Interim Measures for Drug Administration in Primary Medical Institutions in Hubei Province

Article 1 In order to strengthen the management of primary medical institutions drugs, to ensure that the people's medicine is safe and effective, according to the "Chinese People's Republic of China *** and the State Drug Administration Law" (hereinafter referred to as the "Drug Administration Law") and other laws and regulations, combined with the actual situation in this province, the formulation of these measures. Article II of the administrative region of the province's primary health care institutions of the drugs equipped, procurement, storage, use and supervision and management, must comply with these measures.

The primary health care institutions referred to in these measures, including the law has obtained a "medical practice license" of various types of health centers, comprehensive and specialized outpatient clinics (clinics), individual clinics, community health medical service stations, family planning technical service institutions, enterprises and institutions and rural health clinics (rooms), health care (stations) and so on. Article III above the county drug supervision and management department is responsible for the administrative region of the primary health care institutions of drug supervision and management work. Article IV basic medical institutions should be developed in accordance with the diagnosis and treatment of drugs equipped with directory, reported to the drug supervision and management department for the record, and to ensure that the drugs provided to the patient and the scope of diagnosis and treatment compatible. Specific measures by the provincial drug supervision and management departments. Article 5 basic medical institutions should have facilities and sanitary environment in line with the conditions of drug storage, the establishment of rules and regulations to ensure the quality of drugs, and is equipped with at least one pharmacy technician with professional qualifications in pharmacy. Village-level health care institutions should strengthen drug management, and gradually meet the above requirements.

Failure to meet the above requirements of primary health care institutions, shall not be equipped with, procurement, storage and use of drugs. Article VI primary medical institutions should be from the legal drug production and management enterprises to purchase drugs. Article 7 by the township below the primary medical institutions entrusted, township health centers can be unified on behalf of the procurement of drugs. On behalf of the purchase of drugs shall not be for profit, and shall retain complete purchase invoices and distribution vouchers for inspection. Article VIII of primary medical institutions to purchase imported drugs, must be supplied to the imported drugs business enterprises to obtain imported drug registration certificate or drug registration certificate and port drug testing institute of imported drug quality inspection report copy, and stamped with the supply unit quality management organization seal, retained for inspection. Article IX primary medical institutions to purchase drugs, must establish and implement the drug quality inspection and acceptance system to ensure the quality of drugs. Article X basic medical institutions to purchase drugs, there must be real, complete drug purchase records, and properly preserved. Purchase records must indicate the generic name of the drug, dosage form, specifications, production batch number, approval number, expiration date, manufacturer, supplier, purchase quantity, purchase price, purchase date, quality, acceptance signature and drug supervision and management department of the other contents. Article XI individual set up medical institutions shall not be equipped with commonly used drugs and emergency drugs other than drugs. Article XII of the basic medical institutions should develop and implement the drug storage system, the storage and placement of drugs should be appropriate refrigeration, anti-freezing, moisture-proof, insect-proof, rodent-proof, fire prevention and other measures to ensure the quality of drugs.

Flammable, explosive, corrosive and other dangerous drugs storage must meet the safety requirements, special drugs must be strictly in accordance with the provisions of the storage. Article XIII of basic medical institutions should establish the use of drugs, prescriptions, receipts, books and registration management system. Article XIV of basic medical institutions preparation, must have the ability to ensure the quality of the preparation of facilities, management systems, testing instruments and sanitary conditions, and according to the law to receive the "medical institutions preparation license". Preparations prepared by the qualified test, with a physician's prescription for use in the medical institutions, shall not be sold on the market or disguised as sales. Article XV of primary health care institutions shall not be scientific research, clinical needs or other names to use the drugs without the approval number. Unauthorized use of other medical institutions shall not be prepared preparations. Article XVI of primary care institutions shall not sell drugs to non-medical institutions. Article XVII strictly prohibit the use of counterfeit or expired drugs. In the process of drug use, the discovery of fake or shoddy drugs or drugs of doubtful quality, should promptly report to the local drug supervision and management department, shall not be returned or exchanged. Article XVIII of the basic medical institutions should establish an adverse drug reaction reporting system, found that adverse drug reactions, must promptly report to the provincial drug supervision and management departments and health administrative departments.

The drugs have been recognized serious adverse reactions, the provincial drug supervision and management department can take emergency control measures to stop using, and shall make administrative decisions according to law. Article 19 of the direct contact with the drugs of primary medical institutions staff, must be carried out annually for health checks, the results should be archived for inspection. Suffering from infectious diseases or other diseases that may contaminate drugs, shall not engage in direct contact with drugs. Article 20 violation of the provisions of these measures, national laws and administrative regulations have been made to penalize the provisions, from its provisions. Article 21 of the basic medical institutions in violation of the provisions of these measures, one of the following acts, by the county above the drug supervision and management department ordered to make corrections within a certain period of time, failing to make corrections, impose a fine of less than 1,000 yuan:

(a) does not meet the requirements of Article 5 of these measures without authorization to purchase, storage, use of medicines;

(b) unauthorized beyond the scope of diagnosis and treatment of the institution is equipped with, Procurement, storage, use of drugs. Article 22 The township health center in the purchase for profit, by the county above the drug supervision and management department to give a warning, ordered to correct; refused to correct, according to the "Drug Administration Law," the provisions of Article 73 of the treatment.