What will be the impact of the hierarchical management of cancer drugs?

(Health Times reporter Wang Yongwen)
Anti-tumor drugs are about to be graded. Cancer drugs with high toxic side effects, expensive oncology drugs, and short-time-to-market cancer drugs will be included in the restricted use class. After six months of discussion, the National Health and Health Commission's Measures for the Clinical Application of Anti-Tumor Drugs (Draft for Comments) will be officially implemented on March 1, 2021.
Jun, winner of the 2020 Wu Tianping Medical Award and executive vice president of Sun Yat-sen University's Cancer Prevention and Control Center, told the Health Times that in recent years, the accessability of anti-tumor drugs through various efforts has been greatly alleviated. But at the same time, there are still some differences in the scientific and standardized application of anti-tumor drugs in different regions and medical units. We should try to realize the whole process management of anti-tumor drugs from the aspects of anti-tumor drug catalog selection, procurement and supply, graded management, training assessment to clinical application and drug comprehensive evaluation feedback.information picture, Cao Zihao for the picture.
do you want to grade cancer drugs?
Anti-tumor drugs, because of their special therapeutic properties, are a class of drugs that are strictly regulated by national drug regulators and medical departments, such as non-intestinal and oral chemotherapy drugs that, if used improperly, are included in the list of high-alert drugs from the Institute for Drug Safety Practices (ISMP) in the United States.
" has process-specific management practices specifically for use in anti-tumor drug hospitals in many countries around the world, as well as guidelines for rational use of evidence-based medical evidence. Ma Jun told reporters that in recent years, under the great attention of China's health administration departments, a number of relevant regulations and technical specifications have been issued, and gradually improve and strengthen the selection, procurement, storage, prescription, deployment, clinical application and drug evaluation of the entire process of management.
according to the published Measures for the Clinical Application of Anti-Tumor Drugs (Trial), anti-tumor drugs are classified as restricted and general use grades from safety, accessability, economy and other factors. Specific drugs include anti-tumor chemotherapy drugs, molecularly targeted drugs, immunotherapy drugs, endocrine therapy drugs, etc.
Among them, the drug toxic side effects are large, into the toxic drug management, strict evidence of adaptation, more taboos, improper use of anti-tumor drugs may cause serious damage to the human body;
"Considering that there are many types of monoclonal anti-tumor drugs, including immuno-checkpoint inhibitors, which are currently commonly used in clinical practice, especially in recent years, the market speed of new drugs has been accelerating, and tumor treatment is distributed in several clinical departments and other status quo, anti-tumor The clinical application of drugs should be graded management, according to safety, accessability, economy and other factors, anti-tumor drugs are divided into restricted use and ordinary use level, which is necessary for the rational clinical use of cancer drugs," Liu Tao, director of the pharmacy department of Sun Yat-sen University Cancer Prevention and Control Center, told the Health Times.
the impact of oncology drug classification management?
According to Milnet data, in recent years, China's public medical institutions terminal anti-tumor drug sales scale rose rapidly, the market growth rate from 12.44 percent in 2016 to 21.30 percent in 2019, and the market size of 96.1 billion yuan, the introduction of anti-tumor drug management measures or will deeply affect this market pattern.
Ma Jun believes that the grading management of anti-tumor drugs further clarifies that anti-tumor drugs from medical institutions to select and evaluate drugs, graded prescriptions, clinical standards, and so on to further improve the relevant standards. This will put higher demands on the manufacturers of related drugs, and research and development or production enterprises must pay high attention to the use of products after the market, including safety and effectiveness.
In addition, the Measures for the Clinical Application of Anti-Tumor Drugs (Trial) stipulate that anti-tumor drugs may be prescribed only after confirming the application of the patient based on the results of tissue or cytological pathological diagnosis, or special molecular pathological diagnosis, gene target testing, etc. It also requires strict management of the use of drugs that are not clearly defined in the drug instructions but have evidence-based medical evidence.Liu Tao told reporters,
In the field of treatment of malignant tumor diseases, the phenomenon of super-drug instructions is relatively common, the main reason is indeed that scientific research and clinical trials in this field of development is quite rapid, and the update of drug instructions significantly lags behind the development of clinical practice." Super-instruction manual drug use, also known as "unregistered use of drugs", refers to the use of drug use adaptation certificate, dosage, adaptation to the population, drug routes and other uses, not in the drug supervision and administration department approved instructions.
"Measures for the Clinical Application of Anti-Tumor Drugs (Trial)" clearly states that medical institutions shall formulate a hierarchical management directory for anti-tumor drugs, assess and grant corresponding prescription rights to physicians, who shall prescribe corresponding levels of anti-tumor drugs in accordance with the prescribing rights granted.
Liu Tao believes that in addition to following the norms of diagnosis and treatment and clinical guidelines for the use of hyper-instructional drugs, it is necessary to carry out close observation and monitoring in the course of use, timely assessment of drug safety and effectiveness, and regularly organize experts from the Committee on Pharmacology and Pharmacology to conduct a comprehensive clinical evaluation of hyper-instructional drug use to determine whether the treatment can continue to be implemented.
For the vast number of patients, the Measures and hierarchical management require that health administrative departments at all levels and all types of medical institutions at all levels should strengthen publicity and education for the public and cancer patients, promote the knowledge of cancer prevention and treatment of health, improve the scientific understanding of cancer diseases in the whole society, eliminate errors in the field of cancer treatment, establish a scientific concept of treatment, and provide more effective safety and security for the vast number of cancer patients.
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