Recently, the State Food and Drug Administration announced the third batch of drug instructions for the elderly and barrier-free reform pilot list, which also means that there will be more "large-character version" and "simplified" instructions for the elderly in the future. The reporter's investigation found that after the launch of the first batch of reform pilot lists at the end of last year, some drug instructions have been revised and listed. Among them, some revisions have been welcomed by patients, while others still need more tests on how effective they are.
The size of the paper has become larger, and you can see it without glasses
"This instruction manual is really good, I haven't seen it before!" The same medicine, a new box recently opened, was replaced with a simplified and enlarged version of the instructions, which made Tan Hong overjoyed.
More than half a year ago, Tan Hongnian's nearly 90-year-old mother was hospitalized for cerebrovascular disease. After being discharged from the hospital, the doctor prescribed a medicine called "Citicoline Sodium Capsules" for the old mother to take. Every time she gets a medicine she has never seen, Tan Hong has the habit of checking the drug instructions, but she is also over sixty years old, and the whole paper of the instructions for buying drugs this time is only the size of a palm, and the font size of the text on it is not large, so she has to wear glasses and look carefully to see it clearly. It doesn't matter if you look at this, it is mentioned in the usage and dosage column that the capsules should be taken with "warm boiled water", Tan Hong forgot that the doctor told her before, and she took a good look at the instructions before remembering it.
Not only the newly prescribed medicine, but also other medicines that she or her parents had taken before, Tan Hong struggled every time she read the instructions. In her impression, only a few drugs have larger paper and font sizes and fewer words. And the vast majority of manuals are compressing the paper and font size in different ways, as if they are competing to see who can make it more compact. The most outrageous is the instruction manual of a blood pressure medication, the words on it are no longer within the range that can be seen clearly with glasses, you must hold a magnifying glass to read, and there are a lot of words in the instruction manual, and I even feel a little dizzy when I look at it. "Later, when I showed it to my son, he said he couldn't see it clearly."
This time, the old mother had to prescribe medicine every month for this capsule, and it happened to be the third month, when Tan Hong bought the medicine back, she unexpectedly found that the instructions inside were a little different from before. The paper of the instruction manual has doubled in size, and the font size has become much larger, so you can easily read it without glasses. The manual is also printed in color, and the more important items are highlighted in blue.
This is the first time Tan Hong has seen a simplified and enlarged version of the instructions in the medicine box, in her opinion, those drugs for chronic diseases that are often taken, because patients are used to taking them, the instructions are not so important. But there are some medicines that are not particularly common, and the elderly take it for the first time, and it is also a peace of mind to look at the instructions. "It would be nice if this enlarged version of the manual could be promoted, and it would be very helpful for the elderly with bad eyes!"
There are three types of revisions, and the simplified version is more acceptable
The reporter compared the old and new instructions of this capsule drug and found that the content of the new instructions had also been deleted. In the old instructions, there are some contents that have little to do with the patients themselves, and play more of a role as a record. For example, in the upper left corner, the specification was first approved on April 22, 2007, and has since undergone six revisions, each of which is also marked with a date. In the text, in addition to the Chinese name of the drug, the English name and pinyin of the drug are also written. Tan Hong doesn't care too much about these contents. There are also some contents, such as the chemical structure of drugs, that are not simply incomprehensible to non-professionals.
The new version of the instructions has deleted all these contents, and only retained the information of "drug name", "ingredients", "characteristics", "indications", "specifications", "usage and dosage", "contraindications", "storage" and "marketing authorization holder information". In Tan Hong's view, these are indeed relatively important items and should be retained.
How was this revised manual designed? The reporter contacted Qilu Pharmaceutical Co., Ltd., the manufacturer of the drug. Zhang Xiaoyan, senior manager of the company's drug administration management department, said that the revision of the aging instruction manual will be promoted as early as 2023. "Around October 2023, the State Food and Drug Administration issued the "Pilot Work Plan for the Reform of Drug Instructions for Aging and Barrier-free", requiring the selection of several places as pilots, including Shandong. Qilu Pharmaceutical actively participated in the optimization of the instructions for the elderly, and selected 8 drugs mainly suitable for elderly patients and submitted them. ”
At the end of 2023, the State Food and Drug Administration announced the list of the first batch of 657 drugs to participate in the pilot, and the 8 drugs reported by the company were among them. By March this year, the instructions of the 8 drugs had basically been revised.
