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This study primarily sought to compare the incidence of unintentional opioid\u2010related overdose in the year following the prescription initiation in off\u2010label MS users, compared to OST\u2010maintained patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 1075, 20\u00a0834 and 9778 OUD patients without chronic\u2010pain were included in the MS, buprenorphine, and methadone cohorts, respectively. Overdose incidence was 3.8 (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a0.01 [95% confidence interval (CI): 2.1\u20136.8]) and 2.0 (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.02 [95%CI: 1.1\u20133.6]) higher in the MS cohort <jats:italic>vs<\/jats:italic> buprenorphine and methadone, respectively. Death incidence was 9.1 (<jats:italic>P &lt;<\/jats:italic> .01 [95%CI: 3.2\u201325.9]) and 3.9 (<jats:italic>P &lt;<\/jats:italic> .01 [95%CI: 1.4\u201310.7]) higher in the MS cohort <jats:italic>vs<\/jats:italic> buprenorphine and methadone, respectively. The incidences of other associated risks were significantly higher in the MS group <jats:italic>vs<\/jats:italic> OSTs, except for hepatitis C viral infection and thrombotic complications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This first French comprehensive nationwide study reveals increasing overdose, death, bacterial infection, abuse and diversion risks when off\u2010label 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.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.14082","type":"journal-article","created":{"date-parts":[[2019,8,7]],"date-time":"2019-08-07T04:19:42Z","timestamp":1565151582000},"page":"2338-2348","source":"Crossref","is-referenced-by-count":14,"title":["Risk assessment of using off\u2010label morphine sulfate in a population\u2010based retrospective cohort of opioid\u2010dependent patients"],"prefix":"10.1111","volume":"86","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2393-7061","authenticated-orcid":false,"given":"C\u00e9lian","family":"Bertin","sequence":"first","affiliation":[{"name":"CHU Clermont\u2010Ferrand, Inserm 1107, Neuro\u2010Dol, Service de Pharmacologie m\u00e9dicale, Centres Addictovigilance et Pharmacovigilance, Centre Evaluation et Traitement de la Douleur Universit\u00e9 Clermont Auvergne  Clermont\u2010Ferrand 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