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Introduction

Medications are an important component of health care, but each year their misuse results in over a million adverse drug events (ADEs)1 (IOM, 2007) that lead to office and emergency room visits as well as hospitalizations and, in some cases, death. As a patient’s most tangible source of information about what drug has been prescribed and how that drug is to be taken, the label on a container of prescription medication is a crucial line of defense against such ADEs, yet according to Michael Wolf of Northwestern University’s Feinberg School of Medicine, 46 percent of patients across all literacy levels misunderstand one or more dosage instructions and 54 percent misunderstand one or more auxiliary warnings that accompany those medications. To examine what is known about how medication container labeling affects patient safety and to discuss approaches to addressing identified problems, the Institute of Medicine Roundtable on Health Literacy organized a workshop, Changing Prescription Medication Use Container Instructions to Improve Health Literacy and Medication Safety, which was held on October 12, 2007.2

1

Adverse drug events are defined as harm or injury occurring from legal medication use and exclude intentional drug abuse or intentional self-harm or suicide attempts.

2

The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteur as a factual summary of what occurred at the workshop.



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1 Introduction Medications are an important component of health care, but each year their misuse results in over a million adverse drug events (ADEs) 1 (IOM, 2007) that lead to office and emergency room visits as well as hospitalizations and, in some cases, death. As a patient’s most tangible source of information about what drug has been prescribed and how that drug is to be taken, the label on a container of prescription medication is a crucial line of defense against such ADEs, yet according to Michael Wolf of Northwestern University’s Feinberg School of Medicine, 46 percent of patients across all literacy levels misunderstand one or more dosage instructions and 54 percent misunderstand one or more auxiliary warn- ings that accompany those medications. To examine what is known about how medication container labeling affects patient safety and to discuss approaches to addressing identified problems, the Institute of Medicine Roundtable on Health Literacy organized a workshop, Changing Prescrip- tion Medication Use Container Instructions to Improve Health Literacy and Medication Safety, which was held on October 12, 2007.2 1Adverse drug events are defined as harm or injury occurring from legal medication use and exclude intentional drug abuse or intentional self-harm or suicide attempts. 2 The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteur as a factual summary of what occurred at the workshop. 

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 stAndARdizing MediCAtion lABels THE WORkSHOP AgENDA The first part of the workshop consisted of four presentations designed to (1) describe problems in ambulatory care drug safety; (2) examine the role of health literacy in patient care; (3) present findings from the Ameri- can College of Physicians Foundation white paper on drug labeling; and (4) offer a proposal for standardization of drug labeling. The second part of the conference consisted of reactions to the four initial presentations by representatives from federal agencies, the pharmacy field, and other stakeholders, as well as discussion of what it would take to move towards standardization in drug labeling instructions. The workshop was moder- ated by George Isham, M.D., M.S., chair of the IOM Roundtable on Health Literacy.