First, the established management system has basically not been implemented. Without authorization, the quality management links are reduced, the formulated quality management documents are shelved, and the formulated quality management documents are not strictly implemented, resulting in the inability to guarantee the quality of drugs.
Two, enterprise management personnel can not be on the job as required. After gsp certification, some enterprise personnel have been adjusted, especially the main personnel of quality management positions have been transferred from the enterprise, and the enterprise has not hired qualified personnel to take over the work in time. In order to save money, some pharmaceutical retail enterprises dismiss quality managers and prescription auditors after gsp certification, and one or two people in pharmacies sell drugs normally.
Third, air conditioners, thermometers and other equipment are basically not used. At the time of gsp certification, enterprises purchased related equipment such as display, storage and maintenance as required, but after the on-site inspection of gsp certification, these equipment basically became furnishings and no one used them at all. Just make up records and deal with them before law enforcement officers come to check.
4. Changing the licensed project without approval. Some pharmaceutical wholesale enterprises changed their warehouses without authorization, and the warehouse area was not enough before certification. If the warehouse is rented temporarily to supplement the area, then the warehouse rented after certification will exist in name only. Some pharmaceutical retail enterprises have cancelled their warehouses after certification; Some enterprises change the person in charge of the enterprise and the person in charge of quality without approval; Other enterprises deal in biological products beyond the scope.
Five, not according to the provisions of the procurement of drugs. Some enterprises take the varieties sold by the business personnel of some production enterprises as the main varieties for economic benefits. These drugs are very profitable, but the procedures are incomplete. Some business personnel are engaged in multiple varieties of two or more pharmaceutical production enterprises at the same time, and the quality of some drugs is difficult to guarantee. This year, after investigation, our bureau confirmed that most of these drugs are counterfeit drugs and counterfeit drugs. However, in order to avoid inspection, some pharmaceutical trading enterprises do not build inspection records for these drugs, let alone audit the first varieties.
Six, the lack of pharmaceutical professional and technical personnel. At present, there are very few professional technicians who really study pharmacy, that is, our staff engaged in drug supervision, let alone in enterprises. At present, most of the drug managers in enterprises are pharmacists (Chinese pharmacists and pharmacists in charge) with other related majors or junior high school education.
Seven, drug classification management does not solve the problem of patients buying prescription drugs with doctors' prescriptions and drug abuse. On the one hand, the core purpose of implementing classified management of prescription drugs and over-the-counter drugs is to effectively strengthen the supervision and management of prescription drugs and prevent consumers from abusing drugs and endangering their health because of their own misconduct. On the other hand, standardizing the management of OTC drugs and guiding consumers to protect themselves scientifically and reasonably 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 in the implementation of drug classification management in China:
(1) The source of prescriptions is insufficient, and the authenticity of doctors' prescriptions provided by pharmaceutical retail enterprises is suspicious. At present, most medical institutions in China use medicine to support doctors, and medical institutions control the outflow of prescriptions. Drug retail enterprises have no prescription source at all, and even if they see the prescription, they can't confirm the true legitimacy of the prescription. In the process of law enforcement inspection, the authenticity of doctors' prescriptions provided by pharmaceutical retail enterprises is doubtful, and most of them are forged.
(2) The masses lack knowledge of drug classification management, and their awareness of purchasing prescription drugs with doctors' prescriptions is not strong. Due to the short time of promoting drug classification management in China, the masses have not realized the importance of drug classification management and the harm of drug abuse to health. When they are sick, they decide what medicine to buy by feeling. They don't know if they need a doctor's diagnosis. They use the medicine according to the doctor's prescription, and they find it troublesome to ask a doctor to prescribe medicine.
(3) Prescription auditors set up by some pharmaceutical retail enterprises cannot be on duty as required. Some prescription examiners put their seals in pharmacies, while others can stamp prescriptions at any time. Prescription auditors do not perform the actual audit duties.
Eight, the management of Chinese herbal pieces is serious.
(a), the quality of traditional Chinese medicine pieces there is a big problem. In the whole year, a total of 8 batches of Chinese herbal pieces1/kloc-0 operated by drug retail enterprises in our city were randomly selected, and 38 batches were unqualified, accounting for 32.2%. (All drugs were randomly sampled in 8 12 batches, and 57 batches were unqualified, accounting for 7%), which was much higher than other unqualified drugs.
(2) The channels for purchasing Chinese herbal pieces are chaotic. Because the management of Chinese herbal pieces is still in the primary stage in China, only a few of them are managed through the approval number. In addition, Chinese herbal pieces need to be unpacked and sold in Chinese herbal pieces barrels. Once Chinese herbal pieces are packed in barrels, the purchase channel cannot be confirmed, so some enterprises seize this defect and buy Chinese herbal pieces from illegal channels at low prices.
(3), the lack of Chinese medicine professional and technical personnel. Operating Chinese herbal pieces requires operators to master the professional knowledge of Chinese medicine and obtain the professional and technical qualifications of Chinese medicine, but at present, few people in our city have such conditions. Some technicians who run Chinese herbal pieces enterprises have the title of Chinese medicine, but they have not studied Chinese medicine, so they can't guarantee the safe operation of Chinese herbal pieces.
