Today, off-label drug use is officially implemented

Once the off-label drug use made clinicians walk on thin ice, now the overhauled "Physician Law of the People's Republic of China" makes off-label drug use truly legal and will be officially implemented next week
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Article 29 of the new Physician Law stipulates that: Physicians shall adhere to the principles of safe, effective, economical and reasonable drug use, and follow the guidelines for the clinical application of drugs, the guidelines for clinical diagnosis and treatment, and drug instructions for rational drug use
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In special circumstances such as there is no effective or better treatment method, after obtaining the patient's explicit informed consent, the physician can use the drug usage that is not specified in the drug insert but has evidence-based medical evidence to implement treatment
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It fully emphasizes the special attribute of "existence is reasonable" for off-label drug use
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In a limited way, "medical insurance fines" were previously considered to be the biggest risk of off-label drug use, and at the same time, there may be many litigation risks
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But nowadays, rational, reasonable and legal will be the new status of off-label drug use
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Under normal circumstances, off-label drug use occurs in many cases in tumor drug treatment, especially in tumor targeted therapy.
This is because on the one hand, with the development of precision therapy, the in-depth exploration of tumor commonality, such as HER2 target It is reasonable to say that the drug "trastuzumab" should have a good effect on many tumors that overexpress HER2, but in fact, its currently approved indications are mainly concentrated in the fields of breast cancer and gastric cancer, not to mention the instructions on the instructions.
marked indications
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On the other hand, because the update speed of drug instructions generally lags behind clinical research, and there is a clear gap between domestic and overseas clinical research, this has become more and more prominent in the recent rise of immunotherapy
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For example, in order to try the latest treatment drugs that have been approved overseas, some cancer patients do not hesitate to falsify genetic testing reports together with medical representatives, doctors, and testing institutions
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This seemingly absurd approach also points out various problems in the original medical conditions.
At least the needs of patients are not well satisfied..
Xia Xueli, director of Yaozhi.
com's data center and former deputy director of the Pharmacy Department of Chongqing Cancer Hospital, said that there have always been cases of off-label drug use in clinical practice.
Of course, there are some unreasonable aspects, but it is more because after the drug is launched The new indications summed up in the research and clinical experience of drug use are the needs of treatment, in other words, the new use of old drugs.
This time, the inclusion of off-label drug use in the regulations has fundamentally guaranteed the compatibility of off-label drug use.
Regulations, re-research of marketed drugs, and summary of drug use experience are carried out.
Of course, the new Physician Law also has relevant regulations on off-label drug use, thus protecting the rights and interests of patients
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So after this change, which drugs can be justifiably appear in the doctor's diagnosis and treatment manual? According to relevant data, in addition to the fact that off-label drug use is strictly prohibited in India, many countries around the world have provided legislative support for off-label drug use, and related guiding documents and academic guidelines have also been solved one after another
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On the domestic side, with the long-term efforts of various forces in the industry, the specific content of related drugs has basically been obtained
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In March 2010, the Guangdong Pharmaceutical Association issued the first "Expert Consensus on the Use of Unregistered Drugs" in China, and defined the unregistered use of drugs for the first time
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In December 2012, the former general office of the Ministry of Health issued a notice on forwarding the "Guidelines for Special Comments on Prescriptions of Medical Institutions in Beijing (Trial)", which forwarded the "Expert Consensus on the Use of Unregistered Drugs", which is also the only one in China on off-label drug use so far.
The official document of the specification
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In November 2014, the Guangdong Pharmaceutical Association issued a notice on the "Expert Consensus on the Management of Off-label Use of Drugs in Medical Institutions", which integrated the implementation of the "Expert Consensus on the Use of Unregistered Drugs" by major hospitals in Guangdong Province, and formed a consensus on off-label drug use.
The application, the preliminary review by the pharmacy department, and the approval by the Pharmacy Council and the Ethics Committee were explained
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Yaozhi data has been continuously improved and collected to become a unique "drug off-label" database by collating various versions of off-label medication verification and evaluation, off-label medication instructions reference, etc. .
It covers 1,946 off-label use cases of 636 drugs.
Taking the well-known "ibuprofen" as an example, the "off-label drug" database not only lists the changes in approved indications in detail (increase in chronic arthritis) Symptoms of joint swelling and pain), and also listed 12 off-label medications, including irritable bowel syndrome, inner ear vertigo, and nephritic nephropathy
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The source, usage and dosage, mechanism and references of off-label drug use are explained in detail, which not only facilitates the clinician to ask for evidence after taking the drug, but also facilitates the coordination between enterprises and the hospital, which can be used as favorable evidence support
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It is a good thing to write off-label into the law.
It reflects the spirit of respecting science and practice.
By clearly demarcating the boundaries of responsibility, we can make the medical cause more harmonious as much as possible, but we cannot blindly follow the content of off-label medication.
The premise and rationality of off-label use should be clearly defined
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According to the content of the announcement, at least four preconditions can be considered to be the premise of hyperadaptive drug use: ①The drug has evidence-based medical evidence; ②There is no other safer, more effective, economical and reasonable treatment method; ③The patient has informed consent; ④The hospital has established related management mechanisms
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Therefore, it can be basically known that the behavior of off-label drug use is not a simple personal behavior of doctors, but a diagnosis and treatment behavior at the level of medical institutions.
for the record
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For manufacturers, whether or not to use drugs basically depends on the hospital's attitude towards off-label use of drugs
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Taking anticancer drugs as an example, if a manufacturer wants to appear in the doctor's off-label drug catalog, it first needs to be approved by the hospital, and secondly, the doctor's prescription can play a role
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But on the other hand, exploring new treatment options has always been the innate responsibility of top medical centers, and off-label medication is also a necessary process to advance the entire medical career.
It's a happy thing
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However, in essence, off-label drug use is not applicable to any medical institution.
For some grass-roots medicines, the pros and cons cannot be fully controlled, and rashly using off-label drug use may not be a good thing
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Therefore, for the entire medical system, under the premise of establishing a corresponding grading system and precise requirements, flexible processing should be the primary attention at present
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Today, super-adaptive drugs have taken a difficult first step, but at least the government has let us understand that everything aimed at clinical needs will be met as much as possible by the government
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So about the future improvement of super-adaptive drugs, there may be some points that will be worth pondering
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First of all, as the most special case of off-label drug use, children's drug use has always been a "paradox".
The law has always stipulated that any drugs not specially developed for children, including psychotropic drugs, cannot be used before they are marketed.
Do any trials in children
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This also results in that any new and good medicines cannot have indications for children, and children cannot use these medicines
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This is actually another major dilemma of off-label drug use.
With the support of more data in the future, it may also become a new direction for off-label improvement, which is worth looking forward to
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