[Chinese Packaging News] The information on the current pharmaceutical packaging and brochures is presented as visual information. December 3, 2012 is the 21st World Day for Persons with Disabilities. Experts have called for ensuring that the blind have access to effective drug information and achieve safe drug use. The governments, associations, and enterprises need to pay attention and promote them together. Related technical standards and policies and regulations need to be established.
As China's "Pharmaceutical Specifications and Labeling Regulations" does not address the mandatory requirements for drug labeling and labeling for blind and visually impaired people, etc., currently there are only Zhejiang Bede Pharmaceuticals, China Resources Sanjiu Pharmaceutical Co., Ltd. and AstraZeneca. (China) Three pharmaceutical companies marked Braille on some of their drug instructions.
In view of the peculiarities of the drug name and the professionalism of Braille, Braille was marked on the drug packaging and the specification to support the technical standards.
According to Li Weihong, director of the executive committee of the China Disabled Persons Federation, executive vice chairman of the blind association, and visually-impaired person, there are many technical problems in the translation of Braille for drug names in China. For example, Blair Braille used by blind people is pinyin, and how to translate the transliteration of the drug name using the characters α, β, etc., how to translate homonyms, etc. have not formed a unified standard.
Zhang Weimin, director of the Department of External Affairs of the China Pharmaceutical Packaging Association, pointed out that there is a lack of clear specifications for the location, printing area, and printing methods of braille on pharmaceutical packaging. Just one way of printing, there are many technical problems that need to be overcome. For example, Blair Bold Braille has various printing methods such as die-cutting machine embossing, sticking box embossing, screen printing, and jet printing; and if embossing is selected, the height and spacing of the Braille from the Blair bump to the bump are selected. There is a clear requirement that the ductility, rebound coefficient, etc. of the material used in the kit must meet the relevant standards. At the same time, in order to avoid retraction, flattening or damage of the braille, the storage and transportation conditions of pharmaceutical packaging, especially the requirements of temperature and humidity, are relatively high.
Dong Wei, Director of the Chemical Drugs Supervision and Evaluation Division of the Drug Evaluation Center of the State Food and Drug Administration, explained that the EU stipulates that except for medicines used only by medical personnel, all listed drugs must use Braille on the packaging to indicate the name, dosage form and specifications of the drug; If necessary, indicate the applicable population. The guidelines for the implementation of relevant laws and regulations further clarify that for visually impaired people, companies must take into account factors such as typeface, contrast, spacing, and paper quality that affect readability when making drug instruction manuals; for the blind, they must provide tapes, etc. format.
In addition, Germany implemented the "Patient Information Service" project to provide audio, large fonts, or Braille brochures for blind and visually impaired people through the website; UK industry associations, electronic systems providers, and the National Association for the Blind work together for blindness and vision Barriers to the crowd provide a hotline to listen to instructional services; the United States passed the "Prescription Drug Specification Improvement Act" in 2012, specifically establishing a dedicated working group to issue specific guidelines in 2013 to ensure that pharmacies can guide the blind and visually impaired people to safely use drugs.
In terms of safeguarding the safe use of blind people, the experience of European countries and the United States will undoubtedly provide lessons for our country. On the one hand, in terms of working mechanism, the government, associations, and enterprises need to work in a coordinated manner. That is, the government formulates policies, uniform standards, and implements the implementation of the enterprise. On the other hand, when formulating policies, the government needs to focus on the characteristics of actual medications used by the blind and visually impaired people, focusing on self-used common drugs and over-the-counter drugs; in view of China's national conditions, basic drugs and Medicare drug categories may be considered as the first choice.
Li Weihong said that the China Disabled Persons' Federation Blind People’s Association will carry out the work of standardizing the translation of some drug names and Braille. It will facilitate the labeling of Braille by drug manufacturers and the supervision and management of drug administration departments.
