Walden – NURS 6521 – Off-Label Drug Use in Pediatrics

Walden

What’s Coming Up in Week 10?

Next week, you will continue working on your Discussion assigned in Week 9, as you examine the types of drugs used to treat infections and disorders of the hematologic system.

Next Week

To go to the next week:

 

Week 10: Women’s and Men’s Health/Infections and Hematologic Systems, Part II

Bacterial and viral infections may spread through the direct contact of bodily fluids such as blood or through vectors, who help to spread infections via the blood. When you think of infections and the hematologic system, what comes to mind?

Infectious diseases, such as malaria, dengue, or other hemorrhagic fevers are some examples of infections that impact the hematologic system. However, disorders of the hematologic system, such as anemia or blood clotting factor disorders, can also have a deleterious effect on a patient’s health and well-being. As an advanced practice nurse, you will need to understand the different types of pharmacotherapeutics used to treat infections and disorders of the hematologic system as you work to enhance patient-centered approaches for safe, quality, and effective care.

This week, you will examine infections and hematologic disorders, as well as the types of drugs used to treat aspects of these disorders or health systems.

Learning Objectives

Students will:

  • Evaluate patients for treatment of complex health issues
  • Evaluate patients for treatment of infections
  • Evaluate patients for treatment of hematologic disorders
  • Analyze patient education strategies for the management and treatment of complex comorbidities

Learning Resources

Required Readings

Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2nd ed.) St. Louis, MO: Elsevier.

  • Chapter 46, “Anticoagulant and Antiplatelet Drugs” (pp. 372–388)
  • Chapter 47, “Drugs for Deficiency Anemias” (pp. 389–396)
  • Chapter 50, “Estrogens and Progestins: Basic Pharmacology and Noncontraceptive Applications” (pp. 425–436)
  • Chapter 51, “Birth Control” (pp. 437–446)
  • Chapter 52, “Androgens” (pp. 447–453)
  • Chapter 53, “Male Sexual Dysfunction and Benign Prostatic Hyperplasia” (pp. 454–466)
  • Chapter 70, “Basic Principles of Antimicrobial Therapy” (pp. 651–661)
  • Chapter 71, “Drugs That Weaken the Bacterial Cell Wall I: Penicillins” (pp. 662–668)
  • Chapter 75, “Sulfonamides Antibiotics and Trimethoprim” (pp. 688–694)
  • Chapter 76, “Drug Therapy of Urinary Tract Infections” (pp. 695–699)
  • Chapter 78, “Miscellaneous Antibacterial Drugs” (pp. 711–714)
  • Chapter 79, “Antifungal Agents” (pp. 715–722)
  • Chapter 80, “Antiviral Agents I: Drugs for Non-HIV Viral Infections” (pp. 723–743)
  • Chapter 82, “Drug Therapy of Sexually Transmitted Diseases” (pp. 763–770)

 

Lunenfeld, B., Mskhalaya, G., Zitzmann, M., Arver, S., Kalinchenko, S., Tishova, Y., & Morgentaler, A. (2015). Recommendations on the diagnosis, treatment and monitoring of hypogonadism in men. Aging Male, 18(1), 5–15. doi:10.3109/13685538.2015.1004049

This article presents recommendations on the diagnosis, treatment, and monitoring of hypogonadism in men. Reflect on the concepts presented and consider how this might impact your role as an advanced practice nurse in treating men’s health disorders.

Montaner, J. S. G., Lima, V. D., Harrigan, P. R., Lourenço, L., Yip, B., Nosyk, B., … Kendall, P. (2014). Expansion of HAART coverage is associated with sustained decreases in HIV/AIDS morbidity, mortality and HIV transmission: The “HIV Treatment as Prevention” experience in a Canadian setting. PLoS ONE, 9(2), e87872. Retrieved from https://doi.org/10.1371/journal.pone.0087872

This study examines HAART therapy and its sustainability and profound population-level decrease in morbidity, mortality, and HIV transmission.

Roberts, H., & Hickey, M. (2016). Managing the menopause: An update. Maturitas, 86(2016), 53–58. .https://doi.org/10.1016/j.maturitas.2016.01.007

This article provides an update on treatments on Vasomotor symptoms (VMS), genito-urinary syndrome of menopause (GSM), sleep disturbance, sexual dysfunction, and mood disturbance that are common during the menopause transition.

Agency for Healthcare Research and Quality. (2014). Guide to clinical preventive services, 2014: Section 2. Recommendations for adults. Retrieved from http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/guide/section2.html

This website lists various preventive services available for men and women and provides information about available screenings, tests, preventive medication, and counseling.

Document: Final Exam Study Guide (PDF)

Required Media

Laureate Education (Producer). (2019h). Pathopharmacology: Pharmacology and immunological disorders: Improvements in medications and drug administration [Video file]. Baltimore, MD: Author.
Note:
The approximate length of this media piece is 8 minutes.
Nurse Manager, Bette Nunn discusses how technology has improved the practice of administering drugs and created new and improved drug therapies. The importance of using technology as well as a patient’s knowledge of their own drug history is also discussed.

