions The event marketing is an important marketing approach of medicine and health products,also is the most direct and significant influence factor of the purchasing behavior of residents.It is need right now to describe and master the quality,true and false of the medicine and health care products,and relevant department of government should en-force the approval process,supervise and penalties of advertisement and marketing active,in order to avoid the resi-dent being cheated and hazarded.%目的:了解掌握居民参加医药保健品活动营销和购买医药保健品的特征和影响因素,以及参加活动营销对购买医药保健产品的影响。方法采用多阶段分层随机抽样方法,对辽宁省11市2901名居民进行入户问卷调查。结果受访者中参加活动营销的占11.62%,其中48.97%的人购买过医药保健产品,城市中关注信息、相信广告、参加活动营销的老年人更易购买医药保健品,其中参加医药保健品活动营销是最重要、最直接的影响因素(OR=6.60,95%CI =4.67~9.33)。结论活动营销是医药保健产品非常重要的营销方式,也是对居民购买医药保健品行为影响最大的因素,目前急需了解掌握活动

  4. Restrictions on the conduct of advertising of medicinal products in Poland and their violations.

    Science.gov (United States)

    Czerw, Aleksandra; Marek, Ewelina Maria

    2013-01-01

    Similarly to other European countries, the Polish pharmaceutical market is in the phase of maturity characterized by limited speed of increase in sales. In connection with escalation of the competitive struggle, being the result of globalization and development of enterprises producing generic medications, the most important aim for pharmaceutical companies has been to maintain profitability on the right level. To perform this task, companies producing medications have to carry out proper marketing actions. The marketing elements include, apart from the product, the price and the distribution, also promotion which is inextricably linked with advertising. It is a special type of information message that aims at evoking a specific consumer's attitude and belief. Advertising of medicinal products is subject to detailed legislative and non-legislative regulations. The aim of the article is to present legal regulations within the scope of advertising of medicinal products and violations of these regulations based on example decisions of the Main Pharmaceutical Inspector issued in the years 2008-2010. Abundant rulings of the Main Pharmaceutical Inspector prove that both advertisements addressed to public attention and those addressed to specialists often diverge from the criteria determined by the Pharmaceutical Law. In the face of still increasing violations of the provisions of the Pharmaceutical Law act, it seems that introducing a ban on advertising or any possible financial sanctions is not a sufficient punishment for advertisers. Thus, an introduction of other, more rigorous legal regulations as a deterrent for those involved in illegal advertising of medicinal products ought to be considered.

  5. The Effects of Intellectual Property Rights on Access to Medicines and Catastrophic Expenditure.

    Science.gov (United States)

    Jung, Youn; Kwon, Soonman

    2015-01-01

    Since the introduction of Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1995, there has been considerable concern that poor access to essential medicines in developing countries would be exacerbated because strengthening intellectual property rights (IPR) leads to monopoly of pharmaceutical markets and delayed entry of lower-cost generic drugs. However, despite extensive research and disputes regarding this issue, there are few empirical studies on the topic. In this study, we investigated the effect of IPR on access to medicines and catastrophic expenditure for medicines, using data from World Health Surveys 2002-2003. The index of patent rights developed by Ginarte and Park (1997) was used to measure the IPR protection level of each country. Estimates were adjusted for individual and country characteristics. In the results of multilevel logistic regression analyses, higher level of IPR significantly increased the likelihood of nonaccess to prescribed medicines even after controlling for individual socioeconomic status and national characteristics associated with access to medicines. This study's finding on the negative impact of IPR on access to medicines calls for the implementation of more active policy at the supra-national level to improve access in low- and middle-income countries.

  6. Generic Graph Grammar: A Simple Grammar for Generic Procedural Modelling

    DEFF Research Database (Denmark)

    Christiansen, Asger Nyman; Bærentzen, Jakob Andreas

    2012-01-01

    in a directed cyclic graph. Furthermore, the basic productions are chosen such that Generic Graph Grammar seamlessly combines the capabilities of L-systems to imitate biological growth (to model trees, animals, etc.) and those of split grammars to design structured objects (chairs, houses, etc.). This results......Methods for procedural modelling tend to be designed either for organic objects, which are described well by skeletal structures, or for man-made objects, which are described well by surface primitives. Procedural methods, which allow for modelling of both kinds of objects, are few and usually...

  7. Efficacy and motor complications of original and generic levodopa in Parkinson's disease treatment

    Directory of Open Access Journals (Sweden)

    Kasemsap N

    2016-05-01

    Full Text Available Narongrit Kasemsap,1 Satrirat Onsanit,2 Piyawan Chiewthanakul,3 Kannikar Kongbunkiat,1 Chonthicha Tanking,1 Nisa Vorasoot,1 Kittisak Sawanyawisuth,1,4 Somsak Tiamkao1,5 1Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, 2Department of Medicine, Udonthani Hospital, Udonthani, 3Department of Medicine, Khon Kaen Hospital, 4Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH, 5Neuroscience Research and Development Group (NRDG, Khon Kaen University, Khon Kaen, Thailand Background: In general, a generic drug is considered interchangeable with the original formulated drug. In Parkinson’s disease (PD, generic drug use remains debated. This study was aimed to investigate whether the generic drug was as effective as the original in improving the symptoms of PD and the prevalence of motor complications.Methods: This study was a multicenter cohort study of patients with PD enrolled from three northeast hospitals in Thailand between February 2013 and February 2014. The patients were categorized into original and generic levodopa groups. The clinical characteristics, efficacy, and motor complications were compared between the groups.Results: There were 400 eligible patients. Of these, 327 patients (81.75% met the study criteria and were classified as the original levodopa group (200 patients, 61.16% and the generic levodopa group (127 patients, 38.84%. The average age of all patients with PD was 65 years. The duration of PD and the modified Hoehn–Yahr stages were not different between the groups. The total doses of original and generic levodopa-equivalent doses were significantly different (199.97±127.08 versus 305.58±138.27 mg; P-value <0.001 and the actual doses were 198.10±117.92 versus 308.85±139.40 mg (P-value <0.001. Approximately 80% of patients with PD in both groups had good responses (P-value >0.999, but the development of motor complications was significantly greater in the original

  8. 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.

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

    Directory of Open Access Journals (Sweden)

    Luca Gallelli

    2013-01-01

    Full Text Available 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.

  10. Content-Marketing-Strategien in der Unternehmenspraxis: Eine empirische Analyse

    OpenAIRE

    Riekhof, Hans-Christian; Jacobi, Teresa

    2016-01-01

    Although there is currently limited empirical research available on content marketing this topic is discussed quite intensively among marketing experts. Some of these even see a new paradigm on the rise because marketing strategies based on content are fundamentally different from traditional approaches where selling products and directly influencing customers and prospects are the dominating focus of marketing activities. In this paper, content marketing is used as the more generic term wher...

  11. Generic Crystalline Disposal Reference Case

    Energy Technology Data Exchange (ETDEWEB)

    Painter, Scott Leroy [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Chu, Shaoping [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Harp, Dylan Robert [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Perry, Frank Vinton [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Wang, Yifeng [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-02-20

    A generic reference case for disposal of spent nuclear fuel and high-level radioactive waste in crystalline rock is outlined. The generic cases are intended to support development of disposal system modeling capability by establishing relevant baseline conditions and parameters. Establishment of a generic reference case requires that the emplacement concept, waste inventory, waste form, waste package, backfill/buffer properties, EBS failure scenarios, host rock properties, and biosphere be specified. The focus in this report is on those elements that are unique to crystalline disposal, especially the geosphere representation. Three emplacement concepts are suggested for further analyses: a waste packages containing 4 PWR assemblies emplaced in boreholes in the floors of tunnels (KBS-3 concept), a 12-assembly waste package emplaced in tunnels, and a 32-assembly dual purpose canister emplaced in tunnels. In addition, three failure scenarios were suggested for future use: a nominal scenario involving corrosion of the waste package in the tunnel emplacement concepts, a manufacturing defect scenario applicable to the KBS-3 concept, and a disruptive glaciation scenario applicable to both emplacement concepts. The computational approaches required to analyze EBS failure and transport processes in a crystalline rock repository are similar to those of argillite/shale, with the most significant difference being that the EBS in a crystalline rock repository will likely experience highly heterogeneous flow rates, which should be represented in the model. The computational approaches required to analyze radionuclide transport in the natural system are very different because of the highly channelized nature of fracture flow. Computational workflows tailored to crystalline rock based on discrete transport pathways extracted from discrete fracture network models are recommended.

  12. Generic behaviours in impact fragmentation

    Energy Technology Data Exchange (ETDEWEB)

    Sator, N.; Mechkov, S.; Sausset, F. [Paris-6 Univ. Pierre et Marie Curie, Lab. de Physique Theorique de la Matiere Condensee, UMR CNRS 7600, 75 - Paris (France); Mechkov, S. [Ecole Normale Superieure, Lab. de Physique Statistique, 75 - Paris (France)

    2008-02-15

    From atomic nuclei to supernovae, including plates and rocks, every cohesive system can be broken into fragments, provided that the deposited energy is sufficiently large compared to its cohesive energy. We present a simple numerical model for investigating the general properties of fragmentation. By use of molecular dynamics simulations, we study the impact fragmentation of a solid disk of interacting particles with a wall. Regardless of the particular form of the interaction potential, the fragment size distribution exhibits a power law behaviour with an exponent that increases logarithmically with the energy deposited in the system, in agreement with experiments. We expect this behaviour to be generic in fragmentation phenomena. (authors)

  13. Generic maximum likely scale selection

    DEFF Research Database (Denmark)

    Pedersen, Kim Steenstrup; Loog, Marco; Markussen, Bo

    2007-01-01

    The fundamental problem of local scale selection is addressed by means of a novel principle, which is based on maximum likelihood estimation. The principle is generally applicable to a broad variety of image models and descriptors, and provides a generic scale estimation methodology. The focus...... on second order moments of multiple measurements outputs at a fixed location. These measurements, which reflect local image structure, consist in the cases considered here of Gaussian derivatives taken at several scales and/or having different derivative orders....

