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
“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
NCPIE encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, NCPIE does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not NCPIE.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.