Management guideline for the off-label use of medicine in China (2021)

被引：22

作者：

Zuo, Wei ^{[1
]}

Sun, Yajia ^{[2
,3
]}

Liu, Rongji ^{[1
]}

Du, Liping ^{[1
]}

Yang, Nan ^{[3
,4
]}

Sun, Wenjuan ^{[1
]}

Wang, Ping ^{[3
,4
]}

Tang, Xiaowan ^{[1
]}

Liu, Yunlan ^{[2
,3
]}

Ma, Yuanyuan ^{[1
]}

Meng, Min ^{[5
,6
,7
,8
]}

Lei, Ruobing ^{[5
,6
,7
]}

Yan, Xuelian ^{[1
]}

Peng, Hua ^{[9
]}

Chang, Qing ^{[9
]}

Pan, Hui ^{[9
]}

Zhang, Bo ^{[1
]}

Chen, Yaolong ^{[2
,3
,4
,10
]}

Zhang, Shuyang ^{[11
]}

机构：

[1] Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Pharm, State Key Lab Complex Severe & Rare Dis, Beijing 100730, Peoples R China

[2] Lanzhou Univ, Sch Publ Hlth, Lanzhou, Peoples R China

[3] Lanzhou Univ, Inst Hlth Data Sci, Lanzhou, Peoples R China

[4] Lanzhou Univ, Evidence Based Med Ctr, Sch Basic Med Sci, 199 Donggang West Rd, Lanzhou 730000, Gansu, Peoples R China

[5] Chongqing Med Univ, Dept Pediat, Chevidence Lab Child & Adolescent Hlth, Childrens Hosp,Res Inst, Chongqing, Peoples R China

[6] Chongqing Med Univ, Natl Clin Res Ctr Child Hlth & Disorders, China Int Sci & Technol Cooperat Base Child Dev &, Key Lab Child Dev & Disorders,Childrens Hosp,Mini, Chongqing, Peoples R China

[7] Chongqing Key Lab Pediat, Chongqing, Peoples R China

[8] Gansu Prov Hosp, Lanzhou, Peoples R China

[9] Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Med Adm, Beijing, Peoples R China

[10] Lanzhou Univ, Chinese Acad Med Sci 2021RU017, Sch Basic Med Sci, Res Unit Evidence Based Evaluat & Guidelines, Lanzhou, Peoples R China

[11] Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Cardiol, State Key Lab Complex Severe & Rare Dis, Beijing, Peoples R China

来源：

EXPERT REVIEW OF CLINICAL PHARMACOLOGY | 2022年 / 15卷 / 10期

基金：

中国国家自然科学基金;

关键词：

Off-label use of drugs; management; evidence-based medicine; hierarchical management; guideline; ADVERSE DRUG-REACTIONS; MEDICATION USE; ETHICAL-ISSUES; SAFETY; PHARMACOVIGILANCE; NEED; SYSTEM; RECOMMENDATIONS; PRESCRIPTIONS; REIMBURSEMENT;

D O I：

10.1080/17512433.2022.2120468

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

BackgroundOff-label drug use embodies a thorough clinical diagnosis and evaluation of treatment needs and should not be confused with unreasonable drug use, but it also faces potential risks with drug safety and legal issues.Research design and methodsWe first established a guideline working group. Following the guideline development process recommended by the World Health Organization Handbook and the Chinese Medical Association, the key questions were determined through literature searches of PubMed, CNKI (Chinese National Knowledge Infrastructure) and other databases. Both the evidence and the clinicians' diagnosis and treatment workload were considered to formulate the initial recommendations. Finally, two rounds of Delphi surveys and one expert seminar were organized to determine the final recommendations of this guideline. Meanwhile, we graded the recommendations based on the body of evidence.ResultsWe determined nine questions and proposed a total of 23 recommendations regarding the definition of off-label use of drugs, applicable circumstances, classification of evidence, informed consent, legal basis, adverse drug reaction monitoring and evaluation, management procedure, responsibilities and obligations of different stakeholders, medical insurance reimbursement, and the national approval system.ConclusionsThis guideline standardized clinical off-label drug use and provided suggestions and references for the management of off-label drug use.

引用

页码：1253 / 1268

页数：16

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