Opinion of Polish Patients with Epilepsy on Generic Medications.

AIM: The majority of medicines used in Poland are generic drugs and substitutions of the originals. The objective of this study was to obtain information on the current knowledge about generic medicines among Polish patients with epilepsy. MATERIAL AND METHODS: The conducted study was based on a self-developed questionnaire. The questionnaire consisted of 26 questions, including the questions regarding the respondents' knowledge about generics, their previous experience, and the factors behind these choices. RESULTS: Overall, 1220 questionnaires were analyzed. Among all patients, 66.4% reportedly had heard about generics. Of these, 61.5% of patients had used generic drugs in the past. A significant proportion of participants had never been recommended to switch to a generic medicine by their healthcare professional (23% physicians and 13.9% pharmacists). Statistically, relevant differences were observed regarding the respondents' kind and level of education, place of residence, and net income per household. CONCLUSIONS: Significant gaps were identified in the knowledge and perceptions among patients regarding generic medicines, especially in relation to their efficacy and safety. Efforts must be directed towards increasing public awareness of generic medicines and there should also be a focus on educating patients about generic medicines.

New pricing models for generic medicines to ensure long-term sustainable competition in Europe.

Background: Price erosion of generic medicines over time as a result of existing pricing policies in combination with increasing operational costs of these products due to high inflation, undermine long-term sustainable competition in European off-patent medicines markets. Therefore, the aim of this study is to identify new potential pricing models for retail generic medicines in Europe, examine their pros and cons, and illustrate them with examples inside or outside the pharmaceutical sector. Methods: A targeted literature review, one-to-one interviews and a joint advisory board meeting with experts from five European countries were carried out to assess potential pricing models for generic medicines. Results: We identified ten pricing models that can be applied to generic medicines. The tiered pricing model is viewed as a sustainable solution ensuring competitiveness, but requires market monitoring using a supportive IT infrastructure. De-linking the price of generic medicines from that of the off-patent originator medicine prevents the originator from forcing generic medicines' prices to unsustainable levels. Higher costs due to inflation can be compensated in the automatic indexation model. Other pricing models that have less implementation potential include the one-in-one/multiple-out model, tax credits, value-based pricing, volume for savings and guaranteed margin/fee models. The hypothecated tax and cost allocation models, which add a patient fee to generic medicines prices, are not likely to be socially acceptable. Conclusion: When considering a new pricing model for generic medicines, the impact on innovative medicines and the characteristics of the healthcare system in a given country need to be taken into account. Also, there is a need to continuously follow up the level of competition in off-patent medicines markets and to identify sustainability risks.

Trust in the approval process of medicines mediates the effect of an educational intervention on the pain relief induced by a generic analgesic.

BACKGROUND: Generic medicines have been associated with less efficacy compared to originator products. Educational videos explaining generic medicines can have a positive effect on perceptions of generic drugs and their pain-relieving effect. The central aim of the current study was to examine whether trust in the governmental approval process of medicines mediates the effect of educational video interventions on the pain-relieving effect induced by a generic medicine and whether trust can be built by improving individuals' understanding of generic medication. METHODS: This is a secondary analysis of a randomized controlled trial where participants with frequent tension headaches were randomly assigned to either watching a video explaining generic drugs (n = 69) or a video informing about headaches (control group: n = 34). After watching the video, participants took an originator and a generic pain analgesic in a randomized order to treat their next two consecutive headaches. Pain severity was measured before and 1 h after taking the medicine. RESULTS: A multiple serial mediator model showed that improving individuals' understanding of generic medicines is associated with increased trust in medicines. Both factors together, understanding and trust, significantly mediated the effect of the video education about generic drugs on the generic's pain-relieving effect (total indirect effect: coefficient: 0.20, 95% CI: 0.42, -0.0001). CONCLUSION: Results of this study show that improving individuals' understanding of generic medication and trust in the process of approving medicines should be considered as important mechanisms of future educational interventions about generic medicines.

A Retrospective Analysis of Applications for Registration of Generic Medicines Processed by the Medicines Control Authority of Zimbabwe.

