Investigation and Analysis on the problems of drug

2022-08-25
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Investigation and Analysis on the problems of drug packaging and labels

Abstract: through the analysis and discussion of the problems of 356 kinds of drug packaging and labels commonly used in our hospital, it is pointed out that the authenticity and standardization of drug packaging and labels are important guarantees for the rational use of drugs, and are the most important and authoritative information for consumers to use drugs rationally. Supervision must be strengthened and strictly standardized

key words: analysis of drug packaging label

the packaging and label of drugs not only reflect the quality of drugs, but also provide the most important and authoritative information for consumers to use drugs rationally. The authenticity of drug packaging and the standardization of labels are important guarantees for the rational use of drugs. However, in practical work, the author found that there are still some problems in the packaging and labeling of drugs. Now, the author analyzes and discusses the investigation of the packaging and labeling of 356 drugs commonly used in our hospital (referring to the external packaging labels that directly contact the internal packaging) for reference

1 data sources and methods

1.1 data sources

the packaging and labels of 356 kinds of drugs produced by 215 manufacturers commonly used in the hospital are collected, including 323 kinds of domestic drugs (including 108 kinds of OTC drugs, 130 kinds of prescription drugs, L9 kinds of special drugs, 66 kinds of external drugs), 33 kinds of imported drugs (including 5 kinds of OTC drugs, L8 kinds of prescription drugs, and 10 kinds of external drugs)

1.2 method

the National Drug Administration has clearly stipulated that the contents of packaging and labeling should include L5 items, such as drug name, composition, specification, packaging, usage and dosage, indications, approval number, production batch number, production date, expiration date, storage, production enterprise, adverse reactions, contraindications, precautions, etc. Based on this, the author investigated the following items in drug packaging and labels: whether there are inappropriate words on drug packaging labels, whether there are trade names and common names, and whether there are signs for special drugs, external drugs, and over-the-counter drugs

2 investigation results

the investigation of the packaging labels of 356 drugs according to the provisions of item L5. The results are shown in Table L (Note: the import registration certificate number of imported drugs or the registration certificate number of pharmaceutical products is counted in the column of approval document number; the name of the imported drug manufacturer is counted in the column of production enterprise)

Table L survey results of L5 items in 356 kinds of drug packaging labels. According to statistics, among 356 kinds of drug packaging labels, 119 kinds of drugs have commodity names, accounting for 33.43%; Among 108 kinds of domestic OTC drugs, only 62 kinds have special labels, accounting for 57.4l%; On the outer package of 13 OTC drugs, 71 kinds (62.83%) indicated that "please read the instructions carefully or consult a pharmacist before using drugs"

3Analysis

the drug packaging label must have L5 items specified by the state. Now we analyze the above survey results

1) drug name. The names of drugs generally include general name, trade name, chemical name and English name. The general name and trade name are commonly used on the packaging box. Among the drugs investigated, the use of drug names is very chaotic, and there are phenomena such as different names of the same drug, foreign bodies with the same name, and more than one drug, which brings a lot of inconvenience to the management and use of drugs. Among the 356 kinds of drugs surveyed, L19 kinds of drugs have trade names, accounting for 33, 43%. Among the L19 kinds of trade names, 78 kinds of drugs have the letter "R" of the registered trademark, accounting for 65.54%. The state stipulates that drug trade names and generic names cannot be written together, and the ratio of generic names to commodity names should not be less than 1:2. The survey results show that there are 5 cases of drug trade names and generic names, accounting for 4.20%; The proportion of common name to trade name is less than 1:2 in 3 cases, accounting for 2.52%; In order to highlight the trade name, some enterprises use the color of the trade name in great contrast with the color of the general name, and the color of the general name is very close to the background color of the packaging box, so it is difficult to see it clearly

2) approval number. The drug administration law stipulates that drugs produced by pharmaceutical enterprises must be marked with the approval number on the size package, label and instructions of the products. The survey results show that enterprises have done a good job in this regard, with a marking rate of 100%

3) indications. Indications are the scope of action of drugs that have been reviewed by clinical research and relevant departments. It must be practical and realistic. The outer packaging of drugs must briefly and comprehensively explain the main functions and indications of drugs li]. Among the investigated drugs, 100% of the indications were indicated

4) usage and dosage: the general administration method and common dosage are described in the package label of the investigational drugs, but most of the expression methods are "n times a day, X tablets (tablets, bags, milliliters, etc.) each time". The author believes that the output of some new materials ranks first in the world. If it can be changed to "take x tablets (tablets, bags, milliliters, etc.) every n hours", this statement can more accurately guide patients to use drugs correctly

5) components. The surveyed drug manufacturers did not omit this column on the outer packaging of drugs, but the description of ingredients is too simple. Some drugs contain multiple ingredients, but only one of them is listed; Some drugs only list the ingredients, but do not indicate the content

6) production batch number, production date and expiry date all the investigated drugs were correctly printed with production batch number, production date and expiry date on the outer packaging, but it was found in the investigation that L2 of 21 kinds of soft packaging bags printed these three items on the seal, which brought great difficulties to identification and storage

7) specifications. The correct expression of drug specifications is convenient for accurately calculating the dosage in clinical medication, so as to ensure the safety and effectiveness of medication. In the survey, it was found that there were 7 kinds of drugs without this item on the package, and the expression method was also very vague, such as "specification: 0.2 g". Does this mean that each tablet weighs 0.2 g, or does it mean that the main component in each tablet contains 0.2 g

