Multidisciplinary program for detecting and evaluating adverse drug reactions.
An adverse drug reaction (ADR)-reporting program involving detection of charted ADRs by quality assurance nurses and data collection and causality assessment by staff pharmacists is described. The voluntary ADR-reporting mechanism used in a 900-bed, university-based hospital complex produced less than one ADR report per month. The newly implemented system depends on nurses to detect and report documented ADRs through concurrent chart review. Staff pharmacists are then responsible for follow-up chart review, data collection, and causality assignment based on two published algorithms. An inservice education program designed to increase the awareness and understanding of ADRs was provided to the department of pharmacy and the quality assurance nurses. The clinical staff provides quality assurance through weekly ADR committee meetings. Drug information center personnel complete the causality algorithms by using the data collected by the staff pharmacists. The ADR committee then compares the algorithm results of the two assessors. Discrepancies in scoring are evaluated to determine whether a change in the system is necessary. An FDA report is generated if the staff pharmacist assessor and the drug information center assessor obtain results of "probable" for both algorithms. An ADR-reporting program that relies on quality assurance nurses to detect charted ADRs and on staff pharmacists to evaluate reported ADRs increased the average number of ADRs reported from 0.4 to 20 per month.
Keith
M R
MR
Department of Pharmacy, University of Texas Medical Branch, Galveston 77550.
Bellanger-McCleery
R A
RA
Fuchs
J E
JE
D003211:Concurrent Review / Q000458:organization & administration*; D004282:Documentation; D064420:Drug-Related Side Effects and Adverse Reactions; D006746:Hospital Bed Capacity, 500 and over; D006801:Humans; D009741:Nursing Staff, Hospital; D010595:Pharmacists; D010607:Pharmacy Service, Hospital / Q000592:standards*; D011785:Quality Assurance, Health Care; D013781:Texas; D014600:Utilization Review / Q000458:organization & administration*