OTC drug packaging requirements

[Summary of content]: With the implementation of the pharmaceutical classification management system, the pharmaceutical industry in China should attach importance to the packaging design of products. From the dose specifications, packaging specifications, and instructional content of the pharmaceuticals to the pattern color of the packaging, they should meet the requirements of OTC and satisfy the people. Medication needs to protect people's drug safety.

Drugs are a kind of special consumer goods. The purchase and use of drugs is not an ordinary consumption process. It involves people's physical health and life safety. With the implementation of the drug classification management system, people increasingly purchase and use OTC drugs. This requires OTC drug manufacturers to focus on drug packaging from the following aspects and provide consumers with comprehensive knowledge of drug and drug use. To protect people's medication safety.

First, the dosage specifications and packaging specifications of drugs should be complete and standardized, and the choice of packaging and packaging techniques should be convenient for patients.

1. The dosage specifications of the medicine should be complete to ensure that the dosage of patients with different ages and constitutions is accurate. At present, the dose specifications of Chinese medicines are single, and many medicines have only one specification for adults, and there are no specifications for children, the elderly, and the infirm. This phenomenon has a great impact on the safety of drug use by non-adults. There are at least two major hidden dangers: First, the accuracy of the drug dose cannot be guaranteed. Taking children's medication as an example, children use adult-dose OTC drugs, which are usually divided into several adult doses, which are estimated according to the weight of the child. Without other measurement tools, it is difficult to accurately obtain such drugs. The second hidden danger is to change the structure of the drug and fail to achieve the desired effect. After some tablets are divided, the coating layer and the core are destroyed, and the dissolution rate of the drug will change. If it is an enteric-coated tablet, it will become a gastric-dissolved tablet, so that the efficacy of the drug is not guaranteed. It may even cause unexpected side effects. Therefore, manufacturers and distributors of OTC drugs should fully recognize this point. The designed dose specifications of drugs should be complete, and at least one minimum effective dose specification is required to ensure the accuracy and safety of medication for patients of various diseases.

2. The packaging specifications of pharmaceuticals should be complete, and should be standardized to each individual packaging to facilitate the use of patients and the adjustment of the retail industry. A feature of the OTC system is that it is suitable for small symptoms and small pains, and the duration of medication should not exceed 10 days. Therefore, one-time, one-day, and one-course dose packaging specifications for OTC drugs should be complete. In addition, each bottle, each ampoule, and each foil must have basic label descriptions such as validity period, usage, and amount, content, etc., so that each individual has a standard packaging, so as to facilitate the patient Use and pharmacy swaps.

3. The packaging and packaging techniques used for pharmaceutical packaging should be accessible and accessible to patients. Some medicines use sealed packaging for extended shelf life, such as wax seals, hose packaging, etc. To open these medicines, only tools such as scissors or awls can be used, which is troublesome for the patient. Some health products packaging is worth learning, not only easy to open and very characteristic, such as "too oral liquid." In addition to the convenience of opening, it is also necessary to measure the amount of medication or dissolved water in the package. For example, Wuhan Jianmin's "baby vegetarian" package contains a small amount of 0.25g spoon, "Livzon Dele" package contains a small measuring cup 30ml, children's "Tynon" scale straw. These costs do not cost more than a few cents or even a few cents, but they can give patients a lot of convenience in accurately taking and taking medicines.

Second, drug packaging should standardize the use of OTC special logo, color and image should be clear, the drug should have a distinctive appearance, easy to identify.

1. The packaging of the product shall comply with the "Administrative Regulations for Non-prescription Drugs' Special Marks (Interim)". Although non-prescription drug packaging is currently in the transition phase, it is certain that non-prescription drugs and production companies should use OTC in their drug label, instruction manual, inner packaging, and outer packaging after receiving the “non-prescription drug audit registration certificate” for 12 months. Special signs, coordinate proportions, color marks, and positions must all comply with the regulations, otherwise they will not be allowed to leave the factory.

