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PubMed2004

[Generic drugs: an alternative for the Brazilian market].

The analysis of the main characteristics of the pharmaceutical industry worldwide and market aspects of that industry in Brazil leads us to consider a high share of external dependency and oligopolization. This situation is not peculiar to our country, but is rather a global trend. Recent Government initiatives in Brazil, aiming at reducing that dependency, associated with the critical aspects regarding the prices and costs of drugs as compared to international prices, are the background that support the proposal of evaluating generic drugs as an alternative for Brazilian market. One of the most striking aspect is the verification of overpricing of raw materials as demonstrated by "transfer prices", a practice that has been observed in several countries. Analysing international concepts dealing with generic drugs, generic names and pharmaceutical equivalence, based on World Health Organization recommendations and evaluating the experiences of different countries, several actions are proposed in order to gradually enforce a policy of generic drugs, bioequivalent and interchangeable, as a possible regulatory mechanisms for Brazil.

English Abstract↗
PubMedDate not supplied

[Do generic drugs help control expenditure on hypertension? Apropos of a case].

OBJECTIVE: In this article we analyze the influence of generic drugs on pharmaceutical expenditure on hypertension from the payer's perspective (the public health service), by examining the most widely used drugs: angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs). METHODS: Based on billing data to the public health service from all the pharmacies in the Health Area of Malaga, we studied the utilization (containers and cost) of ACEi (generic drugs ACEi+G and brand name) and ARBs (brand name only) (subgroup C09 ATC index) from 1999 to 2002. The mean price (weighted according to sales) and the percentage of deviation of prescriptions from one group of drugs to another was also studied. RESULTS: The increase in consumption of packages in subgroup C09 was 20.79%; the increase was greater for ARBs (136%) and for ACEi+G (177%). The total amount spent during the study period increased by more than 42%. Expenditure on ACEis decreased by almost 7%, despite the increase in expenditure on ACEi+G, whereas expenditure on ARBs increased by more than 154%. The mean price of this subgroup, weighted according to sales, increased by nearly 18%. The mean weighted price of the generic drugs, captopril and enalapril, and that of the brand name, trandolapril, decreased. Notable among ARBs was the increase in mean price weighted according to sales of irbesartan (9%) and valsartan (16%). CONCLUSIONS: The use of generic drugs has reduced expenditure on ACEi and the mean weighted price of the subgroup. However, the increased use of generic drugs has not produced the expected savings for the Department of Health. This could be due to deviation of prescription scores toward drugs not affected by substitution by the pharmacy.

Angiotensin II Type 2 Receptor Blockers↗
PubMed1987

Medical and psychiatric implications of generic drugs.

Among the most controversial issues surrounding the use of generic drugs is the reliance on bioavailability data to approve generic products. Bioequivalence does not necessarily translate into therapeutic equivalence. In some cases, because of the broad interpretation of drug equivalence, patients may not be receiving adequate amounts of medication, while others may be receiving toxic doses. In contrast, rigorous rules exist for the approval of brand-name medications. Resolving the generic drug standard issue by adopting stricter guidelines for generic drug approval based on clinical efficacy and toxicity data rather than on the bioequivalence standard currently being used would more likely result in safer, more effective patient care. Economic burdens for postmarketing research should be shared jointly by the research-oriented and generic drug companies. Such a policy would ensure continued research and new drug development. This paper reviews major scientific, economic, social, and legal issues involved in generic drug use with particular emphasis on the psychotropic drugs.

Biological Availability↗
PubMed1999

[Generic drugs and the rights of substitution].

Compared with other countries with a similar socio-economic environment, generic drugs account for a very small proportion of pharmaceutical sales in France. The recently promulgated law on financing the national healthcare system states that drug dispensers have the right to substitute generic drugs for prescription drugs in accordance with the drug equivalence repertoire established by the national drug agency. How patients, pharmacists, physicians and industrial firms will react to this new situation is an open question as use of generic drugs is basically unknown in France. Prescribing physicians, members of the drug agency, pharmacists, health economists, and insurance company and pharmaceutical firm representatives participated in a round table discussion to clarify the ongoing debate on the effect of this new cultural situation which calls an end to the French "exception" in drug consumption. The concept of generics and their use in substitution for prescription drugs was discussed in light of the outlined economic objectives together with the advantages and disadvantages patients and physicians can expect.

