(People's Daily Health Client Reporter Xu Shiyu) On June 28, Guangdong Pharmaceutical Association released the "Medication Catalog Beyond Drug Instructions (2022 Edition)", which is the eighth edition since 2015 and includes 269 kinds of drugs. Added 37 pieces of medication information. The medical institutions that drafted this version of the catalog include tertiary hospitals in Beijing, Shanghai, Guangdong, Hunan and other places. The updated medication information includes ibuprofen, semaglutide, chymotrypsin and other drugs.
"The most important reference for the catalog is clinical needs and evidence-based medical evidence. What we do is share information in the form of a catalog for off-label medications that have been clinically registered by the hospital." Zheng Zhihua, Vice Chairman and Secretary-General of the Guangdong Pharmaceutical Association In an interview with a reporter from the People's Daily Health Client, he said that the catalog issued by the Pharmaceutical Association does not have legal validity and bias, and is only for reference by each hospital. It saves the time of checking the hospital reference catalog. The decision-making power of actual medication still lies in the hands of the hospital and doctors. superior.
The drafting agency includes a number of domestic tertiary hospitals to meet the actual clinical use needs
Using medicines beyond the drug label is also called "external use of the drug insert" and "unregistered use of the drug", which refers to the indication, dosage, course of treatment, route or use of the drug. Crowds of people, etc. The usage is not within the scope of the drug instructions approved by the drug regulatory department.
Among the medical institutions drafted this time, in addition to the top tertiary hospitals in Guangdong Province, they also include People's Liberation Army General Hospital , Peking University People's Hospital , Shanghai Ruijin Hospital , The Second Affiliated Hospital of Zhejiang University School of Medicine , Xiangya Hospital of Central South University , Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology and a series of domestic top-level hospitals.
Zheng Zhihua said frankly that the update of the catalog and the iteration of and are thanks to the support and recognition of his colleagues. Clinical development is rapid, new drugs are constantly entering the clinic, and new uses are constantly being discovered. Doctors need to find professional and scientific basis for new drugs, new indications, and new uses of old drugs that have strong clinical demand.
The listed drugs need to meet the following five conditions, and need to be evaluated and screened based on the level of evidence, clinical needs, etc.:
1, included in the instructions in the United States, Europe, and Japan;
2, " Chinese Pharmacopoeia Clinical Medication Instructions " " Clinical Included in "Diagnosis and Treatment Guidelines " (authored by the Chinese Medical Association, published by People's Medical Publishing House );
3, included in international mainstream guidelines or consensus (such as NCCN);
4, Micromedex® effectiveness, recommendation level at level IIb, evidence level B or above; RCT research or meta analysis published in
5, the four major medical journals (NEJM, The Lancet, JAMA, The BMJ) or SCI area I journals of this specialty prove that it is suitable.
The new drugs have been registered in some hospitals. The off-label medication process is relatively complex. It generally requires the pharmaceutical department to check the evidence level and clinical needs, provide guidance, and then be judged by the Pharmaceutical Council and the Ethics Committee. The Guangdong Pharmaceutical Association has included some off-label medications that have been filed, have strong evidence, and have high clinical demand into the catalog for reference by various hospitals. Although it does not have legal effect, in Zheng Zhihua's view, it also has a relatively authoritative academic guideline for hospitals. According to changes in clinical medication, some old and less commonly used drugs will be constantly replaced in the catalog.
Comes from the clinic, goes to the clinic
An endocrinologist at a tertiary hospital revealed to the People's Daily Health Client reporter that the anti-diabetic drug semaglutide included in the catalog this time is mainly used to treat 2 type diabetes . There are currently no approved indications for obesity in China, but there are many cases of off-label use in clinical practice. The catalog mentions that the off-label use of semaglutide can be found in the FDA instructions for the treatment of patients with a BMI of 227 kg/m2 combined with at least one obesity complication; or patients with a BMI of 30kg/m2 who are simply obese.
Some hospitals will include off-label medication records in the hospital's in-hospital directory, but they will not be made public and are only for internal use within the hospital.The above-mentioned endocrinologist said that the hospital’s in-hospital catalog will also refer to a series of academic opinions, including the off-label medication catalog of the Guangdong Pharmaceutical Association. For clinicians, there will be one more domestic society basis for reference when using medications. .
Zheng Zhihua introduced that the chymotrypsin included in the catalog this time is an "old drug" that can promote the digestion and removal of blood clots, purulent secretions and necrotic tissue. It is used in eye surgery to relax ligaments and reduce traumatic iris and eyelashes. body inflammation; it can also be used for wounds or local inflammation to reduce local secretion and edema. The newly added "aerosol inhalation" is based on the "Instructions for Clinical Medication in the Pharmacopoeia of the People's Republic of China" (2015 edition) and the "Expert Consensus on the Application of Atomized Inhalation in the Drug Treatment of Pharyngeal Diseases". "What we do is to find the basis for using medicines beyond the drug instructions, list the scientific basis, and then provide it to clinicians for reference."
The update of the drug catalog is more like "from clinical, to clinical ." Through clinical medication feedback, we learn to examine the corresponding evidence-based medical evidence. In clinical medication, the catalog once again serves as a reference for medication. Standardizing off-label medication use was included in the "Physician Law of the People's Republic of China", which was passed on August 20, 2021 and came into effect on March 1, 2022. On September 13, 2021, the International Pharmaceutical Journal (IPJ), the official journal of International Pharmaceutical Federation (FIP), released the results of the Guangdong Pharmaceutical Association’s standardized management of off-label medication. FIP commented: This information is of great significance to pharmacists in China and even the world. They are all very valuable and of great significance.
"In 2013, we published the "Off-label Medication Reference" under the guidance of Professor Li Dakui of Peking Union Medical College Hospital. The Guangdong Pharmaceutical Society is just a small academic group, but academics have no boundaries. We refer to the latest industry trends The catalog will be continuously updated with relevant evidence to achieve information sharing, save hospital research time, and meet clinical medication needs. "Zheng Zhihua said that off-label medication still needs to be controlled by clinicians and guided by the interests of patients.
It is worth noting that the notice emphasizes that the catalog is only listed as evidence and not as a recommended catalog. Off-label medication still needs to be managed according to formal procedures in clinical application.