  14. Occurrence of Potential Bacterial Pathogens and Their Antimicrobial Susceptibility Patterns Isolated from Herbal Medicinal Products Sold in Different Markets of Gondar Town, Northwest Ethiopia

    Directory of Open Access Journals (Sweden)

    Abdela Yesuf

    2016-01-01

    Full Text Available Background. The World Health Organization estimates that about 80% of the world’s population uses herbal medicine to treat various illnesses as means of primary healthcare. However, during preparation, herbal plants may be exposed to contamination by potential pathogens, and this may lead to infections. The aim of this study was to determine bacterial contamination of herbal medicinal products and to assess the antibiotic susceptibility pattern of the isolated bacteria. Methods. A cross-sectional study was conducted from January 1 to May 25, 2013, at Gondar Town. A total of 55 samples used as oral, local, and intranasal routes of administration were collected from the herbalists. Results. In the present study the total aerobic bacterial count ranges from zero to 2.41×109 CFU/g with mean count of 1.99×108 CFU/g or mL while the total coliform count showed an average of 1.05×108 CFU/g or mL with a range of zero to 2.1×109 CFU/g. The most common bacteria isolated were Bacillus spp. followed by Enterobacter spp., Shigella dysenteriae, and Salmonella spp. Multiple drug resistance was not uncommon and it was found that 125 (83.4% of the isolates were resistant to two or more antibiotics. Conclusion. Herbal medicinal preparations were highly contaminated with pathogenic microorganisms with high microbial load. Most of the isolates have multiple drug resistance. Using those contaminated herbal medicines may lead to infection of other health related risks. Therefore, this warrants urgent training of herbalists and management scale-up for quality and safety of medicinal plants.

  15. Information provided by generic and brand-name pharmaceutical manufacturers in response to a request.

    Science.gov (United States)

    Fernandez-Llimos, Fernando; Vazquez Gomez, Isabel

    2007-12-01

    To assess the medical information provided by manufacturers in response to a specific request, and to compare the responses between generic and brand-name companies. Community pharmacy in Spain. A systematic request for product monographs was made between 1999 and 2002 to manufacturers registering new medicines in Spain. A standardised letter was sent to the medical affairs departments. If there was no reply after 3 months, a second standardised letter was sent requesting the monograph. Blood derivatives, intravenous medicines, and radiological contrast agents were excluded. The delay that occurred in receiving information and the type of material sent in response to the request was compared between the two types of companies. About of 833 medicines from 185 manufacturers were registered during the time period studied. After applying exclusion criteria, 805 medicines, including 419 (52.0%) generic and 386 (48.0%) brand-name products, were analyzed. No replies were received for 242 (30.0%) requests 183 (43.7%) generics and 59 (15.3%) brand-names; P request: 140 of 236 (59.3%) generics and 229 of 327 (70.0%) brand-names (P = 0.009). The average response delay was 9.7 days [CI95%: 8.65-10.68]. There was a statistically significant difference between generic and brand-name companies after the first request (P = 0.001), but not after the second request (P = 0.312). Brand-name manufacturers reply more often, more quickly, and with better quality information than generic manufacturers.

  16. Levantamento de dados sobre o conhecimento e informação acerca dos medicamentos genéricos em uma população de pacientes do serviço de saúde ambulatorial do Recife, Pernambuco, Brasil Knowledge and information concerning generic drugs in a public outpatient population in Recife, Pernambuco, Brazil

    Directory of Open Access Journals (Sweden)

    Chiara Erminia da Rocha

    2007-05-01

    Full Text Available A Lei nº. 9.787/99, que regulamenta os medicamentos genéricos, contempla normas para o registro e prevê a expansão do acesso da população a medicamentos seguros, eficazes, com qualidade e baixo custo. Após um quadriênio da introdução dos genéricos no Brasil, propõe-se verificar o conhecimento e a informação sobre genéricos entre os usuários dos serviços públicos de saúde ambulatorial do Recife, Pernambuco. No ano de 2002, foi aplicado um questionário pré-elaborado. Dos entrevistados, 76,1% eram do sexo feminino. Ouviram falar sobre o "medicamento genérico" 95,7% e 68,1% conheciam o medicamento genérico. As ações adotadas pelo governo, quanto à divulgação das propriedades desta especialidade farmacêutica e às vantagens oferecidas ao consumidor, atingiram sobremaneira esta população.Brazilian Federal Act 9,787/99, regulating generic medicines, includes rules for drug registration and provides for the population's access to safe, effective, high-quality, and low-cost medication. Four years after the introduction of generic drugs on the Brazilian market, we proposed to measure knowledge and information on generic drugs among the clientele at a public outpatient clinic in Recife, Pernambuco State, applying a questionnaire in 2000. 76.1% of the interviewees were women, 95.7% had heard of generic drugs, and 68.1% could define generic medication. Government action to publicize the properties of such medicines and their advantages for consumers has thus reached the vast majority of the population.

  17. Can higher prices increase market share? Average wholesale prices and Medicaid drug procurement

    National Research Council Canada - National Science Library

    Fitzgerald, Jay

    2014-01-01

    ..., generic drug manufacturers have an incentive to compete for pharmacy market share by driving up the prices paid to pharmacies by Medicaid. The authors report that a federal government crackdown on Medicaid pricing practices in 2000 led to a 45 percent decrease in the Medicaid market share of the drugs tar geted by the crackdown, which were generic...

  18. Toward a generic UGV autopilot

    Science.gov (United States)

    Moore, Kevin L.; Whitehorn, Mark; Weinstein, Alejandro J.; Xia, Junjun

    2009-05-01

    Much of the success of small unmanned air vehicles (UAVs) has arguably been due to the widespread availability of low-cost, portable autopilots. While the development of unmanned ground vehicles (UGVs) has led to significant achievements, as typified by recent grand challenge events, to date the UGV equivalent of the UAV autopilot is not available. In this paper we describe our recent research aimed at the development of a generic UGV autopilot. Assuming we are given a drive-by-wire vehicle that accepts as inputs steering, brake, and throttle commands, we present a system that adds sonar ranging sensors, GPS/IMU/odometry, stereo camera, and scanning laser sensors, together with a variety of interfacing and communication hardware. The system also includes a finite state machine-based software architecture as well as a graphical user interface for the operator control unit (OCU). Algorithms are presented that enable an end-to-end scenario whereby an operator can view stereo images as seen by the vehicle and can input GPS waypoints either from a map or in the vehicle's scene-view image, at which point the system uses the environmental sensors as inputs to a Kalman filter for pose estimation and then computes control actions to move through the waypoint list, while avoiding obstacles. The long-term goal of the research is a system that is generically applicable to any drive-by-wire unmanned ground vehicle.

  19. 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. 

  20. Generic domain models in software engineering

    Science.gov (United States)

    Maiden, Neil

    1992-01-01

    This paper outlines three research directions related to domain-specific software development: (1) reuse of generic models for domain-specific software development; (2) empirical evidence to determine these generic models, namely elicitation of mental knowledge schema possessed by expert software developers; and (3) exploitation of generic domain models to assist modelling of specific applications. It focuses on knowledge acquisition for domain-specific software development, with emphasis on tool support for the most important phases of software development.

  1. GENERIC COMMODITY PROMOTION AND PRODUCT DIFFERENTIATION

    OpenAIRE

    1999-01-01

    This paper considers whether generic promotion lowers the differentiation among competing brands as claimed in the 1997 Supreme Court case (Wileman et al. v. Glickman). Commodity promotion is modeled as a multi-stage game where products are vertically differentiated. Analytical results show that if the benefits of generic advertising from increased demand are outweighed by the costs from lower product differentiation then high-quality producers will not benefit from generic promotion but prod...

  2. PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES

    Directory of Open Access Journals (Sweden)

    S. N. Tolpygina

    2016-01-01

    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. 

  3. Use of Generics-A Critical Cost Containment Measure for All Healthcare Professionals in Europe?

    Science.gov (United States)

    Godman, Brian; Shrank, William; Wettermark, Bjorn; Andersen, Morten; Bishop, Iain; Burkhardt, Thomas; Garuolienè, Kristina; Kalaba, Marija; Laius, Ott; Joppi, Roberta; Sermet, Catherine; Schwabe, Ulrich; Teixeira, Inês; Tulunay, F Cankat; Wendykowska, Kamila; Zara, Corinne; Gustafsson, Lars L

    2010-08-05

    Pharmaceutical expenditures in ambulatory care rose rapidly in Europe in the 1990s and early 2000s. This was typically faster than other components of healthcare spending, leading to reforms to moderate future growth. A number of these centered on generic medicines with measures to lower reimbursed prices as well as enhance their prescribing and dispensing. The principal objective of this paper is to review additional measures that some European countries can adopt to further reduce reimbursed prices for generics. Secondly, potential approaches to address concerns with generics when they arise to maximize savings. Measures to enhance the prescribing of generics will also briefly be discussed. A narrative review of the extensive number of publications and associated references from the co-authors was conducted supplemented with known internal or web-based articles. In addition, health authority and health insurance databases, principally from 2001 to 2007, were analyzed to assess the impact of the various measures on price reductions for generic omeprazole and generic simvastatin vs. pre-patent loss prices, as well as overall efficiency in Proton Pump Inhibitor (PPI) and statin prescribing. The various initiatives generally resulted in considerable lowering of the prices of generics as well as specifically for generic omeprazole and generic simvastatin vs. pre-patent loss prices. At one stage in the UK, generic simvastatin was just 2% of the originator price. These measures also led to increased efficiency for PPI and statin prescribing with reimbursed expenditure for the PPIs and statins either falling or increasing at appreciably lower rates than increases in utilization. A number of strategies have also been introduced to address patient and physician concerns with generics to maximize savings. In conclusion, whilst recent reforms have been successful, European countries must continue learning from each other to fund increased volumes and new innovative drugs as

  4. 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.

