Transcript Written Drug Information: Now & into the Future

Written Drug Information:
Now & into the Future
A look at where things now stand with the provision of
useful written information to consumers, along with some conjecture as
to how the future of drug information
might evolve.
Ray Bullman
Executive Vice President
National Council on Patient Information and
Education
April 24, 2007
NCPIE, Copyright 2007
Written Drug Information:
Now & into the Future
ABOUT NCPIE
• Produces messages & /materials to promote
better consumer – patient – provider dialogue
about medicines
• Sample Activities: National Brown Bag Medicine
Review, “Talk About Rx” Month, Be MedWise
about OTCs, Consumer Medicine Information
(CMI) Initiative
NCPIE, Copyright 2007
Written Drug Information:
Now and Into the Future
NCPIE’s Role = Catalyst & Convener
– Encourage committed stakeholders to meet
long-range CMI goals established in Public
Law 104-180, outlined in Action Plan for
Provision of Useful Prescription Medicine
Information
– CMI Initiative formed March 2003
NCPIE, Copyright 2007
Written Information:
Recent Regulatory History
• 1995: FDA proposed MedGuide Rule
• 1996: Public Law 104-180; private sector
charged with developing criteria for “useful”
written medicine information (CMI)
• 1997: HHS Secretary accepts Action Plan;
Targets set for 2000 & 2006; FDA = “judge”
• FDA’s interim evaluation released June 2002
NCPIE, Copyright 2007
CMI Targets
• 95% -
Distribution with new Rxs at retail
pharmacies
• 95% -
CMI leaflets that meet Agency’s
interpretation of Action Plan criteria as
delineated in FDA’s Guidance on
Useful Written Consumer
Medicine
Information (July
2006)
NCPIE, Copyright 2007
NCPIE Involvement in
Written Medicine Information
1996:
NCPIE represented on Keystone
Action Plan Committee (“useful” CMI)
‘97-’00:
NCPIE stakeholder conferences
include Action Plan topics
2002:
FDA encourages NCPIE to act as
convener/catalyst to stimulate
stakeholder activity to achieve Action
Plan goals
NCPIE, Copyright 2007
NCPIE Involvement in
Written Medicine Information
July ‘02:
NCPIE presents @ FDA midcourse assessment public hearing
March ‘03: 1st meeting of NCPIE CMI Initiative
stakeholders, FDA, & Svarstad team
March ’04: NCPIE convenes “all-hands”
stakeholder meeting w/FDA
NCPIE, Copyright 2007
NCPIE Involvement in
Written Medicine Information
June ‘04:
NCPIE CMI Criteria Cmtee meets with
FDA team & Svarstad
Aug. ‘04:
NCPIE Criteria Cmtee completes
Guide for Assessing Usefulness of CMI
Sept. ’04: NCPIE submits Assessment Guide
(above) to FDA for input.
Oct. ’04 – No Agency response on Assessment
May ’05: Guide
NCPIE, Copyright 2007
NCPIE Involvement in
Written Medicine Information
April ’05:
NCPIE organizes session on CMI,
PhRMA Paperless Labeling Initiative
& FDA’s Daily Med & Medication
Guide programs @ FDLI annual
mtg.
May ‘05:
FDA publishes draft guidance on CMI
NCPIE, Copyright 2007
NCPIE Involvement in
Written Medicine Information
July ’05:
NCPIE submits comments to FDA
docket on draft CMI guidance; resubmits CMI Assessment
Guide
Aug. ’05:
NCPIE submits comments to FDA
docket on draft Guidance for Industry
on FDA’s “Drug Watch” for Emerging
Drug Safety Information
NCPIE, Copyright 2007
NCPIE Involvement in
Written Medicine Information
July ‘06:
FDA releases final Guidance on Useful
Written CMI (14 months after release
of draft guidance)
July ’06:
NCPIE organizes telecon with FDA &
three dozen stakeholder groups to
provide opportunity for Q & A about
final CMI guidance
NCPIE, Copyright 2007
NCPIE Involvement in
Written Medicine Information
MedGuides / e- MedGuides
Jan. ’05:
FDA invites NCPIE to organize
stakeholder discussions about
Medication Guide dissemination;
NCPIE helps organize 3 meetings:
July ‘05
Oct. ‘05
Sept. ‘06
NCPIE, Copyright 2007
NCPIE: Catalyst for Stakeholder
Meetings with FDA on MedGuides
Sept. 2006 Meeting with FDA:
• Key issues / recommendations from pharmacy
supply chain paper presented
• Summary of NCPIE focus groups to assess
consumers' views on CMI and MedGuides
presented.
