In order to standardize the management of our hospital hospital pharmacy, to ensure the safety and effectiveness of medication, according to the "Regulations on the Management of Medical Institutions" and "Implementation Rules", "People's Republic of China *** and the State Drug Administration Law" and "Implementation Regulations", "Regulations on the Use of Drugs in Shandong Province", "Shandong Province, the use of drugs, quality management norms", "Shandong Province, the drug safety emergencies emergency handling Measures" and other laws and regulations to develop this system.
Chapter I personnel management
I. Personnel files
Personnel engaged in the quality management of drugs, purchase, acceptance, maintenance, storage, deployment of personnel should be set up a personal file containing information such as a copy of ID card, a copy of the relevant professional qualifications, a copy of the professional and technical titles, annual business assessment forms.
Two, health records
Staff engaged in drug quality management, dispensing, acceptance, maintenance, storage and other direct contact with the drug, each year should be in the drug supervision and management department designated above the second level of medical institutions or disease prevention and control institutions for health screening, and the establishment of health records.
Third, the learning system
Personnel engaged in the quality management of drugs, purchase, acceptance, maintenance, storage, deployment of work should be trained in pharmaceutical laws, regulations and professional knowledge, weekly focused learning time of not less than one hour.
Chapter II Drug Management
I. Purchase and Acceptance of Drugs
Purchase of drugs should be to ensure the quality of the premise, from the legally qualified drug production, drug wholesale enterprises to purchase drugs, strict audit of the supply unit, the qualifications of the purchase of drugs and sales personnel, the establishment of the supply unit files.
Establishment and implementation of the purchase inspection and acceptance system, acceptance inspection personnel to check the packaging, specifications, labels, instructions, certificates of conformity and other identification of drugs batch by batch; do not meet the requirements of the regulations, shall not be purchased.
Establish a true and complete record of purchase and acceptance of medicines, so that the ticket, account, and things match. Purchase and acceptance records saved to more than 1 year after the expiration date of drugs, but not less than 3 years.
Second, the storage of drugs
Set up with the scope of treatment and the scale of medication, and treatment areas and treatment areas separated from the pharmacy, drugstore. The walls, ceiling and floor of the pharmacy and drugstore should be clean and smooth, and the doors and windows should be tight.
Storage of drugs at room temperature (temperature of 0-30 ℃), cool (temperature not higher than 20 ℃), refrigerated (temperature of 2-10 ℃) conditions, the relative humidity is maintained between 45-75%. Drugs with special requirements for storage should be stored in accordance with the conditions labeled on the instructions or packaging of the drugs and relevant regulations. Do a good job of monitoring and management of temperature and humidity, temperature and humidity beyond the prescribed range, should be promptly regulated and recorded.
Pharmaceutical maintenance personnel should be regularly inspected and maintenance, and keep records, inventory of drugs quarterly maintenance, display drugs monthly maintenance, key varieties of semi-monthly maintenance; the hidden dangers affecting the quality of medicines should be removed in a timely manner; expiration date, contamination or deterioration and other unqualified products, should be dealt with in a timely manner in accordance with the relevant provisions.
Three, the deployment of drugs
Pharmaceutical deployment of personnel must have a professional and technical qualifications related to pharmacy.
Dispensing of drugs should be compatible with the scope of diagnosis and treatment, must be registered medical practitioners, physician assistant or village doctor issued a prescription or medical advice, non-physician prescription shall not be dispensed drugs.
Drug distribution should follow the "first produced first out", "near-expiry first out" and the principle of distribution by lot number.
Dispensing, zero drugs, should be based on clinical needs to set up an independent dispensing, zero place or special operating table and regular cleaning and disinfection, to maintain a clean working environment; the use of containers and tools should be cleaned regularly, disinfection, to prevent contamination of medicines; zero shall not be bare hands directly in contact with the drugs, should be made a detailed record of at least one year to save.
After completing the prescription dispensing, the prescription must be properly preserved in accordance with the relevant regulations.
