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PubMed2001

United States Food and Drug Administration requirements for approval of generic drug products.

As generic products become more available for the treatment of psychiatric disorders, clinicians must stay abreast of the U.S. Food and Drug Administration (FDA) requirements for the approval of generic drug products. The FDA declares that pharmaceutical equivalents only are therapeutically equivalent, and pharmacokinetic data are all that is usually required to determine therapeutic equivalence. The rationale behind the overall concept of bioequivalence is that if 2 pharmaceutical equivalents provide identical plasma concentration-time profiles in humans, there is no evidence to demonstrate that the 2 identical dosage forms will exhibit a difference in safety and efficacy. This article reviews current terminology used in abbreviated new drug applications for generic products, typical bioequivalence study designs, and FDA bioequivalence guidance for clozapine.

Clozapine↗
PubMedDate not supplied

Impact of generic drug entry on cost-effectiveness analysis.

The market share of generic drugs has grown substantially since the passage of the Waxman-Hatch Act, increasing from 19% in 1984 to 50% in 2001. At entry, the generic drugs typically are priced lower than brand-name drugs; thus, incorporating the impact of the generic drug entry introduces an additional source of uncertainty in economic models as both the timing of entry and the level of generic drug pricing are subject to variation. In this article, the authors explored the impact of generic drug entry on cost-effectiveness analyses of new or brand-name drugs. Using a mathematical model, they argue that failure to incorporate the impact of generic drug entry will underestimate the incremental cost-effectiveness ratio (ICER) and, thus, overstate the economic benefit of the new product. The authors provide 2 examples to illustrate such impact on short-term and long-term cost-effectiveness analyses. To better assess the uncertainty associated with the impact of generic drug entry, in addition to a deterministic analysis, they also employed a Bayesian probabilistic approach to analyze these examples and presented the results using cost-effectiveness acceptability curves. They conclude that incorporating generic drug entry into pharmacoeconomic models will yield more accurate projections of the ICER and lead to better decision making.

Bayes Theorem↗
PubMed1987

Generic drugs and the prescribing physician.

While generic substitution is not a new phenomenon, a number of factors have combined to markedly increase generic drug use. The most important factor is a 1984 law, the Drug Price Competition and Patent Term Restoration Act, which facilitates the entry into the marketplace of generic versions of brand name drugs. This law and Food and Drug Administration (FDA) policies are designed to approve for marketing generic drug products that are therapeutically equivalent to their brand name counterparts. With increased availability of generic drugs, physicians have expressed the need for more information about the FDA process for determining that generic versions of brand name drug products are both safe and effective and that generic drug products will produce the same therapeutic results as those achieved by the brand name products. This article describes FDA procedures for approving generic drug products and examines issues important to the prescribing physician, in particular, therapeutic equivalence. The article also describes the role of the states in generic substitution and the availability of information from the FDA on the therapeutic equivalence of drug products.

Drug Prescriptions↗
PubMed2005

Pharmaceutical policy regarding generic drugs in Belgium.

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

Belgium↗
PubMed1993

Effect of generic drug competition on the price of prescription drugs in Ontario.

OBJECTIVE: To analyse the potential effect of generic drug competition on prices in Ontario to assess the costs and benefits associated with Bill C-22 (An Act to amend the Patent Act). DESIGN: Comparison of the cost of the least and most expensive versions of all products sold by more than one manufacturer in 1991. The number of brand-name and generic drug companies marketing each of the products was recorded. RESULTS: Of 1599 products 437 (27.3%) were made by more than one company. Almost half (44.6%) of the 437 were sold by two companies. The more companies that sold a drug the greater the difference in price between the least and most expensive versions. Similarly, as the proportion of generic drug companies in competition increased, the greater the price difference. When competition was between generic drug companies only, the price spread was smaller than when it was between brand-name drug companies only. CONCLUSIONS: Generic drug competition can result in savings to the Ontario Drug Benefit Plan. A more in-depth analysis of the potential savings is necessary to fully assess the costs and benefits associated with Bill C-22.

Drug Industry↗
PubMedDate not supplied

[How practitioners view generic drugs: an opinion study from general practitioners in Maine-et-Loire (France)].

