Description and outcomes of a hospital-based pharmacovigilance system at a comprehensive cancer centre in Jordan.

Abstract

BackgroundThe fast emergence of new therapies requires monitoring their adverse drug reactions (ADRs) in real world oncology setting to mitigate negative health impacts. A functional Pharmacovigilance (PV) system is essential for detecting, assessing, and preventing ADRs. This study aims to describe the PV system at King Hussein Cancer Centre (KHCC), a comprehensive cancer center, and evaluate its functionality in terms of structure, processes, and outcomes.MethodsThis was a longitudinal descriptive study at KHCC. We used the Indicator Pharmacovigilance Assessment Tool (IPAT) to evaluate the functionality of the PV system in 2013, 2016, and 2020. The IPAT includes 29 adapted indicators, categorized into core and supplementary based on their importance to the PV system. Each indicator is scored based on predefined criteria with a 78.7% threshold defining PV system functionality. Required data were extracted from KHCC policies and procedures, Pharmacy and Therapeutic Committee meeting minutes, official medication safety correspondence, the ADRs documentation database, and drug use evaluation reports.ResultsThe overall functionality score was 74.5% in 2013, rising to 80.8% in 2016, exceeding the minimum IPAT threshold and becoming fully functional. By 2020, the score increased to 87.2%. The study highlights strengths in structural and process indicators, as all were met in 2020, except for two, while also identifying gaps in supplementary outcome indicators.ConclusionThe PV system at KHCC is functional and meets the IPAT minimum threshold for overall indicators. Continued efforts are essential to address the identified gaps, improve performance in outcome indicators and ensure the sustainability of pharmacovigilance activities within oncology practice.