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Sample records for generic medicines market

  1. Developing competitive and sustainable Polish generic medicines market.

    Science.gov (United States)

    Simoens, Steven

    2009-10-01

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

  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.

    Science.gov (United States)

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

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Simoens, Steven

    2015-02-01

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

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

    Science.gov (United States)

    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

  6. 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.

  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

    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

  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.

    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

  9. 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.

  10. Quality of generic medicines in South Africa

    DEFF Research Database (Denmark)

    Patel, Aarti; Gauld, Robin; Norris, Pauline

    2012-01-01

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

  11. Advertising and generic market entry.

    Science.gov (United States)

    Königbauer, Ingrid

    2007-03-01

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

  12. Retailing policies for generic medicines.

    Science.gov (United States)

    Narciso, Susana

    2005-06-01

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

  13. Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market.

    Science.gov (United States)

    Sillo, Hiiti B; Masota, Nelson E; Kisoma, Sunday; Rago, Lembit; Mgoyela, Veronica; Kaale, Eliangiringa A

    2018-01-01

    Availability of correct and adequate information about medicines is an important aspect in ensuring rational use of medicines and hence facilitating safety and expected efficacy of medicines during therapy. Package inserts have proven to be a good source of information to the prescribers and patients whereby they have been useful in highlighting important information pertaining proper use and handling of the medicines. The present study was aimed at establishing the extent to which package inserts of medicines circulating on the markets of the East African Community (EAC) Partner States conform to medicines information requirements as established in the harmonized guidelines as well as national guidelines. A total of 99 package inserts from six (6) types of medicines namely Albendazole, Artemether/Lumefantrine (ALu), Ciprofloxacin, Paracetamol, Amoxicillin and Metronidazole were purposefully collected from three EAC Partner States: Kenya, Tanzania and Uganda. The medicines were selected based on their indications as first line treatments, high rates of utilization within the medicines supply system and their positions in treatment of diseases of public importance across EAC Partner States. The inserts were evaluated on the availability of information regarding fifteen (15) parameters as extracted from the EAC harmonized guidelines for registration of medicines. Moreover, comparisons were made between the percentage conformity of the branded versus generic products, markets from which the samples were collected, origin of the manufacturer and type of medicine. Majority (93.9-100%) of the medicines' package inserts highly conformed to the inclusion of the information regarding the description and composition of the medications, indications, dosage and methods of administration, warnings and precautions, contraindications and storage conditions. However, the information on handling and disposal, container package description, excipients used, clinical pharmacology of

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

    Science.gov (United States)

    King, Derek R; Kanavos, Panos

    2002-08-01

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

  15. Generic penetration in the retail antidepressant market.

    Science.gov (United States)

    Ventimiglia, Jeffrey; Kalali, Amir H

    2010-06-01

    In this article, we explore the accelerated penetration of generic antidepressants in the United States market following the availability of generic citalopram and sertraline. Analysis suggests that overall, generic penetration into the antidepressant market has grown from approximately 41 percent in January 2004 to over 73 percent in January 2010. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

  16. Generic medicine and prescribing: A quick assessment

    Directory of Open Access Journals (Sweden)

    Mainul Haque

    2017-01-01

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

  17. Generic Penetration of the SSRI Market.

    Science.gov (United States)

    Cascade, Elisa F; Kalali, Amir H

    2008-04-01

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

  18. Exploring community pharmacists' views on generic medicines: a nationwide study from Malaysia.

    Science.gov (United States)

    Chong, Chee Ping; Hassali, Mohamed Azmi; Bahari, Mohd Baidi; Shafie, Asrul Akmal

    2011-02-01

    To evaluate the Malaysian community pharmacists' views on generic medicines. A sample of 1419 Malaysian community pharmacies with resident pharmacists. A cross-sectional nationwide survey using a self-completed mailing questionnaire. Pharmacists' views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence. Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia. The Malaysian pharmacists' have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.

  19. Agricultural Market Structure, Generic Advertising, and Welfare

    OpenAIRE

    Cardon, James H.; Pope, Rulon D.

    2003-01-01

    This analysis begins with a definition and discussion of productive advertising. Then, following Dixit and Norman, persuasive advertising is used to study the welfare effects of generic advertising by marketing orders. The study first examines horizontal competition when the competing advertiser is a monopoly, and results show that the socially optimal level of advertising for a competitive marketing order is positive only if advertising raises monopoly output. Next, advertising choices of a ...

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

    Science.gov (United States)

    Puig-Junoy, Jaume

    2012-11-01

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

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

    Science.gov (United States)

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

    2015-12-15

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

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

    Directory of Open Access Journals (Sweden)

    Adheed Khalid Sharrad

    2009-08-01

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

  3. Generic penetration in the retail atypical antipsychotic market.

    Science.gov (United States)

    Lenderts, Susan; Kalali, Amir H; Buckley, Peter

    2010-03-01

    In this article, we explore the penetration of generic atypical antipsychotics in the United States market before and after the availability of generic risperidone in July 2008. Analysis suggests that, overall, generic penetration into the atypical antipsychotic market has grown from approximately three percent in January 2008 to more than 25 percent in December 2009. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

  4. Generic Switching and Non-Persistence among Medicine Users

    DEFF Research Database (Denmark)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    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

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

    African Journals Online (AJOL)

    the difference between brand and generic medicines listed for that algorithm, and also as the median of differences between generic medicines for the same condition. Results: Three of the algorithms .... Protecting the PMBs, as a key element of the new community-rated medical schemes environment, is therefore vital.

  7. Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.

    Science.gov (United States)

    Borg, John Joseph; Tomasi, Paolo; Pani, Luca; Aislaitner, George; Pirozynski, Michal; Leufkens, Hubert; Melchiorri, Daniela

    2014-01-01

    When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioequivalence study), and safety data for the innovator. The extensive experience from bringing generic products to the market over the last decades allows the conclusion that they are well-accepted and provide a useful alternative option for cost-effective pharmacotherapy. While supporting this conclusion, there are a number of issues to be considered during the assessment of a generic product application. Six scenarios are described in total, from an efficacy and a safety perspective, where potential concerns with the current regulatory standards could arise in the approval of generic products. We also propose solutions to these scenarios in order to foster debate on these issues.

  8. 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.

  9. GenMed 010: a one day workshop on generic medicines

    Directory of Open Access Journals (Sweden)

    Shankar PR

    2011-03-01

    Full Text Available This report outlines the content of a one-day workshop onGeneric Medicines that was held at KIST Medical College,Lalitpur, Nepal on 13th December 2010, which was attendedby 32 delegates from different institutions in Nepal, includingpharmacists, pharmacologists and medical doctors. Rightmedicine, right patient, right dose, right frequency andduration, right information and right monitoring areconditions to be fulfilled for the rational use of medicine(RUM. The World Health Organization (WHO defines genericmedicine as ‘a pharmaceutical product, usually intended to beinterchangeable with the innovator product, marketed afterthe expiry of patent or other exclusivity rights’. Economicfactors, supportive legislation and regulation, public andprofessional acceptance and quality assurance are keyenabling factors promoting use of generics. Increased patentprotection for medicines and removing process patents is akey feature of new trade agreements and newer medicines fordiseases like HIV/AIDS, tuberculosis and infectious diseasesare likely to be more expensive. The Medicine andTherapeutics Committee (MTC can play a key role inpromoting generic medicine use in institutions.Nepal being among the Least Developed Countries (LDCsneed not provide patent protection for medicines until 31stDecember 2015. Only a few ‘true’ generics are available inNepal and there is huge cost variation in the price of differentbranded generics. Clinicians have concerns about the qualityof medicines in general, substitution of poor quality brands bypharmacists and about therapeutic substitution. Genericshave to meet the same regulatory requirements and bebioequivalent to reference preparations assuring their quality.

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

    DEFF Research Database (Denmark)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2009-04-01

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

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

    Science.gov (United States)

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

    2014-06-01

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

  13. GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

    OpenAIRE

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

    2017-01-01

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

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

    African Journals Online (AJOL)

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

  15. Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study.

    Science.gov (United States)

    Shraim, Naser Y; Al Taha, Tasneem A; Qawasmeh, Rawan F; Jarrar, Hiba N; Shtaya, Maram A N; Shayeb, Lama A; Sweileh, Waleed M

    2017-12-28

    Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic medicine. However, their knowledge score pertaining the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters in particular was insufficient.

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

    Directory of Open Access Journals (Sweden)

    Andréa Dâmaso Bertoldi

    Full Text Available 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

  17. Medicine, morality, and the market.

    Science.gov (United States)

    Owen, D

    1984-07-07

    In extracts from a lecture given at McGill University, the author describes the rise of a marketing or corporate ethos in medicine, stemming from economic constraints and the demographic pressures of aging populations in the U.S., Canada, and the United Kingdom. To counter the trend to corporate rather than public policy making in medicine, he advocates a holistic approach to health care, a revival of interest in preventive health, and encouragement of the self-help movement. Owen calls for a reorientation of medical attitudes so that traditional moral values of medicine present a "counterweight to the mechanistic, technological, cost-effectiveness of the market place."

  18. Marketing herbal medicines.

    Science.gov (United States)

    Lazarus, M

    1999-01-01

    HIV-positive support groups, together with hospital pharmacists in Thailand are fighting the high cost and lack of access to pharmaceuticals by producing and distributing herbal medicines. In Theung district, Chiang Rai province, members of the local support group for people with HIV produce their own, low-cost, herbal medicines. Although the herbal medicines they produce do not provide a cure for HIV/AIDS, they do offer relief for some of the symptoms of opportunistic infections. The herbs are prepared by the group members under the supervision of the pharmacy department at the district hospital. Local people judge their effectiveness by hearing testimonials from people who have witnessed improvement in symptoms. In response to the popularity and effectiveness of herbal medicines, the Ministry of Public Health has approved plans to sell products derived from local herbs in the pharmacies of government hospitals.

  19. 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

  20. 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

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

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Simoens, Steven

    2015-01-01

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

  2. 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.

  3. Interventions promoting the acceptance and uptake of generic medicines: a narrative review of the literature.

    Science.gov (United States)

    Babar, Z U D; Kan, S W; Scahill, S

    2014-09-01

    The objective of this paper was to undertake a narrative review of the literature regarding strategies and interventions promoting the acceptance and uptake of generic medicines. A literature search was performed between November 2011 and January 2012 to identify published full text original research articles documenting interventions to promote the use of generic medicines. Keywords used were: "generic medicine", "generic drug", "intervention", "promotion", "acceptance", "uptake", "generic/therapeutic substitution" and their related root words. The electronic databases comprised of Embase (1980 - present), Google, Google Scholar, Medline (1948 - present), PubMed, Science Direct, Scopus, Springer Link and The Cochrane Library. An interpretative narrative synthesis was undertaken and emergent themes analysed and reported. Eighteen studies were included in the final analysis. There were seven main themes which including; education, financial incentives, advertising to promote generic medicines, free generic medicine trials, administrative forms and medicines use review (MUR). These themes were further classified into subthemes. Education was subdivided into consumer and physician education. Financial incentives included the influence of financial incentives on both consumers and physicians. The subthemes in the financial incentives category included the changes in co-payment for consumers, reward payment for physicians and fund-holding schemes. Advertising included the sub-themes of print media and the use of anthropomorphic images, while free generic medicines trial was made up of free vouchers for generic medicines and generic medicines sampling system. The studies have mixed results; some interventions in some settings were useful, while others were not. Not all interventions consistently improved the uptake of generic medicines. There was limited literature available and further work is required to develop a range of interventions to support the uptake of generic

  4. 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

  5. [Can we transfer the mechanisms of the generics market to biosimilars?

    Science.gov (United States)

    Jacke, Ch O; Wild, F

    2016-12-15

    Personalized medicines such as biologics and their generic equivalents, biosimilars, are pouring onto the pharmaceutical markets. Data of 16 private health insurance companies were used to describe the market shares of selected biosimilars available in 2014 and 2015. The purpose of this study focuses on the question of whether market access of biosimilars will lead to a price competition of the expense of innovation competition. The results show that prescriptions of biosimilars made up 37% of total prescriptions in 2015 compared to 35% in 2014, and that their share of prescription costs went up from 21% to 23% in the same period. Price competition similar to that found in the generic markets has been established for erythropoietin and filgrastim. The same has not been observed for follitropin alfa and somatropin due to the limited number of competitors and products available at this stage. No definitive conclusions can be drown from the results at this stage. Time will tell whether it will be possible for physicians and individuals with private health insurance to fully leverage the savings potential of biosimilars while safeguarding patient safety.

  6. An evaluation of consumers' knowledge, perceptions and attitudes regarding generic medicines in Auckland.

    Science.gov (United States)

    Babar, Zaheer-Ud-Din; Stewart, Joanna; Reddy, Shiwangni; Alzaher, Woroud; Vareed, Prateeka; Yacoub, Nineweh; Dhroptee, Bandhana; Rew, Anne

    2010-08-01

    The aim of this project was to evaluate the perceptions, knowledge and attitudes regarding generic medicines. A cross-sectional study, with self administered questionnaires, was conducted to survey consumers visiting pharmacies in four regions of Auckland (North Shore, Waitakere, Central Auckland and South Auckland). Through stratified random sampling, approximately 10% of pharmacies from each region were selected, which turn out to be 30 pharmacies. Every alternate customer coming to the pharmacy, who was eligible to participate in the study, was asked by the researchers to complete the questionnaire. A total of 441 questionnaires were included in the analysis. Different response rates were obtained in different regions of Auckland. Of all respondents, 51.6% had previous knowledge of generic medicines. Pharmacists were the main source of information regarding generic medicines followed by doctors and media. A higher level of education had a direct relationship with having correct knowledge of generics (P = .002). Attitude of participants toward the use of generic medicines was determined by their knowledge of generics, whether it was recommended by a pharmacist and their type of illness. Participants were more prepared to change to a generic for a minor illness (79%) than for a major illness (58.7%). Those who had better knowledge were more likely than those with poor knowledge to say they would to use a generic in major illness (P = .001) as well as minor illness (P < .0001). Previous positive experiences with generics also determined consumers' willingness to use generics. Many consumers have misconceptions regarding generic medicines. Having knowledge about generics and the advice by doctors and pharmacists are key indicators to improve the quality use of generic medicines.

  7. Exploring knowledge perceptions and attitudes about generic medicines among finalyear health science students

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-05-01

    Full Text Available Background. The use of generic medicines to reduce healthcare costs has become a mandated policy in South Africa. An increase in the use of generics can be achieved through improved knowledge, attitudes and perceptions of generic medicine among healthcare professionals. Objective. To explore knowledge, attitudes and perceptions among final-year health science students on generic medication. Methods. A cross-sectional survey was carried out among the final-year audiology, dental therapy, pharmacy, physiotherapy, occupational therapy, optometry, speech-language and sport science students enrolled at the University of KwaZulu-Natal. A questionnaire was used as the study tool, developed using information adapted from literature reviews. Data analysis was completed using Statistical Package for the Social Sciences (SPSS version 21, and computed using descriptive statistics. Results. Total number of participants was 211, as follows: audiology (n=14, dental therapy (n=15, pharmacy (n=81, physiotherapy (n=41, occupational therapy (n=6, optometry (n=25, speech-language (n=6 and sport science (n=23. A total of 90.0% of students had heard of generic medicines, with 20.9% of them agreeing that generic medicines are less effective than brand-name medicines. Concerning safety, 30.4% believed that brand-name medicines are required to meet higher safety standards than generic medicines. Regarding the need for information on issues pertaining to safety and efficacy of medicines, 53.3% of participants felt that this need was not being met. Conclusion. All groups had knowledge deficits about the safety, quality and efficacy of generic medicines. The dissemination of information about generic medicines may strengthen future knowledge, attitudes and perceptions.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. Generic Drugs: The Same Medicine for Less Money

    Science.gov (United States)

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

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

    Science.gov (United States)

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

    2017-05-01

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

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

    Science.gov (United States)

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

    2017-04-01

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

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

    Directory of Open Access Journals (Sweden)

    Elize Massard da Fonseca

    2017-04-01

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

  17. 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.

  18. Examining Generic Competitive Strategy Types in U.S. and European Markets

    OpenAIRE

    Susan P Douglas; Dong Kee Rhee

    1989-01-01

    Identification of generic competitive strategy types has recently attracted considerable attention. Most of this research has, however, focused on competitive strategy of U.S. businesses in their domestic market. The present study extends these findings to markets outside the United States, and more specifically Europe, based on a sample of industrial businesses drawn from the PIMS database. Similar dimensions underlying competitive strategy, and similar generic types are found among business...

  19. 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.

  20. The Market for Hospital Medicine in Denmark

    DEFF Research Database (Denmark)

    Hostenkamp, Gisela

    2012-01-01

    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...

  1. 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....

  2. Generic atorvastatin, the Belgian statin market and the cost-effectiveness of statin therapy.

    Science.gov (United States)

    Simoens, Steven; Sinnaeve, Peter R

    2013-02-01

    This study examines how the market entry of generic atorvastatin influences the Belgian statin market and the cost-effectiveness of statin therapy. Using IMS Health data, the Belgian 2000-2011 statin market was analyzed in terms of total expenditure, annual price of statin treatment, and patient numbers. A simulation analysis projected statin market shares from 2012 to 2015 following market entry of generic atorvastatin. This analysis was based on three scenarios regarding the number of patients taking specific statins. Savings associated with an atorvastatin price reduction of 50-70 % were calculated. A literature review of economic evaluations assessed the cost-effectiveness of generic atorvastatin. Statin expenditure increased from €113 million in 2000 to €285 million in 2011 due to higher expenditure on atorvastatin and rosuvastatin. Although the number of patients treated with simvastatin increased by nearly 800 %, the resulting increase in expenditure was partially offset by price reductions. Atorvastatin is projected to become the dominant product in the Belgian statin market (market share of 47-66 % by 2015). Annual savings would attain €108.6-€153.7 million for a 50 % reduction in the atorvastatin price and €152.0-€215.2 million for a 70 % price reduction. The literature suggests that generic atorvastatin is cost-effective as compared to simvastatin. The limited evidence about the cost-effectiveness of rosuvastatin as compared with generic atorvastatin is inconclusive. Generic atorvastatin is cost-effective as compared to simvastatin, is projected to become the dominant product in the Belgian statin market and is expected to generate substantial savings to health care payers.

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

    Directory of Open Access Journals (Sweden)

    Patel Aarti

    2012-09-01

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

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

    Science.gov (United States)

    Feldman, Roger; Lobo, Félix

    2013-08-01

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

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

    Science.gov (United States)

    Puig-Junoy, Jaume

    2010-01-01

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

  6. 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.

  7. [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.

  8. Brands or generics: the dilemma of pharmaceutical marketing in a developing country.

    Science.gov (United States)

    Quraeshi, Z A; Luqmani, M; Malhotra, N

    1983-01-01

    A significant issue in pharmaceutical marketing in many developing countries is whether drugs should be sold by generic or by brand names. In Pakistan, legislation prohibited the sale of brand name drugs in order to increase price competition, and strengthen the market position of indigenous manufacturers to compete against multinationals. However, the government's objectives were not achieved for reasons discussed in the article. The Pakistan case has implications for multinational firms and for other developing countries in similar situations.

  9. Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved?

    Science.gov (United States)

    Cameron, Alexandra; Mantel-Teeuwisse, Aukje K; Leufkens, Hubert G M; Laing, Richard Ogilvie

    2012-01-01

    In low- and middle-income countries, patients and reimbursement agencies that purchase medicines in the private sector pay more for originator brands when generic equivalents exist. We estimated the savings that could be obtained from a hypothetical switch in medicine consumption from originator brands to lowest-priced generic equivalents for a selection of medicines in 17 countries. In this cost minimization analysis, the prices of originator brands and their lowest-priced generic equivalents were obtained from facility-based surveys conducted by using a standard methodology. Fourteen medicines most commonly included in the surveys, plus three statins, were included in the analysis. For each medicine, the volume of private sector consumption of the originator brand product was obtained from IMS Health, Inc. Volumes were applied to the median unit prices for both originator brands and their lowest-priced generics to estimate cost savings. Prices were adjusted to 2008 by using consumer price index data and were adjusted for purchasing power parity. For the medicines studied, an average of 9% to 89% could be saved by an individual country from a switch in private sector purchases from originator brands to lowest-priced generics. In public hospitals in China, US $ 370 million could be saved from switching only four medicines, saving an average of 65%. Across individual medicines, average potential savings ranged from 11% for beclometasone inhaler to 73% for ceftriaxone injection. Substantial savings could be achieved by switching private sector purchases from originator brand medicines to lowest-priced generic equivalents. Strategies to promote generic uptake, such as generic substitution by pharmacists and increasing confidence in generics by professionals and the public, should be included in national medicines policies. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  10. First test of WTO mechanism for procuring generic medicines under compulsory licence, via Canada's Access to Medicines Regime.

    Science.gov (United States)

    Elliott, Richard

    2007-12-01

    In July 2007, Rwanda became the first nation to initiate use of a procedure under the rules of the World Trade Organization (WTO) that is supposed to let developing countries import lower-cost, generic medicines produced in other countries under compulsory licences. And two months later, based on Rwanda's initiative, Canada's Commissioner of Patents issued the first compulsory licence under this system to permit the production of a patented AIDS drug to that country.

  11. A comparative neutron activation analysis study of common generic manipulated and reference medicines commercialized in Brazil

    International Nuclear Information System (INIS)

    Leal, A.S.; Menezes, M.A.B.C.; Rodrigues, R.R.; Andonie, O.; Vermaercke, P.; Sneyers, L.

    2008-01-01

    In this work, a comparative study of neutron activation analysis (NAA) was performed by the nuclear institutes: CDTN/CNEN-Brazil, CCHEN-Chile and the SCK.CEN-Belgium aiming to investigate some generic, manipulated and reference medicines largely commercialized in Brazil. Some impurities such as: As, Ba, Br, Ce, Co, Cr, Eu, Fe, Hf, Sb, Sc, Sm, Ti and Zn were found, and the heterogeneity of the samples pointed out the lack of an efficient public system of quality control

  12. 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...

  13. 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...... 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...

  14. 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

  15. 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.

  16. Influence of generic reference pricing on medicine cost in Slovenia: a retrospective study

    Science.gov (United States)

    Marđetko, Nika; Kos, Mitja

    2018-01-01

    Aim To assess the impact of the generic reference pricing (GRP) system on the prices and cost of medicines in Slovenia approximately 8 years after its introduction in 2003 and before the implementation of the therapeutic reference pricing system. Methods A retrospective study of all medicines (N = 789) included in the GRP system on January 31, 2012 was performed. Medicine prices and cost were analyzed between January 31, 2012 and December 31, 2013 after every update (N = 11) of the maximum reimbursable price (MRP) and were compared to the price and cost on January 31, 2012 (index date). Time trends of different types of medicine prices (maximum allowed price, MRP, and actual wholesale price) were graphically analyzed, and actual wholesale price adjustments to the MRP changes and the budget impact of the GRP were assessed. Results In the 2-year study period, the long-term performance of the GRP system was associated with an approximate 45% decrease in the average MRP or an approximate 20% cost reduction. For each MRP update period, the GRP reduced the cost based on the maximum allowed price for approximately 30%. The wholesale price adjustments were mostly made for medicines priced above the MRP and reduced patients’ out-of-pocket cost. Conclusions In the long term, the GRP system effectively reduced medicine prices and the cost of reimbursed products. PMID:29740992

  17. Influence of generic reference pricing on medicine cost in Slovenia: a retrospective study.

    Science.gov (United States)

    Marđetko, Nika; Kos, Mitja

    2018-04-30

    To assess the impact of the generic reference pricing (GRP) system on the prices and cost of medicines in Slovenia approximately 8 years after its introduction in 2003 and before the implementation of the therapeutic reference pricing system. A retrospective study of all medicines (N=789) included in the GRP system on January 31, 2012 was performed. Medicine prices and cost were analyzed between January 31, 2012 and December 31, 2013 after every update (N=11) of the maximum reimbursable price (MRP) and were compared to the price and cost on January 31, 2012 (index date). Time trends of different types of medicine prices (maximum allowed price, MRP, and actual wholesale price) were graphically analyzed, and actual wholesale price adjustments to the MRP changes and the budget impact of the GRP were assessed. In the 2-year study period, the long-term performance of the GRP system was associated with an approximate 45% decrease in the average MRP or an approximate 20% cost reduction. For each MRP update period, the GRP reduced the cost based on the maximum allowed price for approximately 30%. The wholesale price adjustments were mostly made for medicines priced above the MRP and reduced patients' out-of-pocket cost. In the long term, the GRP system effectively reduced medicine prices and the cost of reimbursed products.