Drug Industry↗
PubMed2002

[Generic drugs].

Various incentives will progressively increase the part of generic drugs on the Belgian market place and will more and more confront the prescriber with the problem of substitution. The equivalence between generic and brand name products and the fear, justified or not, at efficacy or patient safety levels in case of substitution are discussed on the basis of biopharmacy and pharmacokinetic concepts in connection with modalities generally adopted when requesting marketing authorisation. Considering the extent of their utilisation at international level and the low frequency of clinically significant problems linked to bioequivalency, limited to a small number of substances, prescribers should be soon released from their apprehensions on the quality of generic drugs. On another hand, they must be stimulated to be vigilant when they substitute a drug by any other one, especially in the cases of drugs, classes of drugs, or pharmaceutical forms considered as critical and when occurring to patients whose disease or physiological status are able to amplify bioequivalence problems.

Belgium↗
PubMed1996

[Usefulness of prescription of generic drugs for cost containment in pharmaceutics. Analysis in the Community of Navarra].

OBJECTIVE: To determine the effect of the use of generics drugs on the costs of pharmaceutical prescription, in order to help decide on their use. DESIGN: Descriptive study. SETTING: Prescriptions from all the doctors in the Health Service of Navarra-Osasunbidea. MEASUREMENTS AND MAIN RESULTS: Pharmaceutical products with over 5,000 containers consumed during 1994 in Navarra, and with a generic drug which had the same presentation, were selected. The cheapest generics drug was chosen and the hypothetical saving over the brand-name drug was calculated. None of the 285 products in most common use were generics. Use of generics instead of brand drugs would have saved 109,748,344 pesetas. Use of generics drugs instead of commercial products would reduce cost for the drugs studied by 21%. This saving would mean a 1.2% decrease in the overall cost of pharmaceutical prescription. CONCLUSIONS: Although generics drugs are not readily available, their use would decrease the cost of pharmaceutical prescription, with results comparable to those obtained from negotiation with the industry and pharmacists' representatives. The effect would be more long-lasting, as it would mean a change in doctors' prescription habits.

Cost Control↗
PubMed2006

[Generic drugs and legal incentives: which impact?].

The dispositions that regulate generic substitution in Switzerland have been recently revised, and impose definite incentives on prescribers. The benefits and drawbacks associated with the prescription of generic drugs are reviewed, considering the viewpoints of patients, practitioners and third party payers. While the initial prescription of a generic drug raises no specific concerns, the generic switch during long-term treatment may require some caution. The advantages of using International Nonproprietary Names (INN) for drug prescription are discussed. A renewal of prescription habits would be welcomed however several practical issues would have to find rational solutions.

Drug Prescriptions↗
PubMed1999

Pilot trial for the assessment of relative bioavailability in generic drug product development: statistical power.

In developing generic drug products, pilot trials are used for identifying successful test formulations to enter pivotal trials. In this study, we derive the power function based on the log-normal distribution and evaluate the effects of potential influential factors-the true test-reference ratio, intrasubject variability, and sample sizes-on the statistical power of a pilot trial to identify successful test formulations, defined as the probability that the test-reference ratio estimate from a pilot trial falls within a predetermined acceptance range when the true ratio is acceptable. Of these influential factors, the test-reference ratio exhibits the largest impact on the statistical power of a pilot trial, followed by intrasubject variability, sample sizes of pivotal trials, and sample sizes of pilot trials. The sample sizes that are used in pilot trials (8-12 subjects) may be sufficient for test products with low intrasubject variability and true ratio close to 1 and may fall short otherwise.

Biological Availability↗
PubMed2004

Potential savings from increased use of generic drugs in the elderly: what the experience of Medicaid and other insurance programs means for a Medicare drug benefit.

