The cases for and against prescribing generic drugs: generic prescribing benefits patients.
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Drug Industry↗
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A review of the safety of generic drugs.
Generic drugs have been around for many years. The Drug Price Competition and Patent Term Restoration Act 1984 makes the abbreviated new drug application process available to drugs approved after 1962. It does not lower any standards for generic drugs. FDA's comprehensive drug approval process evaluates information concerning (1) chemistry, manufacturing, and controls, (2) in vivo bioequivalence, (3) labeling, (4) in vitro dissolution data where applicable, and (5) inspection and auditing of all facilities. This stringent and comprehensive approval process ensures the quality of generic drug products marketed in the US and assures the health professionals and patients of the safety and efficacy of generic drug products.
Consumer Product Safety↗
Opinion and behaviour of pharmacists towards the substitution of branded drugs by generic drugs: survey of 1,000 French community pharmacists.
OBJECTIVE: In 1999, a new law was introduced, giving French pharmacists the right to switch from branded to generic drugs, unless the prescriber had specified that substitution was not permitted. The purpose of this study was to assess the opinion and behaviour of community pharmacists toward substitution. DESIGN: Self-completion, postal close-ended questionnaires were filled out. SAMPLE AND SETTING: 1,000 French community pharmacists were included. RESULTS: 90% of the pharmacists were favourable to the implementation of the substitution right. 42.5% declared they systematically offered patients the generic drug, whereas 55% chose to target specific populations for substitution. The reluctance of pharmacists could be commercial ('How do I get paid for the time spent? Is it worth risking loosing a customer?'), or cultural ('How do I work this out? Who should I offer generic drugs to? What strategy should I use to offer them?'). CONCLUSION: Generic drug distribution is very recent in France and is not yet common practice. Pharmacists and patients must be informed and trained because substitution is a collaborative act. It does not depend solely on the will and experience of pharmacists.
Adult↗
Survey of pharmacists: impact of the generic drug scandal and implications for marketing generic drugs.
The generic drug scandal that made headlines in 1989 shocked consumers, prescribers, pharmacists, insurers, the pharmaceutical industry, the FDA and Congress. Using data collected after the scandal was reported, this study investigates the impact of scandal on pharmacists' confidence in generics, and their attitudes, opinions and behavior toward generics. Based upon the findings, the author provides a set of recommendations for marketing generic drugs.
Adult↗
Exploring generic drug use behavior: the role of prescribers and pharmacists in the opportunity for generic drug use and generic substitution.
OBJECTIVES: The first objective of this study was to examine the prevalence of prescriptions that offer the opportunity for generic drug use (a prescription for a multisource drug product). The second objective was to examine the prevalence of generic drug use by examining the rate of generic drug prescribing for multisource drug products and the rate of generic substitution by pharmacists. The last objective was to examine the association of prescriber, pharmacist, insurance, patient, and drug variables with the prescribing of drugs allowing the opportunity for generic drug use and generic substitution. RESEARCH DESIGN: A database containing information for 6380 prescription orders was used for analysis. MEASURES: Random-effects logistic regression panel data estimation was used to examine the association of independent variables with whether a prescription allowed the opportunity for generic drug use and whether a prescription allowing generic drug use and written using the brand name was generically substituted. RESULTS: The opportunity for generic drug use existed for 63% of prescription orders. Prescriptions covered by private third party and indemnity insurance were 33% (97.5% CI, 0.56-0.80), and 21% (97.5% CI, 0.62-0.98), less likely, respectively, to allow the opportunity for generic drug use relative to uninsured prescriptions. Unobserved prescriber characteristics accounted for 23% (95% CI, 0.14-0.34) of the variance in the opportunity for generic drug use. Pharmacists generically substituted 83.8% of prescriptions that could be generically substituted. Prescriptions covered by Medicaid were 4.57 (97.5% CI, 2.83-7.39), 5.15 (97.5% CI, 3.25-8.13), and 4.85 (97.5% CI, 2.83-8.17) times more likely, respectively, to be generically substituted relative to uninsured, private third party and indemnity prescriptions. Unobserved characteristics of pharmacists accounted for 44% (95% CI, 0.33-0.55) of the variance in the occurrence of generic substitution. CONCLUSIONS: Pharmacists play a large and important role in generic drug use and efforts to increase generic drug use directed at pharmacists should be maintained. Additional efforts to increase generic drug use likely should be targeted at prescribers.
Adult↗
[Generic drugs: good or bad? Physician's knowledge of generic drugs and prescribing habits].
In this article we analyze the responses of 1220 Spanish physicians who participated in a survery about generic drugs. A previously validated questionnaire was sent to physicians through the Spanish Medical Councils of the different provinces. Four items were analyzed: what doctors know about generic drugs (knowledge); physicians' prescribing habits concerning these drugs (attitude and professional competence); how prescription of generic drugs effects pharmaceutical costs amd, finally, what doctors believe a generic drug should be. The influence of physician-related variables (age, type of contract, specialty, workload, etc.) on prescribing of generic drugs was also analyzed. In view of the results, we believe that to rationalize expenditure through and appropriate policy on generic drugs Spanish health authorities should offer more and better training and information (clear and independent) about what generic drugs are.
