Identification of adverse reactions to new drugs. IV--Verification of suspected adverse reactions. 1983

G R Venning

The verification processes were assessed for 18 important adverse drug reactions. Verification when achieved by formal studies was not obtained through cohort studies such as postmarketing surveillance or other follow up of drug users but through case-control studies or a similar disease orientated approach. When not achieved in this way the most useful aspects of uncontrolled studies were rechallenge and dose-response data. Analysis of the data and of the characteristics of different methods of verification suggested that there were four approaches to earlier discovery. (1) The best system seemed to be some form of record linkage, capable of providing at the same time data on incidence of adverse reactions and on prevalence of drug usage in patients with disease suspected of being drug induced. Until such a system can be established the relative efficacy of alternative approaches appears to be (2) review of all published first alerts, with prompt initiation of case-control or disease orientated studies for verification, (3) postmarketing surveillance of cohorts of drug users, and (4) voluntary reporting systems.

UI MeSH Term Description Entries
D008498 Medical Record Linkage The creation and maintenance of medical and vital records in multiple institutions in a manner that will facilitate the combined use of the records of identified individuals. Record Linkage, Medical,Linkage, Medical Record,Linkages, Medical Record,Medical Record Linkages,Record Linkages, Medical
D011358 Product Surveillance, Postmarketing Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale. Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004305 Dose-Response Relationship, Drug The relationship between the dose of an administered drug and the response of the organism to the drug. Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D064420 Drug-Related Side Effects and Adverse Reactions Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals. Drug-Related Side Effects and Adverse Reaction,Adverse Drug Event,Adverse Drug Reaction,Drug Side Effects,Drug Toxicity,Side Effects of Drugs,Toxicity, Drug,Adverse Drug Events,Adverse Drug Reactions,Drug Event, Adverse,Drug Events, Adverse,Drug Reaction, Adverse,Drug Reactions, Adverse,Drug Related Side Effects and Adverse Reaction,Drug Related Side Effects and Adverse Reactions,Drug Side Effect,Drug Toxicities,Effects, Drug Side,Reactions, Adverse Drug,Side Effect, Drug,Side Effects, Drug,Toxicities, Drug

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