Hangzhou Medical Quality Supervision And Management Measures On Drug Use

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

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(September 12, 2005, Hangzhou City people's Government, the 83rd General session on September 20, 2005, the Hangzhou people's Government promulgated as of November 1, 2005, No. 222) *** first to strengthen quality supervision and management 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 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 shall obtain the practicing certificate for medical institution engaged in disease diagnosis, treatment, medical institutions active in drug procurement, inspection, storage, conservation, allocation and dispensing of drugs using 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 should comply with the relevant national legal provisions and regulations. Article in Hangzhou food and drug supervision and management departments in charge of the city quality supervision and management of hospital drug use.
    District, County (City) food and drug supervision and management is responsible for the area of quality supervision and management of hospital drug use.
    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. Fourth 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.
    Article fifth medical institutions shall, in accordance with their size and need to set pharmaceutical quality management organizations or the implementation of the management of drug quality management personnel, and to clarify its responsibilities.
    Pharmaceuticals quality management organization composed of or pharmaceutical quality management should be legally certified pharmaceutical technical personnel or pharmacist to serve as.
    Sixth recipe reviewer of medical institutions should be by a pharmacist pharmacy professional and technical posts at or above qualifications pharmacy technician or licensed pharmacist who should gain the qualification of personnel in drug dispensing pharmacy technician or pharmacist to serve as.
    Seventh direct contacted with drugs practitioners from medical treatment should be adopted by the municipal food and drug supervision and Management Department under the health check, and health records.
    Suffering from mental illness, infectious diseases or other potentially contaminated medicine diseases of workers shall not engage in direct contact with the pharmaceuticals.
    Article eighth of medical institutions should be on the institutions engaged in drug procurement, inspection, storage, conservation, allocation, allotment of personnel training on a regular basis, and to establish training records.
    Nineth medical institutions of pharmacy technicians and licensed pharmacists should use specialized knowledge and a variety of pharmaceutical information, and provided advisory services to healthcare professionals and patients involved in clinical work, and to make rational drug use recommendations.
    Tenth medical institutions should be from the drug manufacturing license, drug trading license and license of pharmaceutical production, management of purchasing drugs.
    Relationship between supply and demand of medical institution from its first drug manufacturer or drug-handling enterprises (collectively enterprise) purchase, or purchase buy drugs for the first time (the first camp) and imported products, he shall, in accordance with the relevant provisions to obtain and verify information.
    11th medical institutions buy drugs, should strictly abide by 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. 12th 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 3 years; drug is valid for more than 3 years, saved until after the drugs period of validity 1.
    13th medical institutions shall, in accordance with the law approved by the medical subjects and drug use sets the appropriate medicine, pharmacy (medicine cabinet).
    Drug Library, and pharmacy (drug Cabinet) should and clinic, and Office, and life, regional separate, and corresponding configuration following equipment: (a) easy drug displayed of equipment; (ii) meet drug characteristics requirements of at room temperature, and cool, and refrigerated and frozen custody equipment; (three) keep drug and ground Zhijian has must distance of equipment; (four) drug dust, and moisture, and anti-pollution and anti-insect, and anti-rat, and mold variable, equipment; (five) avoidance light, and ventilation equipment; (six) using medicine pieces by needed of about equipment;
    (VII) ensure safe use of the equipment. Article 14th medicine library medical institutions to implement color management system.
    Quarantine medicine library (district), return drug library (district) marked with yellow background; qualified drug library (district), taking the herbal formula zero balance (districts) marked with green background; substandard drugs (district) marked with red and white.
    15th 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 16th maintenance 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%. 17th facility to store drugs in medical institutions with floors, walls and roofs (beam), radiators, heating pipes, medicine stack should have some space between or to take the appropriate measures.
    Among them, the drug with walls and roof (beam) shall not be less than the spacing of 30 cm, with radiators or heating pipes must not be less than the spacing of 30 cm, and the ground shall not be less than the spacing of 10 cm. 18th stockpiling medicines in medical institutions should be relatively centralized storage, batch number classification.
    Drug and non-drug, for internal use and external use medicine should be separate; odor medicine, Chinese herbal medicine, Chinese medicine pieces, and dangerous goods should be kept separate. 19th medical institutions shall regularly check stocks of medicine.
    Substances and to peri-mildew, deliquescent drugs should shorten the inspection cycle, as appropriate.
    20th medical institutions to the defective drugs identification, reporting, loss and destruction should improve the procedures and records and substandard drugs placed in substandard drugs (district).
    21st deployment of drugs in medical institutions of sites, installations and packaging materials shall conform to the requirements for health and safety shall be placed on the drug contamination, affect drug quality.
    22nd used drugs in medical institutions should be commensurate with the scope of diagnosis and treatment, and by practicing physicians, licensed physician assistant or the rural doctors practising certificate issued by the village doctor prescription dispensing medicines. 23rd 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. Article 24th deployment of drugs in medical institutions shall be measured accurately.
    Are required by law to compulsory verification of measuring instruments shall be subject to mandatory Government standards in drug dispensing and examination used within the validity period. 25th medical organizations requiring the original minimum packaging standardizes deployment, shall make standardizes record and save the original minimum packaging. 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.
    26th medical institutions not to off-site hospitals selling drugs.
    Medical institutions shall not be away from the counter or outside this body places free clinic, consultation, trial operation or disguised in the form of drugs.
    27th medical organizations may not use medical drug advocacy advertising, their preparation should publish any advertisements that are configured.
    28th medical institutions fake medicines and medicines of inferior quality shall be used. 29th article quality of medical institutions in 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. Article 30th has been recognized by the food and Drug Administration fake medicines and medicines of inferior quality, medical authorities should immediately stop using, and promptly report to the local food and drug supervision and Management Department, which dealt with according to law. Medical institutions are not allowed to return, replacement or destroyed.

    31st 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 within the first month of each quarter of the 5th report to the provincial adverse drug reactions monitoring body set. 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 provincial, municipal, district and County (City) food and Drug Administration report.
    Discovered groups of adverse drug reactions should be immediately to the provincial, city, district and County (City) food and drug administration, health administration, and provincial adverse drug reactions monitoring reports.
    32nd article violates these rules, laws, rules and regulations on penalties from its provisions.
    33rd article medical institutions violation this approach fourth article, and fifth article, and sixth article, and seventh article, and 11th article, and 12th article, and 13th article, and 15th article and 23rd article provides of, by location of food drug supervision management sector ordered its corrected, give warning, and can sentenced 200 Yuan above 1000 Yuan following of fine; late not corrected of, sentenced 1000 Yuan above 10000 Yuan following of fine.
    34th article violates this article 22nd, 26th, 29th, and 30th article, the local food and drug supervision and management departments of more than 1000 10000 Yuan fine.
    35th medical institutions violating these rules article 27th, medical business advertisements for medicines advertising promotion or release preparations, the local administration for industry and Commerce investigated according to law.
    Article 36th entity or individual without the practising certificate for medical institution, to use drugs in the name of medical institutions, the local Health Administration Department to investigate and punish.
                                                                                                                          37th article of the measures shall take effect on November 1, 2005.