Discussion: Women’s and Men’s Health, Infectious Disease, and Hematologic Disorders

To Prepare

  • Review the resources for this module and reflect on the different health needs and body systems presented.
  • Review your peers case studies from Week 9.
  • Consider how you will practice critical decision making for prescribing appropriate drugs and treatment to address the complex patient health needs in the patient case study you selected.

By Day 6 of Week 10

Read a selection of your colleagues’ responses from Week 9 and respond to at least two of your colleagues on two different days who were assigned a different patient case study, and provide recommendations for alternative drug treatments to address the patient’s pathophysiology. Be specific and provide examples.

Note: For this Discussion, you are required to complete your initial post before you will be able to view and respond to your colleagues’ postings. Begin by clicking on the “Post to Discussion Question” link, and then select “Create Thread” to complete your initial post. Remember, once you click on Submit, you cannot delete or edit your own posts, and you cannot post anonymously. Please check your post carefully before clicking on Submit!

What’s Coming Up in Module 8?

In the next module, you will examine prescribing drugs and the off-label use of drugs to treat pediatric patients. You will also complete your Final Exam.

Looking Ahead: Final Exam

Please review the Resources and content in the previous modules in preparation for your Final Exam in Module 8.

 

To go to the next week:

Module 8

Module 8: Pediatrics

As an advanced practice nurse, you provide patient care across all stages of the lifespan. While you may not necessarily specialize in pediatrics, you will likely come across pediatric patients and may be involved in developing, implementing, and recommending drug therapy plans for pediatric patients. Of special note, the proper dosing and administration of pharmacotherapeutics for pediatric patients ensures their continued growth, development, and promotion of positive health outcomes.

What’s Happening This Module?

Module 8: Pediatrics is a 1-week module, Week 11 of the course. In this module, you will examine the practice of prescribing off-label drugs to children and explore strategies for making off-label drug use safer for children. You also complete your Final Exam.

What do I have to do?     When do I have to do it?    
Review your Learning Resources Days 1-7, Week 11
Assignment: Off-Label Drug Use in Pediatrics Submit your Assignment by Day 5 of Week 11.
Final Exam Complete by Day 7 of Week 11.

Go to the Week’s Content

 

Week 11: Pediatrics

Children, like adults, deal with variety of health issues, but they also have issues that are more prevalent within their population. One issue that significantly impacts children is the prescription of drugs for off-label use. As an advanced practice nurse, how do you determine the appropriate use of off-label drugs in pediatrics? Are there certain drugs that should be avoided with pediatric patients?

This week, you examine the practice of prescribing off-label drugs to children. You also explore strategies for making off-label drug use safer for children from infancy to adolescence, as it is essential that you are prepared to make drug-related decisions for pediatric patients in clinical settings.

Learning Objectives

Students will:

  • Evaluate the practice of prescribing off-label drugs to children
  • Analyze strategies to make the off-label use of drugs safer for children
  • Identify key terms, concepts, and principles related to prescribing drugs to treat patient disorders

Learning Resources

Required Readings

Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2nd ed.) St. Louis, MO: Elsevier.

Chapter 9, “Drug Therapy in Pediatric Patients” (pp. 58—60)

 

Corny, J., Lebel, D., Bailey, B., & Bussieres, J. (2015). Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. The Journal of Pediatric Pharmacology and Therapeutics, 20(4), 316–328. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4557722/

 

This article highlights pediatric governmental initiatives to prevent unlicensed and off-label drug use in children. Review these initiatives and guidelines and how they might impact your practice as an advanced practice nurse.

Panther, S. G., Knotts, A. M., Odom-Maryon, T., Daratha, K., Woo, T., & Klein, T. A. (2017). Off-label prescribing trends for ADHD medications in very young children. The Journal of Pediatric Pharmacology and Therapeutics, 22(6), 423–429. doi:10.5863/1551-6776-22.6.423

This study examines the frequency of off-label prescribing to children and explores factors that impact off-label prescribing. This study also examines off-label prescribing to children with ADHD.

 

Document: Final Exam Study Guide (PDF)

Required Media

Laureate Education (Producer). (2019i). Therapy for pediatric clients with mood disorders [Interactive media file]. Baltimore, MD: Author.

Assignment: Off-Label Drug Use in Pediatrics

The unapproved use of approved drugs, also called off-label use, with children is quite common. This is because pediatric dosage guidelines are typically unavailable, since very few drugs have been specifically researched and tested with children.

When treating children, prescribers often adjust dosages approved for adults to accommodate a child’s weight. However, children are not just “smaller” adults. Adults and children process and respond to drugs differently in their absorption, distribution, metabolism, and excretion.

Children even respond differently during stages from infancy to adolescence. This poses potential safety concerns when prescribing drugs to pediatric patients. As an advanced practice nurse, you have to be aware of safety implications of the off-label use of drugs with this patient group.

