Drug And Medical Devices Used In Medical Institutions In Zhejiang Province Supervision And Administration

Original Language Title: 浙江省医疗机构药品和医疗器械使用监督管理办法

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(September 19, 2007 Zhejiang Province Government makes No. 238, announced since December 1, 2007 up purposes) first chapter General first article to strengthening on medical institutions drug and medical devices using of supervision management, guarantee drug and medical devices of security effective using, maintenance human health and life security, according to People's Republic of China drug management method, and People's Republic of China drug management method implementation Ordinance, and medical devices supervision Management Ordinance, legal, and regulations, combined this province actual,
    These measures are formulated.
    Article in the province within the administrative area of drugs in medical institutions and medical equipment acquisition, storage, use and supervision and management, application of this approach.
    Article of medical institutions in these measures refers to provisions of the regulations, in accordance with the medical institutions, having a medical license to practice agencies. Medical institutions ' use of drugs and medical devices in accordance with the hospital classes and classes for supervision and management in non-hospital. Hospital medical institutions including hospitals, maternal and child health hospital and larger hospitals.
    Specific criteria for larger hospitals in the provincial health Administrative Department, provincial food and drug supervision and administration departments.
    Article fourth medical institutions ' use of drugs and medical devices should follow safe, effective and rational principles.
    Fifth food and drug supervision and management departments above the county level people's Government responsible for the administration of hospital drug management and supervision over the use of medical devices.
    Health Administrative Department in accordance with Division of duties responsible for the administration of hospital drug supervision and management and matters related to the use of medical devices.
    Industry and commerce, price, quality and technology supervision, population and family planning administrative departments concerned, according to their respective duties to do drugs in medical institutions and relevant to medical management.
    Sixth medical institutions in charge of the unit drug and full responsibility for the use of medical devices.
    Medical institutions shall, in accordance with the scale and management needs, setting drug, medical equipment management organization or management staff, establishing management systems, identifying and implementing duties. Second chapter drug, and medical devices of procurement and store seventh article medical institutions should established drug, and medical devices purchase identification system, on related proved file for identification: (a) from drug, and medical devices production enterprise first procurement drug, and medical devices of, should identification drug production license, and drug approved proved file or medical devices production enterprise license, and medical devices products registered certificate; (ii) from drug wholesale enterprise, and medical devices business enterprise first procurement drug, and medical devices of, should identification
    The drug business license, drug approval documents or the medical device distributing Enterprise license, registration certificate of medical device products; (c) procurement of imported drugs shall examine the drug import approval documents and import inspection quality report; buy imported medical devices, shall examine the registration certificate of medical devices, imported quality inspection requirements, which should include examination of import inspection quality report.
    Article eighth of medical institutions to purchase drugs and medical devices should be carried out lot-by-lot inspection and record.
    Accept donations, gifts of medicines and medical equipment in medical institutions, transfers from other medical institutions into the emergency needs of medicines and medical equipment, or purchased directly from the pharmaceutical retail businesses of first-aid needs drugs, should be in accordance with the provisions of the preceding paragraph, before acceptance, and recorded.
    Nineth drug acceptance record shall include the drug generic name, size, lot number, expiry date, manufacturers, suppliers, purchase order number, purchase price, purchase date, date of acceptance, acceptance of the conclusion, and so on.
    Medical device inspection record shall include the name, specification, product lot number (date of manufacture), manufacturers, suppliers, purchase order number, purchase price, purchase date, date of acceptance, acceptance of the conclusion, content; sterilization lot number, expiry date, sterilization lot number, period of validity shall be recorded, medical instruments, equipment inspection records should also include relevant configuration and technical indicators. Acceptance records after being signed by the approval or sealed, on file.
    Inspection records, and related vouchers shall be retained for at least 3 years expiration date, should be kept well beyond their expiration date 1. Article tenth village clinic (the), community health centers (stations) and other medical institutions from drug and medical device manufacturing and business enterprises in the procurement of drugs and medical devices have difficulties, you can entrust other medical institutions to purchase.
