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Regulatory Affairs News and topics related to marketing laws, regulations and guidelines. Includes news feeds from FDA, including press releases, advisory committee meeting announcements, and drug safety notices.

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Old 26th April 2011, 05:38 AM
Pharma Newshound Pharma Newshound is offline
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Default FDA Plans to Test New Standard for Rx Labels

Source: WSJ

'Use Only as Directed' Isn't Easy

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.

As many as three in four Americans say they don't take prescription medicine as directed, according to the National Community Pharmacists Association.

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.

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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.
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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.

With the growing complexity of medication regimens, especially for the elderly and those with multiple, chronic conditions, even highly educated consumers can fail to take their medications correctly, says Karen Weiss, program director of the FDA's Safe Use Initiative. "We need to create better awareness about the gamut of harm that can occur."

Currently, consumers may receive as many as three different types of drug pamphlets with their prescriptions: package inserts written by the manufacturer and approved by the FDA, medication guides for certain classes of drugs and products required by the FDA, and consumer medical information provided by various third-party companies. However, recent studies by the FDA have shown that the information offered is not consistently understandable—and sometimes even conflicting or inaccurate.

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."

In another study, his team filled 100 prescriptions across the country and found that important warnings often were not included on labels. For example, only half the time did prescription labels for Fosamax, an osteoporosis drug, carry the warning that patients should not lie down for 30 minutes after taking the drug; doing so can lead to irritation and erosion of the lining of the esophagus.

The FDA is working with the Brookings Institution on the one-page guides that could eventually replace other materials, says Denise Hinton, a senior program manager with the FDA. A pilot test is awaiting funding from the Office of Management and Budget. It could take five to six years for a final rule to go into effect.

There is some concern that a one-page summary printed on only one side isn't adequate, especially for more complex drugs. The Institute for Safe Medication Practices (ISMP), a nonprofit safety group that investigates medication errors, is working with the Agency for Healthcare Research and Quality on a series of medication brochures printed on two sides of a single page for medications with the potential to cause the most harm, such as the cancer drug methotrexate, which has caused deaths when mistakenly taken daily instead of once or twice a week. ISMP President Michael Cohen says the free brochures will be tested in pharmacies this year.

The American Society of Health-System Pharmacists, which creates medication instructions used by the federal National Library of Medicine, cautions that it will be difficult to boil down instructions to a single page without compromising patient safety, says Gerald McEvoy, assistant vice president of the group.

Kaiser Permanente, the large managed-care organization, has started a training program for pharmacists that includes confirming the directions for use and stressing the importance of taking medication as prescribed. "As reluctant as many pharmacists and consumers are to take the extra time, it is worth one last extra check to make sure nothing will go wrong," says Michael Negrete, chief executive of the Pharmacy Foundation of California.

Write to Laura Landro at laura.landro@wsj.com
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