Try new rules for online drug sales in many places first!

On December 8, the Hubei Provincial Drug Administration formally issued the "Hubei Provincial Social Pharmacy Supervision and Administration Measures (Trial)" (hereinafter referred to as the "Measures") and the Hubei Provincial Social Pharmacy Quality and Service Management Guidelines (Trial) (hereinafter referred to as " "Guide") "Hubei Province Social Pharmacy Pharmaceutical Service Capability Evaluation Management Regulations (Trial)" three documents, provide a strong guarantee for the province to regulate the drug quality of social pharmacies and the management of pharmaceutical services
.
It is worth noting that for social pharmacies engaged in Internet drug sales activities, Hubei has formulated a separate "Internet drug retailing" section in the "Measures", and put forward several regulatory requirements that pharmacies should comply with
.

 

Advanced pharmacy service ability is the first threshold

 

Under the premise of complying with relevant laws and regulations and supervision and management measures for drug online sales, Hubei first clarified that social pharmacies that carry out Internet drug sales should have advanced pharmaceutical service capabilities and be equipped with a corresponding Internet drug sales information management system
.
And if only other eligible social pharmacies undertake the business of “pick-up from online order” and “delivery from online order”, they shall have at least basic pharmaceutical service capabilities and be equipped with a corresponding Internet drug sales information management system
.

 

It is reported that Hubei divides the pharmaceutical service capacity of social pharmacies into three levels: primary pharmaceutical service capacity, basic pharmaceutical service capacity and advanced pharmaceutical service capacity
.
The pharmaceutical supervision and administration department evaluates the pharmaceutical service ability of social pharmacies in accordance with the pharmaceutical GPP, determines the pharmaceutical service ability level based on the drug GSP compliance inspection results, and issues the "Social Pharmacy Pharmaceutical Service Ability Level Evaluation Report" after a comprehensive assessment, and publicizes the evaluation results
.

 

It can be seen from the "Guide" that pharmacists are the protagonists who assume the main responsibility of social pharmacies to provide pharmaceutical services
.
The high-level pharmacy service includes all the content of the low-level and corresponds to the duties performed by the pharmacist
.
Compared with other levels, pharmacists who provide high-level pharmaceutical services have increased the establishment of a drug treatment management system to establish a drug record for patients, and update and maintain the drug record according to the management of drug treatment; for actual or potential drug problems, Comprehensive evaluation of patients’ health and medication treatment status for drug treatment review; Responsibilities such as recycling and processing of waste drugs in accordance with the regulations of the drug supervision and management department
.

 

In addition, Hubei emphasis on social Internet pharmacies shall not exceed the retail pharmaceutical enterprises mode of operation and business scope, may not be sold banned drugs prescribed by the State, not offer Class A non-prescription and prescription drugs
.
Where prescription drugs are sold, the source of electronic prescriptions shall be authentic and reliable
.
Among the requirements that social pharmacies should meet at least for the Internet retail drug quality management activities, Hubei also proposed to establish Internet sales drug quality and safety management, online pharmaceutical services, drug distribution, reporting and complaint handling, and drug recall management systems, and establish effective drugs The recall system ensures that drugs sold through the Internet are traceable and verifiable throughout the entire process
.

 

According to the "Statistical Report on Drug Supervision and Administration" issued by the State Drug Administration, in the first half of this year, the number of pharmacies in Hubei Province increased from 15,647 at the end of 2020 to 19,440, ranking first in the country with an increase of 3,793
.
However, according to related reports, although the number of social pharmacies in Hubei Province is now close to 20,000, there are still at least nearly 10,000 pharmacies that do not meet the advanced pharmaceutical service capabilities, which means that nearly half of the retail pharmacies in the province are not qualified to develop Internet drugs.
Retail services cannot enjoy policy dividends
.
In addition to the threshold of advanced pharmaceutical service capabilities, the ability to effectively establish multiple service systems and configure corresponding drug management information systems proposed by the new regulations will also test the strength of local social pharmacies
.

 

　　Exploring new ways of supervision in various ways according to local conditions

 

　　Under the top-level design of "Internet +" to promote economic innovation and development, China's pharmaceutical e-commerce has been booming in recent years
.
Furthermore, driven by related factors such as the epidemic hindering offline communication and the strong demand for convenient drug purchase by the people, online drug sales have achieved explosive growth, becoming the fourth largest drug sales terminal after hospitals, pharmacies, and primary medical institutions
.
However, because drugs themselves have stricter requirements for supervision, the supervision and innovation of new forms of online drug sales are also facing more challenges
.
The official draft of the "Measures for the Supervision and Administration of Drug Online Sales" has not yet been issued, and Hainan, Guangdong, Shanghai and other places are already exploring measures to suit local conditions
.

 

　　In November this year, Hainan issued the "Interim Regulations on the Supervision and Administration of Online Drug Sales (Draft for Solicitation of Comments)," which emphasized the importance of online prescription drugs "sold by prescription, with prescription first
.
" Pharmaceutical retail companies that sell prescription drugs through the Internet can only display the generic name, product name, dosage form, specification, and holder information of the prescription drug to the public.
At the same time, they should highlight risk warnings such as "prescription drugs must be purchased and used under the guidance of a pharmacist with a prescription.
" Information
.
For individuals who have prescriptions and passed the review, they can show the drug instructions, packaging, and label information
.
Before obtaining a prescription, it is prohibited to provide prescription drug purchase operations through self-built websites or third-party platforms
.
In addition, when receiving online prescriptions issued through Internet hospitals, the scope of prescription sales should meet the requirements of Internet diagnosis and treatment
.