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

    Directory of Open Access Journals (Sweden)

    Philip J Domeyer

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

  19. 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

  20. New Product Development in the Pharmaceutical Industry: Evidence from a generic market.

    Science.gov (United States)

    Yousefi, Nazila; Mehralian, Gholamhossein; Rasekh, Hamid Reza; Yousefi, Mina

    2017-01-01

    In today's competitive world, there are several strategies to deal with the fast changing environment, among which New product development (NPD) is a common strategy. However, almost half of the resources that companies devote to NPD are spent on products that may fail. This issue is particularly highlighted in the pharmaceutical industry mainly because of a long development-time, low success rate, high capital requirement, and market uncertainty. This study identifies critical success factors of NPD based on the relevant literatures and expert opinions in Iranian pharmaceutical industry, then prioritizes them using the methodology of multiple criteria decision making (MCDM) through analyzing 50 filled questionnaires structured based on the AHP (Analytical Hierarchy Process) approach. Although the NPD success factors seem the same in both generic and bio-generic pharmaceutical industries, the underlying factors and related sub-factors show the different importance in these two industries. However, this study reveal that, the company capabilities is the most important factor affecting new product development success in both pharmaceutical generic and bio-generic industry. The results of this study contribute to create baseline information for pharmaceutical industry especially Iranian pharmaceutical companies to be more effective in budget allocation on improving NPD success factors so that they can boost the success rate of NPD more effectively.

  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

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

  2. 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.

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

    Science.gov (United States)

    Mackintosh, Maureen; Chaudhuri, Sudip; Mujinja, Phares Gm

    2011-02-28

    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. 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. 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. 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. 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

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

    Directory of Open Access Journals (Sweden)

    Peter Bai James

    2018-01-01

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

  6. Structure, control and regulation of the formal market for medicinal ...

    African Journals Online (AJOL)

    There are informal and formal markets for medicinal plants' products in Nigeria. ... It is relatively new and underdeveloped. ... physical and facilitating functions while the conduct was described in terms of pricing and promotional strategies.

  7. 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

  8. Reptiles traded in markets for medicinal purposes in contemporary Morocco

    NARCIS (Netherlands)

    Nijman, V.; Bergin, D.

    2017-01-01

    Reptiles are traded globally for medicinal purposes. Historic qualitative accounts of reptiles used as medicine in Morocco are numerous, but contemporary quantitative data are rare. In 2013-2014, we surveyed 49 wildlife markets in 20 towns throughout Morocco, plus the Spanish exclaves of Ceuta and

  9. 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.

  10. [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.

  11. Strategic Marketing for Indonesian Plywood Industry: An Analyse by using Porter Five Forces Model and Generic Strategy Framework

    OpenAIRE

    Makkarennu; Nakayasu, A.; Osozawa, K.; Ichikawa, M.

    2014-01-01

    The target for a marketing strategy is to find a way of achieving a sustainable competitive advantage over the other competing products and firms in a market.Good strategy serves as a road map for effective action. Porter???s five forces model and three generic strategies were used to evaluate the structure and the strategy for positioning of plywood industry in South Sulawesi, Indonesia. Qualitative research was carried out by using in-depth interview method. Having expressed either agree...

  12. Medicinal plants sold in the markets of Antananarivo, Madagascar.

    Science.gov (United States)

    Randriamiharisoa, Maria Nirina; Kuhlman, Alyse R; Jeannoda, Vololoniaina; Rabarison, Harison; Rakotoarivelo, Nivo; Randrianarivony, Tabita; Raktoarivony, Fortunat; Randrianasolo, Armand; Bussmann, Rainer W

    2015-07-28

    This study focuses on the large outdoor markets of the capital of Madagascar, Antananarivo. As the largest metropolitan area in Madagascar with a population of nearly two million, the region has great capacity for consumption of medicinal plant remedies despite numerous pharmacies. Medicinal plant use spans all socioeconomic levels, and the diverse metropolitan population allows us to study a wide variety of people who consume these plants for medical purposes. The purpose of this study is to identify and generate a list of medicinal plants sold in the traditional markets with a focus on those collected in the forests around Antananarivo, get an idea of the quantities of medicinal plants sold in the markets around Antananarivo, and assess the economy of the medicinal plant markets. In order to determine which medicinal plants are most consumed in Antananarivo, ethnobotanical enquiries were conducted in the five main markets of the capital city. Ethnobotanical surveys were conducted with medicinal plant traders, suppliers, harvesters and cultivators, with voucher specimens created from the plants discussed. Trade circuit information was established and the income generated by the trade of some of the species was assessed. The inventory of the Antananarivo markets resulted in a list of 89 commercialized plant species. Ten of the 89 were mentioned by 60-100 % of vendors. Profitability for vendors is high and competitive with other salaried positions within Antananarivo. Transportation costs are also high and therefore lower profitability for other members in the supply chain. The markets of Antananarivo have always played a vital cultural role in the lives of urban Malagasy, but our study shows they also play an economic role not only for urban residents but rural harvesters as well. Continued research and monitoring of the non-timber forest products trade in Antananarivo is needed to better understand the impact of trade on the wild plant populations.

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

    Science.gov (United States)

    Lessing, Charon; Ashton, Toni; Davis, Peter

    2014-10-01

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

  14. 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.

  15. 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

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

    Science.gov (United States)

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

    2012-01-01

    In this paper, we report the results of quality control based in physicochemical characterization 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 III, sample B consisted in pure polymorph II, sample C consisted in a mixture of fluconazole Form III, 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 impurities for each polymorphic form, and a possible relationship could be exist between impurities and crystalline form of fluconazole. PMID:29403776

  17. Herbal Medicine for Market Potential in Malaysia: An Overview

    International Nuclear Information System (INIS)

    Shafii khamis

    2014-01-01

    Due to side effects of synthetic drugs, herbal products are rapidly gaining popularity in the world market. The global herbal market in 2010 was US$65 billion and is estimated to hit US$93 billion in 2015. The Malaysian herbal market is estimated to expand from RM7 billion in 2010 to about RM29 billion by 2020. Inspite of its rich biodiversity and well-practised knowledge of herbal medicine amongst its multi cultured population, the share of Malaysia in the global herbal market is very small and not up to the mark. The present article will deal with the measures to be adopted for global promotion of Malaysian herbal products. The scenario and perceptions of herbal medicine are discussed. (author)

  18. [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.

  19. 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

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

    Science.gov (United States)

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

    2010-05-25

    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. 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. 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. Global initiatives facilitated the creation of fairly efficient markets

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

    International Nuclear Information System (INIS)

    Gebran, N.; Al-Haldari, K.

    2006-01-01

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

  2. 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

  3. 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

  4. 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.

  5. Will they deliver treatment access?: WTO rules and Canada's law on generic medicine exports.

    Science.gov (United States)

    Elliott, Richard

    2006-12-01

    More than two years since Canada enacted the Jean Chrétien Pledge to Africa, no generic medication produced under compulsory license has yet been exported from Canada. In this feature article, Richard Elliott describes attempts by two Canadian generic pharmaceutical companies to navigate the complicated and unwieldy processes established under the Act, and, noting the government's pledge to review the law and fix it to make it work, prescribes a number of ways in which the process should be streamlined.

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

    Science.gov (United States)

    Kuribayashi, Ryosuke; Appleton, Scott

    2017-09-01

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

  7. [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. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  8. 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 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.

  9. [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.

  10. 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."

  11. 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

  12. 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.”

  13. 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.

  14. How Does Advertising Affect Market Performance? The Case of Generic Advertising

    OpenAIRE

    Hamilton, Stephen F.; Richards, Timothy J.; Stiegert, Kyle W.

    2009-01-01

    The effect of advertising on market performance has been a long-standing debate. Advertising that increases the dispersion of consumers’ valuations for advertised goods raises the market power of firms, while advertising that decreases the dispersion of consumers’ valuations leads to narrower price-cost margins and superior performance in markets for advertised goods. Numerous challenges confound the empirical identification of advertising effects on market performance. This paper proposes a ...

  15. Measuring the Effects of Generic Dairy Advertising in a Multi-Market Equilibrium

    OpenAIRE

    Joseph V. Balagtas; Sounghun Kim

    2007-01-01

    We develop a multi-market equilibrium displacement model that allows demand linkages across downstream product markets, and supply linkages through the common use of a raw commodity as the key input. Applying the model to the dairy sector, we find that the effectiveness of producer-funded advertising depends on the demand relationships across dairy product markets (cross-price and cross-advertising elasticities) as well as the reallocation of milk toward the advertised market. We show that th...

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

    Science.gov (United States)

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

    2017-01-20

    The aim of this study was to estimate lowest possible treatment costs for four novel cancer drugs, hypothesising that generic manufacturing could significantly reduce treatment costs. This research was carried out in a non-clinical research setting using secondary data. There were no human participants in the study. Four drugs were selected for the study: bortezomib, dasatinib, everolimus and gefitinib. These medications were selected according to their clinical importance, novel pharmaceutical actions and the availability of generic price data. Target costs for treatment were to be generated for each indication for each treatment. The primary outcome measure was the target cost according to a production cost calculation algorithm. The secondary outcome measure was the target cost as the lowest available generic price; this was necessary where export data were not available to generate an estimate from our cost calculation algorithm. Other outcomes included patent expiry dates and total eligible treatment populations. Target prices were £411 per cycle for bortezomib, £9 per month for dasatinib, £852 per month for everolimus and £10 per month for gefitinib. Compared with current list prices in England, these target prices would represent reductions of 74-99.6%. Patent expiry dates were bortezomib 2014-22, dasatinib 2020-26, everolimus 2019-25 and gefitinib 2017. The total global eligible treatment population in 1 year is 769 736. Our findings demonstrate that affordable drug treatment costs are possible for novel cancer drugs, suggesting that new therapeutic options can be made available to patients and doctors worldwide. Assessing treatment cost estimations alongside cost-effectiveness evaluations is an important area of future research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  17. [EU law on marketing authorization of medicines. History, current state of development and perspectives].

    Science.gov (United States)

    Nettesheim, Martin

    2008-07-01

    The article describes the development of EU policies and regulations on the marketing authorization of medicines. First, it describes the changing perspective of the EU towards the regulation of such authorizations. While its original focus was on the liberalization of national markets, it has today assumed overarching political responsibility for the development and marketing of medicines. Second, the article describes the current, rather fragmented regulatory system. Finally, political perspectives on the integration of markets for medicines are developed.

  18. How to add value to a generic product on the natural gas market

    International Nuclear Information System (INIS)

    Thorborg, L.

    1999-01-01

    The subject of the deregulated gas market continues to stir the blood. It's the 'leitmotif' of lecturers, discussions and professional journals. And of the Circle Day for members of the Royal Dutch Gas Association (KVGN). A representative of a supermarket chain discussed with the participants of the meeting the possibility of selling gas at the supermarket. The Head of Corporate marketing of British Gas warned the Dutch gas distributors against switching customer. The general manager of EnTrade strongly advocated a really deregulated gas market. During the morning session featuring 'Millennium and marketing' a marketing consultant already pointed at the new attitude that is necessary in the free market: 'Use the turn of the millennium to practice cuddling your customers. Take away your customer's fears that they will be without heating on 1 January 2000'

  19. Effectiveness of integrating individualized and generic complementary medicine treatments with standard care versus standard care alone for reducing preoperative anxiety.

    Science.gov (United States)

    Attias, Samuel; Keinan Boker, Lital; Arnon, Zahi; Ben-Arye, Eran; Bar'am, Ayala; Sroka, Gideon; Matter, Ibrahim; Somri, Mostafa; Schiff, Elad

    2016-03-01

    Preoperative anxiety is commonly reported by people undergoing surgery. A significant number of studies have found a correlation between preoperative anxiety and post-operative morbidity. Various methods of complementary and alternative medicine (CAM) were found to be effective in alleviating preoperative anxiety. This study examined the relative effectiveness of various individual and generic CAM methods combined with standard treatment (ST) in relieving preoperative anxiety, in comparison with ST alone. Randomized controlled trial. Holding room area Three hundred sixty patients. Patients were randomly divided into 6 equal-sized groups. Group 1 received the standard treatment (ST) for anxiety alleviation with anxiolytics. The five other groups received the following, together with ST (anxiolytics): Compact Disk Recording of Guided Imagery (CDRGI); acupuncture; individual guided imagery; reflexology; and individual guided imagery combined with reflexology, based on medical staff availability. Assessment of anxiety was taken upon entering the holding room area (surgery preparation room) ('pre-treatment assessment'), and following the treatment, shortly before transfer to the operating room ('post-treatment assessment'), based on the Visual Analogue Scale (VAS) questionnaire. Data processing included comparison of VAS averages in the 'pre' and 'post' stages among the various groups. Preoperatively, CAM treatments were associated with significant reduction of anxiety level (5.54-2.32, peffective than individualized CAM (Peffective than generic CDRGI. In light of the scope of preoperative anxiety and its implications for public health, integration of CAM therapies with ST should be considered for reducing preoperative anxiety. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Assessment of the impact of market regulation in Mali on the price of essential medicines provided through the private sector.

    Science.gov (United States)

    Maïga, Diadié; Williams-Jones, Bryn

    2010-10-01

    In 1998, the government of Mali adopted a national pharmaceutical policy aimed at promoting a supply system for generic essential medicines that would guarantee equal access for all citizens. Distribution and delivery is a shared responsibility of both public and private sectors (wholesalers and pharmacies). To influence private sector behaviour, the national policy uses a combination of government regulation and market forces. In 2006, the government issued a decree fixing maximum prices in the private sector for 107 prescription drugs from the national list of 426 essential medicines. The current study assessed the impact of this intervention on the evolution of market prices (wholesale and retail), and the subsequent availability and public access to essential medicines in Mali. A cross-sectional descriptive survey was conducted in February and May 2006, and January 2009, with 16 wholesalers and 30 private drugstores in Bamako, Mali. The overall availability of essential medicines at private wholesalers (p=1) and pharmacies (p=0.53) was identical before and after the enforcement of the 2006 decree fixing maximum drug prices. Contrary to concerns expressed by wholesalers and pharmacies, and the other stakeholders, the decree did not impact negatively on availability of essential medicines. In fact, median wholesale prices in 2009 were 25.6% less than those fixed by the decree. In private pharmacies, retail prices were only 3% more expensive than the recommended prices, compared with being 25.5% more expensive prior to enforcement of the decree. The study shows that prices of essential medicines in Mali have evolved favourably towards the prices recommended by the government decree. Further, the study contributes to mounting evidence that market regulation by governments does not necessarily negatively affect drug availability; in fact, given the reduction in prices, the study shows that Malians arguably have better access to more affordable essential medicines

  1. The Nature and Operation of Training Institutes: A Generic Marketing Plan for Community Colleges.

    Science.gov (United States)

    Vivelo, Frank R.

    1991-01-01

    Discusses marketing problems and opportunities associated with satisfying demand, product-consumer match, support services, personnel, and personal involvement. Identifies overall marketing and business/financial goals and related objectives. Covers action plans, performance evaluations, curriculum design, advisory committee participation and…

  2. Exploring policy impacts for servicising in product-based markets : A generic agent-based model

    NARCIS (Netherlands)

    van der Veen, R.A.C.; Kisjes, K.H.; Nikolic, I.

    2017-01-01

    The shift to markets based on servicising, i.e. market-level transitions from product-based to service-based production and consumption patterns, may contribute to achieve absolute decoupling, i.e. the combined development of economic growth and environmental impact reduction. However, the

  3. 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

  4. Changing markets - Medicinal plants in the markets of La Paz and El Alto, Bolivia.

    Science.gov (United States)

    Bussmann, Rainer W; Paniagua Zambrana, Narel Y; Moya Huanca, Laura Araseli; Hart, Robbie

    2016-12-04

    Given the importance of local markets as a source of medicinal plants for both healers and the population, literature on market flows and the value of the plant material traded is rather scarce. This stands in contrast to wealth of available information for other components of Bolivian ethnobotany. The present study attempts to remedy this situation by providing a detailed inventory of medicinal plant markets in the La Paz-El Alto metropolitan area, hypothesizing that both species composition, and medicinal applications, have changed considerably over time. From October 2013-October 2015 semi-structured interviews were conducted with 39 plant vendors between October 2013 and October 2015 in the Mercado Rodriguez, Mercado Calle Santa Cruz, Mercado Cohoni, Mercado Cota Cota, and Mercado Seguencoma and Mercado El Alto in order to elucidate more details on plant usage and provenance. The results of the present study were then compared to previous inventories of medicinal plants in La Paz and El Alto studies to elucidate changes over time and impact of interview techniques. In this study we encountered 163 plant species belonging to 127 genera and 58 families. In addition, 17 species could not be identified. This species richness is considerably higher than that reported in previous studies (2005, 129 species of 55 families; 2015, 94 identified species). While the overall distribution of illness categories is in line with older reports the number of species used per application, as well as the applications per species, were much higher in the present study. Overall, informant consensus was relatively low, which might be explained by the large number of new species that have entered the local pharmacopoeia in the last decade, although some species might simply have been missed by previous studies. In course of the present study it became apparent that even well known species might often be replaced by other apparently similar but botanically unrelated species due to

  5. [Discussion on releasing price of Chinese patent medicine to market economy to achieve sustainable development].

    Science.gov (United States)

    Long, Xingchao; Huang, Luqi; Jiang, Erguo; Zhou, Yonghong; Xu, Yanfeng; Zheng, Shuhua; Ning, Xiaoling; Liu, Hongwei; Chen, Lin

    2012-02-01

    To analyze costs of the traditional Chinese medicine industry focusing on production costs. Data of 50 planted Chinese herbal medicines and 50 wild Chinese herbal medicines were summarized and analyzed to see the changes of price of Chinese herbal medicines. The derivative problems of limited price were analyzed by crude drug, quality of Chinese medicine and sustainable utilization of resource. The price of Chinese medicine shall be adapted to sustainable development of market economy.

  6. [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.

  7. 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

  8. 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.

  9. Generic market design issues highlighted: prices soar in Alberta as capacity tightens

    International Nuclear Information System (INIS)

    Anon.

    1999-01-01

    Many Alberta consumers, alarmed by enormous price increases, are asking questions about whether electric sector restructuring in the province has progressed far enough. The average cost of power in Alberta's spot market in October were $70.46 per MWH above the $20-$30 that consumers had paid in recent years. It is widely admitted that the high prices reflect an increasingly tight supply situation in which construction of new capacity has not kept pace with growth in demand. It is a standard case of what happens when the market design focuses on promoting short-term price competition to the detriment of creating compeition in the forward markets. A debate has been produced in Alberta with major power consumers calling for a breakup of the three major generators, and the government suggesting that such intervention would be like returning to the days before competition when government tried to control everything. Competition may not work unless divestiture is revisited. There is a hard time seeing the light at the end of the restructuring tunnel for industrial consumers. Ontario's Market Design Committee struggled with the same issue, believing that an industry composed of many smaller independent generating companies was the only way to achieve lasting and meaningful price competition. The best price protection for consumers is an active and competitive investment market for new capacity, and Alberta should not repeat Ontario's mistake and leave the work until price problems develop

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

    Science.gov (United States)

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

    2017-01-01

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

  11. 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

  12. Perception of antiretroviral generic medicines: one-day survey of HIV-infected patients and their physicians in France.

    Directory of Open Access Journals (Sweden)

    Christine Jacomet

    Full Text Available In the interest of cost effectiveness, switching antiretroviral brand name medications to generics is recommended in France since 2013. The study objective was to evaluate the perception of generics per se and antiretroviral generics in HIV-infected patients and their hospital physicians.556 out of 703 (79% adult HIV+ outpatients and 116 physicians in 33 clinics were included in a multicentric cross-sectional survey performed in September 2013. Patients completed a self-questionnaire on their perception and acceptability of generics. Physicians completed a questionnaire on their acceptability of switching antiretroviral to generic. Socio-demographic data, medical history and HIV history were collected. Among the 556 patients with a median HIV duration of 13 years, 77% were France native, 59% in active employment, 100% covered by social insurance, 95% on antiretroviral therapy. Seventy-six percent of the patients accepted generics and 55% trusted them overall. Antiretroviral generics were accepted by 44% of them but only by 17% if the pill burden was going to increase. The factor significantly associated with acceptability of antiretroviral generics was acceptance of generics per se (p<0.001. Among the 116 physicians following a median of 100 HIV-patients/year, 75% would prescribe generics, dropping to 26% if the combo had to be broken. Factors significantly associated with willingness to prescribe antiretroviral generics were the absence of concern regarding the chemical entity (OR = 0.33, being aware that the patient would accept generics for other pathologies (OR = 2.04 and would accept antiretroviral generics (OR = 1.94. No factor related to sociodemographic conditions, HIV status or comorbidities was associated with the acceptability of antiretroviral generics.Acceptability of antiretroviral generics in this French population was mostly dictated by the patient's and physician's knowledge and use of generics overall. It should be improved

  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. Perception of antiretroviral generic medicines: one-day survey of HIV-infected patients and their physicians in France.

    Science.gov (United States)

    Jacomet, Christine; Allavena, Clotilde; Peyrol, Fleur; Pereira, Bruno; Joubert, Laurence Morand; Bagheri, Haleh; Cotte, Laurent; Garaffo, Rodolphe; Gerbaud, Laurent; Dellamonica, Pierre

    2015-01-01

    In the interest of cost effectiveness, switching antiretroviral brand name medications to generics is recommended in France since 2013. The study objective was to evaluate the perception of generics per se and antiretroviral generics in HIV-infected patients and their hospital physicians. 556 out of 703 (79%) adult HIV+ outpatients and 116 physicians in 33 clinics were included in a multicentric cross-sectional survey performed in September 2013. Patients completed a self-questionnaire on their perception and acceptability of generics. Physicians completed a questionnaire on their acceptability of switching antiretroviral to generic. Socio-demographic data, medical history and HIV history were collected. Among the 556 patients with a median HIV duration of 13 years, 77% were France native, 59% in active employment, 100% covered by social insurance, 95% on antiretroviral therapy. Seventy-six percent of the patients accepted generics and 55% trusted them overall. Antiretroviral generics were accepted by 44% of them but only by 17% if the pill burden was going to increase. The factor significantly associated with acceptability of antiretroviral generics was acceptance of generics per se (pantiretroviral generics were the absence of concern regarding the chemical entity (OR = 0.33), being aware that the patient would accept generics for other pathologies (OR = 2.04) and would accept antiretroviral generics (OR = 1.94). No factor related to sociodemographic conditions, HIV status or comorbidities was associated with the acceptability of antiretroviral generics. Acceptability of antiretroviral generics in this French population was mostly dictated by the patient's and physician's knowledge and use of generics overall. It should be improved with an efficient information of both patients and physicians.

