How to ensure the safety and continuity of medication after putting drugs into centralized purchasing? Shanghai Municipal Party Committee of the Civil Party suggests the following methods:
With the increasing adoption of centralized drug procurement, concerns have arisen regarding drug safety and efficacy. Against this backdrop, the question of how to ensure patient safety and continuity of drug use has become a focal point. At the upcoming 2025 National People’s Congress, the Shanghai Municipal Committee of the China Association for Promoting Democracy plans to submit a proposal on ensuring patient safety and continuity of drug use in the context of centralized drug procurement, offering several specific suggestions on the aforementioned issues.
The proposal points out that centralized drug procurement, as an important measure of medical reform, aims to ensure drug quality, reduce costs through centralized procurement, alleviate patient burden, improve drug accessibility, and ensure continuous supply. However, currently, this initiative still faces several challenges:
1. Drug supply stability and continuity need to be strengthened. At the beginning of a new round of centralized procurement, there may be a window period for the availability of drugs due to factors such as drug production progress, hospital stockpiling, or disease prevalence.
2. Drug efficacy, quality, and patient trust need to be enhanced. Despite the authoritative and rigorous certification system of consistency certification, patients who use drugs have reported differences in drug efficacy for the same drug name from different manufacturers participating in centralized procurement.
3. Auxiliary drug delivery methods and functions need to be improved and promoted. Currently, Shanghai has implemented electronic prescription circulation, integrated drug distribution through medical insurance cards at designated pharmacies, and online hospital drug purchase inquiry through the “Suisharbian” app. These measures enable patients to obtain the required drugs from more channels when hospital drugs are out of stock. However, some patients are unaware of these channels; some hospitals are not familiar with how to set up virtual drug libraries for electronic prescription circulation; doctors also lack knowledge about whether the drugs required by patients are available at designated pharmacies; and the inventory information of drugs in various hospitals in the city on the “Suisharbian” app is not comprehensive enough.
In response to the aforementioned issues, the Shanghai Municipal Committee of the China Association for Promoting Democracy has proposed three specific recommendations in this proposal:
Firstly, improve the drug supply warning system, optimize unified allocation, and establish an information feedback mechanism. The National Health Commission and other departments have jointly issued opinions on reforming and improving the grassroots drug linkage management mechanism to expand the variety of drugs at the grassroots level, with a particular emphasis on improving the grassroots drug shortage warning and disposal mechanism. Based on this mechanism, it is proposed to establish effective linkage, improve information communication on drug supply inventory and manufacturer production arrangement, timely arrange alternative drugs online, encourage hospitals at various levels to plan their drug procurement volume reasonably, establish a drug adjustment mechanism between community hospitals and higher-level hospitals in addition to the drug registration mechanism during shortage supply. When there is a shortage of supply, adjustments should be made through higher-level departments to ensure drug supply. Additionally, it is suggested to reduce the frequency of annual adjustments, adjust the drug list reasonably, develop a handbook for drug replacement guidance, especially when drugs are replaced or out of stock, allowing doctors to provide clearer explanations and guidance on drug use for patients.
Secondly, improve the quality supervision system of drugs and strictly control their quality. The proposal suggests that drug supervision departments should strictly control the entire drug quality supervision system. For drugs that have obtained consistency certification and entered the centralized procurement process, regular or irregular drug inspections should be conducted on pharmaceutical factories, and direct sampling inspections on drugs from hospitals should be ensured to ensure that the sampled drugs are identical to those during the consistency certification process in terms of efficacy. The assessment results of consistency testing, especially the results of bioequivalence studies that need to be clearly indicated, should be fully disclosed beyond simple listing. At the same time, a unified feedback platform should be established to collect clinicians’ feedback on the efficacy and opinions on the use of centralized procurement drugs, and relevant information should be promptly fed back to drug companies.
Thirdly, improve electronic prescription circulation and patient drug supply inquiry system. Strengthen the promotion and publicity of electronic prescription circulation and integrated drug distribution through medical insurance cards at designated pharmacies, provide guidance on the establishment of electronic virtual drug libraries in hospitals, and build a smooth information sharing and circulation platform. Improve the information system on “Suisharbian” app for hospital drug purchase inquiry, regularly update information on the储备情况 of various hospitals in Shanghai for national centralized procurement谈判drugs, and make it convenient for patients to query drug supply status.
