The SSA technique was found to have moderate sensitivity and high specificity for detecting ADRs. These results suggest that SSA is a potential tool for detecting ADRs using administrative claims data that could complement existing pharmacosurveillance methods.
This case study highlights that a post-marketing quantitative method utilising administrative claims data can be a complementary tool to traditional quantitative methods employed in spontaneous reports that may help to verify safety signals detected in spontaneous reporting data.
Trials are insufficiently powered to detect the majority of adverse events that are reported in clinical trials, even for common adverse events. Observations other than primary efficacy endpoints such as AEs that are not prespecified with adequate power should be treated as hypothesis generating only and not justification of evidence. Claims of safety based on trial evidence not designed for the safety endpoint are often premature.
SSA generated potential new signals of HF for some anti-glaucoma and anti-dyspepsia medicines. For some of the potential signals, the event is biologically plausible and some have pre-marketing and post-marketing case reports to support the finding. Confirmation of these signals using cohort studies is required.
Restrictions in face-to-face contact during the COVID-19 pandemic have necessitated the conversion to online teachinglearning activities. To assess relevant competencies of a Master's in Clinical Pharmacy student cohort, an online tele-objective structured clinical examination (OSCE) was developed and conducted using Microsoft Teams®. Afterward, a survey was conducted to determine the acceptance of tele-OSCE by students and faculty members. Students' performance was also compared to a previous cohort that underwent face-to-face OSCE. The majority of students generally agreed that tele-OSCE was operationally easy to undertake (94.0%) and did not deter their exam performance. The majority of faculty members also generally agreed that the online platform did not deter the assessment of students' performance and a minority disagreed on the ease of assessing counselling tasks or calculation work (13.0%). There was no statistically significant difference in students' overall scores between the tele-OSCE and the face-to-face cohort (p > 0.05). A thoughtfully planned tele-OSCE is a feasible method of examination that allows acceptable assessment of attained clinical competencies when social distancing measures are mandated. Stakeholders should look towards fortifying IT and online platform access to support optimal emergency remote teaching.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.