Appendix C
ACP White Paper



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Appendix C ACP White Paper Improving Prescription Drug Container Labeling in the United States A Health Literacy and Medication Safety Initiative A White Paper Commissioned by the American College of Physicians Foundation Presented to the Institute of Medicine Roundtable on Health Literacy October 12, 2007  Appendic C Frontpiece

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0 stAndARdizing MediCAtion lABels REPORT PRESENTED ON bEHALF OF THE ACPF MEDICATION LAbELINg TECHNICAL ADvISORy bOARD Committee Co-Chairs: Michael S. Wolf, PhD, MPH Feinberg School of Medicine, Northwestern University Ruth M. Parker, MD Emory University School of Medicine Members: Carolyn Clancy, MD Agency for Healthcare Research and Quality Frank Frederico, RPh Institute for Healthcare Improvement Charles Ganley, MD Food and Drug Administration William H. Shrank, MD MSHS Brigham and Women‘s Hospital; Harvard Medical School Scott Smith, PhD PharmD Agency for Healthcare Research and Quality Roger Williams, MD U.S. Pharmacopeia Alastair Wood, MD Symphony Capital, LLC Albert Wu, MD MPH Johns Hopkins Bloomberg School of Public Health ACPF Staff: Robert L. Harnsberger, MBA, VP/COO American College of Physicians Foundation Jean A. Krause, EVP/CEO American College of Physicians Foundation Acknowledgments: John Swann, PhD Food and Drug Administration Diane Wendt Smithsonian Institution Special Thanks: Stacy Cooper Bailey, MPH Northwestern University Kara Jacobson, MPH Emory University

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 APPendiX C CONTENTS Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Prologue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Prescription Drug Container Labeling: A Medication Safety Concern . . 74 The Patient Perspective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 A Health Literacy Concern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Sources of Patient Prescription Medication Information . . . . . . . . . . 77 Health Literacy and Medication Safety . . . . . . . . . . . . . . . . . . . . . . . . 78 A Broken System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 The Prescriber. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 The Dispensing Pharmacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Health Information Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 A Brief History of Drug Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Early Attention to Drug Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Beyond the Bottle: The Learned Intermediary . . . . . . . . . . . . . . . . . . 88 The Modern Drug Container Label: Contents and Oversight . . . . . 89 Setting Standards: An Evidence-Based Drug Container Label . . . . . . . . 90 Specific Report Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

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 stAndARdizing MediCAtion lABels ExECuTIvE SuMMARy According to the Institute of Medicine (IOM) 2006 report, Preenting Medication errors, more than half a million adverse drug events (ADEs) occur in the United States each year in outpatient settings. Problems with prescription drug (Rx) labeling were cited as the cause of a large propor- tion of outpatient medication errors and ADEs, as patients may uninten- tionally misuse a prescribed medicine due to improper understanding of instructions. Recent health literacy research has highlighted the alarm- ingly high prevalence of patients misunderstanding seemingly simple instructions and warnings placed on Rx container labels. The elderly, those with limited literacy skills, and individuals managing multiple medication regimens were found to be at greater risk for making errors in interpreting container label instructions. The ability to understand Rx container label instructions is critical, both as health literacy and medication safety concerns. This is especially true since other sources of patient medication information are insufficient. Prior studies have found that physicians and pharmacists frequently miss opportunities to adequately counsel patients on newly prescribed medicines. Other supplementary sources, such as patient information leaflets and Medication Guides dispensed with the prescribed medicine are too complex and written at a reading level unsuitable for the majority of patients to comprehend. As a result, these materials are often ignored. While all of these sources are best viewed as a system of patient informa- tion, the Rx container label is particularly important as it is often the sole source of specific instructions received and repeatedly used by patients on how to self-administer medicines. Despite its potential value, there are clear problems with Rx container labels. Minimal standards and regulations exist regarding their content and format, and Rx labels can vary by dispensing pharmacy. Specific dosage instructions on the container label are dependent on what the prescribing physician writes, as well as how the pharmacist interprets these instructions. While the format and content of Rx container labels may differ between and within local and national pharmacies, all share the common attribute of being unnecessarily complex and not offering a patient-friendly interface. Instead, the greatest emphasis is placed on provider-directed content. This report reviews in detail the problem with Rx container labels in the United States. The “best practices” in drug container labeling are sum- marized. Recommendations are offered to guide medical and pharmacy practice, and related state and federal policy. The overall objective of this paper is to move forward a set of evidence-based, Rx container label stan- dards that will minimize patient confusion and promote patient aware-

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 APPendiX C TAbLE 1 Primary Findings Finding 1 Inadequate patient understanding of prescription medication instructions and warnings is prevalent and a significant safety concern. Finding 2 Lack of universal standards and regulations for medication labeling is a “root cause” for misunderstanding and medication error. Finding 3 An evidence-based set of practices should guide all label content and format. Finding 4 Instructions for use on the container label are especially important for patients and should be clear and concise. Language should be standardized to improve patient understanding for safe and effective use. Finding 5 Drug labeling should be viewed as part of an integrated system of patient information. Improvements are needed beyond the container label, and other sources of consumer medication information should be targeted. Finding 6 Health care providers are not adequately communicating to patients, either orally or in print, about prescribed medicines. More training is needed to promote best practices for writing prescriptions and counseling patients. Finding 7 Support is necessary for research on drug labeling and to identify “best practices” for patient medication information. ness of how to use a prescribed medicine safely and effectively, thereby reducing risk of medication error. PROLOguE Since 2002, the American College of Physicians Foundation (ACPF) has sought to address the problem of limited health literacy by develop- ing initiatives to mitigate the impact of this highly prevalent problem on health outcomes. The issue of inconsistent and confusing medication information and labeling soon became a primary target of the ACPF health literacy agenda. A few projects were commissioned by the ACPF, and informal activities were spearheaded to engage experts and stake- holders from academia, industry, and government. In September 2006, a meeting was held in Washington, D.C. to discuss the ACPF’s medication labeling initiatives and to suggest next steps for ACPF. The overall objec- tive of the meeting was to consolidate an understanding of the broad problem of inadequate patient understanding of medication labels, and to identify a specific course of action to improve drug labeling in the United States. The meeting served as a timely response to Institute of Medi- cine (IOM) reports, released in July and September 2006, which targeted medication error and drug safety, respectively. Participants at this meeting included national experts in health literacy, patient safety, pharmacology,