Four, the management of traditional Chinese medicine tablets
The personnel engaged in the purchase, storage, storage, dispensing of traditional Chinese medicine tablets should undergo appropriate professional and technical training and obtain the relevant qualifications.
The procurement, storage, safekeeping, dispensing and quality management of traditional Chinese medicine tablets shall be carried out in accordance with the relevant provisions of the Code of Practice for the Administration of Traditional Chinese Medicine Tablets in Hospitals.
When dispensing prescriptions, the dispensers of traditional Chinese medicine tablets shall review and dispense the prescriptions in accordance with the relevant provisions of the Measures for the Administration of Prescriptions and the Procedures for Dispensing of Traditional Chinese Medicine Tablets. Dispensing each dose of weight error should be within ±5%.
V. Management of toxic drugs for medical use, narcotic drugs and psychotropic substances
Managed in accordance with the relevant provisions of the "Regulations on the Administration of Narcotic Drugs and Psychotropic Substances"
Purchase of narcotic drugs, psychotropic substances, toxic drugs for medical use, radiopharmaceuticals and other special management of drugs, should be from the corresponding qualification of the pharmaceutical production or business enterprises.
Narcotic drugs, a class of psychotropic substances, toxic drugs for medical use, radioactive drugs should be set up special library or special cabinet storage, to achieve the two-person custody, special account records, the account matches.
The use of narcotic drugs and psychotropic substances must be licensed physician issued a special prescription, the maximum amount of a single prescription should be in accordance with the provisions of the State Council health department. Prescription dispensers, checkers should be carefully checked, sign the name, and be registered; does not comply with the provisions of the prescription dispensers, checkers should refuse to issue drugs.
The prescription of narcotic drugs and psychotropic substances is registered in a special book and management is strengthened. Prescriptions for narcotic drugs are kept for at least three years, and prescriptions for psychotropic drugs are kept for at least two years.
Sixth, drug safety emergencies and emergency treatment
In accordance with the "adverse drug reaction reporting and monitoring management", "Shandong Province, drug safety emergencies and emergency treatment" and other relevant provisions of the management.
Drug safety emergencies emergency response work, should follow the prevention-oriented, unremitting policy, the implementation of unified leadership, hierarchical responsibility, timely response, decisive, according to the principle of handling.
Drug safety emergencies should be immediately after the occurrence of the county-level food and drug supervision and management department report to the location, level by level to the provincial Food and Drug Administration.
After the occurrence of drug safety emergencies, actively cooperate with the relevant departments to find out the causes of serious damage to public health, such as major drug quality incidents, mass drug incidents, serious adverse drug reactions, major cases of production and sale of counterfeit and shoddy drugs, as well as other serious impact on public health emergencies of drug safety.
Chapter III Management of Medical Devices
Managed in accordance with the relevant provisions of the Regulations for the Supervision and Administration of Medical Devices.
From the "medical device manufacturer license" of the manufacturer or "medical device business license" of the business enterprise to purchase qualified medical devices, and check the product certification.
Disposable medical devices shall not be reused; used, should be destroyed in accordance with relevant state regulations and records.
Adverse reactions caused by medical devices, according to the relevant provisions of the "Suspected Medical Device Adverse Event Reporting Form" and reported
Chapter IV of the relevant files, records and vouchers management
1.
2. Relevant personnel, drugs, drug purchasing units and other files are kept by specialized personnel.
3. Physicians' prescriptions are kept by specialized personnel according to relevant regulations.
4. Prescribing authority and physician's signature, after approval by the Medical Section, its prescription signature handwriting should be filed in the pharmacy.
Chapter V Other
1. Staff must have the relevant professional qualification certificate.
2. The management of the pharmacy and drugstore shall be carried out in accordance with the relevant provisions in the Regulations Governing Medical Institutions.
3. Medical waste is handled in accordance with the relevant provisions of the "Regulations on the Management of Medical Waste"
4. This system shall come into force on the date of publication.