Malaria is one of the leading causes of morbidity and mortality globally. In 2020, 241 million malaria cases in 85 malaria endemic countries (including the territory of French Guiana) were reported, increasing from 227 million in 2019, with most of this increase coming from countries in the WHO African Region . It is implicated in millions of deaths over the last decades, with children under 5 years a major victim  African countries are disproportionately affected, with Nigeria and Congo accounting for 37.0% of cases and deaths globally have been implemented across the continent.
Seasonal Malaria Chemoprevention targeted at children under five years is one of such preventive interventions . It involves the administration of a combination of sulphadoxine and pyrimethamine in addition to amodiaquine (SPAQ) to health eligible children between the ages of 3 to 59 months during the peak of rainy season in the Sahel region of Africa [4,5]. Once administered, the therapeutic level attained can protect children against malaria throughout the peak of the rainy season . Provided that the drug is administered according to the recommended guideline, WHO (2012) revealed that this intervention can reduce malaria cases by 75%, and by extension, malaria mortality.
The success of the intervention depends on the efficacy and safety of the SPAQ. While satisfactory efficacy and safety are preconditions for marketing authorization, post marketing surveillance is highly encouraged to identify safety issues that may arise during large scale use. To effectively identify and respond to safety issues post authorization, reliable pharmacovigilance system capable of detecting, monitoring and reporting adverse drug event associated with the drugs used for the SMC campaign must be in place. Countries and health programmes either adopt an active or passive pharmacovigilance strategy and, in some instances, a combination of both. The active pharmacovigilance system involves actively looking for cases of adverse drug reaction. On the other hand, the passive strategy relies on end-users to report suspected adverse drug reaction cases.
In Nigeria, ADR reporting is done in a passive form using the ADR forms, obtained from National Agency for Food and Drug Administration and Control (NAFDAC) state offices in the 36 states in the country, and the National Pharmacovigilance Centre (NPC) NAFDAC Headquarter ,or any of the pharmacovigilance centres across the country [7,8]. The form is expected to be filled and returned to any of the listed collection centers. More recently, an online reporting system was inaugurated . In line with the national strategy, all suspected cases of ADR are expected to be reported using the ADR form and transmitted to the designated centers.
1.1 Aim and Objectives
There are currently no systematically documented findings on the reporting of suspected adverse drug reaction during seasonal malaria chemoprevention campaigns in Nigeria. This paper aims to provide details on the reporting of suspected ADR from the seasonal malaria chemoprevention campaign across seven states in a bid to uncover gaps in pharmacovigilance. This article provides details of the number and type of ADRs associated with SPAQ while highlighting potential strategies for strengthening pharmacovigilance.
1.2 Ethical Approval
Ethical approval for this study was received from the National Health Research Ethics Committee, Abuja , Nigeria. On the 8th of December 2020.
1.3 Nigeria National Pharmacovigilance Reporting System for Adverse Drug Reaction:
The Nigeria National Pharmacovigilance system is coordinated by the National Pharmacovigilance center situated within the National Agency for Food and Drug Administration and Control (NAFDAC) Nigeria’s drug regulatory agency . The agency expects all suspected or actual adverse reactions to drugs and other related substances to be reported using the pharmacovigilance reporting form also known as yellow form . A typical adverse drug reaction form (also known as yellow form or individual case safety report (ICSR) form) provides information on:
- Patient demographics (name, age, sex and weight)
- Adverse drug reaction (description, date reaction started and stopped and outcome–recovered fully, congenital abnormality, recovered with abnormality, life-threatening and death)
- Suspected drug (brand and generic names, batch number, NAFDAC number, expiry date)
- Concomitant medicines (all medicines taken in the last three months)
- Source of report
This form can be obtained from
- Any NAFDAC state office in the 36 states in the country.
- The National Pharmacovigilance Centre (NPC) NAFDAC Headquarters Wuse Zone 7 Abuja.
- Any of the Zonal Pharmacovigilance Centres (ABUTH, Shika, FMC, Owerri, LUTH, Lagos, UBTH, Benin, UITH, Ilorin and UMTH, Maiduguri)
Reports of adverse drug reaction are transmitted to the nearest pharmacovigilance centre. Recently, there is also an ADR reporting form online that can be used to report adverse drug reaction electronically .
In addition to healthcare providers (pharmacists, doctors and nurses), organizations or individuals holding a marketing authorization for medicinal products must report any suspected ADR to their products. Reporting is usually not mandatory; rather it is voluntary . Overall, Nigeria’s pharmacovigilance system is a passive surveillance system that involves the reporting of adverse drug reaction by health facilities across the country after observation of patients presenting such reactions