2. The color of pharmaceutical packaging should be harmonized with the medicinal properties, and the logo image should be clear at a glance. When people are sick, they are psychologically stressed. According to the study of psychology, different colors have different implications for human psychology. In general, the use of cold tones in antipyretic analgesics drugs can reduce the patient's pain and anxiety; and nourishing diaphoretic drugs use warm colors. In the application of color, some western countries have also made different provisions according to the efficacy of medicine: the circulatory system uses yellow-green drugs; the respiratory system uses drugs such as blue. In addition, in order to facilitate patient identification, different symbolic patterns should also be designed for drugs with different pharmacological effects. For example, medicines for eye treatment are marked with an eye pattern; drugs for treating stomach are marked with a pattern for the stomach; drugs for cardiovascular medicine are marked with a heart pattern.

3, the appearance of the drug color, logo should have characteristics, easy to identify. Taking tablets as an example, white tablets of 6 mm x 1.5 mm look like dozens of vitamin B1, chlorpheniramine tablets, and stabilizer tablets. The same appearance sometimes leads to errors in the patient's medication and is not conducive to the manufacturer's promotion of his own brand logo. Some manufacturers have been aware of this, highlighting their own logo in tablets or capsules. For example, in the Xuezhikang Capsule of Peking University Pharmaceutical Co., Ltd., the outer surface of the red capsule is printed with the words of Peking University's Weixin and Xuezhikang.

Third, the contents of the drug instruction manual should be detailed and standardized, and the language should be straightforward to understand. A drug label is a type of drug label and is generally classified as a label of a package (pharmacy box). Drug labels refer to vials, foil bags, tin tubes, and aluminum-plastic blisters (labels for bottles).

1, the contents of the drug instruction book should be exhaustive. Drug instructions are the main basis for patients to judge, select, and use drugs. They have the greatest impact on medication safety. Countries around the world have strict and detailed regulations on the contents of drug labels. China's “Manufacturing Quality Control Standards for Pharmaceuticals” (GMP) requirements manual printed with the main ingredients, pharmacological effects, toxic and side effects, applicable diseases, usage, dosage, taboos, precautions, storage conditions, trademarks and approval text, etc. One content. However, the current situation is far from the standard requirements. According to Zhao Tianqi, a pharmacist at the Guiyang Medical College Affiliated Hospital, a survey of 164 drug product descriptions of 100 manufacturing companies revealed that the incomplete contents of the 11 manuals accounted for about 75 percent. Among them, the deficiency rates of poisonous side effects, precautions, and taboos that have a large relationship with patient drug safety are 34.1, 17.1, and 45.1, respectively. For OTC drugs, the GMP standard cannot fully meet its requirements. With the gradual implementation of the drug classification management system, the drug supervision and management department will certainly put forward higher requirements for OTC drug specifications. The standards and practices of developed countries are worth learning from. One of the main contents of OTC's OTC Office's examination of OTC drugs is the label, which requires the following items: 1. The product name (including the general name and trade name); 2. The name of the manufacturer, packager, or distributor. Address; 3, active ingredients and inactive ingredients in the product (INN name); 4, content and net content (including certain components such as ethanol, alkaloids, etc.); 5. Introduction to indications, usage and dosage ;6. Precautions and advice of consumers for protection; 7. Registration number and registered trademark, storage conditions, expiration date, batch number.
2, the contents of the drug instruction manual should be standardized. The content of drug descriptions should not only be complete, but also standardized, especially the name, validity period, adverse effects, and taboos that are closely related to drug safety.

2.1 Drug names include chemical name, generic name, trade name, patent name, non-proprietary name, common name, abbreviated name, official name, legal name, etc., but the name of the drug appearing on the label and package of drugs is the name of the product. Common name or patent name, non-proprietary name. In addition to the name of the product, there are uniform provisions for other names of drug standards, and the name of the product is the name given to the product by the manufacturer or dealer in order to distinguish it from the product of another person. That is, the same drug has the same generic name or patent name, non-proprietary name, but the trade name is different. At present, a prominent problem is that certain chemical products are only marked with trade names but not common names, patent names, or non-proprietary names, which poses great hidden dangers in drug identification, information exchange, drug safety, and drug management. The correct approach is to label the generic name or English non-proprietary name (INN) on the label or the description. If there is a product name, the application R is marked in the upper right corner with a font that is smaller than the name of the product.

