The Law of the People's Republic of China on Physicians came into effect on March 1
Guangzhou Daily News (all-media reporter Ren Shanshan correspondent Lin Weiyin) The "Physician Law of the People's Republic of China", which will take effect on March 1, 2022, will for the first time include diagnosis and treatment guidelines and off-label drug use supported by evidence-based medicine into the law. This means that doctors who use off-label medication according to the reasonable needs of clinical diagnosis and treatment will be protected by law.
Off-label drug use means that the use of drugs exceeds the scope of the drug manufacturer's drug instructions recognized by the State Drug Administration, such as beyond the applicable age, dosage, dosage form, course of treatment, route of administration or indications.
According to Wu Junyan, director of the Department of Pharmacy of Sun Yat-sen Memorial Hospital of Sun Yat-sen University, on the one hand, because drug instructions are formulated based on medical evidence-based evidence, and medicine is constantly exploring and progressing, drug instructions often lag behind clinical practice and research; , it takes a lot of time and expense for pharmaceutical companies to update drug inserts to obtain clinical research data that meets the requirements of the instruction revision, and the administrative department also needs to check the data and the time for approval. Therefore, the delay in updating the drug inserts is an objective existence, and "off-label drug use" The phenomenon is widespread all over the world.
Off-label drug use has long been a topic of controversy in the medical community: while benefiting the majority of patients, it also exposes doctors to the risk of lawsuits and claims.
Once adverse drug reactions occur, patients often sue doctors or hospitals.
In recent years, in the field of tumor treatment, doctors have also questioned that their counterparts did not formulate treatment plans according to standard guidelines and used anti-cancer drugs off-label.
The controversies have left some doctors baffled and even tied down in treatment.
According to Article 29 of the new Physician Law, which came into effect on March 1, Physicians shall adhere to the principles of safe, effective, economical and reasonable drug use, and follow the guidelines for clinical application of drugs, guidelines for clinical diagnosis and treatment, and drug instructions for rational drug use.
In special circumstances such as no effective or better treatment methods, physicians can use drugs that are not specified in the drug insert but have evidence-based medical evidence to implement treatment after obtaining the patient's explicit informed consent.
"The legislation on off-label drug use in the new version of the Physician's Law is undoubtedly beneficial to hospitals and doctors, and protects the rights and interests of patients." Wu Junyan pointed out that the provisions of the new version of the Physician's Law on off-label drug use are the same as on December 1, 2019. The newly revised "Drug Administration Law" that has been implemented since then is in the same line.
According to Article 72 of the "Drug Administration Law", "Medical institutions shall adhere to the principles of safe, effective, economical and reasonable drug use, follow the guidelines for the clinical application of drugs, clinical diagnosis and treatment guidelines, and drug inserts and other rational drug use. The appropriateness of the drug will be reviewed." The revision of relevant laws will recognize and standardize reasonable off-label drug use.
Wu Junyan said that according to the new version of the Physician Law, off-label use of drugs is not "arbitrary" for doctors to prescribe drugs, but should "follow the guidelines for clinical application of drugs, clinical diagnosis and treatment guidelines and drug instructions" to use drugs rationally.
The reporter learned from the Guangdong Pharmaceutical Association that in order to protect the rights and interests of patients and provide authoritative guidelines for doctors' clinical diagnosis and treatment, the society has formulated the "Expert Consensus on the Use of Unregistered Drugs" since 2010, and took the lead in proposing the principle of off-label drug use in China. , which sparked heated discussions in the medical community.
Since 2015, the Society has taken the lead in publishing the Evidence-Based Medicine-based Drug List of Drugs Beyond the Instructions for Use, which collects domestic and foreign authoritative clinical guidelines and clinical practice cases from well-known domestic top-three hospitals. The eighth edition of the "Catalogue of Drugs Beyond the Instruction Manual" was launched.
Sun Yat-sen Memorial Hospital of Sun Yat-Sen University uses the method of evidence-based medicine and combines the characteristics of off-label medication to formulate evidence-based evaluation methods and procedures for off-label medication. feasibility of the method.
In May 2021, the Guangdong Pharmaceutical Association released the group standard of "Evidence-Based Evaluation of Off-label Drugs" (T/GDPA1-2021) drafted by Sun Yat-sen Memorial Hospital of Sun Yat-sen University, which provides rapid evidence-based evaluation guidelines for off-label drug use.