BACKGROUND: Many applications for registration of medicines are rejected because applicants fail to submit or resolve critical deficiencies in the quality, efficacy, and safety of the medicines. The study aimed to establish approval rates, processing timelines, and common deficiencies of generic medicines applications processed by the Medicines Authority of Zimbabwe (MCAZ). METHOD: A retrospective study of applications finalized by MCAZ between 2018 and 2020 was conducted. Data were collected from the assessment reports and verified with copies of letters sent to the applicants. Deficiencies were classified as administrative, quality, efficacy, and safety. Other characteristics collated included time to finalization, dosage form, region of origin, and therapeutic class. RESULTS: Of the 579 finalized applications, 74.1% were approved while 25.9% were refused. Approved applications had more review cycles (median = 3 cycles) compared to refused applications (median = 2 cycles). However, refused applications had longer review times (median = 25 months) compared to approved applications (median = 18 months). The majority of applications (83.0%) were from Asian manufacturers and intended for oral administration (66.1%). Medicines for the endocrine system (50.0%) and rheumatism/gout (53.3%) had lower approval rates compared to other therapeutical classes (p < 0.001). The most common reasons for refusal of applications included failure to respond to review queries (52.6%), deficiencies in the API information (54.7%), FPP specifications (42.7%), FPP stability data (36.0%), and pharmaceutical development (31.3%). CONCLUSION: To improve the quality of applications and evaluation outcomes, there may be a need for the regulatory authority to engage applicants through training and pre-submission meetings.

Medicines for Europe - 16th Legal Affairs Conference (June 29-July 1, 2022 - Barcelona, Spain).

Medicines for Europe held its 2022 annual conference in Sitges, Spain, from June 29 to July 1. Many topics were discussed including future-proofing healthcare systems in the E.U., methods to build a sustainable European ecosystem to incentivize the development of value-added medicines (VAMs), how to reshape national market policies and build a strong European co-operation to prevent shortages. In addition, attendants discussed key challenges and barriers that need to be addressed to ensure the E.U. remains a leader and an innovator in medicines manufacturing, as well as national strategies and practices influencing the sustainability of the biosimilar medicines market and patient access to biological medicines.

A nationwide survey exploring physicians' and pharmacists' knowledge, awareness and perceptions regarding generic medicines in China.

BACKGROUND: Generic medicines substitution is an important means to control rapid growth of pharmaceutical expenditures for the healthcare system in China. Acceptance and utilization of generic medicines is highly influenced by healthcare providers' perceptions. This study aimed to compare the knowledge, awareness and perceptions of generic medicines between physicians and pharmacists in China. METHODS: We used an online, cross-sectional survey across China. The questionnaire explored four sections: demographic characteristics, assessment of the participants' knowledge and awareness of generic medicines, perceptions of generic medicines and generic substitution practices. Chi-square or Mann-Whitney-U tests were applied to compare differences between physicians and pharmacists. P-values < 0.05 were considered significant. RESULTS: A total of 1644 physicians and 4187 pharmacists participated. Most physicians (82.8%, n = 1362) and pharmacists (89.8%, n = 3760) correctly identified the definition of generic medicines. A similar percentage of physicians and pharmacists agreed that approved generic medicines are as effective (64.1% vs 68.2%) or safe (63.8% vs 69.1%) as brand-name medicines. Most physicians and pharmacists (67.6% vs 71.0%) supported the policy of generic substitution. In practice, 79.4% (n = 1305) of physicians reported that they had prescribed generic medicines. More than 78% of respondents reported an obvious increase in the number of generic medicines prescribed in their medical institutions. The majority of physicians and pharmacists identified lack of trust regarding efficacy and safety of generic medicines and the difficulty of changing patients' preference as top challenges in generic substitution. CONCLUSIONS: Both physicians and pharmacists surveyed had adequate knowledge of generic medicines, and hold positive attitude towards generics and generic substitution. Efficacy and safety are key factors related to prescribing or dispensing generic medicines. Various policies and regulations should be taken to encourage successful generic substitution.

Generic substitution for prescribed brand medicines in Ethiopia: knowledge, attitude and practice among pharmacy professionals in community drug retail outlets.

