Abuse-deterrent formulations and opioid-related harms in North Carolina, 2010-2018

Abuse-deterrent formulations of opioid analgesics (ADFs) were introduced to reduce opioid-related harms among pain patients, but postmarketing study results have been mixed. However, these studies may be subject to bias from selection criteria, comparator choice, and potential confounding by “indica...

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Published in	American journal of epidemiology Vol. 194; no. 3; pp. 680 - 690
Main Authors	DiPrete, Bethany L, Dasgupta, Nabarun, Oh, G Yeon, Moga, Daniela C, Slavova, Svetla, Slade, Emily, Delcher, Chris, Pence, Brian W, Ranapurwala, Shabbar I
Format	Journal Article
Language	English
Published	United States Oxford University Press 04.03.2025
Subjects	Abuse-Deterrent Formulations Adult Analgesics, Opioid - administration & dosage Analgesics, Opioid - adverse effects Delayed-Action Preparations Female Humans Male Middle Aged North Carolina - epidemiology Opiate Overdose - epidemiology Opiate Overdose - prevention & control Opioid-Related Disorders - epidemiology Opioid-Related Disorders - prevention & control Original Contribution North Carolina opioid prescribing postmarketing evaluation studies opioid analgesics opioid-related disorder study design
Online Access	Get full text
ISSN	0002-9262 1476-6256 1476-6256
DOI	10.1093/aje/kwae252

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Abstract	Abuse-deterrent formulations of opioid analgesics (ADFs) were introduced to reduce opioid-related harms among pain patients, but postmarketing study results have been mixed. However, these studies may be subject to bias from selection criteria, comparator choice, and potential confounding by “indication,” highlighting the need for thorough study design considerations. In a sample of privately insured patients prescribed ADF or non-ADF extended-release/long-acting (ER/LA) opioids in North Carolina, we implemented a version of the prevalent new-user design to evaluate the relationship between ADFs and opioid use disorder (OUD, n = 235) and opioid overdose (n = 18) through 6 months of follow-up using inverse probability-weighted cumulative incidence functions and Fine-Gray models. The weighted hazard ratio (HRw) of opioid overdose among patients initiating ADFs was 0.87 (95% CI, 0.23-3.24) times as high as among patients who initiated, restarted, or continued non-ADF ER/LA opioids. We observed a short-term benefit of ADFs for incident OUD (HRw = 0.58; 95% CI, 0.35-0.93) compared to non-ADF ER/LA opioids in the first 6 weeks of follow-up, but this benefit disappeared later in follow-up (HRw = 1.30; 95% CI, 0.86-1.95). In summary, our findings add to the expanding body of evidence that there is no clear long-term reduction in harm from ADF opioids among patients in outpatient use. This article is part of a Special Collection on Pharmacoepidemiology.
AbstractList	Abuse-deterrent formulations of opioid analgesics (ADFs) were introduced to reduce opioid-related harms among pain patients, but postmarketing study results have been mixed. However, these studies may be subject to bias from selection criteria, comparator choice, and potential confounding by “indication,” highlighting the need for thorough study design considerations. In a sample of privately insured patients prescribed ADF or non-ADF extended-release/long-acting (ER/LA) opioids in North Carolina, we implemented a version of the prevalent new-user design to evaluate the relationship between ADFs and opioid use disorder (OUD, n = 235) and opioid overdose (n = 18) through 6 months of follow-up using inverse probability-weighted cumulative incidence functions and Fine-Gray models. The weighted hazard ratio (HRw) of opioid overdose among patients initiating ADFs was 0.87 (95% CI, 0.23-3.24) times as high as among patients who initiated, restarted, or continued non-ADF ER/LA opioids. We observed a short-term benefit of ADFs for incident OUD (HRw = 0.58; 95% CI, 0.35-0.93) compared to non-ADF ER/LA opioids in the first 6 weeks of follow-up, but this benefit disappeared later in follow-up (HRw = 1.30; 95% CI, 0.86-1.95). In summary, our findings add to the expanding body of evidence that there is no clear long-term reduction in harm from ADF opioids among patients in outpatient use. This article is part of a Special Collection on Pharmacoepidemiology. Abuse-deterrent formulations of opioid analgesics (ADFs) were introduced to reduce opioid-related harms among pain patients, but postmarketing study results have been mixed. However, these studies may be subject to bias from selection criteria, comparator choice, and potential confounding by "indication," highlighting the need for thorough study design considerations. In a sample of privately insured patients prescribed ADF or non-ADF extended-release/long-acting (ER/LA) opioids in North Carolina, we implemented a version of the prevalent new-user design to evaluate the relationship between ADFs and opioid use disorder (OUD, n = 235) and opioid overdose (n = 18) through 6 months of follow-up using inverse probability-weighted