Instead it specifically means that evidence for drug efficacy and safety in the

Instead it specifically means that evidence for drug

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experience or data in children. Instead, it specifically means that evidence for drug efficacy and safety in the pediatric population has not been submitted to FDA for review or has not met the regulatory standards of "substantial evidence" for FDA approval" (para. 5). Mayhew (2009) says that reasons medications are prescribed for off-label use include the following: when certain drugs are not approved by insurance and when a logical extension of the mechanism of action is considered. Strategies to Make Drugs Safer in Pediatrics "Increased dissemination of pediatric studies and label information may be helpful to guide clinical practice. Further research should be prioritized for the medications most commonly prescribed off label and to determine outcomes, causes, and appropriateness of off-label prescribing to children" (Bazzano, Mangione-Smith, Schonlau, Suttorp, Brook, 2009, p.81). Wimmer, Neubert, and Rascher (2015) conclude that financial incentives must be created to encourage clinical trials on children to help improve drug safety. Stressing the need for doctors and pharmacists to report adverse reactions in the pediatric population, although not required, should be done to help ensure safety guidelines and practices in the future for children (Wimmer, Neubert, & Rascher, 2015). Lastly, "[a] recognized national standard for
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