NCPIE, Copyright 2007
NCPIE Focus Groups
-- Medication Guides -- Focus group members appreciated formatted
MedGuide more than unformatted CMI
- MedGuide information should be provided by
prescriber:
*
Best time for questions; too late at the
pharmacy;
*
Can ask for alternative medicine
NCPIE, Copyright 2007
Key Issues
• Paper distribution = poor distribution process
• Pharmacists don’t know about MedGuides
• Compliance with regulation (model pharmacy
act)
• Content of MedGuides: variability; confusion due
to quantity of information
• Integration of MG content into CMI
• Cost shift to pharmacy ?
NCPIE, Copyright 2007
Written Information:
Questions to Ponder
What impact will introduction of FDA’s Patient
Information Sheets (PIS) have:
On stakeholders: publishers, systems
vendors, printers, packagers, pharmacies,
pharmacists, prescribers?
On patients and caregivers?
NCPIE, Copyright 2007
Written Information:
Questions to Ponder
• What impact will introduction of more and more
Medication Guides have on CMI?
- On stakeholders (publishers, systems
vendors, pharmacies, pharmacists)?
- On patients and caregivers?
NCPIE, Copyright 2007
Written Information:
Questions to Ponder
• What do we know about consumers’:
– Reaction to CMI? (apart from what FDA says)
– Use of CMI?
– Expectations about or preferences for CMI?
NCPIE, Copyright 2007
Consumer Medicine Information
(circa March 2004)
NCPIE, Copyright 2007
NCPIE, Copyright 2007
NCPIE, Copyright 2007
Action Plan Compliant CMI
(circa 2006)
NCPIE, Copyright 2007
NCPIE, Copyright 2007
NCPIE, Copyright 2007
2007 CMI Assessment
Goal # 1  95% Distribution
• Very obtainable
• “Low hanging fruit” -- 11% of pharmacies that did
not provide CMI @ mid-point have had ample
notification of deficiency
• Preference: include other dispensing sites as
well as community pharmacies (e.g., mail order)
NCPIE, Copyright 2007
2007 CMI Assessment
Goal # 2  95% “Useful” CMI
(per Action Plan and FDA’s interpretive Final Guidance
on criteria for content, design, layout, and readability)
• Full goal attainment much more challenging;
• At retail level – requires universal systems
changes by 60,000+ community pharmacies in
collaboration with 3rd party system vendors
(from large chains to single pharmacy)
NCPIE, Copyright 2007
2007 CMI Assessment
Goal # 2  95% “Useful” CMI
(per Action Plan and FDA’s interpretive Final Guidance
on criteria for content, design, layout, and readability)
• Publishers - content is compliant (self report);
• Publishers – content available in multiple
formats (text, xml)
• Publishers - encouraging FDA to review /
comment on monographs prior to dissemination
(What role might state pharmacy boards play in CMI
feedback / oversight?)
NCPIE, Copyright 2007
2007 CMI Assessment
Goal # 2  95% “Useful” CMI
(per Action Plan and FDA’s interpretive Final Guidance
on criteria for content, design, layout, and readability)
• At the retail level –requires universal systems changes
by 60,000+ pharmacies in collaboration with 3rd party
system vendors (from large chains to single pharmacy)
• If publishers’ content revisions are indeed Action Plan
compliant, challenge becomes roll-out / implementation,
populating marketplace with “new” CMI
NCPIE, Copyright 2007
State of Flux / What’s in Play
Goal # 2  95% “Useful” CMI
(per Action Plan and FDA’s interpretive Final Guidance
on criteria for content, design, layout, and readability)
• Reluctance to commit $ / change in part due to state of
flux related to dissemination of medicine information.
What’s in play:
– CMI (as we now know it)
– Medication Guides (as we now know them)
NCPIE, Copyright 2007
What’s in Play?
– Medication Guides( pdf format, capacity to produce eversion, in conjunction with CMI or stand-alone)
– Package Insert (PI) - paper
– e-Package Insert (PhRMA Paperless Labeling )
– Patient Package Insert (PPI) - paper
– DailyMed (FDA & Library of Medicine)
NCPIE, Copyright 2007
What’s In Play?
ALL OF THE ABOVE ?
NCPIE, Copyright 2007
What’s In Play?
VARIATIONS OF THE ABOVE?
NCPIE, Copyright 2007
Are We Overlooking Something?
Are We Overlooking mething?
