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Introduction and Workshop Overview¹

Research conducted over the past two decades has shown that poor patient understanding of medication instructions is an important contributor to the more than 1 million medication errors and adverse drug events that lead to office and emergency room visits, hospitalizations, and even death (Bates et al., 1995; Budnitz and Layde, 2007; IOM, 2007; Sarkar et al., 2011; Vrijens et al., 2012). Patients who have limited literacy skills, who have multiple comorbidities, and who are elderly face the greatest risk, and limited literacy skills are significantly associated with inadequate understanding and use of prescription instructions and precautions (Davis et al., 2006a,b; Persell et al., 2007; Wolf et al., 2006). The Agency for Healthcare Research and Quality notes that only 12 percent of U.S. adults have proficient health literacy that allows them to interpret a prescription label correctly (AHRQ, 2014).

One cause for patient misunderstanding is that physicians often fail to communicate important elements of medication use when prescribing a new medication (Tarn et al., 2006, 2013). Confusing medication labels, a topic the Roundtable on Health Literacy has tackled previously (IOM, 2008; Wolf et al., 2006), and polypharmacy associated with patients having complex disorders or multiple chronic illnesses (Fialová and Onder, 2009;

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¹ The planning committee’s role was limited to planning the workshop, and the Proceedings of a Workshop was prepared by the workshop rapporteur as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, as they should not be construed as reflecting any group consensus.

Koper et al., 2013) also contribute to poor patient understanding of how to take medications properly.

Given the importance of health literacy to the proper use of medications, and the apparent lack of progress in improving medication adherence (NCPIE, 2013), the Roundtable on Health Literacy formed an ad hoc committee to plan and conduct a 1-day public workshop that featured invited presentations and discussion of the role and challenges regarding clarity of communication on medication. The Statement of Task for the committee (see Box 1-1) cited potential areas of focus to include using health literacy principles to address clarity of materials, decision aids, and other supportive tools and technologies regarding risks, benefits, alternatives, and health plan coverage. The goal of the workshop, said Bernard Rosof, chief executive officer of the Quality in Healthcare Advisory Group and roundtable chair, was to “contribute to efforts to communicate clearly by exploring the research that is currently ongoing and highlighting efforts to promote better communication.” In his introduction to the workshop, Rosof said there is a good reason for the roundtable to revisit the topic of health literacy as it pertains to the proper use of medication. “Medications, of course, are a vital component of health care and health care delivery, but when they are used incorrectly they can result in poor outcomes, injury, and often, death,” said Rosof. “Research has shown that almost half of all patients misunderstand one or more of their dosage instructions and slightly more than half misunderstand one or more warnings related to their medication. This misunderstanding does not necessarily reflect a failure on the part of patients or patients’ families or caregivers, but rather on the rest of us in the health care system, who fail to provide information clearly and simply

and take the time.” He added that communicating about medications with regard to risks, benefits, and adherence has the potential to greatly improve patient understanding, encouragement, and outcomes.

Rosof explained that the workshop included only one presentation on populations with limited English proficiency not because the roundtable or workshop planning committee failed to recognize the needs of these populations. Rather, this workshop focused primarily on materials in English because the U.S. Food and Drug Administration’s regulations governing drug-related materials focus on English-language speakers and because most of the research in this area has been centered on English speakers.

ORGANIZATION OF THE PROCEEDINGS

The workshop (see Appendix A for the agenda) was organized by an independent planning committee in accordance with the procedures of the National Academies of Sciences, Engineering, and Medicine. The planning committee’s members were Irene Chan, Terry Davis, James Duhig, Joan Guthrie Medlen, Laurie Myers, and H. Shonna Yin. This publication summarizes the workshop’s presentations and discussions, and it highlights some lessons, practical strategies, and needs and opportunities discussed by individual workshop participants for applying the principles of health literacy to the task of helping individuals understand how to use the medications they take. Chapter 2 provides the patient perspective on the challenge of understanding and following medication instructions. Chapter 3 describes the current landscape of research on written communications and various approaches to designing medication-related materials at a level appropriate for patients and caregivers. Chapter 4 presents several case studies illustrating how research findings are translated into practice. Chapter 5 discusses the future of health-literate design with regard to medication materials, and Chapter 6 recounts the roundtable members’ reflections on the day.

In accordance with the policies of the National Academies, the workshop did not attempt to establish any conclusions or recommendations about needs and future directions, focusing instead on issues identified by individual speakers and workshop participants. The proceedings should not be construed as reflecting any group consensus. In addition, the organizing committee’s role was limited to planning the workshop. The workshop proceedings was prepared by workshop rapporteur Joe Alper as a factual account of what occurred at the workshop.

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