Responding to the Prescription Opioid and Heroin Crisis: An Epidemic of Addiction

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Responding to the Prescription Opioid and Heroin Crisis: An Epidemic of Addiction Andrew Kolodny, MD Co-Director, Opioid Policy Research Collaborative Heller School for Social Policy and Management Brandeis University Executive Director, Physicians for Responsible Opioid Prescribing

Conflict of Interests I have no relevant financial relationships to disclose. 2

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Preliminary 2016 Data Indicates OD Crisis Still Getting Worse 64,070 20,145 15,446 14,427 4

Heroin treatment admissions : 2003-2013 SOURCE: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, Treatment Episode Data Set (TEDS). Data received through 01.23.15.

Death rates from overdoses of heroin or prescription opioid pain relievers (OPRs), by age group SOURCE: CDC. Increases in Heroin Overdose Deaths 28 States, 2010 to 2012 MMWR. 2014, 63:849-854 7

Source: J. Katz. NYT Short Answers to Hard Questions About the Opioid Crisis August 10, 2017 8

Three Opioid-Addicted Cohorts 1. 20-40 y/o, disproportionately white, significant heroin use, opioid addiction began with Rx use 2. 40 y/o & up, disproportionately white, mostly Rx opioids, opioid addiction began with Rx use 3. 50 y/o & up, disproportionately non-white, mostly heroin users, opioid addiction began with heroin use 9

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Rate 8 Rates of Opioid Sales, OD Deaths, and Treatment, 1999 2010 7 Opioid Sales KG/10,000 Opioid Deaths/100,000 Opioid Treatment Admissions/10,000 6 5 4 3 2 1 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Year CDC. MMWR 2011

Industry-funded educational messages Physicians are needlessly allowing patients to suffer because of opiophobia. Opioid addiction is rare in pain patients. Opioids can be easily discontinued. Opioids are safe and effective for chronic pain. 14

Industry-funded organizations campaigned for greater use of opioids Pain Patient Groups Professional Societies The Joint Commission The Federation of State Medical Boards 15

Opioid prescribing in the U.S. peaked ~ 2011 Prescribing has declined slightly since 2011 Prescribing levels in 2015 were 3 times higher than 1999 Source: Guy GP Jr., Zhang K, Bohm MK, et al. Vital Signs: Changes in Opioid Prescribing in the United States, 2006 2015. MMWR Morb Mortal Wkly Rep 2017;66:697 704.

CDC Opioid Guideline (2016) Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain.

VA/DOD Guideline (2017) We recommend against initiation of long-term opioid therapy for chronic pain Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain

Controlling the epidemic: A Three-pronged Approach Prevent new cases of opioid addiction. Treat people who are already addicted. Reduce supply from pill mills and the black-market. 20

How the opioid lobby frames the problem: Source: Slide presented by Dr. Lynn Webster at FDA meeting on hydrocodone up-scheduling, Jan 25 th, 2013.

This is a false dichotomy Opioid harms are not limited to so-called drug abusers 35% met DSM V criteria for an opioid use disorder 1 Pain Patients Drug Abusers 92% of opioid OD decedents were prescribed opioids for chronic pain. 2 1. Boscarino JA, Rukstalis MR, Hoffman SN, et al. Prevalence of prescription opioid-use disorder among chronic pain patients: comparison of the DSM-5 vs. DSM-4 diagnostic criteria. J Addict Dis. 2011;30:185-194. 2. Johnson EM, Lanier WA, Merrill RM, et al. Unintentional Prescription Opioid-Related Overdose Deaths: Description of Decedents by Next of Kin or Best Contact, Utah, 2008-2009. J Gen Intern Med. 2012 Oct 16.

Buprenorphine Experience in France Introduced in the mid 90s 79% decline in OD deaths in 6 years Use of mono product (not formulated with naloxone) associated with diversion and injection use Source: Auriacombe et al. French field experience with buprenorphine. Am J Addict. 2004

Heroin treatment admissions with planned medication-assisted opioid therapy 2005-2015 SOURCE: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, Treatment Episode Data Set (TEDS). Data received through 01.23.15.

Ten Steps Feds Should Take 1. Improve surveillance of opioid addiction 2. Improve reporting of and response to opioid-related fatalities. 3. Promote more cautious prescribing for acute pain 4. Prohibit marketing of opioids for chronic pain 5. Increase insurance coverage of and access to non-opioid and non-pharmacological management of pain 6. Improve the effectiveness of targeted law enforcement interdiction efforts, including improved coordination between legal and public health authorities 7. Early identification of opioid addiction and linkage to treatment 8. Expand low-threshold access to opioid agonist treatment 9. Ensure access to clean syringes and naloxone 10. FDA should seek removal of ultra-high dosage unit opioid analgesics from the market

Summary The U.S. is in the midst of a severe epidemic of opioid addiction- and it s still getting worse. To bring the epidemic to an end: We must prevent new cases of opioid addiction We must ensure access to treatment for people already addicted.

Andrew Kolodny, MD akolodny@brandeis.edu 28