Evaluating REMS CE: A Standards Based Approach

1. Evaluating REMS CE: A Standards Based Approach MedBiquitous Annual Conference April 9, 2013

2. Evaluating REMS CE: A Standards Based Approach Genesis of the ER/LA Opioid Analgesic REMS Linda Kitlinski, Senior Director Clinical Development & Medical Science Department, Endo Co- Chair, CE Sub-team of the REMS Program Companies (RPC)

3. What is a Risk Evaluation and Mitigation Strategy (REMS)? http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCAct ChapterVDrugsandDevices/default.htm. Accessed March 15, 2013.

4. REMS Program Company (RPC) Members* • Apotex, Inc. • Endo Pharmaceuticals, Inc. • Impax • Janssen Pharmaceuticals, Inc. • Mallinckrodt, Inc. (Covidien) • Mylan Technologies, Inc. • Noven Pharmaceuticals, Inc. • Par Pharmaceuticals • Pfizer, Inc. • Purdue Pharma, L.P. • Ranbaxy Pharmaceuticals, Inc. • Rhodes Pharmaceuticals, L.P. • Roxane Laboratories, Inc. • Sandoz, Inc. • The PharmaNetwork, LLC • VistaPharm, Inc. • Watson Laboratories • * Updated March, 2013

5. ER/LA Opioid Analgesic REMS: Truly Unprecedented & Groundbreaking • Intersection of two major public health crises • Opioid misuse & abuse, resulting in injury & death, has emerged as major public health problem1 • Morbidity, mortality, disability & costs of pain for >116 million Americans2 • Broad impact of ER/LA Opioid Analgesic REMS • 1.4 million prescribers/potential prescribers in DEA registration database •  320,000 active prescribers (wrote  1 ER/LA opioid Rx in 12 mo.) • >4 million unique patients • First use of accredited CE for delivering REMS education • Collaboration among all stakeholders critical for success 1http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ ucm277916.pdf. 2IOM (Institute of Medicine). 2011. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education & Research. Washington, DC:The National Academies Press.

6. Genesis of ER/LA Opioid Analgesic REMS FDA Opioid REMS meeting with Industry (May 2011) Letters to Sponsors that REMS is required (Feb 2009) Public meeting with IWG (Dec 2009) RPC Grants Approved (Jan 2012) Stakeholder meetings (Apr 2009) Advisory Committee meeting (Oct 2010) CE Blueprint in Fed Reg (Nov 2011) RPC CE RFAs (Aug-Nov 2013) Q1 2009 Q2-Q3 2009 Q4 2009 Q1 2010 Q2 2010 Q3-4 2010 Q1 2011 Q2-3 2011 Q4 2011 Q1-3 2012 Q4 2012- Q1 2013 ' 09 ' 13 Sponsor meeting (May 2009) REMS letter to Sponsors (Apr 2011) ER/LA Opioid REMS approval (w/final Blueprint) (July 2012) Public meeting of "Interested Parties" Advisory Committee meeting (Jul 2010) Sponsors submit proposed REMS (Aug 2011) First REMS CE (2/28/2013) MedBiq Working Group Formed (July 2012) MEMS Specs & Implementation Guide (Feb 2013)

7. Genesis of the REMS: Importance of Collaboration and Transparent Communication • First time accredited CE utilized for REMS “training” • Central component of the ER/LA Opioid REMS is voluntary education for DEA-registered prescribers delivered through accredited CE • RPC provides educational grants to accredited providers who develop/provide the CE • ACCME & other Accreditors’ standards already provide effective framework for assuring independence of REMS CE • The education must be provided at no cost, or nominal cost, to participants • Unprecedented opportunity for CE to positively impact patient safety and public health • Unparalleled engagement among REMS stakeholders • CE Community, FDA, RPC, HCPs, Professional Organizations, Patient & Consumer Advocacy Groups, Pain & Addiction Treatment Communities, Government Agencies, etc. • Leadership & insights of Accreditors/Conjoint Committee on CME have provided invaluable guidance to FDA & RPC on operationalizing the REMS

8. Genesis of the REMS: Accompanying Challenges • Utilizing CE for REMS “training” is a new paradigm • Must adhere to FDA statutory/regulatory requirements, as well as the standards for commercially-supported accredited CE • Potential for confusion/misinterpretation because of differences in Regulatory vs CE nomenclature • REMS Education Conundrum: • Uniform data set & collection system needed to aggregate data from numerous Providers/Accreditors for FDA reporting

9. Opportunity It is a Critical Time… US healthcare is at a crossroads Accredited CE is being asked to provide solutions. Opportunity for CE to address the professional practice gaps of learners.