INTRODUCTION: Generic drugs are copies of original drugs, hence their low cost. In France, expansion of the use of generic drugs is not significant and the support of practitioners is essential in increasing this. AIM: The purpose of this study was to survey the opinion and practical experience of physicians regarding generic drugs, in order to develop a proposal for the safer use of these drugs. METHODS: A form was sent to the 1235 general and specialist practitioners in the Maine-et-Loire "département" with assistance from the regional health insurance, in March 2002. The main topics studied were prescribing practices, risks associated with generic drugs and pharmacist substitutions. The chi2 test and Fisher's exact test were used in the data analysis. RESULTS: Four hundred and twenty-nine forms were returned (34.7%). Only 55% of practitioners considered generic drugs to be as safe and effective as original drugs. Fifty-nine percent prescribe generics rarely or never. The prescribing depends on many factors, linked to the practitioner, the patient or the drug. Many practitioners reported adverse events with generic medicines. With regard to the switch by the pharmacist, it was reported that 45% of prescribers would refuse it in some instances. Among the proposals, cooperation between practitioners and pharmacists in the choice of the generic drugs was approved by 57% of physicians. DISCUSSION: The main perception is that the vastness of the generic world and the fear of adverse events are somewhat bewildering for both patients and health professionals. Among the proposals made by practitioners, a decrease in the number of generics for a same molecule and the institution of a standard price are widely approved. CONCLUSION: Practitioners do not refuse to use generic drugs but are very concerned about the risks of adverse effects for their patients. They regard it as important that a patient receiving chronic treatment be given the same generic drug each time.

Attitude of Health Personnel↗
PubMed2004

Generic drugs in cardiology: will they reduce health care costs?

The introduction of generic drugs should lower health care costs by reducing the price of drugs. The realization of this goal may, however, not be fully achieved: generic drugs may be underused or misused in comparison to prescription drugs because of a lack of ongoing postgraduate physician education. More importantly, there is little incentive to explore new indications for soon-to-be generic drugs and drugs that are already generic. The failure to explore new indications for soon-to-be and existing generic drugs may result in a missed opportunity to further reduce health care costs. Thus, the apparent savings resulting from the introduction of generic drugs may not be fully realized unless the government and other third-party payers take a more active role in postgraduate drug education and investigation.

Cardiology↗
PubMedDate not supplied

[Competition for the promotion of essential generic drugs in Africa].

STATEMENT OF THE PROBLEM: in most sub-Saharan countries, an extensive economic crisis coupled with a low level of existing resources has put most pharmaceuticals beyond the reach of the general public. This situation was worsened by the devaluation of the Franc CFA in 1994. The supply of lowprice drugs and the improvement of rational drug use is now a priority. Unfortunately, essential generic drugs are little known and used in Africa. OBJECTIVE: 1. To improve the knowledge of and confidence in essential and generic drugs among providers, prescribers and consumers, through the participation of the general public in an incentive-based, creative competition; 2. To collect locally-adapted promotional material, to be used in the future promotion of essential and generic drugs in Africa. Design, setting and method: a competition was announced in June 1995, via various networks, in French-speaking Africa: the population was invited to create one or several items promoting essential generic drugs. These items included slogans, posters, songs and short plays. Over 550 entries were received before the deadline (15 October 1995), from 22 countries (mostly Sub-Saharan and French-speaking). The entries included 387 slogans, 94 posters, 22 plays, and various (photos, comic strips, songs, poems). RESULTS: 1. Greater awareness of essential generic drugs in Western Africa, through the publicity given to the competition; 2. Selection of a pool of approximately 200 promotional items, produced by the target populations, to be published in a catalog and distributed in African countries; 3. Insights into popular practices and representations of Western medications, and local re-interpretation of the concept. CONCLUSION: this public competition was effective at achieving three important goals: 1. Dynamic promotion (the competition was the opportunity for school projects, radio talkshows, etc. on generic drugs); 2. Re appropriation of a policy, thanks to a participative approach; 3. Analysis of the population's general comprehension of pharmaceuticals, through analysis of competition entries.

Advertising↗
PubMed2000

[Utilization of generic drugs in Spain and Catalonia: possibilities of savings].

