New FDA Initiative Seeks To Decrease Drug Dosage Errors

Greg Webb
Attorney
(866) 735-1102 Ext 530
Posted by Greg WebbNovember 22, 2009 8:52 AM

In an attempt to curb the number of serious deaths and illnesses caused by misuse of medication, the Food and Drug Administration (FDA) is attempting to identify the most serious threats and find ways to avoid them through their Safe Use Initiative. The FDA called on doctors, other healthcare professionals and consumers in order to gain information about which drugs and circumstances may be particular problems; they will also be calling public hearings as well.

One of the main issues the FDA has identified is the overuse of acetaminophen, a pain reliever that can cause liver damage if taken in excess; because the drug is used in so many different medications, it is hard for the consumer to know how much he or she is taking. The FDA will also investigate information given to patients, such as labels, package inserts and directions that pharmacists use when distributing prescriptions. Such an investigation is long overdue since about 99.5% of pamphlets contain unregulated information that is missing critical information.

According to a 2007 study conducted by the Institute of Medicine, about 1.5 million preventable “drug accident events” occur annually in the United States; aside from the toll on health, this costs an estimated $4 billion each year as well. FDA officials acknowledged they do not have these hard figures since the term "preventable harm" encompasses a range of poorly tracked activities including accidental overdoses, distributing the wrong medication or the wrong dosage, abuse of medication and drug-quality defects; medication errors do not contain common side-effects.

This writer thinks this is a good initiative. One wonders how many incidents there are per year of unintended “misuse” of medications, through lack of education or information about the particular drug at issue. Many people overuse over-the-counter pain medications because they cannot afford prescription strength drugs.

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