Alternative methods to enhance adverse event reporting
According to study results reported in Pharmaceutical Medicine, antimalarial adverse event reporting rates in Senegal can be increased by active follow-up using a symptom card provided to caregivers, or by providing a smartphone application to community health workers (CHW) or nurses.
The study was conducted during the 2015 malaria season. Children <10 years of age received seasonal malaria chemoprevention (SMC) with pyrimethamine/sulfadoxine and amodiaquine each month for 3 months. Reporting rates were compared to spontaneous reports using the national reporting form. There were a total of 1983 adverse events from 134 061 monthly treatments.
In the Sedhiou region, reporting of adverse events to a CHW in their village or to a nurse at the health post who had been trained to use a smartphone application was encouraged (enhanced spontaneous reporting). The incidence was 30.6/1000 children/month, compared with 1.65/1000 children/month for spontaneous reports (rate ratio [RR] 18.5; 95% CI 8.65, 39.7). The most commonly reported symptoms were vomiting, fever, and abdominal pain. The incidence of vomiting by enhanced spontaneous reporting versus spontaneous reporting was 10.4 vs 1.0 per 1000 children/month (RR 10.2; 5.8, 18.0).
In the Kolda region, caregivers were actively followed-up after each SMC campaign, and questioned about adverse events which they had been encouraged to record on a symptom care (active surveillance). The adverse event incidence was 21.6/1000 children/month, compared with 3.2/1000 children/month for spontaneous reports (RR 6.7; 1.3, 33.9). The incidence of vomiting by active surveillance versus spontaneous reporting was 10.7 vs 1.5 per 1000 children/month (RR 7.2; 1.8, 29.1).
"Training CHWs in each village and health facility staff to report AEs using a mobile phone application led to much higher reporting rates than through the national system", note the authors. They add that "this approach is feasible and acceptable, and could be further improved by strengthening laboratory investigation and the collection of control data immediately prior to SMC campaigns".
- Ndiaye J-LA, et al. Evaluation of Two Strategies for Community-Based Safety Monitoring during Seasonal Malaria Chemoprevention Campaigns in Senegal, Compared with the National Spontaneous Reporting System. Pharmaceutical Medicine 32: 189-200, No. 3, Jun 2018. Available from: URL: http://doi.org/10.1007/s40290-018-0232-z CrossRefPubMedPubMedCentralGoogle Scholar