Drug packaging, labels and instructions violations and Countermeasures
drug packaging, labels and instructions can be described as the "ID card" of drugs, which plays a very important role and significance in guiding doctors and patients to use drugs rationally. Although the relevant laws and regulations have made clear provisions and requirements on the format and content of drug packaging, labels and instructions, due to the lack of understanding of drug packaging, labels and instructions and defects in supervision, some non-standard drug manufacturers and distributors, in order to increase sales, always make a fuss on drug packaging, labels and instructions, and change drug packaging Format and content of labels and instructions. These non-standard behaviors do harm to the safety and effectiveness of drug use of the people to varying degrees. In order to do a good job in the supervision of drug packaging, labels and instructions, and ensure the safe and effective use of drugs by the people, we investigated the violations of drug packaging, labels and instructions in combination with daily supervision and inspection and the "special supervision and inspection of medical institutions' drug use equipment", and put forward the following countermeasures
I. current major violations
1. Indications or functional indications exceed the regulations. In the investigation, it was found that some drug manufacturers expanded the scope of treatment without authorization, generalizing the whole. For example, compound paracetamol and amantadine tablets or capsules are only applicable to influenza A virus, but the words "antiviral" are marked on their packages; Some drug manufacturers exaggerate the efficacy of drugs. For example, the indications of compound pseudoephedrine hydrochloride sustained-release capsules approved by the State Food and drug administration include "especially suitable for relieving symptoms such as nasal congestion, runny nose and sneezing", while a manufacturer marks on its package that "taking one capsule every 12 hours can quickly relieve the following symptoms: nasal congestion, runny nose and sneezing"; When switching from prescription drugs to over-the-counter drugs, some manufacturers did not change the indications and functional indications as required, marked the word "OTC" during production, but still used the instructions of prescription drugs, so their indications and functional indications exceeded the scope approved by the State Food and drug administration; Some drug manufacturing enterprises deliberately add indications or functional indications when leaving the factory. For example, the functional indications of "Liuwei Dihuang Pill" produced by a pharmaceutical factory in our province are "nourishing yin and tonifying the kidney, reducing blood sugar and blood pressure. It is used for dizziness, tinnitus, aching waist and knees, spermatorrhea and night sweat", in which the content of "reducing blood sugar and blood pressure" is deliberately added
2. The drug name is not standardized. Article 5 of the provisions on the administration of drug packaging, labels and instructions (Provisional) (hereinafter referred to as the "provisions") stipulates that the colors of old and new building blocks must match "the general name of drugs must be prominently marked in Chinese. As there is a commodity name, the proportion of words used in the general name to the commodity name shall not be less than 1:2, and there shall be a certain gap between the general name and the commodity name, which shall not be used together". However, some drug names are obviously illegal, hiding their real names and showing their pseudonyms. For example, the drugs produced by a drug manufacturer with the approval number of "gyzz z620 beginning calibration 2, with outstanding electrical insulation and excellent water resistance 20632" have the pseudonym "Qiangshen pill" highlighted on its outer package, while the real name "Guifu Dihuang Pill" is vague and difficult to see; The general name of some drugs is vague, and the trade name is too large. The general name is used together with the trade name. For example, the trade name "chuanting" is highlighted on the outer package of clenbuterol hydrochloride tablets produced by a drug manufacturer, while its general name clenbuterol hydrochloride tablets is hidden in the red line of its outer package, which is not easy to find
3. Taboos and precautions are not marked or the loss outweighs the gain. The second paragraph of Article 12 of the provisions clearly stipulates that "if a certain item is not clear, the words" not clear "shall be indicated; If it is clear that there is no impact, it should be marked with "None". In order to expand sales, some drug manufacturers should mark taboos and precautions without marking, and some reduce the contents of taboos and precautions, thus increasing the occurrence of some adverse reactions. For example, the instructions of compound pseudoephedrine hydrochloride sustained-release capsules produced by a drug manufacturer are inconsistent with those approved by the State Food and drug administration, reducing the content that "children must be used under adult supervision"
4. The contents of the outer package of drugs are added without authorization. Article 2 of the Regulations stipulates that "drug packaging, labels and instructions must be printed in accordance with the requirements of the State Drug Administration, and their words and patterns must not include any content without approval". During the inspection, it was found that some drug manufacturers or dealers gave the drug to customers at the drug supply meeting in order to publicize a drug and increase sales, and marked the packaging with the words "complimentary" or "not for sale"; Some drugs have added unnecessary contents to their outer packaging, such as the "refined Liuwei Dihuang capsule" produced by a drug manufacturer, and the national drug approval Z, in which the "refined" was added without authorization
5. Unapproved materials are contained in the drug package. Article 3 of the Regulations stipulates that "no unapproved text, audio-visual and other materials that introduce or publicize products and enterprises shall be carried in the drug package". In order to increase sales, some drug manufacturers or distributors carry unapproved words, audio-visual and other materials to introduce or publicize products and enterprises in drug packages. During the inspection, it was found that the packaging of "Liuwei Dihuang pills" produced by a drug manufacturer contained an unapproved rectangular box printed to publicize the product and the enterprise
