Background: As part of implementation quality standards, community distributors are expected to ensure that only age-eligible children (aged 3 – 59 months) receive seasonal malaria chemoprevention (SMC) medicines during monthly campaigns. There is uncertainty about the extent to which SMC medicines are administered to ineligible children. This study therefore aimed to assess the magnitude of this occurrence, while exploring the factors associated with it across nine states where SMC was delivered in Nigeria during the 2022 round. Methods: We extracted data from representative end-of-round SMC household surveys and analyzed data of 3,299 caregiver-child pairs sampled from nine SMC-implementing states in Nigeria. Prevalence of receipt of SMC medicines by ineligible children was described by child-, caregiver- and SMC-related factors. Mixed-effects multivariable logistic regression models were fitted to explore the factors associated with the occurrence. Results: 30.30% (95% CI: 27.80 – 32.90) of ineligible children sampled received at least one dose of SMC medicines in 2022, the majority (60.60%) of whom were aged 5-6 years while the rest were aged 7-10 years. We observed higher odds of an age-ineligible child receiving SMC among caregivers who had poor knowledge of SMC age eligibility (OR: 1.79, 95% CI: 1.24 – 2.57, p=0.002), compared with those who were knowledgeable of age eligibility. Higher odds of receipt of SMC were also found among age-ineligible children whose caregivers had higher confidence in the protective effect of SMC against malaria (OR: 2.01, 95% CI: 1.3 – 4.2, p=0.007), compared with those whose caregivers were less confident. Conversely, ineligible children whose caregivers were older than 20 years had lower odds of receiving SMC than those whose caregivers were younger; with lower odds among children of caregivers aged 20-29 years (OR: 0.48, 95% CI: 0.28 – 0.81, p = 0.007), 30-39 years (OR: 0.41, 95% CI: 0.24 – 0.69, p=0.001), and 40-49 years (OR: 0.52, 95% CI: 0.29 – 0.91, p=0.024). Conclusions: This study contributes important evidence on the magnitude of the receipt of SMC by age-ineligible children, while identifying individual and contextual factors associated with it. The findings provide potentially useful insights that can help inform and guide context-specific SMC implementation quality improvement efforts.

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Background Seasonal malaria chemoprevention (SMC) campaign is known to reduce malaria-related morbidity and mortality among children aged 3 -59 months in the Sahel regions of Africa. However, the success of the intervention may be adversely affected by the absence of a robust pharmacovigilance system to monitor safety. This paper aims to describe our pharmacovigilance reporting experience during the campaigns conducted across seven states in Nigeria in 2020. Methods The SMC campaigns were held from July to November 2020 over 4 cycles with about 12 million eligible children reached by trained community drug distributors. Suspected adverse drugs reactions were reported routinely through the national pharmacovigilance system. Completed PV forms submitted to the National Agency for Food, Drugs Administration And Control were retrieved and analyzed. Results The ADR reporting across the seven states was low, with 5 states failing to report any incidence. Abdominal pain, weakness, diarrhea, fever, rash and vomiting were reported, with vomiting being the commonest. Children aged 12-59 months accounted for most (~86%, 49/57) of the reports, with over 70% (40/57) of these reports completed by Community Health Extension Workers. The System Organ Class showed the gastrointestinal system as the most affected (65%, 37/57). Conclusion Our experience suggests potential ADR underreporting from the campaign. The quality and quantity of reports have been identified as a major concern, highlighting the need for active surveillance, strengthen health workers' capacity and the national pharmacovigilance system for optimum ADR reporting.

Background: The seasonal malaria chemoprevention (SMC) campaign provides malaria preventive medicines to healthy eligible children aged 3-59 month in the Sahel region of Africa. The campaign has helped reduce malaria burden among this age group in sub-Sahara Africa, but inadequate data exist on its supply chain management and pharmacovigilance reporting. To better understand its challenges and uncover areas to direct existing resources for commodity security and reporting of medication safety, this research evaluates the commodity management of Sulphadoxine Pyrimethamine + Amodiaquine (SP+AQ), a drug of choice in SMC and pharmacovigilance reporting during the 2019 campaign in 5 Northern states in Nigeria.Methods: A descriptive cross-sectional study design was used, with a total of 1,189 health facilities (HFs) selected using a multi-stage cluster sampling in Jigawa, Katsina, Sokoto, Zamfara and Yobe States. The health facilities (HFs) were assessed using a structured questionnaire for distribution practices, compliance to good storage practices, staff training in pharmacovigilance (PV) and availability of pharmacovigilance reporting forms. Data were collected using the SurveyCTO data collection tool.Results: Overall, inventory tools were available in 92.2% of the HFs. HFs with non-updated inventory tools ranges from 3% in Jigawa to 23% in Sokoto. Delivery documents were not sighted in 22% and 19% of facilities in Katsina and Sokoto states respectively. Storage practices across the facilities were generally fair with the exception of a significant lack of risk mitigation tools like fire extinguishers, with its availability ranging from 9% in Yobe to 38.6% in Jigawa. An observation of sampled tools showed a significant number of entry errors and missing entries. PV forms were available in 84% of the HFs sampled and 91.6% had at least one personnel trained on PV which varied across the states from 95.6% to 67.7% for the reporting tools and 97.3% to 79.2% for health facility workers (HFWs) trained in Jigawa and Sokoto respectively.Conclusions: Commodity management of SP+AQ during SMC implementation in Nigeria is less than optimum and can negatively impact on commodity security during the campaign. A focused capacity building of HFWs responsible for commodity management, provision of fire extinguishers and PV reporting tools will help address the observed gaps in addition to improved supply of commodity management tools to health facilities.