System for voluntary reporting of adverse drug reactions in a university hospital.

The development and implementation of a system to improve voluntary reporting of adverse drug reactions (ADRs) is described. A preliminary study comparing three concurrent voluntary reporting systems at a 327-bed university teaching hospital demonstrated the ability of medical records personnel to identify ADRs that were documented in the medical record but not reported under the voluntary system. It was concluded that a concurrent voluntary reporting system would be coupled with a medical record review process that would focus reporting on clinically important and unexpected ADRs. Failures to report ADRs would be handled through existing procedures of staff privilege allocation and peer review. The baseline ADR rate was determined. A telephone reporting system was established for the medical staff. After review of reported reactions by pharmacy, feedback was provided to ADR reporters and the medical staff. During the first three months under the new system, 9 of 114 documented ADRs were reported, compared with none in the three months before the program began. All ADRs defined as reportable were reported. An ADR-reporting system designed to encourage voluntary reporting of selected reactions, monitor the baseline rate of ADR occurrence, and assess compliance with reporting criteria appears to operate satisfactorily.