will include as many as 20 states and provides an excellent opportunity for partnering with the FDA at the state level. Sharfstein encouraged contact with Weiss to discuss this further.

Bernard Dreyer from the New York University School of Medicine said that he is concerned that, other than the issue of vaccines in the United States, children are viewed as basically healthy with very few problems. We know in pediatrics that medication errors are generally the result of parent confusion about how to administer over-the-counter and prescription medications. Most of these errors do not lead to mortality, even though they do result in adverse events. When you speak of the Safe Use Initiative, he said to Sharfstein, you mention saving lives, and if that is the criteria by which the FDA chooses issues of importance, then medication errors in children will not rise to the top as a key issue. Yet those children do end up in emergency rooms and require medical treatment.

Sharfstein responded that while he emphasized saving lives in his presentation, other outcomes are extremely important. In fact, there is a tremendous amount of effort being expended on children’s use of OTC medicines. The FDA very much supports the efforts of the American Academy of Pediatrics (AAP) and encourages AAP to bring together individuals to address the issue of safe use of medicines in children.



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