Adult↗
Proprietary drugs vs. generic drugs.
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Drug Industry↗
Legal control of drugs and generic drugs.
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Drug Prescriptions↗
[Calculation of drug information necessity factor of generic drugs].
The utilization of generic drugs has been promoted, but there is concern about the insufficiency of the information provided on generic drugs. To make an objective evaluation of the amount of information supplied by generic drug manufactures, we tried to quantify the information supply. The information described in the package insert and the interview form were used in the evaluation. We sent a questionnaire to 1000 randomly selected hospitals nationwide to determine the necessity of each information item in medical practice, and weighted the score allotted to each item based on replies from 524 hospitals. We applied these procedures to diclofenac sodium products and found that the score for a branded drug was 60.5 points and that for generic drugs ranged from 1.6 to 58.3 points. This indicates that there were great variations in information supply activities among the manufacturers. The Qua value, which was the ratio of the points of a generic drug per unit price in the drug tariff to the points of the branded drug, ranged from 0.1 to 2.4. We think that these procedures will make it possible to select the appropriate generic drugs in medical practice.
Drug Industry↗
[Prescription of generic drugs in general practice. Results of a survey of general practitioners].
BACKGROUND AND PURPOSE: Switching brand-name drugs to generics is reasonable and desired for economic reasons. Few data exist about problems, if any, during the switching in general practice. In this survey, the view of general practitioners (GPs) should be ascertained. METHODS: GPs in five counties in the German federal states Thüringen and Baden-Württemberg, who took part in a study on generic drug prescribing, were asked to complete a questionnaire about experiences and attitudes toward generic drug prescription. RESULTS: A total of 195 (84%) of 233 GPs answered the questionnaire. Two thirds (127/195) stated, that brands and generics are pharmacologically equivalent. Many of these GPs estimated to prescribe generic drugs in > 50% of instances; fewer doctors did so, if they had doubts as to the equivalence of generics (65% vs. 46%; p < 0.05). Nearly 8% reported generics being less effective, and 10% observed new adverse effects after switching. Many GPs appointed the following barriers: cooperation with hospitals and colleagues (86%), GP's lack of time (68%), and communication problems with the patient (50%). GPs estimated that > 10% of patients strictly reject generic drugs. CONCLUSION: An optimized cooperation between GPs and hospital physicians could facilitate the consumption of generic potential in pharmacotherapy. Reasons for the obvious contrast between the proven pharmacological equivalence of brand-name and generic drugs and the problems encountered after switching reported by GPs should be further studied.
Adult↗
What do primary care patients think about generic drugs?
OBJECTIVE: To examine the attitude of patients towards generic drugs and prescriptions containing generic drugs as an alternative to brand-name products, with a special focus on information on patients attitude to generic drugs provided by their general practitioners (GPs). METHODS: A total of 804 patients in 31 general practices were surveyed using a self-questionnaire. The influence of age, sex, education, disease, knowledge of generic drugs, experience with generic substitution and information provided by the GP on patient attitudes towards generic drugs and substitutions were examined. RESULTS: Nearly two thirds of the patients (509/804) stated that they knew of the difference between brand-name drugs and generics; of these, one third were not satisfied with the information given by their GPs and 37% of patients expressed general skepticism towards generic drugs because of their lower price. This attitude was more frequent among those who felt that generic prescribing was "invented" to solve the financial crisis in the German health insurance system at their expense (odds ratio (OR): 6.2; 95% confidence interval: 4.0 - 9.8) and those who had not been confronted personally with a generic substitution (OR: 1.8; 1.3 3.0). Patients who had been skeptical when first confronted with a generic substitution were more frequently among those who considered inexpensive drugs to be inferior (OR: 4.5; 2.0 10.4) and they were frequently not satisfied with the information on substitution provided by their GP (OR: 2.7; 1.2 - 5.9). CONCLUSION: GPs are in an ideal position to inform their patients adequately about the equivalence of brand-name and generic drugs. However, the patient view that inexpensive drugs must be inferior may be difficult to rectify in the short term.
Drugs, Generic↗
A case study of the evolving software architecture for the FDA generic drug application process.
This primary goal of this project was to develop a software architecture to support the Food and Drug Administration (FDA) generic drug application process by making it more efficient and effective. The secondary goal was to produce a scalable, modular, and flexible architecture that could be generalized to other contexts in interorganizational health care communications. The system described here shows improvements over the old system for the generic drug application process for most of the defined design objectives. The modular, flexible design that produced this new system offers lessons for the general design of distributed health care information systems and points the way to robust application frameworks that will allow practical development and maintenance of a distributed infrastructure.
Drug Approval↗
Bioequivalence and other unresolved issues in generic drug substitution.
