A National Perspective on the Abuse and Diversion of Prescription Drugs

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A National Perspective on the Abuse and Diversion of Prescription Drugs Hilary L. Surratt, Ph.D Steven P. Kurtz, Ph.D. ARSH: Center for Applied Research on Substance Use and Health Disparities Faculty Symposium Nova Southeastern University February 7, 2013

Background Prescription drug abuse has escalated dramatically in the past 15 years, particularly opioid analgesics. Treatment and prescribing practices Opioid product availability Diversion is defined as the unlawful channeling of regulated pharmaceuticals to the illicit market; it occurs through a variety of mechanisms.

RADARS System History 2001: Founded by Purdue Pharma 2006: Independently owned and operated by Denver Health & Hospital Authority

RADARS System Goals Measure rates of abuse, misuse and diversion of prescription drugs Identify sentinel events involving the abuse, misuse and diversion of prescription drugs nationwide

RADARS System Mosaic Approach College Survey Early Experimenters Poison Center Acute Events OTP Opioid Tx Program Patients in Treatment SKIP Survey of Key Informant Pts Patients in Treatment Drug Diversion Criminal Justice/ Law Enforcement

RADARS Programs College Survey Self-reported nonmedical use of prescription drugs in previous semester on web-based survey Poison Centers Spontaneous reports of intentional exposure mentions of acute medical events associated with one or more prescription drug of interest SKIP/OTP Opioid dependent persons seeking treatment; Selfreported use of prescription opioids to get high in the past 30 days

Drug Diversion (DD) Number of new cases of pharmaceutical diversion investigated by law enforcement units or reported to state regulatory boards Coverage 260 reporters from 49 states Reporting Timeframe 3 months

RADARS System Data Analysis COUNTS BY SYSTEM UNITED STATES POPULATION = POPULATION RATE Relates abuse/diversion events to disease burden in entire population COUNTS BY SYSTEM URDD = UNIQUE RECIPIENTS OF DISPENSED DRUG (URDD) RATE Relates abuse/diversion events to corresponding patient benefit

RADARS System Opioid Abuse Trends Population Rates (Ranked Highest-Lowest) 2011 Rank Poison Center Opioid Treatment 1 Survey of Key Informant Pts Drug Diversion College Survey hydrocodone oxycodone hydrocodone oxycodone hydrocodone 2 3 4 5 6 7 8 oxycodone hydrocodone oxycodone hydrocodone oxycodone tramadol methadone morphine morphine morphine methadone morphine hydromorphone buprenorphine tramadol morphine hydromorphone methadone methadone fentanyl buprenorphine buprenorphine buprenorphine hydromorphone methadone fentanyl fentanyl fentanyl tramadol buprenorphine hydromorphone tramadol tramadol fentanyl hydromorphone

RADARS System Opioid Abuse Trends URDD Rates (Ranked Highest-Lowest) 2011 Rank Poison Center Opioid Treatment 1 Survey of Key Informant Pts Drug Diversion College Survey methadone methadone hydromorphone methadone methadone 2 3 4 5 6 7 8 buprenorphine hydromorphone methadone hydromorphone hydromorphone morphine morphine morphine buprenorphine morphine hydromorphone buprenorphine buprenorphine morphine fentanyl fentanyl fentanyl fentanyl oxycodone buprenorphine tramadol oxycodone oxycodone fentanyl oxycodone oxycodone hydrocodone hydrocodone hydrocodone hydrocodone hydrocodone tramadol tramadol tramadol tramadol

Impact Assessment Introduction of abuse/ tamper deterrent formulations for long-acting prescription opioids An interesting example involves the examination of trends in the diversion of OxyContin

Background OxyContin is a Schedule II opioid analgesic originally released in 1996. OxyContin is an extended release opioid: each tablet contains a 12-hour dose of oxycodone. This contributes to OxyContin s effectiveness as a pain reliever for persistent pain, but also makes it a target for drug abusers. Abusers crush, break or chew the tablets to destroy the time-release delivery. Crushing the tablets results in a powder that can be readily swallowed, snorted or dissolved for injection. OxyContin has been widely diverted and abused, and is believed by many to have been a major driver of the prescription opioid abuse epidemic over the past 15 years.

Background After several years in the clinical development and FDA approval processes, Purdue Pharma released a new formulation of OxyContin in August 2010. The original formulation is no longer manufactured or distributed in the U.S. The new formulation of OxyContin is tamper-resistant: using a physical barrier it is designed to resist crushing and other manipulation, in order to deter abuse.

Reformulated OxyContin August 2010 OxyContin OC OxyContin OP

OxyContin Reformulation New formulation Original formulation

Law Enforcement Cases Down 50% Cases per 100,000 population 0.50 0.45 0.40 0.35 0.30 0.25 0.20 0.15 0.10 0.05 0.00 The RADARS System Drug Diversion Program OxyContin Cases Population Rates, 4 th Quarter 2008 to 4 th Quarter 2011 Before Introduction of OxyContin-reformulated After Introduction of OxyContin-reformulated

Discussion Overall, the tamper-resistant formulation appears to have dramatically decreased the diversion of OxyContin. Comprehensive surveillance data from law enforcement can be useful in informing important policy and regulatory decisions at the state, regional, and national levels. Surveillance data are also useful for documenting emerging trends in drug diversion that warrant monitoring.

500 450 400 350 300 250 200 150 100 50 0 1Q2011 Top Ten Non-Opioid Drug Mentions Alprazolam 2Q2012 Carisoprodol Clonazepam Diazepam Zolpidem Lorazepam Tenofovir/emtricitabine efavirenz/emtricitabine/teno. Propoxyphene Cyclobenzaprine Atazanavir Butalbital

Thank you! arsh.nova.edu