Off-label medication reissue!

　　On August 25, the Shandong Pharmaceutical Association issued the "Shandong Province Expert Consensus on Drugs That Go Beyond the Instructions for Use (2022 Edition)".
Compared with the version released by Shandong Province in 2021, the variety of drugs has been increased or decreased, and 156 varieties and 247 items have been condensed.
Recommendations are provided for the reference of physician prescriptions and pharmacists reviewing prescriptions in medical institutions
.
Previously (June 28), the Guangdong Pharmaceutical Association also released the "Catalogue of Off-label Drugs (2022 Edition)", adding 37 off-label drug information; in addition to Guangdong, the drafting units of the 2022 version of the catalog include Beijing, Liaoning, The top three hospitals in Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Hubei, Hunan, Hainan, Chongqing, Sichuan, Shaanxi, Fujian and other provinces and cities
.
In fact, there is a consensus on the clinical drug side that there is a lag that is difficult to replace in the face of drug instructions in the face of treatment plans; on the other hand, the first group to discover new drug indications is often doctors
.
The Guangdong Pharmaceutical Association and Shandong Pharmaceutical Association, which have been assisting medical institutions in formulating off-label drug use catalogs in China, have successively issued documents, providing clinicians with space for practice and exploration
.
Experts believe that the inclusion of "off-label drug use" in the new version of the "Physician Law" is a legal norm, giving clinicians a protection; at the same time, the scale and boundaries of off-label drug use are still hot topics in the industry.
With the implementation of the "Physician Law", the challenges faced by the clinical value of drugs and the actual use of therapeutic drugs are far more than that
.
Off-label drug use is gradually "releasing" "Off-label drug use has been arguing for decades, and finally a conclusion has been reached
.
" This is in early March this year, when off-label drug use was written into the new version of the "Physician Law", the industry finally obtained regulatory policies for off-label drug use.
Feelings after support
.
For a long time, the state attaches great importance to the rationality judgment and operation standard of off-label drug use.

.
In September 2013, the Drug Risk Management Group of the Professional Committee of Therapeutic Drug Monitoring and Research of the Chinese Pharmacological Society was established.
The "Expert Consensus on Off-label Drugs" compiled by the group was released in April 2015.
The "access system" is adopted for off-label drug use in the institution, and medical and pharmaceutical workers are organized to conduct access approval and regular assessment of off-label drug use to prevent and control drug risks
.
In the continuous exploration and attempt of medical clinical practice, new discoveries and experience accumulation of drugs will continue to be made in clinical use.
Correspondingly, the update and improvement of drug instructions requires rigorous verification and review, which leads to a relatively long time.
process, there will inevitably be a phenomenon that the instructions lag behind the clinical use of drugs
.
Therefore, in the eyes of many clinicians and pharmacists, off-label drug use is relatively common in actual clinical practice
.
If the doctor takes off-label medication, the effect is not good or even an accident occurs, the patient can sue the doctor according to the law, and the instructions are the basis for the judgment
.
A clinician of a tertiary hospital said bluntly: "In the past, off-label medication did have certain risks.
In actual clinical practice, there are too many patients who need off-label medication in some departments.
The development will be subject to many constraints
.
" On March 1 this year, with the official promulgation and implementation of the "Physician Law", the "off-label drug use" was concluded, and the off-label drug use written into the law for the first time provided more clinical medication possible
.
Article 29 of the "Physicians' Law" stipulates: In special circumstances such as no effective or better treatment methods, after obtaining the patient's explicit informed consent, the physician may use the drug usage that is not specified in the drug insert but has evidence-based medical evidence.
treatment
.
This means that, at the legal level, off-label drug use has been "unbound": as long as there is evidence-based evidence, through the hospital's record and the patient's knowledge, off-label drug use can be used; for clinicians, there are legal Keyi will have a relatively independent elastic space, and will have the confidence to provide better medical treatment for patients.

.
Then at the end of June, the "Catalogue" issued by the Guangdong Pharmaceutical Association provided the latest reference for medical institutions at all levels to regulate off-label drug use
.
According to industry insiders, off-label drug use certainly has the need for clinical drug treatment in the development of medical practice, but at the same time, it may also occur due to irregular practice behavior, the game between manufacturers' interests and drug value
.
Because of this, the market view believes that although off-label drugs may bring some risks, if they can be strictly regulated, under the premise of legal compliance and safety, more new drug functions can be "unlocked".
, so that more patients can benefit from it
.
Objectively review the comprehensive value of drugs After the off-label drug use has a law to follow, new discoveries and new experiences through clinical practice do not have to wait until the instructions are updated, and "old drugs" can be applied to patients more quickly
.
However, the problems faced in the fields of oncology, rare diseases, children , etc.
go far beyond this
.
Due to the obvious urgency of demand for innovative drugs in these fields, in order to allow patients to receive drug treatment faster and better, for drugs with obvious clinical value, the State Food and Drug Administration has accelerated drug approval and access; the application in 2020 is applicable The completion rate of the priority review and approval process reached 72.
87%
.
It is worth noting that different patient groups have different demands for drugs
.
For example, for cancer patients at the end of life, being able to meet the basic demands of prolonging life has become a new threshold to improve the comprehensive quality of life of patients
.
Up to now, my country's drug regulatory review and approval system has been fully established and is being gradually improved.
In the fields of health technology assessment, pharmacoeconomics, health economics, and real-world research, it is also constantly exploring and advancing; The level of drug research and development based on clinical value will continue to improve, and the level of new drug indication development and comprehensive clinical evaluation will also be strengthened
.
In 2021, the Shandong Pharmaceutical Association compiled the "Shandong Province Expert Consensus on Drugs Beyond the Instructions for Use (2021 Edition)", which will be updated in 2022 after a year of practice and feedback based on clinical needs and actual drug use
.
Compared with the 2021 version of the "Consensus", 156 varieties and 247 recommendations were included in the latest version of the expert consensus released by the Shandong Pharmaceutical Association, including 25 antibacterial drugs, 15 antitumor drugs, and 14 cardiovascular drugs.
There are 16 psychiatric and neurological drugs, 11 renal and wind immunity drugs, 33 pediatric drugs, 35 obstetrics and reproductive drugs, and 11 other drugs
.
In the 2022 edition of the catalog released by the Guangdong Pharmaceutical Association, as the earliest release of the "Expert Consensus on Drugs over the Drug Label", the revision of the new edition has also attracted much attention from the industry.
This edition is the 8th edition since 2015, with a total of 269 species.
Drugs, of which 37 are newly added, including anti-tumor drugs such as adalimumab and otuzumab, as well as common drugs such as aspirin, ibuprofen, metformin, moxifloxacin, and levofloxacin
.
　　Attachment: Expert consensus on off-label use of drugs in Shandong Province (2022 version) Off-label drug use is gradually "unbound" at the exhibition Hospitals objectively examine the comprehensive value of drugs for children's drugs and tumors Expert consensus on medication (2022 edition)