Guideline for the management of pediatric off-label use of drugs in China (2021)

被引：8

作者：

Meng, Min ^{[1
,2
,3
,4
]}

Liu, Enmei ^{[1
,2
,3
]}

Zhang, Bo ^{[3
,5
]}

Lu, Quan ^{[6
]}

Zhang, Xiaobo ^{[7
]}

Ge, Bin ^{[4
]}

Wu, Ye ^{[8
]}

Wang, Li ^{[9
]}

Wang, Mo ^{[1
,2
,3
]}

Luo, Zhengxiu ^{[1
,2
,3
]}

Hua, Ziyu ^{[1
,2
,3
]}

Wang, Xiaoling ^{[10
]}

Zhao, Wei ^{[11
]}

Zheng, Yi ^{[11
]}

Wu, Xinan ^{[12
]}

Zhao, Ruiling ^{[13
]}

Meng, Wenbo

Xiang, Li ^{[10
]}

Wang, Gang ^{[1
,2
,3
]}

Jia, Yuntao ^{[1
,2
,3
]}

Chen, Yongchuan ^{[4
,14
]}

Dong, Xiaoyan ^{[6
]}

Hao, Lina ^{[15
]}

Liu, Chengjun ^{[1
,2
,3
]}

Lv, Meng ^{[1
,2
,3
]}

Luo, Xufei ^{[16
]}

Liu, Yunlan ^{[16
]}

Shen, Quan ^{[1
,2
,3
]}

Lei, Wenjuan ^{[4
]}

Wang, Ping ^{[17
]}

Sun, Yajia ^{[17
]}

Zhang, Juanjuan ^{[16
]}

Wang, Ling ^{[16
]}

Lei, Ruobing ^{[1
,2
,3
]}

Hou, Tianchun ^{[1
,2
,3
]}

Yang, Bo ^{[1
,2
,3
]}

Li, Qiu ^{[1
,2
,3
]}

Chen, Yaolong ^{[1
,2
,3
,17
,18
,19
,20
,21
]}

机构：

[1] Chongqing Med Univ, Childrens Hosp, Dept Pediat, Res Inst, Chongqing 400014, Peoples R China

[2] Chongqing Med Univ, Natl Clin Res Ctr Child Hlth & Disorders,Minist E, Key Lab Child Dev & Disorders,Childrens Hosp, China Int Sci & Technnol Cooperat Base Child Dev, Chongqing 400014, Peoples R China

[3] Chongqing Key Lab Pediat, Chongqing 400014, Peoples R China

[4] Gansu Prov Hosp, Lanzhou 730000, Peoples R China

[5] Peking Union Med Coll Hosp, Dept Pharm, Beijing 100730, Peoples R China

[6] Shanghai Jiao Tong Univ, Sch Med, Shanghai Childrens Hosp, Dept Pulmonol, Shanghai 200040, Peoples R China

[7] Fudan Univ, Childrens Hosp, Shanghai 201102, Peoples R China

[8] Peking Univ First Hosp, Beijing 100034, Peoples R China

[9] Peking Univ, Beijing 100871, Peoples R China

[10] Capital Med Univ, Beijing Childrens Hosp, Beijing 100045, Peoples R China

[11] Shandong Univ, Jinan 250100, Peoples R China

[12] Lanzhou Univ, Hosp 1, Lanzhou 730000, Peoples R China

[13] Childrens Hosp Shanxi, Taiyuan 030012, Peoples R China

[14] Third Mil Med Univ, Army Med Univ, Affiliated Hosp 1, Chongqing 400038, Peoples R China

[15] Shandong Univ, Childrens Hosp, Jinan 250022, Peoples R China

[16] Lanzhou Univ, Sch Publ Hlth, Lanzhou 730000, Peoples R China

[17] Lanzhou Univ, Sch Basic Med Sci, Evidence Based Med Ctr, Lanzhou 730000, Peoples R China

[18] Lanzhou Univ, Lanzhou Univ Inst Hlth Data Sci, Chinese Acad Med Sci 2021RU017, Sch Basic Med Sci,Res Unit Evidence Based Evaluat, Lanzhou 730000, Peoples R China

[19] Lanzhou Univ, Inst Hlth Data Sci, Lanzhou 730000, Peoples R China

[20] WHO, Collaborating Ctr Guideline Implementat & Knowled, Lanzhou 730000, Peoples R China

[21] Lanzhou Univ, GRADE Ctr, Lanzhou 730000, Peoples R China

来源：

BMC PEDIATRICS | 2022年 / 22卷 / 01期

关键词：

Off-label use of drugs; Management; Children; Guideline; HEALTH-CARE; MEDICINES; PHARMACOKINETICS; MEDICATION; CHILDREN; OUTPATIENT; FORMULARY; BENEFIT; RISK; TIME;

D O I：

10.1186/s12887-022-03457-1

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

Background The "Law on Doctors of the People's Republic of China," which was officially implemented on March 1, 2022, emphasizes the requirements for rational drug use and the necessity for appropriate management of off-label drug use. The safety and ethical considerations related to off-label drug use are different in children than in adults. There is so far no management guideline for pediatric off-label use of drugs in China, and the applicability of foreign guidelines is limited. Establishing a localized evidence-based management guideline for pediatric off-label use of drugs to support the national legislation and clinical practice is of critical importance. Methods We established a guideline working group, including experts from a broad range of disciplines and developed recommendations following the guidance of the World Health Organization Handbook and the Chinese Medical Association. The following themes were identified by questionnaires and expert interviews to be of great concern in the management of off-label drug use in children: general principles and characteristics of management of pediatric off-label drug use; establishment of expert committees; evidence evaluation; risk-benefit assessment; informed consent; monitoring and assessment of the risk; and monitoring and patient education. Two rounds of Delphi surveys were organized to determine the final recommendations of this guideline. We graded the recommendations based on the body of evidence, referring to the evaluation tool of the Evidence-based management (EBMgt) and the Oxford Center for Evidence-Based Medicine: Level of Evidence (March 2009). Results We developed the first guideline for the management of pediatric off-label use of drugs in China. Conclusions The guideline is to offer guidance for pediatricians, pharmacists, medical managers, policymakers, and primary care physicians on how to manage off-label drug use in pediatrics and to provide recommendations for Chinese healthcare policy in the future.

引用

页数：11

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