After receiving the urgent notice from Shijiazhuang Municipal Health Bureau on forwarding the provincial health department to strengthen the management of special drugs, our hospital organized relevant personnel to actively carry out self-examination. The self-inspection is as follows: 1. Narcotic drugs and psychotropic drugs have sound rules and regulations and clear responsibilities.
2, narcotic drugs, psychotropic drugs practitioners, pharmaceutical personnel equipped with requirements, qualified training.
3. The procedures for the treatment of narcotic drugs and psychotropic drugs of category I are standardized, and the supervision of regular follow-up and follow-up of narcotic patients is lax. Some prescriptions for narcotic drugs and psychotropic drugs prescribed by some medical practitioners do not meet the requirements, and the number of outpatient prescriptions is too large.
4, narcotic drugs, psychotropic drugs use special safe to save, and set up security doors and windows, do someone on duty 24 hours a day.
5, patients with residual narcotic drugs, a kind of psychotropic drugs recovery record is not perfect. In view of the above problems, the following rectification measures are formulated in time:
(1) Conduct in-hospital training for all doctors who are qualified for narcotic drugs and psychotropic drugs of category I, standardize prescription dosage, read relevant laws and regulations, strengthen their sense of responsibility and standardize their use.
(2) Introduce new special cards for narcotic drugs and psychotropic drugs, and standardize the procedures.
(3) Strictly implement the management system of recycling and destruction of surplus narcotic drugs and psychotropic substances of Category I, establish recycling registration files, keep recycling records, and strictly follow the regulations.
Article 2 Self-inspection report on the operation and management of special drugs
* * U.S. Food and Drug Administration: According to the Notice on Organizing Special Drug Production and Operation Enterprises to Carry out Self-examination and Self-correction, our company conducted a serious control inspection in combination with the actual situation of the company. The self-inspection is now reported as follows:
1. Our company has no business scope of narcotic drugs and psychotropic drugs (Category I and II).
2. After self-examination, the company only bought 600 bottles of compound licorice tablets (produced by Guilin Nanyao Co., Ltd., 100 tablets/bottle) from Jiangsu Fosun Pharmaceutical Sales Co., Ltd. on * *, and has not sold them to customers so far. There are no other related varieties.
3. The company appoints a special person to be responsible for the procurement, receipt, acceptance, storage and sales of such drugs.
4. The Quality Control Department strictly examines and keeps the legal qualifications and copies of ID cards of suppliers, buyers, salespeople and purchasers, and obtains complete information, true and complete records, which can be filed in time.
5. The purchase and acceptance of this kind of drugs comply with the company's relevant management system and laws and regulations.
6, this kind of drug sales strictly implement "wholesale enterprises that directly buy drugs from production enterprises, can sell drugs to other wholesale enterprises, retail chain stores and medical institutions; Those purchased from wholesale enterprises can only be sold to retail chain stores and medical institutions in the province (autonomous regions and municipalities). " It is strictly forbidden to sell such drugs to various units or individuals without legal qualifications.
7. When our company buys and sells compound preparations containing special drugs, it is forbidden to use cash for transactions, and ask for and issue invoices according to regulations, so as to ensure that tickets, accounts and goods are consistent and standardize bill management.
8. When the company sells compound preparations containing special drugs, it strictly implements the outbound review system, carefully checks whether the physical objects are consistent with the sales outbound order, and ensures that the drugs are delivered to the warehouse address, registered address of drug retail enterprises or pharmacy of medical institutions specified in the Drug Business License of the buyer. After the medicine is delivered, the buyer shall inspect the goods, and the consignee shall sign the attached documents if there is no mistake. Keep the original attached bill, and return the copy to our company in time after affixing the official seal. The quality management department of our company should check whether there is any abnormality in the contents recorded in the returned copy of the attached form and file it.
After this self-inspection, the safety management of special drugs in our company will be promoted, and all aspects will be more strictly required in future business work. The above is the situation of our self-inspection. Please ask the leaders of the US Food and Drug Administration in Kunming for inspection and guidance!
Article 3 Self-inspection report on the operation and management of special drugs
According to the announcement of China Food and Drug Administration (No.201X 58) on the implementation of quality management standards for medical devices, our company organized relevant personnel to conduct a comprehensive inspection of all medical devices operated by our company. The details are reported as follows: 1. Strengthen system management, improve the quality management system, and ensure the quality and safety of products during operation.
