AARP NOVEMBER 2022 PUBLIC POLICY INSTITUTE Fact Sheet Medication Literacy Series: Prescription Drug Container Labels James McSpadden AARP Public Policy Institute The labels on prescription drug containers provide critical information to consumers. Evidence shows that the use of clear, consistent prescription drug container labels can aid medication decision making and help improve older adults' health outcomes by reducing medication errors.' However, for the millions of adults ages 50 and older with low medication literacy, deciphering information from a prescription drug container label can be difficult. Furthermore, this bridge from encountering a label to taking action is complicated by wide variation in prescription drug container labeling that results from inconsistent state standards for what drug information is presented and how it is presented. Prescription Drug Container Labels and Medication Literacy Prescription drug container labels are the consumer-facing information affixed to the drug containers (.g., pill bottles, vials, inhalers, blister packs) lined up in medicine cabinets and countertops across the United States. Container labels are different from drug product labels, which manufacturers attach to the product to help providers make prescribing decisions.' Container labels convey provider instructions and important information about the prescribed drug and its intended use. Although container labels are only one piece of communication a consumer receives when filling a prescription, they are typically the most visible. Prescription drug container labels are particularly meaningful for older adults, who take a significant portion of the 4 billion prescriptions Americans fill every year.' For the 86 percent of adults ages 65 and older regularly taking at least one prescription drug-and the 42 percent taking five or more- labels can reinforce oral instructions given by providers, serve as the primary means of communication, and deliver concise information to help manage daily medication regimens.* Yet, a container label's effectiveness depends on the presentation of the information and a consumer's ability to read and use it. Consumers view drug labels with varying levels of medication literacy, or the ability to obtain medication information, process received information, and make medication decisions.° One 1 Key Takeaways Y Prescription drug container labels are a key source of information for consumers about the safe and proper use of medications. ¥ Low medication literacy can make deciphering information from a prescription drug container label difficult. v The elements on prescription drug container labels vary due to inconsistent state regulation. ¥ Consumer-centered improvements to the style, organization and content of prescription drug container labels can lead to greater standardization, help consumers manage their medications, and reduce medication errors. third (34 percent) of adults ages 50 to 64 and more than half (59 percent) of adults ages 65 and older have basic or below-basic literacy, meaning that they may lack certain skills that enable medication decision making.' For example these skills include recognizing and understanding certain medication vocabulary, using numeracy to understand dosages, and communicating with their provider about medication use. Evidence indicates that low levels of medication literacy can contribute to consumers' misunderstanding of drug labels and, ultimately, result in nonadherence, medication errors, and adverse events.' Improving Labels and Medication Literacy among Older Adults Poor drug container labeling can render a label useless. A 2006 Institute of Medicine report identified poor and inconsistent labeling as a key cause of medication errors.* Separately, research by Northwestern University, which identified 53 different ways that prescribers write the instruction "Take one tablet twice daily," found that variation in instruction led to pharmacist and consumer confusion.°® Poor drug container labeling can also occur when the printed instructions fail to meet consumers' medication literacy level. One study found that adults with low or marginal health literacy-which includes medication literacy-struggled to understand prescription drug container labels.!° When researchers asked adults how to take five medications based on the label, nearly half (46 percent) misunderstood one or more labels. Among adults with low or marginal health literacy, more than half could not correctly demonstrate the number of pills to take based on the label; these consumers were twice as likely to misunderstand the labels. Federal and State Prescription Drug Container Label Regulations Federal law sets the foundation for container label standards, but states regulate the specific requirements for pharmacies. The federal NOVEMBER 2022 eee rae Cee em uel ETC MWC tte Medication Guide: Included with a prescription, FDA-approved handout that highlights warnings, details potential serious side effects, and provides information to help consumers use the drugs safely and effectively. elt Ti eel Mee ROLE) Instructions for Use: Both tools are developed by the manufacturer, approved by the FDA, and provided in association with certain medications. Food, Drug and Cosmetic Act identifies a core set of elements to include on prescription drug container labels." The US Food and Drug Administration (FDA) also offers guidance on how to shape labels to minimize medication errors." States, in consultation with state boards of pharmacy, fill in the details. All states and the District of Columbia have specific requirements for pharmacies to follow when dispensing retail medications. These include the federal standards and may include additional elements (figure 1). Because of the strong state regulation over container labels, required elements for prescription drug container labels vary from state to state (see appendix). Most states (42) and the District of Columbia explicitly mention the federally required elements for prescription drug container labels and add one or more additional elements. The appendix shows the range of state variation around