Management guideline for the off-label use of medicine in China (2021)
Year: 2022
Type: dataset
Abstract: Off-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. We 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. We 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. This guideline standardized clinical off-label drug use and provided suggestions and references for the management of off-label drug use.
Source: Figshare
Authors: Zuo, Wei, Sun, Yajia, Liu, Rongji, Du, Liping, Yang, Nan, Sun, Wenjuan, Wang, Ping, Tang, Xiaowan, Liu, Yunlan, Ma, Yuanyuan, Meng, Min, Lei, Ruobing, Yan, Xuelian, Peng, Hua, Chang, Qing, Pan, Hui, Zhang, Bo, Chen, Yaolong, Zhang, Shuyang
Institutions: Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital, Tang Du Hospital, Lanzhou University, Vanderbilt University Medical Center, Army Medical University, New York Medical College, Dalian Medical University, Chinese Academy of Agricultural Sciences, First Affiliated Hospital of Dalian Medical University, China Agricultural University, Southwest Minzu University, Sun Yat-sen University, Tongji University, University of Science and Technology of China, Beijing Tongren Hospital, University of Minnesota, Zhongnan University of Economics and Law, Capital Medical University, China Medical University, East Carolina University, Beijing Institute of Genomics, Tianjin Medical University Cancer Institute and Hospital, Donald & Barbara Zucker School of Medicine at Hofstra/Northwell, Affiliated Hospital of Guizhou Medical University, Jackson Laboratory, First Hospital of Jilin University, Third Affiliated Hospital of Sun Yat-sen University, Jilin Agricultural University, University of Chinese Academy of Sciences, Tianjin Medical University, Southern Medical University, Zhejiang University, China Medical University, Guangzhou Medical University, Yantai University, Fudan University, Shanghai Jiao Tong University, Gansu Provincial Hospital, Children's Hospital of Chongqing Medical University, Liaocheng People's Hospital, Chinese Academy of Sciences, Guangzhou Regenerative Medicine and Health Guangdong Laboratory, University of Shanghai for Science and Technology, Kunming Institute of Zoology, Peking University, Eye & ENT Hospital of Fudan University, Harvard University, Minjiang University, University of Miami, Gansu Agricultural University, Xinjiang Agricultural University, Northeast Agricultural University, Xuzhou Medical College, Washington University in St. Louis, Nankai University, Sichuan University, XinHua Hospital, Shanghai Chest Hospital, Lanzhou Jiaotong University, Fudan University Shanghai Cancer Center, Institute of Plant Protection, Ningxia Academy of Agriculture and Forestry Sciences, Zhongda Hospital Southeast University, Wuhan Institute of Virology, Peking University First Hospital, China Academy of Chinese Medical Sciences, Peking University Third Hospital, Henan Agricultural University, Harbin Veterinary Research Institute, University of Pennsylvania, The University of Texas Southwestern Medical Center, Xi'an Jiaotong University, Mississippi State University, Tsinghua University, University of California San Diego
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4394081284