BACKGROUND: Generic medications provide the same clinical effect at lower cost than brand name drugs but little is known about the extent to which such savings are achieved in drug benefit programs serving the elderly. METHODS: Using patient-level claims data for participants aged 65 or more in one state Medicaid program and in a non-Medicaid drug insurance program for the elderly, we compared the expenditures in each program for brand name prescriptions with the amount that would have been paid for generic versions of the same agents. We then estimated potential savings from increased use of substitutable brand name drugs. RESULTS: There was an unrealized annual savings of 3.4 million dollars (3.6% of total drug expenditure) in the Medicaid program studied and 13.7 million dollars (9.5% of total drug expenditure) in the non-Medicaid drug insurance program for the elderly, with corresponding reductions in mean annual per-patient drug costs. CONCLUSIONS: More widespread use of generic medications represents an important source of unrealized savings in drug coverage programs for the elderly. The Medicaid program limits the excess spending on brand name drugs by imposing pricing restrictions, but many non-Medicaid programs could realize even larger savings from reducing the use of brand name drugs when identical generic products are available. These findings offer some insight into the potential expense of a Medicare prescription drug benefit.

Aged↗
PubMed2006

Attitudes of Slovene general practitioners towards generic drug prescribing and comparison with international studies.

BACKGROUND: Over the recent years there has been a steady 7% yearly increase in prescribing costs, which accounts for 17% of the Slovene national health care budget. Substitution of branded products by generic equivalents can offer savings. General practitioners (GPs) are often concerned about the quality of generic products and possible legal liabilities associated with their use. OBJECTIVE: We wanted to examine the attitudes of GPs in Slovenia towards generic drug prescribing. METHODS: We conducted a postal survey of a random sample of 200 out of 800 GPs in Slovenia from the National Health Insurance Institute database. GPs were asked 21 questions regarding their knowledge on generic drugs, awareness of prescribing costs, prices of generic drugs relative to brand name drugs and their attitude towards use of generic drugs. RESULTS: The 117 (58.5%) replies we received represent 15% of the GP population in Slovenia. 66.1% of GPs considered rising costs of medicines to be a serious problem for the health care budget. Each week, over 50% of GPs experienced demands from patients for specific drugs and the majority of GPs usually met their patients' demands or requests from hospital consultants for branded products. 38.3% of GPs did not take price into consideration when prescribing drugs. The majority of GPs (88.9%) perceived generics to have the same effectiveness as branded drugs. One quarter of GPs would prescribe more generics if additional clinical trials were presented. 37.3% would follow advice of academic detailers and 30.3% expected the generics to be even cheaper than they were. Independent detailing was welcomed by 63.8% of GPs because of the big influence of the pharmaceutical industry on the prescribing habits. 15.5% thought that the industry had a tremendous impact on their prescribing patterns. CONCLUSIONS: Slovene GPs are aware of the cost of prescribed drugs. They are willing to accept independent academic detailing to improve their prescribing and are willing to increase generic drugs under certain conditions.

Adult↗
PubMedDate not supplied

[Generic drugs in psychopharmacology: pros and cons].

Legislation to facilitate process for generic products has been enacted and generic drugs have entered the market soon after the patent for the brand-name agent have expired. In every instance, the rationale has been economic since it is generally assumed that the copies are not only therapeutically equivalent but also a great deal less expensive than the original. Sometimes this may be so. In this short review several comments are made in order to establish the variables that may influence bioequivalence between the brand-name drug and its generics. Among them emphasis is given to the particle sizes, pharmaceutical supply, choice of the right excipient, in order to avoid possible interactions with the drug, ingredient quality and purity, etc. All these variables must be carefully controlled. Even so a patient who is changed from a trade name product to a generic drug (or vice versa) may respond a little differently, which is important in Psychopharmacology. Two or more products should be considered biologically equivalent only when it can demonstrated that they fulfil three conditions: that they have the same pharmaceutical properties; that they are equally effective in therapeutic use and that they are tolerated equally by patients being treated for the indicated uses. Regulatory agencies could require subsequent versions of an original therapeutic product the type of data regarding pharmacology, toxicology and chemical assessment that was mandatory for the introduction of the original.

Drugs, Generic↗
PubMed2005

[Social representations of generic drugs by pharmacists: determination of the central and peripheral representational systems].

