超说明书用药的风险及其防范

朱安祥，汪　涛(1.江苏省沭阳县人民医院药剂科，江苏 宿迁　223600； 2.江苏省沭阳县人民医院麻醉科，江苏 宿迁　223600)



超说明书用药的风险及其防范

朱安祥1*，汪涛2 #(1.江苏省沭阳县人民医院药剂科，江苏 宿迁223600； 2.江苏省沭阳县人民医院麻醉科，江苏 宿迁223600)

DOI10.14009/j.issn.1672-2124.2016.01.045

摘要目的：为规范医院超说明书用药管理提供参考。方法：通过对临床超说明书用药问题及可能为临床用药带来的隐患进行分析，探讨存在问题的原因并提出风险防范对策和建议。结果：药品说明书存在自身漏洞和不全面性，其内容更新明显滞后，以致超说明书用药现象客观存在；超说明书用药可能增加患者的用药风险和医师的执业风险，要加强临床规范化和制度化管理；国际已有的管理经验包括规定超说明书用药应有的循证依据、鼓励企业及时更新说明书、设立药品信息的独立机构等。结论：超说明书用药具有合理性和必要性。国家应尽快立法明确超说明书用药的合法性并规范责任范围，临床上超说明书用药时应遵循相应原则、加强临床药师监督指导作用及宣传和教育，以促进临床合理用药。

关键词超说明书用药； 用药安全； 医院药事管理

Risks and Prevention of Off-label Drug Use

ZHU Anxiang1, WANG Tao2(1.Dept.of Pharmacy, People’s Hospital of Jiangsu Shuyang County, Jiangsu Shuyang 223600, China; 2.Dept.of Anaesthesiology, People’s Hospital of Jiangsu Shuyang County, Jiangsu Shuyang 223600, China)

ABSTRACTOBJECTIVE：To provide reference for standardizing management of off-label drug use in our hospital. METHODS: Through analyzing off-label drug use and the hidden danger for clinical drug use, causes of the existing problems and corespondent countermeasures and suggestions for risks prevention were investigated. RESULTS: The phenomenon of off-label drug use was objective reality, for the drug instruction had its loophole and inadequacy, and the update of information were falling behind. Meanwhile, off-label drug use could increase the medication risks in patients and the professional risks in doctors, which should be strengthened in respect of clinical standardization and institutionalized management. The pre-existing management experience in international were stipulate evidence-based basis on off-label drug use, encourage drug companies to update instructions in time and establish independent drug information organization, etc. CONCLUSIONS: Off-label drug use had its rationality and necessity. Related regulations should be formulated as soon as possible and off-label drug use should follow certain principles. It is necessary to strengthen the supervision, guidance, publicity and education by clinical pharmacists so as to promote the clinical rational drug use.

KEYWORDSOff-label drug use; Medication safety; Hospital pharmaceutical administration

超说明书用药已成为全球临床药物治疗中不可避免的问题。尽管超说明书用药具有其存在的客观必要性和合理性，但若临床使用缺乏严格的制度规范，将成为临床用药的安全隐患，也会给患者及医疗执业带来风险。本调查将简述超说明书用药的概念与分类和国内、外超说明书用药的现状及存在的原因，以及超说明书用药的风险及其防范措施。……