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8th 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
talkaboutrx.org
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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…)
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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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How do YOU Define
Special?
Health Illiteracy - 90+
million Americans
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How Do YOU Define Special?
Health Illiteracy - 90+ million
Americans
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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.
3.
Stay with your treatment plan. - 10 point font
4.
Keep a record of your medicines. - 8 point font.
- 12 point font
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How Do YOU Define Special?
Blind or visually impaired – 10 million
Americans; 1/3rd are 65+ years of age.
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How Do YOU Define Special?
Blind or visually impaired – 10 million
Americans; 1/3rd are 65+ years of age. (28)
Blind or visually impaired – 10 million Americans; 1/3rd are 65+
years of age. (20)
Blind or visually impaired – 10 million Americans; 1/3rd are 65+ years of age. (14)
Blind or visually impaired – 10 million Americans; 1/3rd are 65+ years of age. (8)
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Listen.
Do you hear it?
There it is again.
I said, there it is again.
What, are you….
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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.
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That Pretty Much Covers it, Right?
•
•
•
•
•
•
•
•
Cognitive Deficits
Mental Illness
Homeless
Poor / near poor
Uninsured / under-insured
Join in……
Join in…..
Oh, don’t forget (next slide)
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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 )
talkaboutrx.org
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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?
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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.
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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 – 1st of 3 Brookings Institution/FDA) Meetings (Workshop on
prototype design, assessment and distribution)
Sept. 2010 (FDA Public Hearing – design / distribution of PMI)
Oct. 2010 -2nd 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)
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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.
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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).
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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
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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.
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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)
b)
c)
d)
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 ability to reach majority of blind & visually impaired;
Be easy to use; and
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.
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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.
2.
3.
4.
5.
Increasing age;
Co-morbid conditions;
Socioeconomic status;
Severity of visual impairment;
Skill in the use of computer and/or assistive technologies.
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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).
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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
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prescription drug information
accessible to this population
23
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
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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.
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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,
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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.
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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.
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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!
talkaboutrx.org
29
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.
talkaboutrx.org
30
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.
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THAT IS
SOMETHING
SPECIAL !
(80 Point Font)
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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
[email protected] – email
talkaboutrx.org
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