NURS 6521 Week 11: Pediatrics

Sample Answer for NURS 6521 Week 11: Pediatrics Included After Question

NURS 6521 Week 11: Pediatrics 

Children deal with variety of health issues similar to adults, 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. Consider the case of Rebecca Riley. When she was two years old, Riley was diagnosed with ADHD, and by age three, she was diagnosed with bipolar disorder. In the span of two years, Riley’s doctor prescribed four drugs off-label: Clonidine, Depakote, Zyprexa, and Seroquel. Riley’s doctor also approved 13 increases in drug dosages. Then, at age four, Riley died from pneumonia combined with a toxic level of prescription drugs (Lambert, 2010). Cases such as this have brought attention to the off-label use of drugs in pediatric patients, as well as the importance of monitoring patient reactions to prescribed drugs and evaluating the effects of drug-drug interactions. 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 

By the end of this week, 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 
  • Understand and apply key terms, concepts, and principles related to prescribing drugs to treat pediatric patients 

Photo Credit: XiXinXing/Getty Images 

NURS 6521 Week 11: Pediatrics 
NURS 6521 Week 11: Pediatrics

Learning Resources 

Note: To access this week’s required library resources, please click on the link to the Course Readings List, found in the Course Materials section of your Syllabus. 

This page contains the Learning Resources for this week. Be sure to scroll down the page to see all of this week’s assigned Learning Resources. To access select media resources, please use the media player below. 

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.  

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 

Note: Retrieved from the Walden Library databases. 


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


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 


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. 


Note: Although this media piece references Week 12, the content associated with Week 12 is a review of Week 1. 


Optional Resources 

Refer to the Optional Resources listed in Week 1. 


Discussion: 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 Panther et al (2017) and Corney, Lebel, Bailey, and Bussieres (2015) 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: 

By Day 3 

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. 

By Day 6 

Read a selection of your colleagues’ responses and respond to at least two of your colleagues on two different days who provided a different rationale than you did, in one or more of the following ways: 

  • Offer and support an alternative perspective using readings from the classroom or from your own research in the Walden Library. 
  • Validate an idea with your own experience and additional research. 

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! 

Submission and Grading Information 

Grading Criteria  


To access your rubric: 

Discussion Rubric 



Post by Day 3 and Respond by Day 6 


To participate in this Discussion: 

Week 11 Discussion 



Week 11 Quiz 

This week’s Quiz covers the content you have explored this week. The Quiz may include the following topics: 

  • Drug classifications by indication—allergic disorders, childhood immunizations, newborn patient health, pediatric patient health 
  • Drug dosage calculations 
  • Drug interactions 
  • Health promotion drugs for smoking cessation, travel, vaccines, weight loss 

By Day 7 

You have 100 minutes to complete this 41-question Quiz. 

Submission and Grading Information 

Submit Your Quiz by Day 7 


To submit your Quiz: 

Week 11 Quiz 



Week In Review 

This week 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 for this week, you have finished the course. Congratulations! Please complete the Course Evaluation form and submit by Day 7. 

A Sample Answer For the Assignment: NURS 6521 Week 11: Pediatrics

Title: NURS 6521 Week 11: Pediatrics

Nurs 6521 

Week 11 

Off-Label Drug Use in Pediatrics 

Medications are frequently used for reasons other than what they are prescribed for.  When this occurs, it called off label use, and the reason the medication is used is not listed on the medication insert.  Using a medication that off-label does not mean that it is not proper for the child, off-label does not mean improper, illegal, contraindicated, or investigational use (American Academy of Pediatrics, 2014, p. 563).  When using medications for the off-label reason, the child has to be monitored closely.   


