Establishment of the Management Systems for Off-label Drug Use in Medical Institution

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.