Discussion on the application of off label operation in Chinese medical practice and the progress of regulations

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The newly revised "Physician Law of the People's Republic of China" was released recently and will come into effect on March 1, 2022.

The eye medicine incident in Shanghai in 2010 once caused a sensation across the country and attracted much attention

Although the law enforcement agencies in Shanghai have adopted more humane measures, the Shanghai Eye Medicine Gate still allows medical personnel to take warnings against off-label use of drugs

Off-label use of drugs, also known as “off-label use of drugs”, “unregistered drug use”, and “off-label use of drugs” refers to the application of drugs beyond the scope of production approved by the State Drug Administration The scope of the drug instructions provided by the manufacturer includes those beyond the applicable age, dosage, dosage form, route of administration, or indications

At present, China has a number of regulations such as the "Drug Administration Law", "Prescription Management Measures", "Adverse Drug Reaction Reporting and Monitoring Management Measures", "Pharmaceutical Administration Regulations of Medical Institutions", "Practicing Physician Law" and other regulations governing the use of drugs.

1- Drug Administration Law provides for instructions

Article 72 of the "Drug Administration Law" (revised in 2019) states that medical institutions should adhere to the principles of safe, effective, economical and reasonable medication, follow the guidelines for clinical application of drugs, clinical diagnosis and treatment guidelines, and drug inserts and other rational use of drugs, and treat physicians Review the suitability of prescriptions and medication orders

Article 98 of the "Drug Administration Law" (Revised Edition in 2019) clearly states that the scope of counterfeit drugs is that if the indicated indications or functional indications of a drug exceed the prescribed scope, it is a counterfeit drug

2- The prescription management method requires the manual management

Article 14 of the "Prescription Management Measures" stipulates that physicians should prescribe prescriptions based on medical, preventive, and health care needs, in accordance with the diagnosis and treatment specifications, drug indications, pharmacological effects, usage, dosage, contraindications, adverse reactions and precautions in the drug inserts.

3- "Administrative Measures for Adverse Drug Reaction Reporting and Monitoring"

The definition of adverse drug reaction in Article 63 of the "Administrative Measures for Reporting and Monitoring of Adverse Drug Reactions" is: Adverse drug reactions refer to harmful reactions that are not related to the purpose of the drug in the normal usage and dosage of qualified drugs

4- "Regulations on the Administration of Pharmaceutical Affairs in Medical Institutions"

Article 22 of the "Regulations on the Administration of Pharmaceutical Affairs in Medical Institutions" stipulates that medical institutions should combine clinical and drug treatment to carry out clinical pharmacy and pharmaceutical research, provide necessary working conditions, formulate corresponding management systems, and strengthen leadership and management

5- "Practicing Physician Law"

Article 25 of the Law on Practicing Physicians stipulates that physicians shall use drugs, disinfectants and medical devices approved for use by relevant state departments

6-Pharmaceutical Society's recommendations for off label

In March 2010, the Guangdong Pharmaceutical Association issued the "Expert Consensus on the Unregistered Use of Drugs", which is the first specification for off-label use of drugs issued by a professional society in China

In 2015, the Chinese Pharmacological Society compiled and completed the "Experts Consensus on Off-label Drug Use", which has played an industry standard role in clinical drug use in medical institutions

In addition, the Guangdong Pharmaceutical Association has also compiled a catalog of drugs used in the super-instructions, which is currently the seventh edition of the 2021 edition, with a total of 242 super-instructions

In addition, there are the "Expert Consensus of Chinese Pediatric Off-label Drugs" issued by the Pediatric Branch of the Chinese Medical Association, the "Experts Consensus on the Use of Antimicrobial Drugs Off-label Use" issued by the Infectious Diseases Professional Committee of the Chinese Medical Education Association, and the "Clinical Critical Diseases and Pharmaceutical Ultrasounds" issued by the Guangdong Pharmaceutical Association.

7-Regulations of the latest version of the Physician Law

Article 29 of the latest "Physician Law of the People's Republic of China" implemented on March 1, 2022 clearly stipulates: Physicians should adhere to the principles of safe, effective, economical and reasonable medication, and follow the guidelines for clinical application of drugs, clinical diagnosis and treatment guidelines, and drug inserts And other rational use of drugs

Medicine is constantly being updated and improved, and clinical practice is more complex and diverse and requires doctors to deal with them in a timely manner according to the actual situation; and the contents of the drug instructions are always lagging in terms of indications or dosage
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In the past, in clinical work, due to the legal risks associated with off-label use of drugs, doctors often faced greater pressure when using off-label drugs
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