According to the Institute of Medicine (IOM), the misuse of medication results in over one million adverse drug events every year. In a recent blog, our attorneys discussed the current efforts made by the U.S. Pharmacopeial Convention (USP) to establish a universal standard for prescription drug labels and instructions, by issuing a series of recommendations in order to add more consistency to prescription labeling—to reduce medication errors that can result in personal injury or wrongful death.
The USP is a Maryland-based nonprofit organization that issues standards that are legally enforceable for the quality, strength, and purity of medicines in this country. In 2007, the USP developed the Health Literacy and Prescription Container Labeling Advisory Panel to examine the different ways prescription drug labeling could be improved.
The IOM claims that health literacy affects ninety million adults, who are unable to benefit properly from the health care due to a lack of understanding of drug instructions and information about medication interactions. After the IOM called for new drug label standards, the USP panel recently released recommendations that are based on patient well being, and health literacy—as bad health literacy can cause medication errors, and increase the potential for heath risks and personal injury.
According to Joanne G. Schwartzberg, co-chair of the panel, standardizing the medication labels can markedly improve the health and safety of patients, by providing reliable, simple and straightforward information. The USP panel recommendations cover the appearance, content, format and languages on prescription labels, in an effort to optimize patient understanding, and eliminate medication error and misuse.
The USP Advisory panel recommends:
• Organizing the labels on the prescriptions to best represent the way patients look at medication labels—featuring the most important and critical information, so patients can safely comprehend the drug instructions, which leads to the safe usage of the medication.
• Simplifying the language on prescription labels with regular sentences and terms that don’t include unfamiliar words or phrases, like Latin terms, or medical jargon that is unclear, in order to increase patient understanding and promote effective drug use.
• When describing dosage instructions, explicit text should be used in regard to interval and frequency, with numeric text instead of spelling out the numbers. For example, instructions should read “Take 4 tablets every day,” as opposed to “Take two tablets by mouth twice daily.”
• The prescriber’s included purpose should be clearly visible on the label, and stated in a simple language, and any critical information must be included on the drug label in simple, clear text and font, with normal sentence punctuation, and not truncation.
• The labeling of prescription containers should be in a patient’s preferred language. Any translations should be made using a translation process that is high-quality, in order to increase comprehension and drug usage.
• Any supplemental information should be reduced to critical evidence-based information only, and displayed in a manner that is standardized for better patient understanding and comprehension.
• With more e-prescribing, the development of patient standards is important for prescription directions, and could lead to a more consistent language throughout all healthcare systems. All Latin abbreviations should be eliminated as they are often vulnerable to misunderstandings both patient understanding and translation.
If you or a loved one have been harmed by a medication mistake in Maryland or Washington, D.C., contact our experienced attorneys at Lebowitz and Mzhen, LLC today, for a free consultation.
Planned FDA Guidance on Drug Labeling Seeks to Help Reduce Medication Errors, Modern Medicine.com, July 20, 2010
USP Advisory Panel Recommends Standardizing Prescription Container Labeling to Improve Patient Understanding of Medication Instructions, PR Newswire/U.S. Pharmacopeial Convention, May 10, 2010
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