Prescription Drug Information for Consumers and Healthcare Professionals 48 th FDLI Annual Meeting Washington, DC

1. Prescription Drug Information for Consumers and Healthcare Professionals48th FDLI Annual MeetingWashington, DC Wm. Ray Bullman Executive Vice President National Council on Patient Information and Education Bethesda, MD

2. 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 NCPIE CMI Initiative - FDLI Annual Meeting

3. 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 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 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. 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 104-180) 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 104-180, Action Plan called for periodic assessment of quality of written Rx information. NCPIE CMI Initiative - FDLI Annual Meeting

9. 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…… ) 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 CMI @ 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. 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) CMI Initiative: How You Can Help NCPIE CMI Initiative - FDLI Annual Meeting

17. 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 UsefulPrescription Medicine Information * FDA interim CMI assessment * Early CMI prototypes NCPIE CMI Initiative - FDLI Annual Meeting

18. 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 bullman@ncpie.info www.talkaboutrx.org

19. CMI Action Plan -- Eight Criteria for Useful Medicine Information • 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 • Serious/frequent adverse reactions, what to do • General information, encouragement to ask questions 7. Scientifically accurate, unbiased & up-to-date 8. Comprehensible (6-8th 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 NCPIE CMI Initiative - FDLI Annual Meeting