Disclosure 2018 2019: Co chair, Task Force on Protecting the - PDF document

In Intervenin ing in in the the Opioid ioid Epidem Epidemic ic in in the the US: US: Norman Kahn MD CPE Educ ducating ing Heal Health th Convener, Conjoint Committee on Pr Professionals – Continuing Education (CCCE) Challenges, nkahn@cmss.org Successes and Unintended Consequences • 2012 ‐ 2019: Convener, Conjoint Committee on Continuing Education (CCCE) • Coalition of 27 organizations in medicine, nursing, dentistry, pharmacy, PAs, addressing the opioid epidemic through the continuing education of health professionals Disclosure • 2018 ‐ 2019: Co ‐ chair, Task Force on Protecting the Integrity of Continuing Education (ACCME) • 2018 ‐ 2021: Member, Advisory Board, Center for Professionalism and Value in Health Care (ABFM Foundation) • 2017: Co ‐ chair, Planning Committee, Vision Initiative for the Future of Ongoing Certification (ABMS) • 2008 ‐ 2017: EVP/CEO, Council of Medical Specialty Societies (CMSS)

Accreditation Council for Continuing American Dental Education Medical Education Association Accreditation Council for Graduate American Hospital Association Medical Education Conjoint American Medical Association Accreditation Council for Pharmacy American Nurses Credentialing Education Center Committee on Alliance for Continuing Education in American Osteopathic Association the Health Professions Continuing Association for Hospital Medical American Academy of Family Education Physicians Association of American Medical Education American Association of Colleges of Colleges Nursing Council of Medical Specialty American Association of Colleges of (CCCE): Societies Osteopathic Medicine Federation of State Medical Boards American Academy of Physician Assistants Medbiquitous Consortium American Association of State National Association of Boards of Boards of Pharmacy Member Pharmacy American Board of Medical National Board of Medical Specialties Examiners Organizations American Dental Association National Council of State Boards of Commission for Continuing Nursing Education Provider Recognition (n=25) Society for Academic Continuing Medical Education The CCCE’s goal … to use accredited continuing education Conjoint to improve the performance of the U.S. health care system Committee on Continuing The CCCE’s strategic focus… Education: to facilitate the education of prescribers of opioid analgesics, and their practice teams, in Risk Evaluation Objectives and Mitigation Strategies (REMS)

• FDA • Opioid Analgesic REMS Education Blueprint Conjoint for Health Care Providers Involved in the Committee on Treatment and Monitoring of Patients with Pain (9 ‐ 18 ‐ 18) Continuing • REMS Program Companies (RPC) Education • Since 2012, FDA requires opioid (CCCE): manufacturers to collaborate to address FDA Opioid Risk Evaluation and Mitigation Strategies (REMS) through supporting (through pooled funds managed by a FDA and RPC neutral third party) accredited continuing education for clinicians • 3M Company • Depomed, Inc. • Abhai LLC • Egalet Corporation • Akon, Inc. • Elite Laboratories Inc. REMS • Allergan Sales, LLC • Endo Pharmaceuticals Inc. • Alvogen • Epic Pharma, LLC Program • Amneal Pharmaceuticals, LLC • Fosun Pharma USA Inc. • ANI Pharmaceuticals, Inc. • Genus Lifesciences Inc. Companies: • Apotex Inc. • Hikma Pharmaceuticals USA Inc. • Ascent Pharmaceuticals, Inc. • Ingenus Pharmaceuticals NJ, LLC • Aurolife Pharma LLC • Ipca Laboratories Limited • Avanthi, Inc. • Janssen Pharmaceuticals Inc. December 2018 • BioDelivery Sciences • Jerome Stevens Pharmaceuticals, International, Inc. Inc. (n = 59) • Cipher Pharmaceutical, Inc. • Ken Lifescience • Colllegium Pharmaceuticals Inc. • Lannett Company, Inc. • Daiichi Sankyo, Inc. • Larken Laboratories, Inc.

• 31. Lupin Pharmaceuticals Inc./Novel • 50. Teva Pharmaceuticals USA, Inc. Laboratories, Inc. • 51. ThePharmaNetwork, LLC • 32. Macleods Pharmaceuticals Limited • 52. Tris Pharma, Inc. • 33. Mallinckrodt LLC • 53. Upsher ‐ Smith Laboratories, LLC • 34. Mayne • 54. Valeant Pharmaceuticals North • 35. Megalith Pharmaceuticals Inc. REMS • 55. Validus Pharmaceuticals LLC • 36. Mikart, Inc. • 56. VistaPharm Inc. • 37. Mylan, Inc. 57. WESPharm Inc. • Program • 38. Nesher Pharmaceuticals USA LLC • 58. Wockhardt USA • 39. Nexgen Pharma, Inc. • 59. Zydus Pharmaceuticals (USA) Inc. Companies • 40. Osmotica Pharmaceutical Corp • 60. Xiromed/Chemo Research SL • 41. Paddock Laboratories, LLC, subsidiary of Perrigo Company PLC (continued) • 42. Pernix (Bankrupt) • 43. Pfizer, Inc. • 44. Pharmaceutical Associates, Inc. 45. Purdue Pharma LP • • 46. Rhodes Pharmaceuticals LP • 47. Sandoz Inc. • 48. Sentynl Therapeutics, Inc. • 49. Sun Pharmaceutical Industries, Inc. • FDA • CDC • NIDA • SAMHSA • HRSA The national • HHS landscape has • AHRQ • ONDCP expanded • DEA • Surgeon General’s Office • President’s Commission • “Public Health Emergency” • NGA • NAM