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 stAndARdizing MediCAtion lABels and pharmacy policy and practice. The Agency for Healthcare Research and Quality (AHRQ), the Institute of Medicine (IOM), and the Food and Drug Administration (FDA) were represented. Participants reviewed the nature and extent of the problems surround- ing medication labeling, particularly for prescription drugs. Summaries were provided from the July 2006 IOM report, Preenting Medication errors, the FDA over-the-counter (OTC) consumer education initiatives, an ACPF-commissioned medication labeling systematic literature review, and recent health literacy research studies. Herein, this white paper pres- ents the ACPF perspective on the current prescription medication con- tainer labeling system, with a focus on improving the format, content, and dosage and use instructions on the container label. PRESCRIPTION DRug CONTAINER LAbELINg: A MEDICATION SAFETy CONCERN Patient safety remains one of the most important objectives for health care providers and organizations.1-5 Medication errors, in particular, are the most common form of mistakes that lead to patient injury, hospitalization, and death.6-19 According to the recent IOM report, Preenting Medication errors, approximately 1.5 million preventable adverse drug events occur each year; more than one third of these take place in outpatient settings at a cost approaching $1 billion annually.20 Both physicians and patients identify this as an area of serious concern, as a growing number of adults self-administer prescription medicines each year. Errors in ambulatory care are likely to increase as patients are self-managing a greater number of prescription and over-the-counter (OTC) medications. Two thirds of all adults use prescription drugs, representing 16 percent ($73 billion) of all health care expenditures.21 According to the Medical Expenditures Panel Survey (MEPS), the average number of prescription medications filled annually by adults in the United States increased between 1996 and 2003 from 7 to 10 prescriptions. Among adults over 65 years of age, the average number of prescriptions filled increased from 19 to 27 medicines during this same time period.21 Further complicating the problem, elderly patients are cared for by an average of 8 different health providers, each of whom may use different instructions for the same dosing frequencies. A clear understanding of the existing failures has therefore been sought to reduce the potential for costly errors in the future. There is a limited body of evidence detailing the possible causes of outpatient medication error. Attention to the causes of error has most often been directed to the role of the health care provider or the system in caus- ing errors during the prescribing, ordering, dispensing or administering of a medicine.1 This may be an appropriate focus for inpatient hospital or

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 APPendiX C nursing home settings, where most studies investigating medication error have been conducted.15-19 However, studies estimate that many outpatient medication errors occur when patients themselves fail to administer a medicine as intended.6,7,13,14,22,23 For ambulatory care, the patient, rather than the provider, is ultimately responsible for correctly administering a medicine as prescribed. In this setting, the processes of quality control and monitoring of medication use shift from provider to patient.14 Given the formative role patients must play in promoting medication safety in outpatient settings, it is instructive to understand current pro- cesses that can help an individual learn how to use prescribed medicines appropriately. These include both verbal and written communication about taking medication; it is the tangible, written sources that comprise drug container labeling that are of special interest to this report. Figure 1 provides a breakdown of what specifically is meant by the broader term of “drug labeling.” The prescription container label warrants special atten- tion, as it often may be the only prescription drug information seen and used repeatedly by patients. As this report will detail, container labels for prescription drugs have been undervalued and neglected, despite their critical importance in conveying instructions for use to patients. On the Bottle Medication Guides Package Inserts Patient Information Leaflets FIguRE 1 Components of drug labeling.

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 stAndARdizing MediCAtion lABels THE PATIENT PERSPECTIvE The past 100 years have led to a fractured system of delivering ade- quate assurances of instructions for safe and effective use of prescription drugs to patients. In the past decade, the health literacy movement in the United States has placed greater attention on the responsibility of the health care system to support patients‘ ability to read, understand, and act on health information. Health literacy emphasizes the unique value of container labeling for prescription drugs as a patient source of essential health information, vital for drug safety and efficacy. A Health Literacy Concern Recent studies have highlighted limited health literacy as a potential risk factor for higher rates of outpatient medication error that are the result of improper dosing administration.20,22,24 Health literacy, as defined by the IOM report A Prescription to end Confusion and accepted by the National Library of Medicine, is the “degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”24 An esti- mated one third to one half of adults in the United States—as many as 90 million Americans—possess limited health literacy skills, and may have trouble understanding and acting on health materials. Information in less familiar print contexts, such as prescription container labels, may be con- fusing and more difficult to comprehend for less literate patients. 25 According to the National Assessment of Adult Literacy (NAAL) of 2003, 14% of U.S. adults possess skills in the lowest level of prose and document literacy (“below basic”), and 22% are at the lowest level for quantitative literacy.25 These individuals can perform only the most simple, concrete tasks associated with each of these domains. However, those with only ”basic” literacy proficiency have limited abilities and are likely to be hindered in routine daily activities. Considering individuals with basic and below basic skills combined, as many as 34% to 55% of adults in the U.S. have limited literacy skills. Estimates are significantly higher among the elderly; 60% of individuals over the age of 65 have limited levels of prose and document literacy.25 Yet reading fluency and the full range of literacy skills are likely to vary with an individual‘s familiarity with the content of the text.26-28 Health materials and encounters often use difficult and unfamiliar medi- cal terms.29 Therefore, the estimates of limited health literacy using the NAAL general literacy assessment may underestimate the problem. As a response to this concern, the NAAL 2003 included a health literacy assess- ment designed to measure respondents’ abilities to locate and understand health-related information and services. The health literacy assessment

