Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use.

ABSTRACT:

Importance

The US Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to impose safety requirements on drugs with important risks, such as prescriber certification or routine laboratory testing, to ensure that the benefits of use outweighed the risks. However, little is known about patient and caregiver experiences with these Risk Evaluation and Mitigation Strategy (REMS) programs with Elements to Assure Safe Use (ETASU).

Objective

To understand patient and caregiver experiences with and perceptions of REMS programs with ETASU.

Design, setting, and participants

This qualitative study included semistructured qualitative phone interviews conducted between 2016 and 2017, with initial analysis performed in 2017 and reanalysis performed in 2021. Ad

SUBMITTER: Sarpatwari A 

PROVIDER: S-EPMC8777595 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature