Why is the modification of "small as ants" and "suitable for aging" in drug instructions changed?

Chengdu citizen: Some words on the medication instructions are too small for us to see.

Wang Damei, a resident of Lianyungang, Jiangsu: You can't see it at all. You can see the name of the medicine, but how many times a day, you can't even see it.

Mr. Lin, a citizen of Xiamen: It is best to suggest that the content outside the medicine box be more comprehensive, and there is no need to take out the paper instruction manual inside.

Ms. Zheng, a citizen of Xiamen: Take it seriously from doctors or medical staff in pharmacies, pay attention, spend more time, explain more, and give advice. The drug instructions should be as concise and concise as possible, as we may not understand some proprietary terms.

When taking medicine when sick, it is necessary to read the drug instructions. However, as everyone has mentioned, many drug instructions now contain more and more content, from characteristics, indications to toxicology research, pharmacokinetics, and so on; The font size is getting smaller and smaller, making it difficult for young people, not to mention the elderly. Can the text on the drug instructions be larger? Can the content be more concise and concise? Let's first understand why drug instructions use such a small font.

Drug instructions are not only the main way to provide doctors and patients with necessary information about drugs, but also an important legal document for drugs. The Drug Administration Law of the People's Republic of China clearly stipulates that "drug packaging shall be printed or affixed with labels and accompanied by instructions in accordance with regulations", "when the drug regulatory department of the State Council approves drugs", "the quality standards, production processes, labels, and instructions of drugs shall be approved together".

In addition, the National Medical Products Administration issued relevant regulations in 2000 and 2006, specifically issuing detailed instructions for prescription drugs of chemical and biological products, traditional Chinese medicine, and natural medicines.

Zhang Yan, Deputy General Manager and Quality Manager of a pharmaceutical manufacturing enterprise: It needs to include a lot of professional information, most of which is for our professional medical staff to see. With the increasing regulatory requirements, information on the safety and efficacy of drugs has been included, resulting in more and more detailed drug instructions.

There will be a "large font version" of the drug instructions to solve the problem of unclear reading due to small font size

In order to accommodate more content in the instruction manual, drug manufacturers can only continuously reduce the font size within the existing paper range. This is almost a common practice among pharmaceutical companies worldwide. But if the words on the drug instructions are too small, inconvenient to read, and misunderstood by the elderly and disabled, it may pose a great threat to life and health. Based on this consideration, the Accessible Environment Construction Law, which officially came into effect on September 1st this year, stipulates that relevant departments of the State Council should improve the management standards of drug labels and instructions, and require drug manufacturers and operators to provide accessible format versions of labels and instructions such as voice, large text, Braille, and electronic. According to relevant introductions, drug instructions generally require a paper large font version. However, considering that drug instructions are relatively long, providing a full text paper large font version is difficult in practical operation. Therefore, electronic instructions can be provided by scanning.

The pilot reform of making drug instructions "clear" has been launched

The National Medical Products Administration has recently launched a pilot project for the aging friendly reform of drug instructions, encouraging drug marketing license holders to actively explore and solve problems such as unclear drug instructions.

The National Medical Products Administration will select oral and topical drug related preparations commonly used by some elderly people, and determine Shanghai, Jiangsu, Zhejiang, Shandong, Hunan, and Guangdong provinces and cities as pilot provinces based on the principle of organized by provincial drug supervision departments, voluntary application by holders, and step-by-step implementation. The provincial drug regulatory department in the pilot province organizes 5-10 holders within its jurisdiction to participate in the pilot work. Each holder shall determine 5-10 drugs for the pilot reform of drug instructions suitable for aging. Require holders to provide simplified drug instructions and encourage companies to further provide voice broadcasting and Braille services.

Some pharmaceutical companies have started designing "large font" drug instructions

In order to enable patients to read the drug instructions clearly, pilot enterprises are also revising and designing new "large font" drug instructions.

In order to fundamentally solve the problem of unclear drug instructions, Hunan has organized a group of pharmaceutical enterprises to carry out pilot reforms of "large font" instructions for some commonly used oral and topical drug preparations. Located in the national biopharmaceutical industry base in Liuyang, pilot pharmaceutical companies are conducting preliminary modifications and designs on the instructions of their own drugs. On the one hand, the format is standardized, and on the other hand, the needs of professionals and ordinary patients are separated, making it easier for patients to find medication information.

Zhou Shasha, Director of Clinical Medicine Department of Pilot Pharmaceuticals: The previous instructions had a lot of professional content. After the reform of the manual, it retained some important and crucial information that patients need to know in the manual, and enlarged the font while increasing the line spacing. And it requires us to use Arabic numerals as much as possible to represent what we can inside, all in order to make our patients more intuitive and convenient to refer to our instructions.

