Pharmacovigilance of malaria intermittent preventive treatment in infants coupled with routine immunizations in 6 African countries.

BACKGROUND: Intermittent preventive treatment in infants (IPTi) is a new malaria control strategy coupled with the delivery of routine immunizations recommended by the World Health Organization since 2009 for countries with moderate to high endemicity. To evaluate its safety profile and identify potential new adverse events (AEs) following simultaneous administration of sulfadoxine-pyrimethamine (SP-IPTi) with immunizations, we measured AE incidence and evaluated spontaneous AE reporting. METHODS: A cohort event monitoring study was conducted on 24 000 infants in 2 countries after administration of SP-IPTi during routine immunizations. Additional pharmacovigilance training and supervision were conducted to stimulate AE passive reporting in 6 African countries. RESULTS: No serious AEs were found by active follow-up, representing 95% probability that the rate does not exceed 1 per 8000. No serious AEs were found by retrospective review of hospital registers. The rate of moderate AEs probably linked to immunization and/or SP-IPTi was 1.8 per 1000 doses (95% confidence interval, 1.50-2.00). Spontaneous reporting of AEs remained <1% of cases collected by active follow-up. CONCLUSIONS: 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.

Acceptability of coupling intermittent preventive treatment in infants with the expanded programme on immunization in three francophone countries in Africa.

OBJECTIVE: Intermittent preventive treatment in infants (IPTi) is a malaria control strategy currently recommended by WHO for implementation at scale in Africa, consisting of administration of sulphadoxine-pyrimethamine (SP) coupled with routine immunizations offered to children under 1 year. In this study, we analysed IPTi acceptability by communities and health staff. METHODS: Direct observation, in-depth interviews (IDIs) and focus group discussions (FGDs) were conducted in Benin, Madagascar and Senegal during IPTi pilot implementation. Villages were stratified by immunization coverage. Data were transcribed and analysed using NVivo7 software. RESULTS: Communities' knowledge of malaria aetiology and diagnosis was good, although generally villagers did not seek treatment at health centres as their first choice. Perceptions and attitudes towards IPTi were very positive among communities and health workers. A misconception that SP was an antipyretic that prevents post-vaccinal fever contributed to IPTi's acceptability. No refusals or negative rumours related to IPTi coupling with immunizations were identified, and IPTi did not negatively influence attitudes towards other malaria control strategies. Healthcare decisions about children, normatively made by the father, are starting to shift to educated and financially independent mothers. DISCUSSION: Intermittent preventive treatment in infants is well accepted by providers and communities, showing a synergic acceptability when coupled with routine immunizations. However, a misconception that SP alleviates fever should be addressed when scaling up implementation.