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 : EC2
Submitter : Ms. Gale Watson Date & Time: 06/10/2004 04:06:33
Organization : Atlanta VA Medical Center
Health Professional
Category :
Issue Areas/Comments
A. Information About the Population of Interest
2. Is there an appropriate way to divide this population into subpopulations to better evaluate needs and beneficial technologies?
Because reading, writing and numeracy (literacy issues) are important to understanding and complying with medication regimes, please consider persons who are visually impaired in terms of moderately visually impaired (who may be able to benefit from enlarged print), severely visually impaired (who might be able to use optical or electronic magification devices to read and write) and profoundly, nearly total or totally visually impaired (who will require speech output in the form of electronic readers or sighted readers to manage their medication regimes). Further, it is necessary to consider that visual impairment is often associated with other disabling conditions of aging such as hearing impairment, arthritic or other hand/arm disabling conditions, and with reduced cognitive functions such as dementia. These additional disabilities will contribute to additional health literacy issues, and/or inability to use low vision and speech output devices to access medical information and use medications appropriately.
1. What is known about the population of people who are blind and visually-impaired in the United States
Please see research by Massof, et. al., and De l'Aune et. al. in relation to population statistics of US and Department of Veterans Affairs. Most visual impairment is age-related due to macular degeneration, diabetic retinopathy and cataract. See Stelmack and Massof, and De l'Aune et. al. for outcomes of vision rehabilitation programs in the Department of Veterans Affairs. There is currently no information that I am aware of on health literacy of persons who are visually impaired. We have unpublished data that indicates that persons with age-related vision loss are able to read at a similar ability (accuracy and comprehension) as their sighted age-matched peers following vision rehabilitation, but that their reading rate and duration is compromised compared to sighted age-matched peers.