Active Surveillance for Safety and Effectiveness of Health Products for COVID-19
Active surveillance is an approach to collect safety and, less commonly, effectiveness information from individuals who take prescribed or over-the-counter medications or other health products. Knowledge users have expressed a need to better understand the methodologies and tools used in active surveillance, the quality and trustworthiness of the data generated from these approaches and the optimal context for active surveillance once products are approved and available on the market. The COVID‑19 pandemic has created a novel ‘testing’ ground for active surveillance approaches in health product effectiveness and safety. The urgency of the pandemic has also resulted in a number of patient treatment strategies that were implemented rapidly, and that may have been followed using active surveillance methods, or resulted in the development or adaptation of tools for collection of safety and effectiveness data. In this scoping review, we propose to review and clarify the state of knowledge for active surveillance approaches, tools and methods for evaluation of the benefits and harms of health products (drugs, biologics, health products) used for COVID-19. We will collect and synthesize research from the international community about: 1) the tools and methods used or proposed for active surveillance of the safety and effectiveness of health products used to treat COVID-19; 2) the capabilities and characteristics of these approaches; and 3) the quality and trustworthiness of the data collected. In addition, we will explore how approaches may have changed over the course of the pandemic, and/or with evolution of the understanding of COVID‑19 disease and treatment options. This review will provide valuable information as to how various active surveillance methods and tools can be optimized for use in post-market drug safety and effectiveness contexts, and inform potential use of relevant approaches in Canada.