Working Group on Accessible Prescription Drug Labels

Summary of Pharmacy Practices

Below is a summary of information heard by the Access Board from Working Group members on information we heard on January 10-11 on pharmacy practices to ensure that blind, visually-impaired, and elderly individuals have safe, consistent, reliable, and independent access to the information on prescription drug container labels.

The working group considered technical, financial, manpower, and other factors related to the number and operations of pharmacies, including independent retail stores, large chains, and online and/or mail-order pharmacies. The working group also considered methods and techniques of production of drug labels in alternate formats. The considerations included identifying factors that may pose significant challenges to the adoption of the best practices. While all practices may not be feasible at every pharmacy store, it is hoped that pharmacies will adopt practices that provide prescription drug label information in multiple modalities, notably visual and audio formats, directly from the local store, and arrange for the provision of medication with braille drug labels from a centralized process.

The summary is organized by general practices at the beginning, followed by pharmacy practices on producing drug labels in alternate formats.

SUMMARY

In recent years, organizations including the US Pharmacopeia (USP), the National Association of Boards of Pharmacy, and the National Council on Patient Information and Education have urged the adoption of patient-centered pharmacy practices. As an integral, first step pharmacists communicate individually with a patient to discuss medication questions and concerns, and to identify a patient’s need to access drug label information via an audio device, large print, or braille format. This is not a one-size-fits-all approach.

• Toll-Free phone numbers are used to promote individual consultation between patient and pharmacist.
• Secure websites and apps for smart devices are also used to provide patient access to electronic prescription medicine information.

Prescription Drug Labels: A prescription drug label is a legal document that must be prepared by the pharmacist filling the prescription. The pharmacist is responsible for ensuring the accuracy of the prescription medication label.

Patient-Centered Prescription Drug Label Standards Promote Patient Understanding

According to USP, lack of universal standards for labeling on dispensed prescription containers is a root cause for patient misunderstanding, non-adherence, and medication errors. In 2009, USP developed patient-centered label standards for the format, appearance, content, and language of prescription medication instructions to promote patient understanding. The standards are:

• At the top of the label specify the patient’s name, drug name (spell out full generic and brand name) and strength, and explicit, clear directions for use.
• Follow a standard format so the patient can expect that each element will be in a regimented order each time a prescription is received.
• Place in a separate area of the container less critical but important content (e.g., pharmacy name and phone number, prescriber name, fill date, refill information, expiration date, prescription number, drug quantity, physical description, and evidence-based auxiliary information)
  Simplify language. Use clear, simplified, concise, familiar words and sentences, not Latin terms or medical jargon.
• Give explicit instructions. Clearly separate the dose itself from the timing of each dose. Example: “Take 2 tablets in the morning and 2 tablets in the evening” rather than “Take two tablets twice daily.”
• Avoid ambiguous directions such as “take as directed.”
• Include purpose for medication, e.g. high blood pressure.
• Warnings: Provide alerts in simple sentences with standard icons.
• Whenever possible, the directions for use on a prescription container label should be provided in the patient’s preferred language.
• Use a non-condensed or sans serif font, such as Arial.
  
• Use non-glossy paper
• When covering label with protective transparent tape, use non-glossy tape.
• Use high-contrast black print on white background.
• Use Tall Man letters to distinguish between similar medications.
• Use sentence case, with initial capital letter followed by lower-case words except proper noun.
• Use large font size minimum 12-point. Note: 12-point Arial letters are larger than 12-point Times Roman. Do not use type smaller than 10-point font.
• Provide adequate white space between lines of text (i.e., 25–30% of the point size).
• Use horizontal text only.

Design of Prescription Drug Containers to Improve Label Readability:

• Use containers with 2 long flat sides to minimize need to turn container to read text. Reading with a magnifier is easier when the text is printed on a flat surface.
• Offer to place a color mark on all drug containers for a specific patient, e.g. a green mark on all medications for one family member, yellow for all medications for another family member. This practice reduces confusion as to which containers belong to whom, especially when two household members may take the same medicine but in different strengths.

