Key Data Gaps Regarding the Public Health Issues Associated with Opioid Analgesics

  • Teresa D. Schmidt
  • J. David Haddox
  • Alexandra E. Nielsen
  • Wayne Wakeland
  • John Fitzgerald
Article

Abstract

Most pharmaceutical opioids are used to treat pain, and they have been demonstrated to be effective medications for many. Their abuse and misuse pose significant public health concerns in the USA. Research has provided much insight into the prevalence, scope, and drivers of opioid abuse, but a holistic understanding is limited by a lack of available data regarding key aspects of this public health problem. Twelve data gaps were revealed during the creation of a systems-level computer model of medical use, diversion, nonmedical use, and the adverse outcomes associated with opioid analgesics in the USA. Data specific to these gaps would enhance the validity and real-world applications of systems-level models of this public health problem and would increase understanding of the complex system in which use and abuse occur. This paper provides an overview of these gaps, argues for the importance of closing them, and provides specific recommendations for future data collection efforts.

Keywords

Opioid Analgesic Drug Enforcement Administration Chronic Nonmalignant Pain Doctor Shopping Prescription Drug Monitoring Program 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

Funding for this project was provided by Purdue Pharma L.P. Preliminary work that formed the basis for this manuscript was presented at the 72nd Annual Meeting of the College on Problems of Drug Dependence. The authors also appreciate the significant contributions from Howard Chilcoat, Ph.D., Aaron Gilson, Ph.D., Dennis McCarty, Ph.D., and Lynn Webster, M.D., who provided valuable insight into the organization of the manuscript and the relevance of its contents. Additional support was provided from NIDA grant number 5R21DA031361-02.

Conflict of Interest

Wayne Wakeland, Ph.D., Teresa Schmidt, M.A., and Alexandra Nielsen, B.S., were compensated through a research grant to Portland State University funded by Purdue Pharma L.P. John Fitzgerald, Ph.D., is a full-time employee of Purdue Pharma L.P. J. David Haddox, D.D.S., M.D., is a full-time employee of Purdue Pharma L.P. and receives no compensation from Tufts University.