  15. Perception of Antiretroviral Generic Medicines: One-Day Survey of HIV-Infected Patients and Their Physicians in France

    Science.gov (United States)

    Jacomet, Christine; Allavena, Clotilde; Peyrol, Fleur; Pereira, Bruno; Joubert, Laurence Morand; Bagheri, Haleh; Cotte, Laurent; Garaffo, Rodolphe; Gerbaud, Laurent; Dellamonica, Pierre

    2015-01-01

    Background In the interest of cost effectiveness, switching antiretroviral brand name medications to generics is recommended in France since 2013. The study objective was to evaluate the perception of generics per se and antiretroviral generics in HIV-infected patients and their hospital physicians Methods and Findings 556 out of 703 (79%) adult HIV+ outpatients and 116 physicians in 33 clinics were included in a multicentric cross-sectional survey performed in September 2013. Patients completed a self-questionnaire on their perception and acceptability of generics. Physicians completed a questionnaire on their acceptability of switching antiretroviral to generic. Socio-demographic data, medical history and HIV history were collected. Among the 556 patients with a median HIV duration of 13 years, 77% were France native, 59% in active employment, 100% covered by social insurance, 95% on antiretroviral therapy. Seventy-six percent of the patients accepted generics and 55% trusted them overall. Antiretroviral generics were accepted by 44% of them but only by 17% if the pill burden was going to increase. The factor significantly associated with acceptability of antiretroviral generics was acceptance of generics per se (pantiretroviral generics were the absence of concern regarding the chemical entity (OR = 0.33), being aware that the patient would accept generics for other pathologies (OR = 2.04) and would accept antiretroviral generics (OR = 1.94). No factor related to sociodemographic conditions, HIV status or comorbidities was associated with the acceptability of antiretroviral generics. Conclusions Acceptability of antiretroviral generics in this French population was mostly dictated by the patient’s and physician’s knowledge and use of generics overall. It should be improved with an efficient information of both patients and physicians. PMID:25658627

  16. 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.

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

    Directory of Open Access Journals (Sweden)

    Farouk M Sakr

    2016-01-01

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

  18. 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. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  19. Perception of Antiretroviral Generic Medicines: One-Day Survey of HIV-Infected Patients and Their Physicians in France

    OpenAIRE

    Jacomet, Christine; Allavena, Clotilde; Peyrol, Fleur; Pereira, Bruno; Joubert, Laurence Morand; Bagheri, Haleh; Cotte, Laurent; Garaffo, Rodolphe; Gerbaud, Laurent; Dellamonica, Pierre

    2015-01-01

    Background In the interest of cost effectiveness, switching antiretroviral brand name medications to generics is recommended in France since 2013. The study objective was to evaluate the perception of generics per se and antiretroviral generics in HIV-infected patients and their hospital physicians Methods and Findings 556 out of 703 (79%) adult HIV+ outpatients and 116 physicians in 33 clinics were included in a multicentric cross-sectional survey performed in September 2013. Patients comple...

  20. Use of the International Classification of Functioning, Disability and Health Generic-30 Set for the characterization of outpatients: Italian Society of Physical and Rehabilitative Medicine Residents Section Project.

    Science.gov (United States)

    Gimigliano, Francesca; De Sire, Alessandro; Gastaldo, Marco; Maghini, Irene; Paoletta, Marco; Pasquini, Andrea; Boldrini, Paolo; Selb, Melissa; Prodinger, Birgit

    2018-06-11

    The International Classification of Functioning, Disability and Health (ICF) Generic- 30 Set (previously referred to as Rehabilitation Set) is a minimal set of ICF categories for reporting and assessing functioning and disability in clinical populations with different health conditions along the continuum of care. Recently, the Italian Society of Physical and Rehabilitation Medicine (SIMFER) developed an Italian modification of the simple and intuitive descriptions (SID) of these categories. This study was the first one to implement the use of the SID in practice. 1) To implement the use of the ICF in clinical practice and research among Italian Residents in PRM. 2) To verify if the SID made the application of ICF Generic 30 Set more user-friendly than the original descriptions. 3) To examine the prevalence of functioning problems of patients accessing Rehabilitation Services to serve as reference for the development of an ICF-based clinical data collection tool. Multicenter cross-sectional study. Italian Physical Medicine and Rehabilitation (PRM) outpatient rehabilitation services. Patients referring to Italian PRM outpatient rehabilitation services and Italian Residents in PRM. Each School of Specialization involved, randomly, received the ICF Generic-30 Set with the original descriptions or with the SID. Residents collected over a 4-month period (April-July 2016) patients data related to the ICF Generic-30 Set categories. Moreover, the residents self- assessed their difficulty in using the ICF Generic-30 Set with the original descriptions or with the SID, through a Numeric Rating Scale (NRS). Ninety-three residents collected functioning data of 864 patients (mean aged 57.7±19.3) with ICF Generic-30 Set: 304 with the original descriptions and 560 with SID. The difficulty in using the ICF Generic-30 Set with SID was rated as lower than using the original descriptions (NRS = 2.8±2.5 vs 3.5±3.1; p<0.001). The most common disease was the back pain (9.6%) and

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

    Science.gov (United States)

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

    2012-01-01

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

  2. Nano medicine in Action: An Overview of Cancer Nano medicine on the Market and in Clinical Trials

    International Nuclear Information System (INIS)

    Wang, R.; Billone, P.S.; Mullett, W.M.

    2013-01-01

    Nano medicine, defined as the application of nano technology in the medical field, has the potential to significantly change the course of diagnostics and treatment of life-threatening diseases, such as cancer. In comparison with traditional cancer diagnostics and therapy, cancer nano medicine provides sensitive cancer detection and/or enhances treatment efficacy with significantly minimized adverse effects associated with standard therapeutics. Cancer nano medicine has been increasingly applied in areas including nano drug delivery systems, nano pharmaceuticals, and nano analytical contrast reagents in laboratory and animal model research. In recent years, the successful introduction of several novel nano medicine products into clinical trials and even onto the commercial market has shown successful outcomes of fundamental research into clinics. This paper is intended to examine several nano medicines for cancer therapeutics and/or diagnostics-related applications, to analyze the trend of nano medicine development, future opportunities, and challenges of this fast-growing area.

  3. The local knowledge of medicinal plants trader and diversity of medicinal plants in the Kabanjahe traditional market, North Sumatra, Indonesia.

    Science.gov (United States)

    Silalahi, Marina; Nisyawati; Walujo, Eko Baroto; Supriatna, Jatna; Mangunwardoyo, Wibowo

    2015-12-04

    Market is the main place for transactions of medicinal plants and traditional ingredients by local community in the Karo regency, North Sumatra, Indonesia. This is the first study to document the local knowledge of traders on and the diversity of the medicinal plants. The investigation was carried out in the Kabanjahe traditional market, in the Karo regency. The research goal was to reveal the local knowledge, diversity and utilization of medicinal plants, which have been traded in the Kabanjahe traditional market, as a basis for conservation efforts. The study was conducted through ethnobotanical approach using market surveys. All traders of medicinal plants were surveyed applying in-depth interviews and participative observations. Data were analyzed qualitatively using descriptive statistics. The diversity of medicinal plants was expressed in term of the Shannon-Wiener diversity index (H'), whereas the similarity among traders was indicated by Jaccard index (Ji). Traders of medicinal plants stored the simplicia of medicinal plants in chest of drawers, plastic baskets, plastic bags, and in the air by suspending them from the the stall ceilings. We recorded 344 species, 217 genera and 90 families of medicinal plants. Those that were sold mostly belong to Zingeberaceae (20 species), Poaceae (19 species), and Asclepiadaceae (17 species), and the species received high consumers demand, mostly belong to Zingiberaceae, Rutaceae, and Asclepidiaceae. Asclepidiaceae was used to treat diseases like cancer and heart problems. The Shannon-Wiener diversity index of medicinal plants at the Kabanjahe traditional market was high (H'= 5.637). The high Jaccard similarity index (Ji>0.56) suggested that the traders were trading similar species of medicinal plants. Kabanjahe traditional market is the center for the sale of of medicinal plants as traditional ingredients. Several species are well known for their pharmacological properties but others, [such as: Dischidia imbricata (Blume

  4. How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

    Directory of Open Access Journals (Sweden)

    Ran Tian

    2017-10-01

    Full Text Available The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern. The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine. In this paper, we propose a reappraisal protocol called “precise proprietary Chinese medicine” to precisely i define the therapeutic aim; ii design the protocol; iii control the quality of proprietary Chinese medicine; iv implement the protocol in the trial; v study the mechanism-of-action of the proprietary Chinese medicine and vi describe the indications of the proprietary Chinese medicine. We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.

  5. Exploring knowledge, perceptions and attitudes about generic ...

    African Journals Online (AJOL)

    Exploring knowledge, perceptions and attitudes about generic medicines among final-year health science students. ... had knowledge deficits about the safety, quality and efficacy of generic medicines. The dissemination of information about generic medicines may strengthen future knowledge, attitudes and perceptions.

  6. 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.

  7. Generics Pricing: The Greek Paradox.

    Science.gov (United States)

    Karafyllis, Ioannis; Variti, Lamprini

    2017-01-01

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

  8. [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.

  9. Generic drugs: Review and experiences from South India

    Directory of Open Access Journals (Sweden)

    Philip Mathew

    2015-01-01

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

  10. Mixed WTO ruling on generic drug development.

    Science.gov (United States)

    Elliott, R

    2000-01-01

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

  11. [Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Fu, Yingkun; Xie, Yanming

    2011-10-01

    In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

  12. The impact of the Medicines Control Council backlog and fast-track ...

    African Journals Online (AJOL)

    number of generic products for each tracer medicine that had been registered at the ... only 54% of all registered generic brands for the eight medicines were marketed ... not only for new chemical entities (NCEs) considered essential for national ... strategy for the allocation of applications for evaluation from using. ISSUES ...

  13. 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

  14. 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.

  15. 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.

  16. [The marketing evaluation of the consumers' preference as regards the use of medicinal and medicinal table mineral waters].

    Science.gov (United States)

    Babaskin, D V; Babaskina, L I; Pavlova, A V

    2017-12-28

    The development of modern technologies in physiotherapy with the use of mineral waters, the expansion of the assortment of the medicinal and medicinal table waters as well as increasing the competitive advantages of domestic products require the more extensive marketing survey of the consumers' preferences in the market of mineral waters. The objective of the present study was the marketing evaluation of the consumers' preference in the segment of medicinal and medicinal table mineral waters in the city of Moscow. The survey involved 697 consumers of medicinal and medicinal table mineral waters. The sampling was carried out by the deterministic quota method. The field research was conducted by means of personal verbal interviews (32%) and the CATI to Web method (phone recruiting and on-line questioning) (68%) with the use of the structured questionnaire. Positioning was carried out making use of the two-dimensional schematic map and scoring assessment on an individual basis with calculation of integrated indicators. The marketing evaluation has demonstrated that the principal motive for purchasing mineral waters in more than 40% of respondents was the treatment and prevention of various diseases including disturbances in the urogenital system as well as digestive and respiratory disorders that appear to be the most frequent reasons for the consumption of mineral waters. The main factors that form the preferences of the consumers as regards the use of a concrete variety of mineral waters were elucidated. Of crucial importance for approximately 40% of the consumers (p<0.01) proved to be their health condition, the medical indications, and the available information about the therapeutic effectiveness of one or another type of mineral waters. Other factors were the quality of mineral water, its cost, the manufacturer and/or place of production, the attractiveness of the packaging, etc. The evaluation of the positioning of the mineral water consumers' preferences made

  17. Contamination of herbal medicinal products marketed in Kaduna ...

    African Journals Online (AJOL)

    The study aimed to evaluate the bacterial contamination of powdered herbal medicinal preparations sourced from identified herbal retail outlets in different parts of Kaduna metropolis. The assessments of the contamination of the herbal products were carried out using standard procedures: total aerobic bacterial plate count, ...

  18. 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.

  19. 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…

  20. 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

  1. 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.

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

    Science.gov (United States)

    Carrier, Michael A

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

  3. [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.

  4. Identification of marine traditional Chinese medicine dried seahorses in the traditional Chinese medicine market using DNA barcoding.

    Science.gov (United States)

    Hou, Feixia; Wen, Longlian; Peng, Cheng; Guo, Jinlin

    2018-01-01

    Seahorse documented in Chinese pharmacopeia possess important medicinal efficacy and are used as an ingredient in traditional Chinese medicines. The growing international trade threatens the species. DNA barcoding holds a great application potentiality in wildlife conservation and might prevent the illegal trade of threatened species. The COI gene was used to identify seahorse, and nine Hippocampus species were found in the three large traditional Chinese medicines markets of China. All inter-specific genetic variations were larger than 2%. Mean genetic distances between species were 17-fold larger than those within the species. Phylogenetic tree showed that each species clustered in the appropriate branch. All results demonstrated that COI-based barcoding technique could be used to identify seahorse species and played a major role in monitoring the seahorse trade.

  5. [Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

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

    OpenAIRE

    BOBOIA, ANAMARIA; GRIGORESCU, MARIUS RARE?; TURCU - ?TIOLIC?, 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, descr...

  7. [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.

  8. 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.

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

    Science.gov (United States)

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

    2011-01-01

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

  10. 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.

  11. The New South Wales nuclear medicine technology labour market

    International Nuclear Information System (INIS)

    Ridoutt, L.; Cowell, S.; Bush, V.

    1989-01-01

    A workforce study of 30 organisations was conducted in response to staffing difficulties in public hospital nuclear medicine departments. It was found that out of a total of 165.5 full-time equivalent establishment positions existed in public hospitals and the private sector, only 135.38 were filled. The vacancy level of about 15% was considered to be above the acceptable norm. Growth in demand between 1989 and 1993 is estimated at 46.7% and 89.1% in the public and private sector respectively. Recommendations are made to reduce losses from the workforce. 2 figs., tabs

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

    Science.gov (United States)

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

    2018-01-01

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

  13. Internationalization of traditional Chinese medicine: current international market, internationalization challenges and prospective suggestions.

    Science.gov (United States)

    Lin, Annie Xianghong; Chan, Ging; Hu, Yuanjia; Ouyang, Defang; Ung, Carolina Oi Lam; Shi, Luwen; Hu, Hao

    2018-01-01

    Through reviewing the current international market for traditional Chinese medicine (TCM), this paper identified the internationalization challenges for TCM, including unclear therapeutic material basis and mechanism, difficulty of quality control, low preparation level, registration/policy barriers, and shortage of intellectual property. To deal with these challenges, suggestions were given including: (1) product innovation of TCM (study the TCM by using the methods and means of western medicine; innovate the basic theory of TCM; develop TCM health product); (2) standard innovation of TCM; (3) building big data platform of Chinese medicine (big data platform of TCM preparation; big data platform on the quality of TCM).

  14. 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.

  15. 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...

  16. [Application of Markov model in post-marketing pharmacoeconomic evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Sun, Wentao; Xie, Yanming; Wang, Yongyan

    2011-10-01

    In post-marketing study of traditional Chinese medicine (TCM), pharmacoeconomic evaluation has an important applied significance. However, the economic literatures of TCM have been unable to fully and accurately reflect the unique overall outcomes of treatment with TCM. For the special nature of TCM itself, we recommend that Markov model could be introduced into post-marketing pharmacoeconomic evaluation of TCM, and also explore the feasibility of model application. Markov model can extrapolate the study time horizon, suit with effectiveness indicators of TCM, and provide measurable comprehensive outcome. In addition, Markov model can promote the development of TCM quality of life scale and the methodology of post-marketing pharmacoeconomic evaluation.

  17. 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. © 2015, The American Society for Clinical Pharmacology and Therapeutics.

  18. [Strategy of constructing post-market integral evaluation system of traditional Chinese medicine injection].

    Science.gov (United States)

    Zhang, Xiao-Yu; Wang, Yan-Ping; Lin, Li-Kai; Shang, Hong-Cai; Wang, Yong-Yan

    2017-08-01

    As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels: optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects: mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation. Copyright© by the Chinese Pharmaceutical Association.

  19. 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 ...

  20. State of the fight against informal market of medicines in Togo: approaches and limitations.

    Science.gov (United States)

    Gnassingbe, A; Flahault, A; Geissbuhler, A; Sprumont, D; Awesso, A

    2018-02-01

    The extent of medicines sales and consumption in the informal market in Togo raises many ethical and public health issues. In order to report on the situation of public action in the fight against this practice, we conducted a qualitative survey from 15 to 25 February 2016 in the commune of Lomé and in the Maritime Region among the actors of control system and resource people in the general population. This was supplemented by an analysis of Togo's pharmaceutical and health policy documents and a literature review on the illicit drug market issues relating to public health, political science, the social sciences applied to health. In spite of the existence of national and international tools, household poverty, cultural self-medication, ignorance of the population concerning the health risks of informal market medicines, weak political commitment, weakness regulation and enforcement, corruption, constitute obstacles to the success of actions to combat this practice.

  1. Generic Advantages

    Indian Academy of Sciences (India)

    First page Back Continue Last page Overview Graphics. Generic Advantages. Scalability an incremental coverage. Standardization. Business Plan Flexibility. Lifecycle Flexibility. Reliability. Service Interoperability. Changed Industry dynamics.

  2. 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

  3. Market survey on traditional medicine of the third month fair in Dali Prefecture in Yunnan Province, South West China.

    Science.gov (United States)

    Zhang, Dequan; Duan, Lizhen; Zhou, Nong

    2014-01-01

    The Third Month Fair in Dali is a historical festival and fair. The market of traditional medicine (TM) is one of the main parts in the fair, which has important influence on local and peripheral people. In this study, approaches of ethnobotany, pharmacognosy, and participatory rural appraisal were used in market survey. Twenty-six druggists were selected randomly as informants and their TMs were recorded. As a result, 427 TMs were recorded including 362 plant medicines, 33 animal medicines, 13 mineral medicines and 19 unidentified medicines. Xinyi, Shanza and Gancao were the most popular medicines due to their popular usages, whereas Sanqi, Tianma and Renshen were relatively fewer in this investigation probably owing to high price and limited output. The plant medicines were from medicinal plants of 117 families belonged to Angiosperm, Gymnospermae, Pteridophyta, Bryophyta, Lichenes and Fungi. Asteraceae, Apiaceae and Fabaceae provided the maximum numbers of TMs successively. Moreover, these TMs were mainly from the cultivated especially familiar TMs, which reflected significant progress in utilization and conservation of medicinal resource in China. Medicinal market in the Third Month Fair is the most important traditional bazaar in Yunnan province. This study systematically surveyed TMs in the fair for the first time, analyzing and revealing resource compositions and current market situations. These newly gathered data provided precious information for development of medicine cultivation, resource protection and market management as well as further pharmacognostical, pharmacological and clinical researches.

  4. [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.

  5. Identifying the unique characteristics of independent fashion retailers in Scotland by utilising Porter’s generic competitive strategy model and the marketing mix

    Directory of Open Access Journals (Sweden)

    Nicola O’HARE

    2018-01-01

    Full Text Available El mismo texto del Independent retailers in the fashion sector make a substantial contribution to the UK economy at the time of significant change on the high street due to financial pressures and the growth of online trade. They provide an element of creativity and innovation to a homogenous retail landscape. The independent fashion retailer creates a destination and individual identity by presenting a unique offering and differentiated experience. Whilst independent retailers are important to the future of our high street, research is limited, particularly in the area of fashion independents. Therefore this research examines and identifies the unique characteristics of independent fashion retailers within Scotland. The research adopts a case study approach, qualitative methods of data collection in order to fulfil the aim and objectives of the study. Porter’s Generic Competitive Strategies and the marketing mix were utilised as a means of drawing out the individual aspects and unique characteristics of the independent fashion retailer.

  6. 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

  7. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    Science.gov (United States)

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

  8. 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

    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. The methods used in this research were the following: marketing research, method of sampling, descriptive methods, retrospective analysis, method of comparison. 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. 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.

  9. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    Science.gov (United States)

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  10. Generic antibiotics in Japan.

    Science.gov (United States)

    Fujimura, Shigeru; Watanabe, Akira

    2012-08-01

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

  11. 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.

  12. Research and development for botanical products in medicinals and food supplements market.

    Science.gov (United States)

    Miroddi, Marco; Mannucci, Carmen; Mancari, Ferdinando; Navarra, Michele; Calapai, Gioacchino

    2013-01-01

    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.

  13. 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.

  14. 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.

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

    Science.gov (United States)

    Löfgren, Hans

    2007-06-01

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

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

    Science.gov (United States)

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

    2017-04-01

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

  17. [Post-marketing re-evaluation about usage and dosage of Chinese medicine based on human population pharmacokinetics].

    Science.gov (United States)

    Jiang, Junjie; Xie, Yanming

    2011-10-01

    The usage and dosage of Chinese patent medicine are determined by rigorous evaluation which include four clinical trail stages: I, II, III. But the usage and dosage of Chinese patent medicine are lacked re-evaluation after marketing. And this lead to unchanging or fixed of the usage and dosage of Chinese patent medicine instead of different quantity based on different situations in individual patients. The situation of Chinese patent medicine used in clinical application is far away from the idea of the "Treatment based on syndrome differentiation" in traditional Chinese medicine and personalized therapy. Human population pharmacokinetics provides data support to the personalized therapy in clinical application, and achieved the postmarking reevaluating of the usage and dosage of Chinese patent medicine. This paper briefly introduced the present situation, significance and the application of human population pharmacokinetics about re-evaluation of the usage and dosage of Chinese patent medicine after marketing.

  18. MARKETING RESEARCHES OF MEDICINAL AND COSMETIC REMEDIES INTENDED FOR APPLYING IN VARIOUS FORMS OF ALOPECIA

    Directory of Open Access Journals (Sweden)

    I. O. Yarema

    2014-12-01

    Full Text Available Pathological hair loss – alopecia – is an urgent problem that takes one of the leading places in the pathology of skin structure. There are different types of alopecia, the most common forms are androgen and telogen (symptomatic alopecia. Androgenic alopecia (AA isa progressive alopecia caused by androgens action on hair follicle in patients with hereditary predisposition, which is often manifested not only with excessive hair loss, but also with the appearance of dandruff. Uncontrolled use of cosmetic products for combating hair loss is increased in view of high prevalence among young people, and as advertising in the media. Therefore, an important task of modern pharmacy is to create a medicinal remedy that contribute efficient and controlled correction of AA and provide the pharmaceutical market of Ukraine with available economical means. The significant range of cosmetics and medicinal products to eliminate dandruff and hair loss correctionare implementedin Ukraine pharmacy network today. However, the amount of medicinal remedy decreases every year. Most of them, after re-registration movetothe category of cosmeceuticals.This cause the significant increase in the value. For example, the number of medicinal remedy registered in Ukraine for local and systemic treatment of alopecia compared with 2012 decreased approximately on 36%, and drugs to treat dandruff - 17%. Today the amount of native medicines for the treatment of alopecia and dandruff is limited and is only 23%, compared with foreign firms. Leading positions in the import medicines of this group are occupied by India, Germany and France, and the share of foreign drugs is 77% from the total. Cosmetic hair loss remedies are presented significantly numerous, compared to medicinal remedy, an arsenal of forms production, including shampoos, masks, lotions, oil, balms, solutions for rubbing into the scalp, capsules for internal use and so on. The main components of active cosmeceuticals

  19. 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.

  20. [Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments)].

    Science.gov (United States)

    Xie, Yan-Ming; Zhao, Yu-Bin; Jiang, Jun-Jie; Chang, Yan-Peng; Zhang, Wen; Shen, Hao; Lu, Peng-Fei

    2013-09-01

    Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

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

    Science.gov (United States)

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

    2009-10-01

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

  2. The crisis in access to essential medicines in India: key issues which call for action.

    Science.gov (United States)

    Bhargava, Anurag; Kalantri, S P

    2013-01-01

    The government is planning to introduce free generic and essential medicines in public health facilities. Most people in India buy healthcare from the private sector, a compulsion that accounts for a high proportion of healthcare-related expenditure. To reduce the burden of healthcare costs, the government must improve availability and affordability of generic and essential medicines in the market. It can do so because India's large pharmaceutical industry is a major source of generic medicines worldwide. In this article, we discuss three factors that have impeded access to generic and essential medicines: (1) mistaken notions among policymakers, prescribers and patients about branded drugs and generic drugs in India; (2) high prices of medicines due to the progressive dismantling of the system of regulation of medicine prices, and (3) a drug approval and regulatory system that allows medicines (including fixed dose combinations) of doubtful efficacy, rationale, safety and public health relevance to dominate the market at the cost of access to affordable generic and essential medicines. The consequences of ill-health and wasted expenditure on drugs raise issues of public health ethics.Improving access to essential medicines in India is an urgent public health and ethical imperative. This should include improved public provisioning, a system of regulation of drug prices, and an evidence-based drug approval process.

