FDA Redesigns Pharmacy Packet Inserts to Avoid Medication Error Injury

According to a recent article in the Wall Street Journal, a new national initiative is underway to make prescription medications clearer, and to decrease the rise of medication error that lead to hospitalizations and emergency room visits from patients who take their medication incorrectly—which according to the National Community Pharmacists Association happens to three out of every four Americans.

The U.S. Food and Drug Administration (FDA) is reportedly planning to test a new one-page information sheet to replace the many leaflet inserts and medication guides that are widely used in retail pharmacy chains across the country. And the U.S. Pharmacopeial Convention, the organization responsible for setting quality standards that are enforced by the FDA for the strength, purity and quality of medicines, has also developed a new program to create national standards for prescription labels, which currently vary greatly from pharmacy to pharmacy. The national label standard would require clearer instructions on the medication dosage, the medication timing and clearly state the purpose of the medication—to reduce medication and pharmacy error injury.

Currently, in pharmacies across the country, consumers may receive three different forms of drug information and pamphlets with their prescription medication—drug package inserts that are written by the drug manufacturer with FDA approval, drug guides for specific classes of drugs and products that are required by the FDA, and third-party consumer medical information. And according to the WSJ, recent FDA studies have shown that the drug information offered to consumers does not provide reliable understanding with the people taking the drugs, and is often conflicting in instruction, or even inaccurate, which could lead to patient harm or injury.

According to a recent FDA risk-communication advisory panel, more than half of adults misread or misunderstand one or more of common drug prescription precautions or warnings. In one study, patients were found to better understand language on warning labels that was simple and specific, like “use only on your skin” as opposed to “for external use only.” For consumers with lower English literacy skills, picture icons were provided, like a sun with a black bar, with the phrase, “limit your time in the sun.”

In yet another study, the panel reportedly found that with 100 prescriptions filled across the country, important warnings were often not even included on the label—like with the drug Fosamax, prescribed for osteoporosis, where only half of the prescription labels carried the important warning to not lie down for 30 minutes after taking the medication, as this could irritate the esophagus.

Some worry only one page of medication directions and summary will not be adequate, especially for more complex drugs. The Institute for Safe Medication Practices (ISMP) is reportedly working with the Agency for Healthcare Research and Quality (AHRQ) on a series of medication brochures that will have drug information printed on both sides of a single page of paper for serious medications that have potential to cause the most harm—like for methotrexate, the dangerous cancer drug, which if taken daily instead of once or twice during the week, can cause death.

The FDA is reportedly working on the one-page medication guidelines with the Brookings Institution that will eventually replace national drug materials in pharmacies, but could take up to five or six years for the final approval to take effect.

‘Use Only as Directed’ Isn’t Easy, The Wall Street Journal, April 26, 2011

Related Web Resources:

Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services

Institute for Safe Medication Practices, (ISMP)

Institute of Medicine (IOM)

U.S. Food and Drug Administration: Medication Error Reports

Related Blog Posts:

Another Child Receives Prescription Mix-up From Same Walgreens Pharmacy, Pharmacy Error Injury Lawyer Blog, February 23, 2011
A Pharmacy’s Guide to Medication Therapy Management, Pharmacy Error Injury Lawyer Blog, January 6, 2011

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