Opioid use following the introduction of an extended-release oxycodone formulation with tamper-resistant properties: Prospective historical chart review in methadone-maintained patients

Christopher Sankey, MD, CCFP (EM); Beatrice Setnik, PhD; Zoltan Harsanyi, BSc (Hon), MLS, MBA, PStat. (SSC), PSTAT® (ASA); Ken Michalko, PharmD, MBA; Zejiang Yang, PhD; Pierre Geoffroy, MDCM, MSc, FCFP, DABAM

doi:10.5055/jom.2016.0327

Authors

Christopher Sankey, MD, CCFP (EM)
Beatrice Setnik, PhD
Zoltan Harsanyi, BSc (Hon), MLS, MBA, PStat. (SSC), PSTAT® (ASA)
Ken Michalko, PharmD, MBA
Zejiang Yang, PhD
Pierre Geoffroy, MDCM, MSc, FCFP, DABAM

DOI:

https://doi.org/10.5055/jom.2016.0327

Keywords:

oxycodone, opioid abuse, tamper-resistant formulation, urine drug screen, methadone maintenance therapy

Abstract

Objective: Emerging data are demonstrating that tamper-resistant opioids may play an important role in changing prescription opioid abuse behaviors. This study was a chart review to examine if the reformulation of OxyContin® into a version with tamper-resistant properties (OxyNEO®) had an impact on oxycodone-positive urine drug screens (UDSs) in opioid-dependent patients receiving methadone maintenance therapy (MMT).

Design: The historical element of this study examined 250 eligible charts from patients on MMT who had data during the time periods when only OxyContin was available (baseline period), during the transition to OxyNEO, and when only OxyNEO was available. The prospective element included an exploratory questionnaire regarding retrospective opioid use.

Setting: The study was conducted at three methadone clinics, in Oshawa, Peterborough, and Scarborough in Ontario, Canada.

Participants: Male and female patients were eligible if they had a diagnosis of opioid dependency, received MMT, and had at least one oxycodone-positive UDS during the baseline period.

Intervention: This was a noninterventional study.

Main outcome measure: The main outcome was the number of oxycodone-positive UDSs.

Results: The results demonstrated a marked reduction in oxycodone-positive UDSs that showed stepwise, statistically significant decreases during the transition and post-OxyContin periods relative to baseline. While the oxycodone-positive UDS results were decreasing, morphine-related-positive UDSs remained relatively stable during the same periods. There were no significant gender differences noted.

Conclusions: The introduction of OxyNEO was associated with a statistically significant reduction in oxycodone exposure in a population of methadone-maintained patients.

Author Biographies

Christopher Sankey, MD, CCFP (EM)

Physician, Satellite Comprehensive Care Addictions Clinic, Toronto, Ontario, Canada; Vice Chair, OMA Section of Addiction Medicine, Toronto, Ontario, Canada; Medical Director, First Step Clinics, Toronto, Ontario, Canada; Lecturer, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada; Staff, Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Beatrice Setnik, PhD

VP Clinical Pharmacology, INC Research, Raleigh, North Carolina

Zoltan Harsanyi, BSc (Hon), MLS, MBA, PStat. (SSC), PSTAT® (ASA)

Director, Biostatistics and Data Management, Purdue Pharma, Pickering, Ontario, Canada.

Ken Michalko, PharmD, MBA

Retired Pharmaceutical Executive, Purdue Pharma, Pickering, Ontario, Canada

Zejiang Yang, PhD

Principal Biostatistician, INC Research, Raleigh, North Carolina

Pierre Geoffroy, MDCM, MSc, FCFP, DABAM

Physician, First Step Clinics; VP, INC Research, Toronto, Ontario, Canada.

References

Canadian Pain Society: Position statement on opioid analgesics in pain management - 2015 update. Pain Res Manag. 2015; 20(6): 287.

Canadian Centre on Substance Abuse: Canadian Drug Summary: Prescription Opioids. April 2015. Available at http://www.ccsa.ca/Resource%20Library/CCSA-Canadian-Drug-Summary-Prescription-Opioids-2015-en.pdf. Accessed December 7, 2015.

Katz N, Dart RC, Bailey E, et al.: Tampering with prescription opioids: nature and extent of the problem, health consequences, and solutions. Am J Drug Alcohol Abuse. 2011; 37: 205-217.

Statistics Canada: Canadian Tobacco, Alcohol and Drugs Survey: Summary of Results for 2013. Ottawa, ON: Statistics Canada, 2015. Available at http://healthycanadians.gc.ca/science-research-sciences-recherches/data-donnees/ctadsectad/summary-sommaire-2013-eng.php.

Center for Behavioral Health Statistics and Quality: Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Abuse and Health. HHS Publication No. SMA 15-4927, NSDUH Series H-50. Research Triangle Park, NC: RTI International, 2015. Available at http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf. Accessed December 7, 2015.

