Report on self-inspection of drug quality: According to the relevant requirements of drug quality management, our hospital organized personnel to conduct self-inspection and self-evaluation, and now the situation is briefly reported as follows:
First, leaders attach importance to it and the management organization is sound. Set up a pharmaceutical affairs management committee with the vice president in charge of drugs as the team leader, the director of pharmacy department as the deputy team leader and relevant personnel as members, responsible for drug quality management with clear responsibilities.
The second is to establish and improve the drug quality management system, incorporate drug quality and safety management into the departmental responsibility objectives, and conduct regular inspections and assessments.
Third, when purchasing drugs, it is necessary to establish supplier and product files and strictly examine the qualifications of suppliers, drugs purchased and sales personnel. Ensure that legitimate drugs are purchased from legally qualified enterprises.
The fourth is to establish and implement the inspection and acceptance system for incoming goods. If counterfeit and inferior drugs are found in the process of acceptance and use, they should stop using them immediately and report to the drug supervision department.
The fifth is to implement effective drug storage management, and drugs with a validity period of less than 6 months are promoted by various user departments on a monthly basis.
Vi. Standardized management According to the requirements of standardized pharmacy construction, the pharmacy area of drug storeroom reaches the standard and is separated from the living area, diagnosis and treatment area and treatment area.
Seventh, the drug storage meets the quality requirements, and the drugs in stock are classified by attributes. Eighth, drug storage facilities are fully equipped and regularly inspected and maintained.
Nine, narcotic drugs and psychotropic drugs in accordance with the provisions of the management, counter storage, double lock custody, special account records consistent with the account.
Ten is to conscientiously implement the monitoring and reporting system of adverse drug reactions, and there is a special person responsible for the collection and reporting of information.
The responsibility of drug quality and management is great. Our hospital makes full use of the Science Council and the workers' congress to organize cadres and workers to learn the implementation plan of drug quality management. At the same time, the column is used to publicize medical safety-related knowledge, so that the cadres and workers in our hospital can understand the objectives and tasks of drug quality management and fully understand the importance, necessity and urgency of implementing drug quality management. In the next step of management, we will take self-examination and self-correction as a new starting point and carry out the following work in a down-to-earth and effective manner:
(a) to strengthen the management of hospitals and departments, improve drug quality management, to ensure drug safety and medical safety.
(two) improve service awareness, improve service attitude, strengthen communication between doctors and patients, and build a harmonious relationship between doctors and patients.
(3) Establish a long-term mechanism for scientific management of hospital drug quality, and strictly implement laws and regulations on drug quality management.
(4) The leading group for monitoring and reporting adverse drug reactions in hospitals should strengthen leadership, unify thoughts, raise awareness and implement the reporting system for adverse drug reactions; Seriously responsible, closely monitor and report in time; Focus on monitoring the reports of adverse reactions of high-risk preparations, biological products and injections, and prohibit the occurrence of late reporting, omission, concealment and concealment of adverse drug reactions.
(five) to strengthen the management and use of high-risk drugs and antibacterial drugs.
Self-inspection report on drug quality Fan Wen II: I. Drug quality management system
(a) the establishment of drug quality management organization, clear the functions of relevant personnel. (See attached table 1)
(B) the establishment of drug quality management system
Two, the implementation of drug quality management system
(1) Drug procurement:
When purchasing drugs, a legitimate supplier should be selected, and a copy of the Drug Production License or Drug Business License stamped with the supplier's seal, GMP or GSP certification and business license should be obtained. The director of pharmacy department should make a drug purchase plan every month and report it to the purchasing department, and then report it to the general manager of the hospital for approval before using drugs.
(2) Drug acceptance:
1. The inspector shall conduct inspection within one working day after the arrival of the goods, the refrigerated drugs shall be inspected within half an hour after the arrival of the goods, and the special drugs shall be inspected by the person in charge of narcotic drugs and psychotropic drugs. Check the name, specification, quantity, approval number, product batch number, manufacturer, production date, expiration date and quality status of the drug. Refuse to accept unqualified drugs such as drugs with short-term efficacy and quality problems, and the warehouse keeper and purchaser will contact the return for follow-up work. The warehouse keeper inputs the list of qualified drugs into the computer and sends it to the pharmacy.
2. The storage and custody of drugs should be based on the principles of safety, convenience, economy and high efficiency, and the stacking should be standardized, reasonable, neat, firm and without inversion. Chinese and western pharmacies are equipped with air conditioners and thermometers respectively. According to the performance and requirements of drugs, the drugs should be stored at room temperature, in a cool place and in a swimming cabinet. Drugs are stored in order of batch number and expiration date. Observe and register the temperature and humidity once every morning and evening, and do a good job of temperature and humidity adjustment to ensure the safety of drug storage. Pharmacy drugs should be classified management. Drugs for internal use, external use and disassembled drugs should be classified and stored with correct labels and clear handwriting. Unqualified drugs are stored in special counters, and drugs with short-term efficacy are checked once a month by special personnel. The specific information is published with warning signs of drugs with short-term efficacy, and records are made.