BACKGROUND: Substitution of generic drugs for brand-name products is highly controversial and often is met with suspicion by health care providers and patients. Historically, the debate has focused on the issue of bioequivalence, and clinical practice has identified a number of drug classes for which generic substitution should be approached with caution. Current bioequivalence requirements are based on a measure of average bioequivalence; however, there are fears that use of this measure may be inappropriate in the case of a drug with a narrow or wide therapeutic range or high intrasubject or intersubject variability. Under these circumstances, measures of individual and population bioequivalence are proposed to be more accurate than measures of average bioequivalence. OBJECTIVE: This paper addresses issues of bioequivalence and other concerns with generic drug substitution. METHODS: I conducted a MEDLINE search of the English-language literature containing the key terms generic, multisource, quality, and brand and published between 1973 and 2003. The names of branded pharmaceuticals whose patents had recently expired (eg, Ventolin HFA, Adalat, Capoten, Tagamet HB 200, and Valium) also were used to search for articles on generic substitution. Reference lists of relevant articles also were searched. Bioequivalence issues are presented together with more general concerns over generic drug substitution, such as consumer perception of risk, differences in product and packaging appearance, and differences in excipients. RESULTS: The literature reviewed act to highlight a number of different drug categories and patient subpopulations for which generic substitution can still prove to be problematic. CONCLUSION: I recommend that health care providers continue to exercise caution in the consideration of generic drug substitution under certain circumstances.
Clinical Trials as Topic↗
[Antiinflammatory effect of a topical corticosteroid: known brand versus generic drug].
In Mexico, the generic drug market is growing. Regarding topical corticosteroids, there are several preparations on the local market but their clinical efficacy has not been assessed in relation with the original brand name. Using as a model the fluocinolone acetonide cream, the purpose of this study was to evaluate the antiinflammatory effect of different preparations. A double-blind, vehicle-control essay was conducted causing irritation on five sites of the volar aspect of the forearm in twenty healthy volunteers using 10% aqueous sodium lauryl sulfate. On the same part of the forearm, the formulations tested were applied for a period of 4 days with visual score irritation readings at days 2 and 4. The analysis of the results showed that although one of the generic drugs is 80% less expensive than the brandname medication, the clinical response was not as good as the other preparations. This deserves consideration, as newer and more potent generic corticosteroids will be available on the Mexican market.
Administration, Topical↗
Valuable information regarding generic drugs. Cutting costs by going generic.
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Animals↗
[Should the ophthalmologist prescribe generic drugs?].
It seems obvious that an ophthalmologist should encourage the use of generic drugs. However, it is important to know the exact definition of a generic drug and the type of studies to be conducted before a generic drug is released on the market. A generic drug is a drug that has the same composition quantitatively as well as qualitatively of the active compound as the original drug. It also has the same pharmaceutical mode of action and the same bioavailability, as determined with bioavailability studies. Ophthalmic drops contain both an active compound and many adjuvants used to stabilize the drug. Globally speaking, the active compound corresponds to the efficacy of a topical drug and the adjuvant to its tolerance. It is likely that the efficacy of a generic drug is identical to that of the brand-name drug, even though only bioavailability studies in non-human models are required to evaluate tolerance which is less likely to be identical, as adjuvants can differ. A survey of 520 French ophthalmologists has recently been conducted. It shows that doctors rarely think of prescribing generic drugs, as they do not consider cost as a major issue in treating glaucoma. However, they see no reason not to prescribe generic drugs. This mixed perception is shared by patients who willingly accept that doctors prescribe a generic drug, but do not wish the pharmacist to take the initiative of filling a prescription with a generic drug, which sometimes gives patients the impression of being less well treated. The use of generic drugs should be encouraged, keeping in mind that good tolerance should be ensured.
Drugs, Generic↗
Ethical ideology and product confidence: future pharmacists' attitudes toward generic drug substitution.
The impact of generic drugs on the prescription drug market has received widespread attention in the health care and marketing disciplines. Most research to date has focused solely on market factors' effect on pharmacists' attitudes toward generic drug substitution, and little attention has been given to individual factors. The present study extends previous research using Multiple Discriminant Analysis to ascertain the importance of ethical ideology and product confidence on pharmacists' attitudes toward future generic drug substitution across a salient set of market factors. The findings suggest that these individual factors are important in profiling pharmacists' disposition toward making a generic substitution in the future.
Attitude of Health Personnel↗
[Generic drug policy implementation in Brazil].
A generic drug policy has been implemented in Brazil since 1999. Several political and administrative stages transpired between enactment of the legislation and the actual marketing and consumption of these drugs. This article describes the policy implementation process and examines the country's generic drug legislation, approved from 1999 to 2002. To contextualize these measures, the study compares articles published by two national periodicals and interviews with a government representative involved in drafting the legislation and a representative from the pharmaceutical industry. Generic drugs quickly gained considerable space in the Brazilian pharmaceutical market. Ongoing adaptation of the legislation, media support, and the government's involvement in spreading the policy were key success factors. The population's access to medicines did not increase significantly, but people can now purchase medicines at more affordable prices and with quality assurance and interchangeability.
Brazil↗