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

    DEFF Research Database (Denmark)

    Faeh, Andrea Beata

    2013-01-01

    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...... – 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...... of it yielding revenue for the innovator. Hence, fuller harmonization can benefit innovation, but it is just as important, if not more important, to address other factors such as pricing, reimbursement and patent protection....

  4. 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....

  5. 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.

  6. The Brazilian market of herbal medicinal products and the impacts of the new legislation on traditional medicines.

    Science.gov (United States)

    Carvalho, Ana Cecília Bezerra; Lana, Túlio Nader; Perfeito, João Paulo Silvério; Silveira, Dâmaris

    2018-02-15

    the herbal medicinal products (HMP) market is expanding in the world, an expansion that has not occurred in Brazil when considering the number of licensed products. Despite being a megadiverse country, the number of HMP licensed in Brazil is small, and the number of HMP obtained from native species is even smaller. A new legislation for herbal products licensing, which divides the products into two categories, Herbal Medicine (HM) and Traditional Herbal Product (THP) was launched in Brazil focusing on traditional use, as well as a law regulating the use of biodiversity and traditional knowledge. to evaluate the situation of HMP licensed in Brazil and to make a comparison with the data obtained in 2008 and 2011, discussing the evolution of the licensed products and the possible impacts of the new legislation. a survey was carried out in the Brazilian Health Regulatory Agency (Anvisa) database to verify the HMP licensed in Brazil in September 2016. The data obtained were compared with two surveys previously published. There are 332 single, and 27 combined HM, totaling 359 HM licensed in Brazil. There is no THP notified in Anvisa's system yet. There are 214 HM classified as nonprescription (OTC), while 145 are sold under prescription, one of them with prescription retention. There are 101 plant species licensed as active in HM in Brazil, 39 of which are native, adapted or cultivated. The most licensed plant species is Mikania glomerata Spreng., with 25 HM licensed. The article includes tables with plant species that have derivatives licensed as simple and combined HM, their therapeutic classification, the native plant species indication and the distribution of the companies by Brazilian regions. There are few licensed HM in Brazil, and this number has been decreasing in recent years. It is expected that the data obtained, together with the changes promoted in sanitary and environmental rules, will help to develop and regulate HMP chain in Brazil. Copyright © 2017

  7. 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

  8. 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."

  9. 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.

  10. 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

  11. 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.

  12. 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

  13. 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. 2009 Elsevier Ltd. All rights reserved.

  14. 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

    2010-01-01

    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. PMID:20022680

  15. Medicines

    Science.gov (United States)

    Medicines can treat diseases and improve your health. If you are like most people, you need to take medicine at some point in your life. You may need to take medicine every day, or you may only need to ...

  16. Herbal medicinal products versus botanical-food supplements in the European market: state of art and perspectives.

    Science.gov (United States)

    Bilia, Anna Rita

    2015-01-01

    Botanical products marketed in Europe are diverse, classified as herbal medicinal products, dietary supplements, cosmetics, foods and beverages depending on the relevant applicable legislation. Many factors are taken into account in the classification of a botanical product (e.g. intended use, labeling, preparations and dosages) according to how it is placed on the market. Herbal medicinal products (HMPs) can only be sold in pharmacies, under the supervision of a pharmacist, and are marketed after full or simplified registration procedures according to their classification, i.e. as over-the-counter drugs (OTC) available without special restrictions and prescription only medicine (POM), which must be prescribed by a licensed medical practitioner. The dietary supplement segment is also sold in the market in dose form (such as capsules, tablets, ampoules of liquids, drops etc) and represents 15-20% of the botanical market at the European level with high variability among each country (i.e. in Italy it reaches up to 80%). In many cases the distinction between medicinal products and food supplements has generated borderline botanical-sourced products, which generally produce confusion and mislead the consumers. As a consequence, there is an urgent need of consumer education and in addition to collect comprehensive data and make this database systematically available to herbalists, nutritionists and medical specialists for a proper classification and harmonization of the use of botanical ingredients, and, as consequence, a correct use of these products.

  17. EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.

    Science.gov (United States)

    de Wilde, Sofieke; Coppens, Delphi G M; Hoekman, Jarno; de Bruin, Marie L; Leufkens, Hubert G M; Guchelaar, Henk-Jan; Meij, Pauline

    2018-03-21

    A comparative analysis of assessment procedures for authorization of all European Union (EU) applications for advanced therapy medicinal products (ATMPs) shows that negative opinions were associated with a lack of clinical efficacy and identified severe safety risks. Unmet medical need was often considered in positive opinions and outweighed scientific uncertainties. Numerous quality issues illustrate the difficulties in this domain for ATMP development. Altogether, it suggests that setting appropriate standards for ATMP authorization in Europe, similar to elsewhere, is a learning experience. The experimental characteristics of authorized ATMPs urge regulators, industry, and clinical practice to pay accurate attention to post-marketing risk management to limit patient risk. Methodologies for ATMP development and regulatory evaluations need to be continuously evaluated for the field to flourish. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  18. Skin rash during treatment with generic itraconazole

    OpenAIRE

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

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Béatrice Riner

    2017-11-01

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

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

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    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

  1. [Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring].

    Science.gov (United States)

    Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe

    2013-09-01

    To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.

  2. Early Patient Access to Medicines: Health Technology Assessment Bodies Need to Catch Up with New Marketing Authorization Methods.

    Science.gov (United States)

    Leyens, Lada; Brand, Angela

    National and international medicines agencies have developed innovative methods to expedite promising new medicines to the market and facilitate early patient access. Some of these approval pathways are the conditional approval and the adaptive pathways by the European Medicines Agency (EMA); the Promising Innovative Medicine (PIM) designation and the Early Access to Medicines Scheme (EAMS) by the Medicines and Healthcare Products Regulatory Agency (MHRA), as well as the Fast Track, Breakthrough or Accelerated Approval methods by the Food and Drug Administration (FDA). However, at least in Europe, these methods cannot achieve the goal of improving timely access for patients to new medicines on their own; the reimbursement process also has to become adaptive and flexible. In the past 2 years, the effective access (national patient access) to newly approved oncology drugs ranged from 1 to 30 months, with an extremely high variability between European countries. The goal of early patient access in Europe can only be achieved if the national health technology assessment bodies, such as NICE (ENG), HAS (FR), G-BA (DE) or AIFA (IT), provide harmonized, transparent, flexible, conditional and adaptive methods that adopt the level of evidence accepted by the medicines agencies. The efforts from medicines agencies are welcome but will be in vain if health technology assessments do not follow with similar initiatives, and the European 'postcode' lottery will continue. © 2016 S. Karger AG, Basel.

  3. 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...

  4. 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

  5. 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.

  6. Skin rash during treatment with generic itraconazole.

    Science.gov (United States)

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

    2014-04-01

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

  7. Application of electronic business in monitoring marketing and consumption of human medicines in the Republic of Serbia

    Directory of Open Access Journals (Sweden)

    Tešić Danka

    2011-01-01

    Full Text Available The paper describes the application of electronic business (e-business in monitoring marketing and consumption of medicines, as one of e-government services (e-services of the Republic of Serbia (Serbia. It shows methodological framework for development of e-services, through use of RUP (Rational Unified Process methodology. The Unified Modelling Language (UML notation was used for description of the system model. The paper presents modeling of the process of marketing of medications for human use, as well as development of the information subsystem underpinning it. The analysis of the marketing of medications in Serbia was carried out in 2006, 2007, 2008 and 2009, by the Medicines and Medical Devices Agency of Serbia, which was authorized to collect and analyze data on the marketing and consumption of medicines and medical devices. Data gathered for a particular time period were analyzed using Anatomical Therapeutic Chemical Classification and the Defined Daily Doses methodology. The amount of medicines consumed was translated into the DDD by 1000 individuals per day, and gave an insight into the number of individuals (out of 1000 who used the medicine under observation and were under its effect during a single day. The data extracted are correlated with the number of individuals who took the medication during the period under observation. In the year 2006 total marketing of medications for human use amounted to € 510.833.609,54, in 2007 it stood at € 687.588.174,80, in 2008 it was € 799.082.221,05, while the overall marketing of medicines in the year 2009 was € 741.981.960,19. By processing the data by methodology of DDD, the following results were obtained: 1013,70 DDD/1000 individuals/day in year 2006; in year 2007, 1084,34 DDD/1000 individuals/day; in year 2008, 1219,57 DDD/1000 individuals/day and in year 2009, 1177,72 DDD/1000 individuals/day. The implementation of such system produces a series of technological, functional and

  8. [Taking evaluation of post-marketing as point of cut-in to promote systematic research of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Yong-yan; Wang, Zhi-fei; Xie, Yan-ming

    2014-09-01

    Research on post-marketing Chinese medicine should be the systematic study from application to mechanism. Clinical evaluation is the basis of mechanism study, we can find the clue from clinical evaluation, then make a mechanism study to find the reason, then apply the results to clinic. So it is a virtuous circle. In order to achieve it, we cannot be limited to traditional Chinese medicine, we should form multi-disciplinary team under the direction of grand science thinking, try hard to put industry-university-research institute collaboration association to use, and if necessary, explore the new model of the whole nation system. An appropriate operation mechanism is very important.

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

    Directory of Open Access Journals (Sweden)

    Rondineli Mendes da Silva

    Full Text Available Abstract 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.

  10. Decision in the matter of a generic hearing in respect to market issues and conduct related to the sale of gas and customer services in the natural gas industry in New Brunswick

    International Nuclear Information System (INIS)

    2003-01-01

    In response to changes in the Gas Distribution Act and the Gas Distributor Marketing Regulation, the New Brunswick Board of Commissioners of Public Utilities (Board), issued an order in June 2003 for a generic hearing regarding the sale of gas and customer services in the natural gas industry in New Brunswick. The purpose of the hearing was to have an open discussion among intervenors regarding several issues, such as whether the Code of Conduct provides fair and adequate rules for marketers; should Enbridge Gas New Brunswick (EGNB) be required to follow rules similar to the Code of Conduct; the requirements surrounding letters of credit; the Board's decision on Rules and Regulations regarding the billing conduct of gas distributors and marketers; the information that should be provided by a gas marketer or a distributor to the customer before the customer enters into an agreement for the supply of gas; the need for information on price volatility; the need for EGNB to notify potential customers of all possible suppliers of gas; the removal of automatic renewal clauses from gas retailers' contracts; how the Board should determine if prices are reasonably and sufficiently competitive; financial reporting requirements; the role of the Board in response to customer complaints regarding the sale of gas by a distributor; and, the Board's action regarding Enbridge Atlantic's plan to exit the New Brunswick market. This report provided the response to these issues by 10 intervenors

  11. [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.

  12. 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.

  13. [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.

  14. Assessing local market and organizational readiness for the integration of complementary and alternative medicine into ambulatory care centers.

    Science.gov (United States)

    Makowski, Suzana K E

    2004-01-01

    Complementary and alternative medicine (CAM) is one of the fastest growing segments of the health care industry today, with studies suggesting that between 30% and 50% of the adult population in the United States uses some form of CAM. Many ambulatory care centers are considering integrating CAM into their clinical services. This article will review some of the national trends and present a framework for assessing local market demand for CAM in order to help prioritize an organization's CAM integration strategy.

  15. 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.

  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. 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. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

  18. 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.

  19. The Politics and Policies of Regulating Generics in Latin America: A Survey of Seventeen States.

    Science.gov (United States)

    Sweet, Cassandra M

    2017-06-01

    When patents expire, are equivalent generic alternatives available to citizens? This article contributes to current discussion on access to medicine in the aftermath of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The focus is on off-patent or "generic" medicines: their product definitions, quality standards and prescription procedures. Drawing from a survey conducted of seventeen countries across the Latin American region, this article examines the differences in definition of off-patent products and the paradox of their relatively lower consumption across multiple developing states. The findings point to pathways for improving standards, consumer information, and access in off-patent pharmaceutical markets. Copyright © 2017 by Duke University Press.

  20. [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.

  1. 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. Copyright © 2014 Elsevier B.V. All rights reserved.

  2. 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.

  3. 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 http://dx.doi.org/10.5007/2175-7925.2016v29n1p115 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.

  4. 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)

    Timonen, Johanna; Bengtström, Marina; Karttunen, Pekka; Ahonen, Riitta

    2010-10-22

    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. 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. 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 activities of the majority of

  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. 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

  7. Generic Performance Measures. Chapter 8

    Energy Technology Data Exchange (ETDEWEB)

    Daube-Witherspoon, M. E. [Department of Radiology, University of Pennsylvania, Philadelphia, PA (United States)

    2014-12-15

    The generic nuclear medicine imager, whether a gamma camera, single photon emission computed tomography (SPECT) system or positron emission tomography (PET) scanner, comprises several main components: a detection system, a form of collimation to select γ rays at specific angles, electronics and a computing system to create the map of the radiotracer distribution. This section discusses these components in more detail. The first stage of a generic nuclear medicine imager is the detection of the γ rays emitted by the radionuclide. In the case of PET, the radiation of interest are the 511 keV annihilation photons that result from the interaction of the positron emitted by the radionuclide with an electron in the tissue. For general nuclear medicine and SPECT, there is one or sometimes more than one γ ray of interest, with energies in the range of <100 to >400 keV. The γ rays are detected when they interact and deposit energy in the crystal(s) of the imaging system. There are two main types of detector: crystals that give off light that can be converted to an electrical signal when the γ ray interacts (‘scintillators’) and semiconductors, crystals that generate an electrical signal directly when the γ ray deposits energy in the crystal. Scintillation detectors include NaI(Tl), bismuth germanate (BGO) and lutetium oxyorthosilicate (LSO); semiconductor detectors used in nuclear medicine imagers include cadmium zinc telluride (CZT). Radiation detectors are described in more detail in Chapter 6.

  8. [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.

  9. The compounding effect of tariffs on medicines: Estimating the real cost of emerging markets' protectionism

    OpenAIRE

    Bauer, Matthias

    2017-01-01

    Even low import tariff rates have a significant compounding effect on the final retail price of medicines, which in turn impacts on affordability. While much of the "access to affordable medicines" debate is about intellectual property rights (IPRs) and business practices of pharmaceutical manufacturers, import duties and national protectionism are swept under the political rug. In this paper, we provide a synopsis of tariff barriers for exports of pharmaceutical products to the world's major...

  10. Entry decisions in the generic pharmaceutical industry.

    Science.gov (United States)

    Morton, F M

    1999-01-01

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

  11. 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.

  12. 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).

  13. Ethnobotany and trade of medicinal plants in the Qaysari Market, Kurdish Autonomous Region, Iraq.

    Science.gov (United States)

    Mati, Evan; de Boer, Hugo

    2011-01-27

    Marketplaces epitomize a region's culture and trade, and can give a rapid insight into traditions and salience of commercialized medicinal products. The Qaysari bazaar, bordering the citadel in Erbil city in the Kurdistan Autonomous Region, Iraq, has 21 herbalist shops trading natural medicinal products, wild-crafted and cultivated from all over the Middle East and Asia Minor. Freelist surveys were conducted with 18 of these herbalists to determine diversity and salience of traded traditional medicinal plants. Interviews were conducted to document use, trade volume, origin, stock and value of the reported species. Plant species were identified using a combination of morphological identification and molecular barcoding using the ITS region. Vouchers were collected for a total of 158 samples, corresponding to 82 species of plants, 5 animal products, 8 types of stones, minerals or chemicals, as well as 16 mixtures of plant products. Consensus Analysis of the herbalist interviews shows strong support for a single culture of herbalist plant use. Most reported plant species are known to have been used since antiquity, and uses are identical or similar to previously documented uses. Herbalists report a steady year-on-year increase in trade due to the economic stability in recent times. A majority (64%) of medicinal plants is imported from outside Iraq, and the data shows that imported plants trade at a higher price than locally-sourced species, and that these species are stocked in higher volumes by the herbalists to ensure a steady supply to consumers. A strong tradition of herbal medicine exists in Kurdistan today exemplified by the diverse and vigorous trade in medicinal plants commercialized from the provinces around Erbil to countries as far away as India, Spain and Libya. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  14. ROLE OF THE INTERNATIONAL ORGANIZATIONS IN PREVENTING THE COUNTERFEIT MEDICINES ENTRY INTO THE WORLD MARKETS.

    Science.gov (United States)

    Stukina, Valeryia; Dohnal, Jiri; Saloun, Jan

    2016-09-01

    30 years have passed since Conference of Experts on the Rational Use of Drugs was held in Nairobi, Kenya, from 25 to 29 November 1985, where the problem of counterfeit medicines was mentioned as the international for the first time. The problem of counterfeit medicines is not only a major threat to public health and national and private economy, but also it is of great interest for key decision-making actors at the international level. The authors analyzed what has been done since that time by international organizations. Combating the counterfeiting of medicines cannot be successfully achieved by the health sector alone - World Health Organization (WHO), - so the efforts of the other United Nations (UN) organizations relevant to counterfeiting were in need and were studied in the article: World Intellectual Property Organization (WIPO), World Trade Organization (WTO), World Customs Organization (WCO), United Nations Office on Drugs and Crime (UNODC), etc. Today WHO is unable to coordinate all their activities, so the few existing proposals for establishing a new mechanism of international cooperation have been examined. Will the MEDICRIME Convention that will enter into force on January 1, 2016 be the start of the new era in the combating with the counterfeit medicines? - the authors offered their vision on the international developments.

  15. Exploiting science? A systematic analysis of complementary and alternative medicine clinic websites' marketing of stem cell therapies.

    Science.gov (United States)

    Murdoch, Blake; Zarzeczny, Amy; Caulfield, Timothy

    2018-02-28

    To identify the frequency and qualitative characteristics of stem cell-related marketing claims made on websites of clinics featuring common types of complementary and alternative medicine practitioners. The involvement of complementary and alternative medicine practitioners in the marketing of stem cell therapies and stem cell-related interventions is understudied. This research explores the extent to which they are involved and collaborate with medical professionals. This knowledge will help with identifying and evaluating potential policy responses to this growing market. Systematic website analysis. Global. US and English-language bias due to methodology. Representations made on clinic websites in relation to practitioner types, stem cell therapies and their targets, stem cell-related interventions. Statements about stem cell therapies relating to evidence of inefficacy, limited evidence of efficacy, general procedural risks, risks specific to the mode of therapy, regulatory status, experimental or unproven nature of therapy. Use of hype language (eg, language that exaggerates potential benefits). 243 websites offered stem cell therapies. Many websites advertised stem cell transplantation from multiple sources, such as adipose-derived (112), bone marrow-derived (100), blood-derived (28), umbilical cord-derived (26) and others. Plant stem cell-based treatments and products (20) were also advertised. Purposes for and targets of treatment included pain, physical injury, a wide range of diseases and illnesses, cosmetic concerns, non-cosmetic ageing, sexual enhancement and others. Medical doctors (130), chiropractors (53) and naturopaths (44) commonly work in the clinics we found to be offering stem cell therapies. Few clinic websites advertising stem cell therapies included important additional information, including statements about evidence of inefficacy (present on only 12.76% of websites), statements about limited evidence of efficacy (18.93%), statements of

  16. The market dynamics of selective serotonin re-uptake inhibitors: a ...

    African Journals Online (AJOL)

    re-uptake inhibitors: a private sector study in South Africa. Afri Health ... the public and private sectors to reduce medicine costs, and increase ... Fig 1: Comparison between the market volume of generics vs. originators for the period June 2009 ...

  17. 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.

  18. The medicinal animal markets in the metropolitan region of Natal City, northeastern Brazil.

    Science.gov (United States)

    Oliveira, Eduardo S; Torres, Denise F; Brooks, Sharon E; Alves, Rômulo R N

    2010-07-06

    This study investigates the trade of animals for medicinal purposes in Natal metropolitan area, northeastern Brazil, to document which animal species are used, how and for what purposes. This study also discusses the implications of the use of zootherapeutics for wildlife conservation. Based on interviews with merchants of medicinal animals in all open fairs of the metropolitan region of Natal City, we calculated the informant consensus factor (ICF) to determine the consensus over which species are effective for particular ailments, as well as the species relative importance to determine the extent of potential utilization of each species. We describe the therapeutic effects of 23 animal species used medicinally. The zootherapeutical products sold commercially are used to treat 34 health problems that were classified into 14 broad categories. We also highlight those species valued for their effectiveness against a range of ailments. The highest ICF value (1.0) was cited for diseases of the circulatory system, which include relief of symptoms such as stroke, hemorrhage, varicose veins and edema. Our study indicated that the local population holds a great deal of ethnomedical knowledge about their local animal resources, and highlights the need for clinical investigations of these traditional remedies to test the safety and efficacy. The animal species identified in this study not only hold high medicinal value for local populations, but could potentially be a source of healing compounds that could aid pharmaceutical research. While the impact of these practices on animal populations is unknown, the high extractive value of these animal populations and the associated medicinal traditional knowledge, needs to be considered in any conservation strategy aimed at the faunistic resources of this area. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

  19. Markets and medicine: the politics of health care reform in Britain, Germany, and the United States

    National Research Council Canada - National Science Library

    Giaimo, Susan

    2002-01-01

    ...: The Limits of Markets in Health Care 193 Appendix: Information on Interviews and Methodology 225 Notes 233 Bibliography 263 Index 293 List of TablesTables I. Physicians' Earnings Relative to Other Occupations in the United Kingdom, Germany, and the United States, 1965-92 13 2. Physicians' Mean Gross Income in the United Kingdom, Germany, and...

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

    Science.gov (United States)

    Hollis, Aidan

    2002-12-01

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

  1. Evaluation of fungal bio burden and mycotoxins presence in irradiated samples of medicinal plants purchased from wholesale and retail market

    International Nuclear Information System (INIS)

    Aquino, Simone

    2007-01-01

    This present study evaluated the effect of gamma radiation on the fungal survival in packed medicinal plants, purchased from wholesale and retail market, in different period (0 and 30 days) after the treatment. Five kind of medicinal plants (Peumus boldus, Camellia sinensis, Maytenus ilicifolia, Paullinia cupana and Cassia angustifolia), were collected from different cities of Sao Paulo State, and submitted to irradiation treatment using a 60 Co source (type Gammacell 220) with doses of 5,0 kGy and 10 kGy and at dose rate of 3.0 kGy/h. Non-irradiated samples (control group) were used for fungal counts and serial dilutions from 10 -1 to 10 -6 of the samples were seeded in duplicates and plated using the surface culture method in Dichloran 18% Glycerol Agar (DG 18) and were counted after five days at 25 deg C. The control group revealed the presence of genera Aspergillus and Penicillium, which are known as toxigenic fungi and a few samples of control group were within the safety limits of World Health Organization (WHO, 1998) to medicinal plants. In response to resistance of ionizing treatment, in the dose of 5 kGy, it was observed that the genera Aspergillus, Phoma and Syncephalastrum were radio-resistant after the process (day 0 and 30th day). The treatment by gamma radiation was effective in decontamination of all irradiated samples of medicinal plants, after 30 days, with the dose of 10 kGy and kept of veiled conditions. It was not detected aflatoxins in samples of control group, even though these samples were heavily contaminated with Aspergillus flavus. (author)

  2. 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.

  3. 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.

  4. [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.

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

    Science.gov (United States)

    Zapatero Miguel, Pablo

    2015-01-01

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

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

    Science.gov (United States)

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

    2018-02-01

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

  7. 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.

  8. Efficient Generic Functional Programming

    NARCIS (Netherlands)

    Alimarine, A.; Smetsers, J.E.W.

    2005-01-01

    Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular data type. An instance on a specific type is generated by interpretation of the type's structure. A

  9. Optimizing Generic Functions

    NARCIS (Netherlands)

    Alimarine, A.; Smetsers, J.E.W.