Nine, the management of biological products. There are special requirements for the production, transportation, storage and use of biological products. Only by meeting these requirements can the quality of biological products be guaranteed. At present, there are still some problems in the management of some biological products enterprises:
(1) No "cold chain" system has been established during the transportation and storage of biological products. Most biological products need to be refrigerated at a low temperature of 2- 10. At present, biological products on the market are basically transported to our city by ordinary means of transport, and some are even stored in normal temperature warehouses until they are used. The quality of such drugs cannot be guaranteed to be safe.
(2) The management of biological products batch issuance is not standardized. Pharmaceutical trading enterprises do not know enough about biological products that are subject to batch issuance management, and do not realize the importance of batch issuance procedures for biological products. In the course of business, they will not take the initiative to ask the purchasing enterprises for the batch issuance procedures of this batch of drugs, and most ordinary people do not know that there are batch issuance management regulations for biological products. Once there is a problem with the batch issuance procedure, it will seriously endanger the lives of patients.
Ten, the management of pharmaceutical chain enterprises. At present, there are five pharmaceutical chain enterprises in our city, all of which are small enterprises with short start-up time and small scale, relying on pharmaceutical wholesale enterprises to start their business. Because some drug retail chains are franchise chains, the management of drug chain enterprises is not standardized and lack of experience, so that individual drug retail chains buy drugs privately and cannot achieve unified distribution. This year, our bureau investigated and dealt with the illegal behavior of joining drug retail chain stores to buy drugs privately.
Eleven, illegal drug advertising supervision and management has not been effectively curbed. Publishing illegal drug advertisements in the mass media has seriously misled patients and brought serious harm to their economy and life safety. The release forms of illegal drug advertisements are: 1, and advertisements prohibited from being released in the mass media; 2. Advertisements published without approval; 3. Advertisements use the names and images of patients and experts as proof; 4. Exaggerate the brand name of promotional drugs; 5. Illegally promote drugs in the form of drug promotion meeting. These drugs that advertise illegal drugs have high prices, and the advertising media have great interests, and the profits of drug trading enterprises are also great. Our bureau has no punishment function, so illegal drug advertisements have not been effectively curbed. So far this year, our bureau has transferred a total of 1 12 articles to report illegal drugs in the bulletin of the provincial bureau.
In view of the above problems existing in pharmaceutical trading enterprises, I think the following measures should be taken for supervision and management.
First, promote the construction of credit system by correctly guiding pharmaceutical trading enterprises. It is necessary to help enterprises understand the current situation of the pharmaceutical trading industry, guide enterprises to operate independently, give play to their own advantages, maintain the consciousness of quality management, and achieve high-level quality management. It is necessary to promote enterprises to improve their quality management level through the construction of credit system, create a commercial atmosphere of "keeping promises is glorious and breaking promises is shameful" in the pharmaceutical industry and society, and enhance the self-discipline awareness of pharmaceutical trading enterprises.
Two, strengthen the training of enterprise technical management personnel. To supervise the daily training within the enterprise, the training should be planned, and measures should be taken as required to achieve the predetermined results, and it is not allowed to go through the motions and perfunctory things; At the same time, the regulatory authorities should also invite pharmaceutical professionals to conduct professional training for quality management personnel and prescription auditors in a planned way. After the training, those who pass the examination will be hired, and those who fail the examination will be suspended. During this period, the enterprise will suspend the relevant business until the relevant personnel pass the make-up exam.
Three, strengthen the supervision and inspection of pharmaceutical trading enterprises. By strengthening daily supervision, we can find the problems existing in the daily operation and management of enterprises in time, find and rectify them in time, and record the found problems for the record so as to punish the same problems next time; By strengthening special rectification, investigate and deal with serious problems existing in enterprises; By strengthening gsp tracking inspection and flight inspection, we will comprehensively check the implementation of gsp regulations by enterprises. It is necessary to attach great importance to the gsp follow-up inspection of pharmaceutical trading enterprises, organize the gsp inspectors in the city to concentrate on learning, unify the standards and processes of gsp inspection, rectify the problems existing in enterprises within a time limit, and reject those who fail. At the same time, enterprises with more problems in daily supervision files can be raided by means of flight inspection.
Four, drug supervision and inspection personnel should constantly improve their professional level and enhance their sense of responsibility and mission. Drug supervision and inspection personnel should also study professional knowledge hard to adapt to the continuous development of drug market supervision; At the same time, drug supervision and inspection personnel should have a high sense of responsibility and mission in the process of supervision and inspection, and always think about the drug safety of the masses. The inspection work should be meticulous and thoughtful, so as not to let the illegal acts of enterprises escape punishment and bring harm to the lives and safety of the people.
Five, increase the punishment of gsp certification violations. While strengthening the daily and follow-up inspection of gsp certification, the certified qualified enterprises found in the supervision and inspection that do not meet the requirements of the "Quality Management Standards for Pharmaceutical Trading" should be given a warning in accordance with the provisions of Article 79 of the Drug Administration Law and ordered to make corrections within a time limit; If no correction is made within the time limit, it shall 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 shall be imposed; If the circumstances are serious, the Drug Business License shall be revoked. Drug supervision and inspection personnel shall timely record and file the inspection of enterprises, and hell to pay shall be appointed for repeat offenders.
Drug regulatory authorities should fully implement the concept of scientific supervision, strengthen the handling of supervision and inspection in line with the principle of serving the people, protecting the people and benefiting the people, effectively curb the occurrence of illegal acts, better regulate the management behavior of the drug market, and make due efforts to create a harmonious society, ensure the safe and effective use of drugs by the broad masses, and promote the long-term, sustained and healthy development of drug trading enterprises.