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.

Malaria Intermittent Preventive Treatment (IPTi) pharmacovigilance in Malawi: A case of Lilongwe district.

BACKGROUND: Intermittent Preventive Treatment with Sulfadoxine-Pyrimethamine in infants (SP-IPTi) is a malaria control strategy which, together with the delivery of routine childhood immunizations, as recommended by the World Health Organization (WHO) was implemented in Lilongwe district of Malawi from September 2008 to November in 2009. A study was performed by Lilongwe District Health Office (DHO) in collaboration with funding from UNICEF to evaluate the safety of SP-IPTi and identify potential new Adverse Events (AEs) spontaneously identified, reported, monitored and evaluated. METHODS: A cohort event monitoring study was conducted on 15, 000 infants in 4 Health Facilities (HFs) after administration of SP-IPTi to infants during routine immunizations. A total of about 50 Community Health Workers (CHWs) and volunteers were trained in pharmacovigilance and were supervised by senior personnel in all the five HFs.Infants received half tablets of SP immediately after receiving DPT-HepB+Hib (Pentavalent) 2 vaccine / (IPTi 1), Pentavalent 3 / (IPTi 2) at 10 and 14 weeks respectively and Measles vaccines/(IPTi 3) at 9 months. These children were recorded and their mothers were given diary cards with pictures of possible AEs. Community Health Workers (CHWs) and volunteers followed up every child after 10 days of administration/registration to collect the diary cards where parents indicated types of AEs observed on their children as well as starting and end dates of such possible AEs.The indicated AEs were entered into a computer database from all the collected diary cards according to HFs. Possible side effects/AEs that were looked for were; persistent crying, fever, vomiting, diarrhoea, skin rashes, abdominal pains, insomnia, nausea, mouth sores, and itching among other related possible side effects. RESULTS: A total of 15,105 children received the IPTi and were followed in all four health facilities. Out of this, 50.3% (7,594) were male while 49.7% (7, 511) were females. Of these, 19.2% [1247], 95% CI (276-304) developed AEs as follows; 42% persistent crying, 28% fever, 18% vomiting, 5.2% skin rashes and 6.8% presented with other minor symptoms while 80.8% (13,858) did not develop any side effect. 43.2% (1254) of those who showed symptoms were IPTi1 recipients, 35.3% (1022) received IPTi2 while 21.5% (624) were from those who received IPTi3. CONCLUSIONS: This study showed that simultaneous administration of SP-IPTi together with immunizations was a safe strategy for implementation with very minimal serious AEs to infants. In this case therefore, strategies towards strengthening such spontaneous reporting in Malawi should not only be left to service providers but also to beneficiaries or their caregivers.

Lessons Learned from Introducing a Village Health Registry in Malawi.

The Village Health Registry (VHR) was a community health data collection tool introduced in 1998. It was first introduced in Mwanza district of Malawi with the objectives of collecting community-based data, analysing and taking action in a local setting. The tool was collecting and updating data such as demography, immunization status for children under one year, growth monitoring for children under five, monitoring of all pregnant women, incidence of malaria, acute respiratory infections, diarrhoea cases, water and sanitation and deaths, by visiting households in every village every month. The tool was able to collect all targeted information as required. The data collected by the tool appeared to be more reliable than that obtained through a national information system used by the Ministry of Health (MoH) for the same district and the same year. It was easy for health centres to accurately order supplies based on actual requirements, to follow-up cases during disease outbreaks and to identify deficiencies in immunisation coverage rates. Despite promising results, the VHR registry fell into disuse following the establishment of a national register. The MoH's Health Information System (HIS) data used projections which normally did not represent the actual situation on the ground while the VHR registry gave real physical data which was representative and verifiable. The potential of the VHR outweighed that of the HIS. Although the HIS had been rolled out nationally, there were shortfalls which MoH could consider rectifying to reach its full potential. In conclusion, the VHR was worth adopting as it would give MoH realistic statistics to be effectively used at all levels.