Generic Drugs

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 increase...

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.

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.

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.

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

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 tra...

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' 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' 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...

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...

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.