  5. Generic modules for trivial extension algebras

    Institute of Scientific and Technical Information of China (English)

    杜先能

    1995-01-01

    Let A be a finite-dimensional algebra over an algebraically closed field. An indecomposable (right) ,4-module M is called generic provided M is infinite k-dimensional but finite length as (left) EndA(M)-module. Let R = A DA be the trivial extension algebra of A- Generic R-modules are constructed from generic A-modules using some functors between Mod A and Mod R. it is also proved that if A is a tame hereditary algebra, then R has only two generic modules.

  6. Rational use of generic psychotropic drugs.

    Science.gov (United States)

    Carbon, Maren; Correll, Christoph U

    2013-05-01

    For economic reasons, the generic substitution of branded medications is common and welcome. These replacements are based on the concept of bioequivalence, which is considered equal to therapeutic equivalence. Regulatory standards for bioequivalence require the 90 % confidence intervals of group averages of pharmacokinetic measures of a generic and the original drug to overlap within ±20 %. However, therapeutic equivalence has been challenged for several psychotropic agents by retrospective studies and case reports. To evaluate the degree of bioequivalence and therapeutic equivalence of branded and generic psychotropic drugs, we performed an electronic search (from database inception until 24 May 2012 and without language restrictions) in PubMed/MEDLINE, Cochrane Library, and Web of Science. Search terms were "(generic) AND (psychotropic OR psychoactive OR antipsychotic OR antiepileptic OR antidepressant OR stimulant OR benzodiazepine)" or the respective individual substances. We included clinical studies, regardless of design, comparing branded with generic psychotropic drug formulations, identifying 35 such studies. We also included case reports/series reporting on outcomes after a switch between brand and generic psychotropics, identifying 145 clinical cases. Bioequivalence studies in healthy controls or animals, in-vitro studies, and health economics studies without medical information were excluded. An overview of the few randomized controlled studies supports that US FDA regulations assure clinically adequate drug delivery in the majority of patients switched from brand to generic. However, with a growing number of competing generic products for one substance, and growing economic pressure to substitute with the currently cheapest generic, frequent generic-generic switches, often unbeknownst to prescribing clinicians, raise concerns, particularly for antiepileptics/mood stabilizers. Generic-generic switches may vary by more than ±20 % from each other in

  7. 76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-01

    ... COMMISSION Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for... the effects of natural phenomena, including earthquakes, without losing the capability to perform... Electric Power Research Institute models to estimate earthquake ground motion and updated models...

  8. Generic Advertising, Brand Advertising and Price Competition: An Analysis of Free-Riding Effects and Coordination Mechanisms

    OpenAIRE

    Paolo Roma; Giovanni Perrone

    2010-01-01

    The main purpose of generic advertising is to enlarge the total market demand rather than capturing further slices from competitors. Several studies point out emergence of free-riding behavior under independent contribution and suggest use of coordination mechanism. However, existing literature does not shed light on the conditions under which generic advertising can be detrimental (beneficial) to stronger firms weakening (strengthening) their competitive advantage. Also, under a setting incl...

  9. The problem of choosing between the original and of generic drugs in patients with overweight and obesity

    Directory of Open Access Journals (Sweden)

    M L Maksimov

    2013-10-01

    Full Text Available This review article discusses the similarities and differences in the research, production and use in clinical practice, original and generic drugs. Reproduced drugs (generics present on the Russian pharmaceutical market that have the bioequivalence data are not always equal in therapeutic equivalence of the original drug. The article presents evidence base of efficacy and safety of the original drug Xenical in the complex treatment of patients with overweight and obesity.

  10. Marketing; Il marketing

    Energy Technology Data Exchange (ETDEWEB)

    Muscigna, M. [ENEA, Centro Ricerche Casaccia, S. Maria di Galeria, RM (Italy). Dipt. Innovazione

    1999-07-01

    The report discusses marketing strategies oriented to the organizations and analyzes its critical factors, which determine the success of the organization activity. [Italian] Il rapporto analizza i caratteri delle strategie del marketing orientato all'impresa. Vengono infine analizzati i fattori critici che determinano il successo o l'insuccesso delle scelte aziendali.

  11. Traditional, complementary, and alternative medicine: Focusing on research into traditional Tibetan medicine in China.

    Science.gov (United States)

    Song, Peipei; Xia, Jufeng; Rezeng, Caidan; Tong, Li; Tang, Wei

    2016-07-19

    As a form of traditional, complementary, and alternative medicine (TCAM), traditional Tibetan medicine has developed into a mainstay of medical care in Tibet and has spread from there to China and then to the rest of the world. Thus far, research on traditional Tibetan medicine has focused on the study of the plant and animal sources of traditional medicines, study of the histology of those plants and animals, chemical analysis of traditional medicines, pharmacological study of those medicines, and evaluation of the clinical efficacy of those medicines. A number of papers on traditional Tibetan medicines have been published, providing some evidence of the efficacy of traditional Tibetan medicine. However, many traditional Tibetan medicines have unknown active ingredients, hampering the establishment of drug quality standards, the development of new medicines, commercial production of medicines, and market availability of those medicines. Traditional Tibetan medicine must take several steps to modernize and spread to the rest of the world: the pharmacodynamics of traditional Tibetan medicines need to be determined, the clinical efficacy of those medicines needs to be verified, criteria to evaluate the efficacy of those medicines need to be established in order to guide their clinical use, and efficacious medicines need to be acknowledged by the pharmaceutical market. The components of traditional Tibetan medicine should be studied, traditional Tibetan medicines should be screened for their active ingredients, and techniques should be devised to prepare and manufacture those medicines.

  12. Herbal medicinal oils in traditional Persian medicine.

    Science.gov (United States)

    Hamedi, Azadeh; Zarshenas, Mohammad M; Sohrabpour, Maryam; Zargaran, Arman

    2013-09-01

    In Iran, conventional production methods of herbal oils are widely used by local practitioners. Administration of oils is rooted in traditional knowledge with a history of more than 3000 years. Scientific evaluation of these historical documents can be valuable for finding new potential use in current medicine. The current study (i) compiled an inventory of herbal oils used in ancient and medieval Persia and (ii) compared the preparation methods and therapeutic applications of ancient times to current findings of medicinal properties in the same plant species. Information on oils, preparation methods and related clinical administration was obtained from ancient Persian documents and selected manuscripts describing traditional Persian medicine. Moreover, we investigated the efficacy of medicinal plant species used for herbal oils through a search of the PubMed, Scopus and Google Scholar databases. In Iran, the application of medicinal oils date back to ancient times. In medieval Persian documents, 51 medicinal oils produced from 31 plant species, along with specific preparation methods, were identified. Flowers, fruits and leaves were most often used. Herbal oils have been traditionally administered via oral, topical and nasal routes for gastrointestinal, musculoskeletal, and neural diseases, respectively. According to current investigations, most of the cited medicinal plant species were used for their anti-inflammatory and analgesic properties. Medicinal oils are currently available in Iranian medicinal plant markets and are prepared using traditional procedures for desirable clinical outcomes. Other than historical clarification, the present study provides data on clinical applications of the oils that should lead to future opportunities to investigate their potential medicinal use.

  13. Once more the generic name Passerina Vieillot

    NARCIS (Netherlands)

    Oort, van E.D.

    1910-01-01

    The note on the generic name of the Snow-bunting by Dr. E. Hartert in this part of our periodical gives me cause to revert to the subject of my note on the generic name Passerina Vieillot and to state here, that I stand to what I have said about the rejection of this name in Zoology (Notes Leyden Mu

  14. Designing Generic and Efficient Negotiation Strategies

    NARCIS (Netherlands)

    Tykhonov, D.

    2010-01-01

    The central aim of this thesis is the design of generic and efficient automated strategies for two-party negotiations in which negotiating parties do not reveal their preferences explicitly. A strategy for negotiation is the decision mechanism for determining the actions of a negotiator. Generic ref

  15. Typed generic traversals in $S_gamma^'$

    NARCIS (Netherlands)

    Lämmel, R.

