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New Drug Labeling Standards Proposed

Thursday, 11 Oct 2012 02:09 PM



A drug industry group has proposed revamping prescription medicine labels to make them easier to read and less confusing, in an effort to reduce the cases of medication misuse in the U.S.
The new labeling standards, proposed by the U.S Pharmacopeial Convention (USP), were developed to provide a universal approach to the “format, appearance, content, and language of instructions.” The USP noted studies show medication misuse results in more than one million adverse drug incidents in the U.S. every year and that nearly half of patients misunderstand one or more dosing instructions.
One reason cited by the USP: Wide variability in prescription container labels for individual prescriptions, pharmacies, retail chains, and states.
"Lack of universal standards for labeling on dispensed prescription containers is a root cause for patient misunderstanding, non-adherence and medication errors," said Dr. Joanne G. Schwartzberg, an American Medical Association health specialist and member of the USP panel of experts that developed 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."
The new standards call for labeling changes to do the following:
• Emphasize instructions and other information important to patients.
• Prominently display information that is critical for patients' safe and effective use of the medicine.
• Specify the patient’s name, drug name (including brand name) and strength, and clear directions for use in simple language at the top of the label.
• Labels should be designed and formatted so they are easy to read, using high contrast print, adequate white space between lines of text; and large type size.
• Give explicit instructions. For example, labels should say: "Take 2 tablets in the morning and 2 tablets in the evening" rather than "Take 2 tablets twice daily."
• Include purpose for use in simple terms — e.g., "for high blood pressure" rather than "for hypertension."
• Provide alternative access for visually impaired patients (e.g., tactile, auditory, or enhanced visual systems that may employ advanced mechanics or assistive technology).
It is now up to individual state boards of pharmacy to decide if they want to adopt the new labeling guidelines. At its recent annual meeting, the National Association of Boards of Pharmacy passed a resolution urging state boards to require a standardized prescription container label.

© HealthDay

 
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A drug industry group has proposed revamping pill-bottle labels to make them easier to read and less confusing.
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2012-09-11
Thursday, 11 Oct 2012 02:09 PM
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