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Research report on the operation and management of traditional Chinese medicine pieces
From: "3COME Document Channel" - Time: 2010-03-08 Collect this Page: Content summary: Strengthen supervision and inspection of pharmaceutical operating enterprises. By strengthening daily supervision, problems existing in the daily operation and management of the enterprise must be discovered in a timely manner, and rectifications must be made in a timely manner, and the problems discovered must be recorded and filed so that penalties can be imposed when the same problem occurs next time; serious problems existing in the enterprise must be investigated and punished by strengthening special rectification Question; By increasing the intensity of GSP tracking inspections and unannounced inspections
Since 2004, our city’s pharmaceutical operating enterprises have successively passed the pharmaceutical GSP certification organized by the provincial bureau, and the enterprises have achieved comprehensive improvement in standardized operation and management. improvement. However, as time goes by, some companies have shifted their energy to pursuing efficiency after passing GSP certification, and have despised standardized management, resulting in a decline, which is still serious for some companies. According to daily investigation and research, some pharmaceutical operating enterprises in our city currently have the following problems in operation and management:
1. The established management systems are basically not implemented. Unauthorized reduction of quality management links, shelving the formulated quality management documents, and failure to strictly implement the formulated quality management documents resulted in the failure of drug quality to be guaranteed.
2. Business operation and management personnel cannot be on duty as required. After gsp certification, some companies have made adjustments to their personnel. In particular, key personnel in quality management positions have been transferred from the company, but the company has not hired qualified personnel to take over the work in time. In order to save money, some pharmaceutical retail companies fired quality management personnel and prescription auditors after GSP certification, leaving only one or two people in the pharmacy selling medicines normally.
3. Equipment such as air conditioners and thermometers and hygrometers are basically not used. When companies were undergoing GSP certification, they purchased related equipment for display, storage and maintenance as required. However, after the GSP certification on-site inspection was completed, these equipment basically became furnishings and were not used at all. Just make up the records until law enforcement comes to check.
4. Changing licensing matters without approval. Some pharmaceutical wholesale companies have changed their warehouses without authorization. The warehouse area before certification was insufficient and they temporarily rented warehouses to supplement the area. After certification, the rented warehouses existed in name only; some pharmaceutical retail companies canceled their warehouses after certification; some companies made changes without approval. The person in charge of the company and the person in charge of quality; some companies operate biological products beyond their business scope.
5. Failure to purchase drugs in accordance with regulations. For the sake of economic benefits, some companies regard the varieties sold by business personnel of some production companies as their main business varieties. These drugs are highly profitable, but the procedures are incomplete. Some business personnel operate multiple varieties of more than two drug production companies at the same time. , the quality of some drugs is difficult to guarantee. Our bureau has confirmed through co-inspection this year that many such drugs are fake and counterfeit drugs. In order to avoid inspection, some pharmaceutical companies do not maintain purchase and acceptance records for these drugs, let alone conduct first-market variety reviews.
6. Lack of pharmaceutical professional and technical personnel. Nowadays, there are very few professional and technical personnel who really study pharmacy. Even those who are engaged in drug supervision do not have many professional and technical personnel in pharmacy. What’s more, in enterprises, most of the pharmaceutical management personnel in enterprises are other related majors or junior high school or junior high school graduates. Professional title of pharmacist with high school degree.
7. Drug classification management does not solve the problem of patients purchasing prescription drugs based on doctor's prescriptions and drug abuse. The core purpose of implementing classified management of prescription drugs and non-prescription drugs is to effectively strengthen the supervision and management of prescription drugs and prevent consumers from abusing drugs and endangering their health due to their own improper behavior. On the other hand, by standardizing the management of over-the-counter drugs, consumers are guided to carry out their own health care scientifically and rationally. The implementation of drug classification management in our country is an important decision to reduce the occurrence of irrational drug use and ensure the safety and effectiveness of people's drug use. However, there are still many problems that are difficult to solve in China's implementation of drug classification management:
Insufficient prescription sources, and the authenticity of doctors' prescriptions provided by drug retail companies is questionable. Nowadays, our country's medical institutions integrate medicine, and most of them rely on drugs to support medicine. Medical institutions control the outflow of prescriptions. Drug retail companies sell prescription drugs without prescriptions at all. Even if they see the prescriptions, they cannot confirm the true legality of the prescriptions.
