| 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 :||EC21|
|Submitter :||Dr. Aries Arditi||Date & Time:||07/07/2004 06:07:34|
|Organization :||Lighthouse International|
| 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?|
| In general, visually-impaired people, whether blind or partially-sighted, adapt to their vision impairments better than do older people who become impaired late in life. Few elders learn Braille and relatively few (though an increasing number) are generally learn to use adaptive technologies like computer screen readers and screen magnifiers. In addition, many older people who lose vision experience depressive symptoms and depression for extended periods of time. Older people in coming generations will probably become more comfortable with the new technologies of today, but perhaps not those of tomorrow.
One meaningful way to divide this population into segments for purposes of evaluating needs and technologies, is to consider those who are Braille readers, those who access information via computer, and those who have no direct access, i.e. those who require the assistance of a sighted person or another visually-impaired person with access, to obtain their information.
|1. What is known about the population of people who are blind and visually-impaired in the United States|
| There are many good sources of information about the population in question. See, for example http://www.lighthouse.org/research_statistics.htm. The vast majority of visually-impaired people are older Americans, and the bulk of the visually-impaired population encounters vision problems late in life, as the result of with age-related eye diseases. The main age-related eye diseases resulting in low vision and blindness are macular degeneration, diabetic retinopathy, glaucoma and cataract. A smaller but significant number of younger people acquire eye disorders at various ages, or have congenital disorders and disorders resulting from premature birth.
The oldest portion of the older population is the fastest growing segment of the population. This rapid growth is causing a shift in the distribution of the visually-impaired population from more mild forms of low vision to more severe low vision and blindness. In addition, the growing ?oldest old? population is resulting in more people with multiple impairments and disabilities.
The most prevalent forms of low vision (macular degeneration, diabetic retinopathy) produce visual field defects to the central portion of the visual field---that portion that predominantly mediates reading, color perception, and perception of fine details. The advanced forms of other eye diseases also affect central vision. Such problems interfere with reading, of course, of prescription drug labels. The small package size of many prescription medications limits the size of print on the labels, which further compounds the problem, and makes it difficult even for those with very mild low vision
| B. Information About the Use of Prescription Medication Information By People Who Are Blind or Visually-Impaired|
|1. How do people who are blind and visually-impaired currently get their prescription drug information?|
| Blind persons usually get their prescription drug information primarily from sighted family members and friends. Often, a rehabilitation teacher (RT) will help set up a visually-impaired consumer with some kind of system for accessing their current medications, but since the relationship between an RT and a consumer tends to be time-limited, the system is not always easy to update when a new medication is prescribed.
Depending on the severity of their low vision, those with low vision get their prescription drug information either from sighted family members and friends, or by using optical and/or video magnifiers. Video magnifiers, also known as CCTVs (closed-circuit televisions), are especially capable, as they can providemuch higher levels of magnification than optical aids. In addition they often incorporate contrast enhancement and contrast reversal, which can also further increase readability of drug labels and information.
|2. What aspects of visual impairment are important to addressing the issue of access to prescription drug information?|
| For all visually-impaired persons, it is essential to provide accessible information about prescription medication, and about potential interactions with nonprescription medications. Such information should be communicated in a manner that respects privacy, i.e. one that allows the blind person to obtain the information independently. This can be done with Braille for Braille readers, but it must be provided in some other accessible medium for those who do not read Braille. Internet and telephone communications are possible, recognizing that many visually-impaired persons do not have access to the Internet, and many are hearing- as well as vision-impaired.
People with low vision span a huge range of visual acuities and other visual capabilities, so it is impossible to recommend a single fixed large print size, for example, above which everyone can be assumed to be able to read. Those with mild low vision may be able to access drug information with large print; moderate and severe low vision will require more elaborate solutions, including Internet and telephone access.
Probably the most important issue to address in providing accessible information is the recognition that multiple means of communication will be required to make drug information accessible to all visually-impaired people.
|3. How can essential drug information be effectively communicated to people who are blind or visually impaired?|
| Generalizations about this are difficult. Blind and partially-sighted persons use a wide variety of communications methods, including large print, computer screen readers, optical and video magnifiers, computer magnification software, Braille, and telephone. Providing accessible information through all of these will reach a large proportion of visually-impaired people, but restricting it to a subset will not. A central repository of prescription drug information on the Internet is one step toward providing access to all visually-impaired consumers, but making the information accessible to all such consumers requires recognizing that vision impairment is a broad spectrum ranging from mild low vision to complete blindness, and that it affects people with limited access to technology as much as, if not more so, than those who have facility with new and emerging technology.|
| C. Information About Existing and Emerging Technologies (Including Internet-based Information Sources)|
|1. What assistive technologies are currently used by people who are blind or visually-impaired? In what setting?|
| Asko's Aloud system is a labeling device that allows a visually-impaired consumer to hear medication identification information read out to them. The system accepts a range of bottle sizes, but does not accept boxes or nonstandard medication packages. Each talking label, which resides on a chip affixed to the bottom of the bottle, must be recorded (by the pharmacist on one model and by either the pharmacist or the consumer on a second model), and labels and the reading unit must be purchased by the consumer. The playback device costs about $80-90 to the consumer, $50.00 to the pharmacist, and about $12.00 per (reusable) label. Few pharmacists offer this system, but one model can be recorded by the consumer.
En-vision?s ScripTalk system is similar in concept, except that it uses passive RFID tags that can be embedded right in the label. Instead of the sampled voice output of the pharmacist, the consumer hears synthesized speech. The data recorder costs $1,000 to the pharmacist.
Millenium?s TalkingRX system is a $19.95 recording and playback holder for a single medication. It is recorded into by the consumer. One device is needed for each medication taken by the consumer.
The IdentiMed System is a journal system for medications that , in combination with raised dots, lines, and other labeling techniques, can help in effective medication management.
Some Rehabilitation Teachers are recommending the use of talking picture albums as a system for recalling drug information. The picture slot may hold an enlarged image of the bottle or label, or Braille identifier, while the recorded message can include dosage, times taken, and other information.
|2a. What aspects of visual impairement are important to addressing the issue of access to prescription drug information?|
| Most of the technologies described above (except ScripTalk and one model of Aloud) require the consumer to record the information. These systems then, do not address the issue of how the blind or partally-sighted consumer gets prescription drug information in the first place---only how they recall it. The information on these systems, then, is only as good as the information the consumer records into them.
More general accessibility solutions, especially relating to reading and to computers, can be found at http://www.visionconnection.org/Content/Technology/AssistiveTechnologies/default.htm.
|3. Are there data on the effectiveness of these technologies?|
| The prevalence of use of all of these technologies is not known, nor are there studies, to our knowledge, of their effectiveness. Blind and partially- sighted consumers usually learn about such technologies through rehabilitation teacher, or through word-of-mouth.|