Article 1 In order to strengthen the pharmaceutical management of medical institutions, promote the rational application of drugs, and safeguard public health, these provisions are formulated in accordance with the Drug Administration Law of the People's Republic of China, Regulations on the Administration of Medical Institutions and Regulations on the Administration of Narcotic Drugs and Psychotropic Substances, and other relevant laws and regulations.
Second Article The provisions of the medical institutions referred to in the pharmaceutical management, refers to the medical institutions to the patient as the center, based on clinical pharmacy, the clinical use of medication throughout the process of effective organization and implementation and management, to promote clinical science, rational use of medication, pharmacy technical services and related pharmaceutical management.
Article 3 The Ministry of Health, the State Administration of Traditional Chinese Medicine is responsible for the supervision and management of drug management in medical institutions across the country.
Local health administrative departments at or above the county level and the administrative departments of traditional Chinese medicine are responsible for the supervision and management of drug administration in medical institutions within their administrative regions.
The military health administrative department is responsible for the supervision and management of the military medical institutions drug management.
Article IV of the medical institutions, pharmaceutical management and pharmacy is an important part of medical work. Medical institutions shall set up drug management organizations and pharmacy departments in accordance with the provisions of this article.
Article 5 The pharmacy professionals and technicians who have obtained the appropriate qualifications in accordance with the law may engage in professional and technical work in pharmacy.
Article 6 Medical institutions shall not use the purchase, sale and use of medicines as the basis for the economic distribution of medical personnel or departments or sections. Medical institutions and medical personnel shall not be in the purchase and sale of drugs, the use of improper economic interests. Article VII hospitals above the second level shall establish a pharmaceutical management and drug therapy committee; other medical institutions shall establish a pharmaceutical management and drug therapy group.
Two hospitals above the pharmacy management and drug therapeutics committee members with senior technical qualifications in pharmacy, clinical medicine, nursing and hospital infection management, medical administration.
The establishment of medical institutions of pharmaceutical management and drug therapeutics group of medical institutions by the pharmacy, medical, nursing, hospital infections, clinical departments and other department heads and pharmacists, physicians with pharmacists, physicians and other professional and technical positions above the qualifications of personnel.
The head of the medical institution is the chairman of the Pharmaceutical Affairs Management and Drug Therapeutics Committee (Group), and the head of the pharmacy and medical department is the deputy chairman of the Pharmaceutical Affairs Management and Drug Therapeutics Committee (Group).
Article VIII of the Pharmaceutical Affairs Management and Pharmacotherapeutics Committee (group) shall establish and improve the corresponding work system, the daily work of the pharmacy department is responsible for.
Article IX Pharmaceutical Management and Pharmacotherapeutics Committee (Group) duties:
(1) Implementation of health care and pharmaceutical management and other relevant laws, rules and regulations. (d) analyzing and assessing the risks of drug use, adverse drug reactions and drug damage incidents, and providing consultation and guidance;
(e) establishing a drug selection system, reviewing and approving new drug purchases, adjusting drug varieties or supplying enterprises, and declaring hospital preparations applied by clinical departments of the institution;
(f) supervising and guiding the development and implementation of guidelines for the clinical application of narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive drugs.
(f) supervise and guide the clinical use and standardized management of narcotic drugs, psychotropic drugs, toxic drugs for medical use, and radioactive drugs;
(g) educate and train medical personnel on the laws and regulations of pharmacy management, rules and regulations, and knowledge of the rational use of medicines; and propagate the knowledge of the public on the safe use of medicines.
Article X of the medical institutions should be designated by the medical department, responsible for the management of administrative affairs related to drug therapy in medical institutions.
Article XI of the medical institutions should be based on the function, mission, scale of the institution set up the appropriate pharmacy department, equipped with and provide with the pharmacy department work tasks appropriate professional and technical personnel, equipment and facilities.
Tertiary hospitals set up a pharmacy department, and can be set up according to the actual situation of the second level of the department; second-level hospitals set up a pharmacy department; other medical institutions set up a pharmacy.
Article XII of the pharmacy department is specifically responsible for drug management, pharmacy professional and technical services and pharmacy management, to carry out patient-centered, rational use of medication as the core of clinical pharmacy, the organization of pharmacists to participate in the clinical drug therapy, provide pharmacy professional and technical services.
