Search Results 'MN580 Unit 9 Quiz, Chapter 26. Prescribing Medications in Pediatrics Questions With Answers. Chapter 26. Prescribing Medications in Pediatrics Questions 1. A pharmaceutical company has developed a new drug that was tested only on adults. The FDA has declared this drug to have potential benefits for ill children. According to the Pediatric Research Equity Act (PREA), what may the pharmaceutical company be required to do? A. Conduct pediatric drug studies to determine whether the drug is safe and effective in children. Correct B. Provide labeling stating that the safety and efficacy of the drug is not established for children. C. Receive a patent extension for conducting pediatric studies to determine use in children. D. Survey existing data about the drug to determine potential use in the pediatric population. 2. The primary care pediatric nurse practitioner prescribes a new medication for a child who develops a previously unknown adverse reaction. To report this, the nurse practitioner will A. access the BPCA website. B. call the PREA hotline. C. log onto the FDA Medwatch website. Correct D. use the AAP online PediaLink program. 3. The primary care pediatric nurse practitioner is considering use of a relatively new drug for a 15monthold child. The drug is metabolized by the liver, so the nurse practitioner will consult a pharmacologist to discuss giving the drug: A. less often or at a lower dose. Correct B. more often or at a higher dose. C. via a parenteral route. D. via the oral route. 4. The primary care pediatric nurse practitioner is considering using a drug for an “off label” use in a child. The nurse practitioner has used the drug in a similar situation previously, has consulted a pharmacology resource and the FDA website, and has determined that there are no significant contraindications and warnings for this child. What else must the nurse practitioner do when prescribing this drug?. A. Discuss recommendations with the parents and document their consent. Correct B. Document anecdotal reports of previous use of the drug by other providers. C. Follow up daily with the parents to determine safe administration of the drug. D. Report this use to the FDA Medwatch website for tracking purposes.'