Pharmacovigilance of Malaria Intermittent Preventive Treatment in Infants Coupled With Routine Immunizations in 6 African Countries

Sousa, Andreia S. P.; Rabarijaona, L.; Tenkorang, Ofori; Inkoom, Ebenezer; Ravelomanantena, Hantamalala V.; Njarasoa, Sabrina; Whang, Jeremiah Nee; Ndiaye, Jean Louis; Ndiaye, Youssoupha; Ndiaye, Mady; Sow, Doudou; Akadiri, Guinoussa; Hassan, Jacques; Dicko, Alassane; Sagara, Issaka; Kubalalika, Prestor J; Mathanga, Don P.; Bizuneh, Ketema; Randriasamimanana, J. R.; Recht, Judith; Bjelic, Ivana; Dodoo, Alexander

doi:10.1093/infdis/jir799

Cited by 7 publications

(5 citation statements)

References 35 publications

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“…A study in Malawi showed that the incidence of severe skin reactions in children from use of SP for malaria treatment is very low, only 2 events were recorded in over 300,000 treatments [ 12 ]. A study of the safety of SP used for IPTi, through passive follow-up of 217,000 SP treatments and active follow up of 24,000 children treated with SP, found no serious adverse reactions [ 13 ] and an Institute of Medicine review [ 14 ] looked specifically at the safety of SP for IPTi and concluded that it was well tolerated. Our surveillance did not detect any cases of severe cutaneous reactions associated with SMC drugs.…”

Section: Discussionmentioning

confidence: 99%

Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial

et al. 2016

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BackgroundIt is recommended that children aged 3 months to five years of age living in areas of seasonal transmission in the sub-Sahel should receive Seasonal Malaria Chemoprevention (SMC) with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) during the malaria transmission season. The purpose of this study was to evaluate the safety of SMC with SPAQ in children when delivered by community health workers in three districts in Senegal where SMC was introduced over three years, in children from 3 months of age to five years of age in the first year, then in children up to 10 years of age.MethodsA surveillance system was established to record all deaths and all malaria cases diagnosed at health facilities and a pharmacovigilance system was established to detect adverse drug reactions. Health posts were randomized to introduce SMC in a stepped wedge design. SMC with SPAQ was administered once per month from September to November, by nine health-posts in 2008, by 27 in 2009 and by 45 in 2010.ResultsAfter three years, 780,000 documented courses of SMC had been administered. High coverage was achieved. No serious adverse events attributable to the intervention were detected, despite a high level of surveillance.ConclusionsSMC is being implemented in countries of the sub-Sahel for children under 5 years of age, but in some areas the age distribution of cases of malaria may justify extending this age limit, as has been done in Senegal. Our results show that SMC is well tolerated in children under five and in older children. However, pharmacovigilance should be maintained where SMC is implemented and provision for strengthening national pharmacovigilance systems should be included in plans for SMC implementation.Trial RegistrationClinicalTrials.gov NCT 00712374

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Section: Discussionmentioning

confidence: 99%

Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial

et al. 2016

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“…The same estimates may reasonably apply to the alternative combination amodiaquine plus sulfadoxine-pyrimethamine, as this was found as effective as ACT in the study area [42]. As far as safety is concerned, amodiaquine is the partner drug of one of the most widely used ACTs, and the combination, as well as sulfadoxine-pyrimethamine alone, have been tested in several randomized controlled trials [42]–[45], while sulfadoxine-pyrimethamine has been extensively used as intermittent preventive treatment both in pregnancy and in infants, showing an excellent safety profile [46], [47].…”

Section: Methodsmentioning

confidence: 99%

Should Malaria Treatment Be Guided by a Point of Care Rapid Test? A Threshold Approach to Malaria Management in Rural Burkina Faso

et al. 2013

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BackgroundIn Burkina Faso, rapid diagnostic tests for malaria have been made recently available. Previously, malaria was managed clinically. This study aims at assessing which is the best management option of a febrile patient in a hyperendemic setting. Three alternatives are: treating presumptively, testing, or refraining from both test and treatment. The test threshold is the tradeoff between refraining and testing, the test-treatment threshold is the tradeoff between testing and treating. Only if the disease probability lies between the two should the test be used.Methods and FindingsData for this analysis was obtained from previous studies on malaria rapid tests, involving 5220 patients. The thresholds were calculated, based on disease risk, treatment risk and cost, test accuracy and cost. The thresholds were then matched against the disease probability. For a febrile child under 5 in the dry season, the pre-test probability of clinical malaria (3.2%), was just above the test/treatment threshold. In the rainy season, that probability was 63%, largely above the test/treatment threshold. For febrile children >5 years and adults in the dry season, the probability was 1.7%, below the test threshold, while in the rainy season it was higher (25.1%), and situated between the two thresholds (3% and 60.9%), only if costs were not considered. If they were, neither testing nor treating with artemisinin combination treatments (ACT) would be recommended.ConclusionsA febrile child under 5 should be treated presumptively. In the dry season, the probability of clinical malaria in adults is so low, that neither testing nor treating with any regimen should be recommended. In the rainy season, if costs are considered, a febrile adult should not be tested, nor treated with ACT, but a possible alternative would be a presumptive treatment with amodiaquine plus sulfadoxine-pyrimethamine. If costs were not considered, testing would be recommended.

