Use of a database computer program to identify trends in reporting of adverse drug reactions.
A computerized system for concurrent monitoring and reporting of adverse drug reactions (ADRs) in a university hospital is described. The program, which began in 1988, was developed in collaboration with the hospital's pharmacy and therapeutics committee and quality assurance committee. Quality assurance nurses review patients' charts every three days during hospitalization; if an ADR is detected, the nurse completes an ADR report form. A computer database is used to sort and store 15 data elements taken from each ADR form. Individual pharmacists and hospital review committees evaluate the recorded ADRs. The database can present the data for analysis by different variables such as patient age, clinical service, and implicated drugs. Retrieval of such data permits easier evaluation of trends in ADR reports and identification of reactions that should be reported to FDA. Educational programs for staff members can be targeted to address problems occurring within the institution. During the first nine months of the program 340 ADRs were reported; 15 reports were submitted to FDA, and serious problems were reviewed at medical grand rounds. A bimonthly newsletter that reviews recently reported ADRs was begun. The monitoring program has facilitated rapid detection and evaluation of ADRs.
Johnston
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PE
Department of Pharmaceutical Services, Vanderbilt University Hospital, Nashville, TN 37232-7610.
Morrow
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JD
Branch
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D064420:Drug-Related Side Effects and Adverse Reactions; D006746:Hospital Bed Capacity, 500 and over; D007256:Information Systems; D010607:Pharmacy Service, Hospital / Q000458:organization & administration*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012984:Software; D013714:Tennessee; D014481:United States; D014486:United States Food and Drug Administration