Poison Control Center Data
While the ASI-MV® and BHI-MV™ data streams provide early-warning examination of a high-risk, sentinel population, a complete picture of post-marketing abuse potential requires complementary data from a more general population. Consistent with the broad objectives of a full epidemiology program, poison control center data obtained from the National Poison Data System (NPDS) tap a broad, national data source that monitors poisoning events and collects information on exposures to substances, including prescription medications.
Inclusion of poison control center data meets the goals of the FDA guidance on post-marketing studies to provide meaningful measures of abuse and the impacts of abuse deterrent products within a general population-based sample, allowing examination of such clinically relevant outcomes for intentional exposures as death. Poison control center data provide additional context for interpretation of findings from the substance abuse treatment center data source.Request Consultation