Drugs are directly related to the people's health and life safety, to ensure drug safety is the biggest livelihood.
Self-inspection report on drug quality:According to the () Drug Administration on the development of drug quality management requirements, our hospital organization seriously carried out self-inspection and self-assessment, is now a brief report on the situation is as follows:
First, the leadership of the importance of the management of the organization is sound, the establishment of a vice-president of the drug as the leader, the director of the Pharmacy Department for the deputy leader, the relevant personnel as a member of the Pharmaceutical Management Committee, responsible for the management of drug quality, the management of the drug quality of the management committee. Vice President in charge of drugs as the leader, the director of the Pharmacy Department as the deputy leader, the relevant personnel as members of the Pharmaceutical Affairs Management Committee, responsible for the management of drug quality, with clear functions and responsibilities.
Second, the establishment of a sound drug quality management system, drug quality and safety management into the department's responsibility for regular inspection and assessment.
Third, the purchase of drugs, the establishment of supply units and product files, strict audit of the supply unit, the purchase of drugs and sales personnel qualifications. To ensure that legal drugs are purchased from legally qualified enterprises.
Fourth, the establishment and implementation of the purchase inspection and acceptance system. The acceptance and use of the process found in the fake and inferior drugs immediately stop using and reported to the drug supervision department.
Fifth, the implementation of the validity of the drug storage management, the validity of less than six months of the drug should be reported to the use of each department to promote the use of monthly.
Six is in accordance with the standardization of the pharmacy construction requirements to standardize the management of the drugstore pharmacy area up to standard, and living areas, diagnostic and treatment areas, separate.
Seven is the storage of drugs to meet the quality requirements, the stock of drugs according to the attributes of classification storage. Eight, the drug storage facilities and equipment are complete, regular inspection and maintenance.
Nine is the narcotic drugs and psychotropic substances in accordance with the provisions of the management, special cabinet storage, double double-locked safekeeping, special account records, the account matches.
Ten is the serious implementation of the adverse drug reaction monitoring and reporting system, a person responsible for the collection of information and reporting.
The quality and management of drugs is a great responsibility, I make full use of the section meeting, the staff meeting to organize the cadres and workers to learn the implementation of drug quality management program, and at the same time, the use of columns to promote the creation of medical peace and security of the relevant knowledge, so that all the cadres and workers to understand the objectives of the quality of drug quality management, the task, and fully aware of the implementation of the importance of the quality of drug quality management, the necessity of and urgency. In the next step of management, we will take the self-inspection and self-examination as a new starting point, and carry out the following aspects of work in a solid and effective manner:
(a) Strengthening the management of the hospital and departmental level, improve the quality management of drugs to ensure the safety of medication, to ensure the safety of medical care.
( ii ) Improve service awareness, improve service attitude, strengthen doctor-patient communication, and build a harmonious doctor-patient relationship.
( 3 ) To establish a long-term mechanism for scientific management of drug quality in hospitals, and strictly implement drug quality management laws and regulations.
(d) hospital adverse drug reaction monitoring and reporting leading group to strengthen the leadership, unity of thought, raise awareness, the implementation of the adverse drug reaction reporting system; conscientious and responsible, close monitoring, timely reporting; focusing on monitoring high-risk preparations, biological products and injections of the adverse reaction report, and prohibit the phenomenon of delayed reporting of adverse drug reactions, omission of reporting, anonymity and concealment of adverse drug reaction information. The company's website has been updated with the latest information on the latest developments in the field.
(5) Strengthen the management and use of high-risk drugs and antibacterial drugs.
Self-inspection report on drug quality:First, the drug quality management system
(a) the establishment of the drug quality management organization, clear the function of the relevant personnel. (See Exhibit 1)
(b) Establishment of drug quality management system
Second, the implementation of drug quality management system
(a) the purchase of drugs:
Purchase of medicines to choose a legitimate supplier unit, ask for the seal of the supplier unit stamped "Drug Manufacturing License" or "Drug License", GMP or GSP certificates.
(B) the acceptance of drugs:
1. goods to a working day within the acceptance of the acceptance of personnel for acceptance, refrigerated drugs within half an hour of the arrival of acceptance of special drugs by the anesthetic, psychotropic drugs in charge of the staff of the two-person acceptance. Check the physical and bill of lading of the name of the drug, specifications, quantity, approval number, product lot number, manufacturer, date of production, expiration date, quality conditions. Refuse to accept nearly expired drugs, quality problems and other unqualified drugs, the follow-up work by the warehouse personnel and procurement staff to contact the return processing. Acceptance of qualified drugs goods list by the treasurer to enter the computer and out of the warehouse to the pharmacy.
2. The `storage and maintenance of drugs, in accordance with the principles of safety, convenience, economy and efficiency, stacking standardized, reasonable, neat, firm, no inversion phenomenon. The Chinese and Western pharmacies are each equipped with air conditioners and temperature and humidity meters. According to the performance and requirements of the drugs, the drugs are stored in room temperature, cool place and swimming cabinet. Drugs are stored in order of batch number and its expiration date. The temperature and humidity are observed and registered once a day in the morning and once in the afternoon, and the temperature and humidity are well regulated to ensure the safety of drug storage. Drugs in the pharmacy are categorized and managed. Oral medicines, topical medicines, and fragmented medicines are categorized and stored with correctly placed labels and clear handwriting. Unqualified drugs are stored in a special cabinet, near-expiry drugs have a person responsible for the monthly inspection, specific information published near-expiry drug warning signs, and make a good record.
