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.
5. The primary care pediatric nurse practitioner is counseling an adolescent who was recently
hospitalized for an asthma exacerbation and learns that the child usually forgets to use twice
daily inhaled corticosteroid medications that are supposed to be given at 0800 and 2000 each
day. Which strategy may be useful in this case to improve adherence?
A. Ask the adolescent to identify two times each day that may work better. Correct
B. Consider having the school nurse supervise medication administration.
C. Prescribing a daily oral corticosteroid medication instead.
D. Suggest that the parent enforce the medication regimen each day.
6. The primary care pediatric nurse practitioner is treating a toddler who has a lower respiratory
tract illness with a low-grade fever. The child is eating and taking fluids well and has normal
oxygen saturations in the clinic. The nurse practitioner suspects that the child has a viral
pneumonia and will
A. order an antiviral medication and schedule a follow up appointment.
B. prescribe a broad-spectrum antibiotic until the lab results are received.
C. teach the parents symptomatic care and order labs to help with the diagnosis. Correct
D. write a prescription for an antibiotic to be given if the child’s condition worsens.
7. The single mother of a 4yearold who attends day care tells the primary care pediatric nurse
practitioner that she had difficulty giving her child a twice daily amoxicillin for 10 days to treat
otitis media during a previous episode several months earlier because she works two jobs and is
too busy. The child has an ear infection in the clinic today. What will the nurse practitioner do?
A. Administer an intramuscular antibiotic.
B. Order twice daily amoxicillin for 5 days.
C. Prescribe azithromycin once daily for 5 days. Correct
D. Reinforce the need to adhere to the plan of care.