Surprisingly few medications routinely prescribed for children have actually been studied for pediatric use. Medications that are safe for adults may have detrimental effects on children. However, the trend of forgoing pediatric drug research continues. The lack of pediatric data leads to "off-label" prescribing by health care providers, although most advanced practice nurses follow specific prescription protocols. The history and scope of "off- label" prescribing and its effects on the general public are discussed. The need for pediatric clinical trials is addressed as well as the FDA's attempts to improve the safety of pediatric drug therapy.
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