BACKGROUND: Generic substitution is a good approach to reduce pharmaceutical expenses without compromising healthcare quality. Yet, the practice of generic substitution has been contentious due to concerns on quality and efficacy. OBJECTIVE: This study was aimed to assess knowledge, attitude and practice among pharmacy professionals toward generic substitution in community drug retail outlets in Jimma town, Southwest Ethiopia. METHODS: A descriptive cross-sectional study was conducted among pharmacy professionals working in community drug retail outlets. Data was collected using a self-administered questionnaire. Knowledge was tested using a 3-point response format consisting of "Yes," "No" and "I am not sure." Attitude was evaluated using the 5-point Likert scale ranging from 1(strong agreement) to 5 (strong disagreement). The practice was examined as never, seldom, sometimes, often, and always with scores ranging from 0 to 4. The influences of socio-demographic factors on knowledge, attitude, and practice were tested using the Mann-Whitney U and Kruskal-Wallis tests as appropriate. P ≤ 0.05 was considered statistically significant. RESULTS: The mean knowledge score of participants regarding generic medicines was 5.75 ± 1.79. Only 32 respondents (30.2%) of the participants were knowledgeable about the generic substitution. 54 (50.9%) of respondents had positive attitude toward generic substitution and 52 (49.1%) had practiced generic substitution. The year of experience had a significant effect on knowledge (X2 = 9.14, p = 0.01) and practice (X2 = 4.71, p = 0.03) of generic substitution. CONCLUSIONS: Our study found that pharmacy professionals working in community drug retail outlets in Jimma town had lack of knowledge about generic substitution. Conversely, an enormous amount of participants had positive attitude toward generic substitution and nearly half of them had practiced generic substitution. The year of experience had a significant effect on knowledge and practice of generic substitution.

What is the impact of intellectual property rules on access to medicines? A systematic review.

BACKGROUND: It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive review of the empirical evidence on this topic. The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires Member States to implement minimum standards of intellectual property protection including patents for pharmaceutical products, but also contains 'flexibilities' designed to address barriers to access to medicines. National intellectual property laws can also include TRIPS-plus rules that go beyond what is required by TRIPS. We aimed to systematically review literature that measures the impact of intellectual property rules on access to medicines, whether implemented as a result of TRIPS, TRIPS-plus provisions in other trade agreements, or unilateral policy decisions. METHODS: We searched Proquest, SCOPUS, Web of Science, PubMed, JSTOR, Westlaw and Lexis Nexis. Peer reviewed articles, government reports and other grey literature were included. Articles were eligible for inclusion if they were quantitative, in English, included a measure of cost, price, availability of or access to medicines, were about intellectual property or data exclusivity rules and published between January 1995 and October 2020. Ninety-one studies met our inclusion criteria. We systematically reviewed the studies' findings and evaluated their quality using a modified quality assessment template. RESULTS AND CONCLUSION: Five broad overarching themes and 11 subthemes were identified based on the articles' foci. They were: trade agreements (divided into EU FTAs and those that include the USA); use of TRIPS flexibilities (divided into compulsory licencing and parallel importation); patent expiry/generic entry/generic pathway (divided into comparative studies and single country studies); patent policies (also divided into comparative studies and single country studies) and TRIPS-plus rules (divided into data exclusivity, patent term extensions and secondary patenting). Most studies focused not on specific trade agreements, but on TRIPS-plus provisions, which can also be found within some trade agreements. The main finding of this review is that the stronger pharmaceutical monopolies created by TRIPs-plus intellectual property rules are generally associated with increased drug prices, delayed availability and increased costs to consumers and governments. There is evidence that TRIPS flexibilities can facilitate access to medicines although their use is limited to date. There were few studies that included resource poor settings, signalling a need for greater research in such settings where the impact on access to medicines is likely to be more damaging.

Generic Medicine and Generic Prescribing in Nepal: An Implication for Policymakers.