    2001-01-01

    A typed model of strategic rewriting is developed. An innovation is that generic traversals are covered. To this end, we define a rewriting calculus $S'_{gamma$. The calculus offers a few strategy combinators for generic traversals. There is, for example, a combinator to apply a strategy to all imme

  16. Generic drugs in dermatology: part I.

    Science.gov (United States)

    Payette, Michael; Grant-Kels, Jane M

    2012-03-01

    The cost of health care in the United States is increasing. In order to help control these rising costs, all parties involved in the delivery of health care, including dermatologists, need to be part of the solution of ethically reducing the cost of delivery of care. One potential means of meeting this goal is to increase the use of generic medications in daily practice. Generic medications can offer equally efficacious therapy at significantly lower prices, which can translate into large scale savings for the individual patient, the payer, and the overall health care system. Herein we provide an overview of new drug development, review the history of the generic drug industry, describe how generic drugs are approved by the US Food and Drug Administration, and define the concepts of bioequivalence and therapeutic equivalence. In part II, we explore various factors impacting generic drug use, provide cost analyses of dermatologic brand name and generic drugs, and review data addressing potential differences in the effectiveness of brand name versus generic drugs in dermatology. The cost of brand name and generic medications is highly variable by pharmacy, state, and payer. We used one source (www.drugstore.com) as an example and for consistency across all medications discussed herein. Prices included here may not reflect actual retail prices across the United States.

  17. Defining Generic Skills. At a Glance.

    Science.gov (United States)

    National Centre for Vocational Education Research, Leabrook (Australia).

    Generic skills--skills that apply across a variety of jobs and life contexts--are taking on increased importance in Australia and internationally. There is a high demand for generic skills in the workplace because employers seek to ensure business success by recruiting and retaining employees who have a variety of skills and personal attributes as…

  18. Off-Label Prescription of Genetically Modified Organism Medicines in Europe : Emerging Conflicts of Interest?

    NARCIS (Netherlands)

    Schagen, Frederik H. E.; Hoeben, Rob C.; Hospers, Geke A. P.

    2014-01-01

    Recently, the first human medicine containing a genetically modified organism (GMO medicine) was authorized for use in the European market. Just as any medicinal product, the market authorization for a GMO medicine contains a precise description of the therapeutic use for which the medicinal product

  19. Off-Label Prescription of Genetically Modified Organism Medicines in Europe : Emerging Conflicts of Interest?

    NARCIS (Netherlands)

    Schagen, Frederik H. E.; Hoeben, Rob C.; Hospers, Geke A. P.

    2014-01-01

    Recently, the first human medicine containing a genetically modified organism (GMO medicine) was authorized for use in the European market. Just as any medicinal product, the market authorization for a GMO medicine contains a precise description of the therapeutic use for which the medicinal product

  20. The international pharmaceutical market as a source of low-cost prescription drugs for U.S. patients.

    Science.gov (United States)

    Kesselheim, Aaron S; Choudhry, Niteesh K

    2008-04-15

    In response to increasing prescription drug costs, more U.S. patients and policymakers are importing less-expensive pharmaceutical products from other countries. Large-scale prescription drug importation is currently illegal, but the U.S. Food and Drug Administration permits individuals to bring in 90-day supplies of drugs for personal use. As patient use of foreign-bought drugs has increased, federal legislators have continued to debate the full legalization of importation. Three factors help guide whether U.S. patients and policymakers can rely on other countries as sources of imported prescription drugs: whether the safety of the product can be ensured, how the import price compares with domestic prices, and how importation might affect the exporting country's pharmaceutical market. In wealthier countries with active regulatory systems, drug safety can be adequately ensured, and brand-name products are usually less expensive than in the United States (although generic drugs may be more expensive). However, implementing large-scale importation can negatively impact the originating country's market and can diminish the long-term cost savings for U.S. consumers. In low- and middle-income countries, prices may be reduced for both brand-name and generic drugs, but the prevalence of unauthorized products on the market makes ensuring drug safety more difficult. It may be reasonable for individual U.S. consumers to purchase essential medicines from certain international markets, but the most effective way to decrease drug costs overall is the appropriate use of domestic generic drugs, which are available for almost every major therapeutic class.

  1. Is Patent "Evergreening" Restricting Access to Medicine/Device Combination Products?

    Directory of Open Access Journals (Sweden)

    Reed F Beall

    Full Text Available Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as "evergreening", can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market.We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD, diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49 for treating these conditions was extracted from the United States Food and Drug Administration's Orange Book. Additional patent-related data (abstracts, claims, etc were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product's device patents and medicine patents.Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3-15.2 years.Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes "evergreening" depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by

  2. Panorámica mundial del mercado de los medicamentos homeopáticos a partir de las plantas medicinales World panorama of the market of homeopathic drugs starting from medicinal plants

    Directory of Open Access Journals (Sweden)

    Manuel Miguel Collazo Herrera

    2005-04-01

    the characteristics and peculiarities of these today's products for their commercialisation, as well as the prospects existing for their development in Cuba. Nowadays, there is a marked interest in the reestablishment of the practice of homeopathic medicine. The reasons that justify this rebirth are: the existence of a large potential market in several countries and its effect as a possible alternative medicine on the pharmaceutical market, which is reflected by its increasing use by doctors and consumers in various regions of the world. The homeopathic market has grown in the last years not only because of the rise in the knowledge of the homeopathic products and the possible adverse reactions of the traditional drugs, but also because of the growing number of doctors prescribing homeopathic remedies. With the incorporation of homeopathy to the so-called alternative therapies by the Ministry of Public Health of Cuba and with the . training of hundreds of specialists from different branches of medicine all over the country, the demand of homeopathic drugs has increased due to their proved effectivity and to the absence of the adverse effects most of the drugs of synthetic origin have. To give an answer to this increasing demand, the Centre for the Research and Development of Drugs produces and controls the quality of homeopathic tinctures of plant origin to widen the therapeutical stock of the National Health System and the obtention of incomes as a result of their commercialisation.

  3. [General awareness and use of generic medication among citizens of Tubarão, state of Santa Catarina, Brazil].

    Science.gov (United States)

    Blatt, Carine Raquel; Trauthman, Silvana Cristina; Schmidt, Edegar Henrique; Marchesan, Samuel; da Silva, Luana May; Martins, João Luiz

    2012-01-01

    Although generic medication has been introduced in the country to offer an accessible alternative to brand-name medication, it represents only 14% of sales in number of units within the pharmaceutical market. The aim of this work was to research the level of awareness and the use of generic products among residents of the municipality of Tubarão, State of Santa Catarina, Brazil. A transversal study was carried out with a sample of 234 interviewees, distributed among municipal areas. With regard to use, the majority of those interviewed had used generic medication, and half of them had at least one such product in their home. To verify awareness of different types of medication, pictures with the generic, brand name and similar packaging for paracetamol and atenolol were shown and 91% were able to identify all products correctly. To be of higher economic standing, already having used generic products, believing that the generic medication has the same effect as the brand name medication, finding generic products in drugstores easily and being accustomed to buy generic products, were factors that were positively associated with the correct identification.

  4. International Marketing Strategy of Transformations LTD in Sierra Leone

    OpenAIRE

    Alam, Mohammed Touqeer

    2011-01-01

    The central idea of the report is to formulate an international marketing strategy for Transformations Ltd, a learning and development company based in UK for its entry in Sierra Leone market. The company wants to provide accredited British Leadership and Management qualification in Sierra Leone. The report uses theoretical framework for marketing analyses including internationalization models, entry mode, market segmentation, targeting, positioning and generic strategy. The report adopte...

  5. Food systems veterinary medicine.

    Science.gov (United States)

    Hurd, H Scott

    2011-12-01

    The objectives of this review are to suggest the use of the systems thinking framework to improve how veterinary medicine is applied to food production. It applies the eight essential skills of systems thinking to a few selected veterinary examples. Two of the skills determine how we approach or define a problem, and are (i) dynamic thinking (taking a longer term perspective) and (ii) the 30,000 foot view (expanding the boundary of analysis beyond the animal, farm, or even country). The other skills are (iii) system-as-cause, (iv) operational thinking, (v) closed-loop (feedback) thinking, (vi) non-linear thinking, (vii) scientific thinking and (viii) generic thinking. The challenge is to adopt and apply this systems framework to veterinary medicine and food production. The result will be a rigorous new approach to solving the complex food and health problems of the 21st century.

  6. Risks and benefits of generic antiepileptic drugs.

    Science.gov (United States)

    Gómez-Alonso, Juan; Kanner, Andrés M; Herranz, José Luis; Molins, Albert; Gil-Nagel, Antonio

    2008-11-01

    In most therapeutic areas, prescribing generic drugs seems to lower costs without sacrificing efficacy. The use of generic drugs for treating epilepsy may, however, be more controversial. A systematic review of the literature on generic antiepileptic drugs has been carried out based primarily on a bibliographical search in the Medline database. Published studies are usually of a descriptive nature and are sometimes based on generic drugs that were approved in times when regulatory agency requirements were not as strict as they are now. Experts claim that a change in pharmaceutical formulations could cause seizure recurrence in cases that had been successfully controlled in the past, with severe effects on patients. Meanwhile, several health organizations have provided inconsistent recommendations on the use of generic antiepileptic drugs. In order to obtain scientific evidence on the potential risks and benefits of interchanging branded and generic antiepileptic drugs, high methodological comparative studies are necessary. These studies could bring consensus about the role of generic drugs for treating epilepsy.

  7. Generic physical protection logic trees

    Energy Technology Data Exchange (ETDEWEB)

    Paulus, W.K.

    1981-10-01

    Generic physical protection logic trees, designed for application to nuclear facilities and materials, are presented together with a method of qualitative evaluation of the trees for design and analysis of physical protection systems. One or more defense zones are defined where adversaries interact with the physical protection system. Logic trees that are needed to describe the possible scenarios within a defense zone are selected. Elements of a postulated or existing physical protection system are tagged to the primary events of the logic tree. The likelihood of adversary success in overcoming these elements is evaluated on a binary, yes/no basis. The effect of these evaluations is propagated through the logic of each tree to determine whether the adversary is likely to accomplish the end event of the tree. The physical protection system must be highly likely to overcome the adversary before he accomplishes his objective. The evaluation must be conducted for all significant states of the site. Deficiencies uncovered become inputs to redesign and further analysis, closing the loop on the design/analysis cycle.