References

  1. 1.
    Furlan AD, Sandoval JA, Mailis-Gagnon A, et al. Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects. Canadian Medical Association. 2006;174(11):1589–1594. doi:10.1503/cmaj.051528.Google Scholar
  2. 2.
    Whittle SL, Richards BL, Husni E, et al. Opioid therapy for treating rheumatoid arthritis pain. Cochrane Database of Systematic Reviews. 2011;11. Available online at: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003113.pub3/pdf/standard. Accessed August 18, 2013.
  3. 3.
    Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. In: The Cochrane Collaboration, Noble M, eds. Cochrane Database of Systematic Reviews. Chichester, UK: John Wiley & Sons, Ltd; 2010. Available online at: http://doi.wiley.com/10.1002/14651858.CD006605.pub2. Accessed February 10, 2013.
  4. 4.
    Eisenberg E, McNicol E, Carr DB. Opioids for neuropathic pain. Cochrane Database of Systematic Reviews. 2006;3. Available online at: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006146/pdf/standard. Accessed August 18, 2013.
  5. 5.
    Caudill-Slosberg MA, Schwartz LM, Woloshin S. Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000. Pain. 2004;109(3):514–519. doi:10.1016/j.pain.2004.03.006.CrossRefPubMedGoogle Scholar
  6. 6.
    Governale L. Outpatient Prescription Opioid Utilization in the U.S., Years 2000–2009. 2010. Available online at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM220950.pdf. Accessed March 9, 2013.
  7. 7.
    Volkow ND, McLellan TA. Curtailing diversion and abuse of opioid analgesics without jeopardizing pain treatment. Journal of the American Medical Association. 2011;305(13):1346–1347.CrossRefPubMedGoogle Scholar
  8. 8.
    Substance Abuse and Mental Health Services Administration. Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings. 2013. Available online at: http://www.samhsa.gov/data/NSDUH/2012SummNatFindDetTables/NationalFindings/NSDUHresults2012.pdf. Accessed February 26, 2013.
  9. 9.
    Alford DP, Livingston EH. Misuse of Opioid Medication. Journal of the American Medical Association. 2013;309(19):2055–2055.CrossRefPubMedGoogle Scholar
  10. 10.
    Hall AJ, Logan JE, Toblin RL, et al. Patterns of abuse among unintentional pharmaceutical overdose fatalities. Journal of the American Medical Association. 2008;300(22):2613–2620.CrossRefPubMedGoogle Scholar
  11. 11.
    Centers for Disease Control and Prevention (U.S.), National Center for Injury Prevention and Control (U.S.). Unintentional drug poisoning in the United States. 2010. Available online at: http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/brief_full_page.htm. Accessed March 4, 2013.
  12. 12.
    Food and Drug Administration. Extended-release (ER) and long-acting (LA) opioid analgesics risk evaluation and mitigation strategy (REMS). 2013. Available online at: http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm163647.htm. Accessed May 3, 2013.
  13. 13.
    Leiderman DB. Risk management of drug products and the U.S. Food and Drug Administration: Evolution and context. Drug and Alcohol Dependence. 2009;105:S9–S13. doi:10.1016/j.drugalcdep.2009.02.007.CrossRefPubMedGoogle Scholar
  14. 14.
    Fishman SM, Papazian JS, Gonzalez S, et al. Regulating opioid prescribing through prescription monitoring programs: Balancing drug diversion and treatment of pain. Pain Medicine. 2004;5(3):309–324.CrossRefPubMedGoogle Scholar
  15. 15.
    Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. Journal of Pain. 2009;10(2):147.CrossRefPubMedGoogle Scholar
  16. 16.
    Wakeland W, Nielsen A, Schmidt TD, et al. Modeling the Impact of Simulation Educational Interventions on the Use and Abuse of Pharmaceutical Opioids in the United States: A Report on Initial Efforts. Health Education & Behavior. In press.Google Scholar
  17. 17.
    Forrester JW. Industrial dynamics. Cambridge, Mass.: M.I.T. Press; 1961.Google Scholar
  18. 18.
    Sterman J. Business dynamics: systems thinking and modeling for a complex world. Boston: Irwin/McGraw-Hill; 2000.Google Scholar
  19. 19.
