Recognition, evaluation and reporting of adverse drug reactions

Adverse drug reactions (ADR) have occurred for as long as there have been drugs. Within the past decade, much attention has been focused on these types of drug-induced problems. These foci have been directed toward measuring the prevalence and untoward effects of drug use problems, as well as on prevention and problem abatement activities. Reactions are classified based on suspected drugs, the patient population and outcomes. Systemic evaluation methodologies are described in order to assess reactions based on severity, probability, preventability, mechanism of action and the need for further reporting to the FDA and the pharmaceutical manufacturer. While the thrust of this article is about ADRs that occur in health facilities, many of the principles presented are applicable to clinical research. Clinical associates need to know the specifics of monitoring and preventing ADR in their subjects. It is anticipated that some of the suggestions presented her will be beneficial in this regard.