6. Expand publicity of drug packaging, labels and instructions. In order to increase sales, some drug manufacturers have added unapproved contents to the words or patterns of drug packaging, labels and instructions, such as "national new drugs", "GMP certification", "sub packaging of imported raw materials", "supervision", "honorary products", "award-winning products", "quality insurance of insurance companies", "modern science and technology", "precious medicinal materials", etc, For example, the packaging label of "glucose hydrochloride capsule" produced by a drug manufacturer indicates the words "national new drug"
7. Change the usage and dosage. The regulations clearly stipulates that the usage and dosage of drugs should use easy to understand words in addition to the unit content label, so as to correctly guide the use of drugs. As the saying goes, "drugs are three parts toxic", which means that drugs have some toxic reactions or adverse reactions to varying degrees. Therefore, there should be clear provisions on the route of administration and dosage, and the route of administration and dosage of drugs should not be changed at will. However, some drug manufacturing enterprises even changed intramuscular injection to intravenous injection, changing 2 times a day to 3 times a day. For example, the "capreomycin sulfate" produced by a drug manufacturing enterprise increased the medication route of "intravenous injection"
II. Measures and Countermeasures
1. Strengthen learning, raise awareness, and increase publicity. Food and drug administration departments at all levels and drug production, operation and use units should strengthen the study of relevant knowledge of drug packaging, labels and instructions, as well as relevant laws and regulations, especially the provisions, and combine the study with daily work. In this way, the drug production, operation and use units can avoid increasing the operating costs due to their own management reasons, causing unnecessary economic losses, weakening their own market competitiveness, and making the social and economic benefits of the enterprise not well reflected. In this way, food and drug supervision and administration departments at all levels can also be targeted in their work and improve administrative efficiency
the second paragraph of Article 32 of the drug administration law stipulates that "the Pharmacopoeia of the people's Republic of China and drug standards issued by the drug regulatory department under the State Council are the national drug standards". It can be seen that the national drug standards reflect the quality of drugs and are the internal requirements of drugs. Article 54 of the drug administration law stipulates the contents that must be indicated in drug packaging, labels and instructions. Among them, the general name, ingredients, specifications, expiration date, indications, functions, usage and dosage, contraindications, adverse reactions and precautions of drugs specified in the drug packaging, labels and instructions are also specified in the national drug standards. Drug packaging, labels and instructions are the external reflection of the internal quality of drugs, and the quality of drugs must meet the national drug standards. Therefore, some contents of drug standards must be expressed through drug packaging, labels and instructions. This is conducive to protecting consumers' right to know, and strengthening the management of drug quality through the management of drug packaging, labels and instructions. It can be seen that the drug packaging, label and instruction manual are composed of two parts: some items reflecting the drug standard and other items. The drug packaging, label and instruction manual are different from and related to the national drug standard. The content reflecting the drug standard in the drug packaging, label and instruction manual is the national drug standard. Food and drug supervision and administration departments at all levels and drug production, operation and use units should be fully aware of this, and pay attention not only to the quality of drugs, but also to the packaging, labeling and instructions of drugs. Drugs must comply with the national drug standards, and their packaging, labels and instructions must also comply with the provisions
due to the publicity activities of local food and drug administration departments in recent years, the people have learned about the laws and regulations of some drugs and medical devices, and their awareness of safe drug use is also constantly improving. However, some common sense about drug packaging, labels, instructions and relevant laws and regulations is still blank, and the food and drug administration is also a "blind spot" in publicity. Therefore, local food and drug supervision and administration departments should increase publicity, especially the publicity of the regulations. This can not only effectively protect the legitimate rights and interests of the people in using drugs, but also improve the social influence of the food and drug supervision and administration departments
2. Strengthen the supervision of production enterprises and control the source. According to the investigation, drug manufacturers whose drug packaging, labels and instructions do not conform to the regulations are all over the country, including some unknown pharmaceutical factories and drug manufacturers with high popularity in the country. This shows that although the "Regulations" were promulgated as early as October 15, 2000, they have not been well implemented yet because some production enterprises have not paid enough attention to them. Local food and drug regulatory departments should strengthen the supervision of local drug production enterprises, focusing not only on the quality of drugs, but also on the materials and containers used in drug packaging, as well as the standardization of drug packaging, labels and instructions, and urge enterprises to strictly implement the provisions on drug production issued by the state, Put an end to violations of drug packaging labels and instructions from the source
3. Carefully carry out supervision and inspection in the field of drug circulation and ensure good flow and customs clearance. When accepting the purchased drugs, drug distributors and users should focus on the inspection of drug packaging, labels and instructions. If problems are found, they should refuse to purchase and take the initiative to contact the local food and drug administration department. After the drugs enter the circulation field, the quality management personnel of the drug handling and using units should also check the drug packaging labels and instructions, stop selling immediately if any problems are found, take the initiative to contact the local food and drug administration department, and actively cooperate with the food and drug administration department to trace the source of the drugs. Local food and medicine