    Principal purchase agreement shall be filed with the County's food and drug supervision and Administration Department.
    Encourages the drug directly to the medical institution, medical device distributing enterprise distribution pharmaceuticals and medical equipment. 11th medical institution shall establish its scale of Pharmacy (pharmacy).
    Pharmacy (pharmacy) should be separated from the living, Office and medical areas, and have the necessary light, ventilation, pest control, rat-proof condition, temperature, humidity control devices. Hospital medical institutions should maintain cold storage of medicines, medical devices (Cabinet), a cool library.
    Non-hospital medical institutions shall set the cold storage (Cabinet), cool, and stocks of medicines, medical devices the term as short as possible.
    12th medical institutions shall, in accordance with product instructions indicate the storage conditions store medicines, medical devices, and to monitor and record temperature, humidity of the storage area. Medical institution implementing color management to storage of medicines, medical devices, store.
    Odor medicine, Chinese herbal medicine, Chinese herbal medicine should be stored separately from other drugs; expiration, modification, failure of substandard medicines, medical devices should be placed in unqualified (district).
    13th medical institution shall every month to drug and medical device for inspection and maintenance, periodic maintenance of the storage facility, and a corresponding conservation of archives. 14th medical pharmaceuticals, medical devices review system should be established.
    Expiration, modification, failure, the country has been officially eliminated and other substandard medicines, medical devices shall not be used. 15th medical institutions needed in the emergency room, Ward nurse stations and other places of temporary storage of medicines, medical devices, shall be equipped with medicines and medical equipment store counters.
    Require refrigeration of medicines, medical devices, shall be equipped with appropriate devices.
    Chapter III of drug and medical device using the canonical article 16th medical institutions shall use the unit's patients of drug use and drug, this unit of medical certificates or medical clinics to provide medical equipment to patients or medical services.
    17th under the village qualified medical practitioners regulation provides country doctor, except prescription of Chinese herbal decoction, a village doctors in Zhejiang Province, should be in the essential drug list within the scope of the provisions of the prescription of medication. Issued 18th prescriptions should be in accordance with the standards of diagnosis and treatment, and Chinese set forth the clinical diagnosis, drug generic name, specification, quantity, amount of usage, and so on.
    Chinese herbal medicine, hospital pharmacy approved by the official name should be used. Prescriptions should be written norm, clearly legible.
    Patients requesting paper prescriptions, medical institutions shall provide and shall not refuse.
    19th medical institutions should set clear signs on the children's prescriptions, and specific management prescriptions to children.
    Use adult drugs in children's prescriptions, shall conform to the requirements of the children in medicines, fully taking into account the child's physiological characteristics, drugs features existed in the age of specificity and diversity.
    20th medical institution prescribed persons shall have more than medicine, traditional Chinese medicine pharmaceutical technology titles; prescription dispensing staff should have more than medicine, traditional Chinese medicine pharmacy titles or pharmacy, Chinese background. Village Clinic (the) practitioners organized by the local food and drug supervision and management departments of pharmaceutical expertise training, you can engage in village clinics (the) prescription approval and allocation of work.
    Food and drug supervision and management departments of village clinics (the) pharmacy professional training of employees shall not charge any fee requirements assumed by the people's Governments at the same level.
    After 21st Audit audit prescription prescription shall sign or affix a special signature in the prescription.
    Audit prescription believe that prescription drugs are not appropriate, shall inform the prescribing physician, request confirmation or to prescribe; think prescription there is irrational or when a medication error, refuse to deploy, and inform the prescribing physician, and in accordance with the relevant provisions of a written report.
