Policy interpretation
1October 20th, 165438+ The State Administration of Pharmaceutical Products issued the Notice on Standardizing the Use of Licensed Pharmacists in Pharmaceutical Retail Enterprises (hereinafter referred to as the Notice), stipulating that provincial pharmaceutical supervisory and administrative departments can formulate policies to implement differentiated allocation and use of licensed pharmacists without reducing the overall proportion of existing licensed pharmacists, and set a transition period. During the transition period, in areas where there is an obvious gap in licensed pharmacists, pharmaceutical retail enterprises are allowed to equip and use other pharmaceutical technicians to undertake the duties of licensed pharmacists, and the transition period will not exceed 2025. The Notice shall be implemented as of 20211.
According to the relevant personnel of the Certified Pharmacist Certification Center of the State Administration of Pharmaceutical Products, by the end of 2020 10, the number of people who passed the licensed pharmacist qualification examination in China exceeded10/60,000, and the number of registered licensed pharmacists exceeded 560,000. Among them, the number of registered licensed pharmacists in pharmaceutical retail enterprises exceeds 5 1 10,000, accounting for 90.9% of the total number of registered pharmacists. There are about 390,000 pharmaceutical retail enterprises equipped with licensed pharmacists, accounting for 74.4% of the total number of pharmaceutical retail enterprises, and about 70% of licensed pharmacists are distributed in urban areas. This contrast shows that the gap between licensed pharmacists in pharmaceutical retail enterprises is gradually narrowing. On the whole, the number of licensed pharmacists per 10,000 population in China is currently 4.0, which has reached the target requirement of 4 licensed pharmacists per 10,000 population in the Thirteenth Five-Year Plan for National Drug Safety. However, at present, the development of licensed pharmacists is unbalanced and inadequate, and the problem that licensed pharmacists are not in place in some areas, especially in rural areas below the county level, is still outstanding.
In view of the policy of differentiated allocation and use of licensed pharmacists, the relevant personnel of the Department of Drug Administration of the State Administration of Pharmaceutical Products explained that this policy is a transitional policy based on the current situation of insufficient total number and uneven distribution of licensed pharmacists in China. The premise is to adhere to the policy orientation of the allocation and use of licensed pharmacists. The purpose is to promote the allocation and use of licensed pharmacists by stages and regions, steadily improve the allocation and use ratio of licensed pharmacists in pharmaceutical retail enterprises, and finally realize the full allocation of licensed pharmacists. This move is also in line with the spirit of the relevant provisions of the newly revised Drug Administration Law that pharmaceutical retail enterprises are equipped with licensed pharmacists.
According to reports, other pharmaceutical technicians referred to in the Notice include licensed pharmacists, pharmacists with professional titles in health series, and professional technicians with professional backgrounds in pharmacy or medicine who are engaged in drug-related work. In view of the situation that licensed pharmacists are allowed to carry out remote pharmaceutical services in some provinces concerned by the industry, the above-mentioned personnel of the Drug Administration Department of the State Drug Administration said that all localities should be encouraged to adhere to the principle of licensed pharmacists performing their duties and make useful explorations in pharmaceutical service methods. The State Administration of Pharmaceutical Products will also organize a special investigation to study the related contents of remote pharmaceutical services.
In order to standardize the management of pharmacists, the Notice requires that during the transition period, the drug regulatory authorities of cities and counties should strengthen the management of pharmaceutical technicians within their respective administrative areas, register pharmaceutical retail enterprises equipped with pharmaceutical technicians according to regulations, and establish relevant information files. It is necessary to implement the "four strictest" requirements and strictly review and check the newly established pharmaceutical retail enterprises; Strengthen the supervision and inspection of licensed pharmacists (or pharmaceutical technicians) and their on-the-job practice, and urge them to perform their duties. For pharmaceutical retail enterprises that are not equipped according to the regulations and whose rectification is not in place, they should be investigated and punished according to law and take administrative measures such as suspending the sale of prescription drugs. Verified licensed pharmacists should be entered into the national licensed pharmacist registration management information system, and their registration certificates should be revoked and resolutely exposed; It is also necessary to include "licensed pharmacists" in the "blacklist" of credit management and implement multi-departmental joint punishment.
The full text of the notice is as follows.
News news
Original notification
Notice of the State Administration of Pharmaceutical Products on Regulating the Use of Licensed Pharmacists in Pharmaceutical Retail Enterprises
Drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government, and drug administrations of Xinjiang Production and Construction Corps:
Licensed pharmacists are a professional force to carry out drug quality management and provide pharmaceutical services, and are an important guarantee for rational drug use. In recent years, the State Administration of Pharmaceutical Products has continuously strengthened the licensed pharmacist system and team building, continuously promoted the use of licensed pharmacists, and played an active role in ensuring the safety and effectiveness of public medication. However, at present, the development of licensed pharmacists is unbalanced and insufficient, and the problem that licensed pharmacists in pharmaceutical retail enterprises in some areas are not in place is still outstanding. According to the newly revised Drug Administration Law of People's Republic of China (PRC) (hereinafter referred to as the Drug Administration Law), in order to regulate the use of licensed pharmacists, the relevant requirements are hereby notified as follows:
First, adhere to the allocation policy of licensed pharmacists and steadily improve the allocation level.