            There are not many clinical trials if that use children as participants, so results are not clear.  However, just because there is limited prescribing guidance does not mean that the FDA does not allow prescribing these medications in children (Children Hospital, 2018).  What is most feared about prescribing off-label drugs is the fear of harming the child. In certain circumstances when there are no recommended medications in the pediatric form for certain medical issues, the provider has to turn to off-label drugs.  The use of these medications is usually determined by a clinician with a season experienced history among pediatrics (Kimland, 2014).  Children are not little adults in addition to being small their bodies metabolize drugs differently than adults.  It is appropriate to use off label prescribing when the treatment is a benefit to the patient (Pediatrics, 2014).  If the benefit outweighs, the risk off-labeling may be the best choice.  Even though the passage of the Best Pharmaceuticals for Children Act and Pediatric Research Act and Equity Act has caused improvement in rational prescribing for children including more than 500 labeling changes off-label use is still a problem for infants, children, and adolescents because of a large number of drugs still have no information in the labeling for use in pediatrics (Pediatrics, 2014).   

Strategies To Make Safer 

             A strategy for increasing safety in medication prescribing would be to conduct clinical trials to track the effects on children.  The off-label use of drugs should be done in good faith, in the best interest of the patient to conform to accepted professional standards (American Academy of Pediatrics, 2014, p. 565).  When prescriber the provider should ensure that the benefit outweighs the risk. Also, the patient and guardian should be informed with all possible risk and side effects before treatment.   


Drugs, C. O. (2014, March 01). Off-Label Use of Drugs in Children. Retrieved February 6, 2019,  


  1. Kimland (2014) Off-label and unlicensed drug use in children, Paediatrics and International 

Child Health, 34:1, 1-2, DOI: 10.1179/2046905513 

Off-label and unlicensed drug use in children. (2014). Paediatrics & International Child Health,  

34(1), 1–2. 

Off-Label Use of Drugs in Children 


Pediatrics Mar 2014, 133 (3) 563-567; DOI: 10.1542/peds.2013-4060  

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1 month ago  

Antoinette Joseph  

Week 11 Initial Post  


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Main Post 

Off-Label Drug Use in Pediatric Patients 

            Off-label prescribing is defined, by the US Drug and Food Administration (FDA), as the prescribing of approved drugs for diseases process and age groups not included in the approval (Panther, et al., 2017). Off-label prescribing for the pediatric population has been a growing concern in the medical community. This post will address a circumstance in which an Off-label drug has to be utilized, describe strategies for safe utilization of off-label drugs, and provide names and descriptions of off-label drugs. 

Circumstances for Off-Label Drug Use 

            The need to utilize off-label medications usually occur due to either the lack of a drug regime approved for the population in question or current approved drugs being ineffective or contraindicated. The US FDA does not approve medications without the evidence to support the safety and efficacy of the product (Panther, et al., 2017). Propofol is a medication utilized for the induction of anesthesia for the pediatric population, which is considered “off-label” for that population (Chidambaran, Costandi, & D’Mello, 2015). Surgical procedures require effective anesthetics to provide safety and comfort throughout the process, especially in the pediatric population. Propofol still remains off-label because of conflicting literature about the serious side effects and safety groups of patients (Chidambaran, Costandi, & D’Mello, 2015).  

Strategies to Promote Safe Use of Off-Label Drugs 

            Promotion of the safe utilization of off-label drugs can include implementation of a program requiring clinicians to submit documentation indicating the utilization of the medication for an off-label reason. The program should include documentation of the possible intended effects and side-effects the patients have experienced to allow the extraction of data, by the US FDA, which would provide informal data about the safety of the medication provided. Engaging parents in providing information through the utilization of discount medication programs being a reward for providing information can also improve the bank of information provided. Research suggests starting doses small and titrating up to a dose that provides the indicated therapeutic effect (Panther, et al., 2017). 

Name and Descriptions of Off-Label Drugs 

            In addition to propofol for the induction of anesthesia, gabapentin is used in the pediatric population for chronic mixed or neuropathic pain (de Leeuw, et al., 2018). It is used int eh adult population mainly for neuropathic pain (de Leeuw, et al., 2018). Methylphenidate is used for treatment of attention deficit disorder in the pediatric population and is considered off-label (Panther, et al., 2017). Fentanyl is utilized for pain in the pediatric population and is considered off-label (Aagaard, 2015). The Amoxicillin/ Clavulanic Acid combination is also an off-label used medication for the pediatric population (Aagaard, 2015). 


