摘要
目的分析临床急需药品临时进口政策面临的问题与风险,为我国该领域工作提出优化建议方法采用焦点小组访谈法与深入访谈法,选择34名临床急需药品临时进口相关人员参与访谈;基于国内外临床急需药品临时进口政策梳理结果与访谈结论,形成问卷,并采用德尔菲法,选择各相关领域14名专家发放函询问卷并作客观呈现,通过专家共识会形成最终建议。结果基于临床急需药品临时进口各阶段初步形成20条建议。经专家咨询,回收问卷32份(回收率91%),有效问卷32份(有效率100%)。经专家共识会讨论,最终形成政策建议17条。结论建议国家卫生健康部门协同国家药品监督管理部门、海关,共同深入探讨并细化临床急需药品临时进口的具体实施措施,以保障临床用药的安全性、有效性与及时性。
Objective To analyze the issues and risks associated with the policy of temporary import of urgently needed clinical drugs and offer optimized suggestions for this domain in our country.Methods The focus group interview method and in-depth interview method were employed,and 34 individuals related to the temporary import of urgently needed clinical drugs were selected for the interviews.Based on the results of the review of domestic and international policies for the temporary import of urgently needed clinical drugs and the conclusions drawn from the interviews,a questionnaire was formulated.The Delphi expert consultation method was utilized to select 14 experts from various relevant fields,and questionnaires were distributed and collected by mail for objective presentation.Through an expert consensus meeting,the final suggestions were formed.Results Initially,20 suggestions were proposed for each stage of the temporary import of urgently needed clinical drugs.After expert consultation,32 questionnaires were retrieved(a response rate of 91%),and all were valid(a validity rate of 100%).Through discussions at the expert consensus meeting,17 policy suggestions were ultimately formed.Conclusion It is recommended that the National Health Commission,in collaboration with the National Medical Products Administration and the customs,conduct in-depth discussions and refine the specific implementation measures for the temporary import of urgently needed clinical drugs to guarantee the safety,efficacy,and timeliness of clinical drug use.
作者
易秋莎
卢润鑫
邱攀达
曾力楠
张发琼
邹琨
石雨晴
韩璐
张伶俐
YI Qiusha;LU Runxin;QIU Panda;ENG Linan;HANG Faqiong;ZOU Kun;SHI Yuqing;HAN Lu;ZHANG Lingli(Department of Pharmacy/Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Children's Medicine Key Laboratory of Sichuan Province,Chengdu 610041,P.R.China;NMPA Key Laboratory for Technical Research on Drug Products in vitro and in vivo Correlation,Chengdu 610041,P.R.China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Sichuan University,Ministry of Education,Chengdu 610041,P.R.China;West China School of Pharmacy,Sichuan University,Chengdu 610041,P.R.China;West China Biomedical Big Data Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China;West China School of Public Health,Sichuan University,Chengdu 610041,P.R.China;Chinese Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China)
出处
《中国循证医学杂志》
北大核心
2025年第11期1271-1277,共7页
Chinese Journal of Evidence-based Medicine
基金
国家卫生健康委药政司2023年政府购买服务项目
四川省重点研发项目(编号:2024YFFK0082)。
关键词
临床急需
临时进口
药品
焦点小组
Urgently needed in clinical practice
Temporary import
Drugs
Focus group