10. CE is Effective… 2009 2003 2007 2002 Continuing education iseffective in assisting professionals to modify and improve their practice

11. stakeholders…

12. Flashback…. Conjoint Committee on CMENovember 2007 Summit

13. A new stakeholder… “ The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting opioid analgesics while maintaining patient access to pain medications.” ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) – Food and Drug Administration (08/2012)

14. Role of the CE System …Education for prescribers of these medications, which will be provided through accredited continuing education (CE) activities supported by independent educational grants from er/la opioid analgesic companies… • FDA developed core messages to be communicated to prescribers in the Blueprint for Prescriber Education • FDA Blueprint will focus on the safe prescribing of ER/LA opioid analgesics • Accrediting bodies and CE providers will ensure that the CE activities developed under this REMS will be in compliance with the standards for CE of the Accreditation Council for Continuing Medical Education (ACCME) or another CE accrediting body as appropriate to the profession. FDA REMS Blueprint for Prescriber Continuing Education – August 2012

15. Facilitating Conditions…

16. Validity of Requirements FDA Blueprint for Prescriber Education for ER/LA Opioid Analgesics (08/2012) “The expected results of the prescriber education in this REMS are that the prescribers will: Understand how to assess patients… Be familiar with how to initiate therapy, modify dose, and discontinue use… Be knowledgeable about how to manage ongoing therapy… Know how to counsel patients and caregivers… Be familiar with general and product-specific drug information…” Criteria 2. Incorporates into CME activities the educational needs (knowledge, competence, or performance) that underlie the professional practice gaps of their own learners. Criteria 3. Generates activities/educational interventions that are designed to change competence, performance, or patient outcomes as described in its mission statement. Criteria 5. The provider chooses educational formats for activities/interventions that are appropriate for the setting, objectives and desired results of the activity. Criteria 11. The provider analyzes changes in learners (competence, performance, or patient outcomes) achieved as a result of the overall program’s activities/educational interventions.

17. C7: The provider develops activities/educational interventions independent of commercial interests (SCS 1, 2 and 6). C8: The provider appropriately manages commercial support(SCS3) C9: The provider maintains a separation of promotion from education (SCS 4). C10: The provider actively promotes improvements in health care and NOT proprietary interests of a commercial interest (SCS 5). Independence

18. Independence “…REMS CE is a process not a product. Accredited CE will develop as a range of activity formats intended for a diverse target audience. We expect some (CE) will be present on the web, or in print, and some will occur whereprescribers live, work and learn. As I wrote in June 2011, Accredited CE is a diverse array of activities done by a range of providers in a multitude of formats on many topics, to address many needs, and with a range of intended outcomes. The decisions on each of these variables are made by the CE providers. This diversity ensures that the right CE is available to all the professionals. We expect that we will see this same diversity in REMS CE and that the locus of control for these decisions will remain with the providers.” Letter from Murray Kopelow, MD, CEO of ACCME toIndustry Working Group – October 2011

19. Evaluating REMS CE: A Standards Based Approach FDA-mandated Requirements of the ER/LA Opioid Analgesic REMS

20. ER/LA Opioid Analgesic REMS Goal & Requirements Goal: Reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, etc. while maintaining patient access to medications REMS Requirements: • Medication Guide to be dispensed with each Rx • RPC REMS website: www.ER-LA-opioidREMS.com • No promotional content: REMS-related info only • Educational activities will be made available to all HCPs who prescribe ER/LA opioid analgesics • “REMS-compliant CE” must: • Include all elements of FDA Blueprint in the educational activity/materials • Include post-activity assessment covering all sections of FDA Blueprint • Be subject to independent audit (CE Accreditors = auditors) • At least 10% of activities will be audited for compliance with Blueprint, compliance with assessment requirements & compliance with Accreditors’ standards for commercially-supported CE

