Physician experiences with and perceptions of risk evaluation and mitigation strategy programs with elements to assure safe use.

ABSTRACT:

Purpose

The US Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require risk evaluation and mitigation strategy (REMS) programs for drugs with important safety concerns. REMS can have elements to assure safe use (ETASU), such as patient registries, dispensing restrictions, and physician training and certification requirements. We aimed to understand physician experiences with and perceptions of a selection of ETASU REMS.

Methods

Physicians prescribing 1 of 4 ETASU REMS-covered drugs: natalizumab, riociguat, sodium oxybate, and vigabatrin.

Study design

Descriptive phenomenological study based on semi-structured phone interviews.

Data collection/extraction methods

Qualitative content analysis to summarize physician responses to open

SUBMITTER: Sarpatwari A 

PROVIDER: S-EPMC10325060 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature