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Volume 13 Issue 6
Nov.  2022
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ZUO Wei, LIU Rongji, NIU Ziran, DU Liping, CHANG Qing, PENG Hua, PAN Hui, ZHANG Bo. Establishment of the Management Systems for Off-label Drug Use in Medical Institution[J]. Medical Journal of Peking Union Medical College Hospital, 2022, 13(6): 1094-1099. DOI: 10.12290/xhyxzz.2022-0128
Citation: ZUO Wei, LIU Rongji, NIU Ziran, DU Liping, CHANG Qing, PENG Hua, PAN Hui, ZHANG Bo. Establishment of the Management Systems for Off-label Drug Use in Medical Institution[J]. Medical Journal of Peking Union Medical College Hospital, 2022, 13(6): 1094-1099. DOI: 10.12290/xhyxzz.2022-0128
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Establishment of the Management Systems for Off-label Drug Use in Medical Institution

  • 1.

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

  • 2.

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

  • 3.

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

Funds: 

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

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

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

More Information
  • Corresponding author:

    ZHANG Bo, E-mail: zhangbopumch@163.com

  • Received Date: March 18, 2022
  • Accepted Date: April 07, 2022
  • Available Online: April 28, 2022
  • Issue Publish Date: November 29, 2022
    Graphical Abstract
    • Abstract
  • With the implementation of the Law on Doctors of the People's Republic of China on March 1, 2022, off-label use of drugs has been included into the legislation for the first time. The Law on Doctors of the People's Republic of China stipulates: "In the absence of effective or better treatment approaches and other special circumstances, after obtaining the informed consent of the patient/guardian/entrusted agent, the clinician can undertake a usage not specified in the drug instruction if supported with evidence. Medical institutions are suggested to establish a management system to review the suitability of prescriptions and medications and strictly standardize the medication behavior of clinicians". In view of this, Peking Union Medical College Hospital has established the management system for off-label drug use based on evidence-based methods, with the aim to strengthen its management and rational use in our hospital. The measures for off-label drug use have been formulated to safeguard the doctors' legitimate rights, as well as to strictly standardize practicing behavior. Contingency plans have been established for risk prevention and control to protect the patients' rights and escort the off-label use of drugs. Hierarchical management based on the patients' needs and the types of evidence sources for off-label medication use have been adopted to improve its feasibility.
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    • References (17)
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