Article 13 The pharmacy department shall establish and improve the corresponding work system, operating procedures and work records, and organize the implementation.
Article XIV above the second level of the hospital pharmacy department shall have a higher school of pharmacy or clinical pharmacy bachelor's degree or above, and senior technical qualifications of the profession; in addition to clinics, health clinics, infirmaries, health clinics, health stations other than the head of the department of pharmacy of medical institutions shall have a higher school of pharmacy or secondary school pharmacy specialty above graduate education, and pharmacist or above professional qualifications. Graduation degree, and pharmacist above professional and technical qualifications. Article 15 The management of clinical application of drugs is the supervision and management of the whole process of clinical diagnosis, prevention and treatment of disease medication in medical institutions. Medical institutions should follow the principle of safe, effective, economical and rational use of drugs, respect for the patient's right to information on the use of drugs and the right to privacy.
Article XVI of the medical institutions should be based on the national system of basic drugs, antimicrobial drugs, clinical application of guiding principles and principles of clinical application of proprietary Chinese medicines, the development of the institution's clinical application of basic medicines management, the establishment and implementation of clinical application of antimicrobial drugs graded management system.
Article XVII of the medical institutions shall establish a clinical treatment team consisting of physicians, clinical pharmacists and nurses to carry out clinical rational use of drugs.
Article XVIII of the medical institutions should follow the clinical application of drugs guiding principles, clinical paths, clinical diagnosis and treatment guidelines and drug instructions for the rational use of drugs; physician prescriptions, the appropriateness of the medication doctor's orders for review.
Article 19 of the medical institutions should be equipped with clinical pharmacists. Clinical pharmacists should be full-time participation in clinical drug therapy, drug education for patients, guiding patients to safe use of drugs.
Article 20 of the medical institutions shall establish clinical drug monitoring, evaluation and abnormal early warning system, the clinical use of drugs safety, effectiveness and economy of monitoring, analysis, evaluation, implementation of prescriptions and medication review and intervention.
Article 21 of the medical institutions shall establish adverse drug reactions, medication errors and drug damage monitoring and reporting system. Clinical departments of medical institutions found adverse drug reactions, medication errors and drug damage events, should actively treat patients, immediately report to the pharmacy department, and make observations and records. Medical institutions should be in accordance with the relevant provisions of the state to the relevant departments to report adverse drug reactions, medication errors and drug damage events should be immediately reported to the local county-level health administrative departments.
Article 22 of the medical institutions should be combined with clinical and drug therapy, clinical pharmacy and pharmacy research work, and provide the necessary working conditions, develop appropriate management system, strengthen leadership and management. Article 23 The medical institutions shall formulate their own "Drug Formulary" and "Basic Drug Supply Catalog" in accordance with the "National Essential Drugs Catalog", "Prescription Management Measures", "National Formulary", and "Quality Management Standards for Drug Purchase and Supply", and prepare the drug purchase plan to purchase drugs in accordance with the provisions of the purchase of drugs.
Article 24 The medical institutions shall formulate the organization's drug procurement workflow; establish and improve the drug costing and account management system; strictly implement the drug purchase inspection, acceptance system; shall not purchase and use of drugs that do not comply with the provisions.
Article 25 The clinical use of medicines in medical institutions shall be purchased and supplied by the pharmacy department. With the approval of the Committee (Group) of Pharmaceutical Management and Pharmacotherapy, the Department of Nuclear Medicine may purchase and transfer the radioactive drugs required by the specialty. Other departments or divisions shall not engage in the procurement and dispensing of medicines, and shall not use in clinical practice medicines that are not procured and supplied by the pharmacy department.
Article 26 Medical institutions shall formulate and implement a system of drug storage, regular maintenance and quality inspection of the stock of drugs. The storage conditions and management of the drug store should be consistent with the relevant provisions of the quality management standard for the procurement and supply of drugs.
Article 27 The chemical drugs, biological products, proprietary Chinese medicines and traditional Chinese medicine shall be stored separately, categorized and positioned for storage. Flammable, explosive, highly corrosive and other dangerous drugs should be set up in separate warehouses for separate storage, and set up the necessary safety facilities, the development of related work systems and emergency plans.
Narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and other special management of drugs, should be in accordance with relevant laws, regulations, rules and regulations of the relevant provisions of the management and supervision of the use.
