2004N-0221 - Medicare Modernization Act Section 107(f) - Study on Making Prescription Pharmaceutical Information Accessible for Blind and Visually-Impaired Individuals; Establishement of Docket
FDA Comment Number : EC6
Submitter : Ms. Rebecca Criswell Date & Time: 06/18/2004 04:06:17
Organization : Iowa Department for the Blind
State Government
Category :
Issue Areas/Comments
I manage the Independent Living Services for Older Individuals who are Blind program at the Iowa Department for the Blind. In my position I have heard innumerable accounts of the challenges elderly, visually impaired persons face as they struggle to independently meet their own health care needs or those of a dependent spouse (or sometimes an adult child or even grandchild). Chief among these serious concerns are the simple identification of different medicines and access to information about drug usage.

Our staff work with individuals to develop non-visual methods for identifying different medicines and independently administering and managing medication schedules. There are certainly some individuals who can benefit from instruction in and use of tactile labeling techniques and methods of organization. These approaches work well for individuals who are on a limited number of medications. However, there are many individuals who take multiple medications throughout the day. Their medication regimens can involve complex instructions that require some medications to be taken a set amount of time before meals, some to be taken with meals, and still others a set amount of time after meals. When multiple medications are prescribed for varying times and dosages throughout the day it becomes impossible to devise efficient, nov-visual systems that enable individuals to safely manage their own medication.

Currently, the only viable alternative is for the individual to relinquish control over his or her medication to someone else such as another family member, a friend, or a paid in-home health provider. Obviously, this creates a dependency on others for care that is critical to one's good health and well-being, and individuals who were accustomed to being self-sufficient are given another reason to feel both diminished and vulnerable. Additionally, since it is frequently necessary to rely on paid health care providers for this service, another cost has been added to an already financially burdened health care system.

Blind and visually impaired individuals are also critically disadvantaged by an inability to access information about drug usage such as possible side effects, drug interaction, and dietary or behavior restrictions (i.e., avoid dairy products, avoid direct sunlight, or discontinue the use of certain over the counter medicines). Many older, visually impaired individuals do not pick up their own prescriptions. As a result, they frequently miss the advice or cautionary statements made by pharmacists; and, of course, information on print inserts is of no benefit to them. None-the-less this information is extremly important, and without it individuals are at risk of engaging in practices that may have serious consequences to their health.

Clearly there is a pressing need for blind and visually impaired individuals to have independent and immediate access to information that is vital to their health care. It is my hope that advances in technology can be harnessed to meet this need. Past solutions such as tactile markings or reliances on others fall short for many individuals who are on a complex regimen of medication. Simple scanning technologies that allow an individual immediate access to label and package insert information would be ideal. Such an accommodation would allow many to independently and safely manage their own medication and regain control over a significant aspect of their health care.