超说明书用药法律释读及应对策略分析
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摘要
目的解读超说明书用药的法律属性,促进超说明书用药的规范性和合法性使用。方法通过分析药品注册流程,明确药品说明书的法律地位。根据民法基本原则和相关法律规定,界定超说明书用药行为的合法性。对当前文献报道的超说明书用药管理策略进行推荐等级和法律效力评价,进而提出建议。结果药品说明书并非规范性法律文件,其法律效力仅为医务人员临床用药的参考。超说明书用药行为本身并不违反我国相关法律法规,但其合法性在业内外仍缺乏共识。为应对风险,部分学者建议并采取了一系列措施。考虑到临床实际和法律效应,部分措施的适用性有待商榷。结论为规避执业风险,结合我国国情,建议摸索建立高效的医患沟通机制、呼吁政府不断完善药品监管体系和提请最高人民法院发布指导性案例,为合理合规的超说明书用药正名。
OBJECTIVE To interpret the legal attributes of off-label use, promote the standardization and legality of off-label use. METHODS By analyzing the drug registration process, the legal status of off-label use was clarified. According to the basic principles of civil law and relevant legal provisions, the legality of off-label use was defined. The recommendation level and legal effect evaluation of the off-label use management strategy reported in the current literature were made, and then suggestions were put forward. RESULTS The package insert was not a normative legal document, and its legal effect was only a reference for clinical use of medical personnel. The off-label use behavior didn't violate Chinese laws, but its legitimacy still lack consensus of insides and outsides. In response to risks, some scholars had recommended and adopted a range of countermeasures. Due to clinical practice and legal effects, some of them were open to question. CONCLUSION In order to circumvent the practice risks, combined with China's national conditions, it is recommended to explore an efficient communication mechanism for doctors and patients, call on the government to continuously improve the drug regulatory system and request the Supreme People's Court to release guiding cases, for the recertification of reasonable off-label use.
OBJECTIVE To interpret the legal attributes of off-label use, promote the standardization and legality of off-label use. METHODS By analyzing the drug registration process, the legal status of off-label use was clarified. According to the basic principles of civil law and relevant legal provisions, the legality of off-label use was defined. The recommendation level and legal effect evaluation of the off-label use management strategy reported in the current literature were made, and then suggestions were put forward. RESULTS The package insert was not a normative legal document, and its legal effect was only a reference for clinical use of medical personnel. The off-label use behavior didn't violate Chinese laws, but its legitimacy still lack consensus of insides and outsides. In response to risks, some scholars had recommended and adopted a range of countermeasures. Due to clinical practice and legal effects, some of them were open to question. CONCLUSION In order to circumvent the practice risks, combined with China's national conditions, it is recommended to explore an efficient communication mechanism for doctors and patients, call on the government to continuously improve the drug regulatory system and request the Supreme People's Court to release guiding cases, for the recertification of reasonable off-label use.
引文
[1]国家食品药品监督管理局.药品注册管理办法[M].北京:中国法制出版社,2007.
[2]刘利军.超说明书用药现状及管理对策研究--以某血液病专科医院为例[D].北京:北京协和医学院中国医学科学院,2011.
[3]刘鑫.医疗损害技术鉴定研究[M].北京:中国政法大学出版社,2014.
[4]CHEN Y F,HUANG L.FDA’s administration of off-label drug use[J].Chin J New Drugs(中国新药杂志),2013,22(7):743-745.
[5]吴琪.首例吗啡医疗案,为吗啡洗脱“污名”[J].公民与法(综合版),2017(9):26-29.
[6]HOU Q H,YE J F,ZHU G H.Discussion on the rationality of common off-label use in neonates[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(5):760-763.
[7]CULSHAW J,KENDALL D,WILCOCK A.Off-label prescribing in palliative care:a survey of independent prescribers[J].Palliat Med,2013,27(4):314-319.
[8]MARTIN-LATRY K,RICARD C,VERDOUX H.Aone-day survey of characteristics of off-label hospital prescription of psychotropic drugs[J].Pharmacopsychiatry,2007,40(3):116-120.
[9]LIU L J,XIAO L H,LI R,et al.Perception and management strategies on off-label use of drugs[J].Eval Anal Drug Hosp(中国医院用药评价与分析),2014,14(4):361-364.
[10]LIU X.Analyzation and suggestion of irregular usage of drug prescriptions in clinic[J].J Pharm Pract(药学实践杂志),2014,32(6):465-468.
[11]DENG B,WEI B H,HONG X D,et al.Present situation and countermeasures of conflict between off-label drug use and judicial evaluation[J].J China Pharm(中国药房),2017,28(28):3892-3895.
[12]ZHANG M K.On the crime of intentional injury[J].Chin Lega sci,2001(3):117-131.
[13]LAO H Y,WANG Q Y,YANG M,et al.Study on clinical management methods and process of off-label drug use in Guangdong general hospital[J].Chin J Evid-based Med(中国循证医学杂志),2014,14(9):1025-1029.
[14]ZHANG L L,LI Y P,ZENG L N,et al.Evidence-based evaluation on off-label drug use policies in 15 countries[J].Chin J Evid-based Med(中国循证医学杂志),2012,12(4):426-435.
[15]JIANG Y F,ZHAO M.Legal issues related to off-label uses[J].Med Juris(医学与法学),2015,7(5):60-66.
[2]刘利军.超说明书用药现状及管理对策研究--以某血液病专科医院为例[D].北京:北京协和医学院中国医学科学院,2011.
[3]刘鑫.医疗损害技术鉴定研究[M].北京:中国政法大学出版社,2014.
[4]CHEN Y F,HUANG L.FDA’s administration of off-label drug use[J].Chin J New Drugs(中国新药杂志),2013,22(7):743-745.
[5]吴琪.首例吗啡医疗案,为吗啡洗脱“污名”[J].公民与法(综合版),2017(9):26-29.
[6]HOU Q H,YE J F,ZHU G H.Discussion on the rationality of common off-label use in neonates[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(5):760-763.
[7]CULSHAW J,KENDALL D,WILCOCK A.Off-label prescribing in palliative care:a survey of independent prescribers[J].Palliat Med,2013,27(4):314-319.
[8]MARTIN-LATRY K,RICARD C,VERDOUX H.Aone-day survey of characteristics of off-label hospital prescription of psychotropic drugs[J].Pharmacopsychiatry,2007,40(3):116-120.
[9]LIU L J,XIAO L H,LI R,et al.Perception and management strategies on off-label use of drugs[J].Eval Anal Drug Hosp(中国医院用药评价与分析),2014,14(4):361-364.
[10]LIU X.Analyzation and suggestion of irregular usage of drug prescriptions in clinic[J].J Pharm Pract(药学实践杂志),2014,32(6):465-468.
[11]DENG B,WEI B H,HONG X D,et al.Present situation and countermeasures of conflict between off-label drug use and judicial evaluation[J].J China Pharm(中国药房),2017,28(28):3892-3895.
[12]ZHANG M K.On the crime of intentional injury[J].Chin Lega sci,2001(3):117-131.
[13]LAO H Y,WANG Q Y,YANG M,et al.Study on clinical management methods and process of off-label drug use in Guangdong general hospital[J].Chin J Evid-based Med(中国循证医学杂志),2014,14(9):1025-1029.
[14]ZHANG L L,LI Y P,ZENG L N,et al.Evidence-based evaluation on off-label drug use policies in 15 countries[J].Chin J Evid-based Med(中国循证医学杂志),2012,12(4):426-435.
[15]JIANG Y F,ZHAO M.Legal issues related to off-label uses[J].Med Juris(医学与法学),2015,7(5):60-66.