Since the beginning of this year, Guangdong, Yunnan and other places have successively updated and released the expert consensus and catalogue of off-label drug use to further standardize the management of off-label drug use in medical institutions and ensure medical quality and safety.
With the rapid development of the pharmaceutical industry, some drug instructions can no longer meet the actual clinical needs, and off-label drug use is more common. The formulation of the catalogue in various places is based on clinical needs and evidence-based medical evidence, so the catalogue also has certain reference value for other provinces. On December 28, Jin Pengfei, chairman of the Geriatric Pharmacy Committee of the China Medical Education Association and director of the Department of Pharmacy of Beijing Hospital, said in an interview with the reporter of the People's ** Health Client that the update of the catalog was released to standardize the off-label drug use behavior while also protecting the rights and interests of patients.
On December 25, the Guangxi Pharmaceutical Association issued the "Expert Consensus and Catalogue of Off-label Medication in Guangxi Medical Institutions", involving 13 categories and 978 items, including human immunoglobulin, rituximab, atorvastatin calcium, aspirin and other common drugs, which is currently the province with the most off-label drugs in China.
Screenshot of Guangxi Pharmaceutical Association's WeChat***.
Off-label medication generally refers to the use of drugs outside the scope specified in the drug instructions for the purpose of **. "For example, the pathogenesis of the tumor is not clear, it is the result of multiple factors, but the specific leading factors are not clear, resulting in **tumor drugs may not be able to fully meet the clinical **, off-label medication occurs from time to time;Second, there are fewer drugs available to children, and there are more off-label drugsThirdly, elderly patients often have multi-organ morbidity, and off-label medication will also occur in rescueIn addition, patients with rare diseases are more frequent due to the lack of drugs, and off-label medication is more frequent. Zhang Xinping, a professor at the School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, once introduced in an interview with a reporter from the People's Health Client.
Judging from the off-label drug catalogue updated and released by Guangxi, the off-label indications include chronic inflammatory demyelinating polyradiculoneuropathy, neuromyelitis optica, marginal zone lymphoma, autoimmune encephalitis, etc.;Anti-inflammatory drug aspirin tablets, off-label indications in this catalogue include assisted reproductive technologies: ovarian hyporesponse, immuno-related ** sexual miscarriage (RSA) complicated with rheumatic immune diseases, antiphospholipid syndrome, etc.
It is worth mentioning that the new version of the Physician Law also includes diagnosis and treatment guidelines and off-label medication under evidence-based medicine for the first time. Among them, Article 29 clearly points out that under special circumstances such as there is no effective or better means, after obtaining the explicit informed consent of the patient, the physician may use the drug usage that is not clear in the drug instructions but has evidence-based medical evidence. Medical establishments shall establish a management system to review the appropriateness of physicians' prescriptions and prescriptions, and strictly regulate physicians' drug use behaviors.
The update and release of the off-label drug catalogue not only strengthens the supervision and management of pharmacy, reduces the practice risk of medical institutions and medical personnel, and provides evidence-based reference for improving the effectiveness and safety of drugs, but also improves the accessibility of drugs and allows more patients to benefit from them. Jin Pengfei said.