Strengthening Pharmacovigilance Systems in Swaziland to Improve Patient Safety and Treatment Outcomes

SIAPS mobilized stakeholders from the Swaziland National AIDS Program (SNAP) and the National Tuberculosis Control Program (NTCP) to introduce and implement the Sentinel Site-based Active Surveillance System for Antiretroviral and Anti-TB (SSASSA) treatment programs. SIAPS partnered with the Pharmacovigilance Unit of the MOH to create the protocol and tools for the electronic SSASSA system, and developed a patient recruitment system at HIV and TB sites. The new system documents and quantifies incidence rates of adverse events associated with antiretrovirals (ARVs) and anti-TB medicines and determines risk factors at selected sentinel sites. The SSASSA system tracks and reports data on adherence, severity of adverse events, patient demographics, and reasons for switching regimens. The SSASSA was officially launched in 2013, and subsequently installed at five hospitals and one clinic. SIAPS continues to support the implementation of the active surveillance system through supervisory visits to ensure data collation, causality assessments, and other patient analyses are occurring correctly. SIAPS also supports the dissemination of pharmacovigilance data from the SSASSA system at both the national and regional levels.