Article 16 Medical institutions shall provide drugs to patients based on their own drug prescriptions, and provide medical devices or medical device services to patients based on their own medical certification documents or based on diagnosis and treatment needs.
Article 17 Rural doctors who have obtained professional qualifications in accordance with the "Regulations on the Management of the Practice of Rural Doctors" shall, in addition to prescribing traditional Chinese medicine decoctions, within the scope stipulated in the "Basic Medication Catalog for Rural Doctors in Zhejiang Province" Prescribe medications.
Article 18 Medication prescriptions shall be issued in accordance with the requirements of diagnosis and treatment standards, and shall state in Chinese the clinical diagnosis, common name of the drug, specifications, quantity, usage, dosage, etc. Traditional Chinese medicine pieces and hospital preparations should use officially approved pharmaceutical names.
Prescriptions should be written in a standardized and clear handwriting. If a patient requests a paper prescription, the medical institution shall provide it and shall not refuse. Article 19 Medical institutions should set up obvious signs on children’s drug prescriptions and conduct special management of children’s drug prescriptions.
If adult drugs are used in children’s drug prescriptions, they should comply with the relevant requirements for children’s drugs in the drug instructions, and fully consider the physiological characteristics of children and the specificity and differences in drug functions based on age.
Article 20: Personnel reviewing prescriptions in a medical institution shall have technical professional titles of pharmacist, doctor of traditional Chinese medicine or above; personnel preparing prescriptions shall have technical professional titles of pharmacist, doctor of traditional Chinese medicine or above, or majoring in pharmacy or traditional Chinese medicine Technical secondary school degree or above.
Practitioners in village clinics (institutions) who have passed the pharmaceutical professional knowledge training organized by the local food and drug supervision and administration department can engage in prescription review and dispensing work in village clinics (institutions). The food and drug supervision and administration department shall not charge any fees for the pharmaceutical professional knowledge training for village clinic (institution) employees, and the required funds shall be borne by the people's government at the same level.
Article 21: After reviewing the prescription, the prescription review personnel shall sign or stamp the prescription with a special signature.
When the prescriber reviewing the prescription believes that the prescription is inappropriate for medication, he or she should inform the prescribing physician and ask him to confirm or reissue the prescription; when he or she believes that the prescription contains unreasonable medication or incorrect medication, the prescriber should refuse to dispense it and promptly notify the prescribing physician. , and make a written report in accordance with relevant regulations.
Article 22 The tools, facilities, packaging supplies used by medical institutions to prepare medicines, as well as the areas for preparing medicines and concentrated infusions, shall comply with health requirements; the areas for preparing infusions shall be relatively isolated and comply with relevant regulations. Cleanliness requirements.
Article 23 Medical institutions shall distribute drugs in accordance with the requirements of diagnosis and treatment specifications and provide medication guidance when delivering drugs. When distributing medicines for children, detailed instructions on how to take them and precautions should be given.
Article 24 Medical institutions shall use medical devices in accordance with the requirements of the instructions for use.
Single-use medical devices may not be reused. Those that have been used must be disposed of in accordance with relevant national regulations and recorded.
Article 25 Medical institutions shall establish a management system for the safe use of medical instruments and equipment, formulate corresponding operating procedures, and urge technical personnel to strictly follow the operating procedures. Technical personnel should use medical instruments and equipment in strict accordance with operating procedures. Medical institutions should provide training and assessment for technical personnel who use medical instruments, equipment and implantable medical devices; those who do not meet the requirements shall not be allowed to work. Training and assessment situations should be recorded and archived for future reference.
Article 26 Medical institutions should establish a system for maintenance and safety testing of medical instruments and equipment. The maintenance status and safety testing results should be recorded and archived for future reference.
The management of medical devices included in the scope of national compulsory measurement shall be implemented in accordance with the relevant provisions of the "People's Republic of China and the National Metrology Law".
Article 27 When using implantable medical devices listed in the national key regulatory catalog, medical institutions shall register the user status, date of surgery, name of the surgeon, product name, quantity, specification model, production Manufacturer, production batch number (factory number), sterilization batch number, validity period, supplier and other information.
Article 28 Medical institutions that have obtained clinical trial qualifications for drugs and medical devices in accordance with the law shall establish corresponding management systems and assign dedicated personnel to be responsible for the receipt, storage, maintenance, distribution, and use of experimental drugs and medical devices. As well as returning the work and tracking the usage, the scope of usage must not be expanded.
Article 29: Hospital-type medical institutions shall establish a system for controlling the abnormal use of drugs and medical devices, and conduct monthly statistics on the use of drugs and medical devices within the unit; discover the amount of drugs and medical devices used, If the amount or frequency of use is abnormal, experts should be organized to conduct rational analysis and take effective measures in a timely manner.
The statistics, analysis results and measures taken should be signed by the main person in charge of the medical institution and filed for future reference.
Article 30: Hospital-type medical institutions shall establish a prescription evaluation system, conduct spot checks on prescriptions every month at a ratio of no less than 5, and conduct rationality evaluations; if prescriptions are found to contain illegal use of drugs or drug abuse , If the medication is used irrationally, the prescriber should be ordered to make corrections and recorded as a bad record in the physician assessment file. The assessment and handling should be recorded and archived for future reference.
Article 31 Medical institutions shall designate specialized personnel to be responsible for monitoring and reporting in accordance with the national adverse drug reaction and medical device adverse event reporting system. If adverse drug reactions or medical device adverse events are discovered, they should be reported in a timely manner in accordance with regulations, and effective measures should be taken to prevent the expansion of adverse consequences and actively cooperate with the investigations of relevant departments.
Medical institutions shall not conceal or delay the reporting of adverse drug reactions and medical device adverse events.
Article 32 If a medical institution has a safety accident involving the use of drugs or medical devices, it shall promptly report to the local food and drug supervision and administration department and health administration department in accordance with the requirements of the relevant emergency plan, and at the same time take effective measures to Prevent the consequences of accidents from expanding.
Medical institutions shall not conceal or delay reporting safety incidents involving the use of drugs and medical devices.
Article 33: For drugs and medical devices that are substandard or of questionable quality, medical institutions should stop using them, seal them on site, and report them to the local food and drug supervision and administration department in a timely manner.
Medical institutions are not allowed to return, exchange or destroy products on their own before the Food and Drug Administration handles them in accordance with the law.
Article 34 Medical institutions shall truthfully publish the prices of drugs and medical devices, and truthfully provide patients with a price list of drugs and medical devices. The names of drugs in the list shall use the common names of drugs.
If a patient has any objection to the price of drugs or medical devices, he or she has the right to ask the medical institution, and the medical institution shall respond in a timely manner.
Article 35 Medical advertisements shall comply with relevant national regulations. Medical institutions are not allowed to use medical advertisements to promote and recommend drugs and medical devices.
Medical institutions and advertising publishers are not allowed to use news reports, medical information service special sections (columns), etc. to advertise and recommend drugs and medical devices or in disguised form.