Assessment of Pharmacovigilance Across University Hospitals in Morocco.

Abstract

Introduction: Despite the increased scrutiny on vaccine safety following the coronavirus disease 2019 (COVID-19) pandemic, Morocco's Centre of Antipoison and Pharmacovigilance (CAPM) remained concerned that the pharmacovigilance system in Morocco was insufficiently implemented, including limited adverse event (AE) reporting, poor data use, and inconsistent training nationwide.

Objectives: We sought to assess the status of pharmacovigilance activities (PAs) prior to formally institutionalizing them across university hospital centers (UHCs), given their position as the main providers of healthcare in Morocco and key sources for reporting serious AEs.

Methods: We assessed seven UHCs (housing 30 hospitals) in 2023 using a structured questionnaire with pharmacovigilance focal points developed from the World Health Organization's indicators of pharmacovigilance and the Global Benchmarking Tool. Data were grouped into 28 PAs and scored from 0 (not implemented) to 3 (fully implemented). We then calculated an implementation rate for each site on the basis of percent of PAs fully implemented (≥ 70%, well established; > 40% to < 70%, partially implemented; and ≤ 40%, not implemented). A desk review was also performed at the sites. Using the results of the assessment, three working groups of pharmacovigilance stakeholders developed recommendations to be formally adopted by UHCs.

Results: Basic elements of pharmacovigilance (notification forms and VigiFlow^® or Excel databases) were present at all the UHCs assessed. In total, 14 hospitals (47%) had well-established PAs, including advanced activities such as signal detection of adverse events following the use of medicines and vaccines, as well as causality assessment; 9 hospitals (30%) were partially implementing pharmacovigilance, and 7 hospitals (23%) had no established activities or very basic activities. Within four UHCs, activities had not been implemented at the same level from one hospital to another and vaccine vigilance was largely deprioritized. The working groups made recommendations for improving collaboration, standardizing procedures, and outlining a new organizational structure for pharmacovigilance, which was institutionalized by a formal agreement among UHCs in July 2023.

Conclusions: The assessment revealed a subgroup of centers with well-established AE signal detection and causality assessment abilities, which could play a leading role in the country. After the site assessment, our collaborative approach of bringing together focal points to identify next steps and generate buy-in helped to formalize pharmacovigilance across centers.