The revision plan given by the State Food and Drug Administration is divided into three types, the first is the "partial enlarged version", the full text content remains unchanged, only some of the items are selected, and the font and format are enlarged and bolded; The second is the "electronic version", which designs an electronic drug manual, puts the QR code on the original instructions, and the patient can enlarge and view it on the mobile phone after scanning the code, and the content of the electronic instructions and the paper version remains unchanged; The third "simplified version" is the revision method adopted by Citicoline sodium capsules, which deletes part of the original instructions, and increases the font size of the retained content, widens the line spacing, and increases the size of the paper.
Zhang Xiaoyan introduced that because the company is also piloting which version of the manual has a better revision effect, the eight drugs reported have selected three different revision methods. Judging from the company's follow-up survey feedback, the third "simplified version" is more accepted by patients. "We also have a drug that has a more simplified instructions, which originally had 10,423 words, and only 764 words remain. The font has also increased from small five to four, which looks much fresher. ”
Simplification needs to follow guidelines It will still take time to get to market in bulk
The reporter found some drugs on the market that other companies participated in the revision of the instructions for aging, but compared with the one Tan Hong saw, whether the revision effect of some instructions can be accepted by the public remains to be tested by the market.
For example, a capsule drug for the treatment of high blood pressure adopts the "revised scheme two", only a QR code is added to the original manual, and after scanning the code, an electronic manual will appear on the mobile phone, which can be zoomed, but the reporter found that the visual effect is not good after trying. First of all, there is a limit to the magnification of the electronic manual, and it is not possible to zoom in all the time. In addition, after zooming in, you can't see all the content that was originally on the same line, and you have to drag the screen back and forth, left and right, which is very troublesome. The most important thing is that the content of the original manual is too complicated, and the contents of "drug interaction" and "pharmacology and toxicology" not only have many words, but also contain a large number of professional terms, which are of limited significance to ordinary patients, but the electronic instructions do not simplify these contents.
Another drug for the treatment of bacterial infections uses the "revised regimen 3", which is a simplified version. However, the simplified package insert still has more than 3,000 words, and the paper is the size of A3 paper (twice the size of ordinary A4 paper). On the new instructions, the "Indications" column lists 8 conditions, and the dosage column also lists 8 dosages corresponding to these 8 conditions, which is really a bit "dizzy" at first glance. But compared with the original old manual, this new manual is undoubtedly a great improvement, because the words of the old manual are so small that even reporters can't read clearly.
Now that the third "simplified" version of the manual has been chosen, why can't it be streamlined on the basis of more than 3,000 words? According to the staff, this is because the state has issued relevant regulations, and the revision has a guide as a template, not how the enterprise wants to change it.
On the website of the State Food and Drug Administration, the reporter found this compilation guide, which mentions that the "simplified" version of the instructions must retain entries such as "drug name", "characteristics" and "indications", and the content of each article must be consistent with the original instructions. In other words, if the content of the original manual involves items such as "indications" and "usage and dosage", then even if it is revised, the original complex content can only be put in as is.
As for the "partially enlarged version" of option 1, the guidelines mentioned that in fact, the corresponding content of the "simplified version" should be appropriately enlarged and bolded, and the other contents should remain unchanged according to the original small print. The reporter also found a manual modified with this scheme on the Internet, and the font is big and small, which looks a little strange.
Although the third batch of the NMPA's pilot list for the reform of drug instructions for the elderly and barrier-free has been announced, it generally takes several months or even longer because the revision of the instructions needs to go through processes such as redesign and adjustment of production lines. The reporter consulted some pharmaceutical companies and learned that even with the first batch of pilot lists announced at the end of last year, some drug instructions have only just been revised and have not yet been listed in large quantities. Most of the drugs currently circulating in the market are still "old models" produced last year or in the first few months of this year, and patients still have to wait for some time to see more age-appropriate instructions. (Beijing Daily)