The term "medical institutions" as mentioned in these Measures refers to medical institutions established according to law to diagnose and treat diseases.
Family planning technical services, disease prevention and control, medical care and other institutions that use drugs shall be implemented with reference to these measures. Article 3 The food and drug supervision and administration departments of cities, districts and counties shall be responsible for the supervision and administration of drugs in medical institutions within their respective administrative areas.
Health, population and family planning, price, industry and commerce administration and other departments shall, in accordance with their respective responsibilities, do a good job in drug management in medical institutions. Article 4 Medical institutions shall establish and improve the drug management system to ensure the quality of drugs. Chapter II Procurement and Storage of Drugs Article 5 Medical institutions shall purchase drugs from units qualified for drug production and wholesale business, except for Chinese herbal medicines that are not subject to approval number management. Medical institutions shall be responsible for purchasing drugs by their internal specialized agencies or personnel, and other internal agencies and personnel shall not purchase drugs by themselves.
Medical institutions shall not contract drug procurement to individuals. Article 6 When purchasing drugs, medical institutions shall verify the supplier's drug production license or business license, business license, power of attorney and other valid documents, properly keep copies stamped with the supplier's seal, and verify the drug conformity certificate. Do not meet the requirements, shall not be purchased.
If the purchased drugs have special requirements for transportation conditions, the medical institution shall check whether the transportation conditions of the suppliers meet the requirements. Do not meet the requirements, it shall refuse to accept. Article 7 A medical institution shall establish a true and complete record of drug purchase acceptance when purchasing drugs. The acceptance record shall include the following contents:
(a) Manufacturer, common name and approval number;
(2) dosage form, specification, batch number, production date and expiration date;
(3) suppliers;
(4) The quantity, price and date of purchase;
(5) Acceptance conclusion.
The retention period of drug purchase acceptance records shall not be less than three years. If the validity period of the drug exceeds three years, the acceptance record shall be kept until one year after the expiration of the validity period of the drug. Article 8 Medical institutions shall store drugs by category in accordance with the provisions on drug quality and safety.
Drugs and non-drugs, oral drugs and external drugs, Chinese herbal medicines, Chinese herbal pieces, dangerous drugs, odorous drugs and other drugs should be stored separately. Ninth medical institutions should set up pharmacies or medicine cabinets according to the subjects of diagnosis and treatment and the scope of medication. Pharmacy or medicine cabinet should have corresponding equipment, storage facilities and sanitary environment. Article 10 Medical institutions shall maintain the stored drugs, and take corresponding measures such as cold storage, light protection, ventilation, anti-freezing, moisture-proof, fire prevention, insect prevention and rat prevention to prevent drug pollution, deterioration and invalidation. Article 11 Medical institutions shall centrally store expired, invalid, damaged, mildewed and other unqualified drugs in unqualified drug warehouses (districts), and report the name, specification, batch number, expiration date, manufacturer, quantity and amount of unqualified drugs to the food and drug supervision and administration department and the health administrative department at the end of each quarter, and the food and drug supervision and administration department shall supervise the destruction. Chapter III Configuration and Use of Drugs Article 12 When using drugs, medical institutions shall clearly mark the price and provide pharmaceutical technicians with legal qualifications; Other institutions that use drugs shall be equipped with pharmaceutical technicians who have passed the examination by the municipal food and drug supervision and administration department. Article 13 Medical practitioners, assistant medical practitioners and rural doctors in medical institutions shall prescribe drugs of the required type, dosage and quantity according to the patient's condition and the drug use specifications; Prescription or prescription should use the generic name of the drug, and write instructions.
Patients or their families have the right to know the prevention, diagnosis, treatment, side effects and prices of drugs listed in prescriptions or prescriptions, and have the right to choose drugs with the same or similar efficacy. Medical practitioners, assistant medical practitioners and rural doctors have the obligation to inform and should respect the rights of patients or their families. Article 14 Medical institutions shall allocate and use drugs according to prescriptions, prescriptions or doctor's orders.
Pharmacists in medical institutions shall check prescriptions or prescriptions, and shall not change or replace prescriptions or drugs listed in prescriptions without authorization. Prescriptions with incompatibility or overdose should be refused to be prepared; If necessary, it should be corrected or re-signed by the prescriber or the prescriber before deployment. Fifteenth pharmaceutical personnel in medical institutions need to disassemble the minimum package when preparing drugs, they should make disassembly records and keep the original minimum package. The name, specification, usage, dosage, batch number and expiration date of the drug shall be marked on the packaging surface of the unpacked drug. Article 16 Sites, facilities and packaging materials. Medicines prepared by medical institutions shall meet the requirements of hygiene, quality and safety, and shall not pollute or affect the quality of medicines.