The National Medical Products Administration takes action!, Related to solving the problem of unclear drug instructions | Instructions | Drugs

The reporter learned from the National Medical Products Administration that on the 29th, the Administration released a draft for soliciting opinions and decided to carry out a pilot reform of aging friendly drug instructions in some commonly used oral and topical drug formulations for elderly patients.

The aim of this anti-aging reform is to optimize the management of drug instructions, meet the needs of different patients, encourage drug marketing license holders to actively explore, and solve problems such as unclear drug instructions.

According to data from the National Health Commission, as of the end of 2022, the number of elderly people aged 60 and above in China reached 280 million, accounting for 19.8% of the total population. Faced with the increasing problem of an aging population, China has implemented a national strategy to actively respond to the aging population, adhering to the principle of putting people first and taking multiple measures to solve the urgent and difficult problems faced by the elderly, and promoting the construction of an elderly friendly society.

The relevant person in charge of the National Medical Products Administration stated that the scope of this reform pilot includes oral and topical drug preparations for elderly patients. According to the principle of organized by provincial drug regulatory authorities, voluntary application by holders, and step-by-step implementation, Shanghai, Jiangsu, Zhejiang, Shandong, Hunan, and Guangdong are designated as pilot provinces. The provincial drug regulatory authorities in the pilot provinces organize 5 to 10 holders within their jurisdiction to participate in the pilot work. Each holder shall determine 5 to 10 drugs for the pilot reform of aging appropriate drug instructions.

The National Medical Products Administration requires that drug instructions should quote some items and contents of the drug instructions in the original text, only involving font and format adjustments, without modifying the content. The drug instructions should be clear and easy to distinguish, making it convenient for elderly patients to take medication.

The draft for soliciting opinions states that holders should print QR codes on drug packaging or drug instructions, and electronic drug instructions can be obtained by scanning the QR codes.

The draft for soliciting opinions states that drug users and retail enterprises should further improve their service levels to ensure accurate medication for the people. Medical institutions, drug retail enterprises and other units should fully consider the medication characteristics of different patient groups, strengthen medication guidance and services, and practicing pharmacists and other pharmaceutical technicians should further strengthen reasonable and safe medication guidance for special groups such as disabled and elderly patients. Important information in drug instructions should be informed to ensure safe and accurate medication.

Previously reported

One grain of rice can cover four words, and "micro engraving printing" is often seen in drug instructions

Currently, drug instructions are becoming more and more standardized, covering various aspects such as characteristics, indications, toxicology research, and pharmacokinetics; However, the font size is getting smaller and smaller, with the smallest font weighing only 4 pounds, making it difficult for young people to read, let alone the elderly. It can be said that the drug instructions made by "micro engraving printing" have become a stumbling block for the safe use of drugs by the elderly population.

A small matter is not insignificant

"The words on the drug manual are too small and there are too many professional contents, making it difficult to find important information such as usage, dosage, and contraindications." Ms. Guo Jing, who lives in Tonghe Community, Lianyungang City, Jiangsu Province, told a half month talk reporter that she needs to regularly serve her 88 year old mother-in-law who suffers from "three highs" to take medication.

The problems encountered by Guo Jing have a certain universality. Many elderly people contacted by the Half Month Talk reporter believe that the font size of drug instructions is too small, coupled with people's old age and blurred vision, making reading difficult. Taking the commonly used drugs nifedipine and omeprazole for the elderly as an example, the half month interview reporter found that the drug instructions were densely packed, making it difficult for the elderly to see the content clearly even when wearing reading glasses.

Chen Sihan, a staff member of a pharmaceutical company, is making pharmaceutical packaging

In fact, the font size suitable for normal reading groups should be four point, 14 pounds. Currently, the font size of most drug instructions is much smaller than size four, and some even reach size eight, which is about 0.35 millimeters from 4 pounds to 1 pound. With such a size, one grain of rice can cover four words. Not to mention the elderly, even young people can't bear it even with a few glances.

"The small matter is not small, it is related to medication safety." Legal professionals say that drug instructions, as a statutory document containing important information about drugs, are the legal guidelines for selecting drugs, and their aging adaptation has reached an urgent moment.

Why "micro carving"

The font size of drug instructions is too small, and the main reason is that regulatory authorities have increasingly high requirements for the professionalism of the instructions, with more and more labeling content. However, the font size requirements are not specific. Manufacturers, considering production cost control, generally choose to continuously compress the font size within the existing paper size range.

Article 49 of the Drug Administration Law of the People's Republic of China stipulates: "Drug packaging shall be printed or affixed with labels and instructions in accordance with regulations... The text in the labels and instructions shall be clear, and the production date, expiration date, and other matters shall be prominently marked and easy to distinguish." Article 6 of the Drug Instructions and Labels Management Regulations stipulates: "The text in drug instructions and labels shall be clear and easy to distinguish."

"Regarding the content of drug instructions, the relevant regulations are relatively detailed, while the font size only has the principle of" clear and easy to distinguish "four characters, with no specific requirements." Hu Fang, a prosecutor at the Haizhou District People's Procuratorate of Lianyungang City, who has long been concerned about the aging modification of drug packaging, introduced that this makes it easier for pharmaceutical companies not to prioritize the visibility and readability of instructions.

Furthermore, to reverse this situation, pharmaceutical companies are indeed facing significant cost pressures. Half Month Talk reporters visited some pharmaceutical companies and learned that the outer packaging box of general drug instructions is usually smaller. Enlargement of the font of the instructions requires larger paper and replacement of larger drug boxes, which will affect the entire drug production packaging line.

"At present, drug packaging is automated, and modifying and debugging equipment on the entire production line is a huge expense, which may also significantly reduce production efficiency." said Wang Ti, Quality Director of Jiangsu Haosen Pharmaceutical Group Co., Ltd. "The text in the instruction manual is indeed small, but the difficulty of modifying the packaging line for drug production is not small at present."

Where to start with renovation

Although renovation is not an easy task, it still requires someone to try. The Lianyungang Inspection Branch of the Jiangsu Provincial Drug Administration recently selected three pharmaceutical companies, each of which selected a commonly used drug, to explore the aging adaptation of drug instructions. The main measure is to underline or bold the text of important information such as functional indications, usage and dosage, and adverse reactions.

The Market Supervision Administration at the two levels of Lianyungang City and Haizhou District has attempted to set up pharmaceutical service desks and printers in 39 local drug retail pharmacies, providing enlarged versions of drug instructions to the public in need.

Hu Fang believes that under the current legal constraints and without significantly increasing the costs of pharmaceutical companies, these measures are beneficial for the elderly to read the instructions clearly. However, to solve the problem from the source, relevant laws and regulations need to regulate the font size and enhance the awareness of serving the elderly.

Experts have pointed out that not only drug manuals, but also many product manuals in reality have small font sizes, overly professional content, and use a lot of professional terminology and English abbreviations in language expression, without paying attention to the needs of the elderly population, and also need to adapt to aging.