@article{8c97d538f3ab4391a8961aeee27d9a1d,
title = "Response to Propoxyphene Market Withdrawal: Analgesic Substitutes, Doses, and Adverse Events",
abstract = "Objective:Experts cautioned that patients affected by the November 2010 withdrawal of the opioid analgesic propoxyphene might receive riskier prescriptions. To explore this, we compared drug receipts and outcomes among propoxyphene users before and aftermarket withdrawal.Study Design:Using OptumLabs data, we studied 3 populations: commercial, Medicare Advantage (MA) aged (age 65+ y) and MA disabled (age below 65 y) enrollees. The exposed enrollees received propoxyphene in the 3 months before market withdrawal (n=13,622); historical controls (unexposed) received propoxyphene 1 year earlier (n=9971). Regression models estimated daily milligrams morphine equivalent (MME), daily prescription acetaminophen dose, potentially toxic acetaminophen doses, nonopioid prescription analgesics receipt, emergency room visits, and diagnosed falls, motor vehicle accidents, and hip fractures.Principal Findings:Aged MA enrollees illustrate the experience of all 3 populations examined. Following the market withdrawal, propoxyphene users in the exposed cohort experienced an abrupt decline of 69% in average daily MME, compared with a 14% decline in the unexposed. Opioids were discontinued by 34% of the exposed cohort and 18% of the unexposed. Tramadol and hydrocodone were the most common opioids substituted for propoxyphene. The proportion of each group receiving ≥4 g of prescription acetaminophen per day decreased from 12% to 2% in the exposed group but increased from 6% to 8% among the unexposed. Adverse events were rare and not significantly different in exposed versus unexposed groups.Conclusions:After propoxyphene market withdrawal, many individuals experienced abrupt discontinuation of opioids. Policymakers might consider supporting appropriate treatment transitions and monitoring responses following drug withdrawals.",
keywords = "pain management, pharmaceutical care, pharmaceutical policy",
author = "Jeffery, {Molly M.} and Morden, {Nancy E.} and Marc Larochelle and Shah, {Nilay D.} and Hooten, {W. Michael} and Ellen Meara",
note = "Funding Information: M.M.J. has received research support through Mayo Clinic from the National Heart, Lung and Blood Institute (R56HL130496 and R21HL140287), the Agency for Healthcare Research and Quality (R01HS025164), the American Cancer Society (131611-RSGI-17-154-01-CPHPS), the Food and Drug Administration-funded Yale-Mayo CERSI (U01FD05938), the National Center for Advancing Translational Sciences (UL1TR02377 and U01TR 02743-1) and the National Institute for Drug Abuse (UG3DA047003); her spouse owns shares in Vireo Health. N.E.M. has received funding, including for this work, through NIH/NIA (grant P01AG019783-16). M.L. has received research support through Boston Medical Center from the National Institutes of Health via the National Institute on Drug Abuse (K23DA042168) and the National Center for Advancing Translational Sciences (1UL1TR001430), Centers for Disease Control and Prevention (U01CE002780), Food and Drug Administration (HHSF2232009100006I), Office of National Drug Control Policy/University of Baltimore (G1799ONDCP06B), OptumLabs, and a Boston University School of Medicine Department of Medicine Career Investment Award. N.D.S. has received research support through Mayo Clinic from the Food and Drug Administration to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI), from the Agency for Healthcare Research and Quality (R01HS025164; R01HS025402; 1U19HS024075; R03HS025517), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R56HL130496; R01HL131535), National Science Foundation, and from the Patient-Centered Outcomes Research Institute (PCORI) to develop a Clinical Data Research Network (LHSNet). W.M.H. has received research support through Mayo Clinic from the National Center for Advancing Translational Sciences, funding for a clinical trial from US WorldMeds (UL1TR02377 and U01TR 02743-1). E.M. has received funding through NIH/NIA (grants P01AG019783-16 and U01AG046830 and, via NBER grant R01AG060104) From AHRQ under U19HS024075 From NIH/NIMH under R01MH106635 and R01MH109531 from the California HealthCare Foundation under grant 20249, from the 5 foundation initiative on high-cost high need patients (The Commonwealth Fund, Robert Wood Johnson Foundation, The SCAN Foundation, Peterson Center on Healthcare, The John A. Hartford Foundation, from the Social Security Administration Disability Research Center via the National Bureau of Economic Research, and via the Sloan Foundation. Funding Information: N.E.M. and E.M. were supported in this work by a grant from the National Institutes of Health, National Institute on Aging: P01AG019783-16. This work was made possible by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Publisher Copyright: {\textcopyright} 2019 Wolters Kluwer Health, Inc. All rights reserved.",
year = "2020",
month = jan,
day = "1",
doi = "10.1097/MLR.0000000000001221",
language = "English (US)",
volume = "58",
pages = "4--12",
journal = "Medical care",
issn = "0025-7079",
publisher = "Lippincott Williams and Wilkins",
number = "1",
}