OBJECTIVES: To analyze the degree of utilization of generic drugs in Spain and Catalonia. To determine real savings and scope for further savings due to the use of generic drugs. DESIGN: Descriptive, crossover study. SETTING: Public health prescription in Spain and Catalonia in June of 1999 and in Catalonia from January to June of 1999. MEASUREMENTS AND MAIN RESULTS: In June of 1999, the market share of generic drugs in Spain was 1.15% in units and 0.91% in pesetas of the hole drug prescription. The most used were oral ranitidine, oral diclofenac and oral amoxicillin. Catalonia, in this period, has a greater relative utilization of generic drugs, specially in psychotherapeutic agents like alprazolam and fluoxetine. During the first semester of 1999 only in 9.9% of the occasions where generic drugs could be used, were they actually prescribed. Specifically, the drug most used in its generic form was oral diclofenac with 27.1% of the all possible prescriptions. The real savings generated by the generic drugs were 0.2% of the public pharmaceutical bill, and the theoretical capacity of savings with the current generic offer were 2.3%. CONCLUSIONS: There is a low but fast-rising utilization of generic drugs in Spain and Catalonia. Nevertheless the possibilities of savings are at the moment, in relative terms, small. A greater use of them and specially a diversification of the offer is necessary to achieve important relative savings in the overall pharmaceutical bill.

Cost Savings↗
PubMedDate not supplied

Study: U.S. generic drugs cost less then Canadian drugs.

If you think all drugs from Canada are cheaper than U.S. drugs, think again. In the United States, generic drugs--roughly half of all prescriptions--are often cheaper than both Canadian brand-name drugs and Canadian generic drugs, according to a study by the Food and Drug Administration.

Canada↗
PubMedDate not supplied

Understanding the scientific issues embedded in the generic drug approval process.

OBJECTIVE: To review the major scientific issues embedded in the generic drug approval process. DATA SOURCES: Articles indexed initially under terms such as generic medications, generic drugs, bioequivalence, and bioinequivalence. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), and Science Citation Index. Additional data sources included the Code of Federal Regulations and regulatory guidances from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research. STUDY SELECTION: Performed by the authors. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: Despite the fact that regulations regarding bioequivalence have been in place for more than 20 years, controversies over bioequivalence continue to arise. Consensus on many of these issues is driving the development of new FDA guidances regarding bioequivalence. Still, despite the issuance of new guidance and consensus building among scientists, many clinicians and consumers remain uninformed regarding the scientific basis for establishing bioequivalence and the generic drug approval process in general. Although some have suggested that the generic drug approval process is flawed, overall, it appears that the process works. CONCLUSION: Understanding the generic drug approval process and the issues surrounding bioequivalence is of paramount importance to both clinicians and scientists.

Drug Approval↗
PubMed2003

[Generic drug prescription at discharge from a hospital emergency service].

BACKGROUND AND OBJECTIVE: Drug prescription at hospital discharge often implies continuation of the treatment in primary health care. The aim of this study was to assess prescription of generics at discharge from a hospital emergency service. MATERIAL AND METHOD: Longitudinal and retrospective study, on a random sample of medical reports in a hospital emergency service during one year (August 2000 to July 2001). Information on the medical specialty, prescribed generic drugs and marked availability of the corresponding generic drugs pharmaceutical specialties was collected. Factors associated with generic prescription were analyzed by means of logistic regression analysis. RESULTS: A sample of 1,245 medical reports was selected in which 2,315 drugs were prescribed. Although generic drugs were available for 33.3% (CI 95%, 31.4-35.2) of prescriptions, 9.5% (95% CI, 8.3-10.7) of prescribed drugs were generics. The average price of trademark prescribed medicines, for which there was a generic equivalent, was 7.09 Euros (95% CI, 6.54-7.63 Euros), and that of the corresponding generic versions was 5.08 Euros (95% CI, 4.68-5.48 Euros). Variables associated with generic drug prescription included the particular study period (OR=1.35; 95% CI, 0.99-1.84), the medical specialty of the prescriber (OR=1.40; 95% CI, 1.05-1.86), availability of generic drugs (OR=1.76; 95% CI, 1.30-2.39) and low price of prescribed drugs (OR=2.67; 95% CI, 1.80-3.98). CONCLUSION: In spite of the availability of generic drugs, prescription of generic drugs at discharge of this hospital emergency service was low. Prescription and use of generic drugs should be promoted in hospitals.

Costs and Cost Analysis↗
PubMed1998

Generic drug product equivalence: current status.