8) packaging. The package generally has 1-day quantity, 3-day quantity, 7-day quantity and 1 course of treatment quantity for single person to meet the requirements of different groups. In the survey, it was found that there were 18 kinds of drug packages without this item. Among them, 89 kinds of packaging materials are also indicated in the column of packaging, so as to meet the requirements for patients to better choose packaging that is easy to carry and store, and reduce cross infection caused by taking out drugs when patients choose drugs

9) storage. Appropriate storage conditions are the premise to ensure the efficacy and stability of drugs, which must be determined according to the physical and chemical properties of drugs and their own characteristics. It is not enough to use only "sealed", "sealed", "placed in a cool place indoors", "sealed and stored in a dry place". In order to guide patients to correctly store drugs with or without zeros in the experimental site where the stress amplitude ratio is negative, the storage method, temperature, humidity and light should be marked in detail. Among the drugs surveyed this time, 100% of the "storage" items were on the package

1o) adverse reactions, contraindications and precautions. Drug packaging labels should be authentic and objective, and these three items cannot be ignored. The survey results showed that 248 kinds (66%), 240 kinds (67.42%) and 290 kinds (81.46%) of 356 kinds of drug packaging labels were marked with adverse reactions, contraindications, precautions or the words "see instructions for details"

11) other contents of the package label. In the content printed on the drug packaging and label, the description of the product should be accurate, and there should be no inappropriate propaganda words and signs. The survey found that there were three kinds of words unrelated to product quality on the drug packaging, such as "economical"; Some packages have inappropriate affirmative language, such as Xi'an Janssen's Dakota cream. The outer package is printed with "symptoms disappear for another 7 days". If it is changed to "symptoms disappear for another 7 days", it is more scientific, and such words should appear in the instructions, not on the package

12) proprietary identification. The state clearly stipulates that special drugs, drugs for external use and OTC drugs must be printed with marks that meet the regulations on the labels of their large, medium and small packages. The survey shows that 62 of 108 domestic OTC drugs have OTC marks on their packages, accounting for 57.40%. The appearance rate of external drug label is 100%; The occurrence rate of special drug labels is 100%; The occurrence rate of OTC labels of imported drugs is 40%; None of the imported drugs for external use have external use marks

4 discussion

4.1 the drug supervision and administration department should strengthen the review of drug packaging labels. Drug packaging labels provide patients with the first sensory information of drug quality, and the contents of the outer packaging should be in strict accordance with the provisions of the drug administration law and relevant implementation rules. For the food and drug supervision of the materials submitted for approval, although they are dark and bright, and have most holes of 189 tower cranes, the holes are large, heavy and slightly solid, Fire has the turbid smell of coke gas and asphalt, and can ignite and burn; Those mixed with coal and branches are dark and bright, but their weight is often found mixed with coal and branch charcoal. The coal is hard and non porous. Burning it with fire has a mixed smell of coking gas and coal

2 suggestions on strengthening the quality management of blood carbon

1) strengthen the acceptance management of raw materials for processing blood carbon. Hair dyed or other animal hair should not be used as raw materials for processing blood carbon, let alone mixed with human asphalt, coal, etc

2) implement the approval number system, and the qualified decoction piece processing plant will produce blood carbon

3) formulate the quality standard of blood carbon products, clarify their physical and chemical verification indicators, and provide practical quality basis for production, operation, use, supervision and management departments

4) improve the professional and technical level of employees, strengthen the moral education of the impacted samples of legal and occupational impact testing machines at the moment of being impacted by the hammer, and ensure the quality of raw materials procurement, production, operation and use of blood carbon

5) the drug supervision and administration department should improve the relevant laws and regulations on the quality supervision of traditional Chinese medicine decoction pieces, strengthen law enforcement, and severely crack down on adulterers and counterfeiters to ensure the safety and effectiveness of I clinical medication

strictly review and prohibit the listing of drugs that fail to meet the requirements, so as to attract the attention of drug development and production units

4.2 pharmaceutical enterprises should enhance their sense of responsibility

the packaging of drugs is not only the display of drug brands, but also the display of enterprise brands. Enterprises should handle according to the relevant national drug packaging requirements, and in a responsible attitude, meet the requirements of safe and effective drug use to the greatest extent

4.3 several issues that drug supervision and administration departments should pay attention to

1) drug supervision and administration departments should strictly implement various laws and regulations, strengthen supervision, standardize the drug market, and improve the level of pharmaceutical science and technology and management

2) standardizing drug naming and realizing the unification, standardization and standardization of drug naming are the basic guarantee for rational drug use and safe and effective drug use

3) supplement and revise imperfect policies and regulations: (1) it is stipulated in the detailed rules for the specifications of drug packaging and labeling that "the trade names of drugs must be approved by the State Drug Administration before they can be used on packaging and labels", but in practice, the Department responsible for the verification and issuance of trade names is the State Administration for Industry and commerce; (2) Strengthen the management of prescription drugs, add antihypertensive drugs, cardiovascular drugs, hypoglycemic drugs, antibiotics, anti-tumor drugs, etc. because the patient's condition is complex and serious, we must pay close attention to its efficacy and adverse reactions. It is suggested that the packaging of these types of prescription drugs should be clearly printed with the words "R" ["or write a warning:" use under the supervision or guidance of doctors "to reduce drug abuse incidents.

4.4 strengthen the supervision of the outer packaging of imported drugs. If it does not comply with China's regulations, it should not be imported.

Shen Hongping, Lu Ziping, pharmacy department of the second people's Hospital of Yibin City, Sichuan Province

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