21. ER/LA Opioid Analgesic REMS Website

22. ER/LA Opioid Analgesic REMS Requirements (cont’d) • First REMS CE must be available by March 1, 2013 • Boston University launched first CE activity February 28, 2013 • Searchable listing of RPC-supported REMS-compliant CE are posted at www.ER-LA-opioidREMS.com • FDA-mandated “goals” for # of HCPs completing CE on full Blueprint • 80,000 by March 2015 (25% of 320,000 active prescribers) • 160,000 by March 2016 (50% of 320,000 active prescribers) • 192,000 by March 2017 (60% of 320,000 active prescribers) • REMS & REMS CE notification letters with copy of Patient Counseling Document sent to: • All DEA-registered prescribers for Schedule II & III drugs • Professional Organizations & Licensing Boards • Assessments to FDA at 6 mo. post-REMS approval & annually thereafter http//www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformation for PatientsandProviders/UCM311290.pdf Accessed March 12, 2013

23. Requirements for Patient & Prescriber Education Central component of the ER/LA Opioid Analgesics REMS is education for: • Patients • Medication Guide to be dispensed to each patient along with Rx • Patient Counseling Document on risks/safe use to be utilized by Providers • Prescribers: Physicians, NPs, PAs, other “Prescribers” of ER/LA opioids • Prescriber education (see FDA Blueprint) must include information on: • Assessing patients for treatment • Initiating therapy, modifying dosing & discontinuing therapy • Managing therapy & monitoring patients • How to recognize evidence of/potential for opioid misuse, abuse & addiction • Counseling patients & caregivers on safe use • General drug information (class-wide characteristics) • Specific drug information (table listing key safety info for each ER/LA opioid) • Training/education will be developed & conducted by accredited CE providers under educational grants awarded by RPC

24. Easiest path to site: Google “FDA ER LA Opioid REMS”

25. distribution mechanism ACCME Accredited N = 687 State Medical Society AccreditedN = 1,392 2011 Reporting Year

26. Where they live, work, learn

27. Role of MEMS 2009 MEMS: Datastandardfor organizations to bring together data from multiple systems about CE activities. 2013 MEMS 2.0: Revised to include standards for compiling data about REMS CE activities.

28. Role of MEMS CE Providers • record data about CE activities according to MEMS 2.0 standard • transmit to accreditors in XML format ACCME and other Accreditors • Accept data about CE activities into their databases which have been designed to conform to the MEMS 2.0 standard • Transmit data about REMS-compliant CME activities to third-party aggregator

29. PARS currently… • Data descriptive of CME activities provided by ACCME and some SMS-accredited providers • Used by providers each year to enable ACCME to: • select activities for demonstration of Practice in Performance • create ACCME’s Annual Report.

30. PARS currently… • Required Data that must be provided for each CME activity: • Activity Type , Title, Date, and, if applicable, Location • Sponsorship (Direct or Joint) • Hours of Instruction • Designed to change (Competence, Performance or Patient Outcomes)? • Changes in (Competence, Performance or Patient Outcomes) evaluated? • Number of physicians and non-physicians who participated in the activity • Commercial Support Received? (Y/N)- If Yes, # of Commercial Supporters, and nature of support (Monetary and/or in-kind) Optional Data that may be provided for each CME activity: • Provider activity identifier • Description of the activity content, • Subcategories for courses, • AMA PRA Category 1 Credits Designated, • Names of joint sponsors and commercial supporters, • Nature of in-kind support, and • Some activity-specific income and expense information MEMS 1.0 Compliant

