Clarifying the Label: How New USP Standards are helping to Increase Patient Literacy
By: Donna Bohannon, R.Ph., CPPS, United States Pharmacopeial Convention
Take two tablets twice daily. Take one tablet by mouth three times daily. Often times, directions similar to these on the prescription bottle are the only ones that a patient will receive when taking a new medication. While the directions might make sense to a prescriber or a pharmacist, inadequate understanding of prescription directions for use is a widespread problem that can lead to medication misuse and adverse events.
Studies1 have shown that when they take multiple medications, 46 percent of all patients misunderstand one or more of the dosage instructions and that 56 percent misunderstand one or more auxiliary warnings. Medication misuse currently accounts for one million adverse drug events every year in the United States, with most problems occurring in patients with low or marginal literacy or in patients taking four or more medications.
In an effort to improve patient literacy and reduce medication errors and non-adherence, the United States Pharmacopeial Convention (USP) has developed a new United States Pharmacopeia and National Formulary (USP-NF) General Chapter <17> Prescription Container Labeling. The USP effort to create these new standards developed from an Institute of Medicine (IOM)-led initiative to improve health literacy, which is defined as the degree to which people can obtain, process and understand the basic health information and services they need to make appropriate health decisions. The basis of this new general chapter are recommendations made from the Nomenclature, Safety and Labeling Expert Committee, which established the Health Literacy and Prescription Container Labeling Advisory Panel to determine optimal prescription label content and format to promote safe medication use. The Expert Panel critically reviewed factors that promote or distract from patients’ understanding of prescription medication instructions, and helped developed a basis for a standard for the format, appearance, content and language for universal prescription labels.
The new standard includes a number of ways to improve patient understanding including: organize the label in a patient-centered manner; improve readability; emphasize instructions and other information important to patients; simplify language; give explicit instructions; include purpose for use; limit auxiliary information; address limited English proficiency; and address visual impairment.
Organize the label in a patient-centered manner
The label should include only the most important patient information that is needed for safe and effective medication use. Information should also be organized in a clear manner.
Style and format of the text is as important as the content of what appears on the label. High-contrast print is ideal as are simple uncondensed fonts. Punctuation should be sentence case, with the first word capitalized. The most important text should be in a large font size such as Times New Roman in size 12-point or Arial 11-point. No font should be smaller than size 10-point in Times New Roman. There should be adequate white space on the label so the patient can distinguish different sections such as the directions for use and pharmacy information. All labels should be printed horizontally. Important information should never be truncated or abbreviated, and if there are multiple times of day when a dose should be taken those instructions should appear on separate lines.
Emphasize instructions and other information important to patients
The most prominent information on the label should be critical to the safe and effective use of the medicine. The patient’s name, the drug name (full nonproprietary/generic and brand name), the strength and explicit, but simple, instructions for use should be at the top of the label. Other information such as the prescriber name, pharmacy name, fill date, etc., should still be on the label, but none of it should supersede critical patient information. Nonessential information may distract a patient, so it should be placed away from the dosage instructions.
To better assist patients of all literacy levels in more easily understanding what is written on the label, only common terms and sentences should be included and unfamiliar words such as Latin or medical jargon should not be used.
Give explicit instructions
To minimize confusion surrounding doses that are taken multiple times per day, the instructions for use should separate the dosage amount from the timing of the dose. If a certain time of day is required for dosage, then specific times such as morning, noon, evening and bedtime should be used. An example of an explicit instruction is: “take two tablets in the morning and two tablets in the evening.” Directions that include exact times of day or even mealtimes are discouraged as they present conformity issues when a patient has an alternative work schedule.
Include purpose for use
If a prescriber includes a “purpose for use” on the prescription, provided the patient has given permission, that purpose should be included on the label. Including the purpose for use in plain language will ensure that the patient knows exactly what he or she is taking the medicine for especially if the patient is taking multiple drugs. It can also assist caretakers or emergency personnel to identify what types of medicines a patient is taking and why, should a medical emergency occur.
Limit auxiliary information
Often patients, especially those with low literacy, pay little attention to auxiliary information such as: “This drug may impair the ability to drive or operate machinery. Use care until you become familiar with its effects.”
While auxiliary information can be helpful, it should only be on the label if it is critical and it should be spelled out in simple language. While icons are generally ineffective and often lead to more confusion, an icon can be used if there is substantial consumer-tested research showing that it is easily understood by a large audience.
Address limited English proficiency
Increasing numbers of patients in the United States do not speak English as a first language. To accommodate these patients and help reduce medication errors, whenever possible patients should be given the opportunity to have their prescription container label translated into their preferred language. Ideally, if there is room, the label should also include the full English version or, at the very least, the drug name in English so emergency personnel are able to quickly identify the medication. To ensure accuracy, all translations should first be done by a native speaker, then reviewed by another trained translator and finally by a pharmacist who is a native speaker of the language. Understanding that not all pharmacies will have the ability to provide a high quality translation, an alternative would be for the label to be printed in English and a trained interpreter be present at the pharmacy to provide counsel in the patient’s preferred language.
Address visual impairment
Many patients have visual impairments that limit their ability to read the prescription label. To help these patients, access to technologies such as tactile, auditory or enhanced visual systems should be available.
Ensuring patient safety and reducing medication errors is of the foremost importance, and these new standards will help ensure that patients have uniform prescription labels that are more easily understood and read. General Chapter <17> Prescription Container Labeling will be published in USP 36—NF 31 in November 2012, and will become official in May of 2013. Underscoring the urgency of the need for standardized and patient-centric prescription container labels, the National Association of Boards of Pharmacy (NABP) passed a resolution in May 2012 calling for uniform outpatient prescription container labels and recommending that the State Boards of Pharmacy adopt General Chapter <17>. Enforcement of the standard will be the decision of individual state boards of pharmacy, which may choose to adopt it into their regulations—similar to USP standards for sterile and nonsterile pharmaceutical compounding, both of which are widely recognized by states. With the seal of approval from NABP, it is the hope of USP that all State Boards of Pharmacy will recognize the importance of these standards and implement them in states across the country.
More information is available at: uspgo.to/prescription-container-labeling
1. Literacy and misunderstanding prescription drug labels. Davis TC, Wolf MS, Bass PF 3rd, Thompson JA, Tilson HH, Neuberger M, Parker RM. Ann Intern Med. 2006 Dec 19;145(12):887-94. Epub 2006 Nov 29. PMID: 17135578 [PubMed - indexed for MEDLINE]
Donna Bohannon is a scientific liaison for the Nomenclature, Safety and Labeling Expert Committee (NSL EC) at United States Pharmacopeia (USP). She is a licensed pharmacist with more than 30 years experience. She graduated from the University of Maryland School of Pharmacy and has done graduate study in health policy, epidemiology and biostatistics. She has worked in various practice settings that include hospital, retail, industry and consulting. She is a preceptor for University of Maryland and Notre Dame Schools of pharmacy. Before coming to USP, Ms. Bohannon worked as a medication safety officer for Medstar Franklin Square Hospital Center. She is a certified professional in patient safety (CPPS) and a member of several professional organizations which include the American Society of Health System Pharmacists (ASHP), American Society of Professionals in Patient Safety (ASPPS), and the American Society of Medication Safety Officers (ASMSO). Her passion for and experience in medication safety has aptly suited her for facilitating the advancement of the work of the NSL EC such as USP General Chapter <17>, Prescription Container Labeling.