黄体酮注射液事件引起的安全用药思考

Reflections on the Medication Safety for Progesterone Injection Events

目的:探讨黄体酮的用药安全问题。方法:对2015年的浙江黄体酮注射液事件的发生、发展及后续处理情况进行分析,探讨该事件反映出的临床用药及用药监管问题。结果:对该药的不良事件的快速、可控处置(15 d内)体现了监测工作在药品安全隐患早发现、早报告、早评价、早控制中的作用,但也暴露出超说明书用药合法性问题、肌内注射用油溶液注射剂的安全性问题以及信息公开不足的问题。结论:建议应立法保护超说明书用药情况下各方权益;对以大豆油为辅料的肌内注射剂开展再评价,从风险-效益的角度全面评估该类药品的质量标准及安全性;应公开信息以利于发挥药品不良反应监测的作用。

OBJECTIVE：To discuss the safety problems of the rational use of progesterone. METHODS：The occurrence,development and disposal of Progesterone injection events in 2015 in Zhejiang were analyzed,and related problems were discussed as clinical drug use and drug use monitoring. RESULTS：The rapid and manageable disposal（within 15 d）of the event demonstrated the role of ADR monitoring in discovering,reporting,assessing and controlling drug safety hazard at early stages. It also revealed problems such as the legitimacy of off-label drug use,the safety of oil injections for intramuscular injection and the insufficiency of information disclosure. CONCLUSIONS：Off-label drug use needs legislative protection for all interest parties. Intramuscular injections using soybean oil as adjuvant needs reassessment for their quality standard and safety from the aspect of risk-benefit. Information disclosure is beneficial for ADR monitoring.