2. NCPIE, Copyright 2007 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

3. NCPIE, Copyright 2007 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 Written Drug Information: Now & into the Future

4. NCPIE, Copyright 2007 Written Drug Information: Now and Into the Future NCPIEs 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

5. 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 FDAs interim evaluation released June 2002

6. NCPIE, Copyright 2007 CMI Targets 95% - Distribution with new Rxs at retail pharmacies 95% -CMI leaflets that meet Agencys interpretation of Action Plan criteria as delineated in FDAs Guidance on Useful Written Consumer Medicine Information (July 2006)

7. 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

8. NCPIE, Copyright 2007 NCPIE Involvement in Written Medicine Information July 02:NCPIE presents @ FDA mid- course assessment public hearing March 03: 1 st meeting of NCPIE CMI Initiative stakeholders, FDA, & Svarstad team March 04:NCPIE convenes all-hands stakeholder meeting w/FDA

9. 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

10. NCPIE, Copyright 2007 NCPIE Involvement in Written Medicine Information April 05:NCPIE organizes session on CMI, PhRMA Paperless Labeling Initiative & FDAs Daily Med & Medication Guide programs @ FDLI annual mtg. May 05:FDA publishes draft guidance on CMI

11. NCPIE, Copyright 2007 NCPIE Involvement in Written Medicine Information July 05:NCPIE submits comments to FDA docket on draft CMI guidance; re- submits CMI Assessment Guide Aug. 05:NCPIE submits comments to FDA docket on draft Guidance for Industry on FDAs Drug Watch for Emerging Drug Safety Information

12. 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

13. 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

14. 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.

15. 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

16. NCPIE, Copyright 2007 Key Issues Paper distribution = poor distribution process Pharmacists dont 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 ?

17. NCPIE, Copyright 2007 Written Information: Questions to Ponder What impact will introduction of FDAs Patient Information Sheets (PIS) have: On stakeholders: publishers, systems vendors, printers, packagers, pharmacies, pharmacists, prescribers? On patients and caregivers?

18. 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?

19. 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?

20. NCPIE, Copyright 2007 Consumer Medicine Information (circa March 2004)

21. NCPIE, Copyright 2007

23. Action Plan Action Plan Compliant CMI (circa 2006)

24. NCPIE, Copyright 2007

26. 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)

27. NCPIE, Copyright 2007 2007 CMI Assessment Goal # 2 95% Useful CMI (per Action Plan and FDAs 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) 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)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)

28. NCPIE, Copyright 2007 2007 CMI Assessment Goal # 2 95% Useful CMI (per Action Plan and FDAs 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?)

29. NCPIE, Copyright 2007 2007 CMI Assessment Goal # 2 95% Useful CMI (per Action Plan and FDAs 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

30. NCPIE, Copyright 2007 State of Flux / Whats in Play Goal # 2 95% Useful CMI (per Action Plan and FDAs 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. Whats in play: –CMI (as we now know it) –Medication Guides (as we now know them)

31. NCPIE, Copyright 2007 Whats in Play? –Medication Guides( pdf format, capacity to produce e- version, 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)

32. NCPIE, Copyright 2007 Whats In Play? ALL OF THE ABOVE ?

33. NCPIE, Copyright 2007 Whats In Play? VARIATIONS OF THE ABOVE?

34. NCPIE, Copyright 2007 Are We Overlooking Something? t Are We Overlooking Something? (Code: Webdings, Wingdings, Bookshelf Symbol 7, Arial)

35. NCPIE, Copyright 2007 Are We Overlooking Something? Telling consumers to read it & heed it and to ask questions ensures communication of useful medicine information … Right? What if you cant read, or cant read with understanding or dont speak the language of your health care provider?

36. 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 doctors 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)

37. NCPIE, Copyright 2007 Low Health Literacy Most likely to face limited health literacy: –Elderly; –Poor; –New Immigrants. System problem not a patient characteristic.

38. 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)

39. 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:

40. 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!

41. 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.

42. 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).

43. NCPIE, Copyright 2007 Important – but Under-spoken - Aspect of Medicine Communication Medication counseling by: Prescribers and Pharmacists

44. NCPIE, Copyright 2007 Consumers Reported Receipt of Rx Information @ the Physicians Office (told selected info) 1992 2000 2004 How much to take: 55% 62% 64% How often to take:56% 64% 66% Refills: 32% 37% 37% Precautions: 33% 36% 37% Side Effects: 29% 35%35% Any information:61% 68%70% All information:n/a 24%26% (source: FDA; Dec. 2006)

45. NCPIE, Copyright 2007 Consumers Reported Receipt of Rx Information @ the Pharmacy (told selected info) 1992 2000 2004 How much to take: 28% 34% 29% How often to take:27% 34% 31% Refills: 16% 17% 16% Precautions: 18% 24% 21% Side Effects: 11% 20%17% Any information:37% 37%38% All information:n/a 12%6% (source: FDA; Dec. 2006)

46. NCPIE, Copyright 2007 Whats Likely to Change The Status Quo

47. 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

48. NCPIE, Copyright 2007 What Were All Seeking Provision of the most useful information for all consumers to promote safe and appropriate medicine use.

49. NCPIE, Copyright 2007 Questions

50. 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 bullman@ncpie.info – email (301) 656-8565 – phone (301) 656-4464 – fax www.talkaboutrx.org www.bemedwise.org