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Sante Publique (Vandoeuvre-Les-Nancy, France)
|February 29, 2024
Summary
Seasonal malaria chemoprevention (SMC) using SPAQ is effective but vomiting is a common adverse drug reaction (ADR) that can halt treatment. Active surveillance is recommended to improve the safety and success of SMC programs in Burkina Faso.
Area of Science:
- Pharmacovigilance
- Malariology
- Public Health
Context:
- Seasonal malaria chemoprevention (SMC) with sulfadoxine pyrimethamine + amodiaquine (SPAQ) is crucial for reducing malaria burden in children aged 3-59 months in endemic regions.
- Adverse drug reactions (ADRs) can compromise the effectiveness of SMC interventions.
- Limited data exists on SMC-related adverse event surveillance in sub-Saharan Africa, particularly in Burkina Faso.
Purpose:
- To characterize ADRs reported during SMC campaigns in Burkina Faso between 2014 and 2021.
- To evaluate the performance of pharmacovigilance integrated within the SMC program to ensure safe drug administration.
Summary:
- A retrospective analysis of 1,105 individual case safety reports (ICSRs) for 23,311,453 SPAQ doses revealed no pharmacovigilance signals.
- Serious ADRs occurred in 101 children, with 22.8% deemed preventable. Vomiting was the most frequent ADR (48.0%), leading to treatment discontinuation in 42.7% of affected children.
- The SMC program contributed significantly to the national pharmacovigilance database, though reporting rates and ICSR completeness require improvement, suggesting a need for active surveillance.
Impact:
- Vomiting post-SPAQ administration can disrupt SMC, necessitating management strategies to maintain treatment continuity.
- Findings highlight the need for enhanced pharmacovigilance, including active surveillance methods like cohort event monitoring, to improve SMC program safety and efficacy in Burkina Faso.