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FDA
FDA Consumer magazine
May-June 2003
Table of Contents
Bar codes--those tiny arrays of vertical lines and numbers that have become a nearly ubiquitous fixture on everything from newspapers to SUVs--may soon be required on medications regulated by the Food and Drug Administration.
In March, HHS Secretary Tommy G. Thompson proposed placing codes on drugs to help make them easier to identify and to ensure that safe doses are given. In addition, the FDA has proposed a rule that would revamp the way the agency records negative side effects of medications called "adverse events."
A 1999 Institute of Medicine report estimated that as many as 98,000 Americans may die each year due to preventable medical errors. About 7 percent of these deaths involve errors related to medication.
In addition to the human suffering they cause, medication errors represent significant economic cost to the United States. According to the Institute of Medicine and other experts, thousands of deaths and millions of hospitalizations result from medication errors. Bar codes and other measures aimed at preventing medication adverse events could result in an annual benefit of as much as $3.9 billion.
"[These] actions are the start of a comprehensive strategy to build a medical patient protection system for the 21st century," FDA Commissioner Mark B. McClellan, M.D., Ph.D., said in announcing the proposed rules.
For more on these proposed rules and the steps the FDA is taking to reduce medication errors, see our cover story titled "Strategies to Reduce Medication Errors" in this issue.
According to experts, breast-feeding is one of the most important contributors to infant health. Researchers have found that breast-feeding improves a baby's growth, immunity and development.
Despite these findings, the rates of breast-feeding in the United States are low--only 29 percent of all U.S. mothers were breast-feeding their infants at six months after birth in 1998, the most recent statistics available. Even more alarming, researchers say, is the fact that African-American women breast-feed their infants at rates significantly below the overall U.S. rate.
The Department of Health and Human Services has developed a "Blueprint for Action on Breastfeeding" in an effort to increase the rates of breast-feeding among U.S. women. For more on the plan, see our feature story.
Interest in the cloning of livestock for commercial reasons has generated numerous inquiries to the FDA in recent years. The agency's Center for Veterinary Medicine is looking into the safety of animals and their progeny produced as a result of somatic cell nuclear transfer--the method used to produce "Dolly the Sheep." For more on cloning and the FDA's role, see our feature article.
Baltimore Orioles pitcher Steve Bechler had "significant amounts" of a popular weight-loss supplement containing ephedra in his system when he suffered heat stroke and collapsed in February, the Broward County (Fla.) medical examiner says. Find out more about the steps taken by HHS and the FDA to protect consumers tempted to use products containing ephedra.
We also offer tips on how to stay well during a cruise, and discuss the latest agency-wide initiatives aimed at helping to bring new medical products to the marketplace in the shortest possible time.
Ray Formanek Jr.
Editor