for the Advanced Practice Nurse Jnah, Amy
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,Fetal and Neonatal Pharmacology for the
Advanced Practice Nurse
First Edition
Amy J. Jnah, DNP, APRN, NNP-BC, and Christopher
McPherson, PharmD, BCPPS
Editors
Copyright © Springer Publishing Company
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ISBN: 978-0-8261-7318-8
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, Contents
PART I: BASIC PRINCIPLES OF FETAL AND NEONATAL PHARMACOLOGY
Chapter 1: Pediatric Drug Regulation in the United States 5
Chapter 2: Prescriptive Authority 14
Chapter 3: Pharmacokinetics and Pharmacodynamics 21
Chapter 4: Neonatal Pharmacogenomics and Pharmacogenetics 30
Chapter 5: Perinatal Pharmacology 38
Chapter 6: Postpartum Pharmacology 46
Chapter 7: Common Medications Prescribed in the Newborn Nursery 54
Chapter 8: Vaccines and Schedules 63
PART II: COMMON CENTRAL NERVOUS SYSTEM PROBLEMS
Chapter 9: Neonatal Abstinence Syndrome 71
Chapter 10: Apnea of Prematurity 79
Chapter 11: Analgesia and Sedation 89
Chapter 12: Neonatal Seizures 97
PART III: COMMON RESPIRATORY PROBLEMS
Chapter 13: Respiratory Distress Syndrome 105
Chapter 14: Pulmonary Hemorrhage 112
Chapter 15: Persistent Pulmonary Hypertension of the Newborn 119
Chapter 16: Bronchopulmonary Dysplasia 126
PART IV: COMMON CARDIOVASCULAR PROBLEMS
Chapter 17: Patent Ductus Arteriosus 133
Chapter 18: Critical Congenital Heart Defects 140
,Chapter 19: Tachyarrhythmias 146
Chapter 20: Hypotension and Shock 153
PART V: COMMON GASTROINTESTINAL PROBLEMS
Chapter 21: Human Milk as Medicine 160
Chapter 22: Enteral Nutrition and Gastrointestinal Problems: Formulas,
Supplements, and Pharmacotherapeutics 167
Chapter 23: Parenteral Nutrition 174
Chapter 24: Necrotizing Enterocolitis 181
PART VI: COMMON HEMATOPOIETIC AND ENDOCRINE PROBLEMS
Chapter 25: Hyperbilirubinemia 188
Chapter 26: Osteopenia of Prematurity 195
PART VII: COMMON INFECTIOUS DISEASE PROBLEMS
Chapter 27: Congenital Viral Infections 202
Chapter 28: Neonatal Sepsis and Meningitis 209
PART VIII: COMMON OCULAR PROBLEMS
Chapter 29: Retinopathy of Prematurity 216
PART IX: SPECIAL CIRCUMSTANCES
Chapter 30: Central Venous Catheter Care and Occlusion 224
PART X: APPENDIX
Chapter 31: Formulary 231
,Chapter 1: Pediatric Drug Regulation in the United
States
1. In the pursuit of high-quality research on drug efficacy and safety when used in the neonatal
population, the NP understands the use of real-world data compared to randomized controlled
trials (RCTs):
A. Is the gold standard for high-quality research.
B. Requires more time to complete due to the depth of data analysis necessary.
C. Can increase the overall sample size which increases the significance level of the
findings.
D. Can experience delays due to the recruitment process.
Correct Answer: C
Rationale: While randomized controlled trials (RCTs) are considered the gold standard for high-
quality research, real world data, such as data generated from an electronic medical record (EMR)
warehouse, are increasingly being used to reduce the time and resources needed compared with
randomized controlled trials (RCTs) while having the added benefit of larger sample sizes.
Challenges in recruitment for RCTs can result in delayed data collection.
2. When prescribing Fluconazole to a preterm neonate in the NICU as prophylaxis for the
prevention of disseminated candidiasis, what is the best action for the Neonatal NP to take?
A. Refrain from disclosing the off-label use to the family
B. Document the ethical justification for the drug selection
C. Modify the neonate’s gestation to justify the use of the drug to obtain insurance approval
, D. Use a shared decision-making process with the parents to obtain informed consent for the
use of the off-label drug
Correct Answer: D
Rationale: Use of a shared decision-making process in prescribing any new treatment is best
practice in obtaining informed consent, especially for the treatment with an off-label drug. Off-
label use of the drug must be disclosed to the parents as an ethical obligation and a requirement
for informed consent. Documenting the ethical justification for the use of the off-label drug is a
component of obtaining informed consent. Modifying the patient’s age for the purpose of
obtaining insurance approval is unethical and illegal when patient records are falsified.
3. What strategy used in modern legislation aimed at increasing high-quality drug efficacy and
safety research in pediatric populations by pharmaceutical companies is considered to be least
successful?
A. Federally funded financial support
B. Exclusivity incentives
C. Voluntary participation
D. Regulatory mandates
Correct Answer: D
, Rationale: Regulatory mandates have proven to be the least successful strategy in encouraging
pharmaceutical companies to include neonates, infants, and children in clinical drug studies.
Federally funded financial support of pharmaceutical companies designed to address the
economic challenges faced by pharmaceutical companies as a result of including the pediatric
population in clinical drug studies has produced more significant success. In addition, exclusivity
incentives provided even more reasons for pharmaceutical companies to expand their clinical
trials to include neonates, infants, and pediatrics. Finally, voluntary participation by
pharmaceutical companies has been the cornerstone to reduced resistance and improved
participation in such clinical research inclusion of neonates, infants, and pediatrics.
4. Insufficient pediatric dosing information resulting from a lack of high-quality drug efficacy
studies leads to increased risk for…
A. Allergic reactions
B. Medication errors
C. Toxicity or subtherapeutic dosing
D. Side effects
Correct Answer: C
Rationale: Insufficient pediatric dosing information specifically results in increased risk for
administering too much of the drug causing toxicity or too little of the drug to create a therapeutic
response (subtherapeutic). The lack of drug efficacy study data in the pediatric population results
in a failure to discover population specific unintended, harmful drug responses or adverse effects.
Side effects are more common, predictable effects associated with all drugs and that are less
, harmful than adverse effects. Lack of pediatric specific dosing information is not associated with
increased risk of allergic response. An increase in medication error rates is not associated with
lack of pediatric specific dosing information.
5. Which statement most accurately describes the primary rationale used by manufacturers to justify
excluding neonates, infants, and children from new medication studies?
A. Once the pharmacokinetics and pharmacodynamics of a new medication have been
established in adults the data can be extrapolated to be applied to neonate, infant, and
child populations.
B. The risks of exposing neonates, infants, and children to a new medication without prior
understanding of the pharmacokinetics and pharmacodynamics outweighed the potential
benefits.
C. Neonates, infants, and children are considered a vulnerable population that is protected
by the federal government from the risks associated with inclusion in medical research.
D. The excess costs, resources, and time needed for the inclusion of neonates, infants, and
children in new medication studies created undue economic burden.
Correct Answer: D
Rationale: The most significant rationale for inclusion of neonates, infants, and children in new
medication studies was a result of the added costs, resources, and extended timeframes placing an
economic burden on the manufacturer. The ethical challenge associated with conducting new
medication research in any population requires balance of risks versus benefits. While
extrapolation of data from new medication studies on adults has been used to support off-label