Off-Label Drug Use in Pediatrics

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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 Bazzano et al. and Mayhew articles in the Learning Resources. 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.

With these thoughts in mind:

Post an explanation of circumstances under which children should be prescribed drugs for off-label use. Then, 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.

This work should have Introduction and conclusion

– This work should have at 3 to 5current references (Year 2012 and up)

– Use at least 2 references from class Learning Resources

The following Resources are not acceptable:

1. Wikipedia

2. Cdc.gov- nonhealthcare professionals section

3. Webmd.com

4. Mayoclinic.com

Required Readings

Arcangelo, V. P., Peterson, A. M., Wilbur, V., & Reinhold, J. A. (Eds.). (2017). Pharmacotherapeutics for advanced practice: A practical approach (4th ed.). Ambler, PA: Lippincott Williams & Wilkins. Review Chapter 4, “Principles ; ; ; ; ;of Pharmacotherapy in Pediatrics” (pp. 53-63)
; ; ; ; ;This chapter explores concepts relating to drug selection, administration, ; ; ; ; ;and interaction for pediatric patients. It also compares age-related ; ; ; ; ;pharmacokinetic differences in children and adults. Chapter 17, “Ophthalmic ; ; ; ; ;Disorders” (pp. 221-243)
; ; ; ; ;This chapter examines the causes, pathophysiology, diagnostic criteria, ; ; ; ; ;and drug treatment for four ophthalmic disorders: blepharitis, ; ; ; ; ;conjunctivitis, keratoconjunctivitis sicca, and glaucoma. It also explores ; ; ; ; ;methods of monitoring patient response to treatment. Chapter 43, ; ; ; ; ;“Attention-Deficit/Hyperactivity Disorder” (pp. 743-756)
; ; ; ; ;This chapter explains the process of diagnosing ; ; ; ; ;Attention-Deficit/Hyperactivity Disorder (ADHD). It also identifies drugs ; ; ; ; ;for treating patients with ADHD, including proper dosages, selected ; ; ; ; ;adverse events, and special considerations for each drug. Chapter 51, “Immunizations” ; ; ; ; ;(pp. 906-926)
; ; ; ; ;This chapter explores vaccines that are licensed for use in the United ; ; ; ; ;States and provides a recommended vaccination schedule for pediatric ; ; ; ; ;patients and adults. Chapter 52, “Smoking Cessation” ; ; ; ; ;(pp. 927-943)
; ; ; ; ;This chapter examines clinical implications of smoking. It also covers ; ; ; ; ;various approaches for aiding patients who are dependent on nicotine but ; ; ; ; ;want to stop smoking. Chapter 54, “Weight Loss” (pp. 945-956)
; ; ; ; ;This chapter begins by reviewing patient factors that contribute to ; ; ; ; ;obesity. It also examines drug therapy for initiating weight loss in ; ; ; ; ;patients, as well as alternative non-drug treatments.

Bazzano, A. T, Mangione-Smith, R., Schonlau, M., Suttorp, M. J., & Brook, R. H. (2009). Off-label prescribing to children in the United States outpatient setting. Academic Pediatrics, 9(2), 81–88. ;

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

Mayhew, M. (2009). Off-label prescribing. The Journal for Nurse Practitioners, 5(2), 122–123. ;

This article reviews the prevalence of off-label prescribing, including its benefits and risks. It also explores issues regarding the safety of off-label prescribing and when it is unavoidable.

Drugs.com. (2012). Retrieved from http://www.drugs.com/

This website presents a comprehensive review of prescription and over-the-counter drugs including information on common uses and potential side effects. It also provides updates relating to new drugs on the market, support from health professionals, and a drug-drug interactions checker.

Required Media

Laureate Education, Inc. (Executive Producer). (2012). Advanced pharmacology – Final course review. Baltimore, MD: Author. ;

This media is an interactive final review covering course content.