    2004-01-01

    Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular type. An instance on a specific type is generated by interpretation of the type's structure. A direct

  10. [Role of psychiatry and psychotherapy in sexual medicine after introductory marketing of viagra].

    Science.gov (United States)

    Weig, W

    2000-03-01

    Sildenafil (Viagra) is a substance for the treatment of erectile dysfunction. Great expectations are connected with its introduction into the market. In this situation the multidimensionality in the control-mechanismus of the sexual reaction and of the satisfaction in the sexual experience are pointed out. These aspects affect the diagnostic and therapeutic competence of psychiatry and psychotherapy in a high degree. Efficient psycho-educative and psychotherapeutic ways of treatment for sexual dysfunction are available. Increased specific knowledge in this area is required by psychiatrists, medical psychotherapists and neuropsychiatrists.

  11. Intellectual Property Rights and Access to Medicines: International Trade Issues

    Science.gov (United States)

    2009-05-28

    the level of market-based incentives they offer for R&D. • Type I diseases (“chronic diseases”), such as cancer, diabetes , and cardiovascular... diabetes , and asthma may be subject to patents.44 Critics of the TRIPS Agreement maintain that implementation of the agreement will affect...customs authorities temporarily halted shipments of generic medicines manufactured in India and in transit to Colombia and Peru via the Netherlands

  12. Adjuvant radiotherapy after radical prostatectomy: A failure of marketing-based medicine?

    International Nuclear Information System (INIS)

    Shakespeare, Thomas P.

    2016-01-01

    Adjuvant radiotherapy for high-risk patients after radical prostatectomy has been shown to reduce local and metastatic failure, improve overall survival and improve quality of life (QOL). The evidence, based on three randomised studies and a meta-analysis, is so compelling that the national and internatioanl professional bodies, representing urologists and radiation oncologist alike, recommend that high-risk patients be offered immediate adjuvant radiotherapy. Despite this being the standard of care, few patients fo on to recive it. This paper looks at the possibilities of why this is so, highlighting that it could possibly be related to poor marketing, communication and delivery of health information to patients and professional alike. It concludes that we need a more coordinated way to increase utilisation of the gold standard adjuvant radiotherapy post-radical prostatectomy, perhaps learning some valuable lessons from the business community.

  13. 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.

  14. 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.

  15. Associations between generic substitution and patient-related factors

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette

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

  16. Brand versus generic dispensing trend for ciprofloxacin 500 mg, levofloxacin 500 mg, and moxifloxacin 400 mg (oral dosage forms) among pharmacies of Karachi, Pakistan.

    Science.gov (United States)

    Zehra, Fatima; Naqvi, Atta Abbas; Tasneem, Sumbul; Ahmad, Rizwan; Ahmad, Niyaz; Shamsi, Adnan Zia; Asghar, Naqiya Ali; Khan, Ghufran Ullah

    2017-01-01

    Pakistan spends 0.7% of its gross domestic product on health. The public sector health-care system provides services to 22% of population thus paving the way for a dominant private sector. Patients in Pakistan mostly pay their medical expenses directly, and 64% of the health expenditures are borne by the household. Expenditure on medicine constitutes 43% of the total household expenditure. A quantitative cross-sectional study was conducted in Karachi, Pakistan, for a month. It was aimed at gathering response from different pharmacies to understand the brand versus generic dispensing trend of ciprofloxacin 500 mg, levofloxacin 500 mg, and moxifloxacin 400 mg oral dosage forms. The study employed convenience sampling and used a survey checklist. The data gathered was entered in SPSS version 22. The mean price per tablet for ciprofloxacin brand and generic was reported at Pakistani Rupees (PKR) 48.44 and PKR 26.85, respectively. The trend for dispensing ciprofloxacin highlighted a split in the market between brand (51%) and generic (49%). For levofloxacin brand and generic, the price per tablet was reported at PKR 36.50 and PKR 36.15 respectively, and despite same price, the market was dominated by generic levofloxacin (92%). Due to a price difference between brand and generic moxifloxacin, i.e., PKR 129.44 and PKR 71.91, respectively, the market was mostly occupied by the generic form (75%). Pricing mechanism must be revisited, and the authorities should take stern actions against any illegitimate price hike. The surging burden of drug expenditure on poorer sections of the society must be addressed by the government on an urgent basis.

  17. Brand and generic medications: Are they interchangeable

    International Nuclear Information System (INIS)

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

    2008-01-01

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

  18. 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.

  19. 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....

  20. 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

  1. 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

    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. 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. 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. 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. Our findings provide an improved understanding of the ARV market that can help countries strengthen policy measures to increase their bargaining power in price negotiations and the use of TRIPS

  2. Medicine, market and communication: ethical considerations in regard to persuasive communication in direct-to-consumer genetic testing services.

    Science.gov (United States)

    Schaper, Manuel; Schicktanz, Silke

    2018-06-05

    Commercial genetic testing offered over the internet, known as direct-to-consumer genetic testing (DTC GT), currently is under ethical attack. A common critique aims at the limited validation of the tests as well as the risk of psycho-social stress or adaption of incorrect behavior by users triggered by misleading health information. Here, we examine in detail the specific role of advertising communication of DTC GT companies from a medical ethical perspective. Our argumentative analysis departs from the starting point that DTC GT operates at the intersection of two different contexts: medicine on the one hand and the market on the other. Both fields differ strongly with regard to their standards of communication practices and the underlying normative assumptions regarding autonomy and responsibility. Following a short review of the ethical contexts of medical and commercial communication, we provide case examples for persuasive messages of DTC GT websites and briefly analyze their design with a multi-modal approach to illustrate some of their problematic implications. We observe three main aspects in DTC GT advertising communication: (1) the use of material suggesting medical professional legitimacy as a trust-establishing tool, (2) the suggestion of empowerment as a benefit of using DTC GT services and (3) the narrative of responsibility as a persuasive appeal to a moral self-conception. While strengthening and respecting the autonomy of a patient is the focus in medical communication, specifically genetic counselling, persuasive communication is the normal mode in marketing of consumer goods, presuming an autonomous, rational, independent consumer. This creates tension in the context of DTC GT regarding the expectation and normative assessment of communication strategies. Our analysis can even the ground for a better understanding of ethical problems associated with intersections of medical and commercial communication and point to perspectives of analysis of

  3. 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.

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

    Science.gov (United States)

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

    2017-08-04

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

  5. Understanding Market Size and Reporting Gaps for Paediatric TB in Indonesia, Nigeria and Pakistan: Supporting Improved Treatment of Childhood TB in the Advent of New Medicines.

    Science.gov (United States)

    Coghlan, Renia; Gardiner, Elizabeth; Amanullah, Farhana; Ihekweazu, Chikwe; Triasih, Rina; Grzemska, Malgorzata; Sismanidis, Charalambos

    2015-01-01

    We sought to understand gaps in reporting childhood TB cases among public and private sector health facilities (dubbed "non-NTP" facilities) outside the network of national TB control programmes, and the resulting impact of under-reporting on estimates of paediatric disease burden and market demand for new medicines. Exploratory assessments were carried out in Indonesia, Nigeria and Pakistan, reaching a range of facility types in two selected areas of each country. Record reviews and interviews of healthcare providers were carried out to assess numbers of unreported paediatric TB cases, diagnostic pathways followed and treatment regimens prescribed. A total of 985 unreported diagnosed paediatric TB cases were identified over a three month period in 2013 in Indonesia from 64 facilities, 463 in Pakistan from 35 facilities and 24 in Nigeria from 20 facilities. These represent an absolute additional annualised yield to 2013 notifications reported to WHO of 15% for Indonesia, 2% for Nigeria and 7% for Pakistan. Only 12% of all facilities provided age and sex-disaggregated data. Findings highlight the challenges of confirming childhood TB. Diagnosis patterns in Nigeria highlight a very low suspicion for childhood TB. Providers note the need for paediatric medicines aligned to WHO recommendations. This study emphasises the impact of incomplete reporting on the estimation of disease burden and potential market size of paediatric TB medicines. Further studies on "hubs" (facilities treating large numbers of childhood TB cases) will improve our understanding of the epidemic, support introduction efforts for new treatments and better measure markets for new paediatric medicines.

  6. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

    Atanassow, F.; Clarke, D.; Jeuring, J.T.

    2003-01-01

    A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

  7. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

    Atanassow, F.; Clarke, D.; Jeuring, J.T.

    2007-01-01

    A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

  8. COMPETITION ON THE WHOLESALE MEDICATION DISTRIBUTION MARKET IN ROMANIA

    Directory of Open Access Journals (Sweden)

    Alina HAGIU

    2013-09-01

    Full Text Available Wholesale distribution of medicines in Romania was in the constant attention of the competition authority. In order to analyze the operation of the distribution system practiced in Romania, but also changes that may occur in this system on short and medium term, the Competition Council conducted a sector inquiry after which they found some malfunctioning mainly chained to distributors access to certain medications. Conducted on a sample of 23 pharmaceutical groups operating on the Romanian market and holding approximately 80% of the pharmaceutical market in Romania in 2009, the sector inquiry aimed at two objectives, namely: Legislation analysis with impact on the wholesale distribution of drugs; Market analysis of drug distribution.Following the findings of the high concentration of markets analyzed, due to significant market shares held by innovative drugs under investigation were analyzed also the penetration of generics in the market and the factors that led to this situation.

  9. Generic phytosanitary irradiation treatments

    International Nuclear Information System (INIS)

    Hallman, Guy J.

    2012-01-01

    The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies. - Highlights: ► The history of phytosanitary irradiation (PI) treatments is given. ► Generic PI treatments in use today are discussed. ► Suggestions for future research are presented. ► A dose of 250 Gy for most insects may suffice.

  10. Generic robot architecture

    Science.gov (United States)

    Bruemmer, David J [Idaho Falls, ID; Few, Douglas A [Idaho Falls, ID

    2010-09-21

    The present invention provides methods, computer readable media, and apparatuses for a generic robot architecture providing a framework that is easily portable to a variety of robot platforms and is configured to provide hardware abstractions, abstractions for generic robot attributes, environment abstractions, and robot behaviors. The generic robot architecture includes a hardware abstraction level and a robot abstraction level. The hardware abstraction level is configured for developing hardware abstractions that define, monitor, and control hardware modules available on a robot platform. The robot abstraction level is configured for defining robot attributes and provides a software framework for building robot behaviors from the robot attributes. Each of the robot attributes includes hardware information from at least one hardware abstraction. In addition, each robot attribute is configured to substantially isolate the robot behaviors from the at least one hardware abstraction.

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

    Science.gov (United States)

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

    2017-10-01

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

  12. Integration of generic issues

    International Nuclear Information System (INIS)

    Thatcher, D.

    1989-01-01

    The NRC has recognized the need to integrate generic issues (GIs). The GI process includes a number of phases, all of which should recognize the potential for overlap and conflict among related issues. In addition to the issues themselves, other related NRC and industry programs and activities need to be factored into the GI process. Integration has taken place, or is taking place, for a number of GIs. Each case of integration involves a specific set of circumstances and, as a result, the way in which integration proceeds can vary. This paper discusses the integration of issues in the generic issue process and provides a number of examples

  13. 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.

  14. Non-Timber Forest Products Marketing Systems and Market Players in Southwest Virginia: A Case Study of Craft, Medicinal and Herbal, Specialty Wood, and Edible Forest Products

    OpenAIRE

    Greene, Sarah Marsden

    1998-01-01

    Non-timber forest products (NTFPs) are important in rural southwest Virginia as a source of household sustenance and supplemental income. The trade in NTFPs from this region is centuries old and now helps supply growing worldwide demands. Although marketing is a vital part of optimizing the value of these products, it has been ignored in rural natural resource development. This research analyzes marketing systems for selected NTFPs in southwest Virginia by describing marketing chains, inter...

  15. 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 related to one or more of the three critical variables. Thirty-nine of these were assessed as being compliant with SA. Obtaining an SA per se was not associated with outcome (SA vs. no-SA: OR 0.96, 95% CI 0.49; 1.88, p = 0.92), but complying with SA was significantly associated with positive outcome (compliant with SA vs. no-SA: OR 14.71, 95% CI 1.95; 111.2; non-compliant with SA vs. no-SA: OR 0.17, 95% CI 0.06; 0.47, p 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 recommended to engage in

  16. Generic skills requirements (KSA model) towards future mechanical ...

    African Journals Online (AJOL)

    ... Statistics and Discriminant Analysis (DA) as required to achieve the objective of the study. This study will guide all future engineers, especially in the field of Mechanical Engineering in Malaysia to penetrate the job market according to the current market needs. Keywords: generic skills; KSA model; mechanical engineers; ...

  17. European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States.

    Science.gov (United States)

    Qu, Liping; Zou, Wenjun; Wang, YiTao; Wang, Mei

    2018-03-15

    The European Union (EU) has created a regulatory framework for herbal medicinal products (HMPs) since the enforcement of Directive 2004/24/EC. Substantial achievements have been made, with 1719 traditional use marketing registrations (TURs) and 859 well-established use marketing authorizations (WEU-MAs) for HMPs granted by the end of 2016. Apparently, the European regulation model has worked out well and in that the essential feature is the use of EU herbal monographs into those granted WEU-MAs and TURs. A systematic analysis of the European regulation model for HMPs and the EU herbal monograph's part of this model are undertaken to assist understanding of the EU legislation particularly for interested parties those from outside EU area, and afterwards, to help in decision-making in the HMPs registration in European market for pharmaceutical companies, as well as in the establishment of legislation in countries with strong traditional use of herbal remedies. A search of PubMed, ScienceDirect, the European Medicines Agency website and the Heads of Medicines Agencies website was conducted (up to December 2017), and the available information on regulation of HMPs in the EU was collected. The evaluation of applications by National Competent Authorities (NCAs) at a national level together with the assessment of EU monographs by the Committee on Herbal Medicinal Products (HMPC) at the European level constitute the European regulation framework for HMPs. As the scientific opinion about the safety and efficacy of HMPs from HMPC, the EU herbal monographs have been given a constitutional-based meaning to the TURs and WEU-MAs of HMPs and play a supportive function in the marketing procedure in Member States. The European framework has provided a powerful regulation model for harmonization of scientific assessment and facilitation of product marketing. For the pharmaceutical industries particularly those outside the EU, optimal use of the EU herbal monograph in their marketing

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

    OpenAIRE

    Bahram Ranjbarian; Ali Kazemi; Samira Shokrollahi

    2013-01-01

    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 medic...

  19. [The significance of introducing registry study in the post-marketing safety research for Chinese medicine and pharmacy].

    Science.gov (United States)

    Liao, Xing; Xie, Yan-Ming; Yang, Wei; Chang, Yan-Peng

    2014-03-01

    There is a new research model named 'registry study/patient registry' in Western medicine, which could be referred to by Chinese medicine researchers, such as active safety surveillance. This article will introduce registry study from different aspects as the developing history, features, and application in order to inform Chinese medicine researchers of future studies.

  20. 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.

  1. Generic clearance values

    International Nuclear Information System (INIS)

    Bossio, M.C.; Muniz, C.C.

    2009-01-01

    This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document 'Safety Reports Series Nr 44' of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (author)

  2. Generic Clearance Values

    International Nuclear Information System (INIS)

    Bossio, M.C.; Muniz, C.C.

    2010-01-01

    This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on the one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document Safety Reports Series 44 of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (authors) [es

  3. Generic phytosanitary irradiation treatments

    Science.gov (United States)

    Hallman, Guy J.

    2012-07-01

    The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies.

  4. Generic phytosanitary irradiation treatments

    Energy Technology Data Exchange (ETDEWEB)

    Hallman, Guy J [United States Department of Agriculture, Agricultural Research Service, Weslaco, TX (United States)

    2013-01-15

    The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies. (author)

  5. The generic strategy trap.

    Science.gov (United States)

    Miller, D

    1992-01-01

    Management experts claim that for a company to thrive, it must concentrate on a single generic strategy--on one thing it does better than its rivals. But specialization also has its disadvantages. The author suggests that a broader, mixed approach may be preferable.

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

    Science.gov (United States)

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

    2017-12-01

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

  7. 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 ...

  8. 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.

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

    Science.gov (United States)

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

    2013-01-01

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

  10. Generic Reed Solomon Encorder

    Directory of Open Access Journals (Sweden)

    Petrus Mursanto

    2006-11-01

    Full Text Available Reed Solomon (RS codes is a mechanism to detect and correct burst of errors in data transmission and storage systems. It provides a solid introduction to foundation mathematical concept of Galois Field algebra and its application. With the development of digital hardware technology, the RS concepts were brought into reality, i.e. the implementation of RS codec chips. This paper presents the development steps of a generic RS encoder using VHDL. The encoder is able to handle generic width of data, variable length of information, number of error as well as variable form of primitive polynomial and generator polynomial used in the system. The design has been implemented for FPGA chip Xilinx XC3S200-5FT256 and has a better performance than commercially available equivalent encoder.

  11. Generic safety documentation model

    International Nuclear Information System (INIS)

    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

  12. Is bioavailability altered in generic versus brand anticonvulsants?

    Science.gov (United States)

    Jankovic, Slobodan M; Ignjatovic Ristic, Dragana

    2015-03-01

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

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

    Science.gov (United States)

    Xanthopoulou, Sofia-Sotiria; Katsaliaki, Korina

    2018-01-01

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

  14. Generic maintenance immunosuppression in solid organ transplant recipients.

    Science.gov (United States)

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

    2011-11-01

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

  15. 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

  16. 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

  17. 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.

  18. Risks and opportunities for plastic surgeons in a widening cosmetic medicine market: future demand, consumer preferences, and trends in practitioners' services.

    Science.gov (United States)

    D'Amico, Richard A; Saltz, Renato; Rohrich, Rod J; Kinney, Brian; Haeck, Phillip; Gold, Alan H; Singer, Robert; Jewell, Mark L; Eaves, Felmont

    2008-05-01

    The American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery launched a joint Cosmetic Medicine Task Force to address the growing trend of non-plastic surgeons entering the cosmetic medicine field. The task force commissioned two surveys in 2007 to determine consumer attitudes about choosing cosmetic medicine providers and to learn about the cosmetic services that plastic surgeons offer. The first survey obtained responses from 1015 women who had undergone a cosmetic procedure or were considering having one within 2 years. The second survey obtained responses from 260 members of the two societies. Compared with other practitioners, plastic surgeons enjoy higher rates of satisfaction among their patients who undergo noninvasive procedures. Injectables present a particularly promising market for plastic surgeons. Half of consumers surveyed said they were very concerned about complications associated with injectables, and generally, the higher the perceived risk of the procedure, the higher the likelihood that a patient would choose a plastic surgeon to perform it. In addition, injectables were among the noninvasive treatments most frequently being considered by consumers. However, almost half of consumers said that if they had a positive experience with a non-plastic surgeon core provider for a noninvasive procedure, that physician would likely be their first choice for a surgical procedure. These findings suggest that plastic surgeons, and especially those who are building young practices, must expand their offerings of nonsurgical cosmetic services to remain at the core of the cosmetic medicine field.

  19. 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...

  20. Might generic OCs create contraceptive price war?

    Science.gov (United States)

    1987-02-01

    Genora 1/35 and 1/50, the 1st generic oral contraceptives (OCs) in the world, are now being marketed in the US. Clinicians interviewed by "Contraceptive Technology Update" (CTU) offer differing opinions as to what this new OC may mean in the marketplace. Products of Rugby Laboratories, the pills are copy products of Ortho Pharmaceutical's ON 1/35 and ON 1/50 formulations. Most clinicians believe that Genora's success or failure in the OC market depends on its eventual retail price. The price difference of $3-$4 may be sufficiently substantial for retailers to charge less for the generic OCs. If that is the case, many doctors may prescribe a pill which will save their patients $4/month. Dr. Mildred Hanson, a Minneapolis gynecologist/obstetrician, feels any cost savings from Genora will have a significant impact on the OC market. She suggests that the less expensive OCs will catch the attention of health maintenance organizations (HMOs) and the business of women who participate in such health plans. Yet James Burns, director of family planning services for the Hartford City Health Department, thinks that even a full-scale retail price war won't have much effect from a clinic standpoint. He reports that clinics are able to obtain contraceptive supplies rather inexpensively through the contracting system. Hanson also expressed doubt over the potential popularity of Genora 1/50 as clinical concerns about the effects of combined OCs on serum lipid levels and carbohydrate metabolism have resulted in a nationwide push toward OCs containing less than 50 micrograms of estrogen. He indicated concern that declines in pharmaceutical house products from pricing competition with generic pills might have a negative impact on contraceptive research and development. Dick Haskitt, director of business planning for Syntex Laboratories, Inc., who will produce the OCs for Rugby, reports that their market research shows that people are very interested in having a generic OC available

  1. 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

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

    Science.gov (United States)

    Beecroft, Grahame

    2007-01-01

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

  3. Marketing marketing

    NARCIS (Netherlands)

    dr. Karel Jan van Alsem

    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

  4. 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.

  5. How Abbott’s Fenofibrate Franchise Avoided Generic Competition

    Science.gov (United States)

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

    2013-01-01

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

  6. 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.

  7. 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.

  8. Further Validation of a Rapid Screening Semiquantitative Thin-Layer Chromatographic Method for Marketed Antimalarial Medicines for Adoption in Malawi

    Directory of Open Access Journals (Sweden)

    Dorcas Osei-Safo

    2018-01-01

    Full Text Available A recently developed semiquantitative thin-layer chromatographic (SQ-TLC assay has been employed in postmarketing surveillance of antimalarial medicines used in Malawi prior to HPLC assay. Both methods gave analogous results in a significant majority of the samples, with a good correlation (r = 0.9012 for the active pharmaceutical ingredients of the dosage forms assayed. Artemether-containing medicines had the highest percentage (92.67% of samples with comparable results for both assays. The lowest percentage (66.67% was observed in artesunate-containing medicines. The SQ-TLC method was validated for specificity, accuracy, precision, linearity, and stability according to the International Conference on Harmonisation guidelines, with the results falling within acceptable limits. For specificity, retention factor values of the test samples and reference standards were comparable, while accuracy and precision of 91.1 ± 5.7% were obtained for all samples. The method was linear in the range 1.0–2.0 µg/spot with a correlation coefficient of r = 0.9783. Stability tests also fell within acceptable limits. In this study, we present the validation of the SQ-TLC method and propose its adoption as a rapid screening tool for field estimation of the quality of antimalarial and other essential medicines in Malawi and other parts of the developing world prior to a more accurate HPLC assay.

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

    Science.gov (United States)

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

    2006-10-01

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

  10. 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

  11. 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…

  12. The Acquisition of Generic Skills of Culturally-Diverse Student Cohorts

    Science.gov (United States)

    Keneley, Monica; Jackling, Beverley

    2011-01-01

    The changing nature of higher education and the structure of graduate labour markets have increased emphasis on employability and graduate outcomes. Universities have responded to this changed environment by embedding generic skills in the curriculum. This paper examines the generic skills that students perceived they acquired in their accounting…

  13. 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

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

    Masri, Marwan

    2003-06-01

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

  16. Analysis of Medicine Prices in New Zealand and 16 European Countries.

    Science.gov (United States)

    Vogler, Sabine; Kilpatrick, Kate; Babar, Zaheer-Ud-Din

    2015-06-01

    To compare prices of medicines, both originators and generics, in New Zealand and 16 European countries. Ex-factory price data as of December 2012 from New Zealand and 16 European countries were compared for a basket of 14 medicines, most of which were at least partially funded by the state in the 17 countries. Five medicines had, at least in some countries, generic versions on the market whose prices were also analyzed. Medicine price data for the 16 European countries were provided by the Pharma Price Information service. New Zealand medicine prices were retrieved from the New Zealand Pharmaceutical Schedule. Unit prices converted into euro were compared at the ex-factory price level. For the 14 medicines surveyed, considerable price differences at the ex-factory price level were identified. Within the European countries, prices in Greece, Portugal, the United Kingdom, and Spain ranked at the lower end, whereas prices in Switzerland, Germany, Denmark, and Sweden were at the upper end. The results for New Zealand compared with Europe were variable. New Zealand prices were found in the lowest quartile for five medicines and in the highest quartile for seven other products. Price differences between the originator products and generic versions ranged from 0% to 90% depending on the medicine and the country. Medicine prices varied considerably between European countries and New Zealand as well as among the European countries. These differences are likely to result from national pricing and reimbursement policies. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  17. Medicinal plants from open-air markets in the State of Rio de Janeiro, Brazil as a potential source of new antimycobacterial agents.