Equipped with licensed pharmacists according to regulations is the basic requirement for pharmaceutical retail enterprises to maintain the safety of public medication, and it is also the practical need to realize the strategy of "healthy China" and promote the high-quality development of the industry. The Drug Administration Law stipulates that pharmacists or other pharmaceutical technicians who have obtained qualifications according to law shall engage in drug business activities. Pharmacists who are legally qualified in the pharmaceutical business field refer to licensed pharmacists, and other pharmaceutical technicians who are legally qualified include health (pharmacy) series titles (including pharmacists, pharmacists, pharmacists in charge, pharmacists in charge and licensed pharmacists). It is necessary to adhere to and improve the professional qualification access system for licensed pharmacists, and adhere to the requirements for licensed pharmacists in pharmaceutical trading enterprises to be equipped and used according to law. Pharmaceutical retail enterprises dealing in prescription drugs and Class A OTC drugs shall, in principle, be equipped with licensed pharmacists; Drug retail enterprises that only deal in Class B drugs shall be equipped with qualified business personnel who have passed the examination organized by the drug supervision and administration department.
In view of the shortage of licensed pharmacists in some areas, the provincial drug supervision and administration department can formulate and implement the policy of differentiated allocation and use of licensed pharmacists without reducing the overall allocation ratio of existing licensed pharmacists, and set a transition period. During the transition period, in areas where there is an obvious gap in licensed pharmacists, pharmaceutical retail enterprises are allowed to equip and use other pharmaceutical technicians to undertake the duties of licensed pharmacists, and the transition period will not exceed 2025.
Two, detailed implementation of licensed pharmacists equipped with requirements, strengthen the implementation of supervision and inspection responsibilities.
Provincial drug supervision and management departments should formulate specific implementation plans according to the actual situation of licensed pharmacists and pharmaceutical technicians within their respective administrative areas, combined with factors such as business varieties, business scale, regional differences and drug safety risks, promote the use of licensed pharmacists by stages and regions, and steadily increase the proportion of licensed pharmacists in pharmaceutical retail enterprises. The transitional policies and implementation plans for the differentiated allocation and use of licensed pharmacists formulated by the provincial drug supervision and administration departments should be disclosed to the public in a timely manner, and publicity and guidance should be done well.
During the transition period, the departments responsible for drug supervision in cities and counties should strengthen the management of pharmaceutical technicians within their respective administrative areas, register pharmaceutical retail enterprises with pharmaceutical technicians according to regulations, and establish relevant information files. It is necessary to implement the "four strictest" requirements and strictly review and check the newly established pharmaceutical retail enterprises; Strengthen the supervision and inspection of licensed pharmacists (or pharmaceutical technicians) and their on-the-job practice, and urge them to perform their duties. Drug retail enterprises that are not equipped according to regulations and whose rectification is not in place should be investigated and dealt with according to law, and administrative measures such as suspending the sale of prescription drugs should be taken. Verified licensed pharmacists should be entered into the national licensed pharmacist registration management information system, and their registration certificates should be revoked and resolutely exposed; It is also necessary to include "licensed pharmacists" in the "blacklist" of credit management and implement multi-departmental joint punishment.
Third, give full play to the role of licensed pharmacists and continue to strengthen team building.
Licensed pharmacists in pharmaceutical retail enterprises are responsible for the drug quality management of their own enterprises and supervise the implementation of relevant laws, regulations and norms on drug management; Responsible for prescription review and supervision, and provide guidance and consulting services for rational drug use to the public; Responsible for collecting and feeding back information on adverse drug reactions and other pharmaceutical work. Drug retail enterprises should strictly implement the relevant provisions of the Drug Administration Law, adhere to the principle of licensed pharmacists, and give full play to the role of licensed pharmacists.
All localities should attach great importance to the construction of licensed pharmacists, formulate relevant policies to guide pharmaceutical technicians to actively participate in the licensed pharmacist qualification examination, and increase the proportion of licensed pharmacists in their respective administrative regions year by year; It is necessary to standardize the continuing education of licensed pharmacists and promote them to constantly update their professional knowledge and play a better role; It is necessary to explore the establishment of a multi-sectoral policy linkage mechanism to promote the use and healthy development of licensed pharmacists.
This notice shall be implemented as of 20211. If the previous requirements for pharmaceutical retail enterprises to use licensed pharmacists are inconsistent with this notice, this notice shall prevail.
The above is another policy of the State Administration of Pharmaceutical Products that Bian Xiao sent to you today! Differentiated equipment for licensed pharmacists! " I hope it helps you. Generally speaking, the development trend of the pharmaceutical industry in the future is very impressive, so it is suggested that interested candidates prepare for the exam as soon as possible, become a member of the pharmaceutical industry as soon as possible, and shine for the pharmaceutical industry of the motherland.