            In conclusion, prescription of medications for diseases and age groups not approved by the US FDA is considered “off-label” prescribing, Propofol is often utilized for the induction of anesthesia for the pediatric population in addition to a multitude of other medications. Suggestions to promote safe prescription and utilization of off-label medication should include a program requiring documentation and tracking of the utilization of off-label medications including the therapeutic and adverse effects, including the parents int eh documentation through drug discount programs, and starting in small doses and titrating up on the does slowly until the desired effect is reached.  



Aagaard, L. (2015). Off-LAbel and Unlicensed Prescribing of Medicins in the Paediatric Populations: Occurrance and Safety Aspects. Basic Clinical Pharmacology, 215-218. 

Chidambaran, V., Costandi, A., & D’Mello, A. (2015). Propofol: A review of its Role in Pediatric Anesthesia and Sedation. CNS Drugs, 543-563. 

de Leeuw, T. G., Mangiarini, L., Lundin, R., Kaguelidou, F., van der Zaden, T., Pasqua, O. D., . . . de Wildt, S. N. (2018). Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years – evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled t. BMC, 1-12. 

Panther, S., Knotts, A. M., Odom-Maryon, T., Daratha, K., Woo, T., & Klein, T. A. (2017). Off-label Prescribing Trend for ADHD Medications in Very Yound Children. Pediatric Pharmacy and Therapeutics, 423-429. 

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Tiffany Mason  

week 11  


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Tiffany Mason 

Week 11 

Walden University  


Off label refer to drugs not including package insert or approved labeling. The term off-label does not mean improper, illegal, contraindicated, investigational used (Neville, 2014). FDA has to approved drugs to sell and market in the United States. The FDA requires subsequent evidence for safety, in the form of two controlled trials (Neville, 2014). Off-label drug use remains a significant public health issue, especially for infants, young children, and children with rare diseases. The Pediatric Research Equity Act and Best Pharmaceuticals for Children Act have been extraordinarily successful and represent an essential first step in expanding this evidence as a means of achieving the ultimate goal that any drugs used to treat children will have age-appropriate evidence sufficient to provide information for labeling (Neville, 2014). Labeling with pediatric information still exists in less than 50% of products (Neville, 2014). Most drugs prescribed for children have not been tested in children 

The FDA lack evidence of safe and effective use in pediatric patients, the practice of medicine will require that practitioners prescribe medicines off-label to treat pediatric patients (Neville, 2014) appropriately. Practitioners must rely on either less definitive information, such as expert opinion for the age group that they are treating, or use evidence from a different population to guide practice when prescribing medication for the pediatric population (Neville, 2014). Professional standards, the off-label use of a drug should be done in good faith, in the best interest of the patient, and without fraudulent intent (Henderson, 2014). 

Ibuprofen, one of the most common over-the-counter drugs to reduce children’s fevers, carried no dosing information for children younger than two years old until recently (U.S Food & Drug Administration, 2017). Now, studies in thousands of young infants, the dose considered to be safe and effective for over-the-counter use for children ages six months to 2 years (U.S Food & Drug Administration, 2017). The labeling has also been changed for Zantac (ranitidine), this drug is used to treat gastroesophageal reflux (U.S Food & Drug Administration, 2017). It can be life-threatening in infants. When reflux occurs, the stomach contents can flow up the esophagus and be aspirated into the lungs (U.S Food & Drug Administration, 2017). This can harm the lungs of infants and result in breathing problems (U.S Food & Drug Administration, 2017). 


U.S Food & Drug Administration. (2017). Drug Research and Children. Retrieved from 

(U.S Food & Drug Administration, 2017). 