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 APPendiX C reported average health literacy scores on a scale of 100 to 500, with 500 representing the highest possible score. The assessment also reported results by grouping respondents with similar scores into performance levels based on health literacy ability. The performance levels designated by the assessment were: below basic, basic, intermediary, and proficient.30 Results from the health literacy assessment showed the average health literacy scores of Americans to be lower than the average general literacy scores of adults, as measured by the NAAL. Those over 65 years of age had a health literacy mean score of 214 (the lowest average score; thresh- old between below basic and basic proficiency) compared to a mean score of 256 for adults between the age of 25 and 39 (the highest average score).30 The conclusion remains the same: millions of U.S. adults—espe- cially the elderly—lack the health literacy skills that enable them to effec- tively use complex health materials and accomplish more challenging health-related tasks. Sources of Patient Prescription Medication Information The IOM Health literacy report emphasized that the problem of limited health literacy cannot be viewed solely as a patient issue.24 Rather, health literacy is a duality, reflecting both individual capability and the complex- ity of demands placed upon the individual by the health care system. This perspective is equally valid for medication labeling in the United States. While patients must have cognitive capacity and proficiency to read and understand labels, and apply dosage/usage instructions for proper medicine-taking behaviors, the manner in which the current health care system delivers necessary medication information to patients is inad- equate. Understanding the sources available to patients and their deficits provides for a comprehensive picture of current health system failures and remedies. The existing continuum of sources of patient medication information begins at the moment a prescription is issued to the patient by the physician (see Figure 2). Physicians, with legal responsibilities to deliver instructions on proper medication use, have repeatedly been found to be ineffective in this role.31-35 Research has shown physicians frequently miss opportunities to counsel their patients on how to self- administer their medicines.31,34 Health literacy studies have also high- lighted that many physicians do not communicate health and treatment information in a manner that can be understood by patients with limited literacy skills.36-38 Written prescriptions will be passed on to patients, yet these are typically written with unfamiliar shorthand, often in Latin, and therefore of little use to patients.1,39,40 If the patient leaves the physician office without the knowledge needed to correctly implement the prescribed regimen, the pharmacist,

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 stAndARdizing MediCAtion lABels CMI = Consumer Medication Information; PPI = Patient Package Insert FIguRE 2 Sources of patient medication information. NOTE: CMI = Consumer Medication Information; PPI = Patient Package Insert. C-2 at the point of dispensing medicines, would be next in line to counsel patients. Studies have shown that pharmacists also often fail to orally communicate detailed information to patients to support their adherence with prescribed regimens.32,33,35 The last opportunity for counseling is the container label and accompanying print materials (container label, patient package inserts, consumer medication information, Medication Guides), which have been found to be long, complex, and written at a level too difficult for a majority of patients, regardless of literacy level, to comprehend and use.38,42-46 Without accurate and available formal sources of information, indi- viduals may seek out informal sources to learn about their medicines. Informal sources might include social networks (family, informal care- givers, friends), the internet and other reference materials. No assurances can be made to the quality, accuracy, or readability of the information provided within these sources, as their content is not regulated. 41,42,47-49 Health Literacy and Medication Safety Numerous studies have found limited health literacy to be signif- icantly associated with a poorer understanding of medication names,

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 APPendiX C indications, and instructions.50-59 More recently, health literacy skills have been linked to requisite knowledge necessary for adherence to treatment regimens.22,23,60 Recently, health literacy was specifically identified within a seminal report released by the National Council for Patient Information and Education (NCPIE).61 The report refers to health literacy as a national concern with regard to patient understanding, safe use, and proper adher- ence to medication regimens.61 A current and well-publicized body of research has focused on the ability of patients to read, understand, and demonstrate instructions on prescription medication container labels.22,23 This line of inquiry has also been supported by parallel work in human factors research, which has more broadly investigated similar measures, mostly among the elderly.62-68 Davis et al. conducted a multi-site study among adults receiving primary care at community health centers and found a high prevalence of patients, especially those with limited literacy, misunderstanding seemingly simple dose instructions provided on the primary label of medication contain- ers.22 In this study, 46% of adults misunderstood at least one prescription container label they encountered. The problem extends to the auxiliary sticker labels that provide accompanying warnings and instructions for use of the medicine (see Figure 2).23,60 Other studies demonstrated that over half (53%) of patients, especially those with limited literacy, had dif- ficulty interpreting text and icons commonly used on auxiliary warning instructions.23 Beyond the container label, another recent study also found accompa- nying medication information materials that provide indications for use and precautions are not useful for most patients, particularly those with limited health literacy.46 This includes consumer Medication Guides that are required by the FDA to accompany certain prescribed medicines that have been identified as having serious public health concerns.69-75 Patients with limited health literacy were significantly more likely to report not having reviewed these materials. These findings are supported by earlier research studies that suggested consumer medication materials are too difficult for many patients to read.76-77 As a result, the patient information leaflets that accompany many prescription medications may be ignored. Patients with limited health literacy may possess less knowledge of how to take their medicines not only as a result of difficulty with medicine labeling, but due to more limited interactions with health care providers and use of fewer alternative sources of informational support (i.e., inter- net, reference guides).78 Prior research found patients with limited literacy skills to be more likely to report their physician as their sole source of health information, including for medicines taken for a chronic disease. Individuals with limited literacy are also less likely to seek out informa- tion or ask for clarification during medical encounters as a result of feel- ings of shame and concern over stigma for their poor reading ability. 79-81