Gudin JA, Mogali S, Jones JD, et al.: Risks, management, and monitoring of combination opioid, benzodiazepines, and/or alcohol use. Postgrad Med. 2013; 125(4): 115-130.

Gomes T, Mamdani MM, Dhalla IA, et al.: The burden of premature opioid-related mortality. Addiction. 2014; 109: 1482-1488.

Ministry of Community Safety and Correctional Services: Office of the Chief Coroner of Ontario: Report for 2009–2011. Toronto, ON: Government of Ontario, 2013.

Katz N, Fernandez K, Chang A, et al.: Internet-based survey of nonmedical prescription opioid use in the United States. Clin J Pain. 2008; 24: 528-535.

Hays L, Kirsh KL, Passik SD: Seeking drug treatment for OxyContin abuse: a chart review of consecutive admissions to a substance abuse treatment facility in Kentucky. J Natl Compr Canc Netw. 2003; 1(3): 423-428.

Centers for Disease Control and Prevention: CDC grand rounds: prescription drug overdoses—a U.S. epidemic. MMWR Morb Mortal Wkly Rep. 2012; 61(1): 10-13.

Dhalla IA, Mamdani MM, Sivilotti ML, et al.: Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone. CMAJ. 2009; 181: 891-896.

Hays LR: A profile of OxyContin addiction. J Addict Dis. 2004; 23(4): 1-9.

NOxyNEO® (Oxycodone Hydrochloride Controlled Release Tablets) Product Monograph. Pickering, Ontario, Canada: Purdue Pharma. July 30, 2014.

Cicero TJ, Ellis MS, Surratt HL: Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 2012; 367(2): 187-189.

Peacock A, Degenhardt L, Larance B, et al.: A typology of people who tamper with pharmaceutical opioids: response to introduction of a tamper-resistant formulation of controlled-release oxycodone. Pharmacoepidemiol Drug Saf. 2015; 24(12): 1321-1333.

Dart RC, Surratt HL, Cicero TJ, et al.: Trends in opioid analgesic abuse and mortality in the United States. N Engl J Med. 2015; 372(3): 241-248.

Therapeutic Products Directorate, Health Products and Food Branch, Health Canada: Draft Guidance Document: Tamper- Resistant Formulations of Opioid Drug Product Submissions. Ottawa, Ontario, Canada: Health Canada, December 22, 2014. Available at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/drug-medic/draft_guid_opioid_ebauche_ld-eng.pdf. Accessed December 7, 2015.

Lewis M, Herndon CM, Chibnall JT: Patient aberrant drug taking behaviors in a large family medicine residency program: a retrospective chart review of screening practices, incidence, and predictors. J Opioid Manag. 2014; 10(3): 169-175.

Matson SC, Hobson G, Abdel-Rasoul M, et al.: A retrospective study of retention of opioid dependent adolescents and young adults in an outpatient buprenorphine/naloxone clinic. J Addict Med. 2014; 8(3): 176-182.

Matteliano D, Chang YP: Describing prescription opioid adherence among individuals with chronic pain using urine drug testing. Pain Manag Nurs. 2015; 16(1): 51-59.

The College of Physicians and Surgeons of Ontario: Methadone Maintenance Treatment Program Standards and Clinical Guidelines. 4th ed. Toronto, Ontario, Canada: College of Physicians and Surgeons of Ontario, February 2011. Available at https://www.cpso.on.ca/uploadedFiles/members/MMTGuidelines.pdf. Accessed December 7, 2015.

SureStep™ Multi-drug Screen Test Panel [package insert]. San Diego, CA: Innovacon, Inc, 2013. Available at https://cdn.shopify.com/s/files/1/0864/3296/files/SureStep.pdf.

Sessler NE, Downing JM, Kale H, et al.: Reductions in reported deaths following the introduction of extended release oxycodone (OxyContin) with an abuse-deterrent formulation. Pharmacoepidemiol Drug Saf. 2014; 23(12): 1238-1246.

Coplan PM, Kale H, Sandstrom L, et al.: Changes in oxycodone and heroin exposures in the national poison data system after introduction of extended-release oxycodone with abuse-deterrent characteristics. Pharmacoepidemiol Drug Saf. 2013; 22: 1274-1282.

Havens JR, Leukefeld CG, DeVeaugh-Geiss AM, et al.: The impact of reformulation of extended-release oxycodone designed to deter abuse in a sample of prescription opioid abusers. Drug Alcohol Depend. 2014; 139: 9-17.

McNaughton EC, Coplan PM, Black RA, et al.: Monitoring of internet forums to evaluate reactions to the introduction of reformulated OxyContin to deter abuse. J Med Internet Res. 2014; 16(5): e119.