Medication Literacy Series: Prescription Drug Container Labels

Prescription drug container labels are the consumer-facing information affixed to the drug containers (e.g., pill bottles, vials, inhalers, blister packs) lined up in medicine cabinets and countertops across the United States. These labels are particularly meaningful for older adults, who take a significant portion of the 4 billion prescriptions Americans fill every year. Although container labels are only one piece of communication a consumer receives when filling a prescription, they are typically the most visible and convey instructions and important information about the prescribed drug and its intended use. In fact, according to an Institute of Medicine report, poor and inconsistent labeling is a key cause of medication errors.

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Medication Literacy

A container label’s effectiveness depends on the presentation of the information and a consumer’s ability to read and use it. One 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— the ability to obtain medication information, process received information, and make medication decisions—can contribute to consumers’ misunderstanding of drug labels and, ultimately, result in nonadherence, medication errors, and adverse events.

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. 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, such as brand name equivalent if generic, name or initials of dispensing pharmacist, and number of refills. (See appendix in the Fact Sheet for 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 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—to address consumer misunderstanding and medication misuse that result from poor and inconsistent labeling.

The USP container label standards follow several key concepts:

• Appropriate organization
• Direct instructions
• Careful language choices (including high-quality translation into a consumer’s preferred language)
• Limiting unnecessary information
• Improved readability and accessibility

Evidence shows that adoption of consumer-centered container labels can have an impact. 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

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. To help counteract the current state variability in drug container labeling, state boards of pharmacy could take coordinated steps to improve labeling, potentially using the USP standards as a model. Similarly, the FDA could expand its current standards to increase quality and consistency nationwide.

This report is one in a series on the topic of medication literacy. View the series.