https://orcid.org/0000-0003-0594-3887
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Abstract
Background and purpose
Resource-limited countries face challenges in setting up effective pharmacovigilance systems. This study aimed to monitor the occurrence of adverse events (AEs) after the use of artemisinin-based combination therapies (ACTs), identify potential drivers of reporting suspected adverse drug reactions (ADRs) and monitor AEs among women who were inadvertently exposed to ACTs in the first trimester of pregnancy.
Patients and methods
We conducted a prospective observational study from May 2010 to July 2012 in Nanoro Health and Demographic Surveillance System (HDSS), Burkina Faso. The HDSS area was divided into active and passive surveillance areas to monitor AEs among patients (regardless of age or sex) who received a first-line ACT (artemether–lumefantrine or artesunate–amodiaquine). In the active surveillance area, patients were followed up for 28 days, while in the passive surveillance area, patients were encouraged to return voluntarily to the health facility to report any occurrence of AEs until day 28 after drug intake. We assessed the crude incidence rates of AEs in both cohorts and performed Cox regression with mixed random effects to identify potential drivers of ADR occurrence.
Results
In total, 3170 participants were included in the study. Of these, 40.3% had reported at least one AE, with 39.6% and 44.4% from active and passive surveillance groups, respectively. The types of ADRs were similar in both groups. The most frequent reported ADRs were anorexia, weakness, cough, dizziness and pruritus. One case of abortion and eight cases of death were reported, but none of them was related to the ACT. The variance in random factors showed a high variability of ADR occurrence between patients in both groups, whereas variability between health facilities was low in the active surveillance group and high in passive surveillance group. Taking more than two concomitant medications was associated with high hazard in ADR occurrence, whereas the rainy season was associated with low hazard.
Conclusion
This study showed that both passive and active surveillance approaches were useful tools. The HDSS allowed us to capture a few cases of exposure during the first trimester of pregnancy. The passive surveillance approach, which is more likely to be implemented by malaria control programs, seems to be more relevant in the Sub-Saharan African context.
Acknowledgments
We are very grateful to all participants in the study. We also thank the entire medical and field staff team who conducted this study. The medical staff in the health facilities and the CMA de Nanoro are also acknowledged. We would like to acknowledge Prof Umberto d’Alessandro and Dr Ambrose Talisuna, who contributed to finalizing the study protocol. The field work of this project was financially supported by the Tropical Diseases Research of the World Health Organization (WHO-TDR) [grant no. 2010/63792-0] (project HQTDR1003871) and the Sanofi Aventis Group [grant no. DJO-R-D/112066 – Avenant 112066], both awarded to Institut de Recherche en Sciences de la santé -IRSS (Principal Investigator: Halidou Tinto). The laboratory work was financially supported by the Institute of Tropical Medicine (ITM) of Antwerp (Belgium) [grant no. 930600] (project FA3-II). The Data analysis and manuscript drafting was conducted thanks to a travel grant (awarded to Rouamba Toussaint) from Beligium Academy for Research and Higher Education – Commission for Development Cooperation (ARES-CCD)
Data Sharing Statement
All data generated or analyzed during this study are available at Clinical Research Unit of Nanoro data repository and shareable upon request addressed to the corresponding author.
Disclosure
The authors report no conflicts of interest in this work.