Generic Drugs

Background: Previous studies have reported that certain populations are sensitive to high out-of-pocket drug costs, and drug noncompliance leads to poorer health outcomes. Objective: Our aim was to measure patient awareness of discount pharmacy options, cost barriers to medication access, and beliefs about health care provider's use of low-cost medications. Methods: This cross-sectional 17-item survey was administered to patients in the emergency department of an urban trauma center in February 2011. Differences in responses by sex and race groups were assessed. A logistic regression model was created to estimate the association of sociodemographic factors and medication use with awareness of discount pharmacy options. Results: Five hundred and fifty-two surveys were analyzed. Among respondents who were prescribed medications within the past year, three fourths of patients felt comfortable asking physicians for cheaper medicines. Slightly more than half were aware of low-cost pharmacy options, and 78% of these respondents correctly listed at least one of these pharmacies. Caucasian patients were more comfortable than African American patients asking for cheaper medicines (82.5% vs. 72.2%; p < 0.05) and were more aware of low-cost prescription programs (63.9% vs. 43.5%; p < 0.001). When adjusted for insurance status and current medication use, Caucasian patients were 2.7 times more likely to name a valid discount pharmacy option compared to African Americans (95% confidence interval 1.85À 4.07). Conclusions: This study suggests populations may be more uncomfortable initiating a discussion about medica-tion costs and selection of lower-cost alternatives. Health care providers may need to develop communication strategies in which medication cost is addressed with sensitivity and consistency. Ó 2014 Elsevier Inc.

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&#39;s t-test, and the odds ratio for hyponatremia was estimated via logistic regression analysis. Serum creatinine levels after chemotherapy increase...

The in vitro dissolution of albendazole from three different commercially available products (200 mg tablets) was studied using U.S. Pharmacopeia (USP) Apparatus 2 and USP Apparatus 4 in order to compare the release performance of the drug in two essentially different dissolution systems. For both cases, 0.1 N HCl was used as dissolution medium. Only the reference product and one of the generic products studied met the 80% USP 24 specification for albendazole dissolved at 30 min, using USP Apparatus 2. Although the reference product reached 80% of albendazole dissolved at 30 min when Apparatus 4 was used, the generic products' dissolution performance was markedly reduced in this system. Though dissolution rate was slower using Apparatus 4, the total quantity of albendazole dissolved from the reference product, represented by area under the dissolution profile, was practically the same regardless of the system used. Dissolution kinetics of albendazole was adequately described by Weibull's function for all the products. The dissolution time (t d ) derived from data fitting to this function showed significant differences among the products studied. Data analysis based on analysis of variance (ANOVA) showed nonequivalence among the dissolution profiles of generic products compared with the reference product either with the dissolution vessel system or the flow-through cell, as well as nonequivalence among the dissolution profiles using both apparatuses with the same product. Though differences in the dissolution profiles for generic products against the reference product in both systems were found, USP Apparatus 4 showed higher discriminative capacity in differentiating the release characteristics of the products tested.

The study related to pharmaceutical packaging has come to attention for its importance to the quality of drugs and compliance achievement. The aims of this study is to provide a conceptual view of producing a new model of pharmaceutical drug packaging design to overcome existing problems. The proposed methods for this research is to use the process mining techniques to support the construction of a new model for pharmaceutical packaging design process improvement. A case study method was selected for the methodology of the research resulted the flow of packaging design process in pharmaceutical company. The study lengthens the knowledge of drug packaging design process and concludes the importance of drug packaging design process to be investigated for compliance fulfilment purposes. This study is significant to the strong implication of drug quality and safety outcomes for the patients.

Background: Oxacillin continues to be an important agent in the treatment of staphylococcal infections; many generic products are available and the only requirement for their approval is demonstration of pharmaceutical equivalence. We tested the assumption that pharmaceutical equivalence predicts therapeutic equivalence by comparing 11 generics with the innovator product in terms of concentration of the active pharmaceutical ingredient (API), minimal inhibitory (MIC) and bactericidal concentrations (MBC), and antibacterial efficacy in the neutropenic mouse thigh infection model.

