Burn’s pediatric primary Care 7th Edition
Chapter 26 100% verfied
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.
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. -
answer✔✔✨-a
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.
d. use the AAP online PediaLink program. - answer✔✔✨-c
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.
b. more often or at a higher dose.
c. via a parenteral route.
d. via the oral route. - answer✔✔✨-a
Chapter 26 100% verfied
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.
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. -
answer✔✔✨-a
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.
d. use the AAP online PediaLink program. - answer✔✔✨-c
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.
b. more often or at a higher dose.
c. via a parenteral route.
d. via the oral route. - answer✔✔✨-a
