Journal of Clinical Pharmacy and Therapeutics zyxwv (1987) 12,243-247. zyx PILOT PROJECTS TO STIMULATE ADVERSE DRUG REACTION REPORTING Jack E. Fincham Mississippi Adverse Drug Reaction Reporting Program, Assistant Professor, Department of Health Care Administration, The University of Mississippi, School of Pharmacy, University, M S 38677, U.S.A. SUMMARY Schemesfor stimulating adverse drug reporting are described with particular emphasis on a recently introduced Mississippi Adverse Drug Reaction Reporting Programme. BACKGROUND Detection of adverse drug reactions (ADRs) can occur on a pre- or postmarketing basis with drugs. Premarketing clinical trials, however, have major limitations in the detection of ADRs which include: (a) Size-usually no more than 3000-5000 patients are studied. (b) Duration-usually clinical trials in the United States are no longer than zy 3-5 years and possibly less. (c) The scope of the patients and clinicians in the studies- (i) many types of patients who will ultimately use the drug are systematically excluded from the studies (e.g. pregnant women, children, the elderly, etc.); (ii) studies are often limited to specialists affiliated with large medical centres (excluding the average physician engaged in clinical practice). (d) Narrow drug indications are usually examined; other indications may arise after approval and marketing of the drug (1). Thus, the importance of postmarketing continued reporting of ADRs is prominent and crucial. A system for voluntary reporting of ADRs by health professionals in the United States has existed for approximately 2 decades. The principal objective of the entire monitoring system is to provide the regulatory division of the Food and Drug Adminis- tration (FDA) with postmarketing information concerned with the adverse effects of drugs. This information provides an early warning of unsuspected adverse effects and helps to provide important clues for further study by scientifically controlled methods. The early warning and causation hypothesis generation function is specifically related to the voluntary method of reporting of ADRs by health professionals. Despite the existing system in place for reporting ADRs, health professional report- ing is disappointing. Since 1968, the FDA Form 1639 (see Appendix A for a copy of Form 1639) has been made available for reporting of ADRs (2). The form is simple to Correspondence:Jack E. Fincham, Ph.D., Co-project coordinator. 243