Prescription Drug Information for Consumers and Healthcare Professionals 48 th FDLI Annual Meeting Washington, DC Wm. Ray Bullman Executive Vice President.

Prescription Drug Information for Consumers and

Healthcare Professionals

48th FDLI Annual MeetingWashington, DC

Wm. Ray BullmanExecutive Vice President

National Council on Patient Information and Education

Bethesda, MD

NCPIE CMI Initiative - FDLI Annual Meeting

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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 manufacturer-prepared, 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 StakeholdersCMI Stakeholders

• Drug information publishers - First DataBank, Medi-Span, 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 AP-compliant 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

CMI Initiative Contact

Ray BullmanExecutive Vice President

National Council onPatient Information and Education

4915 Saint Elmo Ave., #505Bethesda, MD 20814 - 6082

(301) 656-8565, ext. [email protected]

www.talkaboutrx.org

mailto:[email protected]


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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

Prescription Drug Information for Consumers and Healthcare Professionals 48 th FDLI Annual Meeting Washington, DC Wm. Ray Bullman Executive Vice President.

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