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“…Rather, it was thought key to emphasize the verbal explanation of adverse events by health professionals to caregivers, initiating a more conversational approach that would enable concerns to be addressed and to encourage caregivers to attend the clinic should adverse events occur. The balance between provision of sufficient information on potential adverse events and raising unnecessary concerns has not been well examined, and this is an area which could benefit from further qualitative study, particularly in the context of strengthening pharmacovigilance systems [ 13 , 40 , 52 , 53 ].…”

Section: Discussionmentioning

confidence: 99%

“…Sulfadoxine-pyrimethamine (SP) has been widely used for chemoprevention in Africa, including for PMC, and studies have demonstrated its efficacy safety and tolerability [ 5 – 11 ]. Furthermore, pharmacovigilance studies have confirmed the safety of simultaneous administration of SP and vaccines [ 12 , 13 ], making the Expanded Programme on Immunisation (EPI) a key channel for PMC delivery. PMC has been shown to reduce the incidence of clinical malaria by around 30%, as well as the incidence of anaemia, parasitaemia, and all cause hospital admissions in children aged 12 to 24 months [ 6 – 11 ].…”

Section: Introductionmentioning

confidence: 99%

Field testing of user-friendly perennial malaria chemoprevention packaging in Benin, Côte d’Ivoire and Mozambique

Faye,

Lugand,

Offianan

et al. 2024

Malar J

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Background Perennial malaria chemoprevention (PMC) aims to protect children at risk from severe malaria by the administration of anti-malarial drugs to children of defined ages throughout the year. Sulfadoxine-pyrimethamine (SP) has been widely used for chemoprevention in Africa and a child-friendly dispersible tablet formulation has recently become available. Methods This qualitative non-interventional observational study was conducted in Benin, Côte d’Ivoire, and Mozambique between February and June 2022. Prototype blister packs, dispensing boxes and job aids designed to support dispersible SP deployment for PMC were evaluated using focus group discussions (FGD) and semi-structured in-depth individual interviews (IDI) with health authorities, health personnel, community health workers (CHWs) and caregivers. The aim was to evaluate knowledge and perceptions of malaria and chemoprevention, test understanding of the tools and identify gaps in understanding, satisfaction, user-friendliness and acceptability, and assess the potential role of CHWs in PMC implementation. Interviews were transcribed and imported to ATLAS.ti for encoding and categorization. Thematic content analysis used deductive and inductive coding with cross-referencing of findings between countries and participants to enrich data interpretation. Continuous comparison across the IDI and FGD permitted iterative, collaborative development of materials. Results Overall, 106 participants completed IDIs and 70 contributed to FGDs. Malaria was widely recognised as the most common disease affecting children, and PMC was viewed as a positive intervention to support child health. The role of CHWs was perceived differently by the target groups, with caregivers appreciating their trusted status in the community, whereas health authorities preferred clinic-based deployment of PMC by health professionals. Empirical testing of the prototype blister packs, dispensing boxes and job aids highlighted the context-specific expectations of respondents, such as familiar situations and equipment, and identified areas of confusion or low acceptance. A key finding was the need for a clear product identity reflecting malaria. Conclusion Simple modifications profoundly affected the perception of PMC and influenced acceptability. Iterative quantitative investigation resulted in PMC-specific materials suited to the local context and socio-cultural norms of the target population with the aim of increasing access to chemoprevention in children most at risk of severe malaria.

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Pharmacovigilance of Malaria Intermittent Preventive Treatment in Infants Coupled With Routine Immunizations in 6 African Countries

Abstract: Simultaneous administration of SP-IPTi and immunizations is a safe strategy for implementation with a low risk of serious AEs to infants. Strategies toward strengthening spontaneous reporting in Africa should include not only the provider but also beneficiaries or their caregivers.

Cited by 7 publications

References 35 publications

Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial

Safety of Seasonal Malaria Chemoprevention (SMC) with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial

Should Malaria Treatment Be Guided by a Point of Care Rapid Test? A Threshold Approach to Malaria Management in Rural Burkina Faso

Field testing of user-friendly perennial malaria chemoprevention packaging in Benin, Côte d’Ivoire and Mozambique

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