Controversy persists whether generic antiepileptic drugs (AEDs) are interchangeable with brand name drugs with respect to efficacy and adverse events. Three hundred and one neurologists responded to a survey regarding generic AEDs mailed to 6420 neurologists, for an overall response rate of 4.7%. One hundred and ninety-six (67.8%) neurologists reported breakthrough seizures after a switch from a brand name to generic AED; 93 (32.2%) did not. One hundred and sixty-three neurologists (56%) reported increased side effects in their patients after a switch from a brand name to generic AED; 128 (44%) did not. Fifty-two (18.4%) neurologists agreed that the Food and Drug Administration standards for AED bioavailability are sufficiently narrow; 231 (81.6%) did not.

This paper demonstrates how, by introducing a generic version of its previously-patented product, a branded firm can influence the equilibrium in the generic segment of the market for the product. This in turn can increase the firm's profits from selling the branded version. We then use structural estimates from previous literature to calculate the magnitude of the effects in the generic and branded segments.

Background WHO and Health Action International (HAI) have developed a standardised method for surveying medicine prices, availability, aff ordability, and price components in low-income and middle-income countries. Here, we present a secondary analysis of medicine availability in 45 national and subnational surveys done using the WHO/HAI methodology.

Generic drug product (GDP) competition for market existence and profitability has become a challenging task for the manufacturers. All the generic players are putting intensive efforts to enter the market with competitive price and consistent drug product (DP) quality. The generic firms have to manage the delicate balance between the cost and quality of raw materials, especially the active pharmaceutical Ingredient (API) for market survival. Major Pharma companies have adopted the merger and acquisition strategies with API manufacturers to withstand the competition and price erosion. Still the majority firms don't have their own API manufacturing facility. Since the finished product cost is majorily driven by API, the supplier selection plays prominent role in the generic profitability as well as quality. The supplier screening and selection includes extensive evaluation and comparison of documents, quality and cost. As part of risk mitigation strategy many generic manufactures prefer to include additional or alternate sources for API supplier. This exercise could be triggered anytime during the DP life cycle. The authors have tried to share the view on supplier change process at various stages of product lifecycle and related regulatory authority requirements and expectations. Generic products have been targeted majorly for US and Europe regions and same is being focused here. These two regulatory bodies have almost similar requirement for supplier selection and change, except difference in procedural approaches. The regulatory requirements may vary for each phase of generic product life cycle. At the development stage, the supplier change may not significantly fall into regulatory umbrella. Generally development phase comes under relatively less regulatory scruitiny than CTD submission or post approval phase. The dossier review and post approval phase have almost similar regulatory requirements. All the post approval changes shall be routed through SUPAC filing in US and VARIATION filing procedures in Europe.

The experience with analyzing the potency of piperacillin/tazobactam generic formulations by a precise multiorganism in vitro assay was expanded to 46 lots (29 manufacturers, 17 countries). Across all generic lots, the range of activity compared with a reference branded lot (RLOT; Zosyn®; Wyeth Pharmaceuticals, Philadelphia, PA) was +10% to −42% (average, −16%). Eight lots of Zosyn® were also tested with a range of +7 to −19 (average, only −6%), and the reproducibility (13 replicates) of the RLOT assay was confirmed (±3%). This ongoing quality assurance project demonstrated wide activity variations in piperacillin/tazobactam generic lots with a consistent trend toward subpotent performance (−16%) compared with the branded product. Generic substitutions within hospital formularies should consider parameters of in vitro activity, in addition to applied chemical analyses and measures of bioavailability to avoid potential adverse clinical consequences.

This study was performed to asses and establishes the prevalence of Polypharmacy in geriatric population in the Medicine ward of Rajah Muthaiya Medical College and Hospital, Annamalai University, during one year from January 2013 to January 2014. Demographic analyses of this prospective study revealed that out of 520 patients, 342 (65.76%) were males and 178 (34.23%) were females. All the collected prescriptions were scrutinized for Polypharmacy and were categorized as minor Polypharmacy -concurrent use of ≤ 5 drugs; and major Polypharmacy -concurrent use of > 5 drugs. Out of 502 Prescriptions 61(11.73%) prescriptions were minor Polypharmacy and 457(88.26%) prescriptions were major Polypharmacy. The maximum patients were in the age group of 60-64 (38.84%) range lead to a significant increase in the number of medications. The most common diseases associated systems were Cardiovascular system 147 (28.26 %) patients, and followed by Respiratory system 103(19.80%). Our results show that there is a higher prevalence of Polypharmacy among the males than females. The length of hospital stay of geriatric patients is increase in major Polypharmacy compare with minor Polypharmacy. The prevalence of cardiovascular drugs and respiratory drugs were often involved in Polypharmacy among geriatric patients. Polypharmacy is very common among geriatric patient and health care professional’s interventions to improve the optimal use of medication in geriatric could lead to reduction in the drug related problems associated with Polypharmacy.