Generic medicines are being promoted in many countries for their added benefits over branded drugs, such as reduced price, therapeutic equivalence, and convenience to the patients. However, generic prescribing is still not up to the optimum level in Nepal to assure access to cost-effective, quality medicines to the public and to reduce the overall economic burden and practice-related errors of medications. This review aimed to discuss the current scenario of generic medicine, generic prescribing, hurdles on the one hand, and potentials ways in promoting generic medicine usage and generic prescribing in Nepal on the other. Extensive literature on generic medicine usage and generic prescribing practice in Nepal was reviewed. This review found some of the major challenges to be addressed for the proper implementation of generic medicine prescribing, and utilization. These challenges include lack of facilities and competency to assure therapeutic equivalence of different brand-name medicines, lack of understanding about generic medicines among health care providers (HCPs) and the public, and lack of stringent regulation towards promoting generic medicines. Rational pharmaceutical promotion and awareness about generic medication to the medical students are also inevitable towards promoting the practice of generic medicines. The practice of generic medicine and generic prescribing is not possible without the assurance of therapeutically equivalent generic alternatives. The study recommended the prompt effort of the regulatory authority to enforce the generic prescribing and generic substitution policy through strengthening policies, procedures and laboratory testing to assure citizens' right to access to cost-effective, and affordable quality medicine, as the Nepal's National Health and Drug Policy mandated.

Does TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) prevent COVID-19 vaccines as a global public good?

The article analyses the global public goods approach to COVID-19 technologies, embedded in 2020 affirmations by the World Health Assembly (WHA), the UN Human Rights Council and G20 on broad immunization against COVID-19. After identifying the access to COVID-19 tools (ACT) Accelerator members, the UN efforts are identified, focusing primarily on the UN human rights bodies, acknowledging how these and the WHA have mutually reinforced each others' efforts. The article finds that the global public goods terminology appeared in UN resolutions in 2020, while wording that included vaccines-on an equal footing as medicines-appeared in 2016, and recognition of generic medicines appeared in 2019. The so-called Trilateral Cooperation on IP and public health between two UN specialized agencies and the World Trade Organization (WTO) has increased awareness of the flexibilities within WTO's TRIPS Agreement. These flexibilities are explained. With notable exceptions, like India, these flexibilities are not widely applied in domestic legislation. A different emphasis characterizes the millennium development goals era as compared to the sustainable development goals era, and this shift is explained by applying relevant theories. Among pro-TRIPS developed countries there is an acknowledgment of obstacles created by the IP system, but their overall position has not changed.

Policies and Practices Catalyzing the Use of Generic Medicines: A Systematic Search and Review.

BACKGROUND: The use of generic medicines instead of branded, is one of the main policies to decrease the expenditures and provide access to affordable and essential medicines in low and middle-income countries. The present study aims to systematically create a comprehensive synthesis of demand-side policies, encouraging the use of generic medicines. METHODS: The study systematically searched and reviewed the articles in Medline, Scopus, Web of Science, and Embase from 1.1.2000 to 12.5.2019. A total of 6435 records were identified during this period of time (Medline (n=315), Scopus (n=4323), Web of Science (n=71) and Embase (n=1726)). All stages are conducted according to the Preferred Reporting Item for Systematic Reviews and Meta-Analyzed (PRISMA). RESULTS: The encouraging policies and practices were classified into four categories from 44 articles analyzed, including; Prescribing, Dispensing, Patients/consumers, and healthcare organizations. Subthemes were also explored in relation to each category as; education, financial incentives, generic substitution, advertising approaches, and enforcement. CONCLUSION: Various policies should be taken into consideration to encourage successful generic medication prescribing, dispensing, and consumption in both supply and demand-side. Economic, political, socio-cultural, technological, legal, and structural factors could as such accelerate the policies' effect. Studying the experience of successful countries can be helpful for policymakers.

Changing understanding, perceptions, pain relief of and preference for generic medicines with patient education: An experimental intervention study.

BACKGROUND: Generic medicines have been associated with less perceived efficacy and more side effects compared to brand name drugs. Educational interventions to improve individuals' negative perceptions of generic medicines show contradictory effects. OBJECTIVE: This study investigated whether an interventional video that informs about the approval process of releasing medicines has better effects on outcomes related to perceptions and effectiveness of generic medicines in participants with headaches, in comparison with another interventional video that addresses bioequivalence between brand name and generic drugs or a control video. METHODS: Participants with frequent tension headaches were randomized to one of three groups (one of two interventional videos or the control video). One of the interventional videos explained the process of approval of generic medicines (n = 34), the other one explained the bioequivalence between brand name and generic drugs (n = 35). The control video informed participants about the epidemiology and etiology of headaches (n = 34). After watching the video, participants treated their next two consecutive episodes of headache with a brand name and a generic analgesic in randomized order. MAIN OUTCOME MEASURES: Self-report measures of understanding and perceptions of and preference for medicines, pain severity and side effects. RESULTS: Linear mixed models showed that both interventional videos improved participants' understanding of generic medicines. The generic drug approval process video enhanced the perceived effectiveness, safety and quality of generic drugs. The bioequivalence video positively influenced the preference for generic drugs. The brand name and generic drug were equally effective in relieving pain in participants who watched either the generic drug approval process or the bioequivalence video. CONCLUSIONS: Information about both, approving a switch from brand name medicines to generic counterparts and bioequivalence, can be important and should be addressed in future educational interventions.

