(A-019) Patients’ and Caregivers’ Understanding of the Serious Risks of Opioid Analgesics and How to Use These Products Safely: A Patient/Caregiver Survey

Background: The Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program required by the US Food and Drug Administration for medications with safety concerns to support their safe access and use by patients.

Objectives: To assess patient and caregiver understanding and knowledge of the serious risks and safe use of opioid analgesics for acute and chronic pain management.

Methods: The study design consisted of a cross-sectional survey of patients with acute or chronic pain who currently or recently used prescription opioid analgesics and their caregivers to determine their knowledge regarding the serious risks and safe use of these products. Cognitive debriefing interviews were first conducted to assess and improve the survey tool. In 2023, adult commercially insured, Medicare Advantage, and Medicaid patients who filled a prescription for an opioid analgesic in the past 90 days and a small sample of their caregivers completed a survey that assessed the effectiveness of REMS documents (e.g., medication guide) by evaluating knowledge concerning six Key Risk Messages (KRMs): the serious risks, safe use, safe storage, and safe disposal of opioids, what to do if too much drug is taken, and not to share medication. A Knowledge Assessment Score (KAS) was calculated overall and for each KRM as the percentage of correct knowledge question answers. A KAS of ≥80% was considered successful knowledge of the REMS messages.

Results: A total of 1073 respondents (350 commercially insured, 350 Medicare Advantage, and 351 Medicaid patients and 22 caregivers) completed the survey. Most patients and caregivers (n=952, 89%) reported receiving the Medication Guide the last time they filled their opioid prescription. Fewer than half of patients and caregivers (n=444, 41%) reported that their healthcare provider discussed information in the Patient Counseling Guide when they were last prescribed their opioid analgesic.
Overall, patients and caregivers had a good understanding of the serious risks and safe use of opioid medications and correctly answered 79% of the knowledge questions. However, two KRMs had notably lower scores: only 56% of items in the KRM about what to do if too much drug is taken and 59% of items in the KRM about how to safely dispose of opioids were answered correctly.

Conclusions: This patient and caregiver REMS knowledge survey provided key insights concerning the knowledge of commercially insured, Medicare Advantage, and Medicaid patients and their caregivers about the serious risks and safe use of opioid analgesics. Four of the six KRMs were generally well-understood while improvements need to be made in knowledge on what to do if too much drug is taken, and in the safe disposal of opioid medication.