cumulative incidence functions and Fine-Gray models. The weighted hazard ratio (HRw) of opioid overdose among patients initiating ADFs was 0.87 (95% CI, 0.23-3.24) times as high as among patients who initiated, restarted, or continued non-ADF ER/LA opioids. We observed a short-term benefit of ADFs for incident OUD (HRw = 0.58; 95% CI, 0.35-0.93) compared to non-ADF ER/LA opioids in the first 6 weeks of follow-up, but this benefit disappeared later in follow-up (HRw = 1.30; 95% CI, 0.86-1.95). In summary, our findings add to the expanding body of evidence that there is no clear long-term reduction in harm from ADF opioids among patients in outpatient use. This article is part of a Special Collection on Pharmacoepidemiology.Abuse-deterrent formulations of opioid analgesics (ADFs) were introduced to reduce opioid-related harms among pain patients, but postmarketing study results have been mixed. However, these studies may be subject to bias from selection criteria, comparator choice, and potential confounding by "indication," highlighting the need for thorough study design considerations. In a sample of privately insured patients prescribed ADF or non-ADF extended-release/long-acting (ER/LA) opioids in North Carolina, we implemented a version of the prevalent new-user design to evaluate the relationship between ADFs and opioid use disorder (OUD, n = 235) and opioid overdose (n = 18) through 6 months of follow-up using inverse probability-weighted cumulative incidence functions and Fine-Gray models. The weighted hazard ratio (HRw) of opioid overdose among patients initiating ADFs was 0.87 (95% CI, 0.23-3.24) times as high as among patients who initiated, restarted, or continued non-ADF ER/LA opioids. We observed a short-term benefit of ADFs for incident OUD (HRw = 0.58; 95% CI, 0.35-0.93) compared to non-ADF ER/LA opioids in the first 6 weeks of follow-up, but this benefit disappeared later in follow-up (HRw = 1.30; 95% CI, 0.86-1.95). In summary, our findings add to the expanding body of evidence that there is no clear long-term reduction in harm from ADF opioids among patients in outpatient use. This article is part of a Special Collection on Pharmacoepidemiology. Abuse-deterrent formulations of opioid analgesics (ADFs) were introduced to reduce opioid-related harms among pain patients, but postmarketing study results have been mixed. However, these studies may be subject to bias from selection criteria, comparator choice, and potential confounding by “indication,” highlighting the need for thorough study design considerations. In a sample of privately insured patients prescribed ADF or non-ADF extended-release/long-acting (ER/LA) opioids in North Carolina, we implemented a version of the prevalent new-user design to evaluate the relationship between ADFs and opioid use disorder (OUD, n = 235) and opioid overdose ( n = 18) through 6 months of follow-up using inverse probability-weighted cumulative incidence functions and Fine-Gray models. The weighted hazard ratio (HR w ) of opioid overdose among patients initiating ADFs was 0.87 (95% CI, 0.23-3.24) times as high as among patients who initiated, restarted, or continued non-ADF ER/LA opioids. We observed a short-term benefit of ADFs for incident OUD (HR w = 0.58; 95% CI, 0.35-0.93) compared to non-ADF ER/LA opioids in the first 6 weeks of follow-up, but this benefit disappeared later in follow-up (HR w = 1.30; 95% CI, 0.86-1.95). In summary, our findings add to the expanding body of evidence that there is no clear long-term reduction in harm from ADF opioids among patients in outpatient use. This article is part of a Special Collection on Pharmacoepidemiology . Abuse-deterrent formulations of opioid analgesics (ADFs) were introduced to reduce opioid-related harms among pain patients, but postmarketing study results have been mixed. However, these studies may be subject to bias from selection criteria, comparator choice, and potential confounding by "indication," highlighting the need for thorough study design considerations. In a sample of privately insured patients prescribed ADF or non-ADF extended-release/long-acting (ER/LA) opioids in North Carolina, we implemented a version of the prevalent new-user design to evaluate the relationship between ADFs and opioid use disorder (OUD, n = 235) and opioid overdose (n = 18) through 6 months of follow-up using inverse probability-weighted cumulative incidence functions and Fine-Gray models. The weighted hazard ratio (HRw) of opioid overdose among patients initiating ADFs was 0.87 (95% CI, 0.23-3.24) times as high as among patients who initiated, restarted, or continued non-ADF ER/LA opioids. We observed a short-term benefit of ADFs for incident OUD (HRw = 0.58; 95% CI, 0.35-0.93) compared to non-ADF ER/LA opioids in the first 6 weeks of follow-up, but this benefit disappeared later in follow-up (HRw = 1.30; 95% CI, 0.86-1.95). In summary, our findings add to the expanding body of evidence that there is no clear long-term reduction in harm from ADF opioids among patients in outpatient use. This article is part of a Special Collection on Pharmacoepidemiology.