During normal law enforcement inspections, the authenticity of doctors' prescriptions provided by pharmaceutical retail companies is questionable, and most of them are forged.
The general public lacks knowledge of drug classification management and has low awareness of purchasing prescription drugs based on doctor's prescriptions. Since our country has been promoting drug classification management for a relatively short period of time, the general public has not yet realized the importance of drug classification management and the health risks of drug abuse. If you are sick, you decide what medicine to buy based on your feelings. You do not know that you need to be diagnosed by a doctor if you are sick. I use medicines according to the doctor's prescription and find it troublesome to find a doctor to write a prescription.
Some prescription reviewers set up by drug retail companies cannot be on duty as required. Some prescription reviewers put their name stamps in the pharmacy, and other personnel can stamp their name stamps on the prescriptions at any time. Prescription review Personnel do not perform actual audit duties.
8. There are serious problems in the operation and management of traditional Chinese medicine pieces.
There are major problems in the quality of traditional Chinese medicine pieces. A total of 118 batches of traditional Chinese medicine pieces operated by drug retail companies in our city were randomly inspected throughout the year, and 38 batches were unqualified, with a failure rate of 32.2%, which is much higher than other unqualified drugs.
The purchasing channels for traditional Chinese medicine pieces are confusing. Since the management of traditional Chinese medicine pieces in our country is still in its infancy, only a small number of them are managed with approval numbers. In addition, traditional Chinese medicine pieces need to be unpacked and sold in pieces in buckets. Once the Chinese herbal medicine pieces are packed in the Chinese medicine piece hopper, the purchasing channel cannot be confirmed. Therefore, some companies seize this flaw and purchase Chinese herbal medicine pieces at low prices from illegal channels.
, lack of professional and technical personnel of traditional Chinese medicine. Operating traditional Chinese medicine pieces requires operators to master professional knowledge of traditional Chinese medicine and obtain professional technical qualifications for traditional Chinese medicine. However, there are currently very few people in our city who have such qualifications. Although some technical personnel of enterprises operating traditional Chinese medicine preparations have professional technical titles in traditional Chinese medicine, they have not studied traditional Chinese medicine and cannot guarantee the safe operation of traditional Chinese medicine preparations.
9. There are management problems in the operation of biological products. There are special requirements for the production, transportation, storage, and use of biological products. Only by meeting these specified requirements can the quality of biological products be guaranteed. Nowadays, some biological products operating companies still have some management problems:
There is no "cold chain" system established during the transportation and storage of biological products. Most biological products require a low-temperature refrigeration environment of 2-10 degrees. However, the biological products currently on the market are basically transported to our city by ordinary transportation vehicles, and some are even stored in normal temperature warehouses until use. I can’t say that the quality of such drugs is guaranteed to be safe.
, The batch release management of biological products is not standardized. Drug operating companies do not have enough knowledge about biological products subject to batch release management, and do not realize the importance of batch release procedures for biological products. During the operation process, they do not actively ask purchasing companies for the batch release procedures for this batch of drugs, and most ordinary people do not We know that biological products have regulations on batch release management. Once problems arise in the batch release procedures, the patient's life will be seriously endangered.
10. Operation and management issues of pharmaceutical chain enterprises. There are currently 5 pharmaceutical chain companies in our city, all of which are small enterprises with a short history of establishment and small business scale, relying on the establishment of pharmaceutical wholesale companies. Because some drug retail chain stores are franchise chains, drug chain enterprises are not standardized in management and lack experience, which makes individual franchise drug retail chain stores purchase drugs privately without achieving unified distribution. This year, our bureau has investigated and dealt with the illegal behavior of purchasing drugs privately at franchised drug retail chain stores.
11. The supervision and management of illegal drug advertising has not been effectively curbed. Publishing illegal drug advertisements in mass media seriously misleads patients and brings serious harm to their economic and life safety. The forms of publishing illegal drug advertisements include: 1. Publishing advertisements that are prohibited from being published in mass media; 2. Advertisements published without approval; 3. Using the names and images of patients and experts as proof in advertisements; 4. Exaggerating the promotion of drugs Product name; 5. Use drug promotion meetings to illegally promote drugs, etc. The prices of these illegal drug advertisements are very high. The media for publishing the advertisements is very profitable, and the profits of drug operating companies are also large. Our bureau has no punishment function, so the illegal drug advertisements have not been effectively curbed. So far this year, our bureau has transferred and reported 112 illegal drug advertisements to the provincial bureau.
In view of the above-mentioned problems existing in pharmaceutical operating companies, I think the following measures should be taken for supervision and management.
1. Promote the construction of the integrity system through correct guidance of pharmaceutical operating enterprises. It is necessary to help enterprises understand the current situation of the pharmaceutical business industry, guide enterprises to operate self-discipline, give full play to their own advantages, maintain the consciousness of quality management, and maintain a high level of quality management. It is necessary to promote the establishment of an integrity system to promote enterprises to improve quality management levels, create a business atmosphere of "honesty is glorious, breach of trust is shameful" in the pharmaceutical industry and society, and enhance the self-discipline awareness of pharmaceutical operating enterprises.
2. Strengthen the training of personnel in corporate technical management positions. It is necessary to supervise the daily training within the enterprise. The training must be planned and implemented according to the requirements to achieve the predetermined results. It must not be a formality or perfunctory; at the same time, the regulatory authorities must also systematically invite pharmaceutical professionals to provide professional training to quality management personnel and prescription review personnel. After training, those who pass the exam will be put on the job, and those who fail the exam will be suspended. During this period, the company will suspend relevant business operations until the relevant personnel pass the make-up exam.
3. Strengthen supervision and inspection of pharmaceutical operating enterprises. By strengthening daily supervision, problems existing in the daily operation and management of the enterprise must be discovered in a timely manner, and rectifications must be made in a timely manner, and the problems discovered must be recorded and filed so that penalties can be imposed when the same problem occurs next time; serious problems existing in the enterprise must be investigated and punished by strengthening special rectification Question: By increasing the intensity of GSP tracking inspections and unannounced inspections, we will comprehensively inspect the various regulations on the implementation of GSP by enterprises. It is necessary to attach great importance to the GSP tracking and inspection work of pharmaceutical operating enterprises, organize the city's GSP inspectors to conduct intensive studies, unify the GSP inspection work standards and working procedures, and rectify the problems existing in the enterprise within a time limit, and those that should not be passed will not be passed. , and at the same time, unannounced inspections can be carried out on enterprises with many problems in daily supervision file records.
4. Drug supervision and inspection personnel must continuously improve their professional skills and enhance their sense of responsibility and mission. Drug supervision and inspection personnel themselves must also work hard to learn professional business knowledge to adapt to the ever-evolving drug market supervision work; at the same time, drug supervision and inspection personnel must have a high sense of responsibility and mission during the supervision and inspection process, and always think about the drug use of the general public. In terms of safety, inspection work must be done carefully and thoughtfully, so as to prevent illegal activities of enterprises from escaping punishment and endangering the life and safety of the general public.
5. Strengthen punishment for violations of GSP certification. While intensifying the daily and follow-up inspections of GSP certification, certified enterprises that are found to be inconsistent with the requirements of the "Good Manufacturing Practice for Pharmaceutical Products" during supervisory inspections should follow the provisions of Article 79 of the "Drug Administration Law" A warning will be given and the company will be ordered to make corrections within a time limit; if it fails to make corrections within the time limit, it will be ordered to suspend production and business for rectification, and a fine of not less than 5,000 yuan but not more than 20,000 yuan will be imposed; if the circumstances are serious, the "Drug Business License" will be revoked. Drug supervision and inspection personnel must promptly record and file the inspections of enterprises, and repeat violations must be severely punished.
Drug regulatory authorities must fully implement the concept of scientific supervision, adhere to the principles of serving the people, protecting the people, and benefiting the people, increase supervision and inspection efforts, and effectively curb the occurrence of violations of laws and regulations. We should properly standardize the operation and management of the pharmaceutical market and make due efforts to create a harmonious society, ensure the safety and effectiveness of medication for the general public, and promote the long-term, sustainable and healthy development of pharmaceutical operating enterprises.
Keywords: problems, business management, traditional Chinese medicine, about, drugs, internship report, research report on the management of traditional Chinese medicine pieces Summary of content: Current location: Home >> Office Others >> Research Report >> The text of the research report on the operation and management of traditional Chinese medicine pieces comes from: "3COME Document Channel" - Time: 2010-03-08 Bookmark this page: Content summary: Strengthen the supervision and inspection of pharmaceutical operating enterprises. By strengthening daily supervision, problems in the daily operation and management of enterprises must be discovered in a timely manner
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