For the first time, universal standards for prescription drug labels that reflect how patients read and understand medication instructions are being proposed on a national level, according to the U.S. Pharmacopeial Convention (USP).


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USP develops new standards for Rx labels

January 3rd, 2011

ROCKVILLE, Md. – For the first time, universal standards for prescription drug labels that reflect how patients read and understand medication instructions are being proposed on a national level, according to the U.S. Pharmacopeial Convention (USP).

USP said Monday that the standards, which it developed, guide the content, language, format and appearance of prescription medication labels and stem from a broad effort led by the Institute of Medicine (IOM) to improve the nation's health literacy.

According to USP, the new standards propose that prescription container labels generated by pharmacies have the following characteristics:

• Organized in a patient-centered manner to reflect how most people understand medication instructions, highlighting the most important information for safe and effective understanding and use.

• Emphasize instructions and other important information to patients. Information that is critical to patients' safe and effective use of the medicine (patient name, drug name and strength, clear directions for use) should be prominently displayed. Less critical but important content (such as pharmacy name and number) should not supersede critical patient information.

• Give explicit instructions, clearly separating the dose itself from the timing of each dose and using numeric characters ("Take 2 tablets in the morning and 2 tablets in the evening" rather than "Take two tablets twice daily").

• Include the medication's purpose for use, unless the patient prefers that it not appear. When included, use clear, simple terms (such as "for high blood pressure" rather than "for hypertension").

• Improve readability. Label type should use high-contrast print (such as black print on white background), a large font size and horizontal text only.

• Limit auxiliary information. Labels, stickers, or other supplemental information should be expressed in simple and explicit language that is minimized to avoid distracting patients with nonessential information.

"As more patients enter the health care system, and as the nation becomes increasingly diverse, more patients will have difficulty understanding and using important healthcare information provided to them," Roger Williams, chief executive officer of USP, said in a statement. "One key component of health care information is prescription container labels, which are a patient's best — and often only — source of instruction and background necessary for safely and appropriately using a medication.

"Many studies have shown that patient misunderstanding is widespread, and lack of universal standards is a cause of this problem," Williams noted. "These new standards were designed with the patient in mind, to bring clarity and consistency to the prescription labels they rely upon."

The new USP standards are being proposed for a 90-day public comment period, during which the organization will accept feedback from health care professionals, consumers and other interested parties.

USP said the standards could be adopted by state boards of pharmacy, other governmental authorities, or conformity assessment bodies into state laws, regulations, guidelines or other documents. The organization said adoption of USP standards at the state level is common, such as in the cases of USP's standards for sterile and nonsterile pharmaceutical compounding. Some states, including California and New York, recently developed their own regulations for prescription container labeling, USP added.

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