Use of standardized screening procedures to identify adverse drug reactions.
The development of an adverse drug reaction (ADR)-monitoring program using standardized screening procedures in a 650-bed hospital is described. A concurrent ADR-reporting system that relied on health-care professionals to report observed ADRs to the pharmacy had generated just two ADR reports during the previous year. The pharmacy developed a program that used standardized procedures to screen for ADRs. The Technicon computer was programmed to screen the previous day's orders for antidotes or "tracer" drugs. In addition, pharmacists screened all laboratory reports of serum drug concentration determinations and positive tests for Clostridium difficile toxin. Spontaneous reporting of ADRs by nurses and physicians was strengthened by use of a revised notification form, newsletters, and inservice-education programs. During the first seven months of the program, 298 ADRs were identified, 15 of which were submitted to FDA. The standardized screening procedures accounted for 149 reports. Pharmacists reviewed an average of 21 reports of high serum drug concentrations each month; on average, 11 of these reports involved ADRs. Screening of microbiology laboratory reports identified 29 ADRs. Physicians reported ADRs infrequently and were likely to report only serious or unexpected reactions. Nurses and pharmacists identified reactions sporadically. Quality assurance auditors were consistent in screening ADRs, but not all reported reactions proved to be ADRs. The use of standardized screening procedures was effective in this pharmacy-based ADR-monitoring program.
Koch
K E
KE
Department of Pharmacy, North Mississippi Medical Center, Tupelo 38801.
D000931:Antidotes; D019411:Clinical Laboratory Techniques; D004340:Drug Contamination; D064420:Drug-Related Side Effects and Adverse Reactions; D005568:Forms and Records Control; D006746:Hospital Bed Capacity, 500 and over; D008922:Mississippi; D010607:Pharmacy Service, Hospital / Q000458:organization & administration*; D011358:Product Surveillance, Postmarketing / Q000592:standards*
D000931:Antidotes