    Science.gov (United States)

    Leitão, Fernanda; Leitão, Suzana G; de Almeida, Mara Zélia; Cantos, Jéssica; Coelho, Tatiane; da Silva, Pedro Eduardo A

    2013-09-16

    Several medicinal plants are traditionally traded in open-air markets in Rio de Janeiro State (Brazil) to treat tuberculosis (TB) and related symptoms. Conduct a survey in the open-air markets of 20 cities of Rio de Janeiro State to find medicinal plants that are popularly used to treat tuberculosis and other related diseases and assess their in vitro antimycobacterial activity. We used direct observation and semi-structured interviews and asked herbalists to list species (free listing) in order to gather data about the plant species most commonly used for lung problems. We calculated a Salience Index and acquired two species of "erva-de-passarinho" (mistletoe), Struthanthus marginatus and Struthanthus concinnus (Loranthaceae), commonly used to treat tuberculosis for a bioassay-guided isolation of the antimycobacterial active principles. Extracts, fractions and isolated compounds of both species were assayed in vitro against susceptible (H37Rv) and rifampicin-resistant (ATCC 35338) Mycobacterium tuberculosis strains. From the interviews, we generated a list of 36 plant species belonging to 12 families. The mistletoes Struthanthus marginatus and Struthanthus concinnus showed high Salience Index values among plants used to treat tuberculosis. Bioassay-guided fractionation of hexane extracts from both species led to the isolation and/or identification of steroids and terpenoids. The Minimum Inhibitory Concentration (MIC) of the extracts and isolated compounds ranged from 25 to 200 μg/mL. Some of the isolated compounds have been previously assayed against Mycobacterium tuberculosis, others are reported here for the first time (obtusifoliol: MIC H37Rv 50 μg/mL, MIC ATCC 35338 12.5 μg/mL; 3-O-n-acil-lup-20(29)-en-3β,7β,15α-triol: MIC H37Rv 200 μg/mL, MIC ATCC 35338 100 μg/mL). This study demonstrated the importance of ethnobotanical surveys in markets as a source for new drugs and also for scientific validation of folk medicine. © 2013 Elsevier Ireland Ltd. All

  18. 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 private sector QAACT availability were maintained or improved. In 2014/15, private sector QAACT availability was greater than 70% in Nigeria (84.3%), Kenya (70.5%), Tanzania (83.0%) and Uganda (77.1%), but only 11.2% in Madagascar. QAACT 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

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

    Science.gov (United States)

    Berndt, Ernst R; Murphy, Stephen J

    2018-01-01

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

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

    Science.gov (United States)

    Allavena, Clotilde; Jacomet, Christine; Pereira, Bruno; Morand-Joubert, Laurence; Bagheri, Haleh; Cotte, Laurent; Garaffo, Rodolphe; Gerbaud, Laurent; Dellamonica, Pierre

    2014-01-01

    Switching brand name medications to generics is recommended in France in the interest of cost effectiveness but patients and physicians are sometimes not convinced that switching is appropriate. Some antiretroviral (ARV) generics (ZDV, 3TC, NVP) have been marketed in France since 2013. A multicentric cross-sectional survey was performed in September 2013 to evaluate the perception of generics overall and ARV generics in physicians and HIV-infected patients and factors associated to their acceptability. Adult HIV outpatients were asked to complete a self-questionnaire on their perception of generics. Physicians completed a questionnaire on the acceptability of generics and ARV generics. Socio-demographic data, medical history and HIV history were collected. 116 physicians in 33 clinics (68% in University Hospital) included 556 patients (France-native 77%, active employment 59%, covered by social Insurance 100%, homosexual/bisexual contamination 47%, median HIV duration 13 years, hepatitis coinfection 16%, on ARV therapy 95%). Overall, patients accepted and had confidence in generics in 76% and 55% of the cases, respectively. Switching ARVs for generics was accepted by 44% of the patients but only by 17% if the pill burden was going to increase. 75% of the physicians would prescribe generics, but this decreased to only 26% if the combo had to be broken. The main reasons for non-prescription of generics were previous brand name ARV-induced side effects (35%), refusal of generics overall (37%), lack of understanding of generics (26%), risk of non-observance of treatment (44%), anxiety (47%) and depressive symptoms (25%). In multivariate analysis, factors associated with the acceptability of ARV generics in patients were the use of generics overall (p<0.001) and in physicians, the absence of concern regarding the drug efficacy (p<0.001) and being aware that the patient would accept generics overall (p=0.03) and ARV generics (p=0.04). No factors related to

  1. 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.

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

    DEFF Research Database (Denmark)

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

    2009-01-01

    The purpose of this paper is to find and describe a suitable software framework that can be used to help implement the concept of a Generic Virtual Power Plant in the future power system. The Generic Virtual Power Plant concept, along with the utilization of distributed energy resources, has many...... 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.......The purpose of this paper is to find and describe a suitable software framework that can be used to help implement the concept of a Generic Virtual Power Plant in the future power system. The Generic Virtual Power Plant concept, along with the utilization of distributed energy resources, has many...... 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...

  3. 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.

  4. 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.

  5. Marketing medicines: charting the rise of modern therapeutics through a systematic review of adverts in UK medical journals (1950-1980).

    Science.gov (United States)

    Green, A Richard; Haddad, Peter M; Aronson, Jeffrey K

    2018-02-14

    To examine how pharmaceutical products that were first marketed between 1950 and 1980 were promoted to physicians through advertisements and briefly review advertising regulations and accuracy of the advertisements in the light of modern knowledge. We systematically reviewed advertisements promoting drugs for specific therapeutic areas, namely central nervous system disorders (anxiety and sleep disorders, depression, psychoses, and Parkinson's disease), respiratory disorders, cardiovascular disorders, and gastrointestinal disorders. We examined about 800 issues of the British Medical Journal (1950-1980) and about 150 issues of World Medicine (1965-1984). Advertising material was minimally regulated until the mid-1970s. Many drugs were marketed with little preclinical or clinical knowledge and some with the expectation that prescribers would obtain further data. The peak of advertising occurred in parallel with the surge in the release of novel drugs during the 1960s, but declined markedly after the mid-1970s. Advertisements generally contained little useful prescribing information. The period we investigated saw the release of many novel pharmaceuticals in the therapeutic areas we examined, and many (or their class successors) still play important therapeutic roles, including benzodiazepines, tricyclic antidepressants, phenothiazines, levodopa, selective and non-selective β-adrenoceptor antagonists, thiazide diuretics, β-adrenoceptor agonists, and histamine H 2 receptor antagonists. Advertising pharmaceuticals in the BMJ and World Medicine in 1950-1980 was poorly regulated and often lacked rigour. However, advertisements were gradually modified in the light of increasing clinical pharmacological knowledge, and they reflect an exciting period for the introduction of many drugs that continue to be of benefit today. © 2018 The British Pharmacological Society.

  6. 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.

  7. Incidence of Pyrrolizidine Alkaloids in Herbal Medicines from German Retail Markets: Risk Assessments and Implications to Consumers.

    Science.gov (United States)

    Letsyo, Emmanuel; Jerz, Gerold; Winterhalter, Peter; Lindigkeit, Rainer; Beuerle, Till

    2017-12-01

    The occurrence of potentially toxic pyrrolizidine alkaloids (PAs) in herbal medicines (HMs) is currently intensely being discussed in Europe. Pyrrolizidine alkaloids, particularly the 1,2-unsaturated PAs, are undesired compounds in HMs due to their potential hepatotoxic and carcinogenic properties. In this study, 98 widely patronized HMs from six popular German retail supermarkets/drugstores, as well as from pharmacies, were analyzed by high-performance liquid chromatography-electrospray ionization-tandem mass spectrometry for the presence of PAs. The results showed that about 63% of the HMs were PA positive, whereas the average PA concentration of the samples was 201 μg/kg, the highest concentration of PAs (3270 μg/kg) was attributed to a product that was purchased from the pharmacy and contained Hypericum perforatum L. (St. John's Wort) as an active ingredient. In addition, H. perforatum-containing products were frequently contaminated with PAs from Echium spp., while both Cynara cardunculus L. products and fixed-combination products of Gentiana lutea L., Rumex acetosa L., Verbena officinalis L., Sambucus nigra L., and Primula veris L. products were commonly contaminated with PAs of Senecio spp. The study showed that H. perforatum, C. cardunculus, Urtica dioica L., and fixed-combination products were frequently contaminated with PA levels above the recommended values of both the German and European Medicines Agencies. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

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

    Science.gov (United States)

    Drozdowska, Aleksandra; Hermanowski, Tomasz

    2015-02-01

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

  9. Generic Drugs: Questions and Answers

    Science.gov (United States)

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

  10. Sun Exposure, Sun-Related Symptoms, and Sun Protection Practices in an African Informal Traditional Medicines Market.

    Science.gov (United States)

    Wright, Caradee Y; Reddy, Tarylee; Mathee, Angela; Street, Renée A

    2017-09-28

    Informal workers in African market trade have little formal protection against sun exposure. We aimed to examine sun exposure, sun-related symptoms, and sun protection practices in an informal occupational setting. Trained fieldworkers asked 236 workers in the Warwick Junction market about their workplace, skin and eye sensitivity and skin colour, symptoms faced at work during the summer due to heat, and preventive measures. Data were analyzed using univariate logistic regression to assess the effect of gender and the risk of experiencing symptoms to sun exposure in relation to pre-existing diseases and perception of sun exposure as a hazard. Of the 236 participants, 234 were Black African and 141 (59.7%) were female. Portable shade was the most commonly used form of sun protection (69.9%). Glare from the sun (59.7%) and excessive sweating (57.6%) were commonly reported sun-related health symptoms. The use of protective clothing was more prevalent among those who perceived sun exposure as a hazard ( p = 0.003). In an informal occupational setting, sun exposure was high. Protective clothing and portable shade to eliminate heat and bright light were self-implemented. Action by local authorities to protect informal workers should consider sun exposure to support workers in their efforts to cope in hot weather.

  11. Sun Exposure, Sun-Related Symptoms, and Sun Protection Practices in an African Informal Traditional Medicines Market

    Directory of Open Access Journals (Sweden)

    Caradee Y. Wright

    2017-09-01

    Full Text Available Informal workers in African market trade have little formal protection against sun exposure. We aimed to examine sun exposure, sun-related symptoms, and sun protection practices in an informal occupational setting. Trained fieldworkers asked 236 workers in the Warwick Junction market about their workplace, skin and eye sensitivity and skin colour, symptoms faced at work during the summer due to heat, and preventive measures. Data were analyzed using univariate logistic regression to assess the effect of gender and the risk of experiencing symptoms to sun exposure in relation to pre-existing diseases and perception of sun exposure as a hazard. Of the 236 participants, 234 were Black African and 141 (59.7% were female. Portable shade was the most commonly used form of sun protection (69.9%. Glare from the sun (59.7% and excessive sweating (57.6% were commonly reported sun-related health symptoms. The use of protective clothing was more prevalent among those who perceived sun exposure as a hazard (p = 0.003. In an informal occupational setting, sun exposure was high. Protective clothing and portable shade to eliminate heat and bright light were self-implemented. Action by local authorities to protect informal workers should consider sun exposure to support workers in their efforts to cope in hot weather.

  12. The Generic Data Capture Facility

    Science.gov (United States)

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

    1987-01-01

    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.

  13. 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.

  14. Hanford Generic Interim Safety Basis

    International Nuclear Information System (INIS)

    Lavender, J.C.

    1994-01-01

    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

  15. The Use of Herbal Medicine in Children

    OpenAIRE

    Suryawati, Suryawati; Suardi, Hijra Novia

    2015-01-01

    The herbal medicine has been widely used in children for the treatment of several symptoms and the prevention of diseases before accessing the hospital for professionals help. There are 3 kinds of marketed herbal medicine including empirical based herbal medicine (jamu), standardized herbal medicine (obat herbal terstandar) and clininically tested herbal medicine (fitofarmaka). This study aimed to investigate the utilization of the marketed herbal medicine along with non marketed ones which w...

  16. Generic drugs: myths, facts, and limitations

    Directory of Open Access Journals (Sweden)

    Antonio Marzo

    2012-10-01

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

  17. Generic Example Proving Criteria for All

    Science.gov (United States)

    Yopp, David; Ely, Rob; Johnson­-Leung, Jennifer

    2015-01-01

    We review literature that discusses generic example proving and highlight ambiguities that pervade our research community's discourse about generic example arguments. We distinguish between pedagogical advice for choosing good examples that can serve as generic examples when teaching and advice for developing generic example arguments. We provide…

  18. 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.

  19. 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

  20. Inflated medicine prices in Vietnam: a qualitative study.

    Science.gov (United States)

    Nguyen, Tuan Anh; Knight, Rosemary; Mant, Andrea; Razee, Husna; Brooks, Geoffrey; Dang, Thu Ha; Roughead, Elizabeth Ellen

    2017-06-01

    One third of the world's population lacks regular access to essential medicines partly because of the high cost of medicines. In Vietnam, the cost to patients of medicines was 47 times the international reference price for originator brands and 11 times the price for generic equivalents in the public sector. In this article, we report the results of a qualitative study conducted to identify the principal reasons for inflated medicine prices in Vietnam.Between April 2008 and December 2009, 29 semi-structured interviews were conducted with staff from pharmaceutical companies, private pharmacies, the Ministry of Health, and the Ministry of Finance of Vietnam. Study participants were recruited using a combination of purposive and snowball sampling techniques. Interviews were recorded, transcribed and coded using NVivo8® software and analyzed using a framework of structure-conduct-performance (SCP).Participants attributed high prices of originator medicines to a monopoly of supply. The prices of generic medicines were also considered to be excessive, reportedly due to the need to recoup the cost of financial inducements paid to prescribers and procurement officers. These inducements constituted a dominant cost component of the end price of generic medicines. Poor market intelligence about current world prices, as well as failure to achieve economies of scale because of unwarranted duplication in pharmaceutical production and distribution system were also factors contributing to high prices. This was reported to be further compounded by multiple layers in the supply chain and unregulated retail mark-ups.To address these problems a multifaceted approach is needed encompassing policy and legislative responses. Policy options include establishing effective monitoring of medicine quality assurance, procurement, distribution and use. Rationalization of the domestic pharmaceutical production and distribution system to achieve economies of scale is also required. Appropriate

  1. 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.

  2. 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...

  3. Generic Planning and Control of Automated Material Handling Systems: Practical Requirements Versus Existing Theroy.

    NARCIS (Netherlands)

    Haneyah, S.W.A.; Zijm, Willem H.M.; Schutten, Johannes M.J.; 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,

  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. 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.

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

    Science.gov (United States)

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

    2017-06-26

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

  8. 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.

  9. Testing properties of generic functions

    NARCIS (Netherlands)

    Jansson, P.; Jeuring, J.T.; Cabenda, L.; Engels, G.; Kleerekoper, J.; Mak, S.; Overeem, M.; Visser, Kees

    2007-01-01

    A datatype-generic function is a family of functions indexed by (the structure of) a type. Examples include equality tests, maps and pretty printers. Property based testing tools like QuickCheck and Gast support the de¯nition of properties and test-data generators, and they check if a

  10. Generic component failure data base

    International Nuclear Information System (INIS)

    Eide, S.A.; Calley, M.B.

    1992-01-01

    This report discusses comprehensive component generic failure data base which has been developed for light water reactor probabilistic risk assessments. The Nuclear Computerized Library for Assessing Reactor Reliability (NUCLARR) was used to generate component failure rates. Using this approach, most of the failure rates are based on actual plant data rather then existing estimates

  11. 'Genericism' in Danish welfare professions

    DEFF Research Database (Denmark)

    Larsen, Verner

    and skills in the basic disciplines of the professions also termed as disciplinary and procedural knowledge '. Thus the main research question for this paper is: What consequences do recent reform actions in Danish welfare education concerning generic competence have on developing professional knowledge...

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

    Science.gov (United States)

    Toumi, Mondher; Rémuzat, Cécile

    2017-01-01

    ; (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.

  13. Generic qualitative research: a design for qualitative research in emergency care?

    OpenAIRE

    Cooper, S; Endacott, R

    2007-01-01

    The frequency of qualitative studies in the Emergency Medicine Journal, while still low, has increased over the last few years. All take a generic approach and rarely conform to established qualitative approaches such as phenomenology, ethnography and grounded theory. This generic approach is no doubt selected for pragmatic reasons but can be weakened by a lack of rigor and understanding of qualitative research. This paper explores qualitative approaches and then focuses on “best practice” fo...

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

    OpenAIRE

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

    2013-01-01

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

  15. 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

    , 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. 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.

  16. Decision in the matter of a generic hearing in respect to market issues and conduct related to the sale of gas and customer services in the natural gas industry in New Brunswick; Decision en l'affaire concernant une audience generale en ce qui touche les preoccupations du marche et la conduite relative a la vente de gaz et de services a la clientele dans l'industrie du gaz naturel au Nouveau-Brunswick

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-09-02

    In response to changes in the Gas Distribution Act and the Gas Distributor Marketing Regulation, the New Brunswick Board of Commissioners of Public Utilities (Board), issued an order in June 2003 for a generic hearing regarding the sale of gas and customer services in the natural gas industry in New Brunswick. The purpose of the hearing was to have an open discussion among intervenors regarding several issues, such as whether the Code of Conduct provides fair and adequate rules for marketers; should Enbridge Gas New Brunswick (EGNB) be required to follow rules similar to the Code of Conduct; the requirements surrounding letters of credit; the Board's decision on Rules and Regulations regarding the billing conduct of gas distributors and marketers; the information that should be provided by a gas marketer or a distributor to the customer before the customer enters into an agreement for the supply of gas; the need for information on price volatility; the need for EGNB to notify potential customers of all possible suppliers of gas; the removal of automatic renewal clauses from gas retailers' contracts; how the Board should determine if prices are reasonably and sufficiently competitive; financial reporting requirements; the role of the Board in response to customer complaints regarding the sale of gas by a distributor; and, the Board's action regarding Enbridge Atlantic's plan to exit the New Brunswick market. This report provided the response to these issues by 10 intervenors.

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

    Science.gov (United States)

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

    2014-01-01

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

  18. 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

  19. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2006-01-01

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

  20. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2006-01-01

    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

  1. Proceedings Workshop on Generic Programming (WGP2000)

    NARCIS (Netherlands)

    Jeuring, J.T.

    2000-01-01

    This report contains the papers selected for presentation at the 2nd Workshop on Generic Programming (WGP2000), which was held on July 6, 2000 in Ponte de Lima, Portugal. Generic programming is about making programs more adaptable by making them more general. Generic programs often embody

  2. Nuclear medicine

    International Nuclear Information System (INIS)

    Casier, Ph.; Lepage, B.

    1998-01-01

    Except for dedicated devices for mobile nuclear cardiology for instance, the market is set on variable angulation dual heads cameras. These cameras are suited for all general applications and their cost effectiveness is optimized. Now, all major companies have such a camera in their of products. But, the big question in nuclear medicine is about the future of coincidence imaging for the monitoring of treatments in oncology. Many companies are focused on WIP assessments to find out the right crustal thickness to perform both high energy FDG procedures and low energy Tc procedures, with the same SPECT camera. The classic thickness is 3/8''. Assessments are made with 1/2'', 5/8'' or 3/4'' crystals. If FDG procedures proved to be of great interest in oncology, it may lead to the design of a dedicated SPECT camera with a 1'' crustal. Due to the short half of FDG, it may be the dawning of slip ring technology. (e.g. Varicam from Elscint). The three small heads camera market seems to be depressed. Will the new three large heads camera unveiled by Picker, reverse that trend? The last important topic in nuclear medicine is the emergence of new flat digital detectors to get rid of the old bulky ones. Digirad is the first company to manufacture a commercial product based on that technology. Bichron, Siemens and General Electric are working on that development, too. But that technology is very expensive and the market for digital detection in nuclear medicine is not as large as the market in digital detection in radiology. (author)

  3. 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.

  4. Endogenous versus exogenous generic reference pricing for pharmaceuticals.

    Science.gov (United States)

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

    2017-12-01

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

  5. 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 …

  6. 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...

  7. [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.

  8. 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. © 2016 The Authors Developing World Bioethics Published by John Wiley & Sons Ltd.

  9. Automated analysis in generic groups

    Science.gov (United States)

    Fagerholm, Edvard

    This thesis studies automated methods for analyzing hardness assumptions in generic group models, following ideas of symbolic cryptography. We define a broad class of generic and symbolic group models for different settings---symmetric or asymmetric (leveled) k-linear groups --- and prove ''computational soundness'' theorems for the symbolic models. Based on this result, we formulate a master theorem that relates the hardness of an assumption to solving problems in polynomial algebra. We systematically analyze these problems identifying different classes of assumptions and obtain decidability and undecidability results. Then, we develop automated procedures for verifying the conditions of our master theorems, and thus the validity of hardness assumptions in generic group models. The concrete outcome is an automated tool, the Generic Group Analyzer, which takes as input the statement of an assumption, and outputs either a proof of its generic hardness or shows an algebraic attack against the assumption. Structure-preserving signatures are signature schemes defined over bilinear groups in which messages, public keys and signatures are group elements, and the verification algorithm consists of evaluating ''pairing-product equations''. Recent work on structure-preserving signatures studies optimality of these schemes in terms of the number of group elements needed in the verification key and the signature, and the number of pairing-product equations in the verification algorithm. While the size of keys and signatures is crucial for many applications, another aspect of performance is the time it takes to verify a signature. The most expensive operation during verification is the computation of pairings. However, the concrete number of pairings is not captured by the number of pairing-product equations considered in earlier work. We consider the question of what is the minimal number of pairing computations needed to verify structure-preserving signatures. We build an

  10. Present market for nuclear energy

    International Nuclear Information System (INIS)

    Marzo, M.A.S.

    1987-01-01

    The present market for nuclear energy is present since nuclear production and electric power generation to the utilization of radioisotopes in medicine and biology. Some data about the main world suppliers to this market are shown. (E.G.) [pt

  11. Aquisição de medicamentos genéricos em município de médio porte Adquisición de medicamentos genéricos en municipio de medio porte Procurement of generic medicines in a medium size municipality

    Directory of Open Access Journals (Sweden)

    Gabriela Bevilacqua

    2011-06-01

    . RESULTS: In 2007 and 2008 respectively, 2.6% and 56.9% of items failed. Among medicine purchases, 60.0% were increased and 29.3% decreased from 2008 to 2007.The total procurement costs for 150 medicines, considering per unit costs and average annual consumption was R$ 2,288,120.00 (2007 and R$ 4,270,425.00 (2008. CONCLUSIONS: The requirement for bioequivalence and/or bioavailability tests increased costs by more than 100% for the basic pharmaceutical services component. There is a need to discuss Generic Medicine Policies to agree with Pharmaceutical Assistance Policies and the National Essential Medicines Report.

  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

    2015-01-01

    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 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. PMID:26195933

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

    Science.gov (United States)

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

    2015-07-06

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

  14. 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.