To Prepare

  • Review the interactive media piece in this week’s Resources and reflect on the types of drugs used to treat pediatric patients with mood disorders.
  • Reflect on situations in which children should be prescribed drugs for off-label use.
  • Think about strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Consider specific off-label drugs that you think require extra care and attention when used in pediatrics.

By Day 5 of Week 11

Write a 1-page narrative in APA format that addresses the following:

  • Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
  • Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.

Reminder: The College of Nursing requires that all papers submitted include a title page, introduction, summary, and references. The Sample Paper provided at the Walden Writing Center offers an example of those required elements (available at http://writingcenter.waldenu.edu/57.htm). All papers submitted must use this formatting.

Submission and Grading Information

 



Sample Paper Week 11

Walden NURS 6521 – Off-Label Drug Use in Pediatrics

Advanced Pharmacology

Student’s Name:

Institutional Affiliation:

Circumstances under which Children Should be Prescribed Drugs for Off-label Use

More than 50% of drugs approved by the Food and Drug Administration (FDA) do not contain labeling for children. Therefore, pediatricians have to decide the appropriate prescription based on their clinical judgment. There is however specific guidance by various pediatric associations such as the American Academy of Pediatrics (AAP) on circumstances under which physicians can use drugs off-label on children.

These circumstances include absence of safe and licensed therapeutic options for a specific disease, the failure of the existing standard therapy to achieve success in treating the condition and lack of alternative forms of therapy for children. Other circumstances include lack of clinical trials and availability of convincing evidence on their effectiveness and safety of the of label drugs in children (Panther, Knotts, Odom-Maryon, Daratha, Woo & Klein, 2017).

Strategies to Make the Off-label Use and Dosage of Drugs Safer for Children from Infancy to Adolescence

The risk of adverse drug reaction is high in off-label use compared to approved medication. The risk is even higher for outpatients compared to hospitalized patients due to limited monitoring. Off label, medication requires maximum monitoring since they have not been previously tried on children thus the pediatricians are uncertain of reactions. Safety strategies include administering of label medication to inpatients only to maximize monitoring of the adverse effect. Secondly, physicians should report adverse reactions of off label medication as required by their professional code for purposes of documentation thus reference in subsequent cases (Tanemura, Asawa, Kuroda, Sasaki, Iwane & Urushihara, 2019).

Other strategies include use of electronic health systems to improve the quality of prescribing by integrating parameters such as age, weight, body surface area and renal function status in complex dosage calculations, which is essential in off-label medication. electronic health records facilitates correct dosage  and putting of precaution on negative  drug interactions by sharing patients medical  information to all additional participants in the treatment process (Corny, Lebel, Bailey & Bussières, 2015).

Another strategy is increasing access to evidence-based information regarding off label children medication and integrating pharmacists in pediatric wards for consultation in decisions regarding pediatric prescription of off label medication.

One of the off-label drugs that require extra care and attention when used in pediatrics is Budesonide. It is an inhaled corticosteroid used for asthma treatment. The children’s inability to use inhalers poses a danger of overdose of the drug. Other asthma drugs like mometasone and ciclesonide are new in the market therefor there lacks existing evidence on the implications of their use on children. They should therefore be cautiously prescribed for pediatric use.

 

References

Corny, J., Lebel, D., Bailey, B., & Bussières, J. F. (2015). Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. The Journal of Pediatric Pharmacology and Therapeutics20(4), 316-328.

Panther, S. G., Knotts, A. M., Odom-Maryon, T., Daratha, K., Woo, T., & Klein, T. A. (2017). Off-label prescribing trends for ADHD medications in very young children. The Journal of Pediatric Pharmacology and Therapeutics22(6), 423-429.

Tanemura, N., Asawa, M., Kuroda, M., Sasaki, T., Iwane, Y., & Urushihara, H. (2019). Pediatric off-label use of psychotropic drugs approved for adult use in Japan in the light of approval information regarding pediatric patients in the United States: a study of a pharmacy prescription database. World Journal of Pediatrics15(1), 92-99.

 



 

Final Exam

This Exam covers the content you have explored throughout this course.

This exam is a test of your knowledge in preparation for your certification exam. No outside resources—including books, notes, websites, or any other type of resource—are to be used to complete this exam. You are not allowed to take screenshots or record the exam questions in any other format while taking the exam. You are expected to comply with Walden University’s Code of Conduct.

By Day 7 of Week 11

Complete the Final Exam.

Submission and Grading Information

Complete the Exam by Day 7 of Week 11

To Complete this Exam:

Week 11 Exam

Module in Review

In this module, you evaluated the practice and circumstances of prescribing off-label drugs to children and analyzed the strategies used to make their use and dosage safer for children. After you have completed the Discussion and the Final Exam for this week, you have finished the course. Congratulations! Please complete the Course Evaluation form and submit by Day 7.

Congratulations! After you have finished all of the assignments for this week, you have completed the course. Please submit your Course Evaluation by Day 7.



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