Transcript Prescription Drug Information for Consumers and Healthcare

Prescription Drug Information
for Consumers and
Healthcare Professionals
48th FDLI Annual Meeting
Washington, DC
Wm. Ray Bullman
Executive Vice President
National Council on Patient
Information and Education
Bethesda, MD
Today’s Session
• Rx info. for consumers & healthcare providers:
– Focus on written; 3rd party, govt., industry)
– Variety, intended uses
– What’s new? (development & delivery of Rx info)
Q: Can Rx information from diverse sectors for diverse
purposes work synergistically? (if not-why not;
consequences?....)
Maximize potential of Rx info. to support
safe & appropriate medicine use
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Today’s Batting Order
 Bullman – 3rd party Rx info. 1996-2006
chronology; Consumer Medicine Information
(CMI) initiative
 Seligman – government & Rx info; MedGuides,
PPIs, Drug Watch, HP 2010, assessing CMI
 Goldhammer – Industry & Rx Info; Paperless
Labeling Initiative
 Winckler – Nexus: Rx Info & the pharmacist
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Precursor: Proposed MedGuide Rule
• August 24, 1995, Federal Register: proposed
FDA rules would institute a manufacturerprepared, FDA-approved Rx info. system -”medication guides" -- to accompany all
prescriptions.
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Proposed MedGuide Rule
• Outlined two regulatory alternatives: Plans A and B.
• Under A, voluntary system given opportunity to achieve
specific goals; if goals not met, regulations requiring
Medication Guides would be implemented.
• Under B, matters proceed as in A but, FDA does not
intend to finalize proposed standards or the sections that
defer implementation in the form of regulation. Instead,
the agency intends to use the proposed performance
standards as guidance for the private sector.
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Proposed MedGuide Rule Leads to
Action Plan for Useful Rx Info.
• Public Law 104-180 signed 08/29/96
• Directs HHS Secretary to facilitate
development of long-range Action Plan
• Codifies FDA’s ‘95 proposed Medication
Guide distribution and quality goals of 75%
by 2000 and 95% by 2006.
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Action Plan Development
• HHS Secretary contracts with Keystone Center,
a nonprofit dispute resolution center
• 120 days under statute (PL 104-180) to facilitate
development of Action Plan by interested
stakeholders
• Keystone selected 34 private sector groups to
develop Action Pan
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Action Plan for Provision of Useful
Prescription Medicine Information
Collaboratively developed Action Plan accepted
by the Secretary in January 1997; (no consensus on
implementation mechanism)
Criteria to determine usefulness:
* endorsed broad criteria in the public law
* described 8 specific criteria to be met;
recommended layout /design attributes
(see last four slides)
Consistent with PL 104-180, Action Plan called for
periodic assessment of quality of written Rx information.
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1998 - FDA Final MedGuide Rule
• Rule estimates 5-10 products per year could
have Medication Guide
• MedGuide reserved for drugs with serious and
significant side effects, etc.
• To date (4/07) FDA has required MedGuides for
___Rx drugs & biologics (most recent = SSRIs,
Elidel, Protopic, NSAIDs…… )
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FDA Assesses CMI (2002)
• Dr. Bonnie Svarstad (Univ. WI – Madison)
hired by FDA to assess interim progress
towards meeting Action Plan quantity &
quality standards.
• 384 pharmacies randomly selected from
virtually every state; shopping service
buys 4 Rx drugs and collects CMI.
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FDA Interim Assessment of CMI (2002)
• Distribution of CMI @ 89% (target = 75%)
• Usefulness of CMI variable
50% - 55% criteria met (target =75%)
• Best performance:
– Scientific accuracy, non-promotional
– Pregnancy contraindication
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FDA Interim Assessment of CMI (2002)
• Completeness of CMI is POOR and Variable
Worst: Communication & Risk Information
–
–
–
Contraindication and what to do
Precautions and how to avoid harm
Readability
Poor: Communicating how to get most benefit
–
–
–
ADRs and what to do
Directions for use and monitoring
Encouragement and ask questions
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Consumer Medicine
Information (CMI) Initiative
• NCPIE, in 2003,convenes stakeholders interested in
collaborating to meet Action Plan goals by
Dec. 2006:
– the distribution of useful information to 95% of
individuals receiving new prescriptions;
– Useful defined relative to Action Plan as
assessed by FDA in 2007
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CMI Stakeholders
• Drug information publishers - First DataBank, MediSpan, Micromedex, Catalina Health, Etreby, Cerner Multum
• Pharmacy system vendors - ASAP & members
• Pharmacy/pharmacists –
APhA, ASHP, NACDS,
NCPA, NABP
• Consumer & patient advocacy orgs – AARP, NCL
• PhRMA & several individual companies
• Others – AMA, VA
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Recent CMI Initiative Activities
• A Guide for Determining the Usefulness of
Consumer Medicine Information (CMI) – 2004;
(distribution pending review of FDA draft guidance
document on CMI)
• Stakeholders’ meetings w/ FDA (03/03, 03/04, 06/04)

Next stakeholders’ meeting will follow release of draft
guidance document on CMI by FDA 
• Numerous CMI articles & presentations.
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CMI Initiative: How You Can Help
•
.
•
Support / participate in future CMI
stakeholders’ meetings
Support dissemination of “Guide
for Determining Usefulness of CMI”
•
Support pharmacy / vendor efforts
to integrate CMI prototypes into
pharmacy systems
•
Support research on value / use /
impact of CMI; reaction to APcompliant CMI prototypes
•
Support CMI public awareness (its
function, capacity to inform;
optimizing use of CMI)
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Web Link
For details about CMI Initiative:
 www.talkaboutrx.org
You’ll find background on CMI Initiative and
links to:
* Public Law 104-180
* Action Plan for Provision of Useful
Prescription Medicine Information
* FDA interim CMI assessment
* Early CMI prototypes
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CMI Initiative Contact
Ray Bullman
Executive Vice President
National Council on
Patient Information and Education
4915 Saint Elmo Ave., #505
Bethesda, MD 20814 - 6082
(301) 656-8565, ext. 14
[email protected]
www.talkaboutrx.org
CMI Action Plan -- Eight Criteria for
Useful Medicine Information
1. Drug Names and indications
2. Contraindications and what to do before using
3. Specific directions about how to use, monitor,
get most benefit
4. Specific precautions & how to avoid harm
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CMI Action Plan -- Eight Criteria for
Useful Medicine Information
5. Serious/frequent adverse reactions, what to do
6. General information, encouragement to ask
questions
7. Scientifically accurate, unbiased & up-to-date
8. Comprehensible (6-8th grade) & legible
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Comprehensibility Items
•
•
•
•
•
•
Poorly – well organized
Poor – good length
Unclear – clear
Unhelpful – helpful
Incomplete – complete
Hard – easy to find impt. information
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Legibility and Summary Items
•
Legibility: Poor – good
print size;
print quality;
spacing between lines
•
Summary Items: overall ease of reading,
overall ease of understanding, overall
usefulness
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