President's Message: Making Sausage or, Those Devilish Details, by Mitch Pomerantz

We have all heard that old saw to the effect that there are two things you really don't want to see made: sausage and legislation.  Let me add a third item to that short list; namely, regulations or in this case, a document outlining best practices for the provision of accessible prescription drug label information.  Let me explain.
 
As almost everyone likely knows by now, this past July Congress passed, and the President signed, P.L. 112-144, the Food and Drug Administration Safety and Innovation Act.  Among other things, the statute called for the establishment of a working group "to develop best practices on access to information on prescription drug container labels for individuals who are blind or visually impaired."  On Jan. 10 and 11, I spent a day and a half at the headquarters of the United States Access Board in Washington, D.C., along with nearly a score of individuals representing the blind and visually impaired community, senior citizens' organizations and the pharmacy industry to begin the process of drafting those best practices.  Aside from ACB, other participants from our community included the American Foundation for the Blind (AFB), Blinded Veterans of America (BVA), Council of Citizens with Low Vision International (CCLVI), and the National Federation of the Blind (NFB).
 
Prior to our meeting, participating organizations were invited to submit comments on what we believe would constitute "best practices" for provision of accessible prescription drug label information.  Along with ACB, I am pleased to say that CCLVI submitted a paper, as did our colleagues from AFB.  I need to acknowledge here the efforts of Linda Dardarian, one of our attorneys involved in ACB's structured negotiations efforts, for taking the lead in drafting ACB's best practices document.
 
In ACB's Statement on Best Practices for Prescription Drug Labeling, we recommend a broad range of accessibility options including braille, large print and the use of audio devices, recognizing that blind and visually impaired people represent a broad spectrum of abilities and ages and thus, one or even two methods for providing information may not address everyone's needs.  The full text of ACB's statement may be found at www.acb.org/node/1142. It is also available by going to the Advocacy link on the home page, then clicking the link called ACB's Statement on Best Practices for Prescription Drug Labeling.  Here is an excerpt from the introduction:
 
"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."
 
During the meeting, groups representing the various consumer constituencies were each given an opportunity to describe our positions relative to what we felt should be best industry practices for the provision of accessible information.  I am pleased to say that among those of us representing blindness-specific organizations and agencies, there was absolute agreement regarding the need for a broad range of accessibility accommodations, both low- and high-tech.  Several industry representatives commented that they hadn't realized how many different options were potentially available for making drug label information accessible.
 
Then it was the turn of the industry representatives to talk about what they had already done, or would be doing soon, to provide accessible label information for their blind and visually impaired customers.  Several individuals representing well-known chain pharmacies mentioned their initiatives but, not surprisingly, failed to mention that these initiatives were the direct result of the structured negotiations activities undertaken by Linda Dardarian and Lainey Feingold on behalf of ACB and several state ACB affiliates.  All I could do was to mentally shake my head and smile at the omission.
 
A number of vendors demonstrated products to make it possible to access the printed information contained on prescription labels.  A couple of those products are familiar to ACB members who attend affiliate and/or national conventions, but at least two vendors showed items that were entirely new, at least to me.  Those new products emphasize a point which we made in our written statement: that whatever methods for achieving accessibility are recommended, we must keep the door open for innovative solutions to providing access.
 
It became apparent to all of us representing blind and visually impaired consumers that while the industry agrees in theory that we should have access to the same information as sighted customers, we are still a long way from achieving unanimity regarding how that should happen.  While a couple of participants representing chain and/or mail-order pharmacies did seem genuinely willing to think out-of-the-box in terms of overcoming obstacles such as the small size of printed labels and the length of time available on speech chips (for talking bottles), there was definite resistance from those representing the industry to a number of the proposals suggested by those of us representing blind and visually impaired consumers.
 
At least one teleconference meeting has been scheduled with the expectation that others will be necessary before a final best practices document is released during July, the deadline imposed by Congress in the statute.  It's a good thing that I like sausage.