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Introduction

Tens of millions of people in the United States use prescription and over-the-counter (OTC) medications (FDA, 2009a). When consumers and patients use medications improperly, they risk illness, injury, and death. The Institute of Medicine (IOM) estimates that at least 1.5 million preventable adverse drug events occur within the health care system each year (IOM, 2007).

To reduce unnecessary adverse events resulting from inappropriate use of medications, the Food and Drug Administration (FDA) launched the Safe Use Initiative in November 2009 (FDA, 2009b). The goal of the Safe Use Initiative is to create and facilitate public and private collaborations within the health care community in order to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing, and evaluating cross-sector interventions with partners who are committed to safe medication use.

The IOM Roundtable on Health Literacy brings together leaders from the federal government, foundations, health plans, associations, and private companies to discuss challenges facing health literacy practice and research and to identify approaches to promote health literacy in both the public and private sectors. The roundtable also serves to educate the public, press, and policy makers regarding issues related to health literacy. The roundtable sponsors workshops for members and the public to discuss approaches to resolve key challenges.

The IOM Roundtable on Health Literacy has previously met and discussed standardization of drug labels as a patient-centered approach to



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1 Introduction Tens of millions of people in the United States use prescription and over-the-counter (OTC) medications (FDA, 2009a). When consumers and patients use medications improperly, they risk illness, injury, and death. The Institute of Medicine (IOM) estimates that at least 1.5 million prevent- able adverse drug events occur within the health care system each year (IOM, 2007). To reduce unnecessary adverse events resulting from inappropriate use of medications, the Food and Drug Administration (FDA) launched the Safe Use Initiative in November 2009 (FDA, 2009b). The goal of the Safe Use Initiative is to create and facilitate public and private collabora - tions within the health care community in order to reduce preventable harm by identifying specific, preventable medication risks and develop- ing, implementing, and evaluating cross-sector interventions with part - ners who are committed to safe medication use. The IOM Roundtable on Health Literacy brings together leaders from the federal government, foundations, health plans, associations, and pri - vate companies to discuss challenges facing health literacy practice and research and to identify approaches to promote health literacy in both the public and private sectors. The roundtable also serves to educate the public, press, and policy makers regarding issues related to health literacy. The roundtable sponsors workshops for members and the public to dis - cuss approaches to resolve key challenges. The IOM Roundtable on Health Literacy has previously met and dis - cussed standardization of drug labels as a patient-centered approach to 

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 THe SAFe USe InITIATIVe AnD HeALTH LITeRACY 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, pack - age 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 part- nerships 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 con - sensus committee report, a workshop summary may not contain conclu- sions 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 sum - marize 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.