  8. Generic Magnetic Fusion Reactor Revisited

    Science.gov (United States)

    Sheffield, John; Milora, Stanley

    2015-11-01

    The original Generic Magnetic Fusion Reactor paper was published in 1986. This update describes what has changed in 30 years. Notably, the construction of ITER is providing important benchmark numbers for technologies and costs. In addition, we use a more conservative neutron wall flux and fluence. But these cost-increasing factors are offset by greater optimism on the thermal-electric conversion efficiency and potential availability. The main examples show the cost of electricity (COE) as a function of aspect ratio and neutron flux to the first wall. The dependence of the COE on availability, thermo-electric efficiency, electrical power output, and the present day's low interest rates is also discussed. Interestingly, at fixed aspect ratio there is a shallow minimum in the COE at neutron flux around 2.5 MW/m2. The possibility of operating with only a small COE penalty at even lower wall loadings (to 1.0 MW/m2 at larger plant size) and the use of niobium-titanium coils are also investigated. J. Sheffield was supported by ORNL subcontract 4000088999 with the University of Tennessee.

  9. Drug-related hospital admissions in a generic pharmaceutical system.

    Science.gov (United States)

    Zargarzadeh, A H; Emami, M H; Hosseini, F

    2007-01-01

    1. Generically based pharmaceutical systems exist in a few countries of the world, such as Iran. Most developed countries have free market pharmaceutical systems. Drug-related problems (DRP) have been reported mostly in the Western world but few data are available for generic systems. In this study, we tried to measure the prevalence of drug-related problems leading to hospital admissions in Isfahan, Iran. 2. One thousand consecutive hospital admissions in three major teaching hospitals were studied for a period of 6 months for the presence of DRP as a cause of hospital admissions. Two subcategories of DRP were considered: (i) drug therapy failure; and (ii) adverse drug reactions. Preventability and outcome measures were also assessed. Medications responsible for DRP were classified according to the Anatomic Therapeutic Chemical (ATC) classification of the World Health Organization. 3. Of the 1000 admissions studied, 115 (11.5%) were owing to DRP, 81% as a result of drug therapy failure and 19% as adverse drug reactions. A total of 106 out of the 115 DRP cases (92%) were either preventable or probably preventable, most of which had to do with either prescriber or patient error. An overview of DRP showed that 58.3% resulted in complete recovery, 33.9% in relative recovery and 7.8% in death. Close to 1% of hospital admissions resulted in DRP-related deaths. 4. The overall prevalence of hospital admissions caused by DRP is similar to that in free market pharmaceutical systems. The high preventability rate of these problems should alert clinicians and policy makers to design strategies to curtail this. Also, reasons for differences in subtypes of DRP between the results of this study and those of the literature from free market systems needs to be investigated further.

  10. COMPARATIVE ANALYSIS OF FIVE BRANDS OF LISINOPRIL TABLETS IN YEMENI MARKET

    Directory of Open Access Journals (Sweden)

    Gamil Q. Othman

    2014-12-01

    Full Text Available Background: In poor countries such as Yemen, the cost of drugs is a factor affecting the patient’s decision to buy it and generic medicines are introduced as cheaper alternatives to the high cost brands. Thus, this study aimed to identify the physicochemical similarity of five products of tablets comprising much Lisinopril (antihypertensive taken from various pharmacies where retail medications are rendered to the Yemeni market. Methods: In this study, the researcher has conducted an assessment to the quality and physicochemical uniformity of five various products of Lisinopril tablets. The uniformity of weight, friability, crushing strength, disintegration and dissolution tests and chemical test of the tablets were evaluated as major factors. Results: Results showed that all five products of the Lisinopril 5 mg tablets were compatible to the standards of British Pharmacopoeia (BP in terms of uniformity of weight (91.04 – 137.4%, the crushing strength/hardness test (3.93 – 7.92% and the friability test (0.18 – 0.29%. All the products have showed good results about the disintegration time (15 sec – 7 min and 5 sec and dissolution test (96.67 – 103.7%. The active content of products ranged from 102.8 – 108%. Conclusion: The five brands of Lisinopril 5mg tablets, which were analyzed, have matched the BP quality standards and were physically and chemically consistent. Thus, cheap generic medicine can be used as alternative for innovator products.

  11. [Opening medicine containers].

    Science.gov (United States)

    Glerup, E; Dengsø, H

    1990-07-09

    In connection with self-administration of medicine for patients with rheumatoid arthritis, patients with weak hands and elderly patients in general, the design of many medicine containers makes them awkward to handle for the patients. In this investigation 12 different medicine containers were tested. The 12 containers represent the antirheumatic medicine containers available on the market in Denmark in 1988. Sixty patients participated in the investigation. Thirty had rheumatoid arthritis and 30 had normal hand function. The age range was 40-85 years The patients had the choice between five possible answers concerning each container. In all patients, grip strength was measured. The patients with rheumatoid arthritis were classified in four functional classes, and pulpa-vola distance end thumb--5th MCP point distance were measured. The opening mechanisms of 29% of the antirheumatic medicine containers are unacceptable; these are plastic containers with a "push-off" top and suppository packs. 46%--(containers with screw cap or pressure dispensing) are considered acceptable. For 25% (tablet and capsule blister packs) the patients' estimate varied. It is important that medicine containers can be opened by the patients without difficulty, so that they do not present a hindrance to a correct intake of medicine or result in an unnecessary admission to hospital. The results of this investigation show that it is of continuous importance to encourage the production of medicine containers that comply with the requirements of the patients.

  12. Aerospace Medicine

    Science.gov (United States)

    Michaud, Vince

    2015-01-01

    NASA Aerospace Medicine overview - Aerospace Medicine is that specialty area of medicine concerned with the determination and maintenance of the health, safety, and performance of those who fly in the air or in space.

  13. Nuclear Medicine.

    Science.gov (United States)

    Badawi, Ramsey D.

    2001-01-01

    Describes the use of nuclear medicine techniques in diagnosis and therapy. Describes instrumentation in diagnostic nuclear medicine and predicts future trends in nuclear medicine imaging technology. (Author/MM)

  14. 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

  15. [Herbal medicines alternative to synthetical medicines].

    Science.gov (United States)

    Beer, A M; Schilcher, H; Loew, D

    2013-12-16

    Herbal pharmaceuticals in medical practice are similarly used as chemically well defined drugs. Like other synthetical drugs, they are subject to pharmaceutical legislature (AMG) and EU directives. It is to differentiate between phytopharmaceuticals with effectiveness of proven indications and traditional registered herbal medicine. Through the Health Reform Act January 2004 and the policy of the Common Federal Committee (G-BA)on the contractual medical care from March 2009--with four exceptions--Non-prescription Phytopharmaka of the legal Health insurance is no longer (SHI) refundable and must be paid by the patients. The result is that more and more well-established preparations disappear from the market. This article gives an overview of practical relevant indications for herbal medicines, which according to its licensing status, the scientific assessment by the Cochrane Collaboration and the Institute for Quality and Efficiency in Health Care (IQWiG) and evidence-based Medicine (EBM)/ meta-analyzes as an alternative to synthetics can be used.

  16. [Falsified medicines in parallel trade].

    Science.gov (United States)

    Muckenfuß, Heide

    2017-09-13

    The number of falsified medicines on the German market has distinctly increased over the past few years. In particular, stolen pharmaceutical products, a form of falsified medicines, have increasingly been introduced into the legal supply chain via parallel trading. The reasons why parallel trading serves as a gateway for falsified medicines are most likely the complex supply chains and routes of transport. It is hardly possible for national authorities to trace the history of a medicinal product that was bought and sold by several intermediaries in different EU member states. In addition, the heterogeneous outward appearance of imported and relabelled pharmaceutical products facilitates the introduction of illegal products onto the market. Official batch release at the Paul-Ehrlich-Institut offers the possibility of checking some aspects that might provide an indication of a falsified medicine. In some circumstances, this may allow the identification of falsified medicines before they come onto the German market. However, this control is only possible for biomedicinal products that have not received a waiver regarding official batch release. For improved control of parallel trade, better networking among the EU member states would be beneficial. European-wide regulations, e. g., for disclosure of the complete supply chain, would help to minimise the risks of parallel trading and hinder the marketing of falsified medicines.

  17. Generic substitution, financial interests, and imperfect agency.

    Science.gov (United States)

    Rischatsch, Maurus; Trottmann, Maria; Zweifel, Peter

    2013-06-01

    Policy makers around the world seek to encourage generic substitution. In this paper, the importance of prescribing physicians' imperfect agency is tested using the fact that some Swiss jurisdictions allow physicians to dispense drugs on their own account (physician dispensing, PD) while others disallow it. We estimate a model of physician drug choice with the help of drug claim data, finding a significant positive association between PD and the use of generics. While this points to imperfect agency, generics are prescribed more often to patients with high copayments or low incomes.

