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Pharmacy Practice in Focus: Health Systems
USP provides health literacy standards and solutions that enhance medication safety and improve patient outcomes.
Medication safety is a critical concern in health care as medication errors can lead to adverse events (AEs), increased hospitalizations, and higher health care costs. At least 1.5 million people in the United States are harmed annually by medication errors, with associated costs exceeding $3.5 billion per year.1 Approximately one-third of AEs occur within the outpatient setting, and they are believed to be caused by patients not administering medicine as intended.2
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In 2022, the IQVIA Institute for Human Data Science reported that more than 6.7 billion prescriptions were dispensed in the outpatient setting nationally.3 This equates to approximately 19 prescriptions for every American.3 Patients are dealing with chronic conditions and polypharmacy, defined as the regular use of 5 or more medications at the same time, which can be a contributing cause of errors during the prescribing, dispensing, and administering of medications. For this reason, the main sources of information on why, how, when, and what to look for when taking medication should be the prescription container label, medication information, and provider-patient communication.
Medication errors stemming from unclear or inaccurate labeling pose a significant risk to patient safety and health care outcomes. Clear labeling is of paramount importance in safe medication use. The United States Pharmacopeia (USP) established USP General Chapter <17> Prescription Container Labeling to provide a universal approach to labeling prescription medication.3 This chapter includes guidance on the format, appearance, content, and language of medication instructions, directing health care practitioners to utilize simple, concise language and provide explicit instructions that include the purpose for use and how to handle oral liquid medication dosing tools, if applicable.3 The aim is to present the information on the label in a patient-centered manner that promotes patient understanding and helps mitigate medication errors.
Findings from studies have shown that variability in labeling and the use of certain terminology can adversely affect a patient’s understanding of medication instructions.2 Implementing USP General Chapter <17> Prescription Container Labeling addresses the need for using standardized, explicit instructions to improve patient understanding and promote safe medication use.4 Furthermore, a lack of understanding about the drug product container label can lead to a higher risk of adverse medication use. To help ensure that product container labels are useful to health care providers in directing patients on their medications and treatments, USP General Chapter <7> Labeling emphasize the importance of cautionary statements to convey important safety messages, which should be simple, concise, and printed in a contrasting color to prevent imminent life-threatening situations for patients.5 For example, this standard specifies that product labels and labeling for injectable products should include instructions or medication warnings, such as dilution instructions, storage conditions, and recommended dosage.5
Dispensing medications, a critical component of the pharmaceutical care process, can inadvertently lead to medication errors that jeopardize patient safety and undermine therapeutic outcomes.
The problems that can contribute to dispensing errors include the following6:
USP General Chapter <1265> Written Drug Prescription Information Guidelines provides health care providers with information on how to utilize supplemental documentation, in a prescription drug leaflet format, to optimize the counseling of patients about their medicine. The chapter instructs that this documentation should provide details about the drug, including brand and generic names, pronunciation guides, and indications to ensure understanding of medication information.7
Individuals with low literacy or low English proficiency will greatly benefit from additional interventions, such as counseling and visual aids to mitigate the risk of misinterpretation.8 Findings from studies show that patients with health literacy limitations are 3.4 times more likely to interpret prescription medication warning labels incorrectly.9 Such interventions can significantly reduce medication errors and improve patient outcomes.
Nakia Eldridge, PharmD, MBA, is a director of health care quality, safety, and information at US Pharmacopeia in Rockville, Maryland.
Michael Ryczaj is a class of 2025 PharmD candidate at the University of Pittsburgh School of Pharmacy in Pennsylvania.
USP provides health care professionals access to a database of pictograms, which are standardized graphic images that help convey medication instructions, precautions, and/or warnings to patients. Data have shown that the USP pictograms have been of great value to pharmacists and pharmacy staff seeking to ensure that essential medical information is understood by patients with a lower reading level ability and patients for whom English is a second language.
As a standard-setting organization, USP is committed to improving global public health. The organization collaborates with key stakeholders to develop and refine standards and solutions to address health literacy challenges.7 USP collaborates with health care professionals by equipping them with the most up-to-date materials, guidance, and standards to assist them in delivering safe and efficient patient care.
