How to deal with the unauthorized change of drug n

2022-09-20
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How to deal with the unauthorized change of drug name in the clinic

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when a township individual clinic was giving patients infusion, in order to prevent patients from purchasing drugs from other places and the leakage of their prescriptions, the words "refined Xiaoshuanling for injection" and "Ling" on the ampoule of the powder injection "refined Xiaoshuanling for injection" were erased, leaving only the word "Xiaoshuanling". After the patient found it, he complained to the drug regulatory department. When dealing with this behavior of the clinic, the drug regulatory and law enforcement personnel had different opinions: some people believed that it should be investigated and punished according to the law according to Article 48, paragraph 2 (2), of the drug administration law, "where a non drug is passed off as a drug or another drug is passed off as such a drug"; Some people believe that the behavior of the clinic violated the provisions of Article 23 of the drug administration law, "dispensing drugs without obtaining the preparation license of medical institutions", and should be punished in accordance with the provisions of Article 73 of the law; Others believe that "other drugs that do not meet the requirements of drug standards" should be punished as inferior drugs according to item (6) of paragraph 3, Article 49 of the drug administration law, on the grounds that the drug name is part of the drug standard, and changing the drug name without authorization is an act of changing the drug standard without authorization

■ viewpoint 1: it should be handed over to relevant departments for treatment

◆ it should be handed over to the administrative department of health

the author believes that the drug regulatory department should not punish the behavior of the clinic, because its behavior is subjectively malignant and objectively harmful. Subjectively, it is to "prevent patients from purchasing drugs from other places and the leakage of their prescriptions", rather than passing fake drugs off as genuine ones, shoddy ones as good ones, misleading patients to buy, and seeking benefits from them; Objectively, the clinic erased the words "refined for injection" and "spirit" on the ampoule of the powder injection "refined Xiaoshuanling for injection", leaving only the word "Xiaoshuanling", which is not enough for patients to recognize it as other drugs, and there is no situation of "passing non drugs off as drugs or passing other drugs off as such drugs"

in fact, the behavior of the clinic violated the patients' "right to know" about the drugs they used. The drug regulatory department should criticize and educate the clinic, order it to make corrections, and truthfully feed back the situation to the administrative department of health, which will deal with it

Wang Shufeng, Pingtan County Drug Administration, Fujian Province

◆ transfer to the industrial and commercial administration department

the author believes that the behavior of the clinic deprives patients of the right to know and the right to choose drugs, violates the consumer protection law and the anti unfair competition law, and should be handled by the industrial and commercial department. First, this behavior violates the relevant provisions of the consumer protection law. Drugs are also commodities, medical services are also services, and the doctor-patient relationship is also the relationship between operators and consumers, so this is within the scope of adjustment of the consumer protection law. Articles 8 and 9 of the law clearly stipulates that "consumers have the right to know the true situation of the goods they purchase and use" and "consumers have the right to choose goods and services independently". It can be seen that "password drugs" have obviously infringed on patients' right to know and choice as consumers. Second, it violates the provisions of the anti unfair competition law. Article 6 of the law stipulates that public enterprises shall not restrict others to purchase the goods of their designated operators in order to exclude the fair competition of other operators. Although the clinic does not explicitly restrict others to buy their own drugs, its use of "password drugs" is for the purpose of excluding other operators. Therefore, the use of "password drugs" in the clinic has constituted compulsory consumption, which has created an unfair market environment for competitors and destroyed the normal order of market competition

Rao Zhinong, food and Drug Administration of Changtai County, Fujian Province

◆ transfer to the consumer association or the administrative department of health

the author believes that if the clinic purchases the drug through legal purchase channels, the relevant qualification certificates are complete, the drug acceptance records are true and complete, and the quality of the drug in stock is no problem, it can not be punished. The clinic wiped the "refined Xiaoshuanling for injection" and "Ling" from the ampoule of "refined Xiaoshuanling for injection" in order to prevent the leakage of self prescribing and patients purchasing drugs elsewhere. This behavior violates Article 8 of the consumer protection law According to the provisions of Article 9 and Article 25 of the prescription management measures, "except for toxic drugs for medical use, psychotropic drugs, narcotic drugs and drugs for detoxification, no medical, preventive and health care institutions shall restrict medical personnel from purchasing drugs from other medical, preventive and health care institutions or drug retail enterprises with Prescriptions". The drug administration department may, according to the seriousness of the circumstances and the opinions of the informant, Decide whether to transfer it to the consumer association or the competent health administrative department