3. The director of pharmacy department is responsible for reporting the loss and destruction of drugs near the expiry date, damaged drugs and unqualified drugs. The specific operation is to prepare and sign the documents of drugs that need to be reported for loss every month, and then put the documents and unqualified drugs into the unqualified drug counter, and destroy them after being checked and recorded by financial personnel.
4. Management of special drugs: special personnel management, locked storage of counters, special prescriptions and special account books registration shall be implemented. Prescription review of narcotic drugs and psychotropic drugs: the dosage of the first kind of narcotic drugs and psychotropic drugs injection is once, and the dosage of other dosage forms shall not exceed 3 days; The dosage of prescriptions for psychotropic drugs of category II shall not exceed 7 days. For hydrochloric acid that needs strict control, the prescription is a one-time dosage, but the drug is only used in our hospital.
5. Drug warehouse management
Our hospital has a Chinese medicine warehouse and a western medicine warehouse. The drug storage in the warehouse is managed by color code. The area to be tested and returned is yellow, the qualified area is green and the unqualified area is red. Correct selection of drug storehouse location and rational utilization of storehouse capacity. "Five distances" shall be managed by classification, with clear colors, standardized stacking, reasonable, neat, clean, firm and without inversion, and shall be well protected against theft, fire, moisture, corrosion, rats and pollution. Do a good job in the temperature registration of drug storehouse to ensure the safety of drug storage.
6. Drug distribution and distribution
Strictly implement the "four checks and ten pairs" system, and investigate the object, name and age. Check drugs: check the name, specification, quantity and label of drugs. Check the rationality of drug use, contraindications in clinical diagnosis, drugs and compatibility. For over-dose prescriptions and unqualified prescriptions, communicate with the doctor in time, and the doctor will prescribe the medicine after revision. Explain the usage, dosage and precautions of the patient's medicine when distributing the medicine. Drugs removed:-Record the drugs removed, set up a special removal counter and equip with necessary removal tools.
7. Personnel training and education
The director of pharmacy department is responsible for formulating the annual employee pharmacy laws and regulations and pharmacy professional knowledge training plan, and arranging the training time reasonably. Education and training methods are mainly regular organization and self-study, supplemented by external training, and the time for pharmaceutical professionals to receive continuing education shall not be less than 3 hours per year.
8. Adverse drug reaction report
According to the requirements of the US Food and Drug Administration in longhu district, the hospital has responsible personnel to report their work.
9. Health and personnel health
It is forbidden to bring articles such as daily necessities into the pharmacy and put them on the shelves. Personal daily necessities should be stored in a special place, and should not be placed on drug shelves or counters. Organize all pharmacy staff to have a regular health examination once a year, increase the items of vision and color vision examination for drug acceptance and maintenance personnel, and establish personal health examination files.
Third, the preparation situation
There is no preparation project in our hospital.
Four. Accept the inspection by the Food and Drug Administration.
All the drugs sampled are qualified, and there is no quality problem.
Five, medical device quality management system
(a), the hospital set up a safety management organization with the dean as the team leader and the directors of various departments as members, and conscientiously implemented and abided by the national guidelines, policies, laws and relevant regulations on medical device quality management.
(2) Establish a medical device quality management system.
Six, the implementation of medical device quality management system
(a), medical equipment library according to the classification management, divided into one, two, three kinds of medical equipment stored separately, precision equipment stored separately, set up eye-catching logo. According to different seasons and climate changes, do a good job in humidity and temperature management of warehouses.
(2) All medical equipment warehouses shall be managed by color codes. The areas to be inspected and returned are yellow, the qualified areas and distribution areas are green and the unqualified areas are red.
(3), in accordance with the provisions of the establishment of medical equipment, consumables, reagents and other procurement, receiving, acceptance, acceptance, storage, maintenance ledger, do a good job in all kinds of recording procedures.
(4) In order to ensure the quality and safety of purchased medical devices and prevent unqualified medical devices from entering, our hospital has made strict regulations on the conditions for purchasing medical devices and the qualifications of suppliers.
(5), do a good job of daily storage.
(6) In order to ensure the quality of medical devices in storage, our hospital also specially organizes specialized personnel to do the daily maintenance of medical devices.
(VII) In order to strengthen the management of unqualified medical devices and prevent unqualified medical devices from entering the clinic, our hospital strictly implements the reporting system of adverse reactions of medical devices. In case of adverse reactions of medical devices, the location, time, adverse reactions or basic information of the adverse events shall be made clear, and records and reports shall be made. Through this self-examination, we can basically meet the requirements of "Quality Management Standards for Drugs and Medical Devices", and hope that the superior leaders will put forward valuable opinions on the work of our hospital. In the future work, we will make persistent efforts to improve the management quality of drugs and medical devices in our hospital.