Article 28 The professional and technical personnel of pharmacy shall, in strict accordance with the "Drug Administration Law", "Prescription Management Measures", the quality of drug dispensing management standards and other laws, regulations, rules and technical procedures, carefully review the prescription or medication prescription, after the suitability of the audit of the dispensing of drugs. When issuing medicines, patients should be informed of the dosage and precautions, and patients should be guided to rationalize the use of medicines.
In order to ensure the safety of patients' medication, except for the quality of the medicines, once the medicines are issued, they shall not be returned or exchanged.
Article 29 of the medical institutions outpatient emergency drug dispensing room should be implemented in a large window or counter-type dispensing. Inpatient (ward) drug dispensing room for injections dispensed by the daily dose, the oral preparation of drugs to implement single-dose dispensing.
Parenteral nutritional solution, hazardous drugs for intravenous use should be implemented to centralize the deployment of supply.
Article 30 of the medical institutions in accordance with the clinical needs of the establishment of intravenous drug dispensing center (room), the implementation of centralized deployment of supply. Intravenous drug dispensing center (room) should be in line with the quality of intravenous drug dispensing centralized management specification, by the local municipal health administrative departments above the level of the organization's technical audit, acceptance, qualified before the centralized dispensing of intravenous drugs. In the intravenous drug dispensing center (room) outside the deployment of intravenous drugs, with reference to the centralized dispensing of intravenous drugs quality management practices.
Medical institutions to establish intravenous drug dispensing center (room) should be reported to the provincial health administrative departments for the record.
Article 31 of the preparation of medical institutions in accordance with the "Drug Administration Law" and its implementing regulations and other relevant laws and administrative regulations. Article 32 of the medical institutions, pharmacy professionals and technicians in accordance with the relevant provisions of the corresponding professional and technical qualifications in pharmacy.
Medical institutions in direct contact with the drugs of the pharmacy staff, shall conduct annual health checks. Suffering from infectious diseases or other diseases that may contaminate drugs, shall not engage in direct contact with drugs.
Article 33 of the medical institutions, professional and technical personnel of pharmacy shall not be less than 8% of the health professionals and technicians of the institution. The establishment of intravenous drug dispensing center (room), medical institutions should be based on the actual need to increase the number of pharmacy professionals and technicians.
Article 34 of the medical institutions should be based on the nature of the institution, the task, the size of the appropriate number of clinical pharmacists, clinical pharmacists in third-level hospitals not less than five, clinical pharmacists in second-level hospitals not less than three.
Clinical pharmacists shall have a higher school of clinical pharmacy or pharmacy bachelor's degree or above, and shall undergo standardized training.
Article 35 The medical institutions shall strengthen the training, assessment and management of professional and technical personnel in pharmacy, formulate training plans, organize professional and technical personnel in pharmacy to participate in post-graduation standardized training and continuing medical education, and complete the training and continue medical education credits, as one of the conditions for the assessment of professional and technical personnel in pharmacy, the qualification of professional and technical positions for promotion, and the appointment of professional positions.
Thirdly, the third part of the program is the completion of training and continuing medical education.
Article 36 of the medical institutions pharmacist duties:
(1) responsible for the procurement and supply of drugs, prescriptions or medication doctor's orders review, drug dispensing, intravenous drug centralized dispensing and hospital preparations prepared to guide the wards (districts) nurses to ask for, the use and management of medicines;
(2) participation in clinical drug therapy, individualized drug therapy program design and implementation
(c) Participate in room visits, consultations, case discussions and medical treatment of difficult and critical patients, collaborate with physicians to select drugs for use, make suggestions or adjustments to clinical drug therapy, and be responsible for drug therapy with physicians***;
(d) Carry out monitoring of the clinical application of antimicrobials, implement prescription (d) to monitor the clinical application of antimicrobial drugs, implement prescriptions and over-warning, and promote the rational use of drugs;
(e) to carry out monitoring of the quality of medicines, and to collect, organize, and report on serious adverse reactions to medicines and drug damages;
(f) to grasp information on drugs related to the clinical use of medicines, to provide information on the use of medicines and consulting services of pharmacy, and to promote the knowledge of the rational use of medicines to the public;
(g) to integrate clinical drug Therapy practice, clinical application of pharmacy research; to carry out drug utilization evaluation and clinical application of drug research; to participate in clinical trials of new drugs and new drugs on the market after the monitoring of safety and efficacy;
(viii) other professional and technical work related to hospital pharmacy. Article 37 The local health, traditional Chinese medicine administrative departments at or above the county level shall strengthen the supervision and management of pharmaceutical management of medical institutions.
