The supervision and management of narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive drugs under special management shall be carried out in accordance with the relevant provisions of the state. Article 3 The pharmaceutical supervisory and administrative departments of provinces, cities and counties (including county-level cities and districts, the same below) shall be responsible for the supervision and administration of the use of medical devices in medical institutions within their respective administrative areas. Article 4 A medical institution shall set up a medical device management institution suitable for its scale, or designate qualified personnel to be responsible for the management of medical devices, so as to ensure the safe use of medical devices and prevent the occurrence of unexpected group adverse events of medical devices. Article 5 Personnel who are in direct contact with drugs and sterile medical devices in medical institutions shall undergo health examination every year and establish health records. Persons suffering from infectious diseases and other diseases that may contaminate drugs and sterile medical devices shall not engage in direct contact with drugs and sterile medical devices before the possible pollution is cured or eliminated. Article 6 A medical institution shall establish the following management systems:
(1) Purchase and acceptance of medical equipment;
(2) Examination of medical devices leaving the warehouse;
(three) medical device quality problem report and adverse reaction (incident) monitoring report;
(four) the preparation and evaluation of drugs and the storage and maintenance of drugs;
(5) Monitoring the expiry date of drugs;
(6) Preparation, storage and use of preparations;
(seven) the use and maintenance of medical devices;
(eight) quality tracking of implantable medical devices;
(nine) disposable sterile medical devices are destroyed after use.
Medical institutions at or above the second level (including this level) shall implement computerized management of the matters specified in the preceding paragraph. Article 7 Medical institutions must purchase drugs from enterprises with pharmaceutical production or wholesale business licenses.
All kinds of clinics and health centers in rural areas can purchase drugs from distribution centers with drug wholesale qualifications and their local distribution points; Direct procurement is indeed difficult, you can entrust the local township (town) hospital procurement.
The township (town) health center shall sign a quality responsibility agreement with the entrusting party when purchasing drugs, and shall implement it in accordance with the provisions of these Measures on purchasing drugs, and shall not transfer it to other units or individuals to purchase drugs in any name. Article 8 Medical institutions shall purchase and centrally manage drugs by medical device management institutions or designated personnel, properly keep relevant vouchers that can prove drug purchase information, and establish drug purchase files.
Drug procurement documents shall include the following information provided by suppliers:
(a) a copy of the license and business license for drug production or drug wholesale;
(two) a copy of the certificate of quality management of drug production or operation;
(3) Copies of the registration certificate of imported drugs or the registration certificate of pharmaceutical products, the inspection report of imported drugs, the approval documents of imported drugs, etc. ;
(four) a copy of the inspection certificate of biological products;
(five) the authorization or power of attorney of the drug salesman and his identity certificate.
Copies of the information specified in items (1) to (4) of the preceding paragraph shall be stamped with the seal of the provider. Article 9 Medical institutions shall accept the purchased drugs batch by batch. In addition to verifying the supplier's qualification and relevant drug certification documents, it should also check the appearance, packaging, labels and instructions of drugs, and fill in the true and complete drug acceptance records.
The drug acceptance record shall include the general name, dosage form, specification, batch number, production date, expiration date, manufacturer, supplier, purchase quantity, purchase price, purchase date, acceptance conclusion, etc. And signed by the recipient.
Drug acceptance records shall be kept for not less than 3 years. If the validity period of the drug exceeds 3 years, the drug acceptance record shall be kept until 1 year after the expiration of the validity period of the drug. Article 10 Each package of Chinese medicinal materials purchased by medical institutions shall be marked with the name, place of origin, date and supplier, and shall be accompanied by a quality conformity mark; Name, specification, place of origin, manufacturer, product batch number, production date, etc. It should be marked on each package of the purchased Chinese herbal pieces; Procurement of Chinese herbal medicines and Chinese herbal pieces subject to approval number management shall also indicate the approval number on their packages.
Medical institutions shall not purchase Chinese herbal medicines or Chinese herbal pieces whose packaging does not conform to the provisions of the preceding paragraph. Eleventh medical institutions should manage the storage of drugs in accordance with the relevant provisions of the national "Quality Management Standards for Pharmaceutical Trading". Twelfth medical institutions should use drugs within the scope of medical subjects or services approved according to law. Thirteenth medical institutions should strictly implement the expired drug monitoring and management system, and regularly make an inventory of expired drugs. Expired drugs must be stopped immediately and disposed of in accordance with relevant regulations. Fourteenth medical institutions must allocate drugs to patients according to the doctor's advice of the medical institutions. Do not operate or operate drugs in disguised form by means of free clinic, charity sale, consulting service, trial, exhibition, mailing or giving away.