目的:分析药物不良反应(adverse drug reactions,ADR)相关医疗纠纷的规律及特点,为临床合理用药提供参考.方法:对2011年1月至2023年1月中国裁判文书网上ADR相关医疗损害责任纠纷案例的裁判文书进行分析,建立数据库,汇总相关纠纷的原因并制订较为全面的处方审核策略.结果:共检索到判决书356例,纳入裁判文书201例,导致ADR排名前3的分别是抗菌药(65例,32.34％)、神经系统用药(31例,15.42％)中药饮片及中成药(23例,11.44％),其中,约1/3的案例法院判决医方存在医疗过错与患者出现ADR有一定因果关联,需承担60％～100％的赔偿.判罚缘由主要为医方对患者的用药指征把握不严格,用药风险预见不足,防范监测不足,告知义务履行不严格.结论:医疗机构应加强并完善ADR监测管理制度,关注临床合理用药,重视用药监护,充分运用处方审核系统降低ADR发生率,并发挥药师在处方审核与药学服务中的作用,减少ADR对患者造成的损害及相关用药纠纷,保障医患双方合法权益.
Prescription review strategy and case analysis of medical damage related to adverse drug reaction
OBJECTIVE To explore the regularity and characteristics of medical damage liability related to adverse drug reac-tion(ADR)and provide references for clinical rational use of drugs.METHODS From January 2011 to January 2023,medical damage liability disputes cases caused by ADR were retrieved from the legal-document database of China Judgements Online.And a strategy was formulated for comprehensive prevention and prescription review.RESULTS A total of 356 judgments were retrieved and 201 included as judgment documents.Top three categories of ADR-causing drugs were antibiotics(n=65,32.34％),nervous system agents(n=31,15.42％)and traditional Chinese medicines(n=23,11.44％).Approximately one-third of case courts ruled that physicians committed medical faults due to ADR and shouldered 60％-100％of compensation liabil-ity.The judgments highlighted such major issues as lax prescription indications,inadequate risk assessment,suboptimal preven-tion &monitoring practices and insufficient adherence to notification obligations.CONCLUSION Medical institutions should strengthen and further improve ADR monitoring and management system.It is imperative to emphasize rational drug use and medication monitoring and make full use of prescription review systems to mitigate ADR occurrences,harness the expertise of pharmacists in enhancing prescription reviews and pharmaceutical services,minimize harm and related medication disputes caused by ADR and safeguard legitimate rights and interests of both physicians and patients.
adverse drug reactionsmedical disputesprescription reviewrational drug use
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