week 11 discussion.docx - Post an explanation of circumstances under which children should be prescribed drugs for offlabel use Then describe strategies

week 11 discussion.docx - Post an explanation of...

This preview shows page 1 - 2 out of 4 pages.

Post an explanation of circumstances under which children should be prescribed drugs for off- label use. Then, describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. Main Post Explanation of off label use In general, before a drug is approved for use by the FDA, its efficacy and safety are evaluated by conducting clinical trials on highly selected populations. Children are not sufficiently represented in clinical trials because of safety issues; these drugs, however, have to be administered to children in clinical practice(Rollins DE, et.al. 2016). This is where the term "Off-label" come into the picture. Off label means the medication is being used in a manner not specified in the FDA's approved packaging label, or insert. Every prescription drug marketed in the U.S. carries an individual, FDA-approved label (Miller, K., 2018). Many pediatricians must prescribe drugs off-label, simply because an overwhelming number of critical drugs still have no information on the label for use in children. Strategies Dosage guidelines are not available for most drugs in children, so the empirical dose adjustment method is used to determine the appropriate dosage. Dosage should be based on the child’s age or body weight using the adult drug dosages as guidance. Young’s rule [Adult Dose ×
Image of page 1
Image of page 2

  • Left Quote Icon

    Student Picture

  • Left Quote Icon

    Student Picture

  • Left Quote Icon

    Student Picture