3. Near-expiry drugs, damaged drugs, unqualified drugs reported loss, destruction by the director of the Pharmacy Department is responsible for. Specific operation is the monthly development of the need to report the loss of drugs and sign the documents, and then the documents with the unqualified drugs placed in the unqualified drugs counter, to be verified by the financial personnel after the effect of destruction, and make a good record.
4. The management of special drugs: the implementation of special management, special locker storage, special prescriptions, special books of registration. Narcotic drugs, psychotropic drugs prescription audit: Narcotic drugs, the first class of psychotropic drugs injection prescription for a dosage, other dosage form prescription shall not exceed 3 days of dosage: the second class of psychotropic drugs prescription shall not exceed 7 days of dosage. The special need to strengthen the control of hydrochloric acid shouting abet prescription for a dosage, Dan the drug is limited to the use of the hospital.
5. Pharmaceutical warehouse management
Our hospital has a Chinese medicine warehouse, western medicine warehouse, medicine warehouse drug storage implementation of color-coded management, pending inspection area, return area for yellow, qualified area for green, unqualified area for red. Pharmacy correctly select the warehouse position, rational use of warehouse capacity. "Five distance" proper classification management color clear stacking norms, reasonable, neat, clean, firm, no inverted phenomenon, do a good job of drugstore anti-theft, fire, moisture, corrosion, anticorrosion, anti-rodent, anti-pollution work. Do a good job of temperature registration of the drugstore to ensure the safety of drug storage.
6. Drug preparation, distribution
Strict implementation of the "four check ten" system, check prescription: the section, name, age. The company's website has been updated with the latest information about the company's products and services, as well as the latest information about the company's products and services, and the company's website. Communicate with the doctor about the prescription of overdose and unqualified prescription in time, and the doctor will modify the prescription before issuing the medicine. When issuing drugs, explain to patients the usage, dosage and precautions of drugs. The company's products and services are available in a variety of formats, including: (1) a new product, (2) a new product, (3) a new product, (4) a new product, and (5) a new product.
7. Personnel training and education
The director of the pharmacy is responsible for the development of the annual staff of pharmaceutical laws and regulations and professional knowledge of pharmacy training program and reasonable arrangement of time training. Education and training methods to regularly organize centralized learning and self-study methods, supplemented by external training, pharmacy professionals to receive continuing education each year shall not be less than 3 hours.
8. Adverse drug reaction report
In accordance with the requirements of the Food and Drug Administration of Longhu District, the hospital has a responsible person in charge of reporting.
9. Health and personnel health
It is strictly prohibited to bring daily necessities and other items into the pharmacy, into the shelves, personal household items are unified and centralized in a special location, and shall not be placed in the shelves or counters of drugs. Regularly organize a physical examination of all pharmacy personnel once a year, drug acceptance and maintenance personnel to increase the vision and color vision screening project, and the establishment of personal health examination files.
Third, the preparation of preparations
Our hospital did not carry out the preparation program
Fourth, the Food and Drug Administration to monitor the situation
Sampling of the drug test are qualified, there is no quality problems
Five, Medical device quality management system
(a), the hospital set up to the president of the group, the director of each department as a member of the safety management organization, conscientiously implement and comply with the national guidelines on the management of medical device quality, policy, law and relevant regulations.
(2), the establishment of medical device quality management system
Six, the implementation of medical device quality management system
(1), medical device library according to the classification of management, divided into one, two, three types of medical devices stored separately, precision instruments are stored separately, etc., set up eye-catching target. For different seasons, climate change, do a good job in the warehouse wet temperature management.
(b), the medical device library are the implementation of color-coded management, to be inspected, the return area is yellow, qualified area, the issuance of the area is green, unqualified area is red.
(c), in accordance with the medical equipment, supplies, reagents and other procurement, receipt, acceptance, the establishment of acceptance, storage, maintenance accounts, and do a good job of various record procedures.
(4), in order to ensure the quality and safety of the purchased medical devices, and to eliminate the entry of unqualified medical devices, the hospital has made strict regulations on the conditions of the purchased medical devices and the qualifications of the suppliers.
(5), do a good job of daily storage.
(6), in order to ensure the quality of medical equipment stored in the warehouse, the hospital also specializes in organizing special personnel to do a good job in the daily maintenance of medical equipment.
(7), in order to strengthen the management of unqualified medical devices, to prevent unqualified medical devices into the clinic, our hospital in strict accordance with the system of reporting adverse reactions to medical devices, such as medical devices, adverse reactions should be investigated to identify the location, time, adverse reactions or adverse events, and make a record of the basic situation, and reported. Through this self-audit, we basically meet the requirements of the quality management regulations for drugs and medical devices, and we hope that our superior leaders will give us valuable advice on our work. In the future, we will continue to work hard to improve the quality of drug and medical device management in our hospital.