Henderson, D. (2014).Off-Label Pediatric Drug Prescribing: AAP Updates Guidance. Retrieved from 

Neville, K. (2014). Off-Label Use of Drugs in Children. Retrieved from 

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Kellie White  

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Off label drugs are medications used outside of FDA approval parameters.  Use of off-label drugs are widely utilized in the pediatric population, due to the lack of research and clinical trials involving pediatric aged patients.  In this awareness the FDA waived the need for trials if drug manufacturers could provide satisfactory data supporting pharmacodynamic studies, safety reports and marketing studies in drugs already approved for adults (Arcangelo, Peterson, Wilbur & Reinhold, 2017).  Off-label use is not illegal but should be prescribed in consideration of data available and personal experience. Less than half of medications include specific labeling for pediatrics, as a result the American Academy of Pediatrics (AAP) offers guidance to physicians for off-label use (American Academy of Pediatrics, 2014).  The passage of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act has resulted in more than 500 labeling changes, including expanded labeling that includes pediatric information (American Academy of Pediatrics, 2014).  Pediatricians are encouraged to support research and to prescribe off label drugs based on efficacy, treatment outcomes and personal experience from other age approved studies.  

The prevalence of asthma in children is universal and may continue into adulthood.  Many children experiencing symptoms of asthma are under the FDA approved age range.  The short acting beta agonist (SABA) albuterol is one of the most frequently used off label drugs for treatment of exacerbations (Silva, Ansotegui & Morias-Almeids, 2014).   According to Hendrick, Baker, Atla, et. al. (2009), salbuterol HFA is currently not indicated for use in children less than 4 years of age.  Albuterol is a bronchodilator indicated for quick relief of symptoms, it works by binding to beta-adrenergic receptors in the smooth muscles of the airway, leading to increased levels of cyclic adenosine monophosphate (cAMP) causing a decrease in intracellular calcium which relaxes the smooth muscle (Vallerand, Sanoski & Quiring, 2019).  The main adverse effect seen in children is hyperactivity, other systemic effects such as tachycardia, hyperglycemia, hypokalemia are minimized in inhaled administration (Whalen, Finkel & Panavelil, 2015).  For pediatric patients being aware of their immature respiratory system, and the factors affecting drug deposition such as particle size, lipid solubility, protein binding and drug metabolism should be considered (Arcangelo, Peterson, Wilbur & Reinhold, 2017).  Pediatric patients are constantly undergoing physiologic changes that effect the pharmacokinetics of drugs, until a certain age is reached.  

When presented with a child in an acute exacerbation, the risks involved are greater if no medications were prescribed than if an off label is given, therefore the benefits outweigh the risks.  This also serves as data for publication which supports the use and approval for off label.  For safety issues basing the dosages on the patient’s body weight, stage of development and understanding of the pharmacodynamics in a pediatric patient’s immature system.  In 1994 the Institute for Safe Medication Practices was implemented, since then safety movements have progressed (Arcangelo, Peterson, Wilbur & Reinhold, 2017).  The AAP and Joint Commission has joined in the effort  to issue safety initiatives and and risk reduction aimed in the goal of approved pediatric pharmacotherapy.  



American Academy of Pediatrics. (2014). Retrieved from 

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. 

Hedrick, J. A., Baker, J. W., Atlas, A. B., Naz, A. A., Lincourt, W. R., Trivedi, R., Ellworth, A., … Davis, A. M. (2009). Safety of daily albuterol in infants with a history of bronchospasm: a multi-center placebo-controlled trial. The open respiratory medicine journal, 3, 100-6. doi:10.2174/1874306400903010100. 

Silva, D., Ansotegui, I., & Morais-Almeida, M. (2014). Off-label prescribing for allergic diseases in children. The World Allergy Organization journal, 7(1), 4. doi:10.1186/1939-4551-7-4. 

Vallerand, A. H., Sanoski, C. A., & Quiring, C. (2019). Davis’s drug guide for nurses (16th ed.). Philadelphia, PA: F.A. Davis Company. 

Whalen, K., Finkel, R., & Panavelil, T. A. (2015). Lippincott’s illustrated reviews: Pharmacology. Philadelphia, Pa: Wolters Kluwer. 


