| 吴志鹏,梁毅.基于法国经验探讨完善我国超说明书用药监管[J].中国药事,2023,(4):376-381 |
| 基于法国经验探讨完善我国超说明书用药监管 |
| Discussion on Improving the Regulation of Off -label Drug Use in China Based on France’s Experience |
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| DOI：10.16153/j.1002-7777.2023.04.002 |
| 中文关键词: 超说明书用药 监管框架 患者保护 法国 知情同意 |
| 英文关键词: off -label drug use regulatory framework patient protection France informed consent |
| 基金项目: |
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| 中文摘要: |
| 目的：分析我国超说明书用药监管存在的问题，为完善监管体系提供可行建议，以期降低超说明书用药风险，提高合理用药水平。方法：通过查阅文献资料和法规条款，分析法国超说明书用药的监管框架和核心机制，对比研究我国超说明书用药监管存在的问题和完善路径。结果：法国在法律层面建立了完善的监管框架，并通过多重评估、患者保护、持续监测评估和信息公开机制保证了超说明书用药的监管和使用安全。结论：我国的超说明书用药监管体系尚不完善，缺少法规层面的实施规范，建议我国在法律体系、患者保护、信息公开方面加强建设，明确超说明书用药的使用要求和规范，从而降低超说明书用药的风险，保护医生和患者的合法权益。 |
| 英文摘要: |
| Objective: To analyze the problems in off -label drug use (OLDU) regulation in China and provide feasible suggestions for improving the regulatory system, with the aim of reducing the risk of OLDU and improving the level of rational drug use. Methods: By reviewing the literature and regulations, the regulatory framework and core mechanism of OLDU in France were analyzed, and the existing problems and improvement paths of OLDU regulation in China were compared and researched. Results: France has established a sound regulatory framework at the legal level, and has ensured the regulation and safety of the use of OLDU through multiple assessments, patient protection, continuous monitoring and evaluation, and information disclosure mechanism. Conclusion: Chinese regulatory system of OLDU is still imperfect and lack of implementation standards at the regulatory level. It is suggested that China should strengthen the construction in the legal system, patient protection and information disclosure to clarify the use requirements and standards for OLDU, so as to reduce the risk of OLDU and protect the legitimate rights and interests of doctors and patients. |
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