June 25, 2004

Division of Dockets Management

HFA-305

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

SUBJECT: Docket 2004N-0221

The American Foundation for the Blind is pleased to have the opportunity
to submit comments to the FDA for the *Medicare Prescription Drug
Improvement and Modernization Act of 2003: Study on Making Prescription
pharmaceutical Information Accessible for Blind and Visually Impaired
Individuals.* AFB is providing information in response to the following
requests:

-   Information About the Population of Interest

-   Information About the Use of Prescription Medication Information by
    this population

-   Information About Emerging and Existing Technologies

The mission of the American Foundation for the Blind is to enable
persons who are blind or visually impaired to achieve equality of access
and opportunity in all aspects of society. AFB accomplishes this
mission, in part, by taking a national leadership role in the
development and implementation of public policy and legislation.

These comments were prepared by the Governmental Relations Department in
collaboration with the staff of AFB's National Aging Program, National
Literacy Center, Technology and Employment Center, and Department of
Policy Research and Program Evaluation.

We commend the FDA for the comprehensive outline of questions provided
to assist public comment. When used correctly, prescribed medications
have the potential of greatly improving the health and independence of
older individuals who are blind or visually impaired. However, as we
point out in detailed responses to these questions, older individuals
who are blind or visually impaired face severe and sometimes dangerous
challenges in managing their medication.

Respectfully submitted,

Alan M. Dinsmore

Sr. Governmental Relations Representative

American Foundation for the Blind

Washington, DC 20002

202-408-8171

[[adinsmore@afb.net]{.underline}](mailto:adinsmore@afb.net)

Corinne Kirchner

Dr., Policy Research & Program Evaluation

American Foundation for the Blind

New York, NY 10001

212-502-7640

[[corinne@afb.net]{.underline}](mailto:corinne@afb.net)

**SUMMARY STATEMENT**

Estimates, taken from federal surveys, of the prevalence rates and
numbers of vision impairment (including blindness) vary greatly.
However, those surveys reveal quite consistent *relationships* of visual
impairment with socioeconomic, demographic and health characteristics.
Visual impairment is associated with older age, lower educational and
economic levels, multiple impairments, and poor health. Taken together,
those characteristics have a generally negative affect on the population
of interest\'s health literacy and adaptive learning capabilities
necessary to access prescription information. Other types of impairment
associated with visual impairment, notably hearing loss, further
complicate access to this information.

Organized data regarding inappropriate use of medication while the
medication is in the control of the consumer are lacking because neither
of the national medication error reporting programs has specific codes
related to blindness and vision impairment. Because strong anecdotal
information does exist regarding medication error, we ask that the FDA
provide immediate attention to development and use of such codes.

Technology which can access the full range of information necessary to
effectively manage medication is available, but only at high cost to the
consumer. Outside of the programs of the Department of Veterans Affairs,
no third-party reimbursement is available for any of these devices.
Limited-use technology such as a "talking" prescription bottle is
available at little or not cost. At present, few of these devices have
had the benefit of study to determine their impact in reducing
prescription error.

**RESPONSES TO SECTION A, "INFORMATION ABOUT THE POPULATION OF
INTEREST"**

Prevalence Estimates and Data Sources

\[Note: Because FDA\'s study is focused on Medicare, the population of
interest is predominantly the elderly population, 65 years and older. Of
course, Medicare covers persons under age 65 who qualify on the basis of
disability; thus we refer to data sources that include the broader
group.\]

Several federal surveys inquire about respondent\'s visual status, along
with demographic variables and health-related information relevant to
FDA\'s study on making prescription pharmaceutical information
accessible to the visually impaired population. \[Note: for brevity,
referred to as \"prescribed drug\" below\].

Before listing those surveys as data sources, and then presenting some
findings that help to answer FDA\'s study questions, we must point out a
serious barrier to estimating the "scope of the problem" in terms of the
prevalence of vision impairment. The barrier is that every one of the
relevant federal surveys asks about visual impairment in a different
way. Not surprisingly, therefore, the resulting estimates of prevalence
of visual impairment vary so widely as to be of questionable utility.

