News:At present, there are more and more contents of drug instructions, which are becoming more and more standardized, ranging from traits and indications to toxicology research and pharmacokinetics; however, the font size is getting smaller and smaller, and the smallest The font is only 4 points, and it is difficult for young people to look at it, let alone the elderly. It can be said that the drug instructions produced by "micro-engraving printing" have become a stumbling block to the safe medication of the elderly.
"Drug instructions are simply made by 'micro-engraving printing'" "One grain of rice can cover four or five characters" "Every time you have to take a picture of the instruction with your mobile phone and enlarge the font to see it clearly"... There are many complaints about the manual content too much and the text too small. Some comments pointed out that it is a basic requirement that the text of drug instructions be readable and understandable, which is related to the safety of medication. The "micro-engraving" printing of drug instructions should be changed.
Little things are not small
"Drug instructions are too small and have too much professional content. It is not easy to find important information such as usage, dosage, and contraindications." Ms. Guo, who lives in Tonghe Community, Lianyungang City, Jiangsu Province, told reporters that she often needs to serve the 88-year-old with "three highs" "The mother-in-law took medicine.
Ms. Guo's problems are universal. Many elderly people contacted by the reporter think that the font size of the drug instructions is too small, and because of their old eyesight, it is really difficult to read.
In an interview with a reporter about the medication of the elderly, many elderly people thought that the font size of the drug instructions was too small, and because of their old eyesight, it was really difficult to read. Take nifedipine and omeprazole, commonly used drugs for the elderly, as an example. The drug instructions are so densely packed that it is difficult to read the contents clearly even with reading glasses.
In fact, the font size suitable for normal group reading should be four points, 14 points. At present, the font size of most drug instructions is much smaller than No. 4, and some even reach No. 8, that is, 4 lbs - 1 lb is approximately equal to 0.35 mm. This size, a grain of rice can cover 4 characters, not to mention the elderly, it is young People can't stand it even after a few glances.
"The words are not trivial, and they are related to the safety of medication." Legal professionals said that as a legal document that contains important information about drugs, drug insert sheets are not only the scientific basis for medical personnel and patients to treat medication, but also the drug manufacturers and distributors to medical and health personnel. It is the main medium to publicize and introduce the characteristics of drugs, guide rational and safe drug use and popularize medical knowledge with the general public.
The "Drug Administration Law" stipulates that drug packaging should be printed or affixed with labels and instructions in accordance with the regulations... The text in the labels and instructions should be clear. The "Regulations on the Administration of Drug Inserts and Labels" requires that the text in drug inserts and labels should be clear and legible.
Why "micro-carving"
The instruction manual is the legal standard document of the drug, so can the text be deleted in order to make the text more "clear" and "easy to read" while the paper size remains the same?
For pharmaceutical companies, this is a difficult problem. According to the law of our country, after the approval of a new drug, the instruction sheet cannot be modified by itself; if any modification is required, an application must be made to the competent authority. In May 2020, the State Food and Drug Administration issued the "Notice on Publicly Soliciting Opinions on the "Regulations on the Management of Drug Instructions and Labels" (Revised Draft)", which clearly stated that if the information in the drug instructions is inaccurate, untrue, misleading, or does not provide Without sufficient safety information, warning information, etc., the drug will be judged as counterfeit.
my country's stricter management of drug instructions has made pharmaceutical companies dare not take it lightly. In order to comply with regulatory requirements and avoid risks, they will include as much drug-related information as possible in the instructions. If the paper size of the manual remains the same, if more text is to be placed on it, the font size must be reduced. In fact, from a global perspective, this is the common practice of almost all pharmaceutical companies.
The font size of the drug instructions is too small. There are reasons for this. The main reason is that the regulatory authorities have higher and higher requirements for the professionalism of the instructions and more and more labeling content, but the requirements for the font size are not specific. Considering the control of production costs, manufacturers generally choose Continuously compress the font size within the existing paper size range.
In addition, to reverse this situation, pharmaceutical companies are indeed facing considerable cost pressure. The reporter visited some pharmaceutical companies and learned that the outer packaging boxes of the general drug instructions are small. Enlarging the font of the instructions as a whole requires larger paper and a larger box, which will affect the entire drug production and packaging line.
"Currently, pharmaceutical packaging is all automated operations. It is a huge expense to re-modify and debug the entire production line, and it may also greatly reduce production efficiency." said Wang Ti, quality director of Jiangsu Hansoh Pharmaceutical Group Co., Ltd., " The text of the instructions is indeed small, but it is not easy to change the packaging line of drug production at present."