Development of a hospital-based adverse drug reaction reporting program.
The development of an adverse drug reaction (ADR) reporting program at a university hospital is described in this article. Critical steps in the development process included identifying the personnel responsible for the program, defining ADRs and reportable ADRs, developing an ADR data form, promoting the program, and providing feedback to the health care professionals of the institution. A standing ADR subcommittee was formed to develop, implement, and coordinate the program. Two approaches to data collection were used: the standard format of voluntary reporting and a targeted drug method (targeting specific agents, typically newly approved drugs or those in which new, or potentially serious adverse reactions have been noted). The program was promoted through memorandums to department chairpersons and through a P & T Committee newsletter. The number of ADRs reported per quarter steadily increased from nearly zero to approximately 60 cases per quarter. Details on the implementation of this ADR program, its limitations and successes, are described.
D003625:Data Collection; D064420:Drug-Related Side Effects and Adverse Reactions; D005069:Evaluation Studies as Topic; D005376:Financial Management / Q000379:methods*; D006745:Hospital Bed Capacity, 300 to 499; D006801:Humans; D011358:Product Surveillance, Postmarketing; D012308:Risk Management / Q000379:methods*; D014589:Utah