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0 stAndARdizing MediCAtion lABels State boards of pharmacy may impart their own additional standards for container label content and format. To date, only minimal regulations have been added by states, although enough to require national pharmacy chains to generate 31 different label styles across the 50 states. Without explicit FDA regulatory guidance, it still remains unclear what constitutes “adequate” label instructions and warnings according to the FDCA for the more than 13,000 FDA-approved prescription medicines in use today. With the recent dominance of direct-to-consumer advertising and the 1999 ruling in Perez v. Wyeth Laboratories, Inc., the pharmaceuti- cal industry has had to assume greater liability to directly warn consum- ers, beyond the learned intermediary, of any potential risks associated with using a particular medicine.91 Such risks have usually been conveyed through the prescriber’s insert (for providers) and CMI (for patients), and not directly on the container label, due to space issues. With limited space on the primary container labels which detail dosage/use instructions, auxiliary “warning” stickers had been included with bottles as early as the late 1950s. These secondary container labels provided special instructions and precautions, often given orally to patients by the pharmacist, to support safe patient administration. How- ever, no regulations have existed regarding the use of these auxiliary stickers either. Despite the potential value of these stickers, the accuracy of the specific instructional and/or precautionary messages has not been confirmed through any systematic process derived in pharmacological evidence. SETTINg STANDARDS: AN EvIDENCE-bASED DRug CONTAINER LAbEL While limited, there is evidence available to detail “best practices” for improving dosage/usage instructions written by the prescribing phy- sician, and the format and content of prescription medication container labels designed by the dispensing pharmacy.95 Perhaps most importantly, the use of standard and more explicit dosage/usage instructions can improve patients’ functional understanding of how and when to take a medicine (i.e., take two tablets by mouth twice daily vs. take 4 tablets a day vs. take 2 tablets in the morning, and take 2 tablets in the evening).22 Shrank and colleagues summarized known evidence for best practices in labeling format and content, such as: increasing font size, using clear and simple language, using headers, and placing a more appropriate empha- sis on organizing label content around what is most important for patients (i.e., drug name, dose, dosage/usage instructions, patient name, doctor name, quantity, refill information) instead of the provider content (i.e., pharmacy name/logo, phone number, national drug code number). 95

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 APPendiX C The field of health literacy also offers appropriate recommendations on how best to present print medication information to lower literate audiences. For instance, sans serif font should be used, avoidance of all capital letters for words and phrases, and using numbers instead of the text equivalent (i.e., 2 instead of “two”).22,95 When possible, text should be as large as 12 point font to display patient dosage/usage instructions. Icons for drug warnings have previously been found to be confusing for many older patients and those with limited literacy skills, and should be minimized in practice. A complete list of evidence-based, recommended standards for format, content, and instruction is detailed in Table 3. TAbLE 3 Description of Standards for an Enhanced Rx Container Label Proposed Standard Description 1. Use explicit text Dosage/usage instructions must clearly separate dose to describe dosage/ from interval, and provide the explicit frequency of the interval in instructions. drug (i.e. “take 4 tablets each day. Take 2 tablets in the morning, and 2 tablets in the evening“ vs. “take two tablets by mouth twice daily“). These explicit dose/use instructions will be standardized by the pharmacy to avoid physician variability for the same dose frequency. 2. Use a universal A universal medication schedule (“UMS“) can help medication schedule patients identify and support the explicit text dosage/ (UMS) to convey and usage instructions, following a familiar format to cue simplify dosage/use patients (i.e. a pill organizer external aid; with standard instructions. intervals for taking medicines: breakfast, lunch, dinner, bedtime). 3. Organize label in Patient-directed information must be organized in a a patient-centered way that best reflects how most patients seek out and manner. understand medicine instructions. Patient-directed content will be at the top of the label, while provider-directed content will be placed at the bottom of the label. Drug name and specific dosage/usage instructions will be placed in greatest prominence. 4. Include distinguish- The Rx container label should have two distinct sides— able front and back a front (primary) and back (auxiliary) side on the bottle. sides to the label. The primary label will contain patient information (drug name, dose, dosage/usage instructions, patient name, doctor name, quantity, refill information) and provider content (pharmacy name/logo, phone number, national drug code #). The back should contain all appropriate warning and instruction messages and icons, supplanting the use of stickers. continued

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 stAndARdizing MediCAtion lABels TAbLE 3 Continued Proposed Standard Description 5. When possible, While Rx approval status and confidentiality may limit include indication for inclusion of indications for use, prior studies suggest this use. is very helpful to patients. 6. Simplify language, Language on the label, will avoid the use of unclarified avoiding unfamiliar medical jargon, and common terms and sentences will be words/medical jargon. used only. While readability formulas and software are not recommended for short excerpts of text such as what is included on Rx labels, the principles established by the Suitability Assessment of Materials by Doak, Doak, and Root for maintaining simple language can guide the simplification process. Feedback should also be sought from consumers. 7. Improve typography, A standard for minimum font size (12 pt) will be set for use larger, sans serif patient name, drug name, and specific dosage-usage font. instructions (both in text and in matrix). Health literacy and adult education researchers recommend the use of Sans-Serif font (i.e. Arial) to more clearly present print text information to new adult learners. Patient information on front and back labels will be 12 pt font. Use of all capital letters should be avoided; the first letter of words in text will be capitalized only. 8. When applicable, use Our recent research efforts (see Section C), and a prior numeric vs. alphabet study, provide evidence that presenting numbers instead characters. of the text equivalent (i.e. 2 vs. two) was more helpful to patients for understanding and more rapidly processing dosage/usage instructions. 9. Use typographic Bolding and highlighting will be used for patient- cues (bolding and centered information only. Drug name and dose will be highlighting) for patient highlighted, dosage/usage instructions bolded. content only. 10. Use horizontal text Several national pharmacy chains place text for warning only. and instruction messages vertical to the Rx label; requiring the patient to turn the bottle to read. This may create further difficulty among older adults. Only include horizontal text on the label. 11. Use a standard icon Work towards a standard set of icons, or consider a system for signaling single icon to flag patients that a warning exists for the and organizing prescribed medicine. Warnings will use 12 point font. auxiliary warnings and instructions.

