1. Curbing Diversion of Prescription Opioids Nathaniel Katz, MD, MS Tufts University School of Medicine Analgesic Research Opioid Prescribing to Adolescents in Dental Settings National Institute of Drug Abuse February 23, 2009

2. Outline 1.Define and characterize diversion 2.Present what is known about sources of diverted prescription opioids 3.Speculate about role of dentists 4.Describe potential solutions

3. 1 Define and Characterize Diversion

4. Definition of Diversion “The transfer of a controlled substance from a lawful to an unlawful channel of distribution or use.” Section 309, Diversion Prevention and Control Uniform Controlled Substances Act National Conference of Commissioners on Uniform State Laws, 1994 “means manufacture, possession,delivery or use of a controlled substance by a person or in a manner not specifically authorized by law.” Section 3302.(12) of the New York State Public Health Law

5. Diversion Examples Diversion Sharing Selling, buying Stealing Prescription forgery Doctor shopping Illegal internet Rx Criminal prescribing Not Diversion Using your own legitimately prescribed medication to get high (~20% of NMU)

6. 2 What is Known About Sources of Diverted Prescription Opioids

7. Source of Pain Relievers by Past Year Users Aged ≥12: 2006 Totals may not =100% because of rounding or because suppressed estimates not shown “Other” includes: “Wrote fake prescription,” “Stole from doctor’s office/clinic/hospital/pharmacy,” & “Some other way. 68% from docs

8. 5 Most Common Sources of Misused Prescription Opioids: By Population *For free & bought; † Own prescription, 1 doctor, & >1 doctor ‡ Stolen, stole from friend/family, theft, & forged prescription Percentage

9. Sources of Diverted Dosage Units Distribution System Manufacturers Distributors Pharmacies Hospitals/Clinics Internet Practitioners Nursing Homes Hospices Patients Primary Diversion Theft from Manufacturers Theft from Distributors Theft from Pharmacies Theft from Hospitals/Clinics Illegal Internet Internat’l Smuggling Forgery Script Doc/Pill Mill Doctor Shopping Patient Sells/Gives 2007 Total Doses 3,251,539 706,558 2,633,098 175,000,000? ? Tens of millions? ? ? ? TOTAL 1,000,000,000?

10. Criminal Prescribing: 1 case “The board investigator presented evidence that Brown was the single leading prescriber of OxyContin in the entire state, with his prescriptions accounting for 288,859 of the 922,985 OxyContin tablets sold through pharmacies in 2004.” For a 30-month period, Brown was the state's second largest prescriber of OxyContin

11. Schedule II Opioid Rx Dispensed to Individuals Showing Questionable Activity* *Questionable activity = obtained Schedule II opioid prescriptions from ≥4 pharmacies & ≥4 physicians during the specified yr 0 1 2 3 4 5 6 969899000102030405 Fiscal yr Estimated percentage 63,000 scripts 97 3.5 million doses

12. Quantifying Diversion: Research Agenda Clean up NSDUH data: –Break down “non-medical use” data –How many dosage units ingested –How many dosage units acquired through different sources* –Update drug picture cards Clean up DEA Form 106 Database Compile Internet diversion data Compile criminal prescribing data; validate algorithms for identifying criminal prescribing Compile doctor shopping data; validate algorithms for identifying inappropriate doctor shopping

13. 3 Speculate About the Role of Dentists in Prescription Opioid Diversion

14. 14 Top Specialties Prescribing Immediate-Release Opioids, 1998 vs. 2002 (WITH Hydrocodone & Oxycodone Combination Products) MD Specialty% Prescriptions FAMILY PRACTICE14.6% DENTISTRY12.2% INTERNAL MEDICINE12.2% ORTHOPEDIC SURGERY10.2% OSTEOPATHIC MEDICINE7.8% EMERGENCY MEDICINE6.1% GENERAL SURGERY3.6% OBSTETRICS/GYNECOLOGY3.2% ALL OTHERS30.2% 1998 2002 MD Specialty% Prescriptions DENTISTRY15.5% FAMILY PRACTICE13.0% ORTHOPEDIC SURGERY11.5% INTERNAL MEDICINE11.1% OSTEOPATHIC MEDICINE6.7% EMERGENCY MEDICINE5.5% GENERAL SURGERY4.2% OBSTETRICS/GYNECOLOGY3.5% ALL OTHERS28.9% Source: IMS Health, National Prescription Audit Plus TM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003. Dentists likely prescribe about a billion doses per year of opioids, mostly immediate-release combination products

15. Speculations About Role of Dentists in Prescription Opioid Diversion Dentists prescribe large volumes of drugs most commonly abused by adolescents and others The extent to which opioids are prescribed in greater quantities than necessary is unknown but probably considerable Anecdotal evidence suggests that adolescents use opioids non-medically that they or family members obtain from dentists Dentists rarely screen for opioid abuse risk factors or doctor shopping, monitor pts, educate them on risks of controlled substances or med storage/disposal, etc. It is not clear how well dentists understand the basic pharmacotherapy of pain and the appropriate role of opioids

16. 4 Potential Solutions

18. FDA, Opioids, and REMS FDAAA September 2007 RISK EVALUATION AND MITIGATION STRATEGIES (REMS) REQUIREMENTS Title IX, Subtitle A, Section 901 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) amends the Federal Food, Drug, and Cosmetic Act (FDCA) to authorize FDA to require the submission of a REMS for an approved drug if FDA becomes aware of new safety information and determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks (section 505-1(a)). This provision took effect on March 25, 2008.

19. Switch-Based Retail Solution Prescriber Patient Explains Med Guide REMS registry Patient training- enrollment Retail Pharmacy Prescription brought Enrollment verified Prescription filled Data Client FDA Web-based training Switch company(ies) Closed Distribution

20. Solutions ProblemGeneral ApproachDentists Poor pt selection, monitoring, treatment REMS-based mandatory training (Not education) Guidelines Mandatory training Research Poor monitoringUrine drug monitoring Sharing/sellingUniversal pt education/training Nat’l awareness campaign Lockboxes Training dental pts Lockboxes Nat’l awareness campaign ForgeryTamper-proof scripts Doctor shoppingPrescription monitoring TheftRational disposal