Improving access to the treatment of hepatitis C in low- and middle-income countries: evaluation of a patient assistance programme.

Background Modern antiviral treatments have high cure rates against the hepatitis C virus however, the high cost associated with branded medicines and diagnostic tests, have resulted in poor access for many low-income patients residing in low-and-middle-income countries. Objective This study aimed to evaluate the role of a patient assistance programme and generic medicines in improving access to treatment of low-income hepatitis C patients in a low-and-middle-income country. Setting A major teaching public hospital in Islamabad, Pakistan. Methods Hepatitis C patients who presented and enrolled for the patient assistance programme during 12 months (1st July 2015 and 30th June 2016) were included. Demography, prescription characteristics, the total costs of Hepatitis C treatment, medicine cost supported by the programme, out-of-pocket cost borne by the patient and average cost effectiveness ratio per sustained virologic response were calculated and compared for different generic and branded regimens. Main outcome measure cost contribution of patient assistance programme. Results A total of 349 patients initiated the treatment through the programme and of those 334 (95.7%) completed the prescribed treatment. There were 294 (88.02%) patients who achieved sustained virologic response. Patient assistance programme contributed medicines cost averaging 60.28-86.26% of the total cost of treatment ($1634.6) per patient. The mean (SE) cost per patient for generic option (Sofosbuvir/Ribavirin) was the lowest [$658.36 (22.3) per patient, average cost effectiveness ratio = $720.1/SVR] than branded option (Sovaldi/Ribavirin) [$2218.66 (37.6) per patient, average cost effectiveness ratio = $2361.8/SVR] of the three available treatment regimens. From patients' perspectives, the mean (SE) out-of-pocket cost was $296.9 (6.7) which primarily included diagnostic cost (69.9%) of the total cost. Conclusions Patient assistance programme, combined with generic brands of newer hepatitis C treatment offered a significant reduction in cost and widens access to hepatitis C treatment in low-and middle-income countries. However, substantial out-of-pocket costs of the treatment presents an important barrier for service access. There is a scope to widen such financial assistance programme to offer other costs attributed to patients, specifically for diagnosis, to widen service use in low-and-middle-income countries.

Knowledge and Attitude of Physicians Towards the Cost of Commonly Prescribed Medicines: A Case Study in Three Nigerian Healthcare Facilities.

OBJECTIVE: One of the core principles of rational prescribing is consideration of the cost of the medicines prescribed, especially in countries with high patient copayments and low incomes such as Nigeria. Little is known about Nigerian physicians' knowledge about the cost of commonly prescribed medicines. The principal objective of the study was to assess the knowledge of Nigerian physicians about the cost of commonly prescribed medicines. METHODS: Descriptive cross-sectional survey conducted among physicians in 3 tertiary institutions in Nigeria. Apart from socio-demographic and other information, questions about the estimated costs of branded and generic versions of 11 commonly prescribed medications were included in the questionnaire. RESULTS: One hundred and seventy-nine (179; 95.7%) respondents agreed that costs of medicines were important when writing prescriptions, although only 7 (3.7%) of them had any formal training in the economics of healthcare. The median percentages of respondents with accurate estimated costs for generic and originator brands were 6.2% and 12%, respectively. Respondents were more knowledgeable about the cost of medicines used for the treatment of infectious diseases (malaria, bacterial infections) than noncommunicable diseases (diabetes mellitus, hypertension, and dyslipidemia). CONCLUSIONS: The knowledge of Nigerian physicians in the 3 participating hospitals about the costs of commonly prescribed medicines was poor. This is despite their awareness about the importance of costs of medicines when prescribing.

Knowledge, Perception and Attitude Regarding Generic Medicines among Iraqi Physicians.