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 APPendiX C Current FDA Over-The-Counter (OTC) product labeling standards may provide additional guidance to future strategies to be taken with prescription medications. OTC products, such as “Drug Facts,” have already been developed with health literacy considerations in mind, uti- lize a standard format, and have been marketed to the public, increasing their familiarity and usability. While not all OTC labeling standards are applicable for prescription medicines, patients would likely benefit from a more familiar and consistent format, especially if this could extend to dosage/usage instructions. SPECIFIC REPORT FINDINgS Ideally, medication labeling should be viewed as a system of infor- mation, with key components communicated to the prescriber, the dis- penser, and ultimately to patients. The work of this group has used the lens of health literacy to target patients’ critical need for clear and concise prescription medication instructions to support safe and effective use. Based on the evidence and potential impact for reducing confusion that may lead to medication error, standardization of the container label’s content and format, including dosage instructions, is proposed as a pri- mary evidence-based finding that the committee viewed as necessary for resolving the current prescription labeling problem. It is anticipated that several measures will be required to address the development of low literacy-appropriate patient information leaflets and Medication Guides, and provider education and training programs to increase medication counseling and best practices for writing prescriptions. The findings of this report support the exploration into a standard label format that may potentially include set key intervals (i.e., morning, noon, evening, bedtime) that can most precisely identify dose frequency. Currently, preliminary research activities are under way by members of the committee to investigate the efficacy of a matrix visual aid on the container label to improve patient comprehension of dosage instructions. However, before this or any other standards can be recommended, per- spectives from pharmacology, pharmacy and from prescribing clinicians should be sought. More research is needed to support future actions to be taken with regard to prescription medication labeling, and all modifica- tions to the existing labeling format should be properly evaluated. The Committee concluded with the following findings: 1. Inadequate patient understanding of prescription medication instruc- tions and warnings is prevalent and a significant safety concern. Health literacy research has highlighted the high prevalence of patient misunderstanding of dosage instructions and auxiliary warn-

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 stAndARdizing MediCAtion lABels ings placed on Rx container labels. The elderly, those with limited literacy, and individuals managing multiple medication regimens are at greater risk for misinterpreting prescription instructions. 2. Lack of universal standards and regulations for medication labeling is a “root cause” for medication error. More than a third of all reported adverse drug events occur in ambulatory care settings, where patients primarily assume quality control over prescription medication admin- istration. Patient misuse is a common occurrence, and the clarity and complexity of medication dose/use instructions varies greatly by dispensing pharmacy. State and federal agencies involved in con- sumer medication information and labeling are not united in efforts to provide regulatory guidance. 3. An evidence-based set of practices should guide all label content and format. A major problem for prescription drug labeling relates to con- tent inclusion. Efforts need to be directed at minimizing information placed on the label container, particularly auxiliary instructions sup- porting the safe use of the product. Only warnings and instructions that are supported by pharmacological evidence, or that are otherwise thought to significantly aid the patient in self-administration should be placed on the label. If a warning or instruction message is to be recommended for a specified drug to be on the container label, then it should be required. This would limit the existing variability between and within pharmacies. 4. Instructions for use on the container label are especially important for patients and should be written in the most clear, concise manner. Lan- guage should be standardized to improve patient understanding for safe and effective use. Variability and confusion regarding prescrip- tion drug label dosage/usage instructions is especially problematic. While auxiliary warning and instructions may vary by pharmacy, the actual instructions for dosage and use for a medicine will often vary by prescribing physician. Explicit instructions that segregate dose (number of pills to be taken at one time) from frequency (number of times per day) are more helpful to patients. Standardized, evidence- based dosage/usage instructions with limited variability would pro- vide patients with more useful information, and offer improved drug safety for patients. A universal medication schedule would further simplify medication-taking behavior. 5. Drug labeling should be viewed as an integrated system of patient information. Improvements are needed beyond the container label, and other sources of consumer medication information should be targeted. Consumer-directed materials that accompany the pill bot- tle container currently do not meet acceptable standards set for the design of health information for patients with limited literacy skills.

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 APPendiX C Medication Guides, patient information leaflets, and other supple- mentary sources of medication information should follow the same patient-oriented schema for presenting content as the container label, and be simplified following current health literacy principles. Patients need to be involved in the re-design of these materials, and consider- ations of re-design should focus on all the components of the label as a system of information. 6. Health care providers are not adequately communicating to patients, either orally or in print, for prescribed medicines. More training is needed to promote best practices for writing prescriptions and coun- seling patients. Physicians, nurses, physician assistants and pharma- cists have previously been reported as missing opportunities to ade- quately counsel patients on how to administer prescribed regimens. While recent FDA actions mandate content in the package insert to aid providers on what to convey to patients about specified medicines, additional training and quality improvement efforts are needed to ensure the occurrence of these practices. 7. Research support is necessary to advance the science of drug label- ing and identify “best practices” for patient medication information. Ultimately, funds should be allocated to support research that can systematically review the scientific evidence and detail the neces- sary content for inclusion on prescription container warning labels and supplementary patient medication information materials. Like- wise, health services and human factors research is needed to test new labeling strategies that incorporate known “best practices” and determine whether the changes can improve patient understanding, behaviors, and even health outcomes. CONCLuSION The ACPF Medication Labeling Technical Advisory Board has pro- posed several changes for prescription drug labeling, perhaps most notable being that dosage/usage instructions on the container label be a critical and primary focus for establishing clear standards. The impor- tance of the container label should be reiterated as the most tangible and repeatedly used source of prescription drug instructions for use. In fact, it may be the “last line” of informational support on how and when to take a prescribed medicine. The Advisory Board agreed that prescription medication labeling should be viewed as a system of information, and additional efforts must also seek to standardize and improve labeling beyond the primary prescription container label. It is anticipated that this report will engage policymakers, research- ers, and clinicians to work toward an integrated and standard system

