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

J Opioid Manag. 2017 Sep/Oct;13(5):315-327. doi: 10.5055/jom.2017.0400.

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-tolerant-only 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 opi-oid-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.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Analgesics, Opioid / administration & dosage
  • Analgesics, Opioid / adverse effects
  • Analgesics, Opioid / urine*
  • Child
  • Child, Preschool
  • Chronic Pain / diagnosis
  • Chronic Pain / drug therapy*
  • Chronic Pain / urine
  • Databases, Factual
  • Delayed-Action Preparations
  • Drug Monitoring / methods*
  • Drug Prescriptions
  • Drug Tolerance*
  • Electronic Health Records
  • Female
  • Humans
  • Inappropriate Prescribing
  • Infant
  • Infant, Newborn
  • Male
  • Middle Aged
  • Practice Patterns, Physicians'
  • Predictive Value of Tests
  • Prescription Drug Monitoring Programs*
  • Retrospective Studies
  • Sentinel Surveillance
  • United States
  • United States Food and Drug Administration*
  • Urinalysis
  • Young Adult

Substances

  • Analgesics, Opioid
  • Delayed-Action Preparations