This article aimed to identify the central and peripheral systems in social representations of generic drugs by pharmacists, as well as their social and economic profile, thereby establishing potential mechanisms for improving policies for generic drugs in Brazil. The data collection instruments were a questionnaire and a word association test, the inductive cue of which was the term "generic drug". Data collected through the questionnaire produced a profile of pharmacists in the city of Natal, Rio Grande do Norte State, and key information related to the theme. Data analysis for the word association test used Evoc 99 software while content analysis used Bardin, thereby identifying the central system in social representations of generic drugs, consisting of the categories price, quality, and credibility, while the peripheral system consisted of the categories pharmaceutical care, social impact, novelty, accessibility, options, and interchangeability.

Attitude of Health Personnel↗
PubMed1997

A physician survey on generic drugs and substitution of critical dose medications.

BACKGROUND: Generic substitution has become a common practice since the late 1970s. Because of the increased use of generic alternatives and concerns about the Food and Drug Administration standards for bioequivalency, especially with respect to narrow therapeutic index drugs, the awareness and attitudes of prescribing physicians to generic drugs and generic substitution are important. METHODS: A questionnaire designed to assess attitudes, beliefs, knowledge, and experiences with generic drugs and generic substitution was sent to 3639 physicians nationwide. Cluster analysis was used to identify attitudinal groups that were then analyzed with respect to differences in beliefs, knowledge, and experience with generic drugs. Perceptions of the therapeutic index for 15 branded drugs and comfort in substituting those products with generic alternatives were assessed. RESULTS: Physicians were classified into prosubstitution and antisubstitution groups, with a further division of antisubstitution physicians according to whether they felt influenced by outside pressures to substitute. Significant differences were found between the prosubstitution and antisubstitution groups with respect to beliefs about and experiences with generics and knowledge of the Food and Drug Administration bioequivalency standards. Of particular significance was the low percentage (17%) of physicians who correctly identified the Food and Drug Administration standards for bioequivalency. Prosubstitution physicians generally rated therapeutic indexes as wider than antisubstitution physicians. Physicians in all groups identified similar products they believed were not appropriate for substitution. CONCLUSIONS: Attitudes toward generic substitution are related to prescribing behaviors, beliefs about and experience with generic substitution, and perceptions of therapeutic index and comfort with substitution. Physicians need to understand the issues surrounding generic substitution and remain empowered to influence decisions to substitute.

Adult↗
PubMed1999

Revocation of Office of Generic Drug's interim policy statement on inactive ingredients. Food and Drug Administration, HHS. Notice.

The Food and Drug Administration (FDA) is revoking an interim policy statement on inactive ingredients in parenteral, ophthalmic, otic, and topical generic drug products (Interim Inactive Ingredient Policy). These generic drug products are the subjects of abbreviated new drug applications (ANDA's). The Interim Inactive Ingredient Policy was issued as a memorandum from the Acting Director of the Center for Drug Evaluation and Research's (CDER's) Office of Generic Drugs, FDA, to CDER's Associate Director for Science and Medical Affairs, FDA. FDA is taking this action because the Interim Inactive Ingredient Policy no longer represents current agency policy.

Drugs, Generic↗
PubMed2006

[Generic drugs instead of brand drugs prescriptions--long overdue].

BACKGROUND: Generic substitution of drugs was introduced in Norway in 2001. This implies an obligation for pharmacies to substitute the prescribed drug with a generic equivalent. Instead of using the drug manufacturers' trade names, doctors can prescribe drugs by using the generic (non-proprietary) names. The present paper gives an overview over current practice in different countries and discusses advantages and drawbacks. MATERIALS AND METHODS: Literature on generic substitution and generic prescription was sought on PubMed. Regulatory authorities in Norway and other countries were approached for additional information. RESULTS: In the United Kingdom, generic prescription has been dominating for many years. In Sweden, a successful trial period with generic prescribing was recently reported. We have not identified any pharmacological arguments against generic prescription. INTERPRETATION: Available data suggest that generic prescribing of drugs should be encouraged. Generic prescribing is likely to improve patient safety by assuring that the prescribed drug is in fact what is dispensed.

Denmark↗