    Sterman JD. Learning from evidence in a complex world. American Journal of Public Health. 2006;96(3). Available online at: http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2005.066043. Accessed May 3, 2013.
  20. 20.
    Homer JB. A system dynamics model for cocaine prevalence estimation and trend projection. Journal of Drug Issues. 1993. Available online at: http://psycnet.apa.org/psycinfo/1993-43867-001. Accessed August 18, 2013.
  21. 21.
    Homer JB. Projecting the impact of law enforcement on cocaine prevalence: a system dynamics approach. Journal of Drug Issues. 1993;23:281–281.Google Scholar
  22. 22.
    Milstein B, Homer J, Hirsch G. Analyzing national health reform strategies with a dynamic simulation model. American Journal of Public Health. 2010;100(5). Available online at: http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2009.174490. Accessed February 10, 2013.
  23. 23.
    Dasgupta N, Kramer ED, Zalman M-A, et al. Association between non-medical and prescriptive usage of opioids. Drug and Alcohol Dependence. 2006;82(2):135–142. doi: 10.1016/j.drugalcdep.2005.08.019.CrossRefPubMedGoogle Scholar
  24. 24.
    Fischer B, Manzoni P, Rehm J. Comparing Injecting and Non-Injecting Illicit Opioid Users in a Multisite Canadian Sample (OPICAN Cohort). European Addiction Research. 2006;12(4):230–239. doi: 10.1159/000094425.CrossRefPubMedGoogle Scholar
  25. 25.
    Institute of Medicine (U.S.). Committee on Advancing Pain Research C. Relieving pain in America a blueprint for transforming prevention, care, education, and research. Washington, D.C.: National Academies Press; 2011. Available online at: http://site.ebrary.com/id/10520732. Accessed February 23, 2013.
  26. 26.
    Hardt J, Jacobsen C, Goldberg J, et al. Prevalence of Chronic Pain in a Representative Sample in the United States. Pain Medicine. 2008;9(7):803–812. doi: 10.1111/j.1526-4637.2008.00425.x.CrossRefPubMedGoogle Scholar
  27. 27.
    Gureje O, Simon GE, Von Korff M. A cross-national study of the course of persistent pain in primary care. Pain. 2001;92(1):195–200.CrossRefPubMedGoogle Scholar
  28. 28.
    Roper Starch Worldwide. Chronic pain in America: Roadblocks to relief. American Academy of Pain Medicine, American Pain Society, Janssen Pharmceuticals. 1999.Google Scholar
  29. 29.
    World Health Organization. International statistical classification of diseases and related health problems. Geneva: World Health Organization; 1992.Google Scholar
  30. 30.
    Strom BL. Data validity issues in using claims data. Pharmacoepidemiology and Drug Safety. 2001;10(5):389–392.CrossRefPubMedGoogle Scholar
  31. 31.
    Edlund MJ, Steffick D, Hudson T, et al. Risk factors for clinically recognized opioid abuse and dependence among veterans using opioids for chronic non-cancer pain. Pain. 2007;129(3):355–362. doi: 10.1016/j.pain.2007.02.014.CrossRefPubMedGoogle Scholar
  32. 32.
    Martell BA, O’Connor PG, Kerns RD, et al. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Annals Internal Medicine. 2007;146(2):116–127.CrossRefGoogle Scholar
  33. 33.
    Weisner CM, Campbell CI, Ray GT, et al. Trends in prescribed opioid therapy for non-cancer pain for individuals with prior substance use disorders. Pain. 2009;145(3):287–293.PubMedCentralCrossRefPubMedGoogle Scholar
  34. 34.
    Katz N, Panas L, Kim ML, et al. Usefulness of prescription monitoring programs for surveillance—analysis of Schedule II opioid prescription data in Massachusetts, 1996–2006. Pharmacoepidemiology and Drug Safety. 2010;19(2):115–123.CrossRefPubMedGoogle Scholar
  35. 35.
    Hasin DS, O’Brien CP, Auriacombe M, et al. DSM-5 Criteria for Substance Use Disorders: Recommendations and Rationale. American Journal of Psychiatry. 2013;170(8):834–851. doi: 10.1176/appi.ajp.2013.12060782.PubMedCentralCrossRefPubMedGoogle Scholar
  36. 36.
    Sullivan MD, Edlund MJ, Fan MY, et al. Risks for possible and probable opioid misuse among recipients of chronic opioid therapy in commercial and medicaid insurance plans: The TROUP Study. Pain. 2010;150(2):332.PubMedCentralCrossRefPubMedGoogle Scholar