UNLABELLED: This activity is designed for healthcare professionals involved in the selection of multisource drug products. GOAL: To understand the basis for approval of generic drug products by the Food and Drug Administration. OBJECTIVES: 1. Identify the criteria employed by the Food and Drug Administration to approve generic drug products. 2. Discuss controversial issues that have been raised relative to generic drug products. 3. Identify narrow therapeutic index drugs. 4. Describe the different types of bioequivalence studies that are required by the Food and Drug Administration. 5. Discuss the responsibilities underlying the selection of multisource drug products by healthcare professionals.

Delayed-Action Preparations↗
PubMed1983

Product selection, bioequivalence, and therapeutic equivalence: the generic drug market.

Pharmacists are continually faced with drug product selection decisions. When is a generic drug product equivalent to the innovator product and, thus, a suitable candidate for generic substitution? The FDA policy has been that only drug products that are therapeutic equivalents are candidates for product selection decisions. This paper outlines the regulatory and scientific framework for the FDA's policies and requirements for generic drug products. The history and current status of the Drug Efficacy Study Implementation (DESI) project is described. Originally begun in 1966 as a review of about 3,400 drug products, the review in mid-1983 is more than 90% complete, but its impact has already affected more than 7,000 marketed drug products. The therapeutic equivalence policy and the manner in which decisions on therapeutic equivalence are communicated are reviewed. Regulatory policies for the approval of generic drug products are reviewed and specific litigation challenging the rights of generic drug manufacturers to produce generic "look-alikes" and challenging the FDA's policy that a generic drug product is a new drug requiring an approved New Drug Application for marketing is discussed. The conclusion reached is that the evaluation of regulatory requirements and science is leading to a point where all generic drug products will be known to be safe, effective and therapeutically equivalent, and pharmacists can be optimistic about the quality of products in the generic drug market.

Legislation, Pharmacy↗
PubMed1996

[Strategies for pharmaceutical research and development. II. Generic drugs].

When the patent protection is terminated, the original registered-mark preparation becomes a generic drug, which results in a decrease in its price as compared with the original pharmaceutical. The effects of changes in price relation are discussed from the viewpoint of the generic firms and the manufacturers of original preparations. The differences in the insurance system and legislative regulations of the registration of generic preparations can markedly the size influence of the share of generic drugs in the total consumption of drugs. The future development of generic drugs from a general viewpoint is discussed in relation to the contemporary extensive expiration of patent protection of drugs. The hitherto results are summed up and the topics for the present strategy of the development of generic drugs in the Research Institute for Pharmacy and Biochemistry, or in the Czech Republic, respectively are discussed.

Czech Republic↗
PubMed2002

[Evaluating, improving and monitoring generic drug prescription].

OBJECTIVE: To evaluate and improve generic drug prescription by family physicians in a regional primary care district with a specially-designed intervention. DESIGN: Uncontrolled study of an intervention, based quality evaluation and improvement methods. We selected an indicator that could be constructed with the available data (monthly reports of prescriptions dispensed through the public national health system) and determined the proportion of prescriptions for generic drugs to the total number of prescriptions dispensed, for those medications that had a generic alternative (percentage of generic prescriptions, PGP). After these data were evaluated, an intervention was implemented to increase generic prescriptions. Prescribing behavior was again evaluated and monitored at the end of the intervention period. Setting. Forty-five primary care teams in the Murcia (Southeast Spain) regional primary care district. PARTICIPANTS: A total of 339 family physicians. Interventions. During 15 months, individual reports of prescribing practices, in which changes over time were graphed, were sent to each participating prescriber. Each semester the physicians received a personal letter and a specially-printed, updated card showing the generic medications available and their pharmaceutical forms. One to three face-to-face clinical outreach sessions were held with each primary care team. Specific prescribing goals for the PGP were set and incentives to attain the goals were included in the terms of the contract for clinical services signed between the regional office of primary care management and each primary care team. MAIN OUTCOME MEASURES: The PGP increased from a pre-intervention rate of 2.7% to a post-intervention rate of 17.63%. Absolute improvement was therefore 14.84%, and relative improvement was 15.27%. Variability was monitored and analyzed with control charts. There was no significant variability within the pre- and post-intervention phases, whereas variability increased significantly (indicating improvement) during the intervention phase. CONCLUSIONS: The increase in PGP showed that prescribing for generic preparations improved. Statistical quality control tests were useful in evaluating and tracking the results of the intervention, and were indispensable for monitoring and promptly detecting opportunities to improve prescribing behavior and take appropriate measures.

Drug Prescriptions↗