Estimates of the number of people with difficulty seeing (even when
using one\'s usual eyeglasses), in the U.S. non-institutionalized
population, range from as low as 7 million to as high as 20 million
people (all ages). There is greater consistency in estimates of the
number of people with very severe visual impairment, i.e., cannot see at
all, or almost not at all; the latter group is estimated as
approximately 1.5 million to 2 million people. Of course, the target
population for FDA\'s study should not be limited to that most severely
impaired group. That is because high potential for error in managing
one\'s prescribed drugs applies to people who have *difficulty seeing*,
as well as those who *cannot see*, although the solutions for avoiding
such error in self-care will be different for those sub-groups based on
severity of vision impairment.

Best corrected" versus "usual correction: The surveys referred to above
(and below) use self-reports of people's functional visual ability with
their usual eyeglasses ("usual correction"), or with no eyeglasses if
they are not usually worn. In other words, such surveys reflect the
usual circumstances in which people manage their prescribed drugs. Part
of that reality is economic, keeping many people from using optimal
vision correction. This reality contrasts with recent epidemiological
data published in the *Archives of Ophthalmology,* under National Eye
Institute auspices.

That report estimates that about 3.4 million Americans are visually
impaired (20/40 or worse acuity, including blind), but it employs a
clinical measure by which people in the sample use the best possible
correction of their vision, and are assessed under optimal testing
conditions, e.g., good lighting, lack of clutter, concentration on the
visual task, etc. In other words, the clinical criteria are not relevant
for FDA\'s study because they do not reflect the usual conditions under
which people use vision (or alternatives to vision) for managing their
medications.

Relevant Federal Surveys \[and the agencies responsible for them\]: The
following listing shows whether each survey is conducted on a recurrent
basis, thus indicating its potential as a source for estimating *trends*
in the prevalence of visual impairment by age group. Recurrent studies
also may offer potential for future inclusion of survey items by the FDA
designed to answer questions in its current study that must go
unanswered with existing data. (See \"Long-range and short-run
research...\" below).

1\) National Health Interview Survey (NHIS) \[National Center for Health
Statistics, NCHS, of the Centers for Disease Control and Prevention -
CDC\], conducted annually. For the two-year period, 1994-95, NHIS added
a one-time "Disability Supplement" (NHIS-D)[,]{.underline} which is a
particularly useful source for certain items; of all the surveys, it is
the only one that asked about "legal blindness."

2\) Survey of Income and Program Participation (SIPP) \[Bureau of the
Census\], conducted annually, however, the question about visual
impairment is included only periodically. The following surveys also
provide periodic data on vision impairment:

3\) Medical Expenditure Panel Survey (MEPS) \[Agency for Healthcare
Research and Quality AHRQ\],

4\) Medicare Current Beneficiary Survey (MCBS) \[Centers for Medicare
and Medicaid Services, CMS\].

Long-range and short-run research to answer FDA's questions: For future
research on prescribed drug management, as well as an array of other
health care issues faced by people with visual impairment, it is
critical that work be undertaken to standardize the survey measures that
identify that target population. Of course, methodological work is
necessary first to determine which measure(s) should be promoted as the
standard. That is the long-range task.

For the short run, a focused analysis of the listed surveys, including a
methodological review of the vision items, would have a meaningful
pay-off to answer FDA\'s questions in its current study. The proposed
study \[lasting 6 months -- 1 year\] would provide useful data on health
service utilization patterns, including prescribed drug use, by the
population of interest, and detailed data on their relevant
socio-demographic characteristics. It could yield a solid basis for
projecting the costs and benefits of alternative solutions to the
problem of safely and effectively managing prescribed drugs, with
blindness or visual impairment. Thus, such analysis could answer the
FDA's questions more reliably and with more explanatory power than is
currently possible.

Socio-economic, Demographic and Health Status Patterns. - In spite of
wide variation in estimates of the *size* of the population of interest,
the studies consistently find certain *relationships.* The following
associations of visual impairment and other individual characteristics
are clear and relevant.

\(1\) Aging: the rate of visual impairment increases with aging, e.g.,
the rate is higher in each older cohort. This finding also means that
most people (in the U.S.) who are elderly and visually impaired acquired
the impairment recently, as they aged. A small subgroup, of course,
became visually impaired at birth or in youth and then became aged; that
small subgroup is more aware of and adept at using alternatives to
visual information than is true of the vast majority of their visually
impaired peers.

\(2\) Severity of Vision Loss: By far most people with visual impairment
have some ability to see, although it is more or less severely limited,
even wearing glasses. Even the group mentioned above, estimated as 1.5
-- 2.0 million most severely visually impaired, includes many with
slight ability to see. The \"totally blind\" population is estimated at
well under 500,000.

\(3\) Multiple impairments: most people with visual impairment (i.e.,
two-thirds or more) also have one or more other impairments that must be
considered in selecting solutions to problems with using visual
information about prescribed drugs, e.g., hearing impairment and/or
limited dexterity. Furthermore, the rate of multiple impairments of
which visual impairment is one, increases with aging.

\(4\) Health status: It is important to distinguish between
\"impairment\" and \"general health.\" Indeed, the public health goal
for the nation is for people with impairments, visual or other, to
maintain good health. Nevertheless, studies show that people with visual
and other impairments have poorer health than the general population,
and thus have greater need for prescription drugs.

5\) Economic resources: the rate of visual impairment decreases with
higher family income, e.g., rates are highest among people in poverty,
and conversely, people with visual impairment are likely to be
financially constrained

6\) Educational attainment: Mainly because of the older age of the
visually impaired population, it has substantially lower educational
attainment than the general population. Among people 65 and older, each
younger cohort has a higher percentage who have completed high school
(i.e., people who are 90+ have lower educational attainment than those
in their 80s, etc.), a pattern that applies to the general population.
However, because of the association of poverty and impairment, the
education difference between the visually impaired and general
population persists even in younger cohorts. Education, of course, has a
direct relationship to health literacy, as well as access to and
training in computer and other technologies used as alternatives to
print.

The following are some additional findings from various sources, shared
as preliminary and rough estimates, for purposes of FDA\'s current
study. The proposed short-term focused review of the listed surveys
would allow more certainty around these and similar statements.

-   As an approximate mid-point estimate in the range of prevalence
    estimates: About one in six, or 6.5 million Americans age 55 and
    older, report vision loss even with usual glasses. This number is
    expected to double by 2030 as baby boomers age and the older
    population climbs to 78 million or about 20% of the overall
    population.

-   Four of the five major causes of blindness and vision impairment are
    primarily related to aging: macular degeneration, cataracts,
    glaucoma, and diabetic retinopathy.

-   According to the National Eye Institute, glaucoma rates are
    dramatically higher for the population who are African-American or
    Hispanic than among Whites.

The FDA study asks specifically about prevalence of hearing loss and
other "co morbidities." (See above re \"multiple impairments.\") NHIS-D
shows that the rate of multiple impairments steadily increases with age,
such that virtually everybody 90 years or older who is visually impaired
reports other impairments. It also shows that about 30% of people 65 and
older who are visually impaired, report hearing impairment. Another
source of information on co-morbidities is an analysis of program
participants in the only federally-funded program serving older blind
individuals (Title VII-Chapter 2, \"Independent Living Services for
Older Individuals Who are Blind,\" Rehabilitation Act of 1973, as
amended). Note that \"Chapter 2\" participants are not a representative
sample of the nation. A report of 2002 data from Chapter 2, prepared by
the Mississippi State University\'s Rehabilitation Research & Training
Center on Blindness and Low vision found, in descending order of
prevalence, the following conditions: cardiovascular, muscular/skeletal,
diabetes, and hearing loss.

Health Literacy and Adaptive Learning Capabilities

Technology has significant potential for assisting older individuals who
are blind or visually impaired to more effectively and safely manage
their medications. AFB\'s Technology and Employment Center\'s extensive
experience in evaluating assistive technology provides clear evidence
that *access* to the information is not the same as *learning* the
information. Simply providing the technology without recognizing the
training needs and learning skills of an older individual, almost
guarantees that the device will go unused.

The National Library of Medicine defines health literacy as the "degree
to which individuals have the capacity to obtain, process, and
understand basic health information and services needed to make health
decisions." The National Adult Literacy Survey (NALS) of 1993, indicates
the potential for a serious problem. It found that 75% of American
adults who reported having an impairing health condition scored in the
two lowest literacy levels. (Note: Data from the 2003 survey will be
available for analysis soon; we recommend they be examined as part of
this study.) Two difficulties with NALS concern us for the current
purpose. First, visual impairment was asked in yet another way, compared
to the other federal surveys; second, no questions documented use of
optical aids, screen readers, or non optical aids such as reading stands
and writing guides. We cannot be sure that those reporting vision
impairment scored lower on the tests of literacy because they did not
have adaptive aids. If they did have them, we do not know that they were
able to use them efficiently.

Clearly, the impact of vision loss on document literacy is greater if
consumers also have difficulty using assistive technology, compounding
their difficulty understanding printed prescription material which often
contains charts, graphs, and tables.

We strongly urge the FDA to consider developing a comprehensive study
that explores more fully the relationships among literacy, visual
impairment, and managing one's health care safely and effectively.

**RESPONSE TO SECTION B, "INFORMATION ABOUT THE USE OF PRESCRIPTION
MEDICATION INFORMATION BY PEOPLE WHO ARE BLIND OR VISUALLY IMPAIRED"**

AFB has discussed this issue in detail with U.S. Pharmacopeia. We
understand that they will file in response to this docket. Unfortunately
neither of the two USP medication error reporting programs, USP-ISMP
Medication Errors Reporting (MER) Program and MEDMARX, has codes
specific to blindness or visual impairment. We understand that USP is
sharing some reports which have been generated by general text-querying
methods which produced 13 reports from the MER program and four reports
from MEDMARX.

As stated in our summary, there is anecdotal evidence which, taken in
combination with the MER and MEDMARX findings, indicates the necessity
of addressing the problem of data collection regarding medication error
as it relates to blindness and vision impairment. For example, Drug
Topics of February 23, 2004 published by Advanstar Medical Economics
Healthcare Communications reports that the Institute for Safe Medication
Practices now considers insulin a high alert medication -- one requiring
special handling to insure its safe use.

Good safe use practices should include accentuation of differences
between look-alike products, safe storage, and stickers to call
attention to important but easily missed information. These safe
handling suggestions require visual access to the information.

The report also notes that "Experts are concerned that the problem may
get worse. The American Diabetes Association estimates that as the
population continues to age, more people will develop diabetes, causing
insulin use to increase 26% in Type 2 diabetes patients and 10% among
those with type I by the year 2006." We add our concern that concomitant
incidence of diabetic retinopathy will increase the need for accessible
medication information along with accessible health monitoring
equipment.

Our concern over the lack of reliable data was increased after examining
the findings in the "Since You Care" guides jointly published by the
National Alliance for Caregiving and MetLlife. "Older Americans are
hospitalized six times more than the general population due to adverse
drug reactions." The guides also state the following: "Studies have
shown that fewer than 30% of older adults take their medication
properly."

Because a wide array of issues affects proper use of prescription drugs,
we do not assume that the error rate is entirely due to blindness or
vision impairment. However, the association of aging, vision loss, and
high needs for health care including medication is well-established and
needs to be examined more closely.

The FDA study also asks how people who are blind or visually impaired
currently get their prescription drug information. We asked the
Directors of the above captioned Chapter 2 programs to help us respond.
We provide the bullet items as a summary of responses.

-   Friends and/or family members read the medication bottle information
    or the pharmacist may read the information to them.

-   They try to memorize the shape of the pill as it feels in their
    hands because the print is too small and the bottles are the same
    size.

-   Those with remaining vision use extra task lighting and some use
    magnifiers.

-   Those living alone must often rely on the memory, reading skills,
    and good graces of the next visitor to help them if they become
    confused by the passage of time and the need to memorize other
    information.

-   A few use so-called talking pill bottles which identify medication
    and related prescription information. These devices are not usable
    for individuals with hearing impairment.

-   Patients who are diabetic do not have reliable or wide spread access
    to health monitoring equipment such as blood glucose monitoring
    systems needed to alert them to insulin requirements.

Clearly, fall-back on such approaches creates the potential for serious
error.

**RESPONSE TO SECTION C, "INFORMATION ABOUT EXISTING OR EMERGING
TECHNOLOGIES"**

We combine our response regarding existing and emerging technologies
with a response to the Section B question regarding effective
communication of essential drug information. Currently available
accommodations capable of providing prescription information range from
low-end, low-cost items like bold line or raised line paper for note
taking, and high-intensity lamps to higher cost video magnification
equipment and to the highest end of the cost scale, personal digital
assistants with Braille input/output, and specialized speech output
software for computers. We direct the FDA to
<http://www.afb.org/Section.asp?SectionID=4&TopicID=31> for complete
explanations and price ranges for such equipment.

Effective communication of essential prescription information is
dependent on significant variables like remaining useful vision,
educational attainment, and availability of appropriate training in the
use of technology. Anecdotal evidence from the Chapter 2 program shows
that, when proper instruction is available, older individuals who are
blind or visually impaired effectively used remaining vision to use some
of this equipment. Much of the available assistive technology which
could be used for the purposes described in the study has been evaluated
by AFB's technical experts at the AFB TECH Product Evaluation
Laboratory. These objective evaluations have involved testing of product
performance and ease of use for reading tasks undertaken by a younger
population than targeted by the FDA study. AFB would look forward to
performing evaluations more targeted to the study population.

Before examining available technology, its utility for medication
management, and sources of reimbursement, it is necessary to have a
greater understanding of the tasks which a blind or vision-impaired
person must master in order to manage proper use of prescription drugs.
The FDA's own Center for Drug Evaluation and Research provides a good
sense of the comprehensive range of information necessary for effective
prescription drug management. Almost every one of these elements
pertains to access to printed information. As we read "Medicines and
You: A Guide for Older Adults" it became apparent that older individuals
need more information than is on the prescription container.

Single Purpose Devices

Hand-held magnifiers, plastic pill organizers, and alarms can help.
These items are typically very low cost. However, individuals with
vision impairment require training in use of remaining vision to use
such devices.

Moving toward the higher end of such devices, some pill organizers also
have a record feature so that an individual or a health care provider
can record memos with specific information about each medication. There
are other tools on the market which employ bar codes and hand-held
scanners to label and identify items, and others which can record memos
that correspond to bar codes placed on the items. Although these
approaches can improve access, they rely on the user or health care
provider to create the proper memo for every medication, adding further
potential for error.

Other products use similar scanning technology. However, the labels are
created by the pharmacy when the medication is purchased which does
reduce the potential for user error in labeling. The pharmacy must have
the software to produce the labels.

Multi-Purpose Information Access

One of the more commonly available devices, the closed-circuit
television (CCTV) may have significant utility for accessing
prescription drug information. CCTVs use a stand-mounted or handheld
video camera to project a magnified image onto a video monitor, a TV
screen, or a computer monitor. Such devices range in price from \$400 to
\$1,000 for those that plug into a TV to \$1,800 to \$4,000 for stand
alone devices.

Optical character recognition (OCR) devices provide more versatility.
Initially, a printed document is scanned by a camera. OCR software then
converts the images into recognized characters and words. A synthesizer
in the OCR system than speaks the recognized text. Finally, the
information may be stored in a personal computer or the memory of the
OCR system itself. In some OCR systems these files can be converted into
other formats retrievable by commonly used software. The user can also
access the scanned text by using adaptive technology devices that
magnify the computer screen or provide speech or Braille output. Self
contained OCR systems or those that are bundled with a PC are in the
\$4,000 to \$5,500 price range.

At the highest end, there are currently available several competitive
products using Braille and standard typewriter keyboard input which
function in a fashion similar to a personal digital assistant. These
have highly useful functions for note taking and task management which
can be essential for effective medication management. However, they
range in price from \$1,400 to over \$5,000 and require significant
training and advanced personal computer management skills.

A significant emerging technology is based on a new specification for
digital talking books developed through the Digital Audio-based
Information System consortium which would allow content to be delivered
on a CD-ROM for reading in specially designed players, repurposed into
Braille and large print, accessed over the Internet, or even through a
touch-tone telephone. The great attractiveness of this technology is
that it can be deployed via the telephone which does not require
complicated instructions and experience in use. In addition this
technology can provide important privacy protections.

There are three drawbacks for all high-end multi-purpose access devices.
The first is expense. Outside of the Veterans Administration programs
and limited low-tech purchases for clients of the Chapter 2 program,
there is no third party reimbursement from government or private
insurers. This may be a small factor in the purchase of very low end
products because they are simply not very expensive. It is certainly a
factor for the above referenced devices which can cost a consumer from
several hundred to several thousands of dollars The second drawback is
very significant. There is a general lack of awareness of the existence
of these products by both blind and visually impaired older persons and
their health care providers. Finally, while some of the high end devices
have great utility for displaying, storing and managing prescription
drug information, they are complex devices and effective use depends on
a high degree of literacy.

In conclusion, we commend the FDA for this comprehensive set of
questions. However, AFB believes that further study is needed before
actionable conclusions can be made with regard to prevention of error
and the potential for assistive technology to provide a basis for
reliable management of prescription drug information.