31. Required Data that will be collected for each REMS-Compliant CME activity: • Activity Type, Title, Date, and, if applicable, Location • Provider activity identifier • Sponsorship (Direct or Joint) • Hours of Instruction • Designed to change (Competence, Performance or Patient Outcomes)? • Changes in (Competence, Performance or Patient Outcomes) evaluated? • Number of physicians and non-physicians who participated in the activity • Commercial Support Received? (Y/N)- RPC Funded vs. Non-RPC Funded • # of Prescribers that Successfully Completed the Activity • # of Prescribers by Profession (i.e. physician, nurse practitioner or pharmacist) • # of Prescribers by Practice Type (i.e. primary care, pain specialist, non-pain specialist) PARS for REMS-compliant MEMS 2.0 Compliant

32. Accredited Provider Perspective Emma Trucks, MPH(c) Administrative Manager Boston University School of Medicine www.scopeofpain.com

33. When the rubber meets the road! • Implementing specifications while MEMS 2.0 was still in development • Considering the Learners’ Perspective: • How will a learner interpret a question? • Do questions make sense for our target audience? • Are there too many questions that will become a barrier to completion? • Considering the Provider’s Perspective • Will we collect the information that we need? www.scopeofpain.com

34. Registration:Not as simple as it seems!

35. Defining Prescribers • Vital for RPC and FDA reporting requirements www.scopeofpain.com

36. Are you currently licensed to prescribe schedule II and schedule III opioid analgesics? n (completers) = 246 www.scopeofpain.com

37. Within the last 12 months, have you prescribed opioids for any patients for equal to/greater than 3 months? n (completers) = 246 www.scopeofpain.com

38. Within the last 12 months, have you prescribed extended release long-acting (ER-LA) opioids? n (completers) = 246 www.scopeofpain.com

39. Within the last 12 months, have you prescribed opioids for any patients for equal to/greater than 3 months? Of those saying yes, how many are prescribing ER/LA opioids? n (completers) = 246 www.scopeofpain.com

40. Profession • Certificates vs. Reporting • FDA Requirements vs. CME perspective

41. Profession n (completers) = 246 www.scopeofpain.com

42. Practice Type • What is the background of our participants? • Clearly Defined Categories www.scopeofpain.com

43. Specialty • Helpful outcomes tool • Not required by FDA

44. n (completers) = 246 www.scopeofpain.com

45. Evaluating REMS CE: A Standards Based Approach REMS Assessment Reports to FDA: Bringing Our Collective Efforts Together

46. REMS Assessment Reports: Evaluating “Success” of the ER/LA Opioid Analgesic REMS (cont’d) • Compliance in implementing REMS requirements • Dear HCP Letter to ±1,400,000 registered prescribers plus Professional Orgs & Licensing Boards • Call center established & reports of call activity • Website active & reports of website activity • Training through accredited CE Providers made available to all prescribers • Attainment of “training” performance goals • Number of prescribers completing CE as per timelines set by FDA • First goal: 80,000 by Feb 28, 2015 • Annual reports for 2013 & 2014 will detail progress toward goals • Results of independent audits • Long-term evaluation of CE outcomes • Prescriber knowledge, practice changes 6‐12 mo. post-CE

47. REMS Assessment Reports: Evaluating “Success” of the ER/LA Opioid Analgesic REMS (cont’d) • Prescriber Survey • Levels of knowledge • Changes in practice • Awareness of REMS • Patient Survey • Knowledge and awareness • Receipt of Med Guide & Patient Counseling Document • Changes in adverse outcomes • Misuse, abuse, overdose, addiction, death • Surveillance monitoring • Interventions to Address Surveillance Findings • Evaluation of drug utilization patterns • Levels of knowledge • Changes in practice • Awareness of REMS

48. Summary: ER/LA Opioid Analgesic REMS • ER/LA Opioid REMS = unparalleled opportunity for real collaboration to address a public health imperative • Despite complexities, the “can do” attitude of all stakeholders has resulted in meeting all goals to date • Open, transparent communication is imperative • Interpretations, nuances & terminology differences can lead to misunderstandings – don’t hesitate to ask clarifying questions • RPC is 100% committed to effective implementation of this important patient safety/public health initiative • Your role is critical to the ultimate success of the REMS & we very much appreciate your assistance!

50. Discussion