Hospital Drug Use In Handan City Quality Supervision Management

Original Language Title: 邯郸市医疗机构药品使用质量监督管理办法

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(December 11, 2007, Handan people's Government at the 63rd Executive meeting on December 21, 2007, 124th Handan people's Government promulgated as of February 1, 2008) first to strengthen quality supervision and management of hospital drug use, safeguard human safety, in accordance with the People's Republic of China pharmaceutical administration law and the People's Republic of China such as drug administration regulations for the implementation of laws and regulations, combined with the city's actual, these measures are formulated.
    Second approach applies within the administrative area of the city according to law to engage in medical, health, prevention, family planning service providers (hereinafter referred to as medical institutions) in drug procurement, inspection, storage, conservation, allocation and dispensing of the quality supervision and management.
    Narcotic drugs, psychotropic substances, toxic drugs for medical use and radioactive pharmaceuticals and vaccine use and its quality supervision and management based on relevant laws and regulations shall apply.
    Third, Handan city, food and drug supervision and management departments in charge of the city quality supervision and management of hospital drug use.
    Counties (cities, districts), food and drug supervision and management is responsible for the area of quality supervision and management of hospital drug use.
    Without a county-level area of the food and drug administration, quality supervision and management of drug use by the municipal food and drug supervision and management departments are directly responsible for.
    Health, price, industrial and commercial administrative department shall, within the scope of their respective duties, is responsible for the supervision and administration of hospital drug use.
    Article fourth second-level medical institutions shall set up Pharmaceutical Affairs Management Committee, other medical institutions may establish drug administration group, or a clear (and) staff is responsible for the quality management of drug use.
    Pharmaceutical composition of the Management Board, in accordance with the Pharmaceutical Affairs implementation of the provisional regulations on the management of medical institutions. Fifth article medical institutions should established sound following drug quality management system, and regularly check and assessment system implementation situation, do corresponding records: (a) drug quality management responsibility system; (ii) personnel health status management system; (three) drug procurement, and acceptance management system; (four) drug quality information management system; (five) drug store, and conservation management system; (six) drug measurement apparatus and the store, and conservation equipment of using management system; (seven) special drug management system; (eight) the health management system
    And (I) the prescription management system (10) unqualified drugs and return management system (11) adverse drug reaction reporting management systems; (12) quality management system incident reporting and handling (13) cleanup and destruction of expired drugs regime.
    Sixth medical institutions should be from the drug manufacturing license, drug trading license and license of pharmaceutical production, management of purchasing drugs.
    Article seventh purchase drugs in medical institutions shall strictly comply with the relevant regulations of the State, established examination system of pharmaceuticals certificates and other marks for failure to comply with the requirements of the drug shall purchase and use.
    Relationship between supply and demand of medical institution and the first drug manufacturer or drug-handling Enterprise purchase, or purchase when you buy drugs or imported drugs for the first time, shall, in accordance with the relevant provisions to obtain and verify information. Article eighth medical institutions should establish real and complete record of the medicines purchased.
    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 three years; drug is valid for more than three years, saving to the drugs period of validity after one year.
    Nineth medical institutions shall, in accordance with the law approved by the medical subjects and drug use sets the appropriate medicine, pharmacy (medicine cabinet).
    Article tenth 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 11th conservation personnel should pharmacy, pharmacy (medicine cabinet) of temperature and humidity monitoring and management. When the temperature and humidity is outside the specified limits, shall promptly take measures and make a record.
    Store capsules at room temperature the temperature should be maintained at 10-30; a cool temperature should not exceed 20 c; cold store (counter) temperature should be maintained at 2-10; relative humidity should be kept at the drugstore and pharmacy 45%-75%.
    12th medical institutions to the defective drugs identification, reporting, loss and destruction should have perfect handling and recording, and substandard drugs placed in substandard drugs (district) or clearly identified.
    13th used drugs in medical institutions should be commensurate with the scope of diagnosis and treatment, prescription shall not provide the drug to patients. 14th medical organizations should be strictly based on the prescription dispensing medicines, the deployment of personnel to the prescription drugs listed shall alter or substitute.
    The incompatibility or overdose of prescription, refuse to deploy, returned to the prescribing doctor, signed by the prescribing doctor corrected again before the deployment.
    Prescription audit, redeployment of staff should hold one in the prescription of drugs, prescription required to save for future reference. 15th medical organizations requiring the original minimum packaging standardizes deployment should make standardizes record an original minimum packaging and at least the same lot number. Standardizes the drug should indicate on the packaging the drug name, specifications, usage, quantity, batch number, orders, use-by dates, names and other content of medical institutions.
    Special requirements, considerations should be in writing.
    16th medical institutions not to off-site hospitals selling drugs, not to away from the counter or in the institutions operate or in disguised form drugs.
    17th medical organizations may not use medical drug advocacy advertising, their preparation should publish any advertisements that are configured. 18th medical organizations in the quality of drug use found in the suspicious medicines, should immediately stop using, keep proper and timely report to the local food and drug supervision and administration departments.
    Food and drug supervision and management departments should be dealt with according to law in a timely manner, prior to the inspection to determine medical institution may set their own return, replacement or destroyed. 19th medical institutions shall, in accordance with relevant regulations of the State, strict monitoring of the incidence of adverse drug reactions.
    Discover suspected cases of adverse drug reaction should be recorded by the regulation, investigation, analysis, evaluation and treatment, and in the first month of each quarter of the 5th set to local adverse drug reactions monitoring reports. Discover new or serious adverse drug reactions, medical authorities should immediately take control measures and found the date of the 7th provincial adverse drug reactions monitoring reports, as well as to provincial, city and County (city, district), food and Drug Administration report.
    Discovered groups of adverse drug reactions should be immediately reported to the provincial adverse drug reactions monitoring bodies, as well as to provincial, city and County (city, district), food and Drug Administration report.
    20th levels of food and drug supervision and administration departments, health administrative departments should establish coordinated mechanisms to combat fake medicines and medicines of inferior quality, and share information.
    City, County (city, district) when approved by the health Administrative Department under the new medical institutions, the situation should be to inform the food and drug supervision and management departments at the same level, no establishment where food and drug supervision and management departments at the county level, directly by the health Administrative Department at county level to inform the municipal food and drug supervision and Administration Department.
    21st medical institution in violation of the article fifth, seventh, eighth and tenth article, the local food and drug supervision and Administration Department shall order their correction, given a warning and fined 200 Yuan more than 1000 Yuan fine; it fails, fined 1000 Yuan more than 10000 Yuan fine.
    22nd disobey article 13th without prescription of providing drugs to patients by unlicensed; violations of the provisions of article 18th and 19th, the local food and drug supervision and management departments of more than 1000 10000 Yuan fine.
    Article 23rd disobey article 17th of medical institutions, medical business advertisements for medicines advertising promotion or release preparations, the local administration for industry and Commerce investigated according to law.
    Article 24th entity or individual without the practising certificate for medical institution, to use drugs in the name of medical institutions, the local Health Administration Department shall investigate and handle breach article 14th, dealt with by the health Administrative Department in accordance with the relevant provisions.
    25th article violates these rules, laws, rules and regulations on penalties from its provisions.
                                                                                    26th article of the rules take effect on February 1, 2008.