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Weeek 11- Medication off- label usage  


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NURS 6521- Advanced Pharmacology 


Off-label Medication Usage 

The use of off labels medication is not uncommon in children because most researches that are conducted are normally done adult participants, not on children. According to Czaja, Reiter, Schultz, and Valuck (2015), most usages of off labels medication is used in the pediatric intensive care unit (PICU). These reasons for the high usage is that often times the children are critically ill and there are no other treatment options available. The categories of off labels medications that are oftentimes used are antimicrobials such as azithromycin, levofloxacin; cardiovascular  such as dopamine, amiodarone, respiratory such as terbutaline, levalbuterol, gastrointestinal such as lactulose, ursodiol, hematological such as warfarin, proyamine, endocrine such as insulin aspart, insulin glargine, renal such as mannitol and chlorothiazide (Czaja, et al., 2015). Children that suffer from respiratory, renal or cardiovascular disorders are at increased risk for receiving off -label medications (Czaja et al., 2015).  

There some advantages that are associated with off label use of medication that would not have otherwise discovered due to the lack of research studies that are conducted on children. According to (Czaja et al., 20150 whenever off labels medications are used the permit access to “potentially therapeutic benefits not otherwise available to pediatric patients”.  In addition, off label medications has led to the discovery of new treatment of certain disorders in the pediatric populations (Czaja et al., 2015). While off label medications have proven beneficial there are potential longer-term adverse effects that can accompany their usage. This is because whenever these medications are being used they are limited information that is available about the correct dose to use in children, the effectiveness of medication, adverse effects (Czaja et al., 2015). Majority of the times decision regarding the appropriate dose of medication for children are taken from studies that were done on the adult population. This method of deciding on medication dose in children and the pediatric population can be fatal, due to the fact that children are still developing, therefore their ability to metabolized and eliminate medication varies (Czaja et al., 2015). “This can be further complicated by the disturbed physiology of the critically ill child, often with multiorgan failure, who was at greatest risk of receiving an off-label medication”( Czaja et al., 2015). It is these differences that can a particular medication to fatal due to increased risk of overdosing, adverse effects and ineffective therapeutic outcomes.  

Off -Label Medication Usage Strategies 

Strategies that can be used when using off labels medication in children is to ensure that the smallest dose of medication is used, and careful calculations are done, and accurately diagnoses. Off label medication should be prescribed on an individual base as it is related to their development and growth.  According to Vijay and Dhanya  (2012) WHO states that “The ideal children’s medicine is one that suits the age, physiological condition, and body weight of the child, ”this same principle must be followed in order to prescribe safely for infants and children when using off label medications. There are a safe therapeutic range for all medications when too little is prescribed that particular medication is going to be ineffective, while too much can be toxic. Therefore, it is imperative that the correct dose and correct duration of medication are used in children.  According to  (Vijay and Dhanya, 2012) children are oftentimes being treated by doctors who are not trained to treat the pediatric population which is leading to wrong diagnosis and misuse of antibiotics and other drugs. Another, ways to prevent medical errors in children especially when off label medications are being used it ensure accurate recording of weight, seeing that medications for children are often based on either the weight, body surface area, age, or their body condition (Vijay and Dhanya, 2012).  

Off- Label Medication Description 

The highest off labels medications identified was by (Czaja et al., 2015) there were used in the pediatric intensive care unit are; “dexmedetomidine, dopamine, hydromorphone, ketamine, lorazepam, methadone, milrinone, and oxycodone.” 

Dexmedetomidine -  is used for its sedative effect in the intensive care unit. It can be administered in various ways, highly protein bound of 98%, bioavailability ranging from 65%- 82%,  it has 6 minutes distribution half-life which takes in brain through barriers, metabolized in the liver and excreted by the renal system, potential side effect include, hypertension, dry mouth, agitation, among others (VL – Scott and Sebastian, 2016). Dexmedetomidine is used to sedate children with a neurologic impairment who require mechanical ventilation. The recommended dose is 0.2 to 0.7 mcg/kg/hr and it can be started with a loading dose of 1mcg/kg over ten minutes.  “But some pediatric centers reduce or omit the loading dose in an effort to avoid bradycardia and hypotension. The infusion should be titrated to patient response, with a suggested maximum dose of 2 mcg/kg/hr,” (Buck, 2010) 

Dopamine – Is used to treat shock in children ranging from two days to 18 years and the dose range from 0.3 to 50mcg/kg/minute based on age. Dopamine should not exceed the recommended maximum dose of 50 mcg/kg/minute in children and they should be closely monitored because the medication can cause respiratory suppression and death in children (, 2019).  

