MedBiquitous Annual Conference April 9, 2013 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) A REMS is… •A risk management plan that the FDA has determined is necessary to ensure that the benefits of a drug outweigh the risks of the drug. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCAct ChapterVDrugsandDevices/default.htm. Accessed March 15, 2013. REMS Program Company (RPC) Members* Apotex, Inc. Purdue Pharma, L.P. Endo Pharmaceuticals, Inc. Ranbaxy Pharmaceuticals, Inc. Impax Rhodes Pharmaceuticals, L.P. Janssen Pharmaceuticals, Inc. Roxane Laboratories, Inc. Mallinckrodt, Inc. (Covidien) Sandoz, Inc. Mylan Technologies, Inc. The PharmaNetwork, LLC Noven Pharmaceuticals, Inc. VistaPharm, Inc. Par Pharmaceuticals Watson Laboratories Pfizer, Inc. * Updated March, 2013 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 1 2 http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ ucm277916.pdf. IOM (Institute of Medicine). 2011. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education & Research. Washington, DC:The National Academies Press. FDA Opioid REMS meeting with Industry (May 2011) Public meeting with IWG (Dec 2009) Letters to Sponsors that REMS is required (Feb 2009) Stakeholder meetings (Apr 2009) RPC Grants Approved (Jan 2012) CE Blueprint in Fed Reg (Nov 2011) Advisory Committee meeting (Oct 2010) RPC CE RFAs (Aug-Nov 2013) ' 09 Q1 2009 Q2-Q3 2009 Q4 2009 Q1 2010 Q2 2010 Q1 2011 Q2-3 2011 Q4 2011 Advisory Committee meeting (Jul 2010) Q1-3 2012 Q4 2012Q1 2013 ' 13 ER/LA Opioid REMS approval (w/final Blueprint) (July 2012) REMS letter to Sponsors (Apr 2011) Sponsor meeting (May 2009) Public meeting of "Interested Parties" Q3-4 2010 Sponsors submit proposed REMS (Aug 2011) MedBiq Working Group Formed (July 2012) First REMS CE (2/28/2013) MEMS Specs & Implementation Guide (Feb 2013) 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 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: ACCME = = CE Providers FDA RPC = Continuing Education REMS Success Reflected in Outcomes (Misuse, abuse) Uniform data set & collection system needed to aggregate data from numerous Providers/Accreditors for FDA reporting 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. CE is Effective… Continuing education is effective in assisting professionals to modify and improve their practice stakeholders… Flashback…. Conjoint Committee on CME November 2007 Summit A new stakeholder… ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) – Food and Drug Administration (08/2012) “ The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extendedrelease or long-acting opioid analgesics while maintaining patient access to pain medications.” 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 Facilitating Conditions… 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: a. Understand how to assess patients… b. Be familiar with how to initiate therapy, modify dose, and discontinue use… c. Be knowledgeable about how to manage ongoing therapy… d. Know how to counsel patients and caregivers… e. 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. Independence 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 “…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 where prescribers 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 to Industry Working Group – October 2011 FDA-mandated Requirements of the ER/LA Opioid Analgesic REMS 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 ER/LA Opioid Analgesic REMS Website 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 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 Easiest path to site: Google “FDA ER LA Opioid REMS” distribution mechanism Hours of Activities Instruction 132,768 952,736 ACCME Accredited N = 687 NonPhysician Physician Participants Participants 13,741,621 9,558,789 2011 Reporting Year State Medical Society Accredited N = 1,392 Where they live, work, learn Activities Courses Regularly scheduled series Internet (live) Test-item writing Committee learning Performance improvement Internet searching and learning Internet (enduring materials) Enduring materials (other) Learning from teaching Journal CME Manuscript review 66,509 22,766 2,078 132 598 502 587 27,624 7,097 665 4,136 74 ~133,000 Hours of Instruction 384,881 451,040 6,144 997 1,731 7,137 3,879 47,829 39,549 2,442 6,870 238 ~953,000 Role of MEMS 2009 MEMS: Data standard for 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. 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 PARS currently… • • Data descriptive of CME activities provided by ACCME and some SMSaccredited providers Used by providers each year to enable ACCME to: – select activities for demonstration of Practice in Performance – create ACCME’s Annual Report. 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 nonphysicians 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 PARS for REMS-compliant 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) MEMS 2.0 Compliant Accredited Provider Perspective Emma Trucks, MPH(c) Administrative Manager Boston University School of Medicine www.scopeofpain.com 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 Registration: Not as simple as it seems! Defining Prescribers • Vital for RPC and FDA reporting requirements www.scopeofpain.com Are you currently licensed to prescribe schedule II and schedule III opioid analgesics? 2% 11% YES NO Not Sure 87% n (completers) = 246 www.scopeofpain.com Within the last 12 months, have you prescribed opioids for any patients for equal to/greater than 3 months? 47% 53% YES NO n (completers) = 246 www.scopeofpain.com Within the last 12 months, have you prescribed extended release long-acting (ER-LA) opioids? 46% 54% YES NO n (completers) = 246 www.scopeofpain.com 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? 47% 53% YES NO n (completers) = 246 www.scopeofpain.com Profession • Certificates vs. Reporting • FDA Requirements vs. CME perspective Profession n (completers) = 246 www.scopeofpain.com Practice Type • What is the background of our participants? 12% 41% • Clearly Defined Categories 34% 13% PCP Pain Specialist Non-Pain Specialist N/A www.scopeofpain.com Specialty • Helpful outcomes tool • Not required by FDA n (completers) = 246 www.scopeofpain.com REMS Assessment Reports to FDA: Bringing Our Collective Efforts Together 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 Prescriber Survey Patient Survey Changes in adverse outcomes Levels of knowledge Changes in practice Awareness of REMS Knowledge and awareness Receipt of Med Guide & Patient Counseling Document 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 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!