An observational pilot study of an active surveillance tool to enhance pharmacovigilance in Brazil.

Background: Active surveillance involves systematically monitoring patients to seek detailed information about the occurrence of adverse events (AEs) following drug administration. The Seta technology was developed to improve active surveillance of AEs or pregnancy in low- and middle-income countries and geographically challenging areas. Seta actively solicits responses from participants via WhatsApp messages. The study aimed to determine whether Seta facilitated reporting of AEs and pregnancies to the Brazilian National Health Surveillance Agency (ANVISA).

Methods: Malaria patients participating in the Tafenoquine Roll-out STudy (TRuST) in Brazil's Amazon region were invited to participate in this observational pilot study evaluating Seta. The study was conducted at two sites from 27 July 2022 to 28 October 2022. Seta sent messages to all participants on Day 7 and in Week 8 asking if they had experienced an AE or if they had become pregnant during the time since they took the malaria medication. If a participant responded "yes", a pharmacovigilance coordinator (PVC) called them to collect further details, which the PVC was then encouraged to report to ANVISA.

Results: This pilot study included 149 participants, 50 from Manaus and 99 from Porto Velho. On Day 7, 117 (79%) of 149 participants responded to WhatsApp messages generated by Seta asking whether they had experienced an AE or become pregnant; 45 participants responded "yes". At Week 8, 64 (55%) of the Day 7 responders also responded, 10 of whom indicated that they had experienced an AE or become pregnant. A total of 55 follow-up calls were therefore attempted by PVCs, of which, 25 (45%) were answered and allowed for reporting of AEs and pregnancies, as appropriate, to ANVISA.

Conclusions: This observational pilot study provides insights into how digital reporting tools such as Seta can enhance pharmacovigilance in remote areas and build upon existing signal detection methodologies. Twenty-five AEs or pregnancies were reported to ANVISA that were unlikely to have been reported otherwise.