  15. Generic Safety Requirements for Developing Safe Insulin Pump Software

    Science.gov (United States)

    Zhang, Yi; Jetley, Raoul; Jones, Paul L; Ray, Arnab

    2011-01-01

    Background The authors previously introduced a highly abstract generic insulin infusion pump (GIIP) model that identified common features and hazards shared by most insulin pumps on the market. The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for insulin pump software. Together, these two publications can serve as a basis for discussing insulin pump safety in the diabetes community. Methods In our previous work, we established a generic insulin pump architecture that abstracts functions common to many insulin pumps currently on the market and near-future pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work presented in this article. Results Generic safety requirements for the GIIP model are presented, as appropriate, in parameterized format to accommodate clinical practices or specific insulin pump criteria important to safe device performance. Conclusions We believe that there is considerable value in having the diabetes, academic, and manufacturing communities consider and discuss these generic safety requirements. We hope that the communities will extend and revise them, make them more representative and comprehensive, experiment with them, and use them as a means for assessing the safety of insulin pump software designs. One potential use of these requirements is to integrate them into model-based engineering (MBE) software development methods. We believe, based on our experiences, that implementing safety requirements using MBE methods holds promise in reducing design/implementation flaws in insulin pump development and evolutionary processes, therefore improving

  16. GLAD: a generic lattice debugger

    International Nuclear Information System (INIS)

    Lee, M.J.

    1992-01-01

    Today, numerous simulation and analysis codes exist for the design, commission, and operation of accelerator beam lines. There is a need to develop a common user interface and database link to run these codes interactively. This paper will describe a proposed system, GLAD (Generic LAttice Debugger), to fulfill this need. Specifically, GLAD can be used to find errors in beam lines during commissioning, control beam parameters during operation, and design beam line optics and error correction systems for the next generation of linear accelerators and storage rings. (author)

  17. Generic maximum likely scale selection

    DEFF Research Database (Denmark)

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

    2007-01-01

    in this work is on applying this selection principle under a Brownian image model. This image model provides a simple scale invariant prior for natural images and we provide illustrative examples of the behavior of our scale estimation on such images. In these illustrative examples, estimation is based......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...

  18. Disponibilidade no setor público e preços no setor privado: um perfil de medicamentos genéricos em diferentes regiões do Brasil Availability of generic drugs in the public sector and prices in the private sector in different regions of Brazil

    Directory of Open Access Journals (Sweden)

    Elaine Silva Miranda

    2009-10-01

    Full Text Available Foi realizado estudo para identificar perfil de preços e disponibilidade de medicamentos segundo tipo de provedor, nas cinco regiões do país, para uma lista de medicamentos utilizados no tratamento de doenças prevalentes na população. Utilizou-se a metodologia de avaliação de preços proposta pela Organização Mundial da Saúde (OMS pela Ação Internacional para a Saúde (AIS, adaptada para o cenário brasileiro. A análise evidenciou que no setor público há mais medicamentos similares do que genéricos em todas as regiões. Para a maioria dos medicamentos (71,4% a disponibilidade de genéricos foi menor que 10%. No setor privado, a média do número de diferentes de versões genéricas encontradas nos pontos de venda foi muito inferior ao número de versões existentes no mercado. A análise mostrou correlação positiva entre o número de genéricos comercializados, ou encontrados no ponto de venda, e variação de preços em relação ao preço máximo ao consumidor. Estima-se que medicamentos genéricos estejam competindo em preço entre si e com similares, mas não com medicamentos de referência.A study to identify availability and prices of medicines, according to type of provider, was conducted in the five regions of Brazil. A list of medicines to treat prevalent diseases was investigated, using the medicines price methodology developed by the World Health Organization and Health Action International, adapted for Brazil. In the public sector, bioequivalent (vis-à-vis reference brand generics are less available than multisource products. For most medicines (71.4%, the availability of bioequivalent generics was less than 10%. In the private sector, the average number of different bioequivalent generic versions in the outlets was far smaller than the number of versions on the market. There was a positive correlation between the number of generics on the market, or those found at outlets, and the price variation in bioequivalent

  19. Measuring performance in off-patent drug markets: a methodological framework and empirical evidence from twelve EU Member States.

    Science.gov (United States)

    Kanavos, Panos

    2014-11-01

    This paper develops a methodological framework to help evaluate the performance of generic pharmaceutical policies post-patent expiry or after loss of exclusivity in non-tendering settings, comprising five indicators (generic availability, time delay to and speed of generic entry, number of generic competitors, price developments, and generic volume share evolution) and proposes a series of metrics to evaluate performance. The paper subsequently tests this framework across twelve EU Member States (MS) by using IMS data on 101 patent expired molecules over the 1998-2010 period. Results indicate that significant variation exists in generic market entry, price competition and generic penetration across the study countries. Size of a geographical market is not a predictor of generic market entry intensity or price decline. Regardless of geographic or product market size, many off patent molecules lack generic competitors two years after loss of exclusivity. The ranges in each of the five proposed indicators suggest, first, that there are numerous factors--including institutional ones--contributing to the success of generic entry, price decline and market penetration and, second, MS should seek a combination of supply and demand-side policies in order to maximise cost-savings from generics. Overall, there seems to be considerable potential for faster generic entry, uptake and greater generic competition, particularly for molecules at the lower end of the market. Copyright © 2014. Published by Elsevier Ireland Ltd.

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

    Science.gov (United States)

    Kohli, Erol; Buller, Allison

    2013-02-01

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

  1. Increased Topical Generic Prices by Manufacturers: An Isolated Trend or Worrisome Future?

    Science.gov (United States)

    Bhatt, Mehul D; Bhatt, Birju D; Dorrian, James T; McLellan, Beth N

    2018-03-12

    There is limited data regarding generic medication prices. Recent studies have shown price changes at the retail level, but much is not known about the pharmaceutical supply chain or price changes at the manufacturer level. We sought to examine the extent of price changes for topical generic medications. A comprehensive review of average wholesale prices (AWP) and manufacturers of topical generics and available corresponding branded medications was conducted for 2005 and 2016. A total of 51 topical chemical entities were examined. Between 2005 and 2016, the AWP of topical generics increased by 273% and the AWP of topical branded increased by 379%. The topical generic with the most price change increased by 2529%. Eight of the top twenty topical generics with the highest increase in AWP also had an increase in the number of manufacturers. These findings are not generalizable to medications used in other areas of medicine CONCLUSIONS: Topical generic prices are rapidly increasing at the manufacturer level. Copyright © 2018. Published by Elsevier Inc.

  2. Prioritization of generic safety issues

    International Nuclear Information System (INIS)

    Emrit, R.; Minners, W.; VanderMolen, H.

    1983-12-01

    This report presents the priority rankings for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The report focuses on the prioritization of generic safety issues. Issues primarily concerned with the licensing process or environmental protection and not directly related to safety have been excluded from prioritization. The prioritized issues include: TMI Action Plan items under development; previously proposed issues covered by Task Action Plans, except issues designated at Unresolved Safety Issues (USIs) which had already been assigned high priority; and newly-proposed issues. Future supplements to this report will include the prioritization of additional issues. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolutions of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative

  3. Generic communications index: User's manual

    International Nuclear Information System (INIS)

    Dean, R.S.; Steinbrecher, D.H.; Hennick, A.

    1987-12-01

    This report is a manual for providing information required to use a special computer program developed by the NRC for indexing generic communications. The program is written in a user-friendly menu driven form using dBASE III programming language. It facilitates use of the required dBASE III search and sort capabilities to access records in a database called Generic Communications Index. This index is made up of one record each for all bulletins, circulars, and information notices, including revisions and supplements, from 1971, when such documentation started, through 1986 (or to the latest update). The program is designed for use by anyone modestly acquainted with the general use of IBM-compatible personal computers. The manual contains both a brief overview and a detailed description of the program, as well as detailed instructions for getting started using the program on a personal computer with either a two-floppy disk or a hard disk system. Included at the end are a brief description of how to handle problems which might occur, and notes on the makeup of the program and database files for help in adding records of communications for future years

  4. 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.

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

    Science.gov (United States)

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

    2013-07-01

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

  6. To Market, To Market--Careers in the Online Industry. . .Fifth in a Series.

    Science.gov (United States)

    Kremin, Michael C.

    1985-01-01

    Reviews demand for marketing personnel in online industry and provides brief descriptions of generic positions which include information on background and experience needed: vice president of marketing, sales manager, sales representative, advertising manager, product manager, marketing research manager, distribution manager, service manager,…

  7. 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.

  8. 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. 

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

    Science.gov (United States)

    Sun, Jing

    2013-05-01

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

  10. Nuclear Medicine

    Science.gov (United States)

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

  11. Liquidity in the Dutch wholesale electricity market

    International Nuclear Information System (INIS)

    Newbery, D.; Von der Fehr, N.H.; Van Damme, E.

    2003-05-01

    Industry concerns over perceived reductions in the liquidity of the Dutch wholesale electricity market led the DTe to ask the Market Surveillance Committee (MSC) to examine recent developments. This report starts with a generic examination of wholesale power markets and liquidity and its measurement. An overview of the Dutch wholesale electricity market and its constituent segments follows together with a summary of events and opinions connected to liquidity that have been reported in the trade press. Sources of information on market liquidity are then reviewed. Participation in the market is analysed before examining each market segment and this analysis and the earlier sections are then drawn together in conclusions and recommendations

  12. Generic Hurricane Extreme Seas State

    DEFF Research Database (Denmark)

    Wehmeyer, Christof; Skourup, Jesper; Frigaard, Peter

    2012-01-01

    Extreme sea states, which the IEC 61400-3 (2008) standard requires for the ultimate limit state (ULS) analysis of offshore wind turbines are derived to establish the design basis for the conceptual layout of deep water floating offshore wind turbine foundations in hurricane affected areas....... Especially in the initial phase of floating foundation concept development, site specific metocean data are usually not available. As the areas of interest are furthermore not covered by any design standard, in terms of design sea states, generic and in engineering terms applicable environmental background...... data is required for a type specific conceptual design. ULS conditions for different return periods are developed, which can subsequently be applied in siteindependent analysis and conceptual design. Recordings provided by National Oceanic and Atmospheric Administration (NOAA), of hurricanes along...

  13. 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...... to identify potential issues and barriers, henceforth mentioned as challenges, connected with the introduction of the generic virtual power plant concept. In this paper, three use case scenarios will show how each of these challenges can be overcome by the proposed solution framework. The use case scenarios...

  14. 76 FR 57767 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-16

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors AGENCY: Nuclear Regulatory Commission... FR 54507), that requested public comment on Draft NRC Generic Letter 2011- XX: Seismic Risk...

  15. 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.

  16. Generic versus brand-name North American topical glaucoma drops.

    Science.gov (United States)

    Mammo, Zaid N; Flanagan, John G; James, David F; Trope, Graham E

    2012-02-01

    To determine whether brand-name glaucoma drops differ from generic equivalents in bottle design, viscosity, surface tension, and volume in North America. Experimental study. We studied 5 bottles each of 11 kinds of glaucoma drops. Density-based calculations of drop volume were assessed using 0.1 mg analytic balance. Viscosity was measured using rotational rheometery. Bottle tip diameter was measured using 0.05 mm Vernier calipers. Surface tension was measured using a Fisher Scientific (Ottawa, ON) tensiometer. For the American brand-name Timoptic XE, the average drop volume was 38 ± 3.1 μL versus 24 ± 1.5 μL of Timolol GFS (p brand-name Timoptic XE, the average drop volume was 42 ± 4.0 μL versus 25 ± 2 μL of timolol maleate EX (p brand-name Timoptic drop volume was 28 ± 1.4 μL versus 35 ± 1.9 μL Apo-Timop (p brand-name Timoptic delivered significantly smaller drop volumes than generic Apo-Timop. Careful consideration should be given to drop viscosity and bottle design when generic ophthalmic products are evaluated for interchangeability and market entry. Copyright © 2012 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

  17. 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.

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

    Science.gov (United States)

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

    2014-01-01

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

  19. Generic planning and control of automated material handling systems : practical requirements versus existing theory

    NARCIS (Netherlands)

    Haneyah, S.W.A.; Schutten, Johannes M.J.; Schuur, Peter; Zijm, Willem H.M.

    2013-01-01

    This paper discusses the problem to design a generic planning and control architecture for utomated material handling systems (AMHSs). We illustrate the relevance of this research direction, and then address three different market sectors where AMHSs are used, i.e., baggage handling, distribution,

  20. 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. Copyright © 2011 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

  1. A Generic Approach to Parameter Control

    NARCIS (Netherlands)

    Karafotias, G.; Smit, S.K.; Eiben, A.E.

    2012-01-01

    On-line control of EA parameters is an approach to parameter setting that offers the advantage of values changing during the run. In this paper, we investigate parameter control from a generic and parameter-independent perspective. We propose a generic control mechanism that is targeted to

  2. 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

  3. HTGR generic technology program plan (FY 80)

    International Nuclear Information System (INIS)

    1980-01-01

    Purpose of the program is to develop base technology and to perform design and development common to the HTGR Steam Cycle, Gas Turbine, and Process Heat Plants. The generic technology program breaks into the base technology, generic component, pebble-bed study, technology transfer, and fresh fuel programs

  4. South African patient's acceptance of generic drugs

    African Journals Online (AJOL)

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

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

    Science.gov (United States)

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

    2018-06-01

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

  6. Price and availability survey of essential medicines in the Harare ...

    African Journals Online (AJOL)

    their innovator and/or generic equivalents) in both private retail and public pharmacies. Setting: Private and public sector retail pharmacies in Harare metropolitan province, Zimbabwe. Materials and Methods: Forty medicines were selected for ...

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

    Science.gov (United States)

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

    2003-01-01

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

  8. 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.

  9. Generic Local Hamiltonians are Gapless

    Science.gov (United States)

    Movassagh, Ramis

    2017-12-01

    We prove that generic quantum local Hamiltonians are gapless. In fact, we prove that there is a continuous density of states above the ground state. The Hamiltonian can be on a lattice in any spatial dimension or on a graph with a bounded maximum vertex degree. The type of interactions allowed for include translational invariance in a disorder (i.e., probabilistic) sense with some assumptions on the local distributions. Examples include many-body localization and random spin models. We calculate the scaling of the gap with the system's size when the local terms are distributed according to a Gaussian β orthogonal random matrix ensemble. As a corollary, there exist finite size partitions with respect to which the ground state is arbitrarily close to a product state. When the local eigenvalue distribution is discrete, in addition to the lack of an energy gap in the limit, we prove that the ground state has finite size degeneracies. The proofs are simple and constructive. This work excludes the important class of truly translationally invariant Hamiltonians where the local terms are all equal.

  10. Generic physical protection logic trees

    International Nuclear Information System (INIS)

    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

  11. 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.

  12. Generic theory for channel sinuosity.

    Science.gov (United States)

    Lazarus, Eli D; Constantine, José Antonio

    2013-05-21

    Sinuous patterns traced by fluid flows are a ubiquitous feature of physical landscapes on Earth, Mars, the volcanic floodplains of the Moon and Venus, and other planetary bodies. Typically discussed as a consequence of migration processes in meandering rivers, sinuosity is also expressed in channel types that show little or no indication of meandering. Sinuosity is sometimes described as "inherited" from a preexisting morphology, which still does not explain where the inherited sinuosity came from. For a phenomenon so universal as sinuosity, existing models of channelized flows do not explain the occurrence of sinuosity in the full variety of settings in which it manifests, or how sinuosity may originate. Here we present a generic theory for sinuous flow patterns in landscapes. Using observations from nature and a numerical model of flow routing, we propose that flow resistance (representing landscape roughness attributable to topography or vegetation density) relative to surface slope exerts a fundamental control on channel sinuosity that is effectively independent of internal flow dynamics. Resistance-dominated surfaces produce channels with higher sinuosity than those of slope-dominated surfaces because increased resistance impedes downslope flow. Not limited to rivers, the hypothesis we explore pertains to sinuosity as a geomorphic pattern. The explanation we propose is inclusive enough to account for a wide variety of sinuous channel types in nature, and can serve as an analytical tool for determining the sinuosity a landscape might support.

  13. Generic adversary characteristics: summary report

    International Nuclear Information System (INIS)

    Stewart, J.B. Jr.; Davidson, J.J.; Jones, H.B.; Fulwiler, C.H.; Mullen, S.A.

    1978-07-01

    The adversaries studied were found to be complex, often unpredictable, and dynamic. The adversary typically goes through a complex decision-making process between the time a potential target is identified and the moment the decision to act is made. This study analyzes the adversary characteristics, and the following conclusions are made: one of the least likely methods of attack is an overt armed assault. Terrorists and psychotics depend upon a high degree of personal dedication. No single generic adversary group or individual exhibits strength in every characteristic. Physical danger appears to have some deterrent effect on all adversaries except the psychotics. Organized and professional criminals often try to recruit insiders. Disoriented persons, white-collar criminals, and disgruntled employees tend to operate as insiders. Professional criminals, many terrorist groups, some extremist protest groups, and certain disoriented persons plan carefully before initiating a criminal mission. Organized crime and miscellaneous criminal adversaries rely on deception and ruse to bypass security. After the decision to commit a crime, the resources deployed by terrorists or organized criminals will be a function of their perception of the operational requirements of the crime. The nature of ''threat'' is dynamic; adversary behavior and capability appear to be related to prevailing political, economic, and social conditions

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

    Science.gov (United States)

    Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo

    2004-06-01

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

  15. International Isotopes Markets

    Directory of Open Access Journals (Sweden)

    Stanislaw Z. Zhiznin

    2016-01-01

    Full Text Available The paper studies world markets of stable and radioactive isotopes. Isotopes have found various applications in science, industry, agriculture and other sectors of the economy, but especially - in medicine. Nuclear medicine is developing intensively all over the world thanks to the success in the treatment of various diseases with the help of radioactive pharmaceuticals (radiopharmaceuticals. The article uses empirical data from a forecast study of the global radiopharmaceuticals market made in 2015 by a research company «Markets and Markets» for the European, North American and global markets. The paper also analyzes the statistical data on the global export and import of natural uranium, enriched and depleted uranium, plutonium, thorium and some stable isotopes of non-medical purposes, presented by a company «Trend economy» in 2014. Despite a unique industrial base for the production of isotopes created in the Soviet Union Russia occupies a modest position on the world market of nuclear medicine except for certain areas. More than 80% of isotopes, produced in USSR were consumed domestically, the export of the stable and radioactive isotopes was in equal proportions. Now the country's domestic radiopharmaceuticals market is poorly developed. To radically change the situation, it is necessary to carry out reforms that stimulate the development of nuclear medicine.

  16. 78 FR 22553 - Generic Drug Facilities, Sites, and Organizations

    Science.gov (United States)

    2013-04-16

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

  17. 78 FR 59911 - Generic Information Collection for Land Management Planning

    Science.gov (United States)

    2013-09-30

    ... DEPARTMENT OF AGRICULTURE Forest Service Generic Information Collection for Land Management... organizations on the proposed information collection, Generic Information Collection for Land Management... related to forest management. The intent of this generic information collection request (ICR) is to...

  18. 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.

    NARCIS (Netherlands)

    van der Gronde, T.; Uyl-de Groot, Carin A; Pieters, A.H.L.M.

    2017-01-01

    Context. 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. Method. A systematic review of Pubmed, the Financial Times,

  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

    NARCIS (Netherlands)

    Gronde, T.V. (Toon van der); C.A. Uyl-de Groot (Carin); Pieters, T. (Toine)

    2017-01-01

    markdownabstractCONTEXT: 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. METHOD: A systematic review of Pubmed, the

  20. A multicenter experience with generic tacrolimus conversion.

    Science.gov (United States)

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

    2011-09-27

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

  1. [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.

  2. 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. Copyright © 2012 Elsevier Inc. All rights reserved.

  3. 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

  4. The regulation of herbal medicines in Australia

    International Nuclear Information System (INIS)

    Briggs, David R.

    2002-01-01

    Complementary medicines, including herbal medicines in Australia are regulated under therapeutics goods legislation. Based on risk, Australia has developed a two tiered approach to the regulation of therapeutic goods. Listed medicines are considered to be of lower risk than Registered medicines. Most, but not all, complementary medicines are Listed medicines. Managing the risk associated with therapeutic goods, including complementary medicines, is exerted through the processes of licensing of manufacturers; pre-market assessment of products; and post-market regulatory activity. Herbal medicines may be associated with low or high risk depending on the toxicity of ingredients, proposed dosage, appropriateness of the indications and claims for self-diagnosis and management and the potential for adverse reactions. Registered medicines are individually evaluated for safety, quality and efficacy before they are released onto the market. Listed medicines are individually assessed by the Therapeutic Goods Administration for compliance with legislation, they are not evaluated before release. They may only be formulated from ingredients that have undergone pre-market evaluation for safety and quality and are considered low risk. Listed complementary medicines may only carry indications and claims for the symptomatic relief of non-serious conditions, health maintenance, health enhancement and risk reduction. An important feature of risk management in Australia is that early market access for low risk complementary medicines is supported by appropriate post-market regulatory activity

  5. Molecularly Imprinted Polymer Technology: A Powerful, Generic ...

    African Journals Online (AJOL)

    Molecularly Imprinted Polymer Technology: A Powerful, Generic, Facile and Cost Effective Alternative for Enantio-recognition and Separation: A Glance at Advances and Applications. ... Tanzania Journal of Science. Journal Home · ABOUT ...

  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. Safety in Markets: An Impossibility Theorem for Dutch Books

    OpenAIRE

    Leeat Yariv; David Laibson

    2004-01-01

    This paper explores the extent to which markets constrain intertemporal preferences. First, we show that without transaction costs, agents are immune to exploitation in competitive markets. In particular, a sequence of trades leaving any market participant strictly worse off (termed a money losing Dutch book) is generically impossible. When transaction costs exist in the market, Dutch books are plausible only when agents have inaccurate beliefs about their own future behavior. Thus, markets a...

  8. 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...

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

    Science.gov (United States)

    Probyn, Andrew J

    2004-11-08

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

  10. 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.

  11. 42 CFR 447.506 - Authorized generic drugs.

    Science.gov (United States)

    2010-10-01

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

  12. Market Structure in the Context of Developing Competitive Strategy

    OpenAIRE

    Algirdas Krivka; Romualdas Ginevičius

    2011-01-01

    The abstract deals with the application of positioning strategies under the conditions of classical market structures. It is discovered that the assumptions of pure competition leave no space for M. Porter’s generic cost leadership and differentiation strategies to be applied. The enterprise’s actions, influencing five competitive forces and implementing generic strategies, are reasonable under the conditions of imperfect competition market structures. The game theory models, applied to oligo...

  13. 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.

  14. Optimizing the technological and informational relationship of the health care process and of the communication between physician and patient. The impact of Preventive Medicine and social marketing applied in Health Care on youth awareness- preliminary study.

    Science.gov (United States)

    Petrescu, C M; Gheorghe, I R; Petrescu, G D

    2011-01-01

    In this case study we wanted to find out the impact of Preventive Medicine and implicitly social marketing upon young students with the average age of 19, belonging to the academic environment in Romania. The study lasted one month and consisted of a questionnaire that was conceived and applied to 304 adolescents. The questionnaire contained demographic and personal information, such as age, origin, gender, marital status and some questions related to the respondents' attitude towards several issues that are inserted in the preventive medicine discipline, such as the date of their last consultation, if the respondents were registered to a family physician, suffered from chronic diseases, what was the rate of doing physical exercises, if they ate salty and fat meals, if they were on a diet, their rate of alcohol, caffeine and tobacco consumption. The panel was made up of more female respondents than male, with the average age rate of 19, who had medical consultations in the last 3 months, are included in the evidence of a family physician, had no chronic diseases, usually do workout exercises moderately, are not on a diet and have 3 meals per day. The meals are medium salty and rarely rich in fats. They drink 2 cups of tea per day and are non-alcohol drinkers and non-smokers. After applying several statistical tests to find a correlation between our variables, we reached the conclusion that even if the results are encouraging; there is no correlation between the impact of Preventive Medicine and the respondents' health behavior.

  15. Effect of the Affordable Medicines Facility--malaria (AMFm) on the availability, price, and market share of quality-assured artemisinin-based combination therapies in seven countries: a before-and-after analysis of outlet survey data.

    Science.gov (United States)

    Tougher, Sarah; Ye, Yazoume; Amuasi, John H; Kourgueni, Idrissa A; Thomson, Rebecca; Goodman, Catherine; Mann, Andrea G; Ren, Ruilin; Willey, Barbara A; Adegoke, Catherine A; Amin, Abdinasir; Ansong, Daniel; Bruxvoort, Katia; Diallo, Diadier A; Diap, Graciela; Festo, Charles; Johanes, Boniface; Juma, Elizabeth; Kalolella, Admirabilis; Malam, Oumarou; Mberu, Blessing; Ndiaye, Salif; Nguah, Samuel B; Seydou, Moctar; Taylor, Mark; Rueda, Sergio Torres; Wamukoya, Marilyn; Arnold, Fred; Hanson, Kara

    2012-12-01

    Malaria is one of the greatest causes of mortality worldwide. Use of the most effective treatments for malaria remains inadequate for those in need, and there is concern over the emergence of resistance to these treatments. In 2010, the Global Fund launched the Affordable Medicines Facility--malaria (AMFm), a series of national-scale pilot programmes designed to increase the access and use of quality-assured artemisinin based combination therapies (QAACTs) and reduce that of artemisinin monotherapies for treatment of malaria. AMFm involves manufacturer price negotiations, subsidies on the manufacturer price of each treatment purchased, and supporting interventions such as communications campaigns. We present findings on the effect of AMFm on QAACT price, availability, and market share, 6-15 months after the delivery of subsidised ACTs in Ghana, Kenya, Madagascar, Niger, Nigeria, Uganda, and Tanzania (including Zanzibar). We did nationally representative baseline and endpoint surveys of public and private sector outlets that stock antimalarial treatments. QAACTs were identified on the basis of the Global Fund's quality assurance policy. Changes in availability, price, and market share were assessed against specified success benchmarks for 1 year of AMFm implementation. Key informant interviews and document reviews recorded contextual factors and the implementation process. In all pilots except Niger and Madagascar, there were large increases in QAACT availability (25·8-51·9 percentage points), and market share (15·9-40·3 percentage points), driven mainly by changes in the private for-profit sector. Large falls in median price for QAACTs per adult equivalent dose were seen in the private for-profit sector in six pilots, ranging from US$1·28 to $4·82. The market share of oral artemisinin monotherapies decreased in Nigeria and Zanzibar, the two pilots where it was more than 5% at baseline. Subsidies combined with supporting interventions can be effective in

  16. Trading Platform for the Global Warrant Markets

    Directory of Open Access Journals (Sweden)

    Iosif ZIMAN

    2011-01-01

    Full Text Available Global warrant markets are among the most active financial markets in the retail derivatives investment landscape currently. In this context some of the most relevant markets in the last years have been the ones across Asia and in particular Hong Kong, Korea and Japan. This paper introduces the financial instruments used in connection with the warrant markets, pre-sents and offers suggestions for setting up a generic warrant market making system and in-troduces the main concepts and components that need to be taken into account when develop-ing these systems targeting an exchange driven or E-Businesscontext.

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

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-10-01

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

  18. 76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-01

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic... functions. SSCs in operating nuclear power plants are designed either in accordance with, or have been... nuclear reactors. The background information relevant to this GL includes the individual plant...

  19. [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.).

  20. Different initiatives across Europe to enhance losartan utilization post generics: impact and implications

    Science.gov (United States)

    Moon, James C.; Godman, Brian; Petzold, Max; Alvarez-Madrazo, Samantha; Bennett, Kathleen; Bishop, Iain; Bucsics, Anna; Hesse, Ulrik; Martin, Andrew; Simoens, Steven; Zara, Corinne; Malmström, Rickard E.

    2014-01-01

    Introduction: There is an urgent need for health authorities across Europe to fully realize potential savings from increased use of generics to sustain their healthcare systems. A variety of strategies were used across Europe following the availability of generic losartan, the first angiotensin receptor blocker (ARB) to be approved and marketed, to enhance its prescribing vs. single-sourced drugs in the class. Demand-side strategies ranged from 100% co-payment for single-sourced ARBs in Denmark to no specific measures. We hypothesized this heterogeneity of approaches would provide opportunities to explore prescribing in a class following patent expiry. Objective: Contrast the impact of the different approaches among European countries and regions to the availability of generic losartan to provide future guidance. Methodology: Retrospective segmented regression analyses applying linear random coefficient models with country specific intercepts and slopes were used to assess the impact of the various initiatives across Europe following the availability of generic losartan. Utilization measured in defined daily doses (DDDs). Price reductions for generic losartan were also measured. Results: Utilization of losartan was over 90% of all ARBs in Denmark by the study end. Multiple measures in Sweden and one English primary care group also appreciably enhanced losartan utilization. Losartan utilization actually fell in some countries with no specific demand-side measures. Considerable differences were seen in the prices of generic losartan. Conclusion: Delisting single-sourced ARBs produced the greatest increase in losartan utilization. Overall, multiple demand-side measures are needed to change physician prescribing habits to fully realize savings from generics. There is no apparent “spill over” effect from one class to another to influence future prescribing patterns even if these are closely related. PMID:25339902

  1. Price Determinants of the Tendering Process for Pharmaceuticals in the Cyprus Market.

    Science.gov (United States)

    Petrou, Panagiotis; Talias, Michael A

    2015-09-01

    Tendering has been a promising approach for procuring pharmaceuticals. Significant price reductions have been well documented by several authors. To our knowledge, there are limited data detailing the impact of variables in the tendering process. In this article, our objective was to evaluate the impact of potentially exploratory variables, which included innovation status, total value and volume of sales of each product, health care setting administration (hospital/outpatient), patent status (branded/generic), tendering type, and wholesale price, on price reduction in the tendering process. Financial data of public sector sales during 2011 were analyzed. On the basis of these data, we selected 178 medicines with corresponding sales of €49 million, out of a total market value of €104 million. Medicines were selected according to volume, value, and therapeutic value across all therapeutic areas. We performed a beta regression for the assessment of impact of variables and applied the same methodology to different subgroups. The generic status of medicines is statistically significantly associated with a higher price reduction. Tendering type by alternative, high wholesale prices, and high volume are robust estimators for price reduction. Innovation status does not have any effect on price reduction. Outpatient medicines reach lower prices as compared with hospital medicines. A rather unexpected finding is the negative correlation of high sales value with price reduction. These findings will lead to better understanding of the tendering framework, enabling us to further evolve its operational capacity, aiming to generate more savings. Moreover, our study indicates areas in which a more optimized approach is needed. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

    Rosina, Mônica Steffen Guise; Shaver, Lea

    2012-01-01

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

  3. Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization.

    Directory of Open Access Journals (Sweden)

    Vincent Ahonkhai

    Full Text Available The United Nations Millennium Development Goals galvanized global efforts to alleviate suffering of the world's poorest people through unprecedented public-private partnerships. Donor aid agencies have demonstrably saved millions of lives that might otherwise have been lost to disease through increased access to quality-assured vaccines and medicines. Yet, the introduction of these health interventions in low- and middle-income countries (LMICs continues to face a time lag due to factors which remain poorly understood.A recurring theme from our partnership engagements was that an optimized regulatory process would contribute to improved access to quality health products. Therefore, we investigated the current system for medicine and vaccine registration in LMICs as part of our comprehensive regulatory strategy. Here, we report a fact base of the registration timelines for vaccines and drugs used to treat certain communicable diseases in LMICs. We worked with a broad set of stakeholders, including the World Health Organization's prequalification team, national regulatory authorities, manufacturers, procurers, and other experts, and collected data on the timelines between first submission and last approval of applications for product registration sub-Saharan Africa. We focused on countries with the highest burden of communicable disease and the greatest need for the products studied. The data showed a typical lag of 4 to 7 years between the first regulatory submission which was usually to a regulatory agency in a high-income country, and the final approval in Sub-Saharan Africa. Two of the three typical registration steps which products undergo before delivery in the countries involve lengthy timelines. Failure to leverage or rely on the findings from reviews already performed by competent regulatory authorities, disparate requirements for product approval by the countries, and lengthy timelines by manufacturers to respond to regulatory queries

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

    Science.gov (United States)

    Sheingold, Steven; Nguyen, Nguyen Xuan

    2014-01-01

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

  5. Generic Business Model Types for Enterprise Mashup Intermediaries

    Science.gov (United States)

    Hoyer, Volker; Stanoevska-Slabeva, Katarina

    The huge demand for situational and ad-hoc applications desired by the mass of business end users led to a new kind of Web applications, well-known as Enterprise Mashups. Users with no or limited programming skills are empowered to leverage in a collaborative manner existing Mashup components by combining and reusing company internal and external resources within minutes to new value added applications. Thereby, Enterprise Mashup environments interact as intermediaries to match the supply of providers and demand of consumers. By following the design science approach, we propose an interaction phase model artefact based on market transaction phases to structure required intermediary features. By means of five case studies, we demonstrate the application of the designed model and identify three generic business model types for Enterprise Mashups intermediaries (directory, broker, and marketplace). So far, intermediaries following a real marketplace business model don’t exist in context of Enterprise Mashups and require further research for this emerging paradigm.

  6. Generic modelling framework for economic analysis of battery systems

    DEFF Research Database (Denmark)

    You, Shi; Rasmussen, Claus Nygaard

    2011-01-01

    opportunities, a generic modelling framework is proposed to handle this task. This framework outlines a set of building blocks which are necessary for carrying out the economic analysis of various BS applications. Further, special focus is given on describing how to use the rainflow cycle counting algorithm...... for battery cycle life estimation, since the cycle life plays a central role in the economic analysis of BS. To illustrate the modelling framework, a case study using a Sodium Sulfur Battery (NAS) system with 5-minute regulating service is performed. The economic performances of two dispatch scenarios, a so......Deregulated electricity markets provide opportunities for Battery Systems (BS) to participate in energy arbitrage and ancillary services (regulation, operating reserves, contingency reserves, voltage regulation, power quality etc.). To evaluate the economic viability of BS with different business...

  7. 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.

  8. 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.

  9. PACS in nuclear medicine

    International Nuclear Information System (INIS)

    Kang, Keon Wook

    2000-01-01

    PACS (Picture Archiving and Communication System) is being rapidly spread and installed in many hospitals, but most of the system do not include nuclear medicine field. Although additional costs of hardware for nuclear medicine PACS is low, the complexity in developing viewing software and little market have made the nuclear medicine PACS not popular. Most PACS utilize DICOM 3.0 as standard format, but standard format in nuclear medicine has been Interfile. Interfile should be converted into DICOM format if nuclear images are to be stored and visualized in most PACS. Nowadays, many vendors supply the DICOM option in gamma camera and PET. Several hospitals in Korea have already installed nucler PACS with DICOM, but only the screen captured images are supplied. Software for visualizing pseudo-color with color lookup tables and expressing with volume view should be developed to fulfill the demand of referring physicians and nuclear medicine physicians. PACS is going to integrate not only radiologic images but also endoscopic and pathologic images. Web and PC based PACS is now a trend and is much compatible with nuclear medicine PACS. Most important barrier for nuclear medicine PACS that we encounter is not a technical problem, but indifference of investor such as administrator of hospital or PACS. Now it is time to support and invest for the development of nuclear medicine PACS

  10. Developing a sustainable bioprocessing strategy based on a generic feedstock.

    Science.gov (United States)

    Webb, C; Koutinas, Wang R; Wang, R

    2004-01-01

    Based on current average yields of wheat per hectare and the saccharide content of wheat grain, it is feasible to produce wheat-based alternatives to many petrochemicals. However, the requirements in terms of wheat utilization would be equivalent to 82% of current production if intermediates and primary building blocks such as ethylene, propylene, and butadiene were to be produced in addition to conventional bioproducts. If only intermediates and bioproducts were produced this requirement would fall to just 11%, while bioproducts alone would require only 7%. These requirements would be easily met if the global wheat yield per hectare of cultivated land was increased from the current average of 2.7 to 5.5 tonnes ha(-1) (well below the current maximum). Preliminary economic evaluation taking into account only raw material costs demonstrated that the use of wheat as a generic feedstock could be advantageous in the case of bioproducts and specific intermediate petrochemicals. Gluten plays a significant role considering the revenue occurring when it is sold as a by-product. A process leading to the production of a generic fermentation feedstock from wheat has been devised and evaluated in terms of efficiency and economics. This feedstock aims at providing a replacement for conventional fermentation media and petrochemical feedstocks. The process can be divided into four major stages--wheat milling; fermentation of whole wheat flour by A. awamori leading to the production of enzymes and fungal cells; glucose enhancement via enzymatic hydrolysis of flour suspensions; and nitrogen/micronutrient enhancement via fungal cell autolysis. Preliminary costings show that the operating cost of the process depends on plant capacity, cereal market price, presence and market value of added-value by-products, labour costs, and mode of processing (batch or continuous).

  11. 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

  12. 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

  13. Benefits of Digital Equipment Generic Qualification Activities

    International Nuclear Information System (INIS)

    Thomas, James E.; Steiman, Samuel C.

    2002-01-01

    As a result of nuclear power plant instrumentation and control obsolescence issues, there have been numerous activities during recent years relating to the qualification of digital equipment. Some of these activities have been 'generic' in nature in that the qualification was not limited to plant specific applications, but was intended to cover a broad base of potential applications of the digital equipment. These generic qualifications have been funded by equipment manufacturers and by utility groups and organizations. The generic activities sponsored by the Electric Power Research Institute (EPRI) have been pilot projects for an overall generic qualification approach. The primary benefit resulting from the generic qualification work to date is that a number of digital platforms and digital devices are now available for use in various nuclear safety-related applications. Many of the tests and evaluations necessary to support plant specific applications have been completed. The amount of data and documentation that each utility must develop on a case by case basis has been significantly reduced. There are also a number of additional benefits resulting from these industry efforts. The challenges and difficulties in qualifying digital equipment for safety-related applications are now more clearly understood. EPRI has published a lessons learned document (EPRI Report 1001452, Generic Qualification of Commercial Grade Digital Devices: Lessons Learned from Initial Pilots, which covers several different qualification areas, including device selection, project planning, vendor surveys and design reviews, and electromagnetic compatibility (EMC) qualification. Application of the experience and lessons learned from the EPRI pilot activities should help reduce the effort and cost required for future qualification work. Most generic qualification activities for commercial equipment have been conducted using the approach of EPRI TR-106439, Guideline on Evaluation and Acceptance

  14. Generic tacrolimus in solid organ transplantation

    DEFF Research Database (Denmark)

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

    2014-01-01

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

  15. The SENSEI Generic In Situ Interface

    Energy Technology Data Exchange (ETDEWEB)

    Ayachit, Utkarsh [Kitware, Inc., Clifton Park, NY (United States); Whitlock, Brad [Intelligent Light, Rutherford, NJ (United States); Wolf, Matthew [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Loring, Burlen [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Geveci, Berk [Kitware, Inc., Clifton Park, NY (United States); Lonie, David [Kitware, Inc., Clifton Park, NY (United States); Bethel, E. Wes [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2017-04-11

    The SENSEI generic in situ interface is an API that promotes code portability and reusability. From the simulation view, a developer can instrument their code with the SENSEI API and then make make use of any number of in situ infrastructures. From the method view, a developer can write an in situ method using the SENSEI API, then expect it to run in any number of in situ infrastructures, or be invoked directly from a simulation code, with little or no modification. This paper presents the design principles underlying the SENSEI generic interface, along with some simplified coding examples.

  16. Generic magnetic fusion reactor cost assessment

    International Nuclear Information System (INIS)

    Sheffield, J.

    1985-01-01

    The Fusion Energy Division of the Oak Ridge National Laboratory discusses ''generic'' magnetic fusion reactors. The author comments on DT burning magnetic fusion reactor models being possibly operational in the 21st century. Representative parameters from D-T reactor studies are given, as well as a shematic diagram of a generic fusion reactor. Values are given for winding pack current density for existing and future superconducting coils. Topics included are the variation of the cost of electricity (COE), the dependence of the COE on the net electric power of the reactor, and COE formula definitions

  17. 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.

  18. 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.

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

    Science.gov (United States)

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

    2014-04-01

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

  20. Nuclear medicine

    International Nuclear Information System (INIS)

    Lentle, B.C.

    1986-01-01

    Several growth areas for nuclear medicine were defined. Among them were: cardiac nuclear medicine, neuro-psychiatric nuclear medicine, and cancer diagnosis through direct tumor imaging. A powerful new tool, Positron Emission Tomography (PET) was lauded as the impetus for new developments in nuclear medicine. The political environment (funding, degree of autonomy) was discussed, as were the economic and scientific environments

  1. [Falsified medicines in parallel trade].

    Science.gov (United States)

    Muckenfuß, Heide

    2017-11-01

    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.

  2. 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. © 2015 Elsevier B.V. All rights reserved.

  3. Heart failure - medicines

    Science.gov (United States)

    CHF - medicines; Congestive heart failure - medicines; Cardiomyopathy - medicines; HF - medicines ... You will need to take most of your heart failure medicines every day. Some medicines are taken ...

  4. 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.

  5. 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.

  6. Livestock Marketing.

    Science.gov (United States)

    Futrell, Gene; And Others

    This marketing unit focuses on the seasonal and cyclical patterns of livestock markets. Cash marketing, forward contracting, hedging in the futures markets, and the options markets are examined. Examples illustrate how each marketing tool may be useful in gaining a profit on livestock and cutting risk exposure. The unit is organized in the…

  7. 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…

  8. Towards Generic Interaction Styles for Product Design

    DEFF Research Database (Denmark)

    Buur, Jacob; Stienstra, Marcelle

    2008-01-01

    a wider range of interactive products. In this paper we report on five years of continued research into interaction styles for telephones, kitchen equipment, HiFi products and medical devices, and we show how it is indeed possible and beneficial to formulate a set of generic interaction styles....

  9. Crystallization Kinetics within a Generic Modelling Framework

    DEFF Research Database (Denmark)

    Meisler, Kresten Troelstrup; von Solms, Nicolas; Gernaey, Krist

    2013-01-01

    An existing generic modelling framework has been expanded with tools for kinetic model analysis. The analysis of kinetics is carried out within the framework where kinetic constitutive models are collected, analysed and utilized for the simulation of crystallization operations. A modelling...... procedure is proposed to gain the information of crystallization operation kinetic model analysis and utilize this for faster evaluation of crystallization operations....

  10. Baldrige Theory into Practice: A Generic Model

    Science.gov (United States)

    Arif, Mohammed

    2007-01-01

    Purpose: The education system globally has moved from a push-based or producer-centric system to a pull-based or customer centric system. Malcolm Baldrige Quality Award (MBQA) model happens to be one of the latest additions to the pull based models. The purpose of this paper is to develop a generic framework for MBQA that can be used by…

  11. Generic Checklist for Day Care Monitoring.

    Science.gov (United States)

    Children's Services Monitoring Transfer Consortium.

    This guide presents the results of research on day care monitoring methods conducted by the Children's Services Monitoring Transfer Consortium. It suggests a set of generic predictor items that can be used to monitor day care providers' compliance with standards. The predictor items are at the licensing or minimal compliance level and have been…

  12. Climate Change: Generic Implications for Agriculture

    Indian Academy of Sciences (India)

    Climate Change: Generic Implications for Agriculture. Increasing carbon dioxide: Good for most crops. Increase in mean temperature: orter ... Increasing rainfall intensity and dry days- more floods and droughts: Higher production variability. Himalayan glaciers to recede: irrigation in IGP gradually becomes less dependable ...

  13. A Generic Solution Approach to Nurse Rostering

    DEFF Research Database (Denmark)

    Hansen, Anders Dohn; Mason, Andrew; Ryan, David

    In this report, we present a solution approach to the nurse rostering problem. The problem is defined by a generic model that is able to capture close to all of the problem characteristics that we have seen in the literature and in the realistic problems at hand. The model is used directly in the...

  14. The Generic Style Rules for Linguistics

    OpenAIRE

    Haspelmath, Martin

    2014-01-01

    The Generic Style Rules for Linguistics provide a style sheet that can be used by any linguistics journal or edited book, or for teaching purposes. They regulate aspects of text-structure style such as typographic highlighting, citation style, use of capitalization, and bibliographic style (based on the LSA's Unified Stylesheet for linguistics).

  15. Generic hyper-diversity in Stachybotriaceae

    Czech Academy of Sciences Publication Activity Database

    Lombard, L.; Houbraken, J.; Decock, C.; Samson, R.A.; Meijer, M.; Réblová, Martina; Groenewald, J.Z.; Crous, P. W.

    2016-01-01

    Roč. 36, SI Jun (2016), s. 156-246 ISSN 0031-5850 R&D Projects: GA ČR GAP506/12/0038 Institutional support: RVO:67985939 Keywords : biodegraders * generic concept * human and plant pathogens Subject RIV: EF - Botanics Impact factor: 7.511, year: 2016

  16. Generic Principles for Resolving Intergroup Conflict.

    Science.gov (United States)

    Fisher, Ronald J.

    1994-01-01

    Provides an initial statement of generic principles deemed effective for addressing protracted social conflicts between identity groups. These principles are compatible with certain values for societal organization and approaches to social change, raising questions of value differences between intervenors and the host culture(s). Three case…

  17. Intermediates and Generic Convergence to Equilibria

    DEFF Research Database (Denmark)

    Marcondes de Freitas, Michael; Wiuf, Carsten; Feliu, Elisenda

    2017-01-01

    Known graphical conditions for the generic and global convergence to equilibria of the dynamical system arising from a reaction network are shown to be invariant under the so-called successive removal of intermediates, a systematic procedure to simplify the network, making the graphical conditions...

  18. Generic Certificates. Agricultural Economic Report Number 594.

    Science.gov (United States)

    Glauber, Joseph W.

    The Food Security Act of 1985 authorizes the U.S. Department of Agriculture to issue generic certificates in lieu of cash payments due to program participants and merchants of agricultural products under provisions of several programs. The certificates may be used to acquire stocks held as collateral on government loans or owned by the Commodity…

  19. Regulation of proprietary traditional Chinese medicines in Australia.

    Science.gov (United States)

    Graham, David T

    2017-01-01

    This review article describes the regulation of proprietary Chinese medicines for the Australian market, which may permit many medicines used in Traditional Chinese Medicine to have a simplified process of market access provided that certain criteria for acceptable public safety are met. Copyright © 2017 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.

  20. Improving access to medicines via the Health Impact Fund in India: a stakeholder analysis.

    Science.gov (United States)

    McMullan, Patrick; Ajay, Vamadevan S; Srinivas, Ravi; Bhalla, Sandeep; Prabhakaran, Dorairaj; Banerjee, Amitava

    2018-01-01

    In India, 50-65% of the population face difficulties in accessing medicines. The Health Impact Fund (HIF) is a novel proposal whereby pharmaceutical companies would be paid based on the measured global health impact of their drugs. We conducted a key stakeholder analysis to explore access to medicines in India, acceptability of the HIF and potential barriers and facilitators at policy level. To conduct a stakeholder analysis of the HIF in India: to determine key stakeholder views regarding access to medicines in India; to evaluate acceptability of the HIF; and to assess potential barriers and facilitators to the HIF as a policy. In New Delhi, we conducted semi-structured interviews. There was purposive recruitment of participants with snowball sampling. Transcribed data were analysed using stakeholder analysis frameworks and directed content analysis. Participation rate was 29% (14/49). 14 semi-structured interviews were conducted among stakeholders in New Delhi. All participants highlighted access to medicines as a problem in India. There were mixed views about the HIF in terms of relevance and scaleability. Stakeholders felt it should focus on diseases with limited or no market and potentially incorporate direct investment in research. First, access to medicines is perceived to be a major problem in India by all stakeholders, but affordability is just one factor. Second, stakeholders despite considerable support for the idea of the HIF, there are major concerns about scaleability, generalisability and impact on access to medicines. Third, the HIF and other novel drug-related health policies can afford to be more radical, e.g. working outside the existing intellectual property rights regime, targ