    22nd medical institutions for the deployment of drug tools, facilities, packing supplies, as well as the deployment area, concentrated infusion of drugs shall comply with hygiene requirements; preparation of regional infusion should be separated, and in accordance with appropriate cleaning requirements. 23rd medical institutions shall, in accordance with the requirements of norm of diagnosis and treatment dispensed medicines and medication guide at the time of delivery of drugs.
    Allotment of children using drugs should be detailed description of methods and points for attention.
    24th medical institutions shall, in accordance with the instruction manual requires the use of medical devices.
    Single-use medical devices shall not be used, have already been used, shall be dealt with in accordance with the relevant provisions of the State, and made a record. 25th medical institutions shall establish a safety management system for medical equipment, equipment, development of appropriate procedures, and urge the use of technical personnel in strict accordance with practice operations.
    Technicians should be used strictly in accordance with the rules of medical instruments and equipment. Medical institutions shall on medical devices, equipment and the use of implantable medical device technician training and assessment; do not meet the requirements, not posts.
    Training, examination should be documented and archived for future reference.
    26th medical institutions shall set up medical equipment, equipment maintenance and safety systems, maintenance and security of test results should be documented and archived for future reference.
    Included in the national compulsory metering management of medical devices, in accordance with the People's Republic of China measurement of relevant provisions of the Act. 27th use of implantable medical devices included in the national list of key regulatory, medical institutions should be registered users, date of surgery, surgeon's name, product name, quantity, specifications, manufacturer and lot number (serial number), sterilization lot number, expiry date, supplier and other information.

    28th legally obtained drugs, medical device clinical trials eligibility medical institutions shall establish appropriate management systems, by the person in charge of drugs, medical devices for testing receiving, storage, conservation, distribution, use and return to work, and to track usage, or extend the scope of use.
    29th hospital medical institutions should be the establishment of drug and medical devices non-normal control systems, according to monthly statistics on the usage of the drugs and medical devices and found the use of drugs, medical devices, amount used, frequency of use exceptions, should organize an expert analysis of rationality, and to take effective measures in a timely manner.
    Statistics, analysis, as well as on the measures taken shall be signed by the heads of medical institutions, and archived for future reference. Article 30th evaluation system of hospital medical institutions shall set up a prescription, according to the ratio of not less than 5% per month to check the prescription, and made a reasonable assessment of prescription irregularities discovered drugs, drug abuse, unreasonable use, shall order the prescribing physician to correct, and as bad record physician review archive.
    Assessment, treatment should be documented and archived for future reference. 31st medical institutions shall, in accordance with ADR and the provisions of the medical device adverse event reporting system, with dedicated staff responsible for monitoring and reporting.
    Finding of adverse drug reactions and adverse events of medical devices, shall be reported in accordance with provisions, and take effective measures to prevent negative consequences of enlargement, and cooperate with the relevant departments for investigation.
    Medical agencies shall not conceal, delaying the report adverse drug reactions and medical device adverse events.
    Article 32nd medical institutions ' use of drugs, medical devices safety accidents, shall, in accordance with the relevant emergency plan requirements to the local food and drug supervision and management departments and the Administrative Department of public health reports, and take effective measures to prevent accidents expanded.
    Medical agencies shall not conceal, delaying the report drug and medical device safety.
    Article 33rd substandard or of questionable quality of pharmaceuticals and medical devices, medical agencies should stop using local storage, and report to the local food and drug supervision and administration departments.
    In front of the food and Drug Administration dealt with according to law, medical agencies shall not return, replacement and destruction of their own.
    Article 34th medical agencies should publicize prices of medicines, medical devices, and provide drugs to patients, medical equipment price list drug name drug generic names should be used in the list.
    Patient objects to the prices of medicines, medical devices, are entitled to medical service, medical agencies shall respond in a timely manner. Article 35th medical advertisements shall comply with the relevant provisions of the State.
    Medical institutions must not use medical advertisements for medicines, medical equipment information and recommendations.
