Kenya Vigilance Monitoring and Evaluation Framework and Key Performance Indicators (2022-2025)

A PV system is “a system used by an organization to undertake its legal duties and responsibilities about PV and to monitor the safety of authorized medicinal products and identify any changes in the risk-benefit balance. An effective PV system supports the early detection, assessment, understanding and mitigation of adverse outcomes associated with medicines and medical products PV systems support the collection of data to support decision- making about medicines at various levels of healthcare systems. Regulators rely on this data to inform regulatory actions such as drug withdrawals, drug recalls, change of product labels, and drug safety alerts among others.

Therefore, it is crucial to have a robust pharmacovigilance system in place that allows continuous monitoring of the Health Products and Technologies. The Vigilance Monitoring and Evaluation Framework and Key Performance Indicators will provide a set of measures that will be critical to assess, monitor and evaluate the various constituents of the pharmacovigilance system in Kenya. These indicators will measure the existence and performance of key pharmacovigilance structures and processes, enabling identification of strengths and weaknesses as well as tracking achievements and growth (or lack thereof) in the pharmacovigilance systems. They will also measure the degree of attainment of set strategic objectives.