Best Practice Guidelines for Prescription Labels for the Visually Impaired

JANUARY 05, 2015
In 2012, President Barack Obama signed into law the FDA Safety and Innovation Act (S.3187). Among other items, the Act encourages pharmacies to provide prescription drug labeling for the blind, those with low vision, and seniors.
Under Section 904 of the Act, the US Access Board, which is comprised of representatives of the visually impaired community and the pharmaceutical industry, was tasked with creating and publishing best practice guidelines for accessible prescription drug container labels. These guidelines were specifically meant to direct pharmacies on how to prepare labels for patients with visual impairments. The idea is to help enable these patients to better manage their own medication therapy in an independent and private manner so that they may take their medications confidently as prescribed.
The completed best practices guidelines were published in July 2013, and they currently exist without regulatory enforcement or penalties for noncompliance; however, this month, the Government Accountability Office will begin monitoring how well pharmacies are applying these best practices and help define what barriers remain.
Interestingly, there is nothing written in Section 904 that will limit any action from the Americans with Disabilities Act (ADA) of 1990. So, it is foreseeable that an organization representing the visually impaired community may attempt to apply these best practice guidelines as law under the ADA.
Therefore, it is this pharmacist's recommendation that pharmacies review the best practice guidelines developed by the Access Board and create a plan to implement an accessible prescription label system for visually impaired patients. Pharmacies can speak with their software and hardware vendors to determine what options they currently have available that may meet the best practice guidelines.
As an alternative to their own software, there are options that provide different versions of an audible or "talking" prescription label.  Examples of such companies include AccessaMed and ScripTalk.

Section 904 of the FDA Safety and Innovation Act addresses prescription labeling, but it does not address the Consumer Medication Information (CMI) leaflets that are handed out with each prescription. If pharmacists are going to provide an accessible prescription label, then it only seems natural that they should also provide the CMI in an accessible format.

In addition to offering an audible label, ScripTalk also provides a telephone, dial-up format for patients to listen to a computer voice read the CMI leaflet. Additionally, AudibleRx provides Internet and app-based CMI in a human voice.

Steve Leuck, PharmD
Steve Leuck, PharmD
Steve Leuck, PharmD, has been practicing both hospital and community pharmacy for over 30 years. He founded AudibleRx, in 2011, which provides Consumer Medication Information which is both Useful and Accessible. Content designed to meet health literacy guidelines. Format designed to "read along" with the audio presentation in a simple to use web application. More information at
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