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TESTBANK FOR Fetal and Neonatal Pharmacology for the Advanced Practice Nurse Jnah

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,TESTBANK FOR Fetal and Neonatal Pharmacology
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

,Copyright © 2024 Springer Publishing Company, LLC

All rights reserved.

This work is protected by U.S. copyright laws and is provided solely for the use of instructors in teaching
their courses and as an aid for student learning. No part of this publication may be sold, reproduced,
stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without the prior permission of Springer Publishing Company,
LLC.

Springer Publishing Company, LLC
11 West 42nd Street
New York, NY 10036
www.springerpub.com

ISBN: 978-0-8261-7318-8

The author and the publisher of this Work have made every effort to use sources believed to be reliable to
provide information that is accurate and compatible with the standards generally accepted at the time of
publication. The author and publisher shall not be liable for any special, consequential, or exemplary
damages resulting, in whole or in part, from the readers’ use of, or reliance on, the information contained
in this book. The publisher has no responsibility for the persistence or accuracy of URLs for external or
third-party Internet websites referred to in this publication and does not guarantee that any content on
such websites is, or will remain, accurate or appropriate.

, 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

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