  18. The Commercial Market For Priority Review Vouchers.

    Science.gov (United States)

    Ridley, David B; Régnier, Stephane A

    2016-05-01

    In 2007 the US Congress created the priority review voucher program to encourage the development of drugs for neglected diseases. Under the program, the developer of a drug that treats a neglected disease receives both a faster review of the drug by the Food and Drug Administration and a voucher for a faster review of a different drug. The developer can sell the voucher. We estimated the commercial value of the voucher using US sales of new treatments approved in the period 2007-09. A third of the commercial value of a voucher comes from capturing market share from competitors, nearly half from the value of earlier sales because of the expedited review, and less than a quarter from lengthening the time between approval and the launch of a generic competitor. We estimate that if only one priority review voucher is available in a year, it will be worth more than $200 million, but if four vouchers are available, the value could fall below $100 million. Congress should be cautious about expanding the voucher program, because increasing the number of vouchers sharply decreases the expected price. Lower voucher prices could undermine the incentive to develop new medicines for neglected diseases.

  19. PEACE MARKETING

    OpenAIRE

    2015-01-01

    Peace marketing is a new concept which could be part of the category of the public international marketing  and it is, at the same time, a non-profit marketing. The concept of peace marketing is a new one, but one that should be developed because our future depends on the efficiency of the marketing campaigns for peace.

  20. QUALITY CONTROL OF HYDROCHLOROTHIAZIDE TABLETS MARKETED IN SINOP-MT

    Directory of Open Access Journals (Sweden)

    M. K. Órfão

    2017-10-01

    Full Text Available The thiazide diuretics are of the classes of drugs most frequently used for the treatment of hypertension. Hydrochlorothiazide is the representative of this class and is found in tablet form in doses of 25 and 50 mg. It is marketed in three different categories of drugs: reference, similar and generic. According to the regulator in Brazil, the National Health Surveillance Agency (ANVISA, before pharmaceuticals are released for use, the pharmaceutical industry must meet product quality specifications, but the consumption of counterfeit drugs, contraband or without registration with government laws It is growing in Brazil, which affect the entire drug production chain affecting the health of those who use these medicines. In view of the reported problems about the quality of marketed drugs and being the state of Mato Grosso considered a fake gateway drug, due to its proximity to Bolivia, this study aimed to assess the quality of tablets containing hydrochlorothiazide is already one of the most widely used drugs in the treatment of hypertension in Sinop-MT municipality according local search. Samples from five laboratories that produce hydrochlorothiazide tablets at a dose of 25 mg, and the most market in the municipality of Sinop / MT were analyzed as stablished in the Brazilian Pharmacopoeia. It was found that four of the five samples of drugs in Mato Grosso, performed all the requirements for approval in quality testing, with the exception of a product that has lower hardness values than recommended, which can lead to problems drug presentation as well as directly affect the absorption, bioavailability and action of the therapeutic drug. It was concluded that medicinal products containing hydrochlorothiazide showed adequate quality, ensuring their effectiveness.

  1. Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective.

    Science.gov (United States)

    Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

    2017-06-01

    The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.

  2. Market, Regulation, Market, Regulation

    DEFF Research Database (Denmark)

    Frankel, Christian; Galland, Jean-Pierre

    2015-01-01

    This paper focuses on the European Regulatory system which was settled both for opening the Single Market for products and ensuring the consumers' safety. It claims that the New Approach and Standardization, and the Global Approach to conformity assessment, which suppressed the last technical...... barriers to trade in Europe, realized the free movement of products by organizing progressively several orders of markets and regulation. Based on historical and institutional documents, on technical publications, and on interviews, this article relates how the European Commission and the Member States had...... alternatively recourse to markets and to regulations, at the three main levels of the New Approach Directives implementation. The article focuses also more specifically on the Medical Devices sector, not only because this New Approach sector has long been controversial in Europe, and has recently been concerned...

  3. Market, Regulation, Market, Regulation

    DEFF Research Database (Denmark)

    Frankel, Christian; Galland, Jean-Pierre

    2015-01-01

    This paper focuses on the European Regulatory system which was settled both for opening the Single Market for products and ensuring the consumers' safety. It claims that the New Approach and Standardization, and the Global Approach to conformity assessment, which suppressed the last technical...... barriers to trade in Europe, realized the free movement of products by organizing progressively several orders of markets and regulation. Based on historical and institutional documents, on technical publications, and on interviews, this article relates how the European Commission and the Member States had...... alternatively recourse to markets and to regulations, at the three main levels of the New Approach Directives implementation. The article focuses also more specifically on the Medical Devices sector, not only because this New Approach sector has long been controversial in Europe, and has recently been concerned...

  4. Generic tacrolimus in solid organ transplantation.

    Science.gov (United States)

    Taube, D; Jones, G; O'Beirne, J; Wennberg, L; Connor, A; Rasmussen, A; Backman, L

    2014-05-01

    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 are similar in quality, safety, and efficacy to their approved innovator drugs. There are data available for three generic brands, tacrolimus (Intas), tacrolimus (PharOS), and tacrolimus (Sandoz). Bioequivalence has been demonstrated for generic tacrolimus (Sandoz) within a narrow therapeutic range to its 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 SOT patients, including lung and heart recipients.

  5. Generic substitution: issues for problematic drugs.

    Science.gov (United States)

    Henderson, J D; Esham, R H

    2001-01-01

    The methodology and criteria for bioequivalence testing have been firmly established by the Food and Drug Administration (FDA). For certain drugs with a narrow therapeutic index (e.g., digoxin, levothyroxine, warfarin), generic substitution may not be advisable or even allowable, depending on the substitution laws of individual states. Digoxin and levothyroxine tablets are examples of drugs for which no New Drug Applications (NDAs) currently exist. However, commercially available generic products for both of these drugs have not been determined by the FDA to be therapeutically equivalent to the innovator products. Generic versions of warfarin have been approved by the FDA as being therapeutically equivalent to the innovator products, as have generic versions of the rescue inhaler albuterol. Yet, misinformation and myths persist regarding the adequacy and proven reliability of the FDA's determination of bioequivalence for these products.

  6. 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...

  7. 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...

  8. Generic User Process Interface for Event Generators

    CERN Document Server

    Boos, E; Giele, W T; Hinchliffe, Ian; Huston, J; Ilyin, V A; Kanzaki, J; Kato, K; Kurihara, Y; Lönnblad, L; Mangano, Michelangelo L; Mrenna, S; Paige, Frank E; Richter-Was, Elzbieta; Seymour, Michael H; Sjöstrand, Torbjörn; Webber, Bryan R; Zeppenfeld, Dieter

    2001-01-01

    Generic Fortran common blocks are presented for use by High Energy Physics event generators for the transfer of event configurations from parton level generators to showering and hadronization event generators.

  9. Generic methodology for calibrating profiling nacelle lidars

    DEFF Research Database (Denmark)

    Borraccino, Antoine; Courtney, Michael; Wagner, Rozenn

    is calibrated rather than a reconstructed parameter. This contribution presents a generic methodology to calibrate profiling nacelle-mounted lidars. The application of profiling lidars to wind turbine power performance and corresponding need for calibration procedures is introduced in relation to metrological...... standards. Further, two different calibration procedure concepts are described along with their strengths and weaknesses. The main steps of the generic methodology are then explained and illustrated by calibration results from two types of profiling lidars. Finally, measurement uncertainty assessment...

  10. On the genericity of spacetime singularities

    Indian Academy of Sciences (India)

    Pankaj S Joshi

    2007-07-01

    We consider here the genericity aspects of spacetime singularities that occur in cosmology and in gravitational collapse. The singularity theorems (that predict the occurrence of singularities in general relativity) allow the singularities of gravitational collapse to be either visible to external observers or covered by an event horizon of gravity. It is shown that the visible singularities that develop as final states of spherical collapse are generic. Some consequences of this fact are discussed.

  11. Generic Dynamic Scaling in Kinetic Roughening

    OpenAIRE

    Ramasco, José J.; López, Juan M.; Rodríguez, Miguel A.

    2000-01-01

    We study the dynamic scaling hypothesis in invariant surface growth. We show that the existence of power-law scaling of the correlation functions (scale invariance) does not determine a unique dynamic scaling form of the correlation functions, which leads to the different anomalous forms of scaling recently observed in growth models. We derive all the existing forms of anomalous dynamic scaling from a new generic scaling ansatz. The different scaling forms are subclasses of this generic scali...

  12. On Phases of Generic Toric Singularities

    CERN Document Server

    Sarkar, Tapobrata

    2007-01-01

    We systematically study the phases of generic toric singularities, using methods initiated in hep-th/0612046. These correspond to Gauged Linear Sigma Models with arbitrary charges. We show that complete information about generic $U(1)^r$ GLSMs can be obtained by studying the GLSM Lagrangian, appropriately modified in the different phases of the theory. This can be used to study the different phases of $L^{a,b,c}$ spaces and their non-supersymmetric counterparts.

  13. Access to Medicines : Common problems, common solutions?

    NARCIS (Netherlands)

    Stephens, P.N.

    2015-01-01

    This thesis investigates four cross-cutting controversies in access to medicines – aspects of pharmaceutical R&D, equity, generics policy and scale up. Chapter 2 describes the state of pharmaceutical research and development (R&D). It finds that failure rates remain high with the probability of mark

  14. Access to Medicines : Common problems, common solutions?

    NARCIS (Netherlands)

    Stephens, P.N.

