Prescription Drug Information for Consumers and Healthcare Professionals 48 th FDLI Annual Meeting Washington, DC Wm. Ray Bullman Executive Vice President National Council on Patient Information and Education Bethesda, MD

NCPIE CMI Initiative - FDLI Annual Meeting 2 Todays Session Rx info. for consumers & healthcare providers: –Focus on written; 3 rd party, govt., industry) –Variety, intended uses –Whats 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

NCPIE CMI Initiative - FDLI Annual Meeting 3 Todays Batting Order Bullman – 3 rd party Rx info 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

NCPIE CMI Initiative - FDLI Annual Meeting 4 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.

NCPIE CMI Initiative - FDLI Annual Meeting 5 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.

NCPIE CMI Initiative - FDLI Annual Meeting 6 Proposed MedGuide Rule Leads to Action Plan for Useful Rx Info. Public Law signed 08/29/96 Directs HHS Secretary to facilitate development of long-range Action Plan Codifies FDAs 95 proposed Medication Guide distribution and quality goals of 75% by 2000 and 95% by 2006.

NCPIE CMI Initiative - FDLI Annual Meeting 7 Action Plan Development HHS Secretary contracts with Keystone Center, a nonprofit dispute resolution center 120 days under statute (PL ) to facilitate development of Action Plan by interested stakeholders Keystone selected 34 private sector groups to develop Action Pan

NCPIE CMI Initiative - FDLI Annual Meeting 8 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 , Action Plan called for periodic assessment of quality of written Rx information.

NCPIE CMI Initiative - FDLI Annual Meeting 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…… )

NCPIE CMI Initiative - FDLI Annual Meeting 10 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.

NCPIE CMI Initiative - FDLI Annual Meeting 11 FDA Interim Assessment of CMI (2002) Distribution of 89% (target = 75%) Usefulness of CMI variable 50% - 55% criteria met (target =75%) Best performance: –Scientific accuracy, non-promotional –Pregnancy contraindication

NCPIE CMI Initiative - FDLI Annual Meeting 12 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

NCPIE CMI Initiative - FDLI Annual Meeting 13 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

NCPIE CMI Initiative - FDLI Annual Meeting 14 CMI 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

NCPIE CMI Initiative - FDLI Annual Meeting 15 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.

NCPIE CMI Initiative - FDLI Annual Meeting 16 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)

NCPIE CMI Initiative - FDLI Annual Meeting 17 Web Link For details about CMI Initiative: Youll find background on CMI Initiative and links to: * Public Law * Action Plan for Provision of Useful Prescription Medicine Information * FDA interim CMI assessment * Early CMI prototypes

CMI Initiative Contact Ray Bullman Executive Vice President National Council on Patient Information and Education 4915 Saint Elmo Ave., #505 Bethesda, MD (301) , ext. 14

NCPIE CMI Initiative - FDLI Annual Meeting 19 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

NCPIE CMI Initiative - FDLI Annual Meeting 20 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 (6-8 th grade) & legible

NCPIE CMI Initiative - FDLI Annual Meeting 21 Comprehensibility Items Poorly – well organized Poor – good length Unclear – clear Unhelpful – helpful Incomplete – complete Hard – easy to find impt. information

NCPIE CMI Initiative - FDLI Annual Meeting 22 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