1. talkaboutrx.org1 8 th Annual Patient Adherence, Communication & Engagement (PACE) USA 2011 Special Opportunities to Advance Adherence Ray Bullman National Council on Patient Information and Education October 24, 2011

2. talkaboutrx.org2 Special Opportunities to Advance Adherence Who is special and what makes them so? How do you define special? 18-point font &the groan heard round the Beltway (& beyond) 10,959,000 special opportunities a day to advance adherence The Adherence 4-Step (all join in…)

3. talkaboutrx.org3 Who is Special and What Makes Them So? The short answer: Everyone in some way(s). Behind every presenting problem is an Individual with her/his own unique skill sets, life experiences, physical, psychological, emotional, social issues, financial challenges, perceptions of health, support system (or not).

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5. talkaboutrx.org5 How Do YOU Define Special? Health Illiteracy - 90+ million Americans

6. talkaboutrx.org6 The Adherence 4-Step (all join in) - 18 point font Your Medicine. Be Smart. Be Safe. – 16 point font 1. Give your health care team important information. – 14 point font 2. Get the facts about your medicine. - 12 point font 3. Stay with your treatment plan. - 10 point font 4. Keep a record of your medicines. - 8 point font.

7. talkaboutrx.org7 How Do YOU Define Special? Blind or visually impaired – 10 million Americans; 1/3 rd are 65+ years of age.

8. talkaboutrx.org8 How Do YOU Define Special? Blind or visually impaired – 10 million Americans; 1/3 rd are 65+ years of age. (28) Blind or visually impaired – 10 million Americans; 1/3 rd are 65+ years of age. (20) Blind or visually impaired – 10 million Americans; 1/3 rd are 65+ years of age. (14) Blind or visually impaired – 10 million Americans; 1/3 rd are 65+ years of age. (8)

9. talkaboutrx.org9 Listen. Do you hear it? There it is again. I said, there it is again. What, are you….

10. talkaboutrx.org10 How Do YOU Define Special? Deaf - 1million Americans functionally deaf; more than ½ over 65 years of age. About 8 million people are hard of hearing (some difficulty hearing normal conversation even with use of a hearing aid); more than ½ are over 65 years old.

11. talkaboutrx.org11 That Pretty Much Covers it, Right? Cognitive Deficits Mental Illness Homeless Poor / near poor Uninsured / under-insured Join in…… Join in….. Oh, dont forget (next slide )

12. talkaboutrx.org12 How Do YOU Define Special? Chronic Disease sufferers - asthma, cancer, diabetes, and heart disease affect the quality of life for 133 million Americans and are responsible for 7 out of every 10 deaths in the U.S. – killing more than 1.7 million Americans every year. They are the primary driver of health care costs – accounting for more than 75 cents of every dollar we spend on health care. (Partnership to Fight Chronic Disease; www.fightchronicdiesase.org )

13. talkaboutrx.org13 18-Point Font & the Groan Heard Round the Beltway (& Beyond) In Search of Useful Written Medicine Information or … 16 Years Older and What Do You Get?

14. talkaboutrx.org14 A New Paradigm: Quest for the Single-Document Solution Clear actionable written information that allows a patient to use their Rx medication safely & effectively. Single document that provides Rx medication risk and benefit information in an accurate and balanced form delivered in a consistent and easily-understood format. Provided when a patient receives an Rx medication with the intent that the information be used to take medications properly once the patient has gone home. Purpose is to aid patients who have already received a prescription.

15. talkaboutrx.org15 A New Paradigm: Quest for the Single-Document Solution 1996 – 2006 – 10-Year Keystone Action Plan by private sector Dec. 2008 - FDA final assessment of PMI Feb. 2009 – FDA Risk Communications AC Meeting (single doc. sol) Sept. 2009 – FDA public workshop (elements of useful PMI; prototypes introduced ) May 2010 – FDA releases plan for consumer testing of PMI prototypes (Fed. Register) July 2010 – 1 st of 3 Brookings Institution/FDA) Meetings (Workshop on prototype design, assessment and distribution) Sept. 2010 (FDA Public Hearing – design / distribution of PMI) Oct. 2010 -2 nd of 3 BI/FDA Meetings (ensuring access to PMI) Feb. 2011 – Final BI/FDA Meeting (prototype testing) Sept. 2011 – FDA receives OMP clearance to proceed with consumer prototype testing of PMI FDA hopes to have data available 2013 Full implementation projection (conjecture) 2015-2016 (best case)

16. talkaboutrx.org16 Quest for Useful Written Information for One Special Population Blind and Partially Sighted Consumers Approx. 10 million blind & visually impaired in US: -1.3 million legally blind -more than ½ [6.5 million] are 65 or older Prevalence of blindness & vision impairment increase rapidly in later years, esp. after age 75. People 80 and over = 8% of population but account for nearly 70% of blindness Number affected expected to double within next 3 decades.

17. talkaboutrx.org17 Useful Written Information for the Blind and Partially Sighted Efforts to improve upon clinical content, design, layout, readability and distribution (usefulness) of written medicine information underway since 1995; What these efforts (Keystone Action Plan, Medication Guide Program), etc., said about useful information for blind or visually impaired – NOTHING (beyond recommending minimum 10-point font).

