Risk assessment of using off-label morphine sulfate in a population-based retrospective cohort of opioid-dependent patients.
abuse
addiction
misuse
opioid
overdose
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
received:
04
08
2018
revised:
02
05
2019
accepted:
19
07
2019
pubmed:
8
8
2019
medline:
30
6
2021
entrez:
8
8
2019
Statut:
ppublish
Résumé
Several addictovigilance studies have described the off-label use of morphine sulfate (MS) for nonchronic pain in opioid use disorder (OUD) patients as an alternative to conventional opioid substitution treatments (OSTs). This study primarily sought to compare the incidence of unintentional opioid-related overdose in the year following the prescription initiation in off-label MS users, compared to OST-maintained patients. Sequential cohorts of OUD patients who were regularly dispensed MS, buprenorphine, or methadone, between 1 April 2012 and 31 December 2014, were retrospectively identified using the French nationwide healthcare data system. The incidence of overdoses, deaths, doctor shopping, and complications of a viral, bacterial or thrombotic nature, was compared using the Cox regression method. Overall, 1075, 20 834 and 9778 OUD patients without chronic-pain were included in the MS, buprenorphine, and methadone cohorts, respectively. Overdose incidence was 3.8 (P < .01 [95% confidence interval (CI): 2.1-6.8]) and 2.0 (P = .02 [95%CI: 1.1-3.6]) higher in the MS cohort vs buprenorphine and methadone, respectively. Death incidence was 9.1 (P < .01 [95%CI: 3.2-25.9]) and 3.9 (P < .01 [95%CI: 1.4-10.7]) higher in the MS cohort vs buprenorphine and methadone, respectively. The incidences of other associated risks were significantly higher in the MS group vs OSTs, except for hepatitis C viral infection and thrombotic complications. This first French comprehensive nationwide study reveals increasing overdose, death, bacterial infection, abuse and diversion risks when off-label MS is initiated as alternative to OST. These results question the relevance of prescribing MS as a safe opioid maintenance treatment, considering its health risk profile.
Identifiants
pubmed: 31389036
doi: 10.1111/bcp.14082
pmc: PMC7688539
doi:
Substances chimiques
Analgesics, Opioid
0
Buprenorphine
40D3SCR4GZ
Morphine
76I7G6D29C
Methadone
UC6VBE7V1Z
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2338-2348Subventions
Organisme : Agence Nationale de Sécurité du Médicament et des Produits de Santé
ID : 20145013
Informations de copyright
© 2019 The British Pharmacological Society.
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