The company has established a safety management organization with the general manager as the main leadership core, department managers as the main organizational members, and all employees as the main supervisory and executive members, and put the safety management of medical devices in the top priority of the company. Strengthen leadership, strengthen responsibility, and enhance the sense of quality responsibility.
The company has established and improved a series of management systems related to medical devices: effective quality control measures are taken in the procurement, acceptance, storage, sales, transportation and after-sales service of medical devices to ensure the safe and smooth development of the company's business activities.
Two, clear job responsibilities, strict management system, improve and save the management system of relevant records or files.
From the general manager to the person in charge of quality to the employees of all departments, the company has formulated corresponding management systems in strict accordance with the quality management standards of medical devices, and made strict provisions on the conditions for purchasing medical devices and the qualifications of suppliers to ensure the quality and safety of purchased medical devices and prevent unqualified medical devices from entering the hospital. Ensure the legality and quality of medical devices in storage, and seriously implement the outbound system to ensure the safe use of medical devices.
The person in charge of enterprise quality is responsible for the quality management of medical devices and has independent ruling power. He mainly organizes the formulation of quality management system, guides and supervises the implementation of the system, checks, corrects and continuously improves the implementation of the quality management system, collects relevant laws and regulations on medical device management in time, and implements dynamic management. Organize or assist in quality management training on a regular basis for the confirmation of unqualified medical devices, the collection and reporting of adverse events, the real-time supervision of quality complaints and device recall information. According to the requirements of the new version of "Quality Management Standard for Medical Device Management", the company has reformed and upgraded all computer systems. The latest version of the new spatio-temporal software system can meet the whole process management and quality control of medical device operation, and relevant records and files have been established. In view of the imperfect qualifications of some suppliers in the past, we also asked for supplements in time for further improvement and preservation.
Third, personnel management.
Our company's medical equipment work is undertaken by professional and technical personnel, and regular training on relevant laws, regulations and related systems is conducted to ensure the smooth progress of the work; Organize employees who have direct contact with medical devices to have annual health check-ups and establish health records.
Fourth, storage management.
The company has hardware facilities and equipment that meet the requirements of storage, acceptance, storage and transportation of medical devices. Medical instruments are stored independently and classified, and instruments and non-instruments are stored separately. The latest storage management system and medical device maintenance system have been established, the quality management of stored devices has been strengthened, and special personnel have been assigned to do the daily maintenance of devices. Prevent unqualified medical devices from entering the market and formulate an adverse accident reporting system.
Our company has always adhered to the quality policy of "quality first, customer first", and strictly followed the requirements of "Quality Management Standard for Medical Device Operation", intensified the inspection of medical device safety items in the warehouse, promptly investigated the hidden dangers of medical devices, and conducted self-inspection on a regular basis to ensure the effective implementation of various systems.
Article 4 Self-inspection report on the operation and management of special drugs
According to the requirements of the Drug Administration Law and its implementing regulations, as well as the Quality Management Standard for Pharmaceutical Trading, in order to make xxX pharmacy pass GSP certification as soon as possible, under the guidance of xX US Food and Drug Administration, our pharmacy conducted self-examination in strict accordance with the Guiding Principles for GSP on-site inspection of pharmaceutical retail enterprises, and now the relevant situation is reported as follows: 1. Basic information.
XXX pharmacy is a single pharmacy, with no pollution sources and high-risk facilities around its business address, spacious and bright business premises, clean and tidy, and reasonable layout. The approved business scope of the pharmacy is: Chinese herbal pieces, Chinese patent medicines, chemical preparations, antibiotic preparations and biochemical drugs. According to the requirements of GSP, the pharmacy in our hospital has improved the corresponding equipment, revised the responsibilities and related regulations of each post, and reformed GSP from both hardware and software, and achieved good results. This drugstore insists on operating according to law, is honest and trustworthy, and has no cheating in GSP certification and daily operation.
Second, enterprises implement GSP self-inspection
(A) quality management and responsibility
In accordance with the requirements of relevant laws and regulations and "Quality Management Standards for Pharmaceutical Trading", the pharmacy in our hospital has formulated quality management documents and carried out quality management activities to ensure the quality of drugs. Established the operating conditions suitable for the business scope and scale of this pharmacy, including organization, personnel, facilities and equipment, quality management documents, and set up a computer system according to regulations.