Author	DiPrete, Bethany L Ranapurwala, Shabbar I Oh, G Yeon Slade, Emily Dasgupta, Nabarun Moga, Daniela C Pence, Brian W Slavova, Svetla Delcher, Chris
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Cites_doi	10.1111/jrh.12496 10.1016/j.drugpo.2020.102848 10.1001/jamapsychiatry.2014.3043 10.1002/pds.3723 10.3109/03639045.2012.680468 10.1002/sim.3697 10.1016/0376-8716(84)90039-5 10.1002/pds.3658 10.1007/s40471-015-0053-5 10.1016/j.jpain.2012.08.008 10.1002/pds.4729 10.1002/cpt.390 10.1097/j.pain.0000000000000548 10.1097/ALN.0000000000002031 10.1097/AJP.0b013e318125c5e8 10.1002/pds.4564 10.1007/s40122-021-00343-z 10.1182/blood-2016-08-736579 10.1093/aje/kwaa283 10.1016/j.addbeh.2019.106268 10.1111/pme.12295 10.1093/aje/kwv001 10.1002/pds.5591 10.1097/AJP.0000000000001034 10.1016/j.japh.2022.07.017 10.1097/AJP.0000000000000948 10.1002/pds.4435 10.1093/aje/kwg231 10.2147/JPR.S140990 10.1080/01621459.1999.10474144 10.1016/j.pain.2012.05.029 10.1093/aje/kwu122 10.1002/pds.3522 10.1016/j.drugpo.2017.12.003 10.1177/1740774511420743 10.1097/EDE.0000000000000188 10.1001/jama.1986.03380180124033 10.3109/10826084.2013.866963 10.1016/j.drugalcdep.2021.109114 10.1016/j.drugalcdep.2016.06.009 10.1097/MLR.0000000000000735 10.1111/acem.13121 10.1080/03007995.2023.2178080 10.1111/add.15392 10.1093/aje/kwn164 10.1016/j.drugpo.2018.03.019 10.1016/j.drugalcdep.2016.09.018 10.1111/add.12746 10.1016/j.drugalcdep.2006.01.016 10.1080/00325481.2019.1585688 10.1080/00325481.2016.1120642 10.1257/pol.20170082 10.1016/j.drugalcdep.2014.02.018 10.3109/00952990.2011.569623 10.1002/pds.4107 10.1056/NEJMsa1406143 10.1016/S2215-0366(18)30003-8 10.1111/add.14380 10.1016/j.jpain.2013.04.011 10.1007/s40261-023-01248-9 10.1007/s11926-008-0003-z 10.1016/j.drugalcdep.2015.02.038 10.1002/pds.4287 10.1111/add.15617 10.1002/pds.3434
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Snippet	Abuse-deterrent formulations of opioid analgesics (ADFs) were introduced to reduce opioid-related harms among pain patients, but postmarketing study results...
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SubjectTerms	Abuse-Deterrent Formulations Adult Analgesics, Opioid - administration & dosage Analgesics, Opioid - adverse effects Delayed-Action Preparations Female Humans Male Middle Aged North Carolina - epidemiology Opiate Overdose - epidemiology Opiate Overdose - prevention & control Opioid-Related Disorders - epidemiology Opioid-Related Disorders - prevention & control Original Contribution
Title	Abuse-deterrent formulations and opioid-related harms in North Carolina, 2010-2018
URI	https://www.ncbi.nlm.nih.gov/pubmed/39122991 https://www.proquest.com/docview/3091282540 https://pubmed.ncbi.nlm.nih.gov/PMC11879559
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