Pain medications (hydromorphone, methadone, oxycodone) – These medications are used to control pain in children who are suffering from cancer-related pain, surgical pain, among others.  

Oxycodone recommended pediatric dose – 0.1–0.2 mg/kg 

Hydromorphone recommended initial pediatric dose – 0.05 mg/kg 

“Neonates and infants have a diminished capacity to metabolize medications through the liver, including the cytochrome P450 (CYP) and glucuronidation enzymatic reactions”( Johnson, Miller and Hagemann, 2012),  therefore adjustment of the dose of medication are needed. Glomerular filtration rate and tubular secretion are diminished in neonates; therefore, the dose needs to be adjusted due to decreased ability to efficiently eliminate the drug from the body through the renal system (Johnson et al., 2012). Careful assessment of respiratory rate should be done because these medications can cause suppression of the respiratory system.  

Lorazepam –  is considered to be a part of benzodiazepines family and acts by central nervous system causing sedation, relaxation of muscles, hypnosis, and prevention of seizures (Prescriber’s Digital Reference, 2019). According to prescriber’s digital reference (2019), these are a recommended dose of Lorazepam in children to prevent potentially fatal adverse reactions 

Infants, Children, and Adolescents0.05 to 0.1 mg/kg IV (Max: 4 mg/dose) as a single dose administered slowly over 1 to 2 minutes. Max rate: 2 mg/minute. May repeat dose in 10 to 15 minutes if needed.  

Neonates- 0.05 to 0.1 mg/kg IV as a single dose administered slowly over 2 to 5 minutes. May repeat dose in 10 to 15 minutes if needed 

Lorazepam is also used has been used to burn children with anxiety related to being in the hospital, dressing changes (Prescriber’s Digital Reference, 2019). Because lorazepam contained benzyl alcohol and other compounds that can cause hypotension, lactic acidosis, and suppression of the respiratory system in premature neonates it must be used in great caution and in smallest possible dose. Infants and children are also more susceptible to the therapeutic effects of benzodiazepines (Prescriber’s Digital Reference, 2019).  “Although commonly used off-label in the pediatric population, safe and effective use of oral and parenteral lorazepam has not been established in pediatric patients younger than 12 years and 18 years, respectively”, (Prescriber’s Digital Reference, 2019. 

There are various forms of off-label medication that are used to treat children that are critically ill. While are benefits to the usage of these medications, children should be carefully monitored for any adverse reactions from these medications including respiratory suppression, among others.   




Buck M. L. (2010). Dexmedetomidine use in pediatric intensive care and procedural sedation.  

The journal of pediatric pharmacology and therapeutics: JPPT: the official journal of PPAG, 15(1), 17-29 

Czaja, A. S., Reiter, P. D., Schultz, M. L., & Valuck, R. J. (2015). Patterns of off-label  

prescribing in the pediatric intensive care unit and prioritizing future research. The journal of pediatric pharmacology and therapeutics: JPPT: the official journal of PPAG, 20(3), 186-96.  

Johnson, N. P, Miller, L.J and Hageman M. T. (2012). Sedation and analgesia in critically ill  

children. Retrieved from   

Vijay N. Y. and Dhanya, D, (2012). “Promoting appropriate use of drugs in children,”  

International Journal of Pediatrics, (5). Retrieved from 

VL Scott, W., and  Sebastian, J (2016) Dexmedetomidine: its use in intensive care medicine and  

anesthesia, BJA Education, 16 (1) 242–246, Retrieved from (2019). Dopamine. Retrieved from 

Prescriber’s Digital Reference (2019). Lorazepam. Retrieved from 

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1 month ago  

Sonya Howald  

RE: Week 11- Main Post  


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Week 11 Main Question Post 

NURS-6521 Pharmacology 

Sonya Howald 



Circumstances for Off-label Use in Children 

According to the U.S. Food and Drug Administration (FDA), off-label prescribing is the “unapproved use of an approved drug […] for a disease or a medical condition.” However, when a new medication is approved, the FDA-approved labeling is founded on the indication and age group treated during clinical trials conducted for the approval process (Panther et al., 2017). In addition, most of the drugs prescribed today have not been tested in children for their safety and efficacy due to ethical, scientific and technical issues. Therefore, there is a lack of clinical research in the use of medications in population. Hence, the majority of the medications prescribed to children are on an off-label or unlicensed basis (Silva, Ansotegui, & Morais-Almeida, 2014). 

