Risk Evaluation and Mitigation Strategy (REMS) is a product safety plan required by USFDA which provides tools beyond the routine measures, such as prescribing information, warnings on product labels or prescription status, to ensure that benefits of certain products outweigh their risks. REMS comprises of specialized measures to curtail specific serious safety concerns related to few medications. REMS is supported with one or more elements such as, medication guide or patient package insert, communication plan, Elements to Assure Safe Use (ETASU). These elements can be complemented by an implementation system. Assessment of REMS can be done using both process and outcome indicators. Few challenges are associated with REMS starting from inception to development, implementation, tracking, assessment, and modification of the implemented REMS systems.
This article briefly summarises needs, components of REMS, assessment of REMS and challenges along with their solutions.