WSJ Report on Medication Errors and New Efforts to Improve Labeling

Reported in the Wall Street Journal
By Laura Landro

A new push is under way to make prescription drug information clearer and stem the rise in emergency room visits and hospitalizations resulting from patients incorrectly taking their medicine. The Food and Drug Administration is planning to test single-page consumer information sheets that would replace the multi-page package inserts and medication guides widely used in retail pharmacies. And the U.S. Pharmacopeial Convention, which sets quality standards enforced by the FDA for the quality, strength and purity of medicines, is developing a new national standard for prescription labels, which can vary widely from pharmacy to pharmacy and befuddle consumers. The standards, if adopted, would require clear instructions on dose and timing and state in simple terms the purpose of the drug—such as "for high blood pressure"—unless the patient prefers that it not appear.

Improving Patient Safety By Reducing Medication Errors

• Nearly 1.9 million people were treated in hospitals for illnesses and injuries from taking medicines, a 52% increase from 2004 to 2008.
• Another 838,000 people were treated and released from emergency rooms due to harm from medications in 2008.
• Almost 36% of treat-and-release emergency room visits were patients ages 18 to 44, and 18% were elderly.

Doctors and pharmacists are also being encouraged to counsel patients more effectively about their medications. About 100 industry and nonprofit groups are participating in a national awareness campaign about the importance of taking medication as directed, to be launched in May by the National Consumers League. The campaign includes a website for health professionals and a separate website where consumers can download tools such as work sheets to manage their medications. The group says more than a third of medication-related hospital admissions are linked to poor medication adherence.

Medication mishaps often happen in the hospital, due to clinician error and unexpected allergies or reactions. According to the Agency for Healthcare Research and Quality, the number of people treated in U.S. hospitals for illnesses and injuries from taking medications jumped 52% to 1.9 million between 2004 and 2008, the latest year available, including patients admitted from the emergency room. More than half of the increase was due to corticosteroids, blood thinners, and sedatives and hypnotics.

Another 838,000 patients were also treated and released from the ER with problems related to those and other medications, including painkillers, antibiotics, cardiovascular drugs, insulin and other hormones used to treat common diseases such as asthma, arthritis and ulcerative colitis. FDA officials say inadvertent errors made by patients who misunderstand information are causing significant harm. One reason cited is low literacy skills. A study in 2006 showed that of 70% of patients with low literacy who could correctly state the instructions "take two tablets by mouth twice daily," only 34% could then demonstrate the number to be taken daily.

Michael Wolf, an associate professor at Northwestern University's Feinberg School of Medicine who serves on an FDA risk-communication advisory panel, says in recent studies, more than half of adults misunderstood one or more common prescription warnings and precautions. In one study Dr. Wolf and colleagues found that patients better understood simple, explicit language on warning labels—like "use only on your skin" instead of "for external use only"—and those with lower literacy skills also benefited from picture icons, such as a sun with a black bar across with words, "limit your time in the sun."

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