Medical and psychiatric implications of generic drugs. 1987

B I Diamond, and J W Albrecht
Psychiatry Service, Augusta VA Medical Center, Ga.

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.

UI MeSH Term Description Entries
D011306 Prescription Fees The charge levied on the consumer for drugs or therapy prescribed under written order of a physician or other health professional. Dispensing Fees,Fees, Prescription,Dispensing Fee,Fee, Dispensing,Fee, Prescription,Fees, Dispensing,Prescription Fee
D011619 Psychotropic Drugs A loosely defined grouping of drugs that have effects on psychological function. Here the psychotropic agents include the antidepressive agents, hallucinogens, and tranquilizing agents (including the antipsychotics and anti-anxiety agents). Psychoactive Agent,Psychoactive Agents,Psychoactive Drug,Psychopharmaceutical,Psychopharmaceuticals,Psychotropic Drug,Psychoactive Drugs,Agent, Psychoactive,Agents, Psychoactive,Drug, Psychoactive,Drug, Psychotropic,Drugs, Psychoactive,Drugs, Psychotropic
D003363 Cost Control The containment, regulation, or restraint of costs. Costs are said to be contained when the value of resources committed to an activity is not considered excessive. This determination is frequently subjective and dependent upon the specific geographic area of the activity being measured. (From Dictionary of Health Services Management, 2d ed) Cost Containment,Containment, Cost,Containments, Cost,Control, Cost,Controls, Cost,Cost Containments,Cost Controls
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001682 Biological Availability The extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action. Availability Equivalency,Bioavailability,Physiologic Availability,Availability, Biologic,Availability, Biological,Availability, Physiologic,Biologic Availability,Availabilities, Biologic,Availabilities, Biological,Availabilities, Physiologic,Availability Equivalencies,Bioavailabilities,Biologic Availabilities,Biological Availabilities,Equivalencies, Availability,Equivalency, Availability,Physiologic Availabilities
D013810 Therapeutic Equivalency The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease. Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies

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