  37. 37.
    Lee JH, Kuyateh F, Mehta H. Serious Adverse Events. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology; 2008. Available online at: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM234301.pdf. Accessed August 27, 2012.
  38. 38.
    Katz NP, Birnbaum HG, Castor A. Volume of prescription opioids used nonmedically in the United States. Journal of Pain and Palliative Care Pharmacotherapy. 2010;24(2):141–144.CrossRefPubMedGoogle Scholar
  39. 39.
    Joranson DE, Gilson AM. Drug Crime Is a Source of Abused Pain Medications in the United States. Journal of Pain Symptom Management. 2005;30(4):299–301. doi: 10.1016/j.jpainsymman.2005.09.001.CrossRefPubMedGoogle Scholar
  40. 40.
    Gray JA, Hagemeier NE. Prescription drug abuse and DEA-sanctioned drug take-back events: characteristics and outcomes in rural Appalachia. Archives of Internal Medicine. 2012;172(15):1186–1187.CrossRefPubMedGoogle Scholar
  41. 41.
    Center for Drug and Alcohol Studies. The Delaware School Survey: Alcohol, Tobacco, and Other Drug Abuse Among Delaware Students. 2011. Available online at: http://www.udel.edu/delawaredata/Pages/level03/delschsurv.htm. Accessed March 8, 2013.
  42. 42.
    Center for Drug and Alcohol Studies. Delaware School Survey: Alcohol, Tobacco & Other Drug Abuse Among Delaware Students 2010. Available online at: http://www.udel.edu/delawaredata/Files/2010StateReport.pdf. Accessed March 8, 2013.
  43. 43.
    Center for Drug and Alcohol Studies. Delaware Secondary School Student Assent and Survey instructions. 2011. Available online at: http://www.udel.edu/delawaredata/Files/DSS/225793-13%20secondary%20back%20from%20s.pdf. Accessed March 8, 2013.
  44. 44.
    Johnson LD, O’Malley PM, Bachman JG, et al. Monitoring the Future: National Results on Adolescent Drug Use: Overview of Key Findings, 2012. University of Michigan Institute for Social Research. 2013.Google Scholar
  45. 45.
    Severtson SG, Bartelson BB, Davis JM, et al. Reduced Abuse, Therapeutic Errors, and Diversion Following Reformulation of Extended-Release Oxycodone in 2010. Journal of Pain. 2013. doi:10.1016/j.jpain.2013.04.011.PubMedGoogle Scholar
  46. 46.
    US Department of Justice (USDOJ), Drug Enforcement, Drug Enforcement Administration. ARCOS: Automation of Reports and Consolidated Orders System. Available online at: http://www.deadiversion.usdoj.gov/arcos/index.html. Accessed August 31, 2013.
  47. 47.
    Scott R. Testimony Before the United states House of Representatives Hearing on the Growing of Prescription Drug Diversion.; 2011.Google Scholar
  48. 48.
    Dasgupta N, Freifeld C, Brownstein JS, et al. Crowdsourcing Black Market Prices For Prescription Opioids. Journal of Medical Internet Research. 2013;15(8):e178.PubMedCentralCrossRefPubMedGoogle Scholar
  49. 49.
    Inciardi JA, Surratt HL, Cicero TJ, et al. Prescription drugs purchased through the internet: Who are the end users? Drug and Alcohol Dependence. 2010;110(1):21.PubMedCentralCrossRefPubMedGoogle Scholar
  50. 50.
    Rigg KK, March SJ, Inciardi JA. Prescription Drug Abuse & Diversion: Role of the Pain Clinic. Journal of Drug Issues. 2010;40(3):681–702.PubMedCentralCrossRefPubMedGoogle Scholar
  51. 51.
    Trescot AM, Boswell MV, Atluri SL, et al. Opioid guidelines in the management of chronic non-cancer pain. Pain Physician. 2006;9(1):1.PubMedGoogle Scholar
  52. 52.
    Inciardi JA, Surratt HL, Kurtz SP, et al. Mechanisms of prescription drug diversion among drug-involved club-and street-based populations. Pain Medicine. 2007;8(2):171–183.PubMedCentralCrossRefPubMedGoogle Scholar
  53. 53.
    Kraman P. Drug abuse in America: prescription drug diversion. Council of State Governments. 2004. Available online at: http://www.csg.org/knowledgecenter/docs/TA0404DrugDiversion.pdf. Published in 2004. Accessed July 1, 2012.
  54. 54.
    Califano JA. Under the counter: The diversion and abuse of controlled prescription drugs in the US. National Center on Addiction Substance Abuse at Columbia University. 2005. Available online at: http://buysafedrugs.info/uploadedfiles/section5.pdf. Accessed August 18, 2013.