    Medical institutions and publishers may use news reports, medical information services thematic sections (columns), in the form of drugs and medical devices or disguised advertising and referrals. Supervision and administration of the fourth chapter 36th food and drug supervision and administration, health administrative departments shall, in accordance with the provisions of laws and regulations and these rules, to monitor the use of drugs in medical institutions, medical equipment checking; the problems discovered in the inspection process of the others, should be transferred in a timely manner.
    Food and drug supervision and management, the administrative departments for public health shall complement, forming joint mechanisms. Inspection and processing of the results shall be a written record, signed by the supervising personnel filed after.
    Regular consultations shall be without prejudice to medical institutions supervision and inspection activities shall not solicit or accept a unit under inspection of property, shall not seek other interests.
    Medical institutions shall provide and check the articles and materials relating to the matter, and may not refuse or conceal.
    37th food and drug supervision and management departments of the hospital medical institutions every six months of supervision and inspection shall not be less than 1, the supervision and inspection of non-hospital medical institutions not less than 1 year.
    The health Administrative Department of hospital medical institutions drug and medical devices non-normal control systems, prescription the supervision and inspection of the implementation of the system shall not be less than 1 every six months. Article 38th food and drug supervision and management departments according to the needs of supervision and inspection, medical institutions can be used in medicines, medical equipment and inspection.
    Sampling for selective testing shall be in accordance with the provisions, and shall not charge any fee.
    39th province food and drug supervision and management departments to the public of the drug and medical device quality announcement, should be included on the medical use of drugs, medical device quality and inspection results.
    Quality inspection results of dissent, retest procedure in accordance with the relevant provisions of the State.
    40th adverse drug reactions, medical device adverse events or of pharmaceuticals, medical devices safety accidents, the food and drug administration, health administrative departments shall, in accordance with the provisions of the emergency, and disposed of in a timely manner.
    41st medical institution shall not in medicine, medical device purchasing, using the process of accepting kickbacks or other benefits, may not make use of sponsorship, donation, on behalf of the technical development taking medicines, medical equipment production and operation of enterprises or their agents of property or other benefits.
    Heads of medical institutions, procurement staff, physicians and other personnel shall not in any name accepted drugs, medical equipment production and operation of enterprises or their agents of property or other benefits.
    42nd doctors working facilities must not be used, ask for or accept a patient's property, shall not be required or disguised request clients to specify the units and individuals direct purchase of medicines and medical equipment, to seek illegitimate benefits.
    Article 43rd food and drug supervision and management, the administrative departments for public health shall publicize the complaints and reports of phone, e-mail address, mailing address; after receiving complaints and reports, it should be dealt with in a timely manner, will address the reply to the complainants, informants and complainants, the confidentiality of the source.
    Industrial and commercial administrative departments shall, in accordance with article 44th of the People's Republic of China advertisement law and other laws and regulations to strengthen supervision and administration of medical advertising, medical institutions and publishers in breach of the laws, regulations and acts in this way, it shall promptly investigate and punish. Food and drug supervision and management, the Administrative Department of public health found that medical institutions, publishers have breached article 35th of the present measures, should be stopped, and written or transferred to the Administrative Department for industry and Commerce investigated and dealt with.
    Administration for industry and commerce shall be investigated and dealt with in writing inform the transfer unit.
    Industry and commerce, food and drug supervision and management, the administrative departments for public health shall each year to this area the supervision and administration of medical ads integrated assessment, and publicize the assessment results in a timely manner.
    The fifth chapter legal liability article 45th acts in violation of these rules, provisions of relevant laws and regulations on punishment and punishment from its provisions.
    46th article food drug supervision management, sector and staff has following behavior one of of, by right to organ according to management permission, on directly is responsible for of competent personnel and other directly responsibility personnel give administrative sanctions: (a) not according to this approach 37th article, and 38th article provides implementation supervision check, and checks of; (ii) not according to this approach 39th article provides to social announced medical institutions using drug, and medical devices quality checks test results of;
    (C) is not published in accordance with article 43rd and dealing with complaints and reports; (d) is not in accordance with the provisions in article 44th and deal with transfer and integrated assessment of the supervision and management of medical advertisements, and (v) other malpractices for personal gain, dereliction of duty and abuse of power.
