U.S. Access Board Releases Guidance on Access to Prescription Drug Container Labels

New guidance is now available from the U.S. Access Board on how to make prescription drug container labels accessible to people with vision impairments or who are elderly. The important information labeling prescription medications, including dosage and other instructions, side effects, and expiration dates, is often inaccessible to those unable to read print or small type.

Developed by a stakeholder working group formed by the Board, the advisory guidance covers different solutions for making label information accessible, including braille, large print, and auditory technologies such as "talking bottles" and radio frequency identification tags. Some access alternatives can be delivered digitally through smart phones and personal computers.

In preparing its recommendations, the Working Group on Accessible Prescription Drug Container Labels assessed these alternatives along with technical, financial, or logistical considerations. This 18-member panel, which was comprised of representatives from advocacy organizations and industry, also prepared best practices to follow in providing access, including guidance specific to each access format.

“Many people who cannot read print or fine type, whether it’s due to a disability or is age-related, cannot safely and independently take their own medications,” notes Access Board Chair Karen L. Braitmayer, FAIA. “The information issued by the Board’s working group provides much-needed guidance to pharmacists on steps they can take voluntarily to ensure that label information is independently and reliably accessible to all of their customers.”

The released recommendations are contained in a report, “Best Practices for Making Prescription Drug Container Label Information Accessible to Persons Who are Blind or Visually-Impaired or Who are Elderly,” which is available on the Board’s website. This guidance is advisory only and not mandatory. Pharmacies are not obligated to follow the best practice recommendations. The recommendations were developed under the "Food and Drug Administration Safety and Innovation Act," which President Obama signed into law last July. The law called upon the Board to form a working group to develop the recommendations within one year.

The National Council on Disability will undertake an awareness campaign in cooperation with the working group to inform the public of the best practices, as directed by the Act. In addition, the Comptroller General will initiate a review in 18 months to assess the extent to which pharmacies are following the best practices and to what degree barriers to prescription drug container labels remain.

For further information, visit the Board’s website or contact Marsha Mazz, Director of the Board’s Office of Technical and Information Services, at (202) 272-0020, (202) 272-0076 (TTY), or mazz@access-board.gov.