  55. 55.
    Gilson AM, Ryan KM, Joranson DE, et al. A reassessment of trends in the medical use and abuse of opioid analgesics and implications for diversion control: 1997–2002. J Pain Symptom Management. 2004;28(2):176–188. doi: 10.1016/j.jpainsymman.2004.01.003.CrossRefGoogle Scholar
  56. 56.
    Cepeda MS, Fife D, Chow W, et al. Assessing Opioid Shopping Behaviour. Drug Safety. 2012;35(4):325–334.CrossRefPubMedGoogle Scholar
  57. 57.
    Colliver JD, Kroutil LA, Dai L, et al. Misuse of prescription drugs: data from the 2002, 2003 and 2004 national surveys on drug use and health. Rockville, Md.: Dept. of Health and Human Services, Substance Abuse and Mental Health Services Administration, Office of Applied Studies; 2006. Available online at: http://www.samhsa.gov/data/prescription/toc.htm.
  58. 58.
    Manchikanti L, Cash KA, Damron KS, et al. Controlled substance abuse and illicit drug use in chronic pain patients: An evaluation of multiple variables. Pain Physician. 2006;9(3):215–225.PubMedGoogle Scholar
  59. 59.
    Brecht M-L, Huang D, Evans E, et al. Polydrug use and implications for longitudinal research: ten-year trajectories for heroin, cocaine, and methamphetamine users. Drug and Alcohol Dependence. 2008;96(3):193–201.PubMedCentralCrossRefPubMedGoogle Scholar
  60. 60.
    Cone EJ, Fant RV, Rohay JM, et al. Oxycodone involvement in drug abuse deaths: a DAWN-based classification scheme applied to an oxycodone postmortem database containing over 1000 cases. Journal of Analytical Toxicology. 2003;27(2):57–67.CrossRefPubMedGoogle Scholar
  61. 61.
    Cone EJ, Fant RV, Rohay JM, et al. Oxycodone involvement in drug abuse deaths. II. Evidence for toxic multiple drug-drug interactions. Journal of Analytical Toxicology. 2004;28(4):217–225.CrossRefPubMedGoogle Scholar
  62. 62.
    Jones CM. Frequency of Prescription Pain Reliever Nonmedical Use: 2002–2003 and 2009–2010. Archives of Internal Medicine. 2012;172(16):1265–1267.CrossRefPubMedGoogle Scholar
  63. 63.
    Hser Y-I, Huang D, Chou C-P, et al. Trajectories of Heroin Addiction Growth Mixture Modeling Results Based on a 33-Year Follow-Up Study. Evaluation Review. 2007;31(6):548–563.CrossRefPubMedGoogle Scholar
  64. 64.
    McCabe SE, Boyd CJ. Sources of prescription drugs for illicit use. Addictive Behaviors. 2005;30(7):1342–1350.PubMedCentralCrossRefPubMedGoogle Scholar
  65. 65.
    McCabe SE, Boyd CJ, Teter CJ. Subtypes of nonmedical prescription drug misuse. Drug and Alcohol Dependence. 2009;102(1):63–70.PubMedCentralCrossRefPubMedGoogle Scholar
  66. 66.
    Havens JR, Oser CB, Leukefeld CG, et al. Differences in prevalence of prescription opiate misuse among rural and urban probationers. American Journal of Drug and Alcohol Abuse. 2007;33(2):309–317.CrossRefPubMedGoogle Scholar
  67. 67.
    Young AM, Havens JR. Transition from first illicit drug use to first injection drug use among rural Appalachian drug users: a cross-sectional comparison and retrospective survival analysis. Addiction. 2012;107(3):587–596. doi: 10.1111/j.1360-0443.2011.03635.x.PubMedCentralCrossRefPubMedGoogle Scholar
  68. 68.
    Martins SS, Keyes KM, Storr CL, et al. Birth-cohort trends in lifetime and past-year prescription opioid-use disorder resulting from nonmedical use: results from two national surveys. Journal of Studies on Alcohol and Drugs. 2010;71(4):480–487.PubMedCentralCrossRefPubMedGoogle Scholar

Copyright information

© National Council for Behavioral Health 2014

Authors and Affiliations

  • Teresa D. Schmidt
    • 1
  • J. David Haddox
    • 2
    • 4
  • Alexandra E. Nielsen
    • 1
  • Wayne Wakeland
    • 1
  • John Fitzgerald
    • 3
  1. 1.Systems Science Graduate ProgramPortland State UniversityPortlandUSA
  2. 2.Health PolicyPurdue Pharma L.P.StamfordUSA
  3. 3.Purdue Pharma L.P.StamfordUSA
  4. 4.Public Health and Community MedicineTufts University School of MedicineBostonUSA

Personalised recommendations