Practicing pharmacists equipped with the latest rules released! Implementation from next year (full text attached)

On November 24th, the State Drug Administration officially issued a "Notice on regulating the use of practicing pharmacists in pharmaceutical retail enterprises" (hereinafter referred to as the Notice).
The Notice makes it clear that, in view of the fact that there are not enough practicing pharmacists and difficult to equip in some areas at present, the provincial drug regulatory departments may, without reducing the overall proportion of existing practicing pharmacists, formulate policies for the implementation of differentiated use of licensed pharmacists and set up a transition period.
the relevant officials said that during the transition period, pharmaceutical retail enterprises are allowed to equip other pharmaceutical technicians to assume the duties of practicing pharmacists in areas where there is a clear gap between practicing pharmacists, and the transition period will not exceed 2025.
notice shall be effective from January 1, 2021, and shall be implemented in accordance with this notice if the requirements for the use of the equipment of practicing pharmacists in pharmaceutical retail enterprises are inconsistent with this notice.
only during the transition period, according to the WHO survey, one-third of patients worldwide die from unreasonable medication, not the disease itself.
obviously, in the pharmaceutical production, circulation and use of the link, equipped with the corresponding practicing pharmacists for quality supervision and pharmaceutical services, to ensure the safety of public drug use has a special significance.
data released last November by the National Drug Administration's Center for the Qualification of Practicing Pharmacists showed that there were more than 1.03 million qualified practicing pharmacists nationwide, of whom only 460,000 were registered as practicing pharmacists in retail pharmacies.
based on this data, industry experts estimate that the number of practicing pharmacists available can only meet 70% of the demand of drug retailers, which means that the gap in practicing pharmacists is still very large.
The Drug Administration Law stipulates that pharmacists or other pharmaceutical technicians who have been qualified in accordance with the law shall be involved in drug business activities.
The pharmacist who has been qualified according to law in the field of drug management refers to a practicing pharmacist, and other pharmaceutical technicians who have been qualified according to law include the title of the health (drug) series (including pharmacist, pharmacist, competent pharmacist, deputy director pharmacist, chief pharmacist), practicing pharmacist, etc.
to adhere to and improve the professional qualification access system for practicing pharmacists, and adhere to the requirements for the use of practicing pharmacists in pharmaceutical enterprises in accordance with the law.
In principle, pharmaceutical retail enterprises operating prescription drugs and Class A over-the-counter drugs shall be equipped with practicing pharmacists;
In accordance with the "13th Five-Year Plan" national drug safety plan, the number of practicing pharmacists per 10,000 population will exceed 4, all major managers of retail pharmacies have the qualifications of practicing pharmacists, business with licensed pharmacists to guide the rational use of drugs as an indicator.
from the above data, it is not difficult to see that China's practicing pharmacists gap is still large.
The above-mentioned person in charge further explained that the policy of differential use of licensed pharmacists is a transitional policy based on the overall number of practicing pharmacists in China and uneven distribution of the national conditions, provided that the policy orientation of the use of licensed pharmacists is adhered to, with the aim of steadily increasing the proportion of practicing pharmacists in pharmaceutical retail enterprises through phased and subregional promotion of the use of licensed pharmacists, and ultimately reaching the full staffing of practicing pharmacists.
move is also in keeping with the spirit of the new amendments to the Drug Administration Act relating to the use of licensed pharmacists in pharmaceutical retail enterprises.
multi-sector joint disciplinary practice pharmacists are the professional force to carry out drug quality management and provide pharmaceutical services, and are the important guarantee of rational drug use.
recent years, in order to adjust the staffing situation of practicing pharmacists, the State Drug Administration has strengthened the daily supervision of the use of licensed pharmacists in retail pharmacies, and cracked down on the practice of pharmacists " hanging up" behavior.
, we have further studied and improved the management and staffing policies of practicing pharmacists.
on the one hand, to determine the "three districts and three states" separately delineate the qualification examination qualification standards for practicing pharmacists and restrict the practice of regional policies;
The Notice points out that the provincial drug regulatory departments shall, in accordance with the actual situation of the teams of practicing pharmacists and pharmaceutical technicians in the administrative area, formulate specific implementation plans, promote the use of practicing pharmacists in stages and subregions, and steadily increase the proportion of practicing pharmacists in pharmaceutical retail enterprises.
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 situation of pharmaceutical technical personnel in drug retail enterprises in accordance with the provisions, and establish relevant information files.
pharmaceutical retail enterprises that are not equipped according to regulations and are not in place for rectification shall be investigated and dealt with in accordance with the law, and administrative measures such as suspension of prescription drug sales shall be taken.
To check the "registered" practicing pharmacists to enter the national registered pharmacist management information system, revoke their registration certificate and resolutely expose;
In addition, the Notice clearly states that pharmaceutical practitioners in pharmaceutical retail enterprises shall be responsible for the quality management of their drugs, supervise the implementation of relevant laws and regulations and norms on drug management, be responsible for prescription review and supervision of deployment, provide reasonable drug use guidance and advisory services to the public, and collect feedback on pharmaceutical adverse reactions and other pharmaceutical work.
drug retail enterprises should strictly implement the relevant provisions of the Drug Administration Law, while adhering to the principle of the staffing of practicing pharmacists, but also to give full play to the role of practicing pharmacists.