Process to Ensure Pharmacist Proficiency in Producing Braille Prescription Drug Labels:

Online and mail-delivery pharmacies developed a centralized process to provide blind patients with braille prescription drug labels. The pharmacists in this unit are specially trained to use computer software that, as the pharmacist types the label in print, the corresponding braille letter appears below each print letter. Thus, when a trained pharmacist prints a braille label using a braille embosser, the pharmacist can verify not only the accuracy of the print label but the braille label as well. The practice includes the following:

• Use Grade 2 or contracted braille.
• Print braille label on transparent tape with strong adhesive.
• Place braille label on top of standard print label, or if printing each braille line separately, place each braille line below corresponding print line.
• Preserve full integrity of communication contained in standard print label.
• Do not fold braille label.
• Timely delivery: Consider offering overnight delivery, at no extra charge, for prescription drugs with time sensitive regimen.
• Local retail pharmacies may prefer to make arrangements with a centralized facility to provide prescriptions with braille labels, rather than incurring the expense of acquiring onsite a braille embosser and the challenge of maintaining pharmacist proficiency in producing braille drug labels.
  
  

Practice of Providing Audible Labels -- Digital voice recorders attached to a prescription drug container

Currently, pharmacies, ranging from small, independent stores to large chains, offer patients an option of an audible prescription drug label. Features of a digital voice recorded label include the following:

• Pharmacists maintain an inventory of digital audio devices.
• Upon request for an audio label, the pharmacist records all the prescription drug label information onto the audio device, and affixes it to the prescription drug container. When the patient picks up the prescription medicine, the audio label is attached to the drug container.
• The pharmacist shows the patient how to use the audible label.
• One audio device is used for each filled prescription for patients requesting this device.
• The audio label is provided at no extra charge for the prescription. Some include a dose-timer (beeps alerting the patient that it’s time for a refill).
• When recording, the pharmacist speaks in a clear voice.
• The pharmacist records the device in a location that minimizes any background noise.
• Pharmacist ensures audio device provides adequate time to record all information printed on prescription label.
• Pharmacist reviews recording to ensure it includes all information printed on prescription label.
• Pharmacist ensures that audio device adheres firmly to prescription drug container.
• Pharmacist provides at no extra cost any ancillary equipment and batteries.
• Pharmacist selects devices that provide independent, easy to use, start/stop operation, with adequate volume, and the number of repeat start/stop operations exceeds the life of the prescription.

Practice of Using Audio Labels: Radio Frequency Identification (RFI) Tags

Currently, many pharmacies are using RFI text-to-speech technology to provide patients with vision loss access to information on prescription drug labels. Using this practice, a pharmacy equips a patient with vision loss with a small device at no charge to the patient. When the pharmacist fills a prescription, the pharmacist places an RFI tag on the drug container. The patient waves the drug container over the small hand-held device, which, via synthetic electronic speech, announces all information on the drug label.

• Each time a pharmacist fills a prescription, the pharmacist attaches a radio frequency identification tag to the prescription drug container. The patient uses the same hand-held device for all prescriptions. When the patient waves the prescription drug container over the device, the device announces in a clear, synthetic voice, all of the information contained on the prescription drug label.
• The RFID can be used with containers of various sizes, shapes, and materials.
• RFID audio labels can translate drug label information into several languages.

Practice of Printing Large-Print or Enlarged Duplicate Drug labels:

The practices listed below build upon the patient-centered standard prescription label practices discussed above.

• Use Sentence Case, not all capital letters
• Use sans-serif font,
• Use 18 font size upon request.
• Provide spacing between headings and information; Make headings bigger than text
• Provide 1.5 line spacing; double spacing between paragraphs
• Use bold type; no italics
• Use non-glossy paper (and non-glossy tape)
• Use print with highest possible contrast between text and background color (ideally black text on a white or pale yellow background)
• Affix fold-out large print label to container.