The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 107(f): A Study on How to Make Prescription Pharmaceutical Information, Including Drug Labels and Usage Instructions, Accessible for Blind and Visually Impaired Individuals

A Report to Congress

Executive Summary

Background

On December 8, 2003, President George W. Bush signed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Medicare Modernization Act [MMA] - Public Law 108-173). Section 107(f) of this legislation directs the Secretary of the Department of Health and Human Services to study how to make prescription pharmaceutical information, including drug labels and usage instructions, accessible for blind and visually impaired individuals.

To undertake this study, the United States (US) Department of Health and Human Services formulated study questions which we organized into three broad categories designed to address the fundamental requirements of the study as mandated by the MMA. The categories were: 1) information about the blind and visually impaired population; 2) information about this population's access to prescription medication information; and 3) information about existing and emerging technologies.

To address the study questions, we conducted a comprehensive review of the published literature, reviewed comments we had received from the opening of a 30-day public docket, and consulted several other federal agencies. We also searched the Internet and spoke with several manufacturers to identify reported prices for individual assistive technologies. The literature search yielded 60 articles that addressed our study questions. We received 60 comments to the docket. Information from each of these sources led us to reach several key findings.

Key Findings

  • The number of blind and visually impaired individuals in the US is growing. This is mostly because of the large and continually increasing aging population, who also make up the majority of the blind and visually impaired population.
  • Prevalence estimates of visual impairment in the US vary considerably. However, the varying estimates consistently show relationships of visual impairment with certain factors, most notably older age and lower socioeconomic status. In addition, we found that the presence of comorbid conditions is associated with blindness and visual impairment.
  • Increasing age and socioeconomic status also consistently emerged as factors that can play an important role in a blind or visually impaired individual's ability to access prescription drug information. Increasing age is one of the most commonly identified factors associated with a blind or visually impaired individual's ability to access drug information (which includes the utilization of assistive technologies to facilitate access to this information). Some aspects of increasing age that may adversely impact patient access to drug information include general decline of vision, the presence of non-vision related health problems (and the associated increase in consumption of medications), and unfamiliarity with assistive technologies. Other identified factors that can affect access to such information include, severity of visual impairment, and skill in the utilization of computers and assistive technologies.
  • No single currently available assistive technology or modality can meet the needs of all or even the majority of this population. This population is not homogenous and, therefore, multiple means of communicating drug information are necessary.
  • Many of the more advanced assistive technologies that could be helpful in accessing drug information currently are not practical for a large number of the blind and visually impaired population. By addressing some of the factors identified above (i.e., increasing age; comorbid conditions; socioeconomic status; severity of visual impairment; and skill in assistive technologies), assistive technologies and modalities may be developed or modified to better address the needs of blind and visually impaired individuals.
    • The most practical assistive technology or modality would be one that is easy to use, inexpensive, and is usable by a large proportion of the blind and visually impaired population.
  • Information about assistive technologies and modalities for accessing drug information is communicated to this population only haphazardly. These individuals may be unaware of authoritative sources for learning about available assistive technologies and modalities to help them access drug information.
    • State vocational rehabilitation agencies and/or state agencies for the blind are the best available resource for communicating information about assistive technologies or modalities to this population. These agencies can serve as gateways to assistive technology or modality-related services by referring people to the appropriate state or private programs for their particular situation and needs.
  • Two of the most critical barriers to the use of assistive technologies and modalities are:
    • lack of awareness of available technologies, modalities, and services
    • cost of some assistive technologies.

Recommendations

Based on these findings, we make the following recommendations:

  1. To be most effective, an assistive technology or modality should have four critical features to address the needs of the blind and visually impaired population in accessing prescription drug information. It should:
  • provide essential drug information that is understandable and readily comprehensible to consumers, as well as the most current labeling information, as it becomes available;
  • have the ability to reach the majority of blind and visually impaired individuals;
  • be easy to use; and
  • be affordable.
  1. Mechanisms should be developed and put in place to better inform the blind and visually impaired population about the availability of assistive technologies and modalities that may help them access prescription drug information.

Action Item: The National Eye Health Education Program (NEHEP) of the National Eye Institute will take the lead in strategizing, holding, and funding a workshop. The workshop will:

  • bring together experts and key stakeholders in the fields of health communication and visual impairment;
  • develop a strategy to implement and achieve better communication and increased awareness about available assistive technologies and modalities for accessing prescription drug information;
  • identify the most appropriate resource(s) to which blind and visually impaired individuals should be directed to learn about which solutions are best for them;
  • develop a strategy to achieve better communication and increased awareness about the identified resource(s).

Action Item: As an interim measure (prior to the workshop), NEHEP will fund, design, produce, and disseminate, through various media, an education initiative that will:

  • inform the blind and visually impaired population of available assistive technologies and modalities that may be helpful in accessing drug information;
  • direct individuals to their state vocational rehabilitation agency and/or state agency for the blind to find out more about which solutions would be best for them.
  1. When researching and/or developing assistive technologies or modalities for use by blind and visually impaired individuals to access prescription drug information, the following factors should be taken into consideration:
  • increasing age;
  • comorbid conditions;
  • socioeconomic status;
  • severity of visual impairment;
  • skill in the use of computer and/or assistive technologies.

Action Item:The National Institute on Disability and Rehabilitation Research of the Department of Education will take the lead in strategizing, holding, and funding a workshop. The workshop will:

  • bring together experts and key stakeholders in the fields of visual impairment, rehabilitation research, assistive technologies and modalities, as well as the pharmacy and pharmaceutical industries;
  • develop a research agenda to:
    • evaluate the effectiveness of assistive technologies and modalities to make prescription drug information accessible to blind and visually impaired individuals, taking into consideration the five factors; and
    • address how these five factors can be used to enhance existing options and to develop new technologies and modalities to make prescription drug information accessible to this population.
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