Keith M R, Bellanger-McCleery R A, Fuchs J E
Department of Pharmacy, University of Texas Medical Branch, Galveston 77550.
Am J Hosp Pharm. 1989 Sep;46(9):1809-12.
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.
本文描述了一个药物不良反应（ADR）报告程序，该程序包括由质量保证护士检测病历中记录的ADR，以及由药剂科工作人员进行数据收集和因果关系评估。一所拥有900张床位的大学附属医院采用的自愿性ADR报告机制，每月产生的ADR报告不足一份。新实施的系统依赖护士通过同步病历审查来检测和报告已记录的ADR。然后，药剂科工作人员负责后续的病历审查、数据收集，并根据两种已发表的算法进行因果关系判定。为药剂科和质量保证护士提供了一项在职教育计划，旨在提高对ADR的认识和理解。临床工作人员通过每周的ADR委员会会议提供质量保证。药物信息中心人员利用药剂科工作人员收集的数据完成因果关系算法。然后，ADR委员会比较两位评估人员的算法结果。对评分差异进行评估，以确定是否需要对系统进行调整。如果药剂科工作人员评估人员和药物信息中心评估人员对两种算法均得出“可能”的结果，则生成一份FDA报告。一个依赖质量保证护士检测病历中记录的ADR并由药剂科工作人员评估报告的ADR的报告程序，使每月报告的ADR平均数量从0.4份增加到了20份。
