improving medication safety and health literacy (IOM, 2008). Discussions incorporated all components of the medication labels, including primary and secondary container labels, consumer medication information, package inserts, and medication guides as a system of information seamlessly engineered for patient understanding and safety.
The roundtable seeks to envision ways to advance meaningful partnerships and actionable goals that encourage a systems approach to patient-centered health literate drug safety. Building on prior activity in this area, a workshop was held April 27, 2010. The role of the workshop planning committee was limited to planning the workshop. Unlike a consensus committee report, a workshop summary may not contain conclusions and recommendations. Therefore, this summary has been prepared by the workshop rapporteur as a factual summary of what occurred at the workshop. The workshop featured presentations and discussions on the FDA’s Safe Use Initiative and other activities related to improving drug safety and drug labeling for both prescription and OTC medications. The workshop was moderated by George Isham. The following pages summarize the workshop presentations and discussions. Chapter 2 presents the FDA’s description of the Safe Use Initiative. Chapter 3 focuses on OTC products with data on OTC health literacy challenges. In Chapter 4, existing patient-centered drug safety initiatives are reviewed. Chapter 5 covers actions taken by the pharmaceutical industry, pharmacy groups, insurers, health plans, and consumer advocates. Chapter 6 follows with a general discussion including participants’ suggestions for FDA action to move the Safe Use Initiative forward.