Generic drug product (GDP) competition for market existence and profitability has become a challenging task for the manufacturers. All the generic players are putting intensive efforts to enter the market with competitive price and consistent drug product (DP) quality. The generic firms have to manage the delicate balance between the cost and quality of raw materials, especially the active pharmaceutical Ingredient (API) for market survival. Major Pharma companies have adopted the merger and acquisition strategies with API manufacturers to withstand the competition and price erosion. Still the majority firms don't have their own API manufacturing facility. Since the finished product cost is majorily driven by API, the supplier selection plays prominent role in the generic profitability as well as quality. The supplier screening and selection includes extensive evaluation and comparison of documents, quality and cost. As part of risk mitigation strategy many generic manufactures prefer to include additional or alternate sources for API supplier. This exercise could be triggered anytime during the DP life cycle. The authors have tried to share the view on supplier change process at various stages of product lifecycle and related regulatory authority requirements and expectations. Generic products have been targeted majorly for US and Europe regions and same is being focused here. These two regulatory bodies have almost similar requirement for supplier selection and change, except difference in procedural approaches. The regulatory requirements may vary for each phase of generic product life cycle. At the development stage, the supplier change may not significantly fall into regulatory umbrella. Generally development phase comes under relatively less regulatory scruitiny than CTD submission or post approval phase. The dossier review and post approval phase have almost similar regulatory requirements. All the post approval changes shall be routed through SUPAC filing in US and VARIATION filing procedures in Europe.

Context: Over the last ten years, many research studies concerning pharmacists’ perceptions of generic medicines have been conducted worldwide, although this issue remains underexplored in Vietnam.

Aims: To evaluate pharmacists’ views on generic medicines and to investigate the generic substitution practices in community pharmacies in the context of Vietnam.

Methods: A cross-sectional survey comprising a 24-item self-administered anonymous questionnaire was distributed to 480 pharmacists in eleven provinces in southern Vietnam between December 2016 and March 2017. The main outcome measures were pharmacists’ views on generic medicines.

Results: Of the 480 pharmacists who received the questionnaire, the effective response rate was 35.63% (n=171 pharmacists); however, 45 pharmacists chose all three correct generic names. Some 47.3% of respondents indicated that all the products that are approved as exhibiting generic equivalence can be considered therapeutically equivalent to the innovator drugs. Yet, 25.2% of respondents agreed that generic medicines are of inferior quality to branded medicines. The pharmacists who graduated from universities and those who had undergone only a short period of training differed significantly in terms of their knowledge and perceptions. About 60.2% of pharmacists recommended generics over branded products. Approximately 89% of respondents disagreed with the notion of implementing certain compulsory generic substitutions in Vietnam.

Conclusions: The pharmacists who had completed only a short training period exhibited a lack of knowledge regarding generic names. This issue should hence be addressed by both pharmacy educators and relevant government agencies in order to ensure the wider use of generic products.

Bioavailability and/or bioequivalence studies play a key role in the drug development period for both new drug products and their generic equivalents. For both, these studies are also important in the postapproval period in the presence of certain manufacturing changes. Like many regulatory studies, the assessment of bioavailability and bioequivalence can generally be achieved by considering the following three questions. What is the primary question of the study? What are the tests that can be used to address the question? What degree of confidence is needed for the test outcome? This article reviews the regulatory science of bioavailability and bioequivalence and provides FDA's recommendations for drug sponsors who intend to establish bioavailability and/or demonstrate bioequivalence for their pharmaceutical products during the developmental process or after approval.

