20 19 what are the major events in chinese pharmaceutical affairs management?
The year of 20 19 is obviously not calm for drugstore people.
At the beginning of 20 19, although the pharmaceutical retail industry was surging, it was still calm on the surface. CCTV 3. 15 party, like a Mars, set off the whole industry and set off the tide of industry rectification in 2065.438+09.
1, severely crack down on licensed pharmacists' "registration"
In view of the problems exposed by CCTV, such as licensed pharmacists' "hanging certificates" and irregular sales of prescription drugs, National Medical Products Administration issued the Notice on Regulating the Behavior of Licensed Pharmacists in Drug Retail Enterprises, which triggered a shock in the industry.
On the one hand, local market supervision departments and drug supervision departments have stepped up supervision and severely cracked down on licensed pharmacists' behavior of "hanging certificates"; On the other hand, under the leadership of the regulatory authorities, the "remote trial party" that was almost "frozen" was restarted in various regions with the intention of improving the pharmaceutical service level of retail pharmacies.
According to incomplete statistics, at least nearly 20 regions, including Hunan, Shaanxi, Liaoning, Shandong, Jiangxi, Fujian and Chongqing, have started remote trial work or pilot projects, accounting for more than half of the country.
2, designated pharmacies "non-drugs" off the shelf.
With the arrival of the strong supervision of the National Medical Insurance Fund, the National Medical Insurance Bureau has also put forward stricter requirements for designated pharmacies, the most representative of which is "non-drugs off the shelf".
According to drug search statistics, at least a dozen designated pharmacies in various provinces and cities across the country are prohibited from selling health food. Law enforcement departments often require medical insurance designated pharmacies to remove non-medical products such as health food by means of document notice, agreement, oral notice and meeting notice.
3. Differentiated allocation of licensed pharmacists
In view of the allocation of licensed pharmacists in pharmacies, local regulatory authorities, in combination with local specific conditions, have issued corresponding allocation measures for licensed pharmacists in pharmacies in the documents promoting the development of local pharmaceutical retail industry, which are embodied in the following aspects:
① In order to further solve the problem of shortage of licensed pharmacists in township retail pharmacies, it is clear in some areas that pharmaceutical retail stores run by townships at the county level (excluding urban areas) can employ personnel with the title of pharmacist or above to undertake the duties of licensed pharmacists. Representative area: Shaanxi.
(2) The legal representative and principal responsible person of the headquarters of the pharmaceutical retail chain enterprise must bear legal responsibility for the pharmaceutical business activities of its stores according to law, and the store responsible person of the chain enterprise is no longer required to be a licensed pharmacist. Representative area: Anhui.
(3) Pharmaceutical retail chain enterprises can uniformly register licensed pharmacists at the headquarters of retail chain enterprises, establish licensed pharmacists management files, facilitate unified deployment and use, and strengthen training management. Representative area: Anhui.
In addition, according to the documents issued by various localities, some regions require designated pharmacies with medical insurance to be equipped with at least two nominal licensed pharmacists; Some areas have passed the distance examination, 1 licensed pharmacists can provide pharmaceutical services for several to dozens of stores; In developed areas such as Shanghai, pharmacies need to be equipped with a corresponding number of licensed pharmacists according to their business areas.
4. Are online prescription drugs released?
The Drug Administration Law stipulates that drug marketing license holders and drug trading enterprises shall abide by the relevant provisions of the Drug Exchange Law when selling drugs through the Internet. For vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and pharmaceutical precursor chemicals, the Drug Administration Law stipulates that they may not be sold on the Internet.
5, pharmacy classification management
Since the Ministry of Commerce issued a document to promote the classified management of pharmacies at the end of 20 18, Shandong and Yunnan provinces have successively issued documents and decided to promote the classified management of pharmacies, which was officially implemented in Shandong Province on 20 19 12 1. So far, three provinces in China have clearly put forward (piloted) classified management of pharmacies, namely Guangdong, Shandong and Yunnan.
6. Pharmacies are included in centralized procurement.
Since the country carried out drug procurement with quantity, many provinces and cities have encouraged designated pharmacies to participate, but the most typical ones are Shandong, Zhejiang, Shanghai and Guangdong.
On May 15, Shandong Provincial Medical Insurance Bureau and other four departments jointly issued the Opinions on the Trial Implementation of Centralized Drug Purchase by Private Medical Institutions, which clearly stated that "private medical institutions and chain retail pharmacies managed by medical insurance agreements can purchase drugs online through the provincial centralized drug purchase platform", and requested to apply for opening an account from June 1 day, and officially start related work on July 1 day.
