Drugs are special commodities related to human health and safety, and their use should be subject to strict regulatory requirement.
Recently, the National Health and Medical Commission issued the "Notice on Further Strengthening Drug Safety Management and Improving the Level of Rational Drug Use", which put forward requirements for rational drug use management, and further emphasized the need to strengthen the management of the use of key monitoring drug.
The industry believes that this means that the launch of a new batch of key monitoring drug lists may already be on the wa.
The key monitoring drug list is to ensure the rational use of drugs in public hospitals, standardize clinical drug use behavior, and protect the health rights and interests of patient.
In July 2019, the National Health Commission released the first batch of key monitoring catalogue.
The list involves a total of 20 drugs, all of which are over 1 billion varietie.
Among them, nervous system drugs are the main ones, of which 12 are nerve/vascular protectio.
Dosage drug.
In September 2021, the National Health and Medical Commission issued the "Notice on Printing and Distributing the Work Procedures for the Adjustment of the National Key Monitoring and Rational Drug Catalogue", which means that the key monitoring catalogue has entered the era of standardizatio.
In three years, the number of drug varieties included in the catalog management is generally 30. Compared with the first batch of drug lists for key monitoring, the scope of this time has been expande.
Except for adjuvant drugs such as nerve/vascular protective agents, most of the drugs included in the list of key monitoring drugs are unreasonable clinical use problems and abnormal use amount.
Chemical drugs and biological products that are too high and have a greater impact on the rationality of drug use, including adjuvant drugs, anti-tumor drugs, antimicrobial drugs, proton pump inhibitors, glucocorticoids, and parenteral nutrition drug.
In March 2022, the National Pharmaceutical Council was established, which means that the adjustment of the catalog is being accelerate.
According to the adjustment principle of not less than 3 years, the industry believes that a new batch of key drug lists may be release.
In the notice issued by the National Health and Health Commission this time, it is required to strengthen the key monitoring of the use and management of rational drug use drugs, antimicrobial drugs, anti-tumor drugs, proton pump inhibitors, glucocorticoids, narcotic drugs, traditional Chinese medicine injections, et.
. Through blood drug concentration monitoring, genetic testing, et.
, we can identify drug risks, formulate individualized drug regimens, optimize the selection of drug varieties, and accurately determine drug dose.
It is worth mentioning that in addition to the issuance of documents at the national level, local governments are also strengthening the adjustment of the list of key monitoring and rational drug use drug.
According to incomplete statistics, in addition to the first batch of 20 drugs in the key monitoring catalogue issued by the National Health Commission, provincial, municipal, and even medical institutions have conducted key monitoring of certain varieties, involving more than 200 drug.
For example, in February 2022, Fujian Province released the third batch of medical insurance key drug list, involving 9 drugs, and the "third batch of medical insurance key drug list, involving 21 drug.
It is also clarified that the drugs that originally belonged to the second batch of key monitoring and key monitoring lists, except for the drugs that were included in the third batch of key monitoring and key monitoring lists, are no longer subject to key monitoring and key monitorin.
Hebei Province issued a document in August, clearly strengthening the management of the use of key drug.
It is required to take comprehensive measures to control the use rate of antibiotics in patients and the intensity of antibiotic use in hospitalized patients within a reasonable range, and control the use intensity of antibiotics below 40 DDD/100 person-day.
At the same time, timely adjust the list of key monitoring drugs and the classification management list of clinical application of antimicrobial drugs, and strengthen the use of key monitoring drugs, antimicrobial drugs, anti-tumor drugs, proton pump inhibitors, glucocorticoids, narcotic drugs, and traditional Chinese medicine injection.
management,et.
For pharmaceutical companies, focusing on monitoring or changing the fate of the company brings great challenges to the survival of the compan.
Judging from the sales of the first batch of 20 varieties included in the catalog, the market size of the 20 varieties in 2018 was about 45 billion yua.
down to 19 billion yua.
It can be seen that the sales of drugs entering the key monitoring catalogue will be directly affecte.
In particular, after some injections are subject to key monitoring and are transferred out of the medical insurance catalogue, the sales will plumme.
However, for medical institutions, this kind of adjustment work is conducive to rationalizing the drug structure of the hospita.
Some drugs with poor efficacy, lack of clinical data, and poor safety are transferred out to realize the replacement of birds and protect the rights and interests of patient.
