The latest rules for licensed pharmacists are released
Source: Medical Network
On November 20, the State Food and Drug Administration officially issued the "Notice on Regulating the Use of Licensed Pharmacists in Pharmaceutical Retail Enterprises" (hereinafter referred to as the "Notice").
The "Notice" clarified that, in view of the current situation of insufficient licensed pharmacists in some areas, the provincial drug supervision and administration department can formulate and implement differentiated deployment policies for the use of licensed pharmacists without reducing the overall proportion of existing licensed pharmacists. , And set a transition period.
The relevant person in charge stated that during the transition period, for areas where there is a significant gap in licensed pharmacists, pharmaceutical retail companies are allowed to deploy other pharmacy technicians to assume the duties of licensed pharmacists, and the transition period will not exceed 2025.
This notice will be implemented on January 1, 2021. If the previous requirements for the provision and use of licensed pharmacists in pharmaceutical retail companies are inconsistent with this notice, this notice will be implemented.
is only valid during the transition period
According to WHO survey statistics, 1/3 of global patients die from irrational drug use, not from the disease itself. Obviously, in the production, circulation and use of drugs, the provision of corresponding licensed pharmacists for quality supervision and pharmaceutical services is of special importance to ensuring the safety of drug use by the public.
According to data released by the National Medical Products Administration Licensed Pharmacist Certification Center in November last year, there were more than 1.03 million licensed pharmacists in the country, of which only more than 460,000 were registered in retail pharmacies. Based on this data, industry experts estimate that the current number of licensed pharmacists can only meet 70% of the needs of pharmaceutical retail companies, which also means that the gap of licensed pharmacists is still very large.
The "Drug Administration Law" stipulates that there should be pharmacists or other pharmaceutical technicians who have been certified according to law to engage in drug business activities. Pharmacists who are legally qualified in the field of pharmaceutical business refer to licensed pharmacists. Other pharmacy technicians who have been qualified in accordance with the law include health (pharmaceutical) series titles (including pharmacist, pharmacist, pharmacist in charge, deputy chief pharmacist, chief pharmacist), practicing pharmacist Wait. It is necessary to uphold and improve the professional qualification access system for licensed pharmacists, and insist on the legal provision and use requirements for licensed pharmacists in pharmaceutical business enterprises.
In principle, drug retail companies dealing in prescription drugs and Class A non-prescription drugs should be equipped with licensed pharmacists; drug retail companies that only deal in Class B non-prescription drugs should be staffed with professional personnel who have passed the examination organized by the drug regulatory authority.
According to the "13th Five-Year" National Drug Safety Plan, the number of licensed pharmacists per 10,000 population is more than 4, and the main managers of all retail pharmacies have the qualifications of licensed pharmacists and have licensed pharmacists to guide rational drug use as indicators.
From the above data, it is not difficult to see that the gap of licensed pharmacists in my country is still large.
The above-mentioned person in charge also further explained that the differentiated deployment and use policy of licensed pharmacists is a transitional policy proposed in light of my country’s current overall insufficient number of licensed pharmacists and uneven distribution of national conditions. The premise is to adhere to the policy guidance for the deployment and use of licensed pharmacists, and the purpose is to adopt Promote the deployment and use of licensed pharmacists in phases and regions, steadily increase the proportion of licensed pharmacists in pharmaceutical retail companies, and eventually achieve all licensed pharmacists.
This move is also consistent with the spirit of the relevant provisions of the newly revised "Drug Administration Law" on the provision of licensed pharmacists by pharmaceutical retail companies.
Multi-department joint punishment
A licensed pharmacist is a professional force that carries out drug quality management and provides pharmaceutical services, and is an important guarantee for rational drug use. In recent years, in response to the adjustment of the allocation of licensed pharmacists, the State Food and Drug Administration has strengthened the daily supervision of the allocation and use of licensed pharmacists in retail pharmacies, and cracked down on the “l(fā)icensing” behavior of licensed pharmacists. At the same time, further research has been done to improve the management and deployment policies of licensed pharmacists. On the one hand, the "three districts and three states" shall be determined to separate the qualification standards of licensed pharmacists and the policies for restricting practicing areas; on the other hand, in light of the actual situation, further explore and improve the differentiated allocation policy of licensed pharmacists.
The "Notice" pointed out that the provincial drug supervision and administration department should formulate specific implementation plans based on the actual situation of the licensed pharmacists and pharmacy technicians in the administrative area, combined with factors such as business varieties, business scales, regional differences, and drug safety risks. Promote the deployment and use of licensed pharmacists in different regions, and steadily increase the proportion of licensed pharmacists in pharmaceutical retail companies.
During the transitional period, the departments responsible for drug supervision in each city and county shall strengthen the management of pharmaceutical technicians in the administrative area, register the provision of pharmaceutical technicians in pharmaceutical retail enterprises as required, and establish relevant information files.
Regarding drug retail companies that are not equipped in accordance with regulations and have not been properly rectified, they shall be investigated and dealt with in accordance with the law, and administrative measures such as suspension of prescription drug sales shall be adopted. The verified "certified" licensed pharmacists shall be entered into the national registered management information system for licensed pharmacists, their registration certificates shall be revoked and resolutely exposed; the "certified" licensed pharmacists shall be included in the credit management "blacklist", and multi-departmental joint punishment shall be implemented .
In addition, the "Notice" clarifies that licensed pharmacists in pharmaceutical retail companies should be responsible for the drug quality management of the company, supervise the implementation of relevant laws, regulations and specifications on drug management; be responsible for prescription review and supervision of deployment, provide the public with reasonable drug use guidance and consulting services; be responsible for collecting feedback Pharmaceutical work such as information on adverse drug reactions. Pharmaceutical retail companies must strictly implement the relevant provisions of the "Drug Administration Law", while adhering to the principle of appointing licensed pharmacists, they must also give full play to the role of licensed pharmacists.
All localities should attach great importance to the construction of the team of licensed pharmacists, formulate relevant policies to guide pharmaceutical technicians to actively participate in the qualification examination of licensed pharmacists, and increase the proportion of licensed pharmacists in the administrative area year by year; standardize the continuing education of licensed pharmacists and promote the continuous updating of professional knowledge of licensed pharmacists , To play a better role; it is necessary to explore the establishment of a multi-sectoral policy linkage mechanism to promote the use of licensed pharmacists and the healthy development of the licensed pharmacist team.