2.2 The validity of the drug should be properly marked in a prominent place. The term of validity of a drug refers to the period during which the drug can maintain its quality under certain storage conditions. It is different from the production lot number. The production lot number is used to indicate the date and batch of drug production. According to the unified regulations of the Ministry of Health, the batch number includes the date and semicolon. When marking. The Japanese sign is in the front, the semicolon is in the back, and the middle is connected by a dash. The Japanese number is set to 6 digits. Indicates the year, month, and day of production; the lot indicates the batch of material that was put on that day. According to the Circular on Implementation of the Issues Relevant to the Pharmacopoeia of the People's Republic of China in 1995, the expiration date of drugs is calculated from the date of production of the drug (based on the production lot number) and the expiration date of the drug label should expire. At present, the production batch number and expiration date of pharmaceuticals are not standardized. Some have investigated the drugs of 125 drug manufacturers, and only four of them have been marked according to the above requirements of the Ministry of Health and the expiration date of the calculation validity period. According to another survey, 50 patients each time must see the date of production when purchasing drugs, 35.5 people usually see only 10.8 and 3.8 rarely see and never look. From this point of view, the production batch number and validity period not only have a significant impact on the safety of medications, but also have a close relationship with sales. In addition to correctly marking the production lot number and expiration date, the marked location should also be significant. At present, many drug production lot numbers are on the inside of the package. To view the production lot number, the original package must be opened, which is extremely unfavorable for drug circulation and management. The production lot number and validity should be marked on the outside of the package. It is best for the drug regulatory authority to specify a labeling location (such as the lower right corner of the side (side) of the product name or common name). This will not only facilitate the management of drug distribution, but also facilitate disease. Patient choice.

2.3 Adverse reactions and contraindications should be fully described. Adverse reactions and contraindications are the most important part of drug descriptions. Many countries have strict regulations that require the specification to be consistent with the basic information of the product. The pharmaceutical manufacturer must be responsible for all problems of its own products, including timely reporting of adverse reactions occurred, taking appropriate measures to manage and modify the instructions if necessary. When you need special attention, add a black box to warn. In contrast, domestic manufacturers have no secrets about adverse reactions and contraindications. Some of them are incompletely labelled, avoiding light weight, and some simply do not indicate adverse reactions and taboos, and some even declare "non-toxic and side effects." This mentality may be concerned with identifying adverse reactions and affecting patients to buy drugs. However, there are facts that this worry is purely redundant. Xi'an Jansen's drug descriptions describe the adverse reactions in more detail and comprehensive, but their drugs are favored by patients with the disease. In addition to adverse reactions and contraindications, drug descriptions should also include consumer protection precautions and advisory warnings. The FDA includes this clause in the OTC specification. It mainly explains how to use these drugs safely. Such as "do not apply to damaged skin." "Do not exceed the recommended dose" and so on. Some warnings indicate that the use of the drug is stopped in the event of a condition, such as "stopping use when the pulse speeds up, dizziness, blurred vision." Some warnings help the patient to seek medical advice, such as "If the headache exceeds 10 Days or continued redness, immediately consult the doctor.” In order to patients with drug safety, these are worth our reference to the manufacturer and drug regulatory authorities.

3, the drug instruction language should be easy to understand, the font size should be appropriate. The instructions should be written in the form of ordinary people's understanding, using as few professional terms as possible, and sometimes even graphically. Considering the low illiteracy and universal reading ability in China, drug manufacturers have to solve the difficult problem of drug product specification. In addition, the manufacturer's specifications, design, typesetting, printing, etc., should also be fully considered by the manufacturer to facilitate reading. The font size of the manual should be appropriate and it should be taken care of by the elderly.