For the most part, drugs available on the market are still not particularly tested in children, especially in the younger ones. More specifically, those considered for the treatment of allergic diseases are not tested in pediatrics (Silva et al., 2014). However, Garcia (2018) notes that 93.5% of children with asthma have a concurrent diagnosis of rhinitis with perennial allergic rhinitis with seasonal exacerbations (PARSE) being the most common and severe phenotypic presentation. And even with the use of oral antihistamines and nasal corticosteroids, most children remained symptomatic for rhinitis, regardless of the time of year. These circumstances could perhaps be an appropriate time for the use of off-label drugs. 


Strategies for Safer Off-label Use of Medications in Pediatrics 

For a new medication or formulation to be approved, the manufacturer must provide the national medicines regulatory authority specific information about its safety, efficacy, and quality. Then, a Marketing Authorization is issued along with the Summaries of Product Characteristics (SPC). However, using the drug outside its authorized SPC is not the concern of the authorities but is exclusively the responsibility of the prescriber (Silva et al., 2014). 

Off-label prescribing is not illegal or wrong, however, it does have several clinical, safety, and ethical issues. Furthermore, no clear guidelines exist to help prescribers assess the appropriateness of off-label prescribing. A strategy to make off-label use of drugs safer for the pediatric population is to base it off of clinical indications, risk-benefit analysis, and therapeutic alternatives along with the requirement to obtain informed consent from the patient and guardian (Silva et al., 2014). Because it is often necessary to use medications in an off-label manner, clinicians must be diligent in understanding the potential for different metabolism, absorption, distribution, and excretion in pediatric patients, keeping up to date on new research about off-label drug use in children as well as utilizing valuable resources such as pharmacists.  

Challenges of Off-label Drugs When Used in Pediatrics 

Nearly all drugs that get approval for use in adults should also get approval for use in children. However, because of the lack of clinical research for that population, drug monographs frequently do not discuss the use of the drug in children. Still, in most bodies of law, clinicians can prescribe to children a drug approved for adults (Corney, Lebel, Bailey, & Bussieres, 2015). For example, the mainstay treatment for asthma are inhaled corticosteroids, but guidelines frequently do not provide specific recommendations for upper doses limits in children, more specifically, preschool children. Yet, in the preschool age population, inhaled corticosteroids are also the most recommended drug for long-term asthma treatment, but it is primarily based on the previous experiences in adults and older children (Silva et al., 2014). 

Another challenge in prescribing to preschool-aged children is the inhaler type and the child’s ability to use it correctly. For instance, fluticasone, beclomethasone, and budesonide are available as either a dry powder inhaler (DPI) or a metered dose inhaler (MDI), but preschool children are not able to adequately use a DPI because of improper inhalation technique. Therefore, this device is not licensed for the preschool population. Yet, interestingly, the greatest extent of off-label prescription in children occurs in the first two years of life. And so, as projected, asthma treatment in children under two years of age present the highest prevalence of off-label use (Silva et al., 2014). 







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 

Garcia, J. (2018). Rhinitis common, difficult to control in children with asthma. Retrieved February 6, 2019, from Medscape.  

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 

Silva, D., Ansotegui, I., & Morais-Almeida, M. (2014). Off-label prescribing for allergic diseases in children. World Allergy Organization Journal, 7(48). doi:10.1186/1939-4551-7-4. 

