Standardizing Medication Labels Confusing Patients Less: Workshop Summary (2008) / Chapter Skim
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Appendix C: ACP White Paper
Appendix C: ACP White Paper
Pages 69-100
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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 69 Appendic C Frontpiece
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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.
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. 73 Prescription Drug Container Labeling: A Medication Safety Concern .
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labeling were cited as the cause of a large proportion of outpatient medication errors and ADEs, as patients may unintentionally misuse a prescribed medicine due to improper understanding of instructions. Recent health literacy research has highlighted the alarmingly high prevalence of patients misunderstanding seemingly simple instructions and warnings placed on Rx container labels.
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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.
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Herein, this white paper presents the ACPF perspective on the current prescription medication container 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, Preventing 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.
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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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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 estimated 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.
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adults -- especially the elderly -- lack the health literacy skills that enable them to effectively 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 complexity of demands placed upon the individual by the health care system.
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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)
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.23,60 Other studies demonstrated that over half (53%) of patients, especially those with limited literacy, had difficulty interpreting text and icons commonly used on auxiliary warning instructions.23 Beyond the container label, another recent study also found accompanying 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.
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This is an issue of patient safety and successful therapeutic outcomes. Current drug prescribing and dispensing practices allow for variability in container labels.
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Findings from this study suggest there is high variability in the format and content of container labels across dispensing pharmacies. More importantly, very few labels are currently designed to optimize appropriate and safe prescription medication use.
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The 2006 IOM report, The Future of Drug Safety, directs attention to e‑prescribing and the importance of health technologies for surveillance of errors and events but also to rapidly communicate risk information.83 As more medical practices are incorporating electronic health records, many of these systems are now setting standard "sig" messages for prescribing medications for efficiency and patient safety purposes.84 At the point of dispensing, pharmacy systems also have been using information systems to support drug labeling. This includes default standards for translating prescriber instructions and including auxiliary warnings, with
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A Brief History of Drug Labeling The looming problem of prescription drug container labeling is best appreciated after having a basic understanding of the relevant historical events leading up to the present circumstances. Since the formal establishment of the modern Food and Drug Administration (FDA)
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Many widely-used products were ineffective, addictive, or even lethal.88 This new law focused on the regulation of product labeling rather than pre-market approval. The passage of the Pure Food and Drugs Act marked the beginning of the modern era of the FDA, and with this legislation came the beginning of a limited set of federal labeling standards.
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Specifically the following statement was to be included on the label: "To be used only by or on the prescription of a physician."90 This is referred to as the prescription legend, which is still required on prescription medicine container labels to this day (although this statement was shortened to "Rx Only" in 2000)
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labeling requirements for detailed instructions for use and safety warnings.90 Laws remained unclear for prescription labeling, specifically, as the C-4 FDA assumed that physicians and pharmacists were orally communicating necessary usage directions and warnings to patients for prescribed medicines. Hence, less attention was given to the labeling on prescription drug containers or any accompanying marketing literature provided by the manufacturer.
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Over-the-counter medicines were required to have adequate label instructions and warnings to instill safe use by the consumer, without physician consultation. However, this was not necessary for prescription-only drugs, as again it was expected access required physician consultation and information would be delivered verbally at that time.
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United States that stated supplementary materials not physically attached to the drug container could still be viewed as part of the product label, the Fair Packaging and Labeling Act mandated the inclusion of patient-directed package inserts written in lay language for all prescription drugs. This was to give patients more detailed instructions and warnings about a prescribed drug‘s risks and benefits, in light of container label space limitations.
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The published report called for consumer medication information to be written at a sixth to eighth grade level and for improved format and organization.75 These were recommendations only, as a review of FDAapproved materials a decade later found little improvement in the quality of patient information. The most recent labeling effort by the FDA to ensure patient understanding of appropriate prescription drug use was the June 30, 2006 revision of 21 CFR 201.56 and 201.57, "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products." While the new law had the patient in mind, its provisions reflect the powerful role of the learned intermediary in providing essential information to the ultimate medication consumer.
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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 physician, 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.
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sides to the label. The primary label will contain patient information (drug name, dose, dosage/usage instructions, patient name, doctor name, quantity, refill information)
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will be set for use larger, sans serif patient name, drug name, and specific dosage-usage font. instructions (both in text and in matrix)
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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 primary 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.
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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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Conclusion The ACPF Medication Labeling Technical Advisory Board has proposed 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 importance of the container label should be reiterated as the most tangible and repeatedly used source of prescription drug instructions for use.
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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.
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Literacy and misun derstanding of prescription drug labels. Ann Intern Med 2006; 145: 887-94.
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Readability characteristics of consumer medication information for asthma inhalation devices. J Asthma 2006; 43:375-8.
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70. Medication Guides for Prescription Drug Products.
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The variability and poor quality of medication container labels: A prescription for confusion. In press, Archives of Internal Medicine.
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