"After decades of using drugs in excess of the instructions, we finally have a conclusion." Sun Zhongzhong, an expert at the National Rational Drug Use Monitoring Office of the Chinese Hospital Association, lamented the Health Bureau.
On March 1, 2022, the Physician Law of the People's Republic of China came into effect, and the new version of the Physician Law for the first time included the diagnosis and treatment guidelines and the "over-instruction medication" under evidence-based medicine into the law.
Article 29 of the new version of the Physicians Law first affirms that physicians should "follow the guidelines for the clinical application of drugs, clinical diagnosis and treatment guidelines, drug instructions and other rational use of drugs", but in special cases such as the absence of effective or better treatment methods, "after obtaining the patient's explicit informed consent", the use of drugs that are not clear in the drug instructions but have evidence-based medical evidence can be used for treatment.
This means that some drugs that have been approved for mature use abroad will likely be formally clinically applied in China. For immune drugs such as PD-1, it will be possible to legally expand the scope of application.
Sun Zhongzhong said: "The introduction of the new version of the Physician Law is very good, and I approved with both hands and loosened the ties for the doctors. ”
Give the doctor a reassuring pill
Ai Fen, director of the emergency department of Wuhan Central Hospital, still remembers a lost lawsuit in the hospital: the drug label is marked with a certain taboo, but the doctor chooses to use the drug after measuring it, and finally the patient has an accident, and the two sides have a court.
Because of the over-prescribed medication, many doctors have sat in the dock. Sun Zhongzhong introduced that in this case, the general hospital will choose to pay the medical expenses.
Over-label medication includes hyper-indications, hyper-adaptive populations, over-doses, routes of administration, etc., also known as over-range medications. This is clinically common, and some medicine doctors who have been using it for many years have their own usage.
Jiang Fan, chief physician of the Department of Hematology of Beijing Kyoto Children's Hospital, for example, the hematologist will let some patients take gentamicin injection orally before hematopoietic stem cell transplantation to clean up intestinal bacteria, which is a super-instructional medication on the route of administration; the treatment of myelofibrotic rucortinib will be given to patients when anti-rejection, which is a super indication.
For innovative drugs, the phenomenon of over-label medication is more common.
Sun Zhongzhong introduced that in order to obtain approval faster and save money, new drugs generally only do clinical trials for one or two indications, and the pursuit is to quickly market. However, in pharmacology, these drugs can theoretically treat a variety of diseases, and doctors can often find more efficacy and use them clinically in combination with the actual situation.
In the past, these usages were not legal on closer inspection. Article 14 of the "Prescription Management Measures" issued by the former Ministry of Health stipulates that physicians shall prescribe prescriptions according to medical, preventive and health care needs, in accordance with the diagnosis and treatment specifications, drug indications in drug instructions, pharmacological effects, etc.
The gap between law and practice is too large, and the over-prescribed drugs are placed under legal risk. Especially after 2018, a large number of innovative drugs are listed, and the over-instruction drugs are widely present in major hospitals in China, and after adverse drug reactions, cases of patients suing doctors or hospitals occur from time to time, which makes over-label drugs a controversial topic in the medical community.
"In order to cure patients, many doctors take risks. But if there is a problem to sue, it is necessary to sue one by one. Jiang Fan, attending physician of the Department of Hematology at Beijing Kyoto Children's Hospital, told the Health Bureau.
Sun Zhongzhong learned that in order to take less risks, some hospitals are cautious, and some doctors dare not go beyond the thunder pool.
The United States, Germany and other countries have long had legislation related to over-specification drugs. Sun Zhongzhong believes: "Adding an indication to the clinic is equivalent to developing a new drug, which is a big thing that is beneficial to the country, the people, and the society." ”
Ai Fen told the Health Bureau that after the new physician law is implemented, if there is evidence-based medical evidence of the ultra-prescribed medication, causing legal conflicts, doctors can be better protected.
Clinical opportunities for innovative drugs
Drug instructions lag behind in the face of ever-changing treatment options, which is the understanding of many doctors.
"The new rules are very realistic and should have come out a long time ago." Ruan Xiangyan, director of the Department of Endocrinology of Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University, believes that her hospital has always had specific management methods and process requirements for over-the-instruction medication, which needs to be filed in advance, and must also let patients or family members sign informed consent.
However, these measures are only as risk-proof as possible and have no legal basis. Doctors have been expecting legal protection against over-the-label medications.
Innovative drug companies are more looking forward to the moderate liberalization of ultra-instructional drugs, taking PD-1 as an example, such drugs have the reputation of "broad-spectrum anti-cancer drugs", theoretically all cancers have a certain efficacy, many varieties have been approved in Europe and the United States and other countries a large number of indications. However, when used in China clinically, there are still risks for doctors to "over-adapt" drugs.
Although the law has been liberalized, there are still strict requirements for over-the-instruction medication. Wu Jinchang, the leader of the oncology department of the Second Affiliated Hospital of Xuzhou Medical University, introduced that there are two prerequisites for the use of drugs in the instructions for super drugs: one is that the drug use scheme is reasonable and the interests of patients are the premise; the second is that the drug use behavior is in line with pharmacology, and the treatment value is higher than other programs.
In April 2021, Zhang Yu of peking university third hospital questioned the treatment plan of dr. Lu Wei of Shanghai Xinhua Hospital, which aroused public concern. In the end, the Shanghai Municipal Health Commission and the Shanghai Changning District Health Commission imposed administrative penalties on Lu Wei, Shanghai Xinhua Hospital and the institutions involved respectively.
In this case, one of the reasons for Lu Wei's administrative punishment was "failure to perform the obligation to inform in accordance with the regulations." The basis of punishment is consistent with the legislative spirit of the new Physician Law that "physicians obtain explicit informed consent from patients". Sun Zhongzhong believes that the new physician law solves the controversy between Zhang and Lu from the legal level: only by comparing the law, it can be clear which practices are legal.
However, the release of ultra-prescribed drugs has opened a new window for pharmaceutical companies after all. Sun Zhongzhong stressed that doctors themselves should deepen their learning and improve their theoretical level; pharmaceutical companies should also actively carry out new research on the basis of more clinical experience.
#Medication Instructions ##超适应用药 #