All regions should attach great importance to the construction of the ranks of practicing pharmacists, formulate relevant policies to guide pharmaceutical technical personnel to actively participate in the qualification examination of practicing pharmacists, and increase the proportion of practicing pharmacists in their administrative areas year by year;
The State Drug Administration on regulating the use of pharmaceutical retail enterprises equipped with practicing pharmacists notice of the provinces, autonomous regions, municipalities directly under the Central Government of the Drug Administration, Xinjiang Production and Construction Corps Drug Administration: practicing pharmacists are the quality management of drugs and the provision of pharmaceutical services professional strength, is an important guarantee for rational drug use.
recent years, the State Drug Administration has continuously strengthened the construction and construction of the system and team building of practicing pharmacists, continuously promoted the use of licensed pharmacists, and actively played an important role in ensuring the safety and effectiveness of drug use by the public.
, however, the current development of the ranks of practicing pharmacists is unbalanced and inadequate, and the problem of inadequate staffing of practicing pharmacists in some drug retail enterprises is still more prominent.
In accordance with the relevant provisions of the newly revised Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law), in order to regulate the use of practicing pharmacists, the relevant requirements are heeded as follows: First, adhere to the policy of equipping practicing pharmacists, and steadily improve the level of equipment drug retail enterprises equipped with licensed pharmacists is the basic requirements for maintaining the safety of public drug use, but also to achieve the "healthy China" strategy and promote the high-quality development of the industry.
The Drug Administration Law stipulates that pharmacists or other pharmaceutical technicians who have been qualified in accordance with the law shall be involved in drug business activities.
The pharmacist who has been qualified according to law in the field of drug management refers to a practicing pharmacist, and other pharmaceutical technicians who have been qualified according to law include the title of the health (drug) series (including pharmacist, pharmacist, competent pharmacist, deputy director pharmacist, chief pharmacist), practicing pharmacist, etc.
to adhere to and improve the professional qualification access system for practicing pharmacists, and adhere to the requirements for the use of practicing pharmacists in pharmaceutical enterprises in accordance with the law.
In principle, pharmaceutical retail enterprises operating prescription drugs and Class A over-the-counter drugs shall be equipped with practicing pharmacists;
In view of the fact that there are not enough practicing pharmacists and difficult to equip in some areas at present, the provincial drug supervision and administration departments may, without reducing the proportion of existing practicing pharmacists as a whole, formulate policies for the implementation of differentiated use of licensed pharmacists and set up a transition period.
the transition period, pharmaceutical retail enterprises are allowed to equip other pharmaceutical technicians to assume the duties of practicing pharmacists in areas where there is a significant gap in practicing pharmacists, and the transition period does not exceed 2025.
2. To refine the implementation of the requirements for the staffing of practicing pharmacists, strengthen supervision and inspection responsibilities and implement the provincial drug supervision and administration departments shall, in accordance with the actual situation of the teams of practicing pharmacists and pharmaceutical technicians in the administrative area, formulate specific implementation plans, promote the use of practicing pharmacists in stages and sub-regions, and steadily increase the proportion of practicing pharmacists in pharmaceutical retail enterprises.
and implementation programs formulated by the provincial drug supervision and administration departments for the use of licensed pharmacists shall be made public in a timely manner, and the publicity and guidance shall be done well.
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 situation of pharmaceutical technical personnel in drug retail enterprises in accordance with the provisions, and establish relevant information files.
To implement the "four most stringent" requirements, strictly audit and control new drug retail enterprises, strengthen supervision and inspection of the equipment and on-the-job practice of practicing pharmacists (or pharmaceutical technicians) and urge them to perform their duties and responsibilities.
pharmaceutical retail enterprises that are not equipped according to regulations and are not in place for rectification shall be investigated and dealt with in accordance with the law, and administrative measures such as suspension of prescription drug sales shall be taken.
To check the "registered" practicing pharmacists to enter the national registered pharmacist management information system, revoke their registration certificate and resolutely expose;
3. To give full play to the role of practicing pharmacists and continuously strengthen the construction of the team of pharmaceutical retail enterprises, the practicing pharmacists shall be responsible for the quality management of drugs in their enterprises, supervise the implementation of relevant laws and regulations and norms on drug management, be responsible for prescription examination and supervision of deployment, provide reasonable drug use guidance and advisory services to the public, and be responsible for collecting feedback on adverse drug reactions and other pharmaceutical work.
drug retail enterprises should strictly implement the relevant provisions of the Drug Administration Law, while adhering to the principle of the staffing of practicing pharmacists, but also to give full play to the role of practicing pharmacists.
All regions should attach great importance to the construction of the ranks of practicing pharmacists, formulate relevant policies to guide pharmaceutical technical personnel to actively participate in the qualification examination of practicing pharmacists, and increase the proportion of practicing pharmacists in their administrative areas year by year;
this Notice will be effective from 1 January 2021.
the previous requirements for the use of pharmaceutical retail enterprises for the use of licensed pharmacists are inconsistent with this Notice, according to this Notice.
19, 2020