On May 24th, Zhejiang Medical Machinery Purchasing Center issued a document, allowing six provincial-level pharmaceutical chain pharmacy groups, such as Intertek, Huadong Pharmacy, Guokong Pharmacy, Xinyi Pharmacy, Yunkai Yamei Pharmacy and Jiuzhou Pharmacy, to open the purchasing authority of Zhejiang Medical Machinery Purchasing Platform. The related work will be completed before the end of May, and the scope of drugs to be purchased is drugs for chronic diseases.
On September 1 1, Guangdong Drug Purchasing Center issued the Notice on Doing a Good Job in Drug Transaction Registration of Drug Retailers in our Province, clarifying that Guangdong Drug Trading Center will conduct online drug transactions for drug retailers.
On June165438+1October 2 1 day, Shanghai promoted the work of "all-round online public bargaining for drugs in pharmacies". In the document "Tips for All-round Online Public Bargaining of Pharmacies", it is required that all drugs sold in designated pharmacies (medical insurance counters) should be negotiated by designated pharmacies and pharmaceutical manufacturers themselves.
The agreed price is only valid for designated pharmacies, and the agreed retail price should be consistent with the medical insurance settlement price.
7. The implementation of the new drug administration law
The newly revised Drug Administration Law was officially implemented on 65438+February 1 day. For pharmacies, this revision is of great significance.
First, in the new law, "meeting the requirements of" Quality Management Standards for Pharmaceutical Trading "formulated by the drug supervision and administration department of the State Council according to this law" is listed as a prerequisite for starting a pharmaceutical production enterprise, and the GSP certification that has been implemented for many years is officially cancelled.
Second, the Drug Administration Law has increased the penalties for selling counterfeit and inferior drugs. Even if the circumstances are minor, the illegally produced and sold drugs and illegal income will be confiscated, ordered to stop production and business for rectification, and the drug approval number will be revoked, and a fine of more than 10 and less than 30 times the value of the illegally produced and sold drugs will be imposed.
Third, the revision of the regulations also provides for the establishment of a professional and professional drug inspection team. The regulatory authorities will use the "flying inspection" to further restrain the non-compliance behavior of pharmacies and play a role in strengthening drug safety supervision and inspection.
8. Sell medicine 24 hours a day
Since the beginning of this year, the question of whether pharmacies can sell drugs 24 hours a day has once again attracted the attention of the society and the industry. In view of this social hot issue, the regulatory authorities in some areas have issued corresponding regulations. For example, in Lintong District, Xi City, the local market supervision and management department interviewed the drug retail enterprises in the jurisdiction 17 and asked for a letter of commitment to ensure that drugs can be sold 24 hours a day.
Tangshan medical insurance department plans to cancel the designated medical insurance agreement for the designated pharmacies that cannot provide 24-hour drug sales; In the relevant documents of Guangxi and Anhui, pharmacies are also encouraged to configure 24-hour automatic drug vending machines to provide residents with 24-hour drug sales services.
9, assume the function of medical institutions pharmacy.
In the future, it will become a retail pharmacy or pharmacy in primary medical institutions.
The Notice of Anhui US Food and Drug Administration on Printing and Distributing Specific Measures to Promote the Healthy Development of Drug Retail (Chain) Enterprises points out that drug retail enterprises should be supported to undertake the pharmaceutical service functions of pharmacies in medical institutions such as communities without changing the drug management model.
Coincidentally, the Guiding Opinions on Promoting the Supply of Chronic Diseases Drugs in Designated Retail Pharmacies of Basic Medical Insurance in Guangdong Province issued by Guangdong Medical Insurance Bureau also mentioned that it is necessary to explore the establishment of cooperative relations between primary medical institutions and retail pharmacies.
Retail pharmacies can distribute drugs to the intravenous drug allocation center (room) of medical institutions for the use of insured patients or distribute them to insured patients according to the route of administration and demand.
10, chronic disease patient file management system
In order to facilitate the purchase of drugs by patients with chronic diseases, several provinces have issued documents to encourage pharmacies to establish a file management system for patients with chronic diseases. Licensed pharmacists can establish files for patients with chronic diseases with prescriptions and diagnosis certificates. For patients who buy drugs for treating chronic diseases within a period of time, they can buy them directly according to the records without prescription.