On October 26th, the Chongqing Municipal Health Commission issued a notice soliciting public opinions on the "Chongqing Medical Institution Rational Drug Use Assessment Work Plan (Draft for Comments)" (hereinafter referred to as the "Draft for Comments"), which includes detailed scoring and assessment content for the rational drug use assessment of secondary and above medical institutions (including maternal and child health hospitals and specialized disease prevention and control institutions).

Compared with previous rational drug use documents, the draft for soliciting opinions not only sets requirements for the use of antibiotics, the allocation and use of essential drugs, the monitoring of key drugs, and the use of centrally purchased drugs, but also specifically includes chapters to clarify the use and management of anti-tumor drugs, as well as the regulatory requirements for conducting therapeutic drug monitoring (TDM).

The deepening of the market forces the improvement of standards

According to the "Assessment Standards for Rational Drug Use in Secondary and Higher Medical Institutions in Chongqing (Trial)" (hereinafter referred to as the "Assessment Standards") attached to the draft for soliciting opinions, the use and management of anti-tumor drugs account for a total of 15 points, which is the same proportion as "National Essential Drug Allocation and Use", second only to "Strengthening in-process and post event supervision of prescriptions and improving prescription quality" (30 points).

According to the document requirements, hospitals at or above the second level must establish a working group for the management of anti-tumor drugs, and regularly conduct training on standardized management and rational use of anti-tumor drugs; Implement graded management of anti-tumor drugs, and grant corresponding prescription rights to clinical doctors after standardized management and application training of anti-tumor drugs. At the same time, it is necessary to establish a multidisciplinary tumor diagnosis and treatment team (MDT) including clinical pharmacists to participate in clinical drug treatment work. Conduct a special evaluation on the rationality of the use of anti-tumor drugs, standardize the use of anti-tumor drugs beyond the instructions, establish a list of drugs beyond the instructions, and dynamically adjust it.

As a newly included assessment standard, the high attention paid to anti-tumor drugs is not only influenced by policy factors, but also by market conditions that have shown a relatively high growth rate in the domestic anti-tumor drug market in recent years. According to data from MineNet, the sales scale of terminal anti-tumor drugs in Chinese urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) has rapidly increased in recent years. The growth rates from 2016 to 2019 were 12.44%, 16.36%, 19.10%, and 21.30%, respectively, reaching 96.1 billion yuan in 2019. Despite the influence of the clinical drug recommendation principle of "oral administration without injection", the anti-tumor drug field still has a large market share in the injection market (64.74%), but the growth rate is slightly lower than the horizontal line. The growth rate from 2016 to 2019 remained above 10%, and the market potential is still considerable.

Tumor diagnosis and treatment quality control or comprehensive implementation

In fact, the clinical application monitoring of anti-tumor drugs has been going on for quite some time. In order to standardize the medication behavior of medical institutions and personnel, reduce medical costs, the National Health Commission has not only formulated and issued the "Guidelines for Clinical Application of New Anti tumor Drugs", but also established the "Anti tumor Drug Clinical Application Monitoring Network" to carry out rational drug use monitoring in tertiary comprehensive hospitals and oncology specialty hospitals with oncology departments nationwide.

The director of the National Cancer Center, He Jie, recently revealed that the monitoring of clinical application of anti-tumor drugs is ongoing, monitoring the rational use of anti-tumor drugs in more than 1400 medical institutions across the country, with the aim of comprehensive management of diagnosis and treatment quality control and strengthening the standardized use of anti-tumor drugs.

In addition, 28 provinces have established provincial-level tumor related quality control centers, and quality control management for single disease tumors will be one of the key focuses in the future. It is reported that the National Cancer Single Disease Quality Control Platform is currently under construction. With breast cancer as the pilot, the National Cancer Quality Control Center has carried out the construction of standardized quality control pilot for diagnosis and treatment of breast cancer. At present, 200 hospitals above the third level have been included in the pilot scope, and the single disease genetic control of lung cancer is also in trial. The National Cancer Center and the National Cancer Quality Control Center will continue to monitor indicators related to the quality of cancer diagnosis and treatment in medical institutions, promote continuous improvement of cancer diagnosis and treatment quality, and continuously improve the quality control system for cancer diagnosis and treatment.

In fact, Chongqing's assessment standards also propose multiple detailed indicators, such as requiring clinical pharmacists to carry out drug therapy management (MTM) for potential high-risk patients with organ dysfunction such as advanced age, pregnancy, lactation, liver and kidney dysfunction, including information collection, drug therapy analysis and evaluation, formulation of drug therapy goals and treatment plans, intervention of drug therapy plans, and follow-up.

For the use of anti-tumor drugs beyond the instructions, Chongqing requires the development of a list of anti-tumor drugs beyond the instructions based on the drug usage of this medical institution. At the same time, it is necessary to adjust the list of drugs beyond the instructions in a timely manner according to changes in clinical diagnosis and treatment guidelines for tumors.