• For the public: • Is opioid addiction/opioid use disorder criminal and/or sociopathic behavior? Philosophical Assumptions? • For health professionals: • Is opioid prescribing unnecessary and therefore inappropriate? Overdose Deaths in US ‐ all types 25 Motor Vehicle Crash Overdose Deaths per 100,000 population 20 15 10 5 0 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 Source: National Center for Health Statistics

• America’s per capita consumption of opiates tripled (~ 2,000,000 people, 1865 ‐ 1880) Opioid • Aggressive marketing and over ‐ prescribing of painkillers Epidemic: • Congress introduced the first law to criminalize drug use, the Harrison Narcotic Act of 1915 • Taxed narcotics, prohibited using narcotics in the 19 th Century US treatment of addiction • The Guardian, US Edition, December 2017

Drug overdose deaths in the United States: Continued to increase in 2016 New York Times, September 2, 2017  Source: National Center for Health Statistics, Centers for Disease Control and Prevention Opioid Deaths

Heroin Use Climbed then Stabilized PAST YEAR, 2002 AND 2015- 2017, 12+ See table 7.2 in the 2017 NSDUH detailed tables for additional information and the 2017 CDC MortalityData. 1 5 Progress on Prescription Pain Reliever Misuse and Heroin initiation PAST YEAR, 2017, 12+ P = 0.0008 P = 0.0337 + Difference between this estimate and the 2017 estimate is statistically significant at the .05 level. P = 0.0090 See tables 7.2, 7.28, and 7.34 in the 2017 NSDUH detailed tables for additional information. 1 6

The epidemic is national. 78 people die every day from heroin and opioid overdoses in the U.S. Source: National Vital Statistics System, Mortality file United States 5% of World’s Population 80% of 99% of World’s Opioid World’s The influence of prescription International Narcotics monitoring programs on Painkillers Vicodin Control Board Report, 2008 chronic pain management, Pain Physician, 2009

Opioid Prescribing in the U.S. and other Countries, 2000 ‐ 2016 NYT : August 10, 2017 Sources of Rx Opioids Among Past ‐ year Non ‐ Medical Users Jones, Paulozzi, et al. JAMA Int Med 2014

Pain: The 5 th Vital Sign • History • Introduced by president of American Pain Society 1995 • Embraced by VA system late 1990s • Became Joint Commission standard 2001 ‐ 2017 • Because • Recognition pain undertreated • Untreated pain leads to chronic pain • Chronic pain interferes with quality of life, is costly, and common

Promotion: Oxycodone (OxyContin) • Approved 1995 • Sales: • 1996 $45 million • 2000 $1.1 billion • 2010 $3.1 billion (30% of painkiller market) • 1996 ‐ 2002 funded >20,000 pain ‐ related educational programs • Provided financial support to: American Pain Society, the American Academy of Pain Medicine, the Joint Commission, members of Congress Increase in Opioid Prescribing Associated with Increase in Death Slide from and used with permission of CDC Division of Unintentional Injury Prevention

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Interventions • Enforcement • Closing “pill mills” • Disciplining prescribers • Public Health • Availability of naloxone • Medication assisted/based treatment (good evidence for Methadone, Buprenorphine) • Other… • Education • Prescribers • Health professional team members • Public? Enforcement – a few examples 2017 ‐ • Alabama – John Couch MD ‐ 20 years in prison for prescribing large quantities of opioids, with no legitimate purpose, as part of his pain clinic practice • Rhode Island ‐ Jerrold Rosenberg MD ‐ convicted of healthcare fraud for receiving kickbacks from the manufacturer to prescribe sublingual fentanyl spray for cancer pain that patients did not have • Michigan – Abdul Haq MD – conspiracy conviction for prescribing medically unnecessary opioids 2019 – • US DOJ ‐ Appalachian Regional Prescription Opioid Strike Force

• Dated • Duped 4D Model (DEA) • Disabled • Dishonest Prescription Monitoring Programs that Share Patient Data via PMP InterConnect ‐ as of August 20, 2018