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Abstract Background Low-dose analgesic methoxyflurane (Penthrox®) was approved in Europe for emergency relief of moderate to severe pain in conscious adults with trauma in 2015. A comparative post-authorisation safety study (PASS) was conducted to assess the risk of hepatotoxicity and nephrotoxicity with methoxyflurane during routine clinical practice. Methods This was a comparative hybrid prospective-retrospective cohort study. The comparative cohorts consisted of adults who were given methoxyflurane (methoxyflurane cohort) or another analgesic (concurrent cohort) routinely used for moderate to severe trauma and associated pain in the emergency setting (ambulance and Emergency Department) in the UK between December 2016 and November 2018. Hepatic and renal events were captured in the ensuing 12 weeks. A blinded clinical adjudication committee assessed events. A historical comparator cohort (non-concurrent cohort) was identified from patients with fractures in the English Hospital Episode Statistics (HES) accident and emergency database from November 2013 and November 2015 (before commercial launch of methoxyflurane). Hepatic and renal events were captured in the ensuing 12 weeks via linkage with the Clinical Practice Research Datalink (CPRD) and HES hospital admissions databases. Results Overall, 1,236, 1,101 and 45,112 patients were analysed in the methoxyflurane, concurrent and non-concurrent comparator cohorts respectively. There was no significant difference in hepatic events between the methoxyflurane and concurrent cohorts (1.9% vs. 3.0%, P = 0.079) or between the methoxyflurane and non-concurrent cohorts (1.9% vs. 2.5%, P = 0.192). Renal events were significantly less common in the methoxyflurane cohort than in the concurrent cohort (2.3% vs. 5.6%, P

AbstractResearch objective Medications for opioid use disorder (MOUDs) – including methadone, buprenorphine, and naltrexone – are the most effective treatments for opioid use disorder (OUD). Historically, insurers have required prior authorization for MOUD, but prior authorization is often reported as a key barrier to MOUD prescribing. Some states have passed laws prohibiting MOUD prior authorization requirements. We sought to identify the frequency of MOUD prior authorization prohibitions in state laws and to categorize types of prohibitions.Methods We searched for regulations and statutes present in all U.S. states and Washington DC between 2005 and 2019 using MOUD-related terms in Westlaw legal software. In qualitative software, we coded laws discussing MOUD prior authorization using template analysis – a mixed deductive/inductive approach. Finally, we used coded laws to identify frequencies of states with prior authorization prohibitions, including changes over time.Results No states had laws prohibiting MOUD prior authorization between 2005 and 2015, with the first prohibition appearing in 2016. By 2019, fifteen states had MOUD prior authorization prohibitions. States varied significantly in their approach to prohibiting MOUD prior authorization. In 2019, it was more common for states to have MOUD prior authorization prohibitions applying to all insurers (n = 10 states) than to only Medicaid (n = 7 states) or only non-Medicaid insurers (n = 1 state). In 2019, general prior authorization prohibitions (n = 10 states) were more common than prohibitions only applicable to medications on the formulary, prohibitions only applicable to medications on the preferred drug list, prohibitions only applicable during the first 5 days of treatment, and prohibitions only applicable during the first 30 days of treatment.Conclusions The number of states with an MOUD prior authorization law prohibition increased in recent years. Such laws could help expand access to life-saving OUD treatments by making it easier for clinicians to prescribe MOUD.KEY MESSAGESNo states had MOUD prior authorization prohibitions between 2005 and 2015 in state statutes or regulations, and only one state had such a prohibition in 2016.By 2019, fifteen states had an MOUD prior authorization prohibition law.States varied significantly in their approach to prohibiting MOUD prior authorization, including with respect to the insurer type, duration of the prohibition, and applicable medication.