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Volume 14 Issue 1
Jan.  2023
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ZUO Wei, LIU Rongji, SUN Yajia, ZHANG Bo, CHEN Yaolong, ZHANG Shuyang. Interpretation on Management Guideline for the Off-label Use of Drugs in China(2021 Edition)[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(1): 86-93. DOI: 10.12290/xhyxzz.2022-0588
Citation: ZUO Wei, LIU Rongji, SUN Yajia, ZHANG Bo, CHEN Yaolong, ZHANG Shuyang. Interpretation on Management Guideline for the Off-label Use of Drugs in China(2021 Edition)[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(1): 86-93. DOI: 10.12290/xhyxzz.2022-0588
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Interpretation on Management Guideline for the Off-label Use of Drugs in China(2021 Edition)

  • 1.

    Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

  • 2.

    State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

  • 3.

    School of Public Health, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China

  • 4.

    Institute of Health Data Science, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China

  • 5.

    Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China

  • 6.

    Research Unit of Evidence-based Evaluation and Guidelines, Chinese Academy of Medical Sciences, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China

  • 7.

    Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

Funds: 

CAMS Innovation Fund for Medical Sciences 2021-I2M-1-003

National High Level Hospital Clinical Research Funding 2022-PUMCH-B-059

National High Level Hospital Clinical Research Funding 2022-PUMCH-B-060

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    Graphical Abstract
    • Abstract
  • Off-label drug use represents a reasonable need for diagnosis and treatment in some cases, but it faces potential risks with drug safety and legal challenges. However, there was no guideline on how to manage the off-label drug use in China. Therefore, Peking Union Medical College Hospital, in cooperation with Evidence-based Medicine Center of Lanzhou University, established a working group and an expert group consisting of multidisciplinary group of experts to develop the Management Guideline for the Off-label Use of Drugs in China (2021). The Guideline is guided by the Law on Doctors of the People's Republic of China and the World Health Organization Guideline Development Manual. This is the first management guideline on the off-label use of drugs, aiming to improve the stakeholders' understanding of this topic and establish a standardized management procedure in China. This guideline has determined nine questions and proposed a total of twenty-three recommendations. The English version of the guideline was published in September 2022. This paper offers a detailed interpretation of the key points of the guidelines in order to provide suggestions and references for the management of off-label drug use.
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    • References (32)
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