Article 1 In order to adapt to the situation of deepening the reform of the medical and health system and establishing the drug classification management system in China, to meet the growing self-care needs of the public, and to give full play to the role of social pharmacies in the medical and health system, and with reference to the corresponding internationally recognized norms, the Good Manufacturing Practice (GPP) is formulated.
Article 2 This Code is an industry self-discipline code advocated by China OTC Pharmaceutical Association. Based on the strict implementation of relevant national laws, regulations and norms by social pharmacies, this specification mainly puts forward guiding principles and evaluation basis for pharmaceutical services and the quality of employees in social pharmacies.
Article 3 Social pharmacy is the last link for medical and health system to provide services to the public. Practitioners of social pharmacy, especially pharmaceutical technicians, are important staff in the medical and health system. Their primary responsibility is to ensure that patients or consumers get high-quality pharmaceutical services. Pharmaceutical care is all kinds of activities and services that focus on the health of patients or consumers and aim at ensuring safe and effective medication, thus promoting the health level and quality of life of patients or consumers.
Article 4 By standardizing the service standards of social pharmacies and the responsibilities of employees, we will ensure the safety, effectiveness and convenience of people's drug use, promote the full utilization of medical resources in China, improve the competitiveness and management level of social pharmacies, and guide fair competition in the industry.
Chapter II Pharmaceutical Services
Article 5 Pharmaceutical service is a modern pharmaceutical working mode that provides various services related to medication. In order to provide high-quality pharmaceutical services, social pharmacies should meet the requirements of the following Article 6 to 12.
Article 6 The operation and sale of drugs shall conform to the requirements of relevant laws and regulations and the good manufacturing practice, and shall be equipped with corresponding personnel, facilities and equipment.
Article 7 A pharmacy with a certain scale shall establish a professional division of labor and service areas, ensure the provision of appropriate and qualified drugs and health care products, guide rational drug use, conduct free drug consultation, protect the privacy of special patients or consumers in consultation and dialogue, and provide other high-quality services.
Article 8 A drug calendar system shall be established according to the needs of patients or consumers for drug sales records and drug tracking. Drug calendar refers to the medication files established for patients. The contents of the drug calendar include general information of patients, family history, hobbies, allergy history, drug name, dosage, course of treatment, adverse reaction records, etc. The establishment of pharmaceutical calendar system can ensure the safety and effectiveness of patients' medication, enhance customer relationship and promote the process of pharmaceutical care.
Ninth to provide patients or consumers with a variety of special services, which must include quality services for special groups, community public health lectures and services.
Tenth released by the government, legal academic or industry groups compiled by the self-medication, self-care and other health science information, the information content should comply with the relevant provisions of the state.
Eleventh equipped with corresponding pharmaceutical service reference books for pharmaceutical technicians and patients or consumers.
Article 12 When a drug is sold separately, a drug sales label must be provided, that is, a label is attached to the outer package of the drug purchased by the patient or consumer, and the contents of the label include the name, dosage, usage method, batch number, expiration date, precautions for use, taboos and other contents of the drug sold. The drug sales label is established and used to ensure the safety and effectiveness of patients' medication when the drug packaging is split and the drug instructions cannot be provided.
Chapter III Social Pharmacy Personnel and Training
Thirteenth social pharmacy practitioners' ideological and moral and cultural level must meet the requirements of GSP. On this basis, the main medical practitioners are divided into four grades according to their functions, namely, shop assistant, assistant pharmacist, pharmacist and licensed pharmacist.
Article 14 A shop assistant must have a high school education or above and obtain the qualification certificate of the relevant state department. According to the actual situation, pharmacies can divide the clerks into three levels: primary, intermediate and advanced, or primary and advanced. The training of pharmacy clerk qualification examination (GPC) organized by China OTC Pharmaceutical Association can be used as one of the important bases for clerk's career and promotion. Shop assistants should be able to complete general sales tasks and daily business, and provide related pharmaceutical services to patients or consumers under the guidance of higher-level pharmaceutical technicians.
Fifteenth assistant pharmacists refer to pharmaceutical technicians who have passed the examination by the relevant state departments and obtained the professional and technical post certificate of assistant pharmacists. His duties include understanding patients' or consumers' drug demand on the basis of effective communication with them, accurately providing over-the-counter drugs, conducting prescription testing and sales under the guidance of licensed pharmacists, and recording prescriptions, drug allergic reactions and adverse drug reactions. Provide self-medication and health care guidance for patients and consumers, and provide appropriate pharmaceutical services for patients or consumers independently or through guidance of shop assistants.
Sixteenth pharmacists refer to pharmaceutical technicians who have passed the examination by the relevant state departments and obtained the "Pharmacist Professional and Technical Position Certificate". In addition to the duties of assistant pharmacists, they should also be able to formulate and review drug sales labels, drug calendars and drug publicity materials; Independently review and allocate prescriptions; Participate in or guide assistant pharmacists to do a good job in patient follow-up and information feedback analysis; Assist licensed pharmacists in pharmacy management.
Seventeenth licensed pharmacists refer to pharmaceutical technicians who have passed the national unified examination, obtained the qualification certificate of licensed pharmacists and registered to practice in social pharmacies. Licensed pharmacists are responsible for the examination and supervision of prescriptions, providing medication consultation and information, guiding rational drug use, monitoring therapeutic drugs and evaluating drug efficacy. Licensed pharmacists have the responsibility to put forward suggestions, stop and refuse to implement acts or decisions that violate the Drug Administration Law and relevant laws and regulations, and report to their superiors. Responsible for the supervision and management of drug quality within the scope of practice, participate in the formulation and implementation of total quality management of drugs, and deal with violations of relevant regulations by the unit.
Eighteenth social pharmacy assistant pharmacists, pharmacists must regularly participate in the continuing education provisions of this specification.