OBJECTIVES: The study aim was to explore the knowledge, perceptions, and attitudes of Iraqi physicians regarding generic and locally manufactured medicines. METHODS: A total of 124 physicians were involved in this cross -sectional study. The convenience sample was collected from five public hospitals in Baghdad. A self-administered questionnaire was distributed and collected in-person. Fisher's Exact Test was used to measure the association between physician years of experience, gender and categorical (perception and knowledge) variables. RESULTS: Most respondent answers regarding the knowledge of generic medicines were incorrect. Only up to one-third of the participants knew that generic medicines are therapeutically equivalent to brand name medicines (26.6%), as safe as brand name medicines (34.7%) and required to meet similar safety standards as brand name medicines (12.1%). With respect to perception, many physicians had negative perceptions about generic medicines such as viewing generic medicines as lower quality (57.3%) and cause more side effects (41.1%) compared to brand name medicines. Regarding physician attitudes toward generic medicines, about two-thirds (64.5%) of the physicians were willing to prescribe low cost medicines; however, only about half (51.6%) of the physicians reported they offer generic medicines to their patients. Finally, 64.5% of the participants were not comfortable with pharmacist replacing prescribed brand with generic medicines. CONCLUSIONS: In general, Iraqi physicians have negative perceptions and attitudes about generic and locally manufactured medicines. Significant gaps were identified in the knowledge and perceptions among physicians regarding generic medicines especially in relation to efficacy and safety of generic medicines.

Impact of “4+7” City Drug Centralized Procurement Program on the utilization of original and generic cardiovascular drugs in a tertiary hospital / 药学实践杂志

Objective To analyze the impact of “4+7” City Drug Centralized Procurement Program on the utilization of cardiovascular medicines, and to provide a reference for optimizing the policy of generic medicines as substitutes for original medicines. Methods Eleven drugs, both generic and original were selected for treatment of cardiovascular diseases in an outpatient clinic of a tertiary hospital in Shanghai. The proportion of use of generic drugs and original drug, ratio of used amount, daily cost ratio, and potential cost savings rate of replacement of original drug by generic drug were analyzed before the “4+7” (2018.04.01-2018.09.30) and after the “4+7” (2019.04.01-2019.09.30). Results After the “4+7”, the proportion of the original research drug used decreased from 84.32% to 58.12%, and the ratio of amount of used money decreased from 86.02% to 78.16%; the proportion of generic medicines used increased from 15.68% to 41.88%, and the ratio of amount used increased from 13.98% to 21.84%; the daily cost ratio of generic medicine to original medicine decreased from 0.87 to 0.39. Under the same condition, the potential cost savings of replacing the original drug with generic drugs before and after the “4+7” were RMB 3.703 million and RMB 3.399 million, respectively, and the cost saving rate was 35% and 61%, respectively. Conclusion The “4+7” City Drug Centralized Procurement Program significantly increase the use of cardiovascular generic drugs and significantly reduce the cost of drugs; however, it has a small impact on the quantity and amount of generic drugs used. There is still a significant potential for cost saving. It is recommended to further increase the publicity of the policy on the substitution of original drug by generic, expedite the consistency evaluation process of generic drugs and take measures to avoid the widening of the price gap between original drugs and generics.

The Brazilian private pharmaceutical market after the first ten years of the generics law.

OBJECTIVES: To describe changes in the private market for selected originators, branded generics ('similares'), and generic products during the 10 years following passage of the Brazilian Generics Law. METHODS: We analyzed longitudinal data collected by IQVIA® on quarterly sales by wholesalers to retail pharmacies in Brazil from 1998 through 2010, grouped by originators, branded generics, and generic products in three therapeutic classes (antibiotics, antidiabetics, and antihypertensives). Outcomes included market share (proportion of the total private market volume), sales volume per capita, prices and number of manufacturers by group. RESULTS: In the private market share, generics became dominant in each therapeutic class but the speed of uptake varied. Originators consistently lost most market share while branded generics varied over time. By the end of the study period, generics were the most sold product type in all classes, followed by branded generics. The number of generic manufacturers increased in all classes, while branded generics increased just after the policy but then decreased slowly through the end of 2010. For approximately 50% of the antibiotics analyzed, branded generics and generics had lower prices than originators. For antidiabetics, branded generic and generic prices were quite similar during the period analyzed. Price trends for the various subclasses of antihypertensive exhibited very different patterns over time. CONCLUSION: Sales of branded generics and originators decreased substantially in the three therapeutic classes analysed following the introduction of the generics policy in Brazil, but the time to market dominance of generics varied by class.