XXX is the main person responsible for drug quality, responsible for the daily management of pharmacies, ensuring that quality management personnel effectively perform their duties, and urging post personnel to implement the laws and regulations on drug management and the requirements of this specification. Equipped with quality administrator XXX to be responsible for drug quality, and formulated quality management documents. The quality administrator carefully examines the qualifications of suppliers and their sales personnel, is responsible for reviewing the legality of purchased drugs, guiding and supervising the quality management of drug procurement, storage, display and sales, doing a good job in drug quality inquiry and quality information management, identifying and handling unqualified drugs, reporting adverse reactions of counterfeit and inferior drugs, doing a good job in drug quality management education and training, auditing and controlling the operation authority of computer systems, maintaining basic data of quality management, and calibrating and verifying measuring instruments. Responsible for other duties that should be performed by the quality manager.
(2) personnel management
The personnel engaged in drug management and quality management in our pharmacy meet the requirements of relevant laws and regulations and the Code, and there is no industry ban. XXX, the person in charge of the enterprise, has the qualification of XXX pharmacist to guide rational drug use. The quality administrator is XXX, and the technical title is XXX pharmacist. Clerk XXX education XXX, Chinese herbal medicine dispensing personnel XXX education XXX.
XXX and XXX received pre-job training and continuing education and training in relevant laws and regulations and pharmaceutical professional knowledge and skills. The enterprise has made an annual training plan and carried out training. Conduct annual health examination every year, obtain health certificates, establish health files, and meet post requirements. Our pharmacy does not store articles and personal items that have nothing to do with business activities and behaviors that affect the quality and safety of drugs.
(3) documents
The pharmacy in our hospital has formulated feasible quality management documents according to relevant laws and regulations, including quality management system, post responsibilities, operating procedures, files, records and vouchers. And review it regularly and revise it in time. Through training, personnel in all positions can correctly understand the contents of quality management documents and ensure the effective implementation of quality management documents. And formulated the drug quality management system: drug procurement, acceptance, display, sales, storage, maintenance and other aspects of the management system, supplier and procurement varieties audit system, prescription drug sales management system. Drug dismantling management system, special management drugs and drugs with special management requirements of the state, records and vouchers management system, quality information collection and inquiry management system, quality accident and quality complaint management system, prescription review, deployment and verification management system of Chinese herbal pieces, drug expiration management system, unqualified drugs and drug destruction management; Formulation of post responsibilities such as environmental hygiene, personnel hygiene system, pharmaceutical service management system such as drug consultation and rational drug use guidance, personnel training and assessment system, adverse drug reaction reporting system, computer system management system, implementation of drug electronic supervision system, enterprise leadership, quality management, procurement, acceptance, sales personnel, prescription review and deployment. More than a dozen operational processes, such as drug procurement, acceptance, sales, prescription review, deployment and verification, have been established.
Relevant records of drug procurement, acceptance, sales, display inspection, temperature and humidity monitoring, and disposal of unqualified drugs have been established. , to be true, complete, accurate, effective and traceable. Records and related vouchers shall be kept for at least 5 years.
When recording data through the computer system, the relevant post personnel should log in to the computer system through authorization and password according to the operating procedures, and enter the data to ensure that the data is original, true, accurate, safe and traceable.
(4) Facilities and equipment
The business place of the enterprise is suitable for the scope and scale of its drug business. The business area of the enterprise is XX square meters, with clean environment, reasonable layout, good ventilation and no pollutants, and the business place is separated from the living area. Commercial shelves XX group, counter XX group, sales cabinet group logo eye-catching. Because there are legal and reliable drug supply channels, the drugs sold can be replenished in time and put on the shelves in time after acceptance, so our store has no warehouse. The medicine rack and medicine cabinet can keep the distance between the medicine and the ground above 10cm. Drugstores are equipped with dust-proof, moisture-proof, insect-proof and rat-proof equipment. There are 1 hygrometer, 1 dehumidifier, 1 ventilator, 1 rat-sticking board, equipped with matching deployment tools and packaging supplies, which are used for drug sales. And there is a counter containing ephedrine.
