Evaluation of adverse drug reaction reporting systems

In July 1979, in accordance with the Joint Commission on Accreditation of Hospitals (JCAH) standards, the Pharmacy and Therapeutics Committee approved a policy for reporting adverse drug reactions (ADRs) occurring within the 370-bed University of Utah Hospital. This policy was intended "to provide a mechanism to accurately and completely report adverse drug reactions which are suspected within the hospital." It required the health care provider initially suspecting the adverse drug reaction to complete an Adverse Drug Reaction Experience Reports Form (FDA Form #1639). These report forms were to be available at each inpatient unit out outpatient clinic. A follow-up was then conducted on each of these reports. The results were to be sent to the Food and Drug Administration and a copy kept on file within the Drug Information Center. The objectives of this study study were: 1.) To assess the general compliance rate of a more accessible reporting system; 2.) To determine whether the format of a short versus a long form is more acceptable to physicians; 3.) To compare the incidence of reported adverse drug reactions using a reporting form to the incidence of adverse drug reactions reported in the medical record, and; 4.) To compare the incidence of adverse drug reactions with the new system versus the incidence for the prior system.