药品说明书中肝功能不全患者用药警示信息标注情况调查分析

Investigation and Analysis of Medication Warning Information Annotation for Patients with Liver Insufficiency in Package Inserts

关键词:  药品说明书  肝功能不全  警示信息

Key words:  package insert  liver insufficiency  warning information

摘要:

目的 调查415种药品的药品说明书中肝功能不全患者用药警示信息，为规范药品说明书中肝功能不全患者用药警示信息标注提供参考。方法 搜集Hepatox、Livertox中具有肝毒性警示信息的药品品种在Mcdex合理用药信息支持系统中收录的药品说明书肝功能不全患者用药警示信息标注信息，对肝功能不全患者用药警示信息的标注情况进行统计分析。结果 26.26%的药品品种，18.04%的说明书并无肝功能不全患者用药提示信息；53.92%的药品品种存在通用名相同的药品不同厂家说明书提示信息不同的情况；13个品种的药品进口厂家与国产厂家的肝功能不全患者用药提示信息不相同；仅17.65%的药品说明书中包含肝功能不全患者剂量调整信息，但5个品种不同厂家的药品说明书剂量调整信息并不完全一致。结论 药品生产企业应主动承担起药品说明书修订完善的责任，临床医师及药师在临床使用中，需加强对肝功能不全患者的用药监护，并重视药品信息收集，促进说明书在临床应用中的不断完善。

Abstract:

OBJECTIVE To provide reference for the regulation of medication warning information for patients with liver insufficiency by investigating the warning information for patients with liver dysfunction in package inserts of 415 varieties. METHODS The medication information for patients with liver insufficiency in Mcdex was sorted out. All the drugs are recorded in Hepatox and Livertox with hepatotoxicity. Statistical analysis was applied on the labeling of medication warning information in patients with liver dysfunction. RESULTS 26.26% of the drugs, 18.03% of their package inserts had no medication warning information on patients with liver insufficiency. 53.92% of the drugs had different warning information from different manufacturers. Thirteen of them had differences in warning information between domestic manufacturers and imported manufacturers. Only 17.65% of the drugs had dose adjustment information for patients with liver insufficiency, while 5 of them had different information on the dose adjustment from different manufacturers. CONCLUSION Pharmaceutical manufacturers shall undertake the responsibility of revising and improving the drug instructions on their own initiative. In clinical, clinicians and pharmacists shall strengthen pharmaceutical monitoring for patients with liver dysfunction and attach importance of drug information collection to promote the improvement of the drug instructions.