(5) Procurement and acceptance of drugs
1, drug procurement
Drug procurement management is a key link to ensure the quality of drug management. To effectively supervise and control the drug procurement process, in order to strengthen the management of drug procurement, we first formulated a strict procurement management system in the procurement process, and effectively controlled and stipulated the specific matters, the first enterprise and the purchase and sale contract in the procurement process.
(1) Legitimacy of purchasing enterprises
To evaluate the legitimacy of qualified suppliers and start-up enterprises, the buyer is responsible for obtaining relevant information from the suppliers, such as the pharmaceutical production or business license stamped with the original seal of the enterprise, a copy of the business license and its annual inspection certificate, a copy of the quality management standard certificate of pharmaceutical business or a copy of the quality management standard certificate of pharmaceutical business, relevant seals, the attached bill (ticket) style, account name, and after investigation, fill in the bank and account number, a copy of the tax registration certificate and a copy of the organization code certificate in the approval form of the first-run enterprise, which will be audited by the quality administrator.
(2) the legality of purchasing drugs
When purchasing drugs, the buyer shall ask the supplier for an invoice. The invoice shall specify the generic name, specification, unit, quantity, unit price and amount of the drug; Procurement records shall be established for purchasing drugs. The purchase records shall include the generic name, dosage form, specifications, manufacturer, supplier, quantity, price, purchase date, etc.
(3) The legitimacy of the supplier's salesman and the signing of the quality assurance agreement.
Check whether the business behavior of the supplier's salesman is consistent with the business mode and business scope approved by the company's License. Obtain a copy of the salesman's ID card of the supplier's salesman and the original official seal of the supplier; Check the original official seal of the supplier and the seal or signed power of attorney of the legal representative. The power of attorney shall specify the name and ID number of the authorized person, as well as the variety, area and time limit of the authorized sales; Information about suppliers and varieties.
The signing of the quality assurance agreement should clarify the quality responsibilities of both parties; The supplier shall provide materials that meet the requirements and be responsible for their authenticity and effectiveness; Suppliers shall issue invoices in accordance with state regulations; The packaging, labels and instructions of drugs comply with the relevant provisions; Quality assurance and responsibility of drug transportation; The validity period of the quality assurance agreement.
The quality manager is responsible for verifying and auditing the above work, and the qualified materials and quality assurance agreements are put into the files of qualified suppliers.
2. Acceptance of drugs
In order to ensure the quality of purchased drugs and prevent counterfeit and inferior drugs from entering our store, we have formulated the management regulations on drug acceptance.
After the drug arrives, the inspector verifies the drug in kind according to the purchase record and the bills (tickets) attached by the supplier to ensure that the tickets and goods match.
Enterprises shall, in accordance with the prescribed procedures and requirements, check and accept the arriving drugs batch by batch, and the samples taken for inspection and acceptance shall be representative. Inspectors shall inspect and check the appearance, packaging, labels, instructions and relevant supporting documents of the sampled drugs one by one.
According to the actual situation of quality acceptance, the inspector records the quality of the accepted drugs, makes the acceptance conclusion at the same time, and keeps the acceptance records. Reject unqualified drugs and report to the quality manager.
(6) Display and storage
Our store strictly abides by the requirements of "Quality Management Standards for Pharmaceutical Trading" and implements the principle of "four separations", that is, drugs and non-drugs, drugs for oral use and drugs for external use are stored separately, prescription drugs and over-the-counter drugs are stored separately, easily-smelled drugs are stored separately from general drugs, classified according to the characteristics of drugs, disassembled drugs are stored in the disassembling counter, and the original packaging labels and instructions are kept.
The quality and packaging of the drugs on display meet the requirements. Check the quality of drugs on display every month and make records. If there is any problem with the drug, immediately remove the shelf and fill in the relevant records. Drug display places, shelves and counters shall be kept clean and hygienic. There are facilities and equipment that are fire-proof, moisture-proof, insect-proof, rat-proof and light-proof.
In order to ensure the storage quality of drugs, drug custodians regularly check the displayed drugs every month, and check the quality of perishable, near-effective and deliquescent drugs every week, and take effective measures in time when problems are found. At the same time, do a good job in maintaining inspection records, and regularly summarize, analyze and report drug maintenance quality information.