ACCMEs Member Organizations AC American Board of Medical - PDF document

ACCME at the FDA Murray Kopelow MD July 22, 2010 ACCME Accredited Continuing Education as a Strategic Asset to REMS ACCME @ the Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Advisory Committee and Drug Safety and Risk Management Advisory Committee July 22, 2010 Murray Kopelow MD, MS(Comm), FRCPC Chief Executive Accreditation Council for Continuing Medical Education ACCME’s Member Organizations AC American Board of Medical Specialties American Hospital Association American Medical Association Association for Hospital Medical Education Association of American Medical Colleges Council of Medical Specialty Societies Federation of State Medical Boards of the US, Inc. 1

ACCME at the FDA Murray Kopelow MD July 22, 2010 Scope 2009 Hours of Activities Instruction 96,042 714,759 Non- Physician Physician Participants Participants 10,775,113 6,781,572 Not “business as Usual” in CME CME AS A BRIDGE TO QUALITY • Using practice-based g p Accredited CME needs is linked to • Matching content to learner’s scope of the practice and practice focused on • Measuring change in competence or quality gaps performance or patient outcomes as part of the process Sept 2006 – Change in Emphasis 2

ACCME at the FDA Murray Kopelow MD July 22, 2010 Evidence Based Continuing education is effective in assisting g professionals to modify and improve their practice Focus on Practice Gaps Upper Respiratory Tract Infection Upper Respiratory Tract Infection Upper Respiratory Tract Infection Allergic Rhinitis Allergic Rhinitis Allergic Rhinitis Acne Acne Acne “On average, “On average, “On average, Fever Fever Fever “On average, “On average, “On average, according to data in according to data in according to data in Childhood Immunizations Childhood Immunizations Childhood Immunizations according to data in according to data in according to data in the medical records, the medical records, the medical records, the medical records the medical records the medical records Urinary Tract Infection Urinary Tract Infection Urinary Tract Infection f f f the medical records, the medical records, the medical records, children in the study children in the study children in the study Vaginitis and STD Vaginitis and STD Vaginitis and STD children in the study children in the study children in the study received 46.5% … of received 46.5% … of received 46.5% … of Asthma Asthma Asthma received 46.5% … of received 46.5% … of received 46.5% … of the indicated care.” the indicated care.” the indicated care.” Well-child Care Well-child Care Well-child Care the indicated care.” the indicated care.” the indicated care.” Acute Diarrhea Acute Diarrhea Acute Diarrhea Adolescent Prev Services Adolescent Prev Services Adolescent Prev Services 50 50 50 Rita Mangione-Smith et al, The Quality of Ambulatory Care Delivered to Children Rita Mangione-Smith et al, The Quality of Ambulatory Care Delivered to Children in the United States, NEJM, Volume 357:1515-1523 October 11, 2007 in the United States, NEJM, Volume 357:1515-1523 October 11, 2007 3

ACCME at the FDA Murray Kopelow MD July 22, 2010 …but not just any CME Physician Physician Analysis Performance Performance Synthesis This is CPD Judgment J d t Regnier et al, JCEHP, Fall 2005 …but not just any CME Physician Physician Analysis Performance Performance Synthesis This is CME J d Judgment t Regnier et al, JCEHP, Fall 2005 4

ACCME at the FDA Murray Kopelow MD July 22, 2010 Historically…. Our challenge is to Via overcome… overcome interventions interventions that are … – Overuse – Predisposing – Under use (Prepare for change) – Misuse – Enabling …in clinical care in clinical care ( ( Link new to what learner already doing, in practice) – Reinforcing (Via reminders and Grol, JAMA, 286,20,2001 feedback) Cantillon and Jones, BMJ, 318:127, 1999 Describes the ‘Gap’ “ The misuse and abuse of the long-acting and extended-release opioid drug products have and, serious public health crisis of addiction; overdose and death. The FDA can intervene in some addiction; overdose and death Th FDA i t i aspects of this problem, but thoroughly addressing the problem will require a much broader set of interventions coming from the numerous stakeholders affected by this crisis. It is critical that we find ways to intervene that will limit the increasing problems of addiction, overdose and death associated with the long-acting and extended-release opioids, while maintaining the necessary balance to assure continued access to these important analgesic drug products for people with chronic pain .” From July 22, 2010 FDA Memo of Invitation 5

