Open Access Open Access  Restricted Access Subscription or Fee Access

Opioid tolerance and urine drug testing among initiates of extended-release or long-acting opioids in Food and Drug Administration's Sentinel System

Marc R. Larochelle, MD, MPH, Noelle M. Cocoros, DSc, MPH, Jennifer Popovic, DVM, MA, Elizabeth C. Dee, MPH, Cynthia Kornegay, PhD, Jing Ju, PharmD, PhD, Judith A. Racoosin, MD, MPH

Abstract


Objective: A risk evaluation and mitigation strategy for extended-release and long-acting (ER/LA) opioid analgesics was approved by the Food and Drug Administration in 2012. Our objective was to assess frequency of opioid tolerance and urine drug testing for individuals initiating ER/LA opioid analgesics.

Design: Retrospective cohort study.

Setting: Sentinel, a distributed database with electronic healthcare data on >190 million predominantly commercially insured members.

Patients, participants: Members under age 65 initiating ER/LA opioid analgesics between January 2009 and December 2013.

Main outcome measure(s): We examined the proportion of opioid-tolerantonly ER/LA opioid analgesic initiates meeting tolerance criteria: receipt of 30 mg oxycodone equivalents per day in 7 days prior to the first opioid-tolerant-only dispensing. We separately examined the proportion of new users of extended-release oxycodone (ERO) and other ER/LA opioid analgesics with a claim for a urine drug test in the 30 days prior to, and separately for the 183 days after, dispensing.

Results: We identified 79,824 ERO, 7,343 extended-release hydromorphone, and 91,778 transdermal fentanyl opioid-tolerant-only episodes. Tolerance criteria were met in 64 percent of ERO, 64 percent of extended-release hydromorphone and 40 percent of transdermal fentanyl episodes. We identified 210,581 incident ERO and 311,660 other ER/LA opioid analgesic episodes. Use of urine drug testing for ERO compared with other ER/LA opioid analgesics was: 4 percent vs 14 percent respectively in the 30 days prior to initiation and 9 percent vs 23 percent respectively in the 183 days following initiation.

Conclusions: These results suggest potential areas for improving appropriate ER/LA opioid analgesic prescribing practices.


Keywords


opioid analgesics, opioid tolerance, urine drug testing

Full Text:

PDF

References


Center for Behavioral Health Statistics and Quality. Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health. 2015. Report No.: HHS Publication No. SMA 15-4927, NSDUH Series H-50.

Substance Abuse and Mental Health Services Administration. Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits. 2013. Report No.: HHS Publication No. (SMA) 13-4760, DAWN Series D-39.

Prescription Opioid Overdose Data [Internet]. 2016. Available at http://www.cdc.gov/drugoverdose/data/overdose.html. Accessed October 15, 2017.

Imtiaz S, Shield KD, Fischer B, et al.: Harms of prescription opioid use in the United States. Subst Abuse Treat Prev Policy. 2014; 9(43): 597X-9-43.

Paulozzi LJ, Ryan GW: Opioid analgesics and rates of fatal drug poisoning in the United States. Am J Prev Med. 2006; 31(6): 506-511.

Bohnert AS, Ilgen MA, Trafton JA, et al.: Trends and regional variation in opioid overdose mortality among Veterans Health Administration patients, fiscal year 2001 to 2009. Clin J Pain. 2014; 30(7): 605-612.

Hall AJ, Logan JE, Toblin RL, et al.: Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA. 2008; 300(22): 2613-2620.

Bohnert AS, Valenstein M, Bair MJ, et al.: Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011; 305(13): 1315-1321.

Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids [Internet]. Available at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm. Accessed October 15, 2017.

FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics [Internet]. 2017. Available at https://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM515636.pdf. Accessed October 15, 2017.

Willy ME, Graham DJ, Racoosin JA, et al.: Candidate metrics for evaluating the impact of prescriber education on the safe use of extended-release/long-acting (ER/LA) opioid analgesics. Pain Med. 2014; 15(9): 1558-1568.

Robb MA, Racoosin JA, Sherman RE, et al.: The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety. Pharmacoepidemiol Drug Saf. 2012; 21(suppl 1): 9-11.

Platt R, Carnahan RM, Brown JS, et al.: The US Food and Drug Administration's Mini-Sentinel program: Status and direction. Pharmacoepidemiol Drug Saf. 2012; 21(suppl 1): 1-8.

Curtis LH, Weiner MG, Boudreau DM, et al.: Design considerations, architecture, and use of the Mini-Sentinel distributed data system. Pharmacoepidemiol Drug Saf. 2012; 21(suppl 1): 23-31.

McGraw D, Rosati K, Evans B: A policy framework for public health uses of electronic health data. Pharmacoepidemiol Drug Saf. 2012; 21: 18-22.

Products covered under the ER/LA Opioid Analgesics REMS Program [Internet]. Available at http://www.er-la-opioidrems.com/IwgUI/rems/products.action. Accessed October 15, 2017.

Foley KM: The treatment of cancer pain. N Engl J Med. 1985; 313(2): 84-95.

Salzman RT, Roberts MS, Wild J, et al.: Can a controlled-release oral dose form of oxycodone be used as readily as an immediate-release form for the purpose of titrating to stable pain control? J Pain Symptom Manage. 1999; 18(4): 271-279.

Opioid Morphine Equivalent Conversion Factors [Internet]. May 2014. Available at https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf. Accessed October 15, 2017.

Morasco BJ, Duckart JP, Carr TP, et al.: Clinical characteristics of veterans prescribed high doses of opioid medications for chronic non-cancer pain. Pain. 2010; 151(3): 625-632.

Starrels JL, Becker WC, Weiner MG, et al.: Low use of opioid risk reduction strategies in primary care even for high risk patients with chronic pain. J Gen Intern Med. 2011; 26(9): 958-964.

Krebs EE, Ramsey DC, Miloshoff JM, et al.: Primary care monitoring of long-term opioid therapy among veterans with chronic pain. Pain Med. 2011; 12(5): 740-746.

Cicero TJ, Inciardi JA, Munoz A: Trends in abuse of Oxycontin and other opioid analgesics in the United States: 2002-2004. J Pain. 2005; 6(10): 662-672.

Nuckols TK, Anderson L, Popescu I, et al.: Opioid prescribing: A systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med. 2014; 160(1): 38-47.

Dowell D, Haegerich TM, Chou R: CDC guideline for prescribing opioids for chronic pain—United States, 2016. JAMA. 2016; 315(15): 1624-1645.

Summary Minutes of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Joint Meeting, May 3-4, 2016. Available at https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM509895.pdf. Accessed August 10, 2017.




DOI: http://dx.doi.org/10.5055/jom.2017.0407

Refbacks

  • There are currently no refbacks.