Chapter 26: Prescribing Medications in Pediatrics

Garzon Maaks: Burns’ Pediatric Primary Care, 7th Edition

MULTIPLE CHOICE

1. A pharmaceutical company has developed a new drug that was tested only on adults. The
Federal Drug Administration (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.
ANS: A
The PREA gives the FDA more leverage over the types of new drugs developed for children
and can require pharmaceutical companies to conduct pediatric drug trials if the FDA declares
a drug as possibly useful to ill children or one that might be used by a substantial number of
children. The Food and Drug Administration Modernization Act (FDAMA) allowed labeling
that “safety and effectiveness in pediatric patients have not been established” on drugs with
insufficient evidence to support pediatric indications. The Best Pharmaceuticals of Children
Act (BPCA) grants a patent extension when a drug company voluntarily studies a known or
new drug in children. The FDAMA also requires pharmaceutical companies to survey existing
data and determine potential drug use and indications in pediatric populations.

2. The primary care pediatric nurse practitioner prescribes a new medication for a child who
develops a previously unknown adverse reaction. To report this, what action will the nurse
practitioner take?
a. Access the BPCA website.
b. Call the PREA hotline.
c. Log onto the FDA Medwatch website.
d. Use the AAP online PediaLink program.
ANS: C
The FDA Medwatch website is available for reporting of drug-related adverse effects, and all
providers are encouraged to report these here. BPCA and PREA are legislative acts and do not
have a hotline or website for adverse effects reporting. The AAP PediaLink program is a
source for labeling changes of drugs.

3. The primary care pediatric nurse practitioner is considering use of a relatively new drug for a
15-month-old 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.
ANS: A
Infants metabolize drugs more slowly than older children due to decreased levels of oxidases
and conjugating enzymes produced in the immature liver, so they may need drugs given less
often or at lower doses to avoid toxicity. The route does not necessarily play a role in this
case.

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.
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.
ANS: A
Many prescriptions are written for “off-label” uses for children because the drug doesn’t have
enough substantial evidence for FDA approval. The PNP should make sure to discuss the drug
and this use with the family and document the decision-making process and their consent for
this use. It is not enough to base a decision solely on what someone else has done. Unless the
drug is experimental or has many serious adverse effects, close daily monitoring is not
necessary. The PNP is not required to report off-label drug use to the FDA.

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.
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.
ANS: A
When working with adolescents who take medication, it is important to allow the adolescent
to have input into dosing schedules and what works for them. Having the school nurse
supervise does not allow autonomy and creates continued dependency. Daily oral
corticosteroids are not used for maintenance. The PNP should assist the family with
transitioning the adolescent from parent to teen administration and not suggest that parents
enforce medication rules.

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 anti-viral 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.
d. write a prescription for an antibiotic to be given if the child’s condition worsens.
 ANS: C
To decrease antibiotic overuse and resistance, the PNP should order an antibiotic only if
laboratory data confirm a bacterial infection. This child is mildly ill and can be treated
symptomatically. It is not necessary to treat with an anti-viral medication. A broad-spectrum
antibiotic will only increase the risk of antibiotic resistance. Writing a prescription for the
parents to fill if needed is not recommended; parents may give an antibiotic believing that it is
indicated when it is not.

7. The single mother of a 4-year-old 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.
d. Reinforce the need to adhere to the plan of care.
ANS: C
To improve adherence, the PNP should shorten the length of treatment, if possible and, if
possible, reduce the number of times per day that a medication is given. This mother indicated
that she had difficulty giving two doses per day, so a once daily for 5 days medication is ideal.
It is not necessary to give an IM injection unless the child refuses to take the medication.
Reinforcing the need to adhere to the plan is important but does not address the underlying
difficulty associated with scheduling.

8. The parent of a school-age child who has asthma tells the primary care pediatric nurse
practitioner that the child often comes home from school with severe wheezing after gym
class and needs to use his metered-dose inhaler right away. What will the nurse practitioner
do?
a. Recommend that the child go to the school nurse when symptoms start.
b. Review the child’s asthma action plan and possibly increase his steroid dose.
c. Suggest asking the school to excuse the child from gym class.
d. Write the prescription for two metered-dose inhalers with spacers.
ANS: D
When children have to take a medication at school or day care, the PNP should dispense two
units of the medication so that one can remain at school and one at home to avoid missed
doses. The school nurse will not be able to order a medication that the child does not have
available. The child is missing his rescue medication and just needs access to his inhaler. It is
not necessary to excuse the child from gym class if his symptoms can be controlled.