Establishing Pharmacovigilance for a New HIV Drug in Mozambique
Monitoring patients who are taking a new medicine is critical for patient safety and an essential component of a well-functioning pharmaceutical sector. The USAID MTaPS Program is working in Mozambique to establish an active surveillance system to assess the safety of an HIV drug in HIV/TB co-infected patients, including pregnant women, that has recently been introduced in the country. The concern for pregnant women stems from earlier indications of neural tube defect in babies born to women taking the medicine and the fact that women are disproportionately affected by HIV in Mozambique. Women make up 60% of the estimated 2 million people living with the disease in the country, according to UNAIDS.
MTaPS is working with Mozambique’s national HIV program and the Directorate of Pharmacy (DNF), the agency responsible for regulating medicines and implementing pharmacovigilance (PV), to monitor adverse reactions or new reactions from the dolutegravir-based antiretroviral medicine, a drug introduced in the country in 2018 in a phased manner. The effort identified 10 facilities to participate in the initial establishment of the active surveillance system.
The collaboration started in 2018 with developing and planning for an active surveillance strategy for the dolutegravir-based regimen. As a first step in implementing the strategy, MTaPS worked with the DNF’s PV and national HIV program teams to revise the protocol and obtain approval from the Ministry of Health’s ethics committee to implement a safety surveillance system. The DNF and the national HIV program, with support from MTaPS, had a three-day training to orient 72 health care workers from participating health facilities and provincial focal persons on the protocol for active surveillance of patients on the new dolutegravir-based antiretroviral medicine. Additionally, MTaPS supported the DNF and the HIV program in organizing on-site trainings at the facilities to sensitize more staff about active surveillance and secure their cooperation.
Photo credit: MTaPS staff
Effective PV systems must provide for timely tracking and reporting to ensure patient safety. To serve this need, MTaPS is helping with the implementation of PViMS, a web-based PV tool for monitoring medicine safety. Developed by MTaPS’ predecessor, the USAID-funded SIAPS program, PViMS provides a comprehensive PV solution as it addresses both active surveillance and spontaneous reporting. The MTaPS Mozambique team worked with the DNF and HIV program to agree on a data capture approach in the tool for health facility focal points and procured tablets for data entry for the 10 participating health facilities.
“Before, Mozambique had not implemented an active surveillance system needed to identify signals and determine risk factors for adverse events in patients and relate this with a medicine, in real time. The support from MTaPS will serve the dual purpose of establishing a system for active surveillance and providing an electronic tool to support timely signal generation in pharmacovigilance. We are excited about the support from MTaPS. PViMS tool’s electronic system is serving our purpose to capture data and provide information in a timely manner,” said Dr. Jamal Mario, Head of the Pharmacovigilance Department at the DNF.
To start using the PV system, MTaPS provided training-of-trainers May 6–8 to the national team on the use of PViMS. The team will in turn train focal persons for HIV and PV at the provincial level and at the participating health facilities. The training, adapted to a virtual platform in response to the COVID-19 pandemic, imparted skills on data capture and entry. A follow-up second phase training focused on data analysis is scheduled for July 2020 and will fully equip DNF staff to conduct causality assessment, analyze the data, and identify possible drug-related problems that may not have been identified previously. Further, a system administrator will be trained to manage the PViMS tool and its use at the central level.
The findings from the PV system will not only inform the DNF’s clinical and regulatory decisions related to medicine use but also inform the global community to better assess the medicine’s risk-benefit trade-offs and profile the medicine for optimal use.
The PV work in Mozambique is being carried out in collaboration with MTaPS consortium partner University of Washington and is funded through USAID’s PEPFAR program.