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Patients understand Risk Evaluation and Mitigation Strategy (REMS) drug risks but face challenges with prescriber access and administrative burdens. Improving care coordination and patient engagement can enhance REMS program effectiveness.

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Area of Science:

  • Pharmacovigilance
  • Health Services Research
  • Patient Experience

Background:

  • Risk Evaluation and Mitigation Strategy (REMS) programs are FDA-mandated interventions to manage drug risks.
  • These programs require specific actions like patient education and laboratory testing.
  • Understanding patient and caregiver perspectives is crucial for optimizing REMS effectiveness.

Purpose of the Study:

  • To explore patient and caregiver perceptions and experiences with REMS programs.
  • To identify challenges and facilitators in the implementation of REMS with elements to assure safe use.
  • To gather insights for improving REMS program design and delivery.

Main Methods:

  • Conducted semi-structured interviews with 135 patients or caregivers of patients using specific high-risk medications.
  • Participants used alemtuzumab, ambrisentan, clozapine, isotretinoin, lenalidomide, pegvaliase, or sodium oxybate.
  • Recruitment utilized patient registries, social media, and support groups.

Main Results:

  • Patients demonstrated knowledge of REMS risks and requirements.
  • Difficulties were reported in finding prescribers, especially for clozapine.
  • Administrative burdens caused frustration, mitigated by care coordination.
  • Pregnancy and clozapine testing presented emotional and logistical challenges.
  • Participants desired broader risk communication beyond REMS materials.

Conclusions:

  • While patients are knowledgeable about REMS, system-level improvements are needed.
  • Addressing prescriber access, administrative burdens, and care coordination can enhance REMS.
  • Improved patient engagement and communication regarding all drug risks are essential.