Drug Used In Medical Institutions In Hunan Province Supervision And Administration

Original Language Title: 湖南省医疗机构药品使用监督管理办法

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(November 7, 2003, Hunan provincial people's Government, the 19th General meeting on November 25, 2003 182th promulgated by the people's Government of Hunan province as of February 1, 2004) first in order to strengthen the supervision and administration of hospital drug use, ensure medication is safe and effective, according to the People's Republic of China pharmaceutical administration law and the People's Republic of China pharmaceutical administration law implementing regulations and other laws and regulations, combined with the actual situation in our province, these measures are formulated.
    Article in medical institutions in the province of drug use and supervision of drug use, these measures shall apply.
    Qian paragraph by said medical institutions, including hospital, and hospital, and hospitals, and nursing home, and clinic (containing individual), and clinic (containing individual), and clinic (room), and emergency Center (station), and disease control Hospital (by, and station), and nursing Hospital (station), and community health service center (station), engaged in disease diagnosis, and treatment, and health activities of clinic institutions and family planning technology service institutions. Article provincial government drug regulatory agency responsible for drug supervision and administration of medical institutions in the province.
    The city divided into districts, autonomous prefectures, counties (cities and districts) the pharmaceutical supervisory and administrative departments shall be responsible for the supervision and administration of medical institutions within the administrative area of drug use.
    Relevant administrative departments of the people's Governments above the county level in the context of their respective responsibilities is responsible for the management of hospital drug use.
    Fourth medical institutions must be authorized by law in medical subjects within the scope of the drug use, family planning technical services, licensed physician, licensed physician assistant village doctor practitioner or registered certificates of village doctors ' prescription dispensing medicines.
    The fifth medical institutions in accordance with relevant regulations of the State, legally authorized medical subjects and drug use within the pharmacy or medicine cabinet.
    Medical institutions set the pharmacy or medicine cabinet, shall have the appropriate premises, equipment, storage facilities and a hygienic environment, equipped with corresponding pharmacy technicians sets drug quality management or quality management staff, establishment of drug use management system. Sixth clinics, clinic, Health Center (room), community health centers (stations) and other medical institutions, other than medicines and first-aid medicines may not be equipped with medicines.
    Range and variety of commonly used drugs, emergency drugs, the provincial health Administrative Department in conjunction with the provincial drug supervision and Administration Department. The scope of family planning technical service institutions and drug use should be in accordance with approved service scope, service project, operation are consistent, you may not use family planning technical service institutions other than the essential drug list and drug.
    List of family planning technical service institutions use, by the provincial drug supervision and Management Department of the Government, in conjunction with the provincial family planning administrative departments under the people's Government. Medical institutions listed in article sixth of seventh article this approach of using drugs range and variety may not be changed.
    Alteration, shall notify the home pharmaceutical supervisory and Administrative Department, health department or family planning administrative departments. Eighth medical organizations must have the drug manufacturing license, drug trading license and license of pharmaceutical production, management of purchasing drugs.
    Village clinics, private clinics can also entrust the Township to buy drugs.
    Township township village clinics, private clinics in purchasing drugs, should hold a village clinics, individual power of Attorney issued by the clinic, and accept the supervision and inspection of local drug regulatory authorities, shall not subcontract drug purchasing eligible individual or other unit shall not fare sales to village clinics and individual clinics.
    Nineth purchase drugs in medical institutions, must strictly abide by State regulations, establishment of examination system qualified certificates and other pharmaceuticals packaging; do not meet prescribed pharmaceuticals may not be purchased and used. Tenth medical institutions must establish a complete drug purchase records.
    Drug purchase records shall have the following contents: (a) the generic name of the drug, dosage form, specifications, batch number, expiry date, (ii) purchase order number, purchase price, purchase date and (iii) manufacturers and suppliers; (d) the provisions of other laws, rules and regulations.
    Drug purchase records kept for not less than 3 years; drug is valid for more than 3 years, saved until after the drugs period of validity 1.
    11th medical institutions are allowed to post, open-shelf optional forged prescriptions, over-the-counter and free clinics, charity, counselling, probation, fair name and disguise drugs or other ways to operate.
    12th medical institutions must develop and implement system of storage of pharmaceuticals, in accordance with the relevant provisions of drug quality and safety store medicines.
    Drug and non-drug, medication and topical medicine, Chinese herbal medicine, Chinese herbal medicine, dangerous drugs, the odor of drugs and other medicines, should be kept separate.
    Narcotic drugs, a class of psychoactive drugs, toxic drugs for medical use and radioactive pharmaceuticals, detoxification medicines, library or store counters, double double locking storage, separate account records.
    13th stockpiling medicines in medical institutions shall be determined according to quality requirements, refrigeration, freezing, moisture, protected from light, ventilation, fire protection, pest control, prevention measures such as preventing drug contamination, deterioration or failure.
    For stockpiling medicines in medical institutions shall carry out maintenance, you may not use expired, inoperative, eliminated, mildew, moth and bad drugs. Article 14th medical institution and prescription dispensing pharmacists must be legally certified pharmaceutical technical personnel. Prescription dispensing must be checked, not change.
    Pharmacy personnel to incompatibility, pregnancy taboos, illness is taboo or overdose of prescription, refuse to deploy if necessary, signed by the original prescriptions issued by doctors to correct or to confirm, before deployment.
    Medical prescription issued by the Agency, shall, in accordance with the national save the life saving. 15th deployment of drugs in medical institutions of measuring instruments, the quality and technical supervision Department regularly checks.
    Deployment of drugs must be measured accurately.
    16th deployment of drugs in medical institutions of staff deployment and provisioning tools, packing materials and container, working environment, shall comply with the health requirements shall be placed on the drug contamination, affect drug quality. Deployment of drugs in medical institutions requiring the original minimum packaging standardizes, shall make standardizes record and retain the original minimum packaging.
    Standardizes the packaging surface, you should indicate the name of the drug, specifications, usage, and the amount of content. Medical institutions shall, in accordance with the relevant provisions of article 17th, on the deployment of the unit using the quality, efficacy and response tracking study.
    Possible drug-related serious adverse reactions was found, must promptly to the provincial drug supervision and management of the Government departments, health administration or planning authority. 18th medical institutions shall not purchase, use substandard drugs. Counterfeit drugs found during drug use, you must immediately stop using, report to the local drug supervision and management in a timely manner, it may not.
    Pharmaceutical supervisory and administrative departments shall, without delay after receipt of the report shall investigate.
    Quality of medical institutions in drug use found in the suspicious medicines, should be suspended, time laboratories established or designated by the drug regulatory agency inspection; test identified as counterfeit drugs, in accordance with the provisions of the preceding paragraph. 19th medical institutions for staff in direct contact with drugs must undergo an annual medical examination and setting up health records.
    Direct contact with drugs in medical institutions of persons suffering from a communicable disease or suspected infectious disease, as well as people with other diseases might contaminate the drug, in front of a cure for diseases or removing possible drug may not engage in direct contact with drugs. 20th medical organizations engaged in drug procurement, storage, maintenance, acceptance, deployment of personnel, should receive professional training and continuing education.
    Shall obtain the qualifications set by the State, from its provisions. 21st medical institutions must strictly implement the State Council and the provincial Department in charge of price-related provisions of drug prices, subject to Government pricing, Government-guided prices and Government price controls of drugs, not to raise rates without in any way. On bidding procurement of medicines should be taken according to law, it shall take the bidding procurement, reduce drug prices.
    Prohibit price fraud profits and harm the interests of patients.
    Medical drug prices should be made public, query system to provide patients with the drugs price lists, protect the legitimate rights and interests of patients.
    Government price departments above the county level in accordance with the deployment of drug price supervision and inspection of medical institutions to receive complaints and reports of drug prices, investigate and punish drug pricing violations in a timely manner.
    22nd medical organizations may not use medical drug advocacy ads, which of the medicinal preparations should publish any advertisements.
    23rd violates this article eighth paragraph Township the township village of fare sales, private clinics in purchasing drugs, or subcontract drug purchase qualifications of an individual or other unit, the local pharmaceutical supervisory and administrative departments shall impose fines of less than 500 Yuan more than 20000 Yuan.
    24th article violates these measures set forth in the tenth, 19th, medical authorities did not establish true of drug purchase records, or for staff in direct contact with drugs not required health checks, the local pharmaceutical supervisory and administrative departments shall be ordered to correct and give a warning; it fails, fined 500 Yuan more than 2000 Yuan fine.
    25th article violates this way 11th section, drugs or disguised drugs in medical institutions, the local pharmaceutical supervisory and administrative departments shall be ordered to correct, and a fine of 1000 Yuan more than 30000 Yuan fine.
    26th article violates this article approaches the 21st, medical institutions violating the drug price regulations, without raising prices, price gouging or profiteering impairment interests, by pricing authorities to investigate and punish.
    27th in violation of provisions of this article 22nd, medical care business drug advocacy advertising, or published advertising of medical preparations, by the Administrative Department for industry and Commerce investigated according to law.
    28th other acts in violation of this regulation, the relevant provisions of laws and regulations from its provisions.
    29th pharmaceutical supervisory and Administrative Department and other administrative staff, in the supervision and administration of hospital drug use abuse, malpractice, neglect their duties, shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
        30th these measures shall come into force on February 1, 2004.

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