The pharmaceutical industry is emerging as a significant industrial sector with tremendous potential for providing innovative drugs to treat life-threatening diseases as well as for providing economical generic alternatives of supreme quality. Hence this sector is not only responsible to provide the much desired boost to the health of the society, especially of the developing countries, but also it is a competitive yet profitable sector from a business perspective. Currently, the primary focus of the pharmaceutical industry is to raise the bar for the quality, safety and efficacy of the drug products that are made available in the global market place. Product quality, price of raw materials [API (active pharmaceutical ingredient) and excipients] and market return competition are vital factors that determine the longevity or existence and profitability of a company in the crowded pharmaceutical market.. Hence these critical factors receive special consideration from drug product manufacturers. Active Pharmaceutical Ingredient (API) is the primary constituent of a pharmaceutical drug product that governs the final cost of the drug product as well as the commercial profit earned by the company. Most of the major generic drug manufacturing companies have their own API manufacturing facility and hence may not prefer to screen independent API suppliers as part of their generic drug development plan to procure additional API. Contradictorily, the generic drug manufacturers who do not synthesize the API themselves are dependent on external and independent API manufacturers for procurement of the API. Such generic drug manufacturing companies have to select suitable API suppliers by adapting a risk aversive approach. This article presents an informed and comprehensive discussion on the primary and alternate API supplier selection processes for generic drug products manufacturing firms. This API supplier selection process can be categorized into several stages which include preliminary assessment, documents review, samples analysis, onsite or offsite audit, results evaluation and final approval or rejection. This API selection process includes the anticipated product specific risk assessment with relation to API characteristics, specifications, analytical results, document review observations and inspection results. A generic drug product manufacturing company can choose an alternative API supplier or change the existing API supplier either during the development phase or after development of the drug product. Generic drug product manufacturing companies should rework on development activities if any API supplier change happens during the development phase. API supplier change or addition of an alternative API supplier has to be followed as per SUPAC guidance for US market and VARIATION filing procedures for European market.

To compare the level of availability and rational use of drugs in primary health care (PHC) facilities where the Bamako Initiative (BI) drug revolving fund programme has been operational, with PHC centres where the BI-type of drug revolving fund programme is not yet operational.

Estudo sobre a proteção de dados de teste (data package) de medicamentos de uso ano exigidos para fins de registro sanitário no Brasil. Texto de dissertação de mestrado, mais tarde transformado em em livro eletrônico.

Study on the protection of test results (data package) demanded for regulatory market approval in Brasil. Original version of text presented for LLM in Law and Public Policies.

C’s key conclusion is that ‘generics must not be evaluated in isolation, but rather with respect to a set of alternatives under consideration.’ (191) Furthermore, generics ‘are systematically ambiguous between readings,’ e.g. the sentence The Frenchman eats horsemeat. may be making a statement about a custom current among a small number of French people, or may refer to a specific individual. C claims that ‘the notion of alternatives under discussion can account for both.’

This paper presents the first results of the research project “Lexical Variants in Portuguese toponymy: the generic”, linked to the future “ Toponymic Atlas of Portugal”. We study the designation of geographical entities related to hydrography (rivers, streams, lakes, waterfalls, etc. ..) and their distribution in Portuguese territory, according to the lexical variation. This article is complemented by another (to be published in 2012), presented at the XXIV International Congress of ICOS of Onomastic Sciences (Barcelona, September 2011). Link:
http://www.ileel.ufu.br/anaisdosilel/pt/arquivos/gt_lg04_artigo_6.pdf

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.

Objectives The aim of this project was to evaluate the perceptions, knowledge and attitudes regarding generic medicines. Methods 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. Results 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. Conclusion 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.

Background: Generic medicines are commonly used in New Zealand; however, Pharmaceutical Management Agency of New Zealand (PHARMAC) has indicated a need for better information to the public. Studies on consumers' perceptions suggest that pharmacists play an important role in consumers' choice; hence, "quality use of generic medicines" can be promoted with a better understanding of pharmacists' views, knowledge, and perception. Objectives: (1)To evaluate pharmacists' perceptions, views, and knowledge of and willingness to recommend generic medicines. (2) To explore pharmacists perceptions of the safety, quality, and efficacy of generic medicines. (3) To assess pharmacists' views on current policy with respect to substitution of generic medicines. Methods: A cross-sectional survey using a postal questionnaire was conducted, and questionnaires were sent to 625 randomly selected pharmacists from a list of 1594 pharmacists who had agreed to release their details for research purposes. Results: Three-hundred and sixty pharmacists responded to the questionnaire (a response rate of 58%). Seventy percent of pharmacists stated there is no difference in safety between original brand and generic medicines. However, 65% stated that original brand medicines were of higher quality than their generic counterparts, and half stated that generic medicines and original brand medicines are equally effective. A large number of pharmacists reported concerns regarding brand substitution and offered suggestions, such as the need for advertising campaigns, patient pamphlets, updating prescribers' software, and distinct packaging for generic medicines. It was found that pharmacists' perceptions of generic medicines are primarily driven by PHARMACs policies and their experiences with consumers. Conclusions: About one-third of pharmacists correctly defined the term "generic medicines," suggesting discrepancies in pharmacists' knowledge and perceptions of generic medicines. Concerns were raised regarding: quality, safety, and effectiveness; however, most of the pharmacists acknowledged the economic benefits to the health care system.

