Drug Safety Monitoring Report for Tenofovir Disoproxil, Lamivudine and Dolutegravir (TLD) Pre-exposure Prophylaxis (PrEP)

To address this issue, the national government has introduced and scaled up new prevention and treatment regimens, including tenofovir, lamivudine, and dolutegravir (TLD) and pre-exposure prophylaxis (PrEP). Introducing and scaling up these regimens requires identifying adverse drug reactions related to their use and close monitoring of safety through pharmacovigilance (PV). The overall implementation of PV in the Philippines is anchored on the Administrative Order (AO) 2011-0009 of the Food and Drug Administration (FDA), which focuses on the spontaneous reporting of Adverse Events (AEs) using the Suspected Adverse Reactions (SAR) Form of the FDA. Additionally, the Department of Health (DOH) AO 2018-0024 and the Department Memorandum 2021-0017 highlighted the need to implement pharmacovigilance for antiretrovirals (ARV) and preventive treatments. The World Health Organization (WHO) technical advisory "Scale-up of Dolutegravir-containing antiretroviral therapy regimens in the Philippines" emphasized the need to introduce active drug safety monitoring (aDSM) to update the safety profile of newly introduced drugs. Implementing active surveillance requires resources, including significant data and skilled human resources, to assess the causal relationship between the drug and the AE. The USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) program has been collaborating with the FDA and DOH to strengthen the PV system and promote the rational use of health commodities. In 2021, MTaPS and DOH held discussions on the implementation of the Pharmacovigilance Information System (PViMS), a web-based application used to monitor the safety and effectiveness of medicines for AE reporting. The DOH agreed to include new ARVs for active surveillance monitoring for one year, and MTaPS supported the DOH to develop an action plan to guide the ongoing and planned activities in setting up active surveillance for TLD and PrEP. However, the DOH highlighted that there are several policies requiring health facilities to adhere to PV practices, but little is known about the current capacity and capacity building needs of HIV care facilities to implement active surveillance and use of PViMS. The priority shifted to determining these foundational requirements prior to implementation of active surveillance and PViMS. MTaPS supported the DOH, FDA, and Centers for Health Development (CHDs) in accordance with the action plan to implement active surveillance of TLD and PrEP. The implementation support activities included stakeholder engagement, developing PV eLearning contents, and organizing PV webinars with FDA. Key informant interviews and site visits to selected facilities were conducted to support the DOH in validating the information highlighted during the active surveillance action planning session and to determine whether targeted spontaneous reporting (TSR) is more appropriate to implement than active surveillance. The USAID MTaPS visited HIV outpatient care facilities and conducted interviews with health workers from May 2022 to August 2022 to determine their knowledge of AE reporting, tools used to report AE, and site-level AE documentations. The interviews and site visits aimed to better understand the current PV practices, capabilities to implement active surveillance, and adherence to national policies on PV. The findings from these activities will inform the next steps in implementing active surveillance for TLD and PrEP in the Philippines.