Rockville, Md., October 9, 2012 — With medication misuse resulting in more than one million adverse drug events per year in the United States, new standards released today by the U.S. Pharmacopeial Convention (USP) for the first time provide a universal approach to the format, appearance, content and language of instructions for medicines in containers dispensed by pharmacists. Wide variability in prescription container labels exists today across individual prescriptions, pharmacies, retail chains and states. The USP standards provide specific direction on how to organize labels in a "patient-centered" manner that best reflects how most patients seek out and understand medication instructions.
"Lack of universal standards for labeling on dispensed prescription containers is a root cause for patient misunderstanding, non-adherence and medication errors," said Joanne G. Schwartzberg, M.D., director, aging and community health for the American Medical Association and a member of the USP Nomenclature, Safety and Labeling Expert Committee, the group of independent experts responsible for the new standard. "With an aging and increasingly diverse population, and people utilizing a growing number of medications, the risks are more pronounced today than ever. These USP standards will promote patient understanding of their medication instructions, which is absolutely essential to preventing potentially dangerous mistakes and helping to ensure patient health and safety."
Studies have found that 46 percent of patients misunderstood one or more dosage instructions on prescription labels. The problem is particularly troublesome in patients with low or marginal literacy (one study showed patients with low literacy were 34 times more likely to misinterpret prescription warning labels), and in patients receiving multiple medications that are scheduled for administration using unnecessarily complex, non-standardized time periods. However, even patients with adequate literacy often misunderstand common prescription directions and warnings.
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.
Elements of the new USP standards, contained in General Chapter <17> Prescription Container Labeling, of the United States Pharmacopeia and the National Formulary, include:
"Patients' best—and often only—source of information regarding the medications they have been prescribed is on the prescription container label," Dr. Schwartzberg noted. Although other written information and oral counseling may be available, the prescription container label must fulfill the professional obligations of the prescriber and pharmacist. These include giving the patient the most essential information needed to understand how to safely and appropriately use the medication and to adhere to the prescribed medication regimen.
USP issued a draft version of this standard for public review and comment by all interested stakeholders—including healthcare practitioners, retailers, software vendors, consumers and others—in December 2011. The final standard will be published in November 2012, and incorporates multiple additions based on comments received, including more detail on producing high-quality translations, the visual impairment section, and the direction to include both brand and nonproprietary names on labels.
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.
Examples of prescription container labels that comply with the new USP standard are available at http://uspgo.to/prescription-container-labeling. Media inquiries may be directed to firstname.lastname@example.org.
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The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP's standards are relied upon and used worldwide. For more information about USP visit http://www.usp.org.
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