Do Patients Understand Medication Guides? Survey Says: Sometimes

Patient awareness and use of medication guides

Do Patients Understand Medication Guides? Survey Says: Sometimes

Patient understanding of the risks associated with their medications is critical for safe and effective product use. As the number and complexity of medicinal products on the market increases, communication and education between healthcare professionals and patients becomes both more difficult and more important.

For products with greater than minimal risks, the FDA may require the creation and distribution of a Medication Guide, a product-labeling document designed to explain risk information to patients in layperson language. When there are more serious risks with a medication, the FDA may require a Risk Evaluation and Mitigation Strategy (REMS), of which the Medication Guide may be a component. REMS with Medication Guides typically include quantitative assessments of patients’ understanding of treatment-associated risks through periodic surveys of knowledge, attitude, and behavior (KAB).

The poster “Patient Awareness and Use of Medication Guides” presented at the ISPOR 20th Annual Meeting describes the collective results of KAB surveys that measured patient or caregiver understanding of risk information included in specific Medication Guides. Here are some of the findings:

  • 58.1%– 99.6% of patients reported receiving a Medication Guide with their medication. Those who reported not receiving the Medication Guide may have in fact not received it or may have received it, but did not realize they had. In either case, they were not able to read and process the information.
  • Of those who reported receiving a Medication Guide, 77% – 100% of patients reported they read at least some of the document.
  • 36.8% – 100% of patients reported understanding all or most of what they read in the Medication Guide; however, 60.2% – 91.5% of respondents were able to correctly answer questions pertaining to the information presented in the Medication Guide.

More than 75% of patients and caregivers who reported getting a medication guide reported reading some or all of it, indicating a desire to learn about their medication and its safety issues. For some products though, there is a discrepancy between reported understanding and demonstrated understanding, as measured by the correct response rate to key safety questions. This may be due to the style of communication or the contents of the message.

The factors acting as barriers to communication and comprehension must be investigated further in order to effectively manage medication risk. UBC’s robust Risk Management offering can support safety programs of all sizes from Medication Guide writing to designing and implementing REMS, including REMS with ETASU. Our experts have designed, implemented, or evaluated more than 100 REMS programs. Contact us to put our expertise to work for your product.