Adverse drug reaction reporting system: developing a well-monitored program.
The spontaneous reporting of adverse drug reactions (ADRs) at the St. John's Hospital and Memorial Medical Center was well below that reported in the literature. After review of procedures for reporting of ADRs at these institutions, the authors developed a system that was approved by their joint P & T Committee. The ADR reporting program developed uses concurrent monitoring of most hospital inpatients and a retrospective review of all emergency room patients. In the year after program implementation, 162 ADR reports were documented. From this program, a group of serious ADRs to one agent was identified and reported, both to the Food and Drug Administration and to the manufacturer. A well-developed ADR monitoring program may lead to heightened physician and nurse awareness and early problem identification, possibly decreasing morbidity for hospitalized patients.
D004282:Documentation; D064420:Drug-Related Side Effects and Adverse Reactions; D005069:Evaluation Studies as Topic / Q000379:methods*; D005572:Formularies, Hospital as Topic; D006746:Hospital Bed Capacity, 500 and over; D006801:Humans; D007087:Illinois; D007591:Joint Commission on Accreditation of Healthcare Organizations; D010606:Pharmacy and Therapeutics Committee; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration