| 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 :||EC16|
|Submitter :||Mrs. Shelia Wright||Date & Time:||07/07/2004 06:07:09|
|Organization :||National Federation of the Blind|
| A. Information About the Population of Interest|
|1. What is known about the population of people who are blind and visually-impaired in the United States|
| Estimates tell us that 74% of blind persons who are of working age are either unemployed or under employed; Therefore, methods of perscription identification need to be developed that will be affordable and/or covered by medicare. Furthermore, the largest population of newly blind persons are senior citizens and this population will triple as baby boomers reach retirement age. While some blind people can read braille which can be helpful in identifying perscriptions, a majority of blind and visually impaired citizens cannot read braille and many have difficulty feeling tactile markings because of neuropathy. Therefore, audable devices and other reliable methods are needed to enable blind persons to manage their medications independently. |
| 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?|
| I am blind and because I have never had to take more than thre medications at one time, I generally ask my doctor and the pharmacist about perscriptions. I rely mostly on my memory to remember the details. I go by the size of the bottle and the size and shape of the pill to tell the descriptions apart. I occasionally will make braille notes about specific drugs. I have attempted to find additional information about a few drugs on the internet but most information seems to be promotional material produced by the manufacturer of the drug. I do occasionally find that when I have medications which may be used as needed for a condition that is ongoing that they may be in the medicine cabinet a long time and that details about that drug and even identification of that drug becomes vague if I have not taken the time to make braille labels and/or notes on pertinent information.
I have seen other blind people use a variety of techniques such as placing a rubber band around one of the bottles, a piece of tape on the bottle or some other tactile marking to help them keep up with different perscriptions. I have seen some people keep up with their medication by storing different perscriptions in different places. All of these methods are cues that prompt the memory and also depends on the blind/visually impaired person being able to control our environment. Of course, if someone comes along and changes the system that was so carefully set up to organize the medication the blind person has a real problem.
I think that when people have to take more than two or three perscriptions that the simple techniques become much more difficult and that the opportunity for error increases drastically. Unfortunately, it seems like the older one gets the more perscriptions become necessary. I have known
| older blind and visually impaired persons who have been on as many as twenty-eight perscriptions at one time. I have also seen family members institutionalize loved ones because they could not manage their medication independently and the family member was not in a position to monitor it on a daily bases. |
| 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?|
| There are several approaches that have been develop to help blind and visually impaired persons have access to more information. I have seen advertisements of pharmacys that provide large print labels or that color code the bottles. This can help some persons who have enough residual vision.
There is a pharmacy in the Kansas City Area that pre-sorts medications for customers into trays according to when the medication is to be taken. Of course, it is necessary that all of a persons perscriptions be purchased from the same pharmacy.
I believe some of the newly developed devices that verbally speaks information contained on the label of a perscription hold a lot of promise. There is a talking Pill Bottle, an RX Perscription Reader, and possibly other products that are now available or under development. I have seen demonstration of the RX Perscription Reader. The pharmacist stores information about a specific drug on a chip that is put in the bottle. The person purchasing the perscriptions has a small device that verbally speaks the information that has been stored on the chip. The device cost around $500 each perscription cost the user an additional $1.50. I know of one person in the Kansas City Metropolitan that has one of these devices. She has too send her perscriptions to Omaha, Nebraska and receives her medication in the mail.
With today's technology, such devices certainly could become the answer to a problem that many people have struggled with for years. Once one device is really on the market and becomes other devices should be forthcoming and result in lower prices. At the same time, as the number of users increase, the cost per perscription should also become much less.