In addition, the improved drug instructions will adjust the corresponding paper, folding method, and drug packaging. After the official implementation of the Accessible Environment Fitness Law, various regions will gradually require drug manufacturers and operators to provide label instructions in accessible formats such as voice, large text, Braille, and electronic, in accordance with relevant regulations.

Xiao Bo, Director of the Drug Distribution Supervision Department of the Changsha Municipal Market Supervision Bureau: We will urge all drug retail stores in the city to promote the new version of drug instructions, because we have relevant health knowledge promotion, including legal education. Secondly, we will put some improved measures on the drug purchase receipts, so that the elderly and disabled can be more clear and quickly aware of our optimization measures.

Multi department promotion of "aging friendly" transformation of drug instructions

In recent years, various regions and departments have been promoting the "aging friendly" transformation of manuals at different levels. Last year, the People's Procuratorate of Lianyungang City and the People's Procuratorate of Haizhou District in Jiangsu Province jointly handled a public interest lawsuit case involving drug instructions. During the investigation, prosecutors found that the "aging friendly" modification of drug instructions could not be easily solved by simply expanding the word.

The person in charge of relevant pharmaceutical companies introduced that drug instructions are important documents with legal effect. Generally speaking, after the content and format of drug instructions are approved, they are handed over to printing factories for printing, and then transported to drug manufacturers for packaging operations. If the manual is printed with a larger font size directly, it will inevitably cause the paper to become larger. For high-speed production lines, even small changes can have a significant impact.

Zhang Deming, the production manager of the pharmaceutical manufacturing enterprise Lianyungang Pharmaceutical Branch: Our current instruction manual size is already well matched with our automated equipment. If the font is further enlarged, it may affect the size of the entire paper, thereby affecting the folding method of our entire instruction manual. Later, it may affect the size of the entire box. From a equipment perspective, if the changes are too large, it may affect the overall production efficiency, and even say that this production line does not have the packaging capacity of this product.

After sorting out, prosecutors found that the issue of "aging suitability" in drug instructions is essentially a matter of medication safety for the elderly population, running through the entire process from production to sales. On the production side, the Lianyungang Inspection Branch of the Jiangsu Provincial Medical Products Administration convened a symposium with the heads of three large pharmaceutical companies in Lianyungang. At the meeting, the three companies decided to take out one over-the-counter drug variety for an attempt at "aging friendly" transformation. After the attempts and efforts of several pharmaceutical companies, the version of the improved drug instructions has now been launched.

In the terminal sales process of drugs, it is possible to carry out "aging friendly" transformation more flexibly and universally than in the drug production process. The procuratorial organs have provided procuratorial suggestions to the market supervision department.

Wang Bo, Director of the Market Supervision Administration of Lianyungang City: In response to the issue mentioned in the prosecutor's recommendation that the elderly special group cannot read and understand the drug instructions clearly, we have taken the lead in exploring and constructing a number of pharmaceutical service demonstration points in the province.

Starting from the second half of 2022, some retail pharmacies in Lianyungang have set up pharmacy service desks with dedicated pharmacists on duty to provide medication guidance for the elderly, as well as printing enlarged versions of drug instructions. At present, the "aging friendly" transformation of drug instructions promoted by the two levels of procuratorial organs in Lianyungang has shown some initial results.

Zhang Li, Prosecutor General of the People's Procuratorate of Haizhou District, Lianyungang City: The road is long, the road is long, because there are so many drug instructions, the redesign of the content, the selection of paper, the transformation of the assembly line, and the increase in costs. These issues need to be addressed step by step, and on the basis of reaching consensus among all parties, we must steadily and actively promote it.

How to read drug instructions prompted by pharmacists

The big font version of drug instructions is coming, and pharmacists remind us that in the current situation, it is also regular to look at the small font version of drug instructions.

Consumers: The instructions are a bit too complicated because we are concerned about usage, dosage, function, and indications. The second one is taboo or has some side effects, but it seems that we cannot understand the pharmacology and experiments involved.

Generally, prescription drugs are taken by patients according to the doctor's instructions. When purchasing self purchased drugs, pharmacists remind that the instructions should focus on both ends and draw a line in the middle.

Wang Juan, a practicing pharmacist at Chengdu Tongkang Pharmacy: Our main task is to first confirm whether the name of the medicine he purchased is the same, as well as the usage, dosage, and precautions of the medicine. If he takes a lot of medication, we may want to understand whether other medications will interact with each other. Generally speaking, we have one head and one tail, with the main ingredients on the head, followed by the storage methods at the tail, and some usage, dosage, precautions, adverse reactions, etc. in the middle. So when going home to read the manual, just follow the content of the middle line from beginning to end.