An international comparative policy analysis of opioid use disorder treatment in primary care across nine high-income jurisdictions.

BACKGROUND: Opioid use disorder (OUD) and opioid-related harms are current health priorities in many high-income countries such as Canada. Opioid agonist therapy (OAT) is an effective evidence-based treatment for OUD, but access is often limited. AIMS: To describe and compare OUD treatment policies across nine international jurisdictions, and to understand how they are situated within their primary care and health systems. METHODS: Using policy documents, we collected data on health systems, drug use epidemiology, drug policies, and OUD treatment from Australia, Canada, France, Germany, Ireland, Portugal, Sweden, Switzerland, and Taiwan. We used the health system dynamics framework and adapted definitions of low- and high-threshold treatment to describe and compare OUD treatment policies, and to understand how they may be shaped by their health systems context. RESULTS: Broad similarities across jurisdictions included the OAT pharmacological agents used and the need for supervised dosing; however, preferred OAT, treatment settings, primary care and specialist physicians' roles, and funding varied. Most jurisdictions had elements of lower-threshold treatment access, such as the availability of treatment through primary care and multiple OAT options, but the higher-threshold criteria of supervised dosing. CONCLUSIONS: From the Canadian perspective, there are opportunities to improve accessibility of OUD care by drawing on how different jurisdictions incorporate multidisciplinary care, regulate OAT medications, remunerate healthcare professionals, and provide funding for services.

Conflict of interest policies at Australian medical schools.

BACKGROUND: Pharmaceutical industry exposure is widespread during medical training and may affect education and clinical decision-making. Medical faculties' conflict of interest (COI) policies help to limit this exposure and protect students against commercial influence. AIMS: Our aim was to investigate the prevalence, content and strength of COI policies at Australian medical schools and changes since a previous assessment conducted in 2009. METHODS: We identified policies by searching medical school and host university websites in January 2021, and contacted deans to identify any missed policies. We applied a modified version of a scorecard developed in previous studies to examine the content of COI policies. All data were coded in duplicate. COI policies were rated on a scale from 0 (no policy) to 2 (strong policy) across 11 items per medical school. Oversight mechanisms and sanctions were also assessed, and current policies were compared with the 2009 study. RESULTS: Of 155 potentially relevant policies, 153 were university-wide and two were specific to medical schools. No policies covered sales representatives, on-site sponsored education or free samples. Oversight of consultancies had improved substantially, with 76% of schools requiring preapproval. Disclosure policies, while usually present, were weak, with no public disclosure required. CONCLUSION: We found little indication that Australian medical students are protected from commercial influence on medical education, and there has been limited COI policy development within the past decade. More attention is needed to ensure the independence of medical education in Australia.

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies.

Information on rare adverse effects is often limited when a medication is initially approved for marketing. Medicines regulators use safety advisories to warn health professionals and consumers about emerging harms. This study aimed to identify characteristics and advice provided in cardiac safety advisories released by regulators in Australia, Canada, the United Kingdom, and the United States. This was a retrospective study of safety advisories about cardiac-related adverse events issued by these four international medicines regulators between 2010 and 2016. A descriptive overview was followed by a more detailed content analysis, focusing on recommended actions for health professionals, including monitoring advice. For the latter, we applied the systematic information for monitoring (SIM) scale to assess adequacy. Over this period, 164 safety advisories about cardiac harms were issued by the four regulators. There were 61 drugs with advisories of cardiac risk, only 9 (14.7%) of which had advisories from all regulators in countries where the drug was approved. The most common adverse events were cardiac arrhythmias (n = 97, 59.1%) and coronary artery disorders (n = 39, 23.8%). The most frequent advice to prescribers was to monitor patients (n = 74, 45.1%), although only 41.2% of these advisories provided detailed advice on how monitoring should occur. We found many differences in the decision to warn and the advice provided. Patient monitoring was most often recommended, but key information such as frequency or thresholds for action was often lacking. Healthcare professionals and consumers need consistent information about rare serious harms so that they can make informed decisions.