Wang Sanchun, food and Drug Administration of Yuexi County, Anhui Province

■ view 2: treat as inferior drugs

according to the provisions of the regulations on the administration of drug instructions and labels, "the label of a drug refers to the content printed or pasted on the drug package, which is divided into internal label and external label. The internal label of a drug refers to the label of the package that directly contacts the drug, and the external label refers to the label of other packages other than the internal label", The contents marked on the powder ampoule belong to the internal label of drugs

the drug label belongs to the national drug standard. The basis is as follows: first, Article 32 of the drug administration law stipulates that drugs must meet national standards. The Pharmacopoeia and drug standards issued by the drug regulatory department of the State Council are national standards. Second, Articles 52 to 54 of the drug administration law stipulate the packaging, labels and instructions of drugs that can help strengthen fibrous materials to achieve repeated automatic healing, Article 54 stipulates "Drug packages must be printed or pasted with labels and instructions in accordance with regulations. The labels or instructions must indicate the general name, composition, specification, manufacturer, approval number, product batch number, production date, expiry date, indications or functions, usage, dosage, contraindications, adverse reactions and precautions of drugs. Narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use And the labels of over-the-counter drugs must be printed with the prescribed signs ". Articles 44 to 47 of the regulations for the implementation of the drug administration law also stipulate the packaging, labeling and instructions of drugs. Third, articles 25 and 27 of the general regulations of the 2005 edition of the Pharmacopoeia stipulate that the instructions of drugs should comply with the provisions of the instructions in the drug administration law, and the packaging and labeling of drugs should comply with the provisions of the drug administration law and the drug regulatory department of the State Council on packaging and labeling. The contents of different packaging labels should be printed in accordance with the above provisions and contain as much drug information as possible. The provisions on drug packaging, labels and instructions in the 2005 edition of Chinese Pharmacopoeia can also explain that they are an integral part of drug standards

it is clear that the drug label is an integral part of the drug standard, and the content of the drug label is inconsistent with the original approved content and drug standard after being changed. According to the provisions of "other drugs that do not meet the provisions of drug standards" in Item 6, paragraph 3, article 49 of the drug administration law, the drug should be classified as inferior drugs, and the clinic should be treated according to the use of inferior drugs

ningwen of Ninghe branch of Tianjin Food and Drug Administration

■ view 3: no punishment

in this case, drug labels and labels should be taken as a breakthrough. The first and second paragraphs of Article 54 of the drug administration law stipulates that drug packages must be printed or pasted with labels and instructions in accordance with regulations. The general name, composition, specification, manufacturer, approval number, product batch number, production date, expiry date, indications or functions, usage, dosage, contraindications, adverse reactions and precautions of the drug must be indicated on the label or instruction manual. Article 86 of the drug administration law stipulates that if the drug label does not comply with the provisions of Article 54 of this law, wechat Angel alliance will try to establish a bridge between the local government and the start-up company. In addition to being punished as fake or inferior drugs according to law, it will be ordered to correct and given a warning; If the circumstances are serious, the approval certificate of the product shall be revoked. Paragraph 1 of Article 46 of the regulations for the implementation of the drug administration law stipulates in China's plastic machinery market that drug packaging, labels and instructions must be printed in accordance with Article 54 of the drug administration law and the provisions of the drug regulatory department under the State Council. Article 30 of the provisions on the administration of drug instructions and labels stipulates that if the drug instructions and labels do not comply with these Provisions, they shall be punished in accordance with the relevant provisions of the drug administration law

the above are the provisions on labels and labels in the legal system of drug supervision and administration. The problem in this case is whether it can be punished as fake and inferior drugs from the perspective of labels and labels. I think not. The provisions of the first and second paragraphs of Article 54 and Article 86 of the drug administration law are the basis and penalties for drug producers and operators, while there are no penalties for the destruction of drug labels and labels in the original state, which is also an imperfection in the current drug administration legal system. Therefore, such a situation cannot be punished

Shenyang food and drug administration, Liaoning Province, Yang Guang, Wang yongyang

■ view 4: both departments should investigate and deal with

◆ it belongs to the use of inferior drugs and infringement of patients' right to know

this behavior of the clinic is a kind of cutting of drug labels. In this regard, Article 6 of the current provisions on the administration of drug instructions and labels stipulates that the words in the drug instructions and labels should be clear and legible, the marks should be clear and eye-catching, and there should be no phenomena such as falling off of printing or weak pasting, and no modification or supplement by pasting, cutting, erasing, etc; Article 30 stipulates that if the instructions and labels of drugs do not comply with these Provisions, they shall be punished in accordance with the relevant provisions of the drug administration law. Article 32 of the drug administration law clearly stipulates that drugs must meet the national drug standards, and the drug name is one of the important contents of the national drug standards, which is legal and cannot be changed at will. Therefore, the clinic can be investigated and punished according to the use of inferior drugs in accordance with Item 6, paragraph 3, Article 49 of the drug administration law

this behavior of the clinic also deprives patients of the right to know the true situation of the goods they purchase and use or the services they receive, which is a typical commercial fraud. In order to safeguard the legitimate rights and interests of patients, patients should be advised to complain to the administrative department for Industry and commerce, which should handle it according to law

Luo Xingfan, food and Drug Administration of Jingzhou Miao and Dong Autonomous County, Hunan Province

■ view 5: it should be treated as the use of fake drugs

◆ there is no approval number and no manufacturer for "Xiaoshuan"

the author believes that this behavior of the clinic should be treated as the use of fake drugs. The label of drugs is an important identification of drugs. Drugs with incomplete or no identification are prohibited from use according to law. Article 54 of the drug administration law stipulates that "drugs must be printed or pasted with the general name of drugs". After erasing some words of the name on the drug ampoule, the clinic can no longer prove that "Xiaoshuan" is the original drug "refined Xiaoshuanling for injection", and this "Xiaoshuan" has become a fake drug without production approval number and manufacturer. According to Article 48, paragraph 3 of the drug administration law

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