Original Posting: 09–Oct–2012; Last Update: 13–Nov–2012
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In November 2012, USP will publish a new General Chapter <17> Prescription Container Labeling in USP 36–NF 31. The standard provides, for the first time, a universal approach to the format, appearance, content and language of instructions for medicines in containers dispensed by pharmacists. The new USP general chapter offers specific direction to label manufacturers, pharmacies and prescribers on how prescription labels should be organized in a “patient-centered” manner that reflects how most patients seek out and understand medication instructions.
Patients’ best (and often only) source of information regarding the medications they have been prescribed is on the prescription container label. Although other written information and oral counseling sometimes may be available, the prescription container label must fulfill the professional obligations of the prescriber and pharmacist. These obligations include giving the patient the most essential information needed to understand how to use the medication safely and appropriately and to adhere to the prescribed medication regimen.
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. According to IOM, 77 million Americans have limited health literacy, and a majority of Americans have difficulty understanding and using currently available health information and services. At a 2007 IOM workshop on Standardizing Medication Labels: Confusing Patients Less, USP Chief Executive Officer Roger L. Williams pledged that the organization would initiate work on a standardized prescription container label. The resulting standard was finalized by the USP Nomenclature, Safety, and Labeling Expert Committee, which is chaired by Thomas Reinders, Pharm.D. The standard was developed by experts in patient safety, health literacy, pharmacy, medicine, human factors research and labeling technology. Key areas covered in General Chapter <17> include organizing the label in a patient-friendly way, using explicit language to describe dosages and intervals, improving readability with clear formatting, including “purpose for use” (e.g., “for high blood pressure”) and addressing those with visual impairments and those with limited English comprehension.
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. At its 2012 annual meeting, the National Association of Boards of Pharmacy passed a resolution supporting state boards in requiring a standardized prescription container label.
This proposed new general test chapter provides information on prescription container labeling. On May 18, 2007, the USP Safe Medication Use Expert Committee established an Advisory Panel to (1) determine optimal prescription label content and format to promote safe medication use by critically reviewing factors that promote or distract from patient understanding of prescription medication instructions and (2) create universal prescription label standards for format/appearance and content/language. In November 2009, the Health Literacy and Prescription Container Labeling Advisory Panel presented its recommendations to the Safe Medication Use Expert Committee, which then requested that USP develop patient-centered label standards for the format, appearance, content, and language of prescription medication instructions to promote patient understanding. Those recommendations formed the basis of this general test chapter.