Many countries have established procedures for the introduction of generic pharmaceutical products. In order to protect consumers, these generic products must be demonstrated to be therapeutically equivalent to a previously approved product, typically an innovator product. The therapeutic equivalence of a generic and an innovator product is most commonly based on the demonstration of bioequivalence, i.e. clinically insignificant differences in the rate and extent of drug absorption usually assessed from pharmacokinetic measurements. This article reviews the bioequivalence requirements for generic products and, in the interest of promoting international harmonisation, highlights those areas where differences exist among countries.

A randomized crossover study was conduaed on 26 healthy Arab males to compare the bioavailabiity of two formulations of fluconazole 150mg capsules, FluconazoleTM (test) and Diflucan (reference). The formulations were adminEstered after an overnight last with a washout period of 2 weeks. Twenty blood samples (per period) were collected over lash, plasma fluconazole concentrations were determined by locally validated high performance liquid chromatography (HPLC) assay and pharmacokinetic parameters were analysed by the standard non-cornpartmentnl method.

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 &#39;regulatory&#39; 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&#39;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 tra...

Background: This phase I study was designed to determine the bioavailability and bioequivalence of 400 mg Eudorlin ® extra* (Ibuprofen) in comparison to two reference formulations (400 mg Nurofen ® forte and 400 mg Migränin ® after single dose administration under fasting conditions in healthy subjects. Therefore the design of a randomized, open label, multiple sequence cross-over study with a wash-out period of 7-10 days was used.

The accessibility of medicines and medical treatment is but one facet of health care delivery. One can argue that other aspects like human health resource availability, health infrastructure provision and competent public health administration are issues equal or even greater in weight than that of cheaper drugs. However, the problem of high drug prices is relatively the less complex one. As the adage goes, one should try to fight the battles that can be won. But are we employing the right battle plan?

Senate Bill No.1658 (The Quality Affordable Medicines Act), in brief, attempts to address this problem by amending the Intellectual Property Code (IPC), to allow “flexibilities” in responding to the high cost of medicines through parallel importation of cheaper drugs and by guaranteeing the immediate entry of generic drugs, which are priced lower compared with the branded products.

This paper aims to evaluate the current policy proposals embodied in SB 1658. Specifically, this paper seeks to:

• Ascertain the existence of the problem of drug pricing in the country
• Explain how the patent rights can affect the pricing of drugs
• Measure the probable impact of the SB 1658’s proposal on parallel importation and immediate generic drug entry into market 

There are 5 chapters in this paper. Chapter 1 highlights the gravity of the problem of drug pricing in view of the people’s health needs, government policy directions and the economic situation in the country.  Chapter 2 explains how the current patent system contributes to limited competition in the drug sector and why there is the need to amend the IPC and make it “flexible”. It also debunks the arguments against “softening” of patent laws. Chapter 3 lays down the policies proposed under SB 1658 to provide the needed “flexibilities” and relates them with other practices. Chapter 4 evaluates the probable impact of the proposed amendments to drug pricing through the use of economic models and available empirical data. The authors conclude with a summary of the findings, an assessment of their limitations, as well as recommendations.

Post-script:  After this paper was written, the Philippine Congress passed
Republic Act 9502 or the Universally Accessible Cheaper and Quality Medicines Act of 2008.

Objective. To estimate the impact of a soft cap (a ceiling on utilization beyond which insured enrollees pay a higher copayment) on low-income elders&#x27; use of prescription drugs.Data Sources and Setting. Claims and enrollment files for the first year (  June 2002 through May 2003) of the Illinois SeniorCare program, a state pharmacy assistance program, and Medicare claims and enrollment files, 2001 through 2003. SeniorCare enrolled non-Medicaid-eligible elders with income less than 200 percent of Federal Poverty Level. Minimal copays increased by 20 percent of prescription cost when enrollee expenditures reached $1,750.Research Design. Models were estimated for three dependent variables: enrollees&#x27; average monthly utilization (number of prescriptions), spending, and the proportion of drugs that were generic rather than brand. Observations included all program enrollees who exceeded the cap and covered two periods, before and after the cap was exceeded.Principle Findings. On...

Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the fi rst biosimilar was approved in the European Union, but do policies in the Member States take the differences between biological medicines and small-molecule generics into account? To map the policy landscape in Europe, European Biopharmaceutical Enterprises (EBE) has conducted a second round of its descriptive survey of pricing and reimbursement policies for off-patent biologicals. Methods: The EBE survey was conducted among national pharmaceutical trade associations in 32 countries, the 28 EU Member States plus Norway, Serbia, Switzerland and Turkey. The questionnaire was a revised version of the previous survey of 2014 and was developed by the EBE Biosimilars Working Group. It contained 44 questions about eight policy areas: Availability of biological medicines, Tendering, Health Technology Assessment, International Nonproprietary Name prescribing, Internal Reference Pricing, Substitution, Interchangeability and Quotas. Results: Responses were received from all national trade associations contacted. According to the responses, the majority of the 32 countries surveyed have specifi c policies for off-patent biologicals in place and therefore take account of the specifi cities of biologicals. Nevertheless, variations exist and refl ect the responsibilities in healthcare policy-making in Europe. In the majority of countries, treatment decisions remain in the hands of physicians. Compared to the fi rst EBE survey, shifts have been seen in the areas of substitution and interchangeability. Conclusion: The second EBE survey on biological medicines policies indicates that nearly all jurisdictions have policies in place that refl ect the diff erent nature of biological medicines. However, policies and their implementation vary among diff erent jurisdictions.

Fees charged by drug regulatory authorities (DRAs) may be used as a policy instrument to speed up regulatory approval, to encourage retention of quality staff and to stimulate introduction of generics versus new chemical entities. Often, the cost recovery function of these registration fees is not related to the true cost of the pharmaceutical regulatory process. In this paper, we scaled new drug registration fees of various DRAs to indices of economic development - the GNP per capita and the total government health expenditure per capita. Based on our analyses of 34 countries, most DRA registration fees for new drug applications for developing/non-OECD countries are less than the current GNP/capita of that country or are about US dollars 5000 for each US dollars 1000 spent per capita on healthcare. At present, each US dollars 1000 new drug registration fee for the developing/non-OECD countries analyzed corresponds to a total pharmaceutical market share of about US dollars 85 millio...

Cost containment-driven drug substitution, whether generic or therapeutic, is defined as switching to another drug because it is cheaper. So far, such substitutions have drawn their public legitimacy from the general belief that they would not compromise the clinical interests of patients and certainly not violate their right to decline them if they did. This article does not enter the debate on whether or not such substitutions must give exclusive priority to the patient's interests and choices in order to be ethical. Indeed, it acknowledges the plurality of views on this matter. It simply argues that when such substitutions involve a cheaper drug that is known to have different effects and side effects, or even a drug whose effects and side effects are unknown, they are potentially deleterious to the patient, and that no competent and well-informed patient would ever consent to them. Such substitutions are thus unethical in their very own terms.

Purpose The present study was carried out to investigate current prescribing and dispensing practices in the largest two teaching hospitals in Sudan and compare them with those of published studies in developing countries. Methods A descriptive, quantitative and cross-sectional study was conducted among hospital outpatients. The sample was selected using systematic random sampling. In each hospital, prescribing indicators were investigated through collection of data on 100 patient encounters, determination of consultation time and dispensing time for 100 patients, and by interview of 100 patients for the evaluation of dispensing practices. Results The present findings showed that 96% (95% CI: 92.0–98.1%) of patient encounters did not include one or more necessary elements. Strength of drug and the quantity to be dispensed were omitted in 57.5% (95% CI: 50.3–64.4%) and 91% (95% CI: 85.9–94.4%) of patient encounters, respectively. Other variables measured per patient encounter were mean (SD) number of drugs prescribed, 1.9 (0.9); percentage prescribed by generic name, 43.6 % (95% CI: 38.6–48.8%); percentage of patient encounters involving an antibiotic, 65.0% (95% CI: 57.9–71.5%); percentage of patient encounters with an injection prescribed, 10.5% (95% CI: 6.5–15.8%). The mean (SD) consultation and dispensing times were 4.5 (2.8) min and 46.3 (21.8) s, respectively. The percentages of dispensed drugs that were adequately labeled was 37.6% (95% CI: 33.1–41.8%), whilst adequate patient knowledge was demonstrated for 37.2% (95% CI: 32.3–42.0%) of drugs. Conclusions Cost-effective, multifaceted interventions are needed to improve current prescribing and dispensing practices at the teaching hospitals in Khartoum State, Sudan.