ACCME at the FDA Murray Kopelow MD July 22, 2010 The ACCME Requirements Concurrent Validity Valued Requirements Education Criteria Standards for Commercial Support “ The new accreditation elements will “ We applaud the Accreditation Council for prove to be valuable in the national Continuing Medical Education’s efforts to provide additional guidance for ensuring initiatives to assure competence of physicians. research independence and a free flow of scientific exchange, while safeguarding This level of activity is just what has accredited CME from commercial been needed to place the continuing influence. medical education community at the forefront of improving quality in the Your vigilance in this important matter practice of medicine.” contributes to the best practices of ib h b i f unbiased information-sharing and will benefit, ultimately, the health of the American public.” James Thompson, M.D. CEO and President Raynard S. Kington, M.D., Ph.D. Federation of State Medical Boards Deputy Director, National Institutes of Health August 30, 2006 July 8, 2010 6

ACCME at the FDA Murray Kopelow MD July 22, 2010 Alignment of Purpose Final Report of the [FDA] Prescriber Education Working Group June 2010 “ Therefore, the stakeholders , and the WG recommend that the REMS prescriber training be designed to exceed the goal of traditional CME methods (knowledge acquisition) and instead aim to demonstrate optimized practitioner ti i d titi performance and improved patient outcomes.” Alignment of Purpose Final Report of the [FDA] Prescriber Education Final Report from the ACCME Task Force Working Group on Competency and the Continuum June 2010 April 2004 “ Therefore, the stakeholders , “To meet the needs of the and the WG recommend 21st century physician, that the REMS prescriber CME will provide support training be designed to for the physicians' exceed the goal of professional development traditional CME methods that is based on (knowledge acquisition) and continuous improvement instead aim to demonstrate in the knowledge, optimized practitioner ti i d titi strategies and t t i d performance and improved performance-in-practice patient outcomes.” necessary to provide optimal patient care.” 7

ACCME at the FDA Murray Kopelow MD July 22, 2010 Content /Concurrent Validity Final Report of the [FDA] Criteria 2. Incorporates into CME activities the Prescriber Education Working educational needs (knowledge, Group competence, or performance) that June 2010 underlie the professional practice gaps of p p g p “ Therefore the “ Therefore, the their own learners. stakeholders and the Criteria 3. Generates activities/educational WG recommend that the interventions that are designed to change REMS prescriber competence, performance, or patient training be designed to outcomes as described in its mission exceed the goal of statement. traditional CME methods (knowledge Criteria 5. The provider chooses educational formats for activities/interventions that are acquisition) and instead aim to demonstrate appropriate for the setting, objectives pp p g, j optimized practitioner and desired results of the activity. performance and Criteria 11. The provider analyzes changes in improved patient learners (competence, performance, or outcomes.” patient outcomes) achieved as a result of the overall program’s activities/educational interventions. Content /Concurrent Validity Final Report of the [FDA] Criteria 16. Integrates CME into the process for Prescriber Education Working improving professional practice. Group June 2010 Criteria 17. Utilizes non-education strategies to “ Therefore, the “ Therefore the enhance change as an adjunct to its stakeholders and the activities/educational interventions). WG recommend that the REMS prescriber Criteria 18. Identifies factors outside the provider’s training be designed to control that impact on patient outcomes. exceed the goal of traditional CME Criteria 19. Implements educational strategies to methods (knowledge remove, overcome or address barriers to acquisition) and instead physician change. aim to demonstrate optimized practitioner Criteria 20. Builds bridges with other stakeholders performance and through collaboration and cooperation. improved patient outcomes.” Criteria 21. Participates within an institutional or system framework for quality improvement. 8