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 stAndARdizing MediCAtion lABels of patient medication information. The IOM report Preenting Medica- tion errors issued a call to action to improve patient-directed medication information, including labeling and provider-patient communication. To go one step beyond the report, an agenda should be detailed that targets the prescription drug container label, and then works to integrate other formal information sources. Lessons from both the field of health literacy and human factors design should be observed. Above all, lessons from the field of health literacy underscore the need for this work to be done with patients as partners in the process, ensuring the best deliverables possible. REFERENCES 1. Institute of Medicine. To err is human: Building a safer health system. Kohn L, Corrigan J, Donaldson M, editors. Washington, D.C.: National Academy Press; 2000. 2. Altman DE, Clancy C, Blendon RJ. Improving patient safety—five years after the IOM report. N Engl J Med 2004; 351: 2041-3. 3. Blendon RJ, DesRoches CM, Brodie M, Benson JM, Rosen AB, Schneider E, et al. Views of practicing physicians and the public on medical errors. N Engl J Med. 2002; 347: 1933-40. 4. Vincent C. Understanding and responding to adverse events. N Engl J Med 2003; 348:1051-6. 5. Leape LL. Reporting of adverse events. N Engl J Med 2002; 347:1633-8. 6. Elder NC, Dovey SM. Classification of medical errors and preventable adverse events in primary care: a synthesis of the literature. J Fam Pract 2002; 51: 927-32. 7. Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, Burdick E, et al. Adverse drug events in ambulatory care. N Engl J Med 2003; 348: 1556-1564. 8. Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger A, et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA 2003; 289: 1107-1116. 9. Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med 2003;138: 161-7. 10. Hammons T, Piland NF, Small SD, Hatlie MJ, Burstin HR. Ambulatory patient safety. What we know and need to know. J Ambul Care Manage 2003; 26:63-82. 11. Gandhi TK, Burstin HR, Cook EF, et al. Drug complications in outpatients. J Gen Intern Med 2000; 15:149-54. 12. Dovey SM, Meyers DS, Phillips RL, et al. A preliminary taxonomy of medical errors in family practice. Qual Saf Health Care 2002; 11:233-8. 13. Plews-Ogan ML, Nadkarni MM, Forren S, Leon D, White D, Marineau D, et al. Patient safety in the ambulatory setting. A clinician-based approach. J Gen Intern Med 2004; 19:719-25. 14. Budnitz DS, Layde PM. Outpatient drug safety: new steps in an old direction. Pharma- coepidemiol Drug Saf; 2007; 16: (2) 160. 15. Bates DW, Spell N, Cullen D, Burdick E, Laird N, Peterson L, et al. The costs of adverse drug events in hospitalized patients. JAMA 1997; 277:307-311. 16. Poon EG, Cina JL, Churchill W, Patel N, Featherstone E, Rothschild JM. Medication dispensing errors and potential adverse drug events before and after implementing bar code technology in the pharmacy. Ann Intern Med 2006; 145:426-34.

OCR for page 69
 APPendiX C 17. Barker KN, Flynn EA, Pepper GA, Bates DW, Mikeal RL. Medication errors observed in 36 health care facilities. Arch Intern Med 2002;162:1897-903. 18. Barker KN, Mikeal RL, Pearson RE, Illig NA, Morse ML. Medication errors in nursing homes and small hospitals. Am J Hosp Pharm 1982; 39: 987-91. 19. Gurwitz JH, Field TS, Judge J, Rochon P, Harrold LR, Cadoret C, et al. The incidence of adverse drug events in two large academic long-term care facilities. Am J Med 2005; 118:251-8. 20. Institute of Medicine. Preventing Medication Errors. Aspden P, Wolcott J, Bootman L, Cronenwett LR (eds). Washington D.C., National Academy Press, 2006. 21. Medical Expenditure Panel Survey [on-line]. Available at http://www.meps.ahrq.gov. Accessed January 3, 2007. 22. Davis TC, Wolf MS, Bass PF, Tilson H, Neuberger M, Parker RM. Literacy and misun- derstanding of prescription drug labels. Ann Intern Med 2006; 145: 887-94. 23. Davis TC, Wolf MS, Bass PF, Middlebrooks M, Kennan E, Baker DW, Bennett CL, Durazo-Arvizu R, Savory S, Parker RM. Low literacy impairs comprehension of pre- scription drug warning labels. J Gen Intern Med 2006; 21: 847-851. 24. Institute of Medicine. Health Literacy: A prescription to end confusion. Nielsen- Bohlman L, Panzer A, Kindig DA, editors. Washington, D.C., National Academy Press 2004. 25. Kutner M, Greenberg E, Baer J. A first look at the literacy of America‘s adults in the 21st century. National Center for Education Statistics, U.S. Department of Education, 2005. 26. Baker DW. The meaning and the measure of health literacy. J Gen Intern Med 2006: 21: 878-883. 27. DeWalt DA, Pignone MP. Reading is fundamental: the relationship between literacy and health. Arch Intern Med 2005 Sep 26;165(17):1943-4. 28. Rudd RE, Renzulli D, Pereira A, Daltroy L. Literacy demands in health care settings: the patient perspective, in Schwartzberg JG, VanGeest JB, Wang CC (eds.): Understanding health literacy: Implications for medicine and public health. Chicago, IL, AMA Press, 2004, pp. 69-84. 29. Castro CM, Wilson C, Schillinger D. Babel- should this Babble? Babble: Physicians’ use of unclarified medical jargon with patients who have type 2 diabetes and limited health literacy. In press- still in press?, Am J Health Behav 2007. 30. Kutner, M., Greenberg, E., Jin, Y., & Paulsen, C. (2006). The Health Literacy of America‘s Adults: Results from the 2003 National Assessment of Adult Literacy (NCES 2006- 483). U.S. Department of Education. Washington, DC: National Center for Education Statistics. 31. Tarn DM, Heritage J, Paterniti DA, Hays RD, Kravitz RL, Wenger NS. Physician com- munication when prescribing new medications. Arch Intern Med 2006; 166:1855-62. 32. Morris LA, Tabak ER, Gondel K. Counseling patients about prescribed medications: 12-year trend. Med Care 1997; 35: 996-1007. 33. Metlay JP, Cohen A, Polsky D, Kimmel SE, Koppel R, Hennessy S. Medication safety in older adults: home-based practice patterns. J Am Geriatr Soc 2005; 53: 976-982. 34. Sleath B, Roter D, Chewning B, et al. Asking questions about medication: analysis of physician-patient interactions and physician perceptions. Med Care 1999; 37:1169-73. 35. Stevenson FA, Cox K, Britten N, et al. A systematic review of the research on commu- nication between patients and health care professionals about medicines: the conse- quences for concordance. Health Expect 2004; 7: 235-45. 36. Schillinger D, Piette J, Grumbach K, Wang F, et al. Closing the loop: Physician commu- nication with diabetic patients who have low health literacy. Arch Intern Med 2003:163: 83-90.