    2015-01-01

    This thesis investigates four cross-cutting controversies in access to medicines – aspects of pharmaceutical R&D, equity, generics policy and scale up. Chapter 2 describes the state of pharmaceutical research and development (R&D). It finds that failure rates remain high with the probability of

  15. Competencia y precios en el mercado farmacéutico mexicano Competition and prices in the Mexican pharmaceutical market

    Directory of Open Access Journals (Sweden)

    Raúl E Molina-Salazar

    2008-01-01

    Full Text Available Las formas que asume la competencia en el mercado definen el nivel de precios. El mercado farmacéutico contiene submercados con diferente grado de competencia; por un lado existen productos innovadores con patente y, por el otro, genéricos con marca comercial o sin ella. Por lo general, los medicamentos innovadores con patente tienen precios monopólicos, pero a su vencimiento éstos bajan al enfrentar la competencia de alternativas terapéuticas. La marca permite conservar las rentas económicas del monopolio. En México los precios de los medicamentos en el mercado privado son elevados, de acuerdo con las estimaciones agregadas y para medicamentos específicos, lo cual refleja las limitaciones de la competencia en el mercado y el poder de la marca comercial. En el segmento público se obtienen precios competitivos con la estrategia de los medicamentos esenciales de la Organización Mundial de la Salud, con base en el listado de productos del Cuadro Básico.The forms of market competition define prices. The pharmaceutical market contains submarkets with different levels of competition; on the one hand are the innovating products with patents, and on the other, generic products with or without trade names. Innovating medicines generally have monopolistic prices, but when the patents expire prices drop because of competition from therapeutic alternatives. The trade name makes it easier to maintain monopolistic prices. In Mexico, medicine prices in the private market are high -according to aggregated estimates and prices for specific medicines- which reflect the limitations of pharmaceutical market competition and the power of the trade name. The public segment enjoys competitive prices using the WHO strategy for essential medicines on the basis of the Essential List.

  16. Plantas medicinales que se venden en el mercado El Río, Camagüey, Cuba Medicinal plants sold at the El Río Market, Camagüey, Cuba

    Directory of Open Access Journals (Sweden)

    Daimy Godínez-Caraballo

    2008-06-01

    Full Text Available Con la información obtenida de las plantas medicinales vendidas en el mercado El Río, Camagüey, Cuba, se registró un total de 184 especies pertenecientes a 69 familia de plantas vasculares. La familia más importante fue Fabaceae s.l. con 13 especies, seguida por Lamiaceae con 12 y Asteraceae con 8. Más de 90 indicaciones medicinales en general fueron recogidas para tratar un amplio rango de enfermedades y dolencias. El mayor número de especies y aplicaciones fueron reportadas para desórdenes del sistema digestivo, sistema musculoesquelético (reumatismo y contusiones, problemas renales y trastornos ginecológicos. Las partes de las plantas más usadas fueron la hoja (42.9% y el fruto (22.3%. Los remedios se preparan principalmente como decocción (51.6% e infusión (39.1%. Los datos recolectados muestran el conocimiento y uso de la medicina herbolaria por parte de la población camagüeyana para tratar varias enfermedades.Information regarding medicinal plants sold in the El Río Market, Camagüey, Cuba, revealed 184 species belonging to 69 vascular plant families. The most important family was Fabaceae s.l. with 13 species, followed by Lamiaceae with 12, and Asteraceae with 8. More than 90 general medicinal indications were recorded to treat a wide range of illnesses and ailments. The highest number of species and applications were reported for digestive system disorders, the musculoskeletal system (rheumatism and the complex of contusions, kidney and other urological problems, and gynecological disorders. The part of the plant most frequently used was the leaf (42.9% and the fruit (22.3%. The remedies were mainly prepared as a decoction (51.6% and an infusion (39.1%. The present data document the knowledge of herbal medicine by villagers of Camagüey for to treat health problems.

  17. Prioritising Investments in Marketing Activities to Improve Business Performance

    DEFF Research Database (Denmark)

    Martensen, Anne; Mouritsen, Jan

    2014-01-01

    dimensions: (1) Small m: marketing strategy and marketing implementation and (2) big M: cross-functional coordination and innovation. Big M and small m interact and influence BP similarly. When considering investing in marketing activities to improve financial performance, the first priority is to recruit......The purpose of this study is to prioritise investments in marketing activities based on their effect on business performance (BP). On the basis of the European Foundation for Quality Management (EFQM) model adapted to a marketing context, four generic marketing activities are structured in two...

  18. 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.

  19. Developing Strategic Planning for the Retail Market.

    Science.gov (United States)

    Greenawalt, Richard A.

    1983-01-01

    Retailers need a strategic plan that will enable them to adapt to changing trends and work with new ideas. Questions retailers should ask to shape the strategic plan and generic strategies--overall cost leadership, differentiation, and marketing to a particular group or offering a special service--are discussed. (SR)

  20. Diabetes market grows ever more crowded.

    Science.gov (United States)

    Gohil, Kunj; Enhoffer, Devin

    2014-12-01

    Global prevalence of type-2 diabetes is expected to reach 330 million cases by 2022, with medication sales of $67.7 billion. The market is crowded with generic medications, and most products now in the development pipeline are "me-too" drugs.

  1. Diabetes Market Grows Ever More Crowded

    OpenAIRE

    Gohil, Kunj; Enhoffer, Devin

    2014-01-01

    Global prevalence of type-2 diabetes is expected to reach 330 million cases by 2022, with medication sales of $67.7 billion. The market is crowded with generic medications, and most products now in the development pipeline are “me-too” drugs.

  2. Developing Strategic Planning for the Retail Market.

    Science.gov (United States)

    Greenawalt, Richard A.

    1983-01-01

    Retailers need a strategic plan that will enable them to adapt to changing trends and work with new ideas. Questions retailers should ask to shape the strategic plan and generic strategies--overall cost leadership, differentiation, and marketing to a particular group or offering a special service--are discussed. (SR)

  3. Different initiatives across Europe to enhance losartan utilisation post generics: impact and implications

    Directory of Open Access Journals (Sweden)

    James eMoon

    2014-10-01

    Full Text Available Introduction: There is an urgent need for health authorities across Europe to fully realise 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 versus single-sourced drugs in the class. Demand-side strategies ranged from 100% co-payment for patented ARBs in Denmark to no specific measures. We hypothesised 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. Utilisation measured in defined daily doses (DDDs. Price reductions for generic losartan were also measured. Results: Utilisation 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 utilisation. Losartan utilisation 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 utilisation. Overall, multiple demand-side measures are needed to change physician prescribing habits to fully realise 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.

  4. [Performance of Slovak hospitals as related to Porter's generic strategies].

    Science.gov (United States)

    Hlavacka, S; Bacharova, L; Rusnakova, V; Wagner, R

    2001-01-01

    Porter's generic strategies characterize organizations in terms of their competitiveness, and are related to the performance of the organization. The aim of this study was to analyze the Porter's generic strategies and their effect on performance in the context of the Slovak hospital industry. Acute care hospitals with more than 30 beds were included into the study. National institutes providing specialized service were excluded from the study. Strategy and performance were evaluated on the basis of self-reported questionnaires, completed by chief administrators of hospitals (total 76 completed questionnaires were obtained, out of 81 distributed, i.e. 94% response rate). The cluster analysis was used for the identification of strategic orientation. Performance differences across strategic groups were tested using multivariate analysis of covariance (MANCOVA). The hierarchical cluster analysis uncovered a four-group taxonomy of hospitals: the group "Focused Cost Leadership" included 33% of hospitals, the group "Stuck-in-the middle" 49%, the group "Wait and See" 13% and the group "Cost leadership" 5%. Significant differences in performance were related to the Porter's pure, or hybrid strategies, respectively. In terms of industry evolution, the Slovak hospital industry could be characterized as fragmented, having a large number of small and medium size mainly state owned hospitals, with absence of market leaders, and with high exit barriers (mainly social and political) that hold back consolidation. (Tab. 1, Ref. 35.).

  5. 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...

  6. Generics and the specific features of their regulation

    Directory of Open Access Journals (Sweden)

    E. A. Ushkalova

    2016-01-01

    Full Text Available The article discusses the factors that influence the efficacy and safety of generic drugs, including regular generics, biosimilars, and generic nonbiological complex drugs. It emphasizes the importance of adequate regulatory requirements to provide a comparable therapeutic efficacy and a comparable cost-effectiveness ratio for generics versus brand-name drugs.

  7. Knowledge Base Grid: A Generic Grid Architecture for Semantic Web

    Institute of Scientific and Technical Information of China (English)

    WU ZhaoHui(吴朝晖); CHEN HuaJun(陈华钧); XU JieFeng(徐杰锋)

    2003-01-01

    The emergence of semantic web will result in an enormous amount of knowledge base resources on the web. In this paper, a generic Knowledge Base Grid Architecture (KB-Grid)for building large-scale knowledge systems on the semantic web is presented. KB-Grid suggests a paradigm that emphasizes how to organize, discover, utilize, and manage web knowledge base resources. Four principal components are under development: a semantic browser for retrieving and browsing semantically enriched information, a knowledge server acting as the web container for knowledge, an ontology server for managing web ontologies, and a knowledge base directory server acting as the registry and catalog of KBs. Also a referential model of knowledge service and the mechanisms required for semantic communication within KB-Grid are defined. To verify the design rationale underlying the KB-Grid, an implementation of Traditional Chinese Medicine(TCM) is described.

