ACB's Statement on Best Practices for Prescription Drug Labeling

Introduction

The American Council of the Blind is proud of our role in promoting language which was incorporated into S 3187, the Food and Drug Administration Safety and Innovation ACT which Became P.L. 112-144 on July 9, 2012

(SEC. 904. ACCESSIBILITY OF INFORMATION ON PRESCRIPTION DRUG CONTAINER LABELS BY VISUALLY-IMPAIRED AND BLIND CONSUMERS).

This initiative was spurred by numerous incidences reported to ACB of blind and visually impaired persons inadvertently taking the wrong pill or the incorrect dose of medication. Knowing that the majority of individuals who experience vision loss do so in their 60's and beyond, and that such individuals also experience other limitations which can affect cognitive and physical functioning, ACB believed that it was long past time for all prescription drug information available to the sighted public to likewise be made available to those of us with little or no vision.

Accessible prescription information is critical to the safety, privacy and independence of people who are blind or visually impaired (customers with visual impairments). All pharmacy customers, whether sighted or visually impaired, have an expectation and a right to manage their medications independently and privately and to have the confidence that they are taking their medications safely, securely, and as prescribed. For pharmacy customers with visual impairments, the inability to read medication labels, instruction sheets and medication inserts puts them at serious risk of taking the wrong medication at the wrong time and in the wrong amount, to the jeopardy of their health and safety. Without having ready access to their prescription information, customers with visual impairments are also at risk of taking expired medications, of not being able to timely obtain refills, and of being unable to detect pharmacy errors.

While many in-store and mail order pharmacies provide staff to consult with pharmacy customers, such consultations are not sufficient to protect the health and safety of customers with visual impairments. In most cases, customers take medications at home, often days or weeks after a verbal consultation at a pharmacy. Many customers have multiple prescription containers and may not be able to remember instructions for each container or identify which container is which. They may also confuse their pill bottles with those of other family members. These same pharmacies would never sell blank pill bottles to sighted customers and send them home after a brief personal consultation, but, except in rare instances, that is essentially what current policies provide with respect to customers with visual impairments.

Accordingly, the American Council of the Blind submits what we believe are best practices to ensure that pharmacy customers with visual impairments have access to prescription information which is available to customers who have sight, and which is necessary for safe, private and independent use of medications.

Prescription Medication Labels:

All information on prescription medication labels (including medication identification, usage instruction and warning labels) that a pharmacy affixes to prescription medication containers (including bottles, boxes, vials, tubes or other containers), must be made available in alternative formats, including Braille, Large Print, and audio devices.

To ensure completeness and consistency, prescription medication label information should be presented in the following sequence:

  1. Name of customer
  2. Name of medication
  3. Dosage instructions
  4. Expiration date
  5. Refill Information and Prescription Number
  6. Pharmacy name and phone number
  7. Prescribing doctor's name and phone number
  8. Warning label information
  9. Reminder for patient to "Check Information Sheet" for other important medication details.

Braille label information should be embossed on transparencies and affixed to the medication container, over the standard print label. Braille labels should be Grade 2 and comply with printing standards issued by the Braille Authority of North America ("BANA").

Large Print labels should be affixed to the medication container, and comply with the guidelines issued by the Council of Citizens with Low Vision, International (CCLVI) (see CCLVI Best Practices and Guidelines for Large Print Documents Used by the Low Vision Community, available at www.cclvi.org). In accordance with CCLVI guidelines, Large Print means: (i) a sans serif font (e.g., Arial or Verdana); (ii) font size of at least 18 point; (iii) bold type; (iv) limited, if any, use of ALL CAPITALS; (v) no use of italics; (vi) block paragraphs; (vii) page numbers in the upper right corner of each page, in the same font style and at least the same font size as other text on the page; (viii) emphasis provided by setting text apart with asterisks, dashes, double bolding, or lines, and not through use of colored text; (ix) line spacing of at least 1.5 and double-spacing between paragraphs; and (x) headings and titles that are larger than the document text, with both upper and lower case letters.

Audio devices must provide audible delivery of all prescription label information clearly and completely. Audio devices must include all ancillary equipment and batteries necessary to render the information audible to customers with visual impairments. Examples of audio devices include ScripTalk, and Talking Rx. However, the likelihood that other types of audio equipment or devices may be developed in future should not limit the choice to those mentioned.

Other Prescription Information:

It is also crucial that all other prescription information - patient information sheets or drug monographs and medication information product insert sheets - provided to sighted pharmacy customers also be made available in Braille, Large Print, audio and electronic formats. Braille must comply with BANA standards, and Large Print must comply with CCLVI guidelines.

Policy and Training Issues:

  1. Customers with visual impairments must not be charged any fee for receiving prescription information in any alternative format, including any fee for devices, batteries, or other equipment needed to access prescription information in that alternative format.
  2. Customers with visual impairments must not be required to prove disability as a condition for receiving prescription information in any format.
  3. To ensure effective delivery of prescription information in alternative formats, pharmacy personnel must be trained regarding: (i) the availability of alternative formats for prescription labels, information sheets and product inserts to customers with visual Impairments; (ii) the procedures for receiving and processing requests for prescription information in alternative formats; (iii) informing customers about the availability of alternative formats for prescription information; (iv) demonstrating the operation of any audio device used to communicate prescription information; (v) inventory procedures for ensuring adequate availability of alternative formats; and (vi) appropriate communications with customers with visual impairments.

The American Council of the Blind looks forward to participating on the working group and to promulgating best practices for pharmacies on providing safe, consistent, reliable, and independent access to prescription drug container labels to blind and visually impaired persons. Questions and/or comments regarding this document may be directed to Mitch Pomerantz, President, American Council of the Blind, (202) 467-5081, mitch.pomerantz@earthlink.net