A retrospective longitudinal analysis of mental health admissions : measuring the fallout of the pandemic

Background: In this research article, we review the infrequently considered long-term impact of the pandemic on inpatient mental health, by reviewing the clinical parameters of all psychiatric admissions to Mount Carmel Hospital, our region’s main psychiatric healthcare facility, from 2019–2021. Methods: 4292 patients were admitted during the research period of this retrospective longitudinal analysis. Taking 2019 as the pre-COVID reference year, we compared mean monthly admissions from 2020 and 2021, looking at patient demographics, status under the Mental Health Act, diagnosis, and self-injurious behaviour. Results: While the pandemic was reflected in a moderate increase in mean monthly presentations with suicidal ideation and suicidal self-injury, presentations in 2020 otherwise remained largely stable. This contrasted with a surge in presentations in 2021 with mood disorders, schizophrenia, anxiety, personality disorders, and autism spectrum disorders. Furthermore, presentations involving self-injurious behaviour continued to grow. Involuntary admissions also increased significantly in 2021. Conclusions: This paper highlights the pernicious long-term impact of the pandemic on mental health presentations, demonstrated by an increase in hospital admissions and more serious presentations. These findings should be considered in the guidance for responses to any future pandemic, giving attention to the evidence of the impact of restrictive measures on mental health.peer-reviewe

Changing paradigms in bioequivalence trials submitted to the EMA for evaluation – A clinical and regulatory perspective

Background: The selection of a robust bioequivalence (BE) study designs for registering a generic product remains still a hard task. This task is still challenging despite the fact that generic products are much needed by health care providers in economical terms. Thus, BE study designs could be a means to allow companies to reduce costs and reach the market earlier. We therefore investigated whether different approaches in various products assessed by the European Medicines Agency during the approval phase resulted in a reduction in resources required to show bioequivalence for different medicinal products. Methods: European Public Assessment Reports (EPARs) for off-patent medicinal products authorised within the European Union (EU) through the centralised procedure during the period 2007–2015 were retrieved and reviewed to identify the clinical studies that resulted in fewer number of subjects, the number of centres or trial duration versus the two-period crossover design. Results: 7 studies out of 108 were considered as having benefitted from having a different design. Differences noted included having a different dose allocation scheme, having a different number of dosing periods, having a different number of treatment arms, and having one study evaluating different strengths. Benefits noted included a decrease in the number of subjects and centres required, decreases in study duration and a reduced number of studies required to demonstrate bioequivalence. Conclusion: Bioequivalence studies can be designed in a specific manner to require fewer resources to carry out. Fewer resources required to register a medicinal product, could impart an advantage to companies (such as to be first on the market) or could even translate to making medicines more accessible (such as cheaper) to patients