Off-Label Drug Use

Off-Label Drug Use

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 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.

ADDITIONAL INSTRUCTIONS FOR THE CLASS

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• Discussion Questions (DQ)

Initial responses to the DQ should address all components of the questions asked, including a minimum of one scholarly source, and be at least 250 words. Successful responses are substantive (i.e., add something new to the discussion, engage others in the discussion, well-developed idea) and include at least one scholarly source. One or two-sentence responses, simple statements of agreement or “good post,” and responses that are off-topic will not count as substantive. Substantive responses should be at least 150 words. I encourage you to incorporate the readings from the week (as applicable) into your responses.

• Weekly Participation

Your initial responses to the mandatory DQ do not count toward participation and are graded separately. In addition to the DQ responses, you must post at least one reply to peers (or me) on three separate days, for a total of three replies. Participation posts do not require a scholarly source/citation (unless you cite someone else’s work). Part of your weekly participation includes viewing the weekly announcement and attesting to watching it in the comments. These announcements are made to ensure you understand everything that is due during the week.

• APA Format and Writing Quality

Familiarize yourself with the APA format and practice using it correctly. It is used for most writing assignments for your degree. Visit the Writing Center in the Student Success Center, under the Resources tab in Loud-cloud for APA paper templates, citation examples, tips, etc. Points will be deducted for poor use of APA format or absence of APA format (if required). Cite all sources of information! When in doubt, cite the source. Paraphrasing also requires a citation. I highly recommend using the APA Publication Manual, 6th edition.

• Use of Direct Quotes

I discourage over-utilization of direct quotes in DQs and assignments at the Master’s level and deduct points accordingly. As Masters’ level students, it is important that you be able to critically analyze and interpret information from journal articles and other resources. Simply restating someone else’s words does not demonstrate an understanding of the content or critical analysis of the content. It is best to paraphrase content and cite your source.

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For assignments that need to be submitted to Lopes Write, please be sure you have received your report and Similarity Index (SI) percentage BEFORE you do a “final submit” to me. Once you have received your report, please review it. This report will show you grammatical, punctuation, and spelling errors that can easily be fixed. Take the extra few minutes to review instead of getting counted off for these mistakes. Review your similarities. Did you forget to cite something? Did you not paraphrase well enough? Is your paper made up of someone else’s thoughts more than your own? Visit the Writing Center in the Student Success Center, under the Resources tab in Loud-cloud for tips on improving your paper and SI score.

• Late Policy

The university’s policy on late assignments is a 10% penalty PER DAY LATE. This also applies to late DQ replies. Please communicate with me if you anticipate having to submit an assignment late. I am happy to be flexible, with advance notice. We may be able to work out an extension based on extenuating circumstances. If you do not communicate with me before submitting an assignment late, the GCU late policy will be in effect. I do not accept assignments that are two or more weeks late unless we have worked out an extension. As per policy, no assignments are accepted after the last day of class. Any assignment submitted after midnight on the last day of class will not be accepted for grading.

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