OCR for page 69
 stAndARdizing MediCAtion lABels 37. Weiss BD, Coyne C, and Michielutte, R., et al. Communicating with patients who have limited literacy skills: Consensus statement from the National Work Group on Literacy and Health. J Family Practice 1998, 46:168-176. 38. Davis TC, Williams MV, Branch, Jr., WT, Green KW. Explaining illness to patients with limited literacy. In: Whaley, Bryan B. (ed.). Explaining Illness: Research, Theory, and Strategies. Mahway, New Jersey: Larence Erlbaum Associates, 2000: 123-146. 39. Dunn EB, Wolfe JJ. Let go of Latin! Vet Hum Toxicol 2001; 43: 235-6. 40. Wolf MS, Shrank WH, Choudry NK, Agnew-Blais J, Parker RM, Shekelle P. Variability in Pharmacy Interpretations of Physician Prescriptions. Under review, Journal of Gen- eral Internal Medicine. 41. Wallace LS, Roskos SE, Weiss BD. Readability characteristics of consumer medication information for asthma inhalation devices. J Asthma 2006; 43:375-8. 42. Wallace LS, Rogers ES, Turner LW, Keenum AJ, Weiss BD. Suitability of written sup- plemental materials available on the Internet for nonprescription medications. Am J Health Syst Pharm 2006 Jan 1;63(1):71-8. 43. Kang E, Fields HW, Cornett S, Beck FM. An evaluation of pediatric dental patient education materials using contemporary health literacy measures. Pediatr Dent 2005; 27: 409-13. 44. Kaphingst KA, Zanfini CJ, Emmons KM. Accessibility of web sites containing colorec- tal cancer information to adults with limited literacy. Cancer Causes Control 2006; 17: 147-51. 45. Weintraub D, Maliski SL, Fink A, Choe S, Litwin MS. Suitability of prostate cancer education materials: applying a standardized assessment tool to currently available materials. Patient Educ Couns 2004; 55:275-80. 46. Wolf MS, Davis TC, Shrank W, Neuberger M, Parker RM. A critical review of FDA- approved Medication Guides. Pat Educ Counsel 2006; 62: 316-22. 47. Peterson G, Aslani P, Williams KA. How do consumers search for and appraise infor- mation on medicines on the Internet? A qualitative study using focus groups. J Med Internet Res 2003; 5: e33. 48. Batchlor E, Laouri M. Pharmaceutical promotion, advertising, and consumers. Health Aff 2003; Jan-Jun Suppl: W3-109-11. 49. Rosenthal MB, Berndt ER, Donohue JM, Frank RG, Epstein AM. Promotion of prescrip- tion drugs to consumers. N Engl J Med 2002; 346: 498-505. 50. Wolf MS, Davis TC, Arozullah A, Penn R, Arnold C, Bennett CL. Relationship between literacy and HIV treatment knowledge among individuals enrolled in HAART regi- mens. AIDS Care 2005; 17: 863-873. 51. Wolf MS, Davis TC, Cross JT, Marin E, Green KM, Bennett CL. Health literacy and patient knowledge in a Southern U.S. HIV clinic. Int J STD AIDS 2004; 15: 747-752. 52. Davis TC, Fredrickson DD, Potter L, Brouillette R, Bocchini AC, Williams MV, Parker RM. Patient understanding and use of oral contraceptive pills in a southern public health family planning clinic. South Med J 2006; 99:713-8. 53. Dowse R, Ehlers MS. The influence of education on the interpretation of pharmaceuti- cal pictograms for communicating medicine instructions. Intern J Pharm Pract 2003; 11: 11-18. 54. Insel K, Morrow D, Brewer B, Figueredo A. Executive function, working memory, and medication adherence among older adults. J Gerontol B Psychol Sci Soc Sci 2006: 61: 102-107. 55. Stilley CS, Sereika S, Muldoon MF, Ryan CM, Dunbar-Jacob J. Psychological and cogni- tive function: predictors of adherence with cholesterol lowering treatment. Ann Behav Med 2004: 27: 117-124.

