Zhejiang province medical institutions drugs and medical equipment use supervision and management measures for the use of norms

Article XVI of the medical institutions should be based on the unit of the prescription of medicines to patients with medicines, with the unit of the medical documents or according to the diagnosis and treatment need to provide medical equipment or medical equipment services to patients.

Article XVII in accordance with the "rural doctors practice management regulations," the rural doctors qualified to practice, in addition to the prescription of traditional Chinese medicine soup, should be in the "zhejiang province rural doctors basic medication directory" within the scope of the prescription of medication.

Article 18 of the prescription shall be issued in accordance with the requirements of the diagnosis and treatment specifications, and in Chinese clinical diagnosis, generic name of drugs, specifications, quantity, usage, dosage and other content. Chinese medicine tablets, hospital preparations should be used by the officially approved name of the medicine.

Prescriptions should be written in standardized, clear handwriting. Seekers request paper prescriptions, medical institutions shall provide, shall not be refused. Article 19 of the medical institutions should be set in the children's prescriptions for medication on the obvious signs, and special management of children's prescriptions for medication.

Children's prescriptions for the use of adult drugs, should be in line with the relevant requirements for children's medication in the instructions for medicines, and give full consideration to children's physiological characteristics, drug function in the age of the existence of the specificity and variability.

Article 20 of the medical institutions to review the prescription staff, should have a pharmacist, Chinese medicine doctor above the technical title of pharmacy; dispensing prescription staff, should have a pharmacist, Chinese medicine doctor above the technical title of pharmacy or pharmacy, Chinese medicine specialized secondary school education.

Village health room (office) practitioners by the local food and drug supervision and management department of the organization of professional knowledge of pharmacy training, can be engaged in the village health room (office) prescription review and dispensing work. Food and drug supervision and management department of the village health office (office) practitioners of pharmacy expertise training shall not charge any fees, the necessary funds borne by the people's government at the same level.

Article 21 of the audit of the prescription personnel to review the prescription, should be signed or stamped with a special signature on the prescription.

Audit prescription personnel that there is a prescription for medication is not appropriate, should inform the prescriber, please confirm or re-issue of the prescription; that there is an unreasonable prescription of medication or medication errors, should refuse to deploy, inform the prescriber in a timely manner, and in accordance with the relevant provisions of the written report.

Article 22 of the medical institutions for the dispensing of drugs, tools, facilities, packaging supplies, and the dispensing of drugs, centralized infusion area, shall meet the health requirements; preparation of infusion area should be relatively isolated, and meet the appropriate cleanliness requirements.

Article 23 of the medical institutions shall dispense medicines in accordance with the requirements of the diagnostic and therapeutic specifications, and provide guidance on the use of medicines in the delivery of medicines. Dispensing of medicines for children, should explain in detail how to take and precautions.

Article 24 of the medical institutions should be in accordance with the requirements of the instructions for the use of medical equipment.

One-time use of medical equipment shall not be reused, has been used, shall be disposed of in accordance with relevant state regulations, and make records.

Article 25 of the medical institutions shall establish medical instruments, equipment safety management system, develop appropriate operating procedures, and supervise the use of technical personnel in strict accordance with the operating procedures. The use of technical personnel should be strictly in accordance with the operating procedures for the use of medical instruments, equipment. Medical institutions should be on medical instruments, equipment and implantable medical devices, the use of technical personnel for training and assessment; does not meet the requirements, shall not be on duty. Training, assessment should form a record, and archived for inspection.

Article 26 of the medical institutions shall establish medical instruments, equipment maintenance and safety testing system, maintenance and safety testing results should be recorded and archived.

Included in the national compulsory measurement of the scope of the management of medical equipment, in accordance with the "Chinese People's **** and State Metrology Law" relevant provisions.

Article 27 of the use of implantable medical devices included in the national key regulatory directory, the medical institution shall register the user's situation, the date of surgery, the surgeon's name, product name, quantity, specifications and models, manufacturers, production batch number (factory number), sterilization batch number, expiration date, supply units and other information.

Article 28 of the law to obtain drugs, medical devices, clinical trials of medical institutions shall establish the appropriate management system, a person in charge of the trial of drugs, medical devices, the receipt, storage, maintenance, distribution, use and return work, and the use of tracking, shall not expand the scope of use.

Article 29 of the hospital class medical institutions shall establish drugs and medical devices abnormal use control system, monthly statistics on the use of drugs and medical devices; found that the use of drugs and medical devices, the use of abnormal amount, use of money, the frequency of use, shall organize experts to carry out a rational analysis, and take effective measures in a timely manner.

Statistics, analysis results and the measures taken should be signed by the main person in charge of the medical institution, and archived for inspection.

Article 30 of the hospital-type medical institutions shall establish a prescription assessment system, at a rate of not less than 5% of the monthly sampling of prescriptions, and reasonableness assessment; found that there are violations of the prescription of medication, drug abuse, irrationality of the use of medication, the prescribing physician shall be ordered to make corrections and as a bad record in the assessment of the physician's file. Assessment, treatment shall form a record, archived for inspection.

Article 31 of the medical institutions shall, in accordance with the provisions of the national adverse drug reactions and medical device adverse event reporting system, designate special personnel responsible for monitoring and reporting. Discovered adverse drug reactions and medical device adverse events, should be promptly reported in accordance with the provisions, while taking effective measures to prevent the expansion of adverse effects, and actively cooperate with the relevant departments of the investigation.

Medical institutions shall not conceal or delay the report of adverse drug reactions and adverse events of medical devices.

Article 32 of the medical institutions in the use of drugs, medical equipment safety accidents, should be in accordance with the requirements of the relevant emergency plan in a timely manner to the local food and drug supervision and management department and the administrative department of health report, and at the same time to take effective measures to prevent the consequences of the accident from expanding.

Medical institutions shall not conceal, slow report of drug and medical device safety incidents.

Article 33 of the unqualified or doubtful quality of drugs and medical devices, medical institutions shall stop using, seal in place, and promptly report to the local food and drug supervision and management departments.

Before the food and drug supervision and management departments in accordance with the law, medical institutions shall not return, exchange and destroy.

Article 34 of the medical institutions shall truthfully announce the price of drugs, medical equipment use, and to provide patients with a truthful list of the price of drugs, medical equipment use, the list of drug names should be used in the generic name of drugs.

The patient has the right to ask the medical institution about the price of drugs and medical equipment, and the medical institution shall make a timely reply.

Article 35 of the release of medical advertisements shall comply with the relevant provisions of the state. Medical institutions shall not use medical advertisements for drugs, medical equipment publicity and recommendation.

Medical institutions, advertisers shall not use news reports, medical information services and other forms of thematic programs (columns) on drugs and medical devices or disguised advertising and recommendation.