  8. Scaling-up the use of generic antiretrovirals in resource-limited countries: generic drugs for health.

    Science.gov (United States)

    Beck, Eduard J; Passarelli, Carlos; Lui, Iris; Guichard, Anne-Claire; Simao, Mariangela; De Lay, Paul; Loures, Luiz

    2014-01-01

    The number of people living with HIV (PLHIV) continues to increase around the world because of the increasing number on antiretroviral therapy (ART) and their associated increase of life expectancy, in addition to the number of people newly infected with HIV each year. Unless a 'cure' can be found for HIV infection, PLHIV can anticipate the need to take antiretroviral drugs (ARVs) for the rest of their lives. Because ARVs are now being used for HIV prevention, as well as for therapeutic purposes, the need for effective, affordable ARVs with few adverse effects will continue to rise. It is important to note that the dramatic growth in treatment coverage of PLHIV seen during the past decade has been primarily due to the increased use of generic ARVs. Thus, there will be a need to scale-up the research and development, production, distribution and access to generic ARVs and ART regimens. However, these processes must occur within national and international regulated free-market economic systems and must deal with increasingly multifaceted patent issues affecting the price while ensuring the quality of the ARVs. National and international regulatory mechanisms will have to evolve, which will affect broader national and international economic and trade issues. Because of the complexity of these issues, the Editors of this Supplement conceived of asking experts in their fields to describe the various steps from relevant research and development, to production of generic ARVs, their delivery to countries and subsequently to PLHIV in low- and middle-income countries. A main objective was to highlight how these steps are interrelated, how the production and delivery of these drugs to PLHIV in resource-limited countries can be made more effective and efficient, and what the lessons are for the production and delivery of a broader set of drugs to people in low- and middle-income countries.

  9. Diferencias entre prescripción y dispensación de genéricos en atención primaria: la excepción como regla Differences between prescription and dispensing of generic medicines in primary care: when the exception is the rule

    Directory of Open Access Journals (Sweden)

    Rafael M. Torres García

    2007-10-01

    Full Text Available Objetivo: Cuantificar los cambios de marca de genérico en el momento de la dispensación en las farmacias y su coste. Métodos: Estudio descriptivo transversal que compara la prescripción y la dispensación de genéricos en un cupo de atención primaria, sirviéndose de los datos informáticos de la consulta y del Programa de Gestión de la Prestación Farmacéutica durante el año 2005. Resultados: De las 16.181 recetas prescritas, se incluyen en el estudio 3.759 genéricos, cuyo precio medio es de 7,61 euros frente a los 8,01 euros del dispensado. En el 62,9% de los casos no se respetó la marca prescrita por el médico, que se cambió en el 65,1% de esos casos por otro genérico de mayor coste. Conclusiones: El cambio del genérico pautado fue habitual en el cupo estudiado, con una tendencia a dispensar otro más caro y el consiguiente aumento del gasto.Objectives: To quantify the frequency and cost of switching prescribed generic brand drugs for others at dispensation in pharmacies. Methods: We performed a descriptive cross-sectional study to compare prescription and dispensation of generic drugs in a primary care quota by using computerized data from medical consulting rooms and the Pharmaceutical Service Management Program in 2005. Results: Of 16,181 prescriptions, 3,759 generic prescriptions were included in the study, with a mean price of 7.61 euros as opposed to 8.01 euros for those dispensed in the retail pharmacy. In 62.9% of drugs, the brand prescribed by the doctor was not dispensed. In 65.1% of cases in which the brand was switched, the drug was changed for another generic drug with a higher price. Conclusions: Changing the prescribed generic drug was common in the quota studied with a tendency to dispense another drug that was more expensive, thereby increasing costs.

  10. Sustainable Marketing

    NARCIS (Netherlands)

    Dam, van Y.K.

    2017-01-01

    In this article, three different conceptions of sustainable marketing are discussed and compared. These different conceptions are referred to as social, green, and critical sustainable marketing. Social sustainable marketing follows the logic of demand-driven marketing management and places the

  11. Sustainable Marketing

    NARCIS (Netherlands)

    Dam, van Y.K.

    2017-01-01

    In this article, three different conceptions of sustainable marketing are discussed and compared. These different conceptions are referred to as social, green, and critical sustainable marketing. Social sustainable marketing follows the logic of demand-driven marketing management and places the resp

  12. Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA

    OpenAIRE

    Nair, Anil K.; Anand, Om; Chun, Nam; Conner, Dale P.; Mehta, Mehul U.; Nhu, Duong T.; Polli, James E.; Yu, Lawrence X.; Davit, Barbara M.

    2012-01-01

    The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. The objective of this study was to use the World Health Organization Model List of Essential Medicines to determine the distribution of BCS Class 1, 2, 3, and 4 drugs in Abbreviated New drug Applications (ANDA) submissions. To categorize solubility and intestinal permeability properties of generic drugs under development, we used a list of 61 drugs which were cl...

  13. Branding From Above: Generic Cultural Branding in Shetland and other Islands

    OpenAIRE

    Adam Grydehøj

    2008-01-01

    This paper considers the development of a generic cultural brand for islands. In 2002, Shetland’s local government and the Corporate Edge consultancy developed a modernized, internationally-oriented Shetland brand. This official brand conflicts with Shetlanders’ traditional, locally-oriented identity concept, which has impeded the brand’s success. With emphasis on printed tourism marketing materials, Shetland’s experience is compared with those of other European islands. This comparison highl...

  14. FDA Critical Path Initiatives: Opportunities for Generic Drug Development

    OpenAIRE

    Lionberger, Robert A.

    2008-01-01

    FDA’s critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document “Critical Path Opportunities for Generic Drugs” that identified some of the specific challenges in the development of generic drugs. The key steps in generic product de...

  15. Generic Competency Profile among Students in Institute of Higher Learning: A Case of Universiti Kebangsaan Malaysia (UKM), Malaysia

    Science.gov (United States)

    Ahmad, Shaharuddin; Ishak, Noriah Mohd; Ismail, Khaidzir; Selamat, Jumali

    2010-01-01

    Generic competency is an instrument to assess and measure personal trait of students using 13 constructs with 102 items. Students' abilities to master each of the 13 constructs are very important in order for them to improve their marketability values. This is because nowadays employer is not only looking at the academic intellectual but the most…

  16. Effects of generic versus non-generic feedback on motor learning in children.

    Directory of Open Access Journals (Sweden)

    Suzete Chiviacowsky

    Full Text Available Non-generic feedback refers to a specific event and implies that performance is malleable, while generic feedback implies that task performance reflects an inherent ability. The present study examined the influences of generic versus non-generic feedback on motor performance and learning in 10-year-old children. In the first experiment, using soccer ball kicking at a target as a task, providing participants with generic feedback resulted in worse performance than providing non-generic feedback, after both groups received negative feedback. The second experiment measured more permanent effects. Results of a retention test, performed one day after practicing a throwing task, showed that participants who received non-generic feedback during practice outperformed the generic feedback group, after receiving a negative feedback statement. The findings demonstrate the importance of the wording of feedback. Even though different positive feedback statements may not have an immediate influence on performance, they can affect performance, and presumably individuals' motivation, when performance is (purportedly poor. Feedback implying that performance is malleable, rather than due to an inherent ability, seems to have the potential to inoculate learners against setbacks--a situation frequently encountered in the context of motor performance and learning.

  17. Internet marketing

    OpenAIRE

    2009-01-01

    In the bachelor thesis are introduced theoretical concepts of the Internet and marketing, accented the need of marketing mix along with its specifics of the internet environment. Next is interpreted which tools can be used for marketing of firms and which marketing instruments are to be deployed. Final chapter illustrates socio-demographics of Czech internet users along with media market allocation from the perspective of all media as well as in the segment of the Internet.

  18. Hospital marketing.

    Science.gov (United States)

    Carter, Tony

    2003-01-01

    This article looks at a prescribed academic framework for various criteria that serve as a checklist for marketing performance that can be applied to hospital marketing organizations. These guidelines are drawn from some of Dr. Noel Capon of Columbia University's book Marketing Management in the 21st Century and applied to actual practices of hospital marketing organizations. In many ways this checklist can act as a "marketing" balanced scorecard to verify performance effectiveness and develop opportunities for innovation.

  19. Strategic Marketing

    OpenAIRE

    Potter, Ned

    2015-01-01

    This chapter from The Library Marketing Toolkit focuses on marketing strategy. Marketing is more successful when it happens as part of a constantly-renewing cycle. The aim of this chapter is to demystify the process of strategic marketing, simplifying it into seven key stages with advice on how to implement each one. Particular emphasis is put on dividing your audience and potential audience into segments, and marketing different messages to each group. \\ud \\ud It includes case studies from T...

  20. HUMANE MARKETING, PEACE MARKETING AND REBRANDING MARKETING

    Directory of Open Access Journals (Sweden)

    Alexandru Mircea NEDELEA

    2016-08-01

    Full Text Available According to humane marketing, the entire population of the Earth must be happy, content and even delighted, not only the clients of certain companies (as considered by the classical marketing. Therefore, from this viewing point, we are dealing with the necessary activity of rebranding the marketing itself. Humane marketing represents and concerns the entire economic system regarded from the point of view of the final result, seen by comparison to the happiness of the entire humanity. Humane marketing represents a new concept, a new vision, a new way of seeing the relationship between the individual and the society he lives in. The essence of the concept (orientation of humane marketing consists in identifying, anticipating and quantifying the needs and desires of humans and their satisfaction. Rebranding marketing will allow passing from a vicious marketing to a beneficial, humane marketing. We think that the society has reached a level of development which allows only one viable solution for evolution, namely to make a qualitative leap in the consciousness of the humanity, which should include, among others, the waiver of aggressive marketing made only in order to obtain profit, to the detriment of attaining human happiness, both individually and of the entire humanity.