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At least 19 recordsLinked to original sources
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↗
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↗
PubMed1987

Family physicians and generic drugs: a study of recognition, information sources, prescribing attitudes, and practices.

A survey of a national sample of family physicians was undertaken to investigate several aspects of attitudes and prescribing patterns related to generic drugs. Questionnaires were returned by 317 of 501 eligible respondents for a response rate of 63.3 percent. Of the respondents, 62.5 percent said they had enough confidence in generic drugs to prescribe them in their practices, but only 26.9 percent said they actually prescribed mostly generics. Respondents were also asked to indicate the relative importance of several potential sources of information on new drugs and to test their ability to recognize a list of generic and trade name drugs. Several associations were identified between physicians' sources of drug information and generic drug recognition, attitudes, and prescription patterns. The habit of prescribing mostly generic drugs, for example, was found to be more common among family physicians who were residency trained, who relied least on drug company representatives, and who were regular readers of the New England Journal of Medicine. The ability to recognize all ten generic names was found to be highest among these same groups of physicians and also among those who relied least on journal advertisements and those who were regular readers of The Medical Letter.

Attitude of Health Personnel↗
PubMed1990

Physicians' attitudes toward generic drug substitution by pharmacists.

Physicians in Southeast Texas were surveyed to obtain information on attitudes and practices concerning generic drug substitution. Questionnaires were sent to all practicing primary care physicians in the area, and responses were received from about 36% of them. The investigation revealed that a large percentage of physicians did not readily permit substitution. Two major reasons given for not permitting substitution were concerns about therapeutic inequivalency and doubts about pharmacists' ability to substitute safely.

Attitude of Health Personnel↗
PubMed1991

The new Philippine Generic Drugs Act: a physician's viewpoint.

To ensure that affordable and effective drugs are made available to all Filipinos, the Philippine government passed the Generics Act of 1988. The Act has generated much heated debates from both local and international health providers. A preliminary evaluation of a survey of the knowledge, attitude and practice (KAP) of physicians towards the Act showed that 70% are opposed to the Act. A majority of these physicians believe that the Bureau of Food and Drugs is not capable of ensuring the quality of the generic drugs. The success of the Act's implementation may lie in the ability of the government to ensure the quality of generic drugs and to disseminate relevant information to the practicing physicians.

Attitude of Health Personnel↗
PubMed1987

Savings from generic drug substitution in the RSA--is its cost justified?

The causes of the recent rapid increases in health care costs in the RSA are briefly studied. Drug costs have increased largely through the use of new innovations, greater usage and price factors, but price increases have been below the rate of inflation. The savings in drug costs to be expected from the introduction of generic substitution have been calculated to be low in relation to overall health care costs, although of significance in relation to the survival of individual drug manufacturing businesses. The thrust towards generic substitution is possibly misplaced in that the potential savings in hospitalisation costs from the discovery of new drugs are so large that they justify the encouragement of the innovative drug manufacturers.

Cost Control↗