(051) Monitoring of adverse events during seasonal malaria chemoprevention campaigns in children aged 3-59 months in Burkina Faso: A real-world evidence

Publication Number: 1047

Background: Seasonal malaria chemoprevention (SMC) by administering Sulfadoxine-pyrimethamine + amodiaquine (SP-AQ) reduces the burden of malaria in children aged 3-59 months. However, even SMC is a widely used drug, a real-life monitoring of adverse event is limited in endemic countries such as Burkina Faso.

Objectives: This study aimed to: (i) describe the characteristics of adverse drug reactions reported (ADRs) with SMC in children under 5 years of age, and (ii) assess the performance of pharmacovigilance integrated into the SMC program in Burkina Faso.

Methods: We conducted a retrospective analysis of all individual case safety reports (ICSRs) related to SMC drugs notified to the National Centre for Health Product Vigilance (CNVPS) of Burkina Faso and registered in VigiBase®, the WHO global pharmacovigilance database, for the period from January 2014 to December 2021. WHO criteria were used to evaluate pharmacovigilance activities. Categorical variables were described using percentage and continuous variable with median and interquartile range. The Pearson chi square test was used to compare categorical variables. The statistical significance level was 0.05.

Results: A total of 1105 ICSRs related to SMC were recorded for 23,311,453 doses administered. The main ADRs reported were vomiting 48.0% (665/1385), somnolence 15.6% (216/1385), abdominal pain 8.4% (116/1385) and diarrhoea 8.3% (115/1385). ADRs resulted in 38.1% (212/556) of children discontinuing SMC. The proportion of children whose treatment was stopped for vomiting was 42.7% while the proportion of treatment discontinuation for other ADRs was 32.8% (p= 0.01). The percentage of serious ICSRs was 9.1% (101/1105). Of the serious cases 22.8% were preventable.
Pharmacovigilance of the SMC program contributed 46.2% (1105/2393) to the national pharmacovigilance database. The reporting rate per year was 0.08 (2016), 0.05 (2017), 0.14 (2018), 0.02 (2019), and 0.03 per 1000 exposed children in 2021. No ICSRs were recorded in VigiBase® for the years 2014, 2015, and 2020. Reporters were nurses 97.3%, physicians 1.4%, and pharmacists 1.3%. The median ICSR completeness score was 0.7 (IQR: 0.5-0.7). The median time to report to the CNVPS was 115 (IQR: 1-185) days. The median time from the start of the adverse event to registration in VigiBase® was 204 (IQR: 143-333) days.

Conclusions: Post-drug administration vomiting can undermine the goal of the SMC program. It is important for the program to develop a management guide for severe vomiting. Sensitization of community distributors is crucial to reduce the risk of occurence of ADRs for the sustainability of the SMC program. Based on the information on reporting time and reporting rate, spontaneous reporting should be supported by active surveillance in Burkina Faso