label elements. Consumer-Centered Container Labels A growing number of states and pharmacies have sought to cut through label variation and promote patient understanding of medication by adopting consumer-centered container labels. These labels build on the standards NOVEMBER 2022 FIGURE 1 Required Elements on a Prescription Drug Container Label Federally Required Prescriber name Pharmacy name and address Patient name and date of birth Directions for use Drug name and strength Prescription serial number Fill date Cautionary statements Quantity developed by the United States Pharmacopeia (USP)-an independent, scientific nonprofit working to build consumer and provider trust in the safety and quality of medications-in 2009 to address consumer misunderstanding and medication misuse that result from poor and inconsistent labeling." The USP container label standards follow several key concepts: e Appropriate organization-Labels should arrange information according to how consumers receive and process information, emphasizing information that enables safe and effective use (e.g., drug name and strength, directions for use) and minimizing less critical information. e Direct instructions-Labels should include directions for use that clearly articulate medication dosages and when to take them. To avoid confusion, labels should use consistent and standardized directions. e Careful language choices-Labels should use simplified-clear, concise, and standard- language, avoiding uncommon words and jargon. As appropriate, pharmacies should print labels in a consumer's preferred language using a high-quality translation. e Limiting unnecessary information-Labels should only include icons and text that are evidence based and shown to work for consumers with limited literacy. Any Additional Elements Required in Certain States National Drug Code (NDC) number Brand name equivalent, if generic Generic or interchangeable biosimilar substitution notice Name or initials of dispensing pharmacist Number of refills Expiration date Warning labels and auxiliary information nonessential information should appear on other types of communication. e Improved readability-Labels should attend to various features that enhance readability and, thus, accessibility. These features include font size, contrast between the text and background, adequate blank space to create separation among elements, limited use of colors, and alternative access for consumers with limited vision. Recently, a Wisconsin-based organization conducted a pilot program with 67 pharmacies-which later expanded to 21 percent of pharmacies across the state-to redesign labels using USP standards. Limited results showed improved drug adherence in three therapeutic classes and 82 percent of consumers reporting that they liked the new labels more than or as much as the older labels." A Future for Container Labels Prescription drug container labels have long served as an important tool to communicate information to older adults about medications. Yet the medication literacy levels of older adults may directly affect the ability to process and act on the information conveyed in the label. Consumer-centered drug labels that emphasize, in easily readable fonts, the most important information can better meet older adults at their current literacy levels and promote safe and effective medication use." NOVEMBER 2022 To help counteract the current state variability quality and consistency nationwide. Regardless in drug container labeling, state boards of of the means to the end, consumer-centered pharmacy could take coordinated steps to container labels have the potential to better improve labeling, potentially using the USP equip older adults to use medications correctly, standards as a model. Similarly, the FDA could prevent unnecessary medication errors, and expand its current standards to increase lead healthier lives. 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Morris, Ellen R. Tabak, and Kathleen Gondek, "Counseling Patients About Prescribed Medication: 12- Year Trends, " Medical Care 35, no. 10 (1997): 996-1007, 5 Annie Pouliot, "Health Literacy in the Context of Medication Use or Medication Literacy: Development of a Consensus Definition" (Presentation, Boston, MA: BUMC Health Literacy Research Conference, June 2016), https://www,bumc,bu.edu/ healthliteracyconference/files/2016/06/Annie_Pouliot.pdf. 6 James McSpadden, Medication Literacy: A Helpful Concept for Understanding Medication Decision Making among Older Adults (Washington, DC: AARP Public Policy Institute, January 2022), https://www.aarp.or: ntent/dam/aar' i/2022/01/medication- literacy-older-adults.doi,10,26419-2Fppi,00156.001.pdf. 7 Terry C. Davis et al., "Literacy and Misunderstanding Prescription Drug Labels," Annals of Internal Medicine 145, no. 12 (2006): 887-94, https://doi.org/10.7326/0003-4819-145-12-200612190-00144. 8 Institute of Medicine, Preventing Medication Errors. 9 Stacy Cooper Bailey et al., "Comparison of Handwritten and Electronically Generated Prescription Drug Instructions," Annals of Pharmacotherapy 43, no. 1 (2009): 151-52, https://doi.org/10.1345/aph.1L388. 10 Davis et al., "Literacy and Misunderstanding Prescription Drug Labels." 11 21U.S. Code § 353. 12 US Food and Drug Administration, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors Mashington. DC: Center for Drug Evaluation and Research, May 2022), ntips: dhww fda. govlregu/atory-information/search 13 United States Pharmacopeia, <17> Prescription Container Labeling (Rockville, MD: USP, November 2012), https://www.nmpharmacy.org/Resources/Documents/USPC_Labeling Guidelines%5B1%5D.pdf. 14 Steven W. Sparks et al. Adopting an Easy-to- Read Medication Label in Wisconsin (Madison, WI: Wisconsin Health Literacy, September inli 15 AARP, AARP Policy Book: 2021-2022 (Washington, DC: AARP, 2021), https: i k.aarp.or Fact Sheet 1426607, November 2022 © AARP PUBLIC POLICY INSTITUTE 601 E Street, NW Washington DC 20049 Follow us on Twitter @AARPpolicy on facebook.com/AARPpolicy www.aarp.org/ppi For more reports from the Public Policy Institute, visit http://www.aarp.org/ppi/. https://doi.org/10.2641 i.00174.001 AARP