The use of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radiopharmaceuticals and vaccines and the supervision and management of their quality shall comply with the provisions of relevant state laws and regulations. Article 3 The market supervision department of Hangzhou City shall be in charge of the quality supervision and management of the use of drugs in medical institutions in the city. The market supervision department of each district and county (city) shall be responsible for the quality supervision and management of the use of medicines in medical institutions within its jurisdiction.
Health, medical security and other administrative departments shall be responsible for the supervision and management of the use of medicines in medical institutions within their respective areas of responsibility. Article 4 medical institutions shall establish and improve the following drug quality management system, and regularly check and assess the implementation of the system, and make appropriate records:
(a) drug quality management responsibility system;
(b) personnel health status management system;
(c) drug procurement, acceptance management system;
(d) drug quality information management system
(v) Drug storage, maintenance management system;
(vi) Drug measuring instruments and storage, maintenance equipment use management system;
(vii) Special Drugs Management System;
(viii) Hygiene Management System;
(ix) Prescription Dispensing Management System;
(x) Unqualified Drugs and Returns Drug management system;
(xi) adverse drug reaction reporting management system;
(xii) quality incident reporting and handling management system. Article 5 medical institutions shall set up drug quality management organization or implement drug quality management personnel according to its size and management needs, and clarify their responsibilities.
The composition of the drug quality management organization or drug quality management personnel shall be qualified according to law by the pharmacy technicians or licensed pharmacists. Article VI of the medical institutions of prescription reviewers should have pharmacist pharmacist or more professional and technical qualifications of pharmacy technicians or licensed pharmacists, drug dispensers should be qualified according to law by the pharmacy technicians or licensed pharmacists. Article VII of the medical institutions in direct contact with the drug personnel, should be through the municipal market supervision departments to provide items of health checks, and the establishment of health records.
People suffering from mental illness, infectious diseases or other diseases that may contaminate the drugs, shall not engage in direct contact with drugs. Article VIII of the medical institutions shall be engaged in drug purchasing, acceptance, storage, maintenance, deployment, dispensing of regular training of personnel, and the establishment of training files. Article 9 The pharmacy technicians and licensed pharmacists of the medical institutions shall use their professional knowledge and all kinds of pharmacy information to provide consulting services to the medical staff and patients, participate in clinical work, and put forward suggestions for the rational use of drugs. Article 10 medical institutions should be from the "drug production license", "drug business license" and business license of drug production and business enterprises to purchase drugs.
Medical institutions from its first supply and demand relationship with drug manufacturers or drug companies (collectively referred to as the first enterprise) procurement of drugs, or procurement of drugs purchased for the first time (referred to as the first varieties) and imported medicines, should be in accordance with the relevant provisions of the relevant information for requesting and checking. Article XI of the medical institutions to purchase drugs, should strictly comply with the relevant provisions of the state, the establishment of purchase inspection and acceptance system, inspection of drug certificates of conformity and other identification; do not meet the requirements of the provisions of the drug, shall not be purchased and used. Article XII of the medical institutions shall establish a true and complete record of drug purchases. Records of drug purchases shall have the following contents:
(a) the generic name of the drug, dosage form, specifications, batch number, expiration date;
(b) the number of purchases, the purchase price, the purchase date;
(c) manufacturers, suppliers;
(d) laws, regulations and rules stipulate the other contents.
Pharmaceutical purchase record retention time shall not be less than three years; drug expiration date of more than three years, save until one year after the expiration date of the drug. Article XIII of the medical institutions shall be approved in accordance with the law of the diagnosis and treatment subjects and the use of drugs set up the appropriate pharmacy, pharmacy (medicine cabinet).
Pharmacy, pharmacy (medicine cabinet) should be separated from the diagnosis and treatment, office, life and other areas, and accordingly configure the following equipment:
(a) equipment to facilitate the display of medicines;
(b) in line with the characteristics of the drug requirements of ambient temperature, cool, cold and frozen storage equipment;
(c) to maintain a certain distance between the drugs and the ground equipment;
(d) the drugs dust, moisture, pollution and insect, rodent, mildew and other equipment;
(e) light, ventilation equipment;
(f) the use of traditional Chinese medicine tablets required for the relevant equipment;
(g) other to ensure the safe use of medicines equipment. Article XIV of the medical institutions of the drugstore to implement color-coded management system. To be examined drugs library (area), returned drugs library (area) with a yellow background marked in white; qualified drugs library (area), with traditional Chinese medicine tablets formulations of zero stock weighing library (area) with a green background marked in white; unqualified drugs library (area) with a red background marked in white.