18. talkaboutrx.org18 Along Comes Medicare Part D. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 107(f) mandated HHS to prepare a report to Congress: A Study on How to Make Prescription Pharmaceutical Information, Including Drug Labels and Usage Instructions, Accessible for Blind and Visually Impaired Individuals Study questions organized into 3 broad categories designed to address: 1) Information about the blind and visually impaired population; 2) Information about this population's access to prescription medication information; 3) Information about existing & emerging technologies

19. talkaboutrx.org19 HHS Report to Congress – Much focus on Potential of Technology. 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; multiple means of communicating drug information are necessary. Many of the more advanced assistive technologies are not practical for a large number of the blind and visually impaired population. 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 & 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.

20. talkaboutrx.org20 Three Recommendations to Congress 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: a) Provide essential drug information that is understandable and readily comprehensible to consumers, as well as the most current labeling information, as it becomes available; b) Have ability to reach majority of blind & visually impaired; c) Be easy to use; and d) Be affordable. 2. 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.

21. talkaboutrx.org21 Three Recommendations to Congress 3. When researching and/or developing assistive technologies or modalities for use by blind and visually impaired individuals to access prescription drug information, the following FIVE factors should be taken into consideration: 1.Increasing age; 2.Co-morbid conditions; 3.Socioeconomic status; 4.Severity of visual impairment; 5.Skill in the use of computer and/or assistive technologies.

22. talkaboutrx.org22 Two Action Items to Congress Action Item 1: National Eye Health Education Program (NEHEP) of NEI will take lead in strategizing, holding, & funding a workshop to: bring together experts/key stakeholders in health communication & visual impairment; develop strategy to implement & achieve better communication and increased awareness about available assistive technologies and modalities for accessing Rx drug information; identify 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).

23. talkaboutrx.org23 Two Action Items to Congress Action Item 2: National Institute on Disability and Rehabilitation Research (DoE) will take lead in strategizing, holding, & 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

24. talkaboutrx.org24 Guidelines for Rx Labeling & Consumer Medication Information for People with Vision Loss Collaborative Project of American Society of Consultant Pharmacists Foundation and American Foundation for the Blind (March 2008). Provide pharmacists & pharmacies with specific recommendations for making important medication information accessible for patients with vision loss. Serve as a resource for persons with vision loss and organizations serving this population. For full report: www.ascpfoundation.org/programs/visuallyimpaired.cfm

25. talkaboutrx.org25 Format Recommendations: Rx Label and Written Information (partial) Contrast: Text should be printed with the highest possible contrast. –Use black letters on white or pale yellow Background: Avoid the use of red, yellow, or blue type and backgrounds other than white or yellow.

26. talkaboutrx.org26 Format of Written Information for People with Vision Loss –Use single column, left justified text. –Minimum one inch margins. –Avoid bullet points; instead left justify text and use extra spacing between lines to differentiate between points and sections. –Make meaningful headings boldface in larger font. –Bold critical portions of narrative sections within text. –Provide a summary of most critical points for quick reference,

27. talkaboutrx.org27 Format of Written Information for People with Vision Loss Leading (spacing between lines of text) Font size plus 30%; 24 pt leading for 18 point font. Alternative: 1.5 lines between text. Type size Use minimum 18-point type. There may be patients who require larger font size for readability, or for whom large print is not useful.

28. talkaboutrx.org28 American Foundation for the Blind Launched Rx Label Enable campaign to ensure that people with vision loss have ready access to the vital information available to all consumers via prescription labeling and consumer medication information, enabling them to take medications safely, effectively, and independently. Reaching out to all stakeholders, including consumers experiencing vision loss, policymakers, federal regulators, doctors, the pharmaceutical industry, retailers, assistive technology providers, and public and private insurers to promote solutions, build consensus, and take action.

29. talkaboutrx.org29 4 Billion Prescriptions per Year By breaking the challenge into manageable pieces: That gives us only 10,959,000 Special Opportunities a day to advance adherence!

30. talkaboutrx.org30 The Adherence 4-Step (all join in) Your Medicine. Be Smart. Be Safe. 1. Give your health care team important information. 2. Get the facts about your medicine. 3. Stay with your treatment plan. 4. Keep a record of your medicines.

31. talkaboutrx.org31 Tip of the Hat to Just a Few Adherence 4-Step Partners Agency for Health Care Research and Quality (AHRQ); co-developed Your Medicine Be Smart. Be Safe with NCPIE (English and Spanish); National Consumers League – Script Your Future national adherence campaign. NCPIE member groups for many innovative adherence products, programs, and services. Everyone here today working to make a difference.

32. talkaboutrx.org32 THAT IS SOMETHING SPECIAL ! (80 Point Font)

33. talkaboutrx.org33 Contact / Questions Ray Bullman Executive Vice President National Council on Patient Information and Education (NCPIE) 200-A Monroe Street, Suite 212 Rockville, MD 20850 (301) 340-3940 – phone bullman@ncpie.info – email