1. Drug Diversion, Sources, and Extent: United States Case Study Aaron M. Gilson, MS, MSSW, PhD Research Program Manager/Senior Scientist Pain & Policy Studies Group International Pain Policy Fellowship Pain & Policy Studies Group WHO Collaborating Center for Pain Policy & Palliative Care University of Wisconsin Carbone Cancer Center August 7, 2012

2. Morphine Equivalence (Mg/person) U.S. National Retail Sales of Opioid Analgesics 1980-2010 Data sources: Consumption data - International Narcotics Control Board Population – United Nations World Population Prospects, 2010 Revision ME conversion factors – WHOCC Centre for Drug Statistics Methodology

3. Past-Month Use of Pain Relievers and Illicit Drugs 1990-2010 PercentagePercentage Source: National Survey on Drug Use and Health – Substance Abuse and Mental Health Services Administration. Note: “Pain relievers” (previously called “Analgesics”) include opioid analgesics as well as noncontrolled drugs such as tramadol and now comprise almost 30 separate medications; “Illicit drugs” include cocaine, hallucinogens, heroin, inhalants, marijuana/hashish, and prescription-type psychotherapeutics used non-medically (including pain relievers).

4. Prescription Pain Medication Diversion Event: A.Increased prescribing of opioids for pain Event: A.Increasing reports of non-medical use Causal Attribution: A.Diversion is due primarily to increased availability to patients for pain management B.Prescribers and patients are to blame –Increased stigmatization C.Safety of prescription opioids is questioned Fallacy

5. Prescription Pain Medication Diversion  Increased monitoring of prescribers  Tightening prescription requirements  Imposing undue limits on legitimate prescribing  Increased scrutiny of patients  Publicize risks of pain medicines But... What if there are non-medical diversion sources? If attribution is correct, Then the main solutions are:

6. Manufacturers Distributors 1. DISTRIBUTION SYSTEM (lawful distribution) Pharmacies Hospitals/Clinics Internet w/Rx Practitioners Prescribers Dispensers Nursing homes Hospices Patients (Lawful medical use) (Prescribed medication) (Common Carriers)  International smuggling Abusers, addicts, impaired health care professionals use what they steal 2. PRIMARY DIVERSION (unlawful; supplies some abusers and re-distribution)  Theft from manufacturers and distributors*  Theft in transit * Theft from hospitals*  Pharmacies/robbery*  Employee/customer Pilferage * Script docs/pill mills Inappropriate prescribing Doctor shopping  Internet sales without Rx  Theft of Rx/forgery Patient sells or gives Theft from home Theft from patient Improper disposal Dealers Peers Relatives 3. REDISTRIBUTION (Layers of re- distribution; illicit industry) All Nonmedical users: Used for reward, high, recreation; compulsive use due to addiction; treatment of withdrawal; Self medication for mood, sleep, pain 4. NON MEDICAL USES 5. MEASUREMENT OF IMPACTS Surveys Postmarketing Nonmedical use Abuse Addiction Addiction treatment Key informants Pain patients Reporting systems Adverse events Accident/Poisoning Emergency Dept Internet surveillance Medical Examiner Treatment episodes Arrests Literature Misuse, abuse, addiction Self medication Unprescribed drugs Diversion Schematic: Lawful distribution; primary diversion; layers of redistribution, non medical uses; measurement of impacts PPSG, 2007 Prescribed medications * = Amounts reported by law on DEA Form 106 WHOLESALEWHOLESALE RETAILRETAIL ULTIMATEUSERULTIMATEUSER

7. Recent Federal and State Responses to Medication Abuse and Diversion  FDA Risk Evaluation and Mitigation Strategies (REMS)  Reducing Volume of Unused Medications  DEA Take Back  DEA Disposal Regulations  Electronic Prescribing of Controlled Substances  Prescription Series for Controlled Substances  Prescription Monitoring Programs (PMP)  Office of National Drug Control Policy Prescription Drug Abuse Prevention Plan

8. Office of National Drug Control Policy (ONDCP) White House Report: Prescription Drug Abuse Prevention Plan (April, 2011, pp. 1-10 )

9.  Domain #1: Education  Healthcare practitioners  CE  Curricula in health professional schools  Methods to facilitate and assess adequateness and effectiveness of pain treatment  Parent, youth, and patient  Research and development Office of National Drug Control Policy Prescription Drug Abuse Prevention Plan

10.  Domain #2: Tracking and Monitoring  PMPs  Electronic prescribing  Epidemiology  Domain #3: Proper Medication Disposal  Domain #4: Enforcement  Reduce “doctor shopping” and “pill mills” Office of National Drug Control Policy Prescription Drug Abuse Prevention Plan

11.  ONDCP  Bureau of Justice Assistance  Centers for Disease Control and Prevention  Centers for Medicare and Medicaid Services  Department of Justice  Environmental Protection Agency  Health Resources and Services Administration  High Intensity Drug Trafficking Area Program  Indian Health Service  National Institute of Justice  National Institute on Drug Abuse Office of National Drug Control Policy Prescription Drug Abuse Prevention Plan Federal Agencies Involved

12.  Office of the National Coordinator for Health Information Technology  State Medical Boards  Substance Abuse & Mental Health Services Administration  U.S. Bureau of Prisons  U.S. Department of Defense  U.S. Department of Education  U.S. Department of Health and Human Services  U.S. Drug Enforcement Administration  U.S. Food and Drug Administration  Veterans Administration Office of National Drug Control Policy Prescription Drug Abuse Prevention Plan Federal Agencies Involved

13. Prescription Drug Abuse Prevention Plan Addressing UNODC Recommendations  Interagency cooperation  Practitioner training  Model laws  Medication monitoring systems  Engaging the public ONDCP Strategy  National policies  Trandisciplinary committees to share information  Illegal internet sales Other U.S. Activities

14. Conclusions  Medical use of pain medications has increased contemporaneously with non-medical use, with little understanding of the relationship  Efforts to reduce pain medication abuse and diversion historically has focused on the prescriber/patient relationship  A comprehensive approach has been slow to come  The U.S. government has recently issued a comprehensive strategy to reduce abuse/diversion  More evidence is needed to guide interventions

15. Action Steps: A Critical Need for More Information  Target multiple sources of diversion  Are there non-medical diversion sources?  Is diversion only/mostly the result of increased prescribing for pain?  Quantify amounts diverted and motivations for use  Evaluate effectiveness of interventions attempted  Improving prescribing and dispensing practices  Improving monitoring and coordination  Improving treatment of people who use non-medically  Limit adverse impact on medical availability  Epidemiological understanding