 

　　As one of the most developed and highly active provinces in the country’s pharmaceutical e-commerce, Guangdong also proposed in the “Fourteenth Five-Year Plan for Drug Safety and High-quality Development in Guangdong Province (2021-2025)” issued in August this year.
Adhere to the network management network, promote the construction of a network monitoring system, and improve the quality of supervision and management of drugs, medical devices and cosmetics online transactions
.
Innovate the supervision of the new business format of online sales to ensure that there is no leakage or loss of control, and the orderly development of the new business format
.
At the same time, special rectification of "online net network, offline source clearing" was carried out , and the investigation and handling of suspected illegal and illegal clues transferred by the national drug /medical device network transaction monitoring platform were strictly followed
.

 

　　Coincidentally, in the "Several Opinions on Promoting the Healthy Development of Shanghai Pharmaceutical Retail Industry" issued in September this year, Shanghai emphasized the need to promote the standardized management of drug online sales platforms, and increase the inspection and monitoring of drug information display, prescription review and monitoring, and sales management.
, Distribution management, drug traceability, adverse reaction collection, complaint management and dispute resolution systems
.
The drug regulatory department is required to urge third-party platforms for drug online transactions to strictly review the qualifications of Internet hospitals, evaluate the quality of online diagnosis and treatment management, standardize and improve the operation process of online prescription drugs, set up identity verification and real-name authentication for prescription drug sales, and pass system restrictions and Data retrospective management to strengthen risk control
.

 

　　While actively exploring new paths for online drug sales supervision at the local level, the top level of the country has not slowed down
.
In October of this year, the Medical Administration and Administration Bureau of the National Health Commission issued the "Internet Diagnosis and Treatment Regulations (Draft for Solicitation of Comments)", prohibiting artificial intelligence consultations, first buying drugs and replenishing prescriptions, drug rebates, etc.
, and conditions for online sales of prescription drugs Let go and reinforce safety dams
.
In the same month, the Drug Supervision Department of the State Food and Drug Administration held a special video conference on drug business supervision and epidemic prevention and control.
It also pointed out that the preparation and revision of the drug business and use supervision and management measures, and the drug online sales supervision and management measures were actively promoted, and the regulatory ecological system for drug business supervision was accelerated.
Build
.
The industry generally believes that with the gradual implementation of relevant regulations in the future, it will bring about a new situation for regulating drug online sales and drug online transaction service behavior, supporting the development of Internet prescription drug sales, and ensuring the safety of public use of drugs, or reshaping the market competition landscape
.

　　On December 8, the Hubei Provincial Drug Administration formally issued the "Hubei Provincial Social Pharmacy Supervision and Administration Measures (Trial)" (hereinafter referred to as the "Measures") and the Hubei Provincial Social Pharmacy Quality and Service Management Guidelines (Trial) (hereinafter referred to as " "Guide") "Hubei Province Social Pharmacy Pharmaceutical Service Capability Evaluation Management Regulations (Trial)" three documents, provide a strong guarantee for the province to regulate the drug quality of social pharmacies and the management of pharmaceutical services
.
It is worth noting that for social pharmacies engaged in Internet drug sales activities, Hubei has formulated a separate "Internet drug retailing" section in the "Measures", and put forward several regulatory requirements that pharmacies should comply with
.

 

　　Advanced pharmacy service ability is the first threshold

 

　　Under the premise of complying with relevant laws and regulations and supervision and management measures for drug online sales, Hubei first clarified that social pharmacies that carry out Internet drug sales should have advanced pharmaceutical service capabilities and be equipped with a corresponding Internet drug sales information management system
.
And if only other eligible social pharmacies undertake the business of “pick-up from online order” and “delivery from online order”, they shall have at least basic pharmaceutical service capabilities and be equipped with a corresponding Internet drug sales information management system
.

 

　　It is reported that Hubei divides the pharmaceutical service capacity of social pharmacies into three levels: primary pharmaceutical service capacity, basic pharmaceutical service capacity and advanced pharmaceutical service capacity
.
The pharmaceutical supervision and administration department evaluates the pharmaceutical service ability of social pharmacies in accordance with the pharmaceutical GPP, determines the pharmaceutical service ability level based on the drug GSP compliance inspection results, and issues the "Social Pharmacy Pharmaceutical Service Ability Level Evaluation Report" after a comprehensive assessment, and publicizes the evaluation results
.

 

　　It can be seen from the "Guide" that pharmacists are the protagonists who assume the main responsibility of social pharmacies to provide pharmaceutical services
.
The high-level pharmacy service includes all the content of the low-level and corresponds to the duties performed by the pharmacist
.
Compared with other levels, pharmacists who provide high-level pharmaceutical services have increased the establishment of a drug treatment management system to establish a drug record for patients, and update and maintain the drug record according to the management of drug treatment; for actual or potential drug problems, Comprehensive evaluation of patients’ health and medication treatment status for drug treatment review; Responsibilities such as recycling and processing of waste drugs in accordance with the regulations of the drug supervision and management department
.

 

　　In addition, Hubei emphasis on social Internet pharmacies shall not exceed the retail pharmaceutical enterprises mode of operation and business scope, may not be sold banned drugs prescribed by the State, not offer Class A non-prescription and prescription drugs
.
Where prescription drugs are sold, the source of electronic prescriptions shall be authentic and reliable
.
Among the requirements that social pharmacies should meet at least for the Internet retail drug quality management activities, Hubei also proposed to establish Internet sales drug quality and safety management, online pharmaceutical services, drug distribution, reporting and complaint handling, and drug recall management systems, and establish effective drugs The recall system ensures that drugs sold through the Internet are traceable and verifiable throughout the entire process
.

 

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