    47th article medical institutions has following case one of of, by County above food drug supervision management sector ordered deadline corrected; late not corrected of, can at 1000 Yuan above 10,000 yuan following of fine: (a) not in accordance with this approach seventh article provides on drug, and medical devices for purchase identification of; (ii) not in accordance with this approach eighth article, and Nineth article provides on purchased into of drug, and medical devices made acceptance records of; (three) not in accordance with this approach provides store, and conservation drug, and medical devices of;
    (D) not in accordance with the approach set forth in 25th and 26th the creation and implementation of medical apparatus, equipment safety management system, staff training systems as well as maintenance and security detection systems (v) these measures are not in accordance with the article 27th the registration of implantable medical devices.
    48th article medical institutions has following case one of of, by County above health administrative sector ordered deadline corrected; late not corrected of, can at 1000 Yuan above 10,000 yuan following of fine: (a) violation this approach 16th article, and 17th article provides using drug and medical devices of; (ii) not in accordance with this approach provides issued, and audit, and deployment prescription, dispensed drug of; (three) not according to this approach 34th article provides to visits who provides price listing, or on visits who of asked not timely made replies of.
    49th hospital medical institutions are not in accordance with this article 29th, 30th article creation and implementation of drugs, medical devices and non-normal control system evaluation system of prescription, the health administration departments at or above the county level shall order correction within; it fails to mend, to a fine of less than 3000 Yuan and 30,000 yuan.
    50th medical institution in violation of the first paragraph of article 33rd, continue to use substandard drugs and medical equipment, food and drug supervision and management departments in accordance with the relevant State laws and regulations to deal with continued use of dubious quality of pharmaceuticals and medical devices, used by the food and Drug Administration ordered to stop, according to circumstances, the fines of between 50,000 yuan and 20,000 yuan. Violation of paragraph II of this article 33rd in medical institutions, substandard or of questionable quality medicines and medical devices on their own return, replacement, by the food and Drug Administration ordered the recovery, to a fine of up to 5000 Yuan and 50,000 yuan.

    51st medical institutions and their associated personnel violating these rules article 41st, kickbacks or other benefits in accordance with the People's Republic of China pharmaceutical administration law and the People's Republic of China against unfair competition law the relevant provisions of the sanctions.
    Physicians in violation of these regulations article 42nd, seeking illegitimate interests, in accordance with the People's Republic of China Law on practitioners 37th article of the imposition of penalties.
    52nd medical institutions conceal, delaying the report adverse drug reactions, adverse events of medical devices, health administrative departments at and above the county level shall give notice of criticism, to a fine of less than 1000 Yuan and 30,000 yuan; directly responsible and other persons directly responsible, disciplinary action by the authority.
    53rd medical institutions conceal, delaying the report drug and medical device safety, food and drug supervision and administration departments at or above the county level shall give notice of criticism, to a fine of less than 3000 Yuan and 30,000 yuan; directly responsible and other persons directly responsible, disciplinary action by the authority.
    54th medical institutions was not released in accordance with this regulation drug, medical device prices from competent price administrative departments to be dealt with according to law.
    55th medical institutions violating these rules, harm is done to patients, the violator shall bear liability.
    Sixth chapter supplementary articles article 56th on the medical use of narcotic drugs, psychotropic drugs, toxic drugs and radioactive drugs as well as the supervision and administration of vaccines, in accordance with the relevant laws and regulations shall apply.
    57th family planning technical service institutions ' use of drugs, medical equipment supervision and management, in accordance with the measures implemented.
                                                                                                    58th article this way come into force on December 1, 2007.

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