The June 2013 issue of AccessWorld discussed the difficulty many individuals with visual impairments have accessing the information printed on their over-the-counter and prescription medicine containers. In that same issue, I reviewed the ScripTalk Station, a prescription label reader available on free long-term loan from En-Vision America.
Over the past few months there has been significant movement on the accessible prescription label front. In this article I'll discuss recently published best practices guidelines for pharmacists, and review an upcoming technology solution, the Audio Talking Label from AccessaMed.
The Access Board Stakeholder Working Group
On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act. Section 904 of the act authorized the US Access Board to convene a stakeholder working group to develop best practices for making information on prescription drug container labels accessible to "people who are blind or visually-impaired or who are elderly."
In October of 2012, the Access Board formed an 18-member working group composed of representatives from the American Foundation for the Blind, the American Council of the Blind, the American Association of Retired Persons, and other national advocacy organizations, along with representatives from industry groups, including Walgreens, Wal-Mart, Express Scripts, and Target. The goal was to create and publish best practices guidelines for accessible prescription drug container labels, including "guidance to pharmacies on how to provide accessible prescription drug container labels to patients with visual impairments to enable them to manage their medications independently and privately, and have the confidence that they are taking their medications safely, securely, and as prescribed."
The completed best practices guidelines were published on the Working Group's web site in July of 2013, and the National Council on Disability is preparing an awareness campaign to inform consumers and pharmacists of these best practices. Currently, these best practices guidelines are just that: guidelines without regulatory enforcement or penalties for non-compliance. But after 18 months the Government Accountability Office will undertake a review to assess the extent to which pharmacies are following the best practices and identify remaining barriers to information on prescription drug container labels.
The Audio Talking Label from AccessaMed
Just as these best practices guidelines are being rolled out, a new accessible prescription label option is also about to be released. The Audio Digital Label will be available in early 2014 from Seattle-based AccessaMed.
Description and Use
The Audio Digital Label is a device shaped like a chewing-gum package, measuring approximately 2 inches high by 1 inch wide by .5 inch thick, that is affixed by the pharmacist to the prescription container. The sample I received from the company came affixed with its long side running vertically against a standard-size child-proof prescription bottle. The Audio Digital Label is attached to the prescription bottle with special tape from 3M that is used in construction projects to replace nails and screws. I twisted and pulled, but the seal was so tight, I sensed either the bottle or the label itself would break before the seal would fail. The label is made of sturdy, putty-colored plastic, and there are only two visible features: A tiny speaker grille on the upper portion of the outward facing side, and a single button at the very center.
Accessing the prescription data could not be simpler. Press the button once to begin the voice announcement. Press the button again anytime during playback to silence the reading.
My sample label used the Microsoft US Zira female voice speaking at 350 words per minute. After conducting user testing, however, the company will be switching to the NeoSpeech Julie voice prior to production.
The speaker plays at 70 decibels. Holding the bottle at arm's length, the sound was a bit tinny but the information was clear and easy to understand. It was also easy to hold the speaker directly against my ear cupped in the fingers of one hand, which left my thumb free to press the button and start the voice playback, which at this point was painfully loud. Overall, the voice was loud enough to be understood easily but not so loud that the prescription information could be heard across a room.
The label begins by announcing the patient's name and the name of the medication, followed by the dosage instructions. My sample bottle contained M&Ms, and I was advised to take two tablets three times a day. (Full disclosure: I may have strayed just a bit from the prescribed dosage and frequency.)
The above information was followed in succession by the prescription number, the fill date, number of refills, and the quantity of pills contained in the prescription. Then there was something new: a description of the physical characteristics of the medication. Here the pharmacist can enter information such as "liquid gel capsules," or "oblong white pill, medium-size." This is an extremely useful feature, especially for those with a number of generic medications whose size and shape can vary between refills because the pharmacy has changed suppliers.
The label concluded by voicing the expiration date, the manufacturer's name, and the pharmacy name and phone number. The entire label took nearly 30 seconds to voice, however the information users will most often want, the patient name and medication name, are the very first to be spoken, so with two presses of the button, one to start speech and another to stop it, it only takes a few seconds to make sure you are about to swallow the right medication.
The law states that prescription containers cannot be reused, so the labels are one-time-use, after which they should be disposed of, or even better, recycled with other electronic components. The label's Coin/Button Lithium Manganese Dioxide Battery boasts a ten-year shelf life, which is far longer than any medication should ever be kept. But that's if the container sits unused on a shelf. In actual, day-to-day use the battery provides over 400 complete voicings, so even if you have a 90-day supply of a medication you can safely expect between four and five complete voicings per day for the life of that refill.
Programming the Audio Digital Label
To program the labels, participating pharmacists use a special AccessaMed docking station that attaches to their computer via a standard USB cable. The docking station costs $20 and labels run about $3 apiece, which compares more than favorably to $1,000 for the ScripTalk Programming unit and software, and $1 each for their Talking Labels.
When the docking station is connected the pharmacist is given the option to program the Audio Digital Label with the same information to be printed on the medication container. The pharmacist can also include the physical description of the pills or tablets, and choose whether to include a letter-by-letter spelling of the prescription name to be voiced immediately after the name is announced. This is a must-have feature, in my opinion. Many medicines have long and confusing names. Others may not voice properly because of unique spellings or quirks with the text-to-speech engine. There are also a number of medicines with names that sound alike, no matter how clearly they are spoken. You would not want to accidently take Xanax anti-anxiety medication when the pill you really mean to take is a Zantac to help lower stomach acid.
The "Spell" option is checked or unchecked by the pharmacist, but in my opinion it should be mandatory. Confusion over the name of a medication simply does not have to happen.
The pharmacist can change the voice speed before sending the information to the label and affixing it to the container. If the AccessaMed user picks up a prescription from the pharmacy there will be the opportunity to review the label with the pharmacist and make voice speed changes and add spelling, if necessary. But what if a family member picks up the prescription, or the medicine comes by way of one of the increasingly popular mail-order pharmacies? It would be much better if reading speed could be controlled by the use, but I'm not sure if the current hardware would allow this without cost-prohibitive modifications. Besides, offering this option would require at least one additional control, which would detract from the label's marquee feature: its utter simplicity and ease of use.
The Bottom Line
It's great to see a new player in the accessible prescription label arena. Competition leads to innovation, and it's always good to have choices.
The AccessaMed Audio Digital Labels cost three times as much as the ScripTalk Talking Labels: $3 each as opposed to $1 each, but the startup costs for AccessaMed is significantly lower: $20 versus $1,000. Smaller pharmacies that serve only a few visually impaired individuals will doubtlessly find AccessaMed the better solution. Larger chain pharmacies and mail order services may discover the ScripTalk will actually cost them less in the long run. With just twenty visually impaired customers each refilling two prescriptions per month, the extra costs of the ScripTalk solution disappears after just over one year, and after that the less expensive labels become a definite cost advantage.
People who are deaf-blind and others who rely on braille will prefer the ScripTalk solution, since it offers a computer interface. Myself, I prefer the AccessaMed solution. It's quick and easy, I can get the information I need in mere seconds, and best of all, I do not have to own and maintain yet another piece of single-purpose access equipment.
Currently, the company plans to begin production during the final quarter of calendar 2013, and begin shipping to participating pharmacies in early 2014.
208 West 13th Street
Vancouver, Washington 98660