Are
WeOverlookingSomething?
Are We OverlookingSomething?
Are We Overlooking Something?
(Code: Webdings, Wingdings, Bookshelf Symbol 7, Arial)
NCPIE, Copyright 2007
Are We Overlooking Something?
Telling consumers
to “read it & heed
it” and to ask
questions ensures
communication of
useful medicine
information …
What if you can’t
read, or can’t read
with understanding or
don’t speak the
language of your
health care provider?
Right?
NCPIE, Copyright 2007
Low Health Literacy
• “Half of all adults are unable to understand much
of what they need to know to take care of
themselves and to follow their doctor’s
instructions.” (Dr. Harvey V. Fineberg, President, IOM)
• 90 million adults (1 in 3) may lack the functional
reading and math skills to effectively use the
U.S. health system; most are native born,
English speakers. (Health Literacy: A Prescription to End
Confusion, IOM)
NCPIE, Copyright 2007
Low Health Literacy
• Most likely to face limited health literacy:
– Elderly;
– Poor;
– New Immigrants.
• System problem  not a patient
characteristic.
NCPIE, Copyright 2007
Three Approaches Showing Promise
1. Culturally appropriate health education
2. Patient advocacy
3. Medical education recognizing the critical
importance of patient communication in
the training of hcps at all levels.
(IOM: Health Literacy: A Prescription to End Confusion, 2004)
NCPIE, Copyright 2007
Healthy People 2010 – Chapter 17
Federal goals for ensuring better (more useful)
medicine communication:
FDA is lead agency for monitoring progress to
meet objectives in Chapter 17: Medical Product
Safety.
Objectives 17.3  17.5 of relevance here:
NCPIE, Copyright 2007
Healthy People 2010 – Chapter 17
17-3.
Increase the proportion of primary
care providers, pharmacists, and other hcps
who routinely review with their patients aged
65 years & older and patients with chronic
illnesses or disabilities all new prescribed &
OTC medicines.
DELETED from HP 2010 @ mid-course review!
NCPIE, Copyright 2007
Healthy People 2010 - Chapter17
17.4: Increase the proportion of
patients receiving, at the time their new
prescriptions are dispensed, written
information that conforms to the
“Action Plan for the Provision of
Prescription Medicine Information.”
NCPIE, Copyright 2007
Healthy People 2010 – Chapter 17
17.5: Increase the proportion of patients
receiving from prescribers, pharmacists, and
other hcps oral counseling information that
conveys directions for use and risk
information (precautions and warnings).
NCPIE, Copyright 2007
Important – but Under-spoken - Aspect
of Medicine Communication
Medication counseling by:
• Prescribers and
• Pharmacists
NCPIE, Copyright 2007
Consumers’ Reported Receipt of Rx Information
@ the Physician’s Office (told selected info)
How much to take:
How often to take:
Refills:
Precautions:
Side Effects:
Any information:
All information:
1992
55%
56%
32%
33%
29%
61%
n/a
2000
62%
64%
37%
36%
35%
68%
24%
(source: FDA; Dec. 2006)
NCPIE, Copyright 2007
2004
64%
66%
37%
37%
35%
70%
26%
Consumers’ Reported Receipt of Rx Information
@ the Pharmacy (told selected info)
How much to take:
How often to take:
Refills:
Precautions:
Side Effects:
Any information:
All information:
1992
28%
27%
16%
18%
11%
37%
n/a
2000
34%
34%
17%
24%
20%
37%
12%
(source: FDA; Dec. 2006)
NCPIE, Copyright 2007
2004
29%
31%
16%
21%
17%
38%
6%
What’s Likely to Change
The Status Quo
NCPIE, Copyright 2007
In the (very) Near Future
• FDA Public Hearings:
– Electronic dissemination of Package Insert
(PI)  April 27 in DC
– Medication Guides (electronic dissemination,
integration of content with CMI, etc)
– June 12-13 in DC
NCPIE, Copyright 2007
What We’re All Seeking
• Provision of the most useful information for
all consumers to promote safe and
appropriate medicine use.
NCPIE, Copyright 2007
Questions
NCPIE, Copyright 2007
Contact Information
Wm. Ray Bullman
Executive Vice President
National Council on Patient Information and Education
4915 Saint Elmo Ave., Suite 505
Bethesda, MD 20814-6082
[email protected] – email
(301) 656-8565 – phone
(301) 656-4464 – fax
www.talkaboutrx.org
www.bemedwise.org
NCPIE, Copyright 2007