Burn’s pediatric primary Care 7th
Edition Chapter 26 Questions with
Accurate Answers
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. - ANSWERSa
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. - ANSWERSc
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. - ANSWERSa
The primary care pediatric nurse practitioner is considering using a drug for an "offlabel"
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.
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. - ANSWERSa
Edition Chapter 26 Questions with
Accurate Answers
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. - ANSWERSa
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. - ANSWERSc
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. - ANSWERSa
The primary care pediatric nurse practitioner is considering using a drug for an "offlabel"
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.
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. - ANSWERSa
