Background: Causality assessment is used to determine the likelihood that a drug caused a particular adverse event. There are multiple methods for assessing the causality of suspected adverse drug reactions (ADRs). Undertaking some form of causality assessment of suspected ADRs is part of pharmacovigilance practice, but potentially without value if reproducibility of the results is consistently poor, and may vary with the background and experience of the assessor. Objective: The aim of this study was to compare inter-assessor agreements for causality assessment of epidemiological study data from an individual perspective and between individuals from different healthcare backgrounds. Study Methods: Six assessors (two pharmacists, two physicians and two nurses), assessed 200 ADR reports for causality using the Naranjo ADR Probability Scale, the Venulet algorithm and the WHO causality term assessment criteria. Agreement between assessors using the same algorithms was examined, and agreement between the algorithms for the same assessor was also measured. Results: For all methods, the majority of the causality assessments resulted in 'probable' or 'possible' categorization. Physician and pharmacist assessment was more likely to result in 'definite' or 'certain' causality assessments than nurse assessment, when using the Naranjo and WHO algorithms. Use of the Venulet algorithm resulted in a higher number of 'unlikely' or 'unrelated' assessments than the other two methods. The inter-assessor agreement measured was no greater than 'fair' (weighted kappa [k

Polypharmacy in people living with HIV/AIDS (PLWHA) is a rising morbidity that exacts hefty economic burden on health budgets in addition to other adverse clinical outcomes. Despite recent advances, uncertainty remains around its exact definition in PLWHA. In this systematic review and Meta-analysis, we explored relevant databases (PUBMED, EMBASE, CROI) for studies evaluating polypharmacy in PLWHA from January 2000 to August 2021 to ascertain the exact numerical threshold that defines this morbidity. Two independent reviewers extracted and reviewed relevant variables for analyses. The review included a total of 31 studies involving n = 53,347 participants with a mean age of 49.5 (SD ± 17.0) years. There was a total of 36 definitions, with 93.5% defining polypharmacy as the concomitant use of 5 or more medications. We found significant variation in the numerical definition of polypharmacy, with studies reporting it as “minor” (N = 3); “major” (N = 29); “severe” (N = 2); “excessive” (N = 1); and “higher” (N = 1). Most studies did not incorporate a duration (84%) in their definition and excluded ART medications (67.7%). A plurality of studies in PLWHA have established that polypharmacy in this cohort of patients is the intake of ≥ 5 medications (including both ART and non-ART). To standardize the approach to addressing this rising morbidity, we recommend incorporation of this definition into national and international PLWHA treatment guidelines.