Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With...

Area of Science:

• Pharmacovigilance
• Drug Safety
• Regulatory Science

Background:

• The FDA Amendments Act of 2007 allows safety requirements for high-risk drugs.
• Risk Evaluation and Mitigation Strategy (REMS) programs with Elements to Assure Safe Use (ETASU) aim to ensure drug benefits outweigh risks.
• Patient and caregiver experiences with REMS ETASU programs are not well understood.

Purpose of the Study:

• To explore patient and caregiver experiences with REMS programs that include ETASU.
• To understand perceptions of REMS ETASU program requirements, education, and impact on treatment.

Main Methods:

• Qualitative phone interviews with patients and caregivers (2016-2017).
• Included patients prescribed natalizumab, sodium oxybate, vigabatrin, or riociguat.
• Assessed knowledge, decision-making, medication access, and privacy concerns.

Main Results:

• Most participants knew REMS requirements but not that they were FDA-mandated.
• Educational materials were often difficult to understand.
• REMS facilitated treatment initiation for some but created access burdens for others.
• Concerns were raised regarding manufacturer access to personal health information.

Conclusions:

• REMS ETASU programs can increase patient confidence and support treatment initiation.
• Improvements are needed in REMS educational material clarity and accessibility.
• Addressing medication access barriers and patient privacy concerns is crucial for REMS effectiveness.