OCR for page 69
 APPendiX C 56. Gazmararian JA, Kripalani S, Miller MJ, Echt KV, Ren J, Rask K. Factors associated with medication refill adherence in cardiovascular-related diseases: a focus on health literacy. J Gen Intern Med 2006; 21:1215-1221. 57. Kalichman SC, Ramachandran B, Catz S. Adherence to combination antiretroviral therapies in HIV patients of low health literacy. J Gen Intern Med 1999; 14:267-273. 58. Chia LR, Schlenk EA, Dunbar-Jacob J. Effect of personal and cultural beliefs on medica- tion adherence in the elderly. Drugs Aging 2006; 23:191-202. 59. Brown M, Frost R, Ko Y, Woosley R. Diagramming patients’ views of root causes of ad- verse drug events in ambulatory care: an online tool for planning educational research. Pat Educ Counsel 2006; 62: 302-315. 60. Wolf MS, Davis TC, Bass PF, Tilson H, Parker RM. Misunderstanding prescription drug warning labels among patients with low literacy. Am J Health System Pharm 2006; 63: 1048-55. 61. National Council on Patient Information and Education (NCPIE) [on-line]. Available at: http://www.talkaboutrx.org/. Accessed August 15, 2007. 62. Morrow DG, Leirer VO, Sheikh J. Adherence and medication instructions: review and recommendations. J Am Geriatric Soc 1988; 36: 1147-1160. 63. Park DC, Jones TR. Medication adherence and aging. In Fisk AD, Rogers WA (eds) Handbook of Human Factors and the Older Adult (pp. 257-287), San Diego, CA: Aca- demic Press, 1997. 64. Rice GE, Okun MA. Older readers’ processing of medical information that contradicts their beliefs. J Gerontol: Psych Sci 1994: 49: 119-128. 65. Gien L, Anderson JA. Medication and the elderly: a review. J Geriatric Drug Ther 1989; 4: 59-89. 66. Park DC, Morrell RW, Frieske D, Blackburn AB, Birchmore. Cognitive factors and the use of over-the-counter medication organizers by arthritis patients. Human Factors 1991; 33: 57-67. 67. Park DC, Morrell RW, Frieske D, Kincaid D. Medication adherence behaviors in older adults: effects of external cognitive supports. Psychol & Aging 1992; 7: 252-256. 68. Morrow DG. Elder‘s schema for taking medication: implications for instructional de- sign. J Gerontol Psych Sci 1991; 46: 378-385. 69. Prescription drug product labeling: FDA Medication Guide requirements. Final rule. Fed Regist 1998; 63: 66378-400. 70. Medication Guides for Prescription Drug Products. Code of Federal Regulations 2004 ed. Title 21; Pt 208: 111-114. 71. Status of Useful Written Prescription Drug Information for Patients; Docket No 00N- 0352. Federal Register 65 (28 April 2000): 7022. 72. American Pharmaceutical Association. Committee Policy Report on Health Literacy 2001-2002. 73. American Society of Health-System Pharmacists. ASHP Guidelines on Pharmacist- Conducted Patient Education and Counseling. Medication Therapy and Patient Care: Organization and Delivery of Services-Guidelines 1997; 192-4. 74. The American Pharmaceutical Association and APhA Foundation: Pharmacy and You: www.pharmacyandyou.org.- accessed on February 28, 2007. 75. Keystone Center. 1996. The final report of the Keystone national policy dialogue on food, nutrition, and health. Keystone, CO and Washington, DC. 76. Krass I, Svarstad BL, Bultman D. Using alternative methodologies for evaluating pa- tient medication leaflets. Patient Educ Couns 2002; 47: 29-35. 77. Gustafsson J, Kalvemark S, Nilsson G, et al. Patient information leaflets: patients’ com- prehension of information about interactions and contraindications. Pharm World Sci 2005; 27: 35-40.

OCR for page 69
00 stAndARdizing MediCAtion lABels 78. Wolf MS, Davis TC, Cross JT, Marin E, Green KM, Bennett CL. Health literacy and patient knowledge in a Southern U.S. HIV clinic. Int J STD AIDS 2004; 15: 747-752. 79. Wolf MS, Williams MV, Parker RM, Parikh NS, Nowlan AW, Baker DW. Patient’s shame and attitudes toward discussing the results of literacy screening. Journal of Health Communication, in press 2007. 80. Baker DW, Parker RM, Williams MV, Pitkin K, Parikh NS, Coates W, Imara M. The health care experience of patients with low literacy. Arch Fam Med 1996;5:329-34. 81. Parikh NS, Parker RM, Nurss JR, Baker DW, Williams MV. Shame and health literacy: the unspoken connection. Patient Educ Couns 1996;27:33-9. 82. Shrank WH, Agnew-Blais J, Choudry N, Wolf MS, Kesselheim A, Avorn JL, Shekelle. The variability and poor quality of medication container labels: A prescription for confusion. In press, Archives of Internal Medicine. 83. Institute of Medicine. The future of drug safety: promoting and protecting the health of the public. Baciu A, Stratton K, Burke S, editors. Washington, D.C.: National Academy Press; 2006. 84. Epic Company [on-line]. Available at http://www.epicsystems.com/Company/About. php. Accessed August 20, 2007. 85. Medi-Span [on-line]. Available at http://www.medispan.com. Accessed August 20, 2007. 86. National Council for Prescription Drug Programs [on-line] Available at http://www. ncpdp.org. Accessed August 20, 2007. 87. Electronic Prescribing Initiative eHealth Initiative. Electronic Prescribing: Toward Maxi- mum Value and Rapid Adoption. Recommendations for optimal design and implemen- tation to improve care, increase efficiency and reduce costs in ambulatory care. Agency for Healthcare Research and Quality (AHRQ); Washington DC, April 14, 2004. 88. Swann J. Evolution of the drug label. Food, Drug, Cosm Med Device L Digest 1998; 15: 23-31. 89. US Pharmacopeia History [on-line]. Available at http://www.usp.org/aboutUSP/ history.html. Accessed February 8, 2007. 90. Swann J. The FDA and the practice of pharmacy: prescription drug regulation before 1968, in Spillane JF, Erlen J (eds.): Federal drug control: The evolution of policy and practice. New York, NY, Haworth Press, 2004, pp 145-166. 91. Gemperli MP. Rethinking the role of the learned intermediary: the effect of direct-to- consumer advertising on litigation. JAMA 2000; 284:2241. 92. 33 Fed. Reg. 8812 (1968) (codified at 21 C.F.R. §201.305). 93. Public Law 93-608, 3 Nov. 1966, 80 U. S. Stat. 94. Avorn J, Shrank W. Highlights and a hidden hazard—the FDA’s new labeling regula- tions. N Engl J Med. 2006 Jun 8;354(23):2409-11. 95. Shrank WH, Avorn J, Rolón C, Shekelle P. The Effect of the Content and Format of Pre- scription Drug Labels on Readability, Understanding and Medication Use: A Systematic Review. Ann Pharmacother. 2007 May;41(5):783-801.