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.