1. 1 Findings from the Drug Abuse Warning Network Judy K. Ball, Ph.D., M.P.A. Office of Applied Studies Substance Abuse and Mental Health Services Administration 6 May 2008 http://DAWNinfo.samhsa.gov

2. SAMHSA / OAS 2 Today's Agenda  No conflicts of interest  Overview of DAWN  Key findings from 2006 –Nonmedical use of opiates/opioids –2004-2005 comparisons –Extended- vs. immediate-release fentanyl

3. SAMHSA / OAS 3 DAWN Methods  Stratified probability sample of hospitals –Short-term, general, nonFederal hospitals with 24-hour emergency departments (EDs) –Oversample areas –Remainder area  National estimates account for: –Sample design –Unit nonresponse –Partial nonresponse in responding hospital Entire U.S.

4. SAMHSA / OAS 4 National Estimates Oversample areas (urban) + Remainder area (urban & rural)

5. SAMHSA / OAS 5 Source of DAWN Estimates, 2004-2006 200420052006 Eligible hospitals4,5054,5494,568 Sample of hospitals556562544 Responding hospitals220224205 Response rate39.639.937.7 Design weight response rate26.725.824.9 Weighted response rate23.928.926.1 Drug-related ED visits168,841268,128269,339 Drug reports275,829420,420419,438

6. SAMHSA / OAS 6 DAWN Data Collection: Retrospective Review of Medical Records Source: DAWN, 2006 data, 4/3/2008 National estimates charts reviewed 9,837,481 cases found 346,946 Drug-related ED visits reviewed ED visits not reviewed

7. SAMHSA / OAS 7 Analysis Domains Drug-related ED visits Medical use Pharmaceuticals Nonmedical use Pharmaceuticals Illicit drugs Alcohol

8. SAMHSA / OAS 8 Definition: Nonmedical Use of Pharmaceuticals  Based on retrospective chart review –Exceeded prescribed or recommended dose –Used drugs prescribed for another –Malicious poisoning –Substance abuse –Excludes drug-related suicides –Includes suicide ideation, plan, gesture

9. SAMHSA / OAS 9 Drug-Related ED Visit Rates, 2004-2006 Source: National estimates from DAWN, 2004-2006 No significant change*Significant change, 2004 vs. 2006 2005 vs. 2006

10. SAMHSA / OAS 10 Nonmedical Use of Pharmaceuticals, Selected Opiates/Opioids, 2006 Source: National estimates from DAWN, 2006 * Single- & multi-ingredient formulations CI lower bound estimate CI upper bound

11. SAMHSA / OAS 11 Nonmedical Use of Pharmaceuticals, Selected Opiates/Opioids, 2006 Source: National estimates from DAWN, 2006 * Single- & multi-ingredient formulations CI lower bound estimate CI upper bound

12. SAMHSA / OAS 12 Classification of Fentanyl Reports  Extended release (ER) –Duragesic (2%) –Duragesic Patch (23%) –Fentanyl Patch (74%) Alternate terms: –Duragesic-100 –Duragesic-12 –Duragesic-25 –Duragesic-50 –Duragesic-75  Immediate release (IR) –bupivacaine-fentanyl –droperidol-fentanyl Innovar –fentanyl Actiq (89%) Fentora (11%) Ionsys Sublimaze –fentanyl-ropivacaine

13. SAMHSA / OAS 13 Classification of Fentanyl Reports (cont'd)  Unknown release type (UK) –Fentanyl (95%) alternate terms: –China white narcotic –Fentanyl citrate –Fentanyl lollipop –Fentanyl metabolite –Fentanyl pops –Fentanyl suckers

14. SAMHSA / OAS 14 Nonmedical Use of Pharmaceuticals, Fentanyl, by Release Type, 2004 Source: National estimates from DAWN, 2004 CI lower bound estimate CI upper bound

15. SAMHSA / OAS 15 Nonmedical Use of Pharmaceuticals, Fentanyl, by Release Type, 2005 Source: National estimates from DAWN, 2005 CI lower bound estimate CI upper bound

16. SAMHSA / OAS 16 Nonmedical Use of Pharmaceuticals, Fentanyl, by Release Type, 2006 Source: National estimates from DAWN, 2006 CI lower bound estimate CI upper bound

17. SAMHSA / OAS 17 Fentanyl, ER vs. IR – All Visits Source: DAWN estimates for the U.S., 2004-2006 No significant change*Significant change, 2004 vs. 2006 2005 vs. 2006

18. SAMHSA / OAS 18 Fentanyl, ER vs. IR – Medical Use Source: DAWN estimates for the U.S., 2004-2006 No significant change*Significant change, 2004 vs. 2006 2005 vs. 2006

19. SAMHSA / OAS 19 Fentanyl, ER vs. IR – Nonmedical Use Source: DAWN estimates for the U.S., 2004-2006 No significant change*Significant change, 2004 vs. 2006 2005 vs. 2006

20. SAMHSA / OAS 20 Fentanyl, IR vs. ER – Nonmedical vs. Medical Use Source: DAWN estimates for the U.S., 2004-2006 % of visits Nonmedical useMedical use

21. SAMHSA / OAS 21 Nonmedical Use: Disposition from ED, Fentanyl by Release Type, 2006 Source: DAWN estimates for the U.S., 2006 % of ED visits ExtendedUnknownImmediate Treated & released Admitted Other

22. SAMHSA / OAS 22 Nonmedical Use: Number of Drugs, Fentanyl by Release Type, 2006 Source: DAWN estimates for the U.S., 2006 % of ED visits ExtendedUnknownImmediate 1 drug Multiple drugs

23. SAMHSA / OAS 23 Fentanyl by Release Type: Unweighted Reports to DAWN, 2007-2008 Source: DAWN Live!, 4/30/2008 N=648 N=1,879 N=21

24. SAMHSA / OAS 24 Actiq and Fentora Reports to DAWN, by Type, 2007-2008 (unweighted) Source: DAWN Live!, 4/30/2008 Nonmedical use Medical use Seeking detox Suicide attempt N=11 N=8

25. SAMHSA / OAS 25 Actiq and Fentora Reports to DAWN, by Disposition, 2007-2008 (unweighted) Source: DAWN Live!, 4/30/2008 N=11 N=8 Discharged home Admitted Left AMA ActiqFentora

26. SAMHSA / OAS 26 Conclusions  Reports of immediate release fentanyl too infrequent to produce national estimates  Small number of Fentora reports to DAWN, 2007-2008 (to 4/30/2008) –First report in 2006 –Similar numbers of medical- and nonmedical-use visits; possibly more inpatient admissions

27. SAMHSA / OAS 27 Important Considerations: DAWN and ED Medical Records  Link between ED visit and use of drug –New linkages may need to be discovered for a new drug  Dose levels and source of drug unavailable  Nonspecific drug reports –Unknown release-type  DAWN surveillance can begin with (or before) drug approval