Evaluating access to essential medicines for treating childhood cancers: a medicines availability, price and affordability study in New Delhi, India.

INTRODUCTION: Limited access to essential medicines (EMs) for treating chronic diseases is a major challenge in low-income and middle-income countries. Although India is the largest manufacturer of generic medicines, there is a paucity of information on availability, price and affordability of anti-neoplastic EMs, which this study evaluates. METHODS: Using a modified WHO/Health Action International methodology, data were collected on availability and price of 33 strength-specific anti-neoplastic EMs and 4 non-cancer EMs. Seven 'survey anchor' hospitals (4 public and 3 private) and 32 private-sector retail pharmacies were surveyed. Median price ratios (MPRs) were calculated by comparing consumer prices with international reference prices (IRPs). RESULTS: On average, across survey anchor areas (hospital and private-sector retail pharmacies combined), the mean availability of anti-neoplastic EMs and non-cancer medicines was 70% and 100%, respectively. Mean availability of anti-neoplastic EMs was 38% in private-sector retail pharmacies, 43% in public hospital pharmacies and 71% in private hospital pharmacies. Median MPR of lowest-priced generic versions was 0.71 in retail pharmacies. The estimated cost of chemotherapy medicines needed for treating a 30 kg child with standard-risk leukaemia was INR 27 850 (US$442) and INR 17 500 (US$278) for Hodgkin's lymphoma, requiring 88 and 55 days' wages, respectively, for the lowest paid government worker. CONCLUSION: Most anti-neoplastic EMs are found in survey anchor areas, however, mean availability was less than non-cancer medicines; not meeting the WHO target of 80%. Medicine prices were relatively low in New Delhi compared with IRPs. However, the cost of chemotherapy medicines seems unaffordable in the local context.

The effect of rebranding generic medicines on drug efficacy and side effects.

Objective: Branded medicines have a greater placebo effect, resulting in a heightened therapeutic response, whereas generics are associated with greater side effect reporting. These two studies investigated whether enhancing the appearance of a generic medicine could increase placebo and decrease nocebo responding.Design: Two experimental studies allegedly examining the effect of ß-blockers (actually placebos) for pre-examination anxiety. In Study 1, participants received either a generic ß-blocker with enhanced packaging, a plainly packaged generic or a branded ß-blocker. Study 2 compared an enhanced packaging generic to a plainly packaged generic ß-blocker.Main outcomes measures: Blood pressure, heart rate, anxiety and the number of symptoms and side effects reported.Results: Study 1 found no differences between the three groups for blood pressure, heart rate, or anxiety. Study 2 showed similar results but a significant difference in anxiety was found with the plain generic group experiencing a greater reduction in anxiety than the enhanced generic group. No differences in symptoms or side effects were found in either study.Conclusions: While the sample characteristics and familiarity of the medicines may have influenced the findings, we found no evidence that enhancing the branding of generic medicines improved response to the medication or reduced side effects.

The effects of the financial crisis on the general and dental health status of Greek citizens.

PURPOSE: To present the impact of the financial crisis on health status and dental health in Greece and compare it to the European Union and Finland and to identify any changes in health-related expenditure focusing on pharmaceutical expenditure and generic medicines. DESIGN/METHODOLOGY/APPROACH: Databases as Scopus, Pubmed, Google Scholar, World Health Organization, Eurostat, and Elstat were used. FINDINGS: Indicators, such as mortality and life expectancy, show that there is no clear correlation between health deterioration and financial crisis while dental health has deteriorated. Out-of-pocket expenses were found to be catastrophic, and the use of generic medicines is still limited. PRACTICAL IMPLICATIONS: Proper prescribing of medicines, coverage of health care costs by the government, and cost savings from the use of generic medicines were implemented. As regards dental care, the state should focus on prevention as well as reinforcement of public dental care services. ORIGINALITY/VALUE: The break through idea is to compare the impact of the financial crisis on health indexes in Greece with the European Union and Finland, to focus on pharmaceutical expenditure, generic medicines, and dental health.