Article 38 Medical institutions shall not use non-pharmacy professional and technical personnel engaged in professional and technical work in pharmacy or employed as the director of the pharmacy department.
Article 39 A medical institution in one of the following circumstances, by the local health, traditional Chinese medicine administrative department at or above the county level shall be ordered to make corrections, notification of criticism, and given a warning; for those directly responsible for the personnel in charge and other personnel directly responsible, shall be given a demotion, dismissal, expulsion, and other sanctions in accordance with the law:
(1) Failure to establish the organization of the management of pharmaceutical affairs, the management of the management of pharmacy affairs and pharmacy professional and technical work chaos, resulting in medical safety hazards. (b) Failure to equip professional and technical personnel in pharmacy and establish clinical pharmacist system in accordance with the provisions of this regulation, and the problem of irrational use of drugs is serious and has caused adverse effects;
(c) Failure to implement the relevant norms and regulations for quality management of medicines, leading to problems in the quality of medicines or errors in the use of medicines, and resulting in potential risks to medical safety and serious adverse effects;
(d) Failure to implement relevant norms and regulations for quality management of medicines, leading to problems in the quality of medicines or errors in the use of medicines, causing potential risks to medical safety and serious adverse consequences;
(4) non-pharmacy departments engaged in drug purchasing, dispensing or preparation activities;
(5) the purchase, sale and use of drugs as a basis for personal or departmental or sectional economic allocation, or in the purchase, sale and use of drugs to make undue profits.
(F) violation of other provisions of this regulation and cause serious consequences.
Article 40 of the medical institutions in violation of laws, rules and regulations relating to drug management, according to the circumstances of the local health administrative departments at or above the county level shall be dealt with according to law.
Article 41 above the county level local health, traditional Chinese medicine administrative departments shall regularly supervise and inspect the management of medicines in medical institutions.
Article 42 The staff of the administrative department of health, traditional Chinese medicine in accordance with the law on the supervision and inspection of the management of pharmaceutical affairs of medical institutions, shall show their credentials. The inspected medical institutions shall cooperate, truthfully reflect the situation, provide the necessary information, and shall not be refused, obstructed or concealed. Article 43 The meaning of the following terms in these provisions:
Clinical pharmacy: refers to the combination of pharmacy and clinical, direct patient-oriented, patient-centered, research and practice of clinical drug therapy, improve the level of drug therapy, a comprehensive application of the discipline.
Clinical pharmacist: refers to the systematic pharmacy professional knowledge as the basis, and has a certain medical and related professional basic knowledge and skills, directly involved in the clinical use of medication, to promote the rational application of drugs and to protect the patient's safety of medication of pharmacy professionals and technicians.
Hazardous Drugs: refers to drugs that can produce occupational exposure risks or hazards, i.e., drugs with genotoxicity, carcinogenicity, teratogenicity, or damaging effects on reproduction as well as drugs that can produce severe organ or other toxicity at low doses, including tumor chemotherapeutic drugs and cytotoxic drugs.
Drug damage: refers to the damage to the patient caused by the quality of the drug not complying with the national drug standards.
Medication error: refers to any preventable medication misuse that occurs throughout the clinical use of a qualified drug.
Article 44 The management of traditional Chinese medicine tablets in medical institutions shall be carried out in accordance with the Code for the Management of Traditional Chinese Medicine Tablets in Hospitals.
Article 45 Clinics, health clinics, infirmaries, health care clinics and health stations may not set up drug management organizations and pharmacy departments, and the head of the institution shall designate medical personnel to be responsible for drug affairs.
Clinics of traditional Chinese medicine, ethnomedicine clinics may not set up drug management organization and pharmacy department, by the Chinese medicine and ethnomedicine professionals and technicians responsible for pharmaceutical work.
Article 46 These provisions shall come into force on March 1, 2011 onwards. The Interim Provisions on Pharmaceutical Management in Medical Institutions (Health Medical Development [2002] No. 24) shall be repealed simultaneously.