The drug label is "as small as an ant", who will supervise the change
Open the drug insert, and the lines of small ant-like words are densely packed.
"It's a little dizzy to watch." This is the "first impression" of Jiang Yanling, director of the Sixth Procuratorate Department of the People's Procuratorate of Lianyungang City, Jiangsu Province, when she first saw the instructions for the drug nifedipine.
Nifedipine is a common drug used in people with high blood pressure. As an important basis for patients to correctly select and use drugs, drug inserts are too small and often cause problems to drug users, mainly elderly groups.
Since last year, the Lianyungang Municipal Procuratorate has played its role in public interest litigation and promoted the drug regulatory authorities to carry out pilot work on the "age-appropriate" transformation of drug inserts in several pharmaceutical companies in the city through the formulation and issuance of procuratorial recommendations.
At the same time, the procuratorate has promoted market supervision departments to carry out pilot pharmaceutical service desks in a number of drug retail stores to ensure the safe use of medicines by the elderly.
Today, improved versions of the relevant drug inserts included in the pilot are available and can be easily purchased in pharmacies.
"Eye-catching" instructions plague the elderly
In February last year, Hu Fang, a prosecutor in the public interest litigation department of the Haizhou District People's Procuratorate, approached Jiang Yanling with a "densely handwritten" drug insert.
"The words are so small, what does this make the elderly think! This is a common medicine. Hu told Jiang Yanling about a problem that ordinary young people do not think, but that is common in the elderly group.
Hu Fang's mother has high blood pressure and needs to take a variety of drugs such as lowering blood pressure and lowering blood lipids every day. The old man is old, and the words in the instruction manual are very small. When she read key contents such as drug dosage and contraindications, she wore reading glasses and held up a magnifying glass, and she could not read the words on the instructions clearly.
Hu Fang recalled that his mother had to read the instructions hard every time she got a box of medicine, which was very worrisome. With corresponding questions, she and her colleagues visited many grassroots communities in Lianyungang City, such as Yulong Community and Xinlong Community.
Through holding a symposium on public interest litigation and conducting questionnaire surveys, she learned in detail about the use of drug inserts by the elderly group. What she didn't expect was that when she talked about this issue, the old man quickly opened the chatterbox.
They also reported that key information such as how to take, dosage, and contraindications is very difficult to find on the instructions with dense handwriting on both sides. In addition, the entire drug label is full of jargon, "making it confusing what is being said."
"I can't read or understand the words, and many times there is no way to take medicine by feeling." Uncle Cai, a resident of the Yulong community, said to Jiang Yanling, "We ordinary people have a question, why can't the words in the drug insert be printed larger?" ”
Modifying the instructions is not simple
In response to the problems reported by the masses, Jiang Yanling and her colleagues learned about the entire process of drug inserts from design and printing to filling into medicine boxes in several pharmaceutical companies in Lianyungang City. In the process, they discovered that changing the handwriting of the manual was not simple.
The person in charge of a number of pharmaceutical companies reported to Jiang Yanling that the drug label is an important document with legal effect after being reviewed and approved by the national drug regulatory department and cannot be easily modified. In addition, there are many factors that affect the size of the instruction manual.
The person in charge of the pharmaceutical company said that in order to ensure the safety of medication, the instructions need to be marked with more and more content. Drug packaging, labels and instructions have a unified format and category, must be printed in strict accordance with the relevant requirements, in order to write the content completely, in the existing paper range can only reduce the font size.
In addition, if the manual is directly changed to a larger font size, it will inevitably cause the paper to become larger. For a high-speed production line that can complete nearly 500 boxes of pharmaceutical packaging per minute, "it affects the whole body".
After careful preparation, in April last year, with the support of He Jianming, chief procurator of the Lianyungang Municipal People's Procuratorate, Jiang Yanling and her colleagues held a roundtable on public interest litigation on the ageing transformation of drug labels.
Deputies to the National People's Congress, members of the Chinese People's Political Consultative Conference, people's supervisors and relevant responsible persons of several local pharmaceutical companies discussed the improvement of the level of pharmaceutical services in retail pharmacies and the transformation of drug labels.
At first, pharmaceutical companies were reluctant to change the instructions. They believe that professional drug instructions are for the doctor's reference, and ordinary patients only need to take the medicine under the guidance of the doctor.
In this regard, Jiang Yanling said that for over-the-counter drugs, many elderly people go to pharmacies to buy them on their own. "Who doesn't have an old man, how can they see such a small word!" Jiang Yanling said.
The procurator also argued for the legal provisions. They said that there is no strict regulation of font size in the current national standard of drug instructions, and the comprehensive and professional drug instructions do not contradict the drug group's access to simple and clear and effective information.
On April 2022, 4, the Lianyungang Municipal People's Procuratorate decided to formulate and issue procuratorial recommendations, suggesting that drug regulatory authorities promote pharmaceutical companies to "age-appropriate" the transformation of drug inserts under existing laws and regulations and without significantly increasing printing costs.
The proposal points out that the market supervision department will optimize retail pharmacy services and introduce convenient measures such as providing enlarged copies of instructions and usage and dosage notes.
Subsequently, focusing on the problem of small font size of drug instructions, the Lianyungang Inspection Branch of the Provincial Food and Drug Administration held a symposium for pharmaceutical enterprises. In the end, three pharmaceutical companies in Lianyungang City selected an over-the-counter drug to try to improve "suitable for aging", including ibuprofen suspension, loratadine tablets, aconite pills (concentrated pills), etc. By increasing the font size of the usage and dosage, and appropriately improving the treatment of text describing the applicable symptoms and adverse reactions by underlining or bolding font, the pilot work of age-appropriate transformation of drug instructions officially began.
Improve the safe medication service space for the elderly
As soon as he got the drug with the new instructions, Hu Fang brought the instructions home. She gave her mother an instruction manual with key information such as shelf life, indications, and contraindications that had been enlarged. My mother was very happy looking at the new version of the manual.
While pharmaceutical companies are adapting drug inserts to the ageing, market supervision departments at the municipal and district levels have set up pharmaceutical service desks in 39 drug retail stores within their jurisdiction. They carried out the pilot of pharmaceutical service desks by formulating pharmaceutical service conventions, setting up special service desks, and configuring printers to provide "enlarged" versions of drug instructions, reading glasses, and expired drug recycling bins.
In order to truly implement the procuratorial recommendations, in June last year, the Lianyungang City procuratorial organ invited deputies to the municipal and district people's congresses, members of the Chinese People's Political Consultative Conference, people's supervisors and volunteers of "Yixin for the Public" to "look back" at the rectification of drug inserts suitable for aging.
Seeing the smooth development of the "age-appropriate" transformation of drug instructions, Jiang Yanling has a renewed outlook for the future. She believes that as a commodity circulating nationwide, drugs can only promote the "age-appropriate" transformation of the instructions among several pharmaceutical companies in the city, which cannot fundamentally solve the problem of difficulty in reading drug labels.
At present, the Supreme People's Procuratorate is also actively promoting the "enlargement" of the handwriting on drug labels. Hu Fang said to his mother, "Mom, in the future, you don't have to worry about not being able to read clearly or understand the manual." ”
Sun Xinxin Zong Shen Zhongqing Daily / Zhongqing Net reporter Li Chao Source: China Youth Daily