Michel D J, Knodel L C
Am J Hosp Pharm. 1986 Sep;43(9):2202-5.
A program coordinated by a drug information service to improve adverse drug reaction (ADR) reporting in a hospital is described. At a 520-bed teaching hospital, the drug information service was asked to design a new adverse drug reaction reporting system that would encourage clinicians to report ADRs. A new system was implemented on a general medical unit: A physician, pharmacist, or nurse telephoned the drug information service when an adverse drug reaction was suspected, and drug information personnel followed up on the report, completing all subsequent investigation and documentation. A standard algorithm was used to evaluate causality of the reported reactions. Pertinent data were entered on a form and retained in the drug information service. The primary physician's approval was obtained before a reaction could be reported on an FDA drug-experience form. Drug information service personnel reviewed the ADR data monthly to detect any trends that clinicians should be aware of and to prepare a report for the pharmacy and therapeutics committee. Nurses, physicians, and pharmacy personnel were oriented to the new system before its implementation and were subsequently informed about reported ADRs and use of the system through newsletters and meetings. In the initial three-month period, 23 ADRs involving 19 drugs were reported from the medical unit; in a six-month period before development of the new system, no ADRs had been reported. This ADR reporting system developed and implemented by the drug information service was effective in improving reporting of adverse drug reactions.
本文描述了一个由药品信息服务部门协调实施的项目,旨在改善某医院的药品不良反应(ADR)报告情况。在一家拥有520张床位的教学医院,药品信息服务部门被要求设计一个新的药品不良反应报告系统,以鼓励临床医生上报不良反应。新系统在一个普通内科病房实施:当怀疑发生药品不良反应时,医生、药剂师或护士致电药品信息服务部门,药品信息工作人员跟进报告,完成所有后续调查和文件记录工作。采用标准算法评估所报告反应的因果关系。相关数据记录在表格上,并保存在药品信息服务部门。在通过FDA药品经验表格报告反应之前,需获得主治医生的批准。药品信息服务人员每月审查药品不良反应数据,以发现临床医生应注意的任何趋势,并为药学与治疗学委员会编写一份报告。在新系统实施前,对护士、医生和药学人员进行了系统培训,随后通过时事通讯和会议向他们通报所报告的药品不良反应及系统的使用情况。在最初的三个月里,该内科病房报告了23起涉及19种药物的药品不良反应;在新系统开发前的六个月里,未报告任何药品不良反应。药品信息服务部门开发并实施的这个药品不良反应报告系统,在改善药品不良反应报告方面是有效的。