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RE: Discussion – Week 11  


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Week 11: Off-Label Drug Use in Pediatrics 


Off-label use of drugs involves the unapproved use of approved drugs. Off-Label use of drugs is common in children. Pediatric guidelines of dosage are typically missing in children since few drugs have been researched or tested specifically for children. Off- label drugs are described as drugs prescribed for use in pediatric patients. These are drugs that has not been formally studied and approved by the Food and Drug Administration (FDA) to be safe for use in pediatric population, based on the demonstration of their safety and efficacy in adequate, well-controlled clinical trials (Food and Drug Administration, n.d.). Sometimes, pharmacists often adjust medications necessary for adults to accommodate the weight of children thus hindering proper treatment of children. Children should not assume to be ‘smaller’ adults. Children and adults have different processing and response to drugs, especially in the absorption, distribution, metabolism, and excretion. The response for children is unique as they grow from infancy to adolescence. Therefore, it poses a safety concern when healthcare providers are prescribing drugs to pediatric patients. Advanced Practice Nurses should be aware of the safety implications of the off-label use of drugs with various patients.   

Circumstances for off-label prescription in children 

The government has increased its regulations and initiatives that increase drug research in children by development and marketing of new drugs. Therefore, the off-label prescription is high in children because providers continue to use many old drugs which contain current, active generic manufacturers. This limits clinical research in children especially for twelve years and above. There is no upgrade on drug monographs. Also, healthcare professionals make health decisions based on past information, and they are used to prescribing, dispensing and drug monitoring in children. They use currently available drug data rather than expected information provided in drug monograph. This information may mislead the drug industry, thinking that a particular drug can be used or reimbursed in children without considering the drug monograph (Sarganas, Zhuang, & Rascher, 2013). Healthcare practitioners are in agreement regarding the importance of practicing evidence-based medicine. However, for the pediatric population, gold standard clinical trials are often not available, so practitioners must rely on either less definitive information, such as expert opinion for the age group that they are treating or use evidence from a different population to guide practice (American Academy of Pediatrics, 2014). 

Also, it is complicated to conduct pediatric research considering the balance between its advantages and risks, the issues of consent depending on the age of children, the necessity of providing appropriate drug information, parent’s interventions and the pharmacokinetic and pharmacodynamics particularities. Therefore, it is essential for all stakeholders including the drug companies, government departments, decision-makers, funding institutes, hospitals, and research centers to work together in support and promotion of drug research in children (Arcangelo, Peterson,  Wilbur & Reinhold, 2017).  

Strategies to ensure the safety of off-label use and dosage of drugs in children 

It is essential for the stakeholders to address the issue of including third-party payers, therapeutic committees, physicians, pharmacists in favoring drugs with approved indications and children information. The process should also consider other medications in the current pediatric practice. In this case, all stakeholders should use proper information in the decision-making process to send an appropriate evaluation or data to the drug industry. 

At the same time, all the stakeholders should make sure they support dug research in children. For instance, these efforts should include pediatric research networks that improve healthcare in pediatrics. It involves conducting multi-institutional studies, support of collaboration in research and encouraging the exchange of information between healthcare providers (Arcangelo, Peterson,  Wilbur & Reinhold, 2017). Most the public and private healthcare organizations develop initiatives that provide information on research and safety in the use of drugs. Consequently, drug monographs depend on research at the time of drug development and most of them fail to be updated based on current clinical practice. Therefore, the use of off-label drugs is prevalent in older drugs. Examples of off-label drugs used by children in pediatrics and require extra care include  

Off-label drugs that should be prescribed with extra care to pediatrics include Midazolam hydrochloride syrup and injection, this drug is used as a sedative. It is proven that using this drug in pediatric patient poses a higher risk of serious and life-threatening adverse effects for children with congenital heart disease and pulmonary hypertension. To prevent respiratory problems in this special pediatric population, the drug cane be started on a lower dose possible (Shah, et al., 2007). Ibuprofen, is one of the most common over-the-counter drugs used to reduce fevers, now lists dosage considered to be safe and effective for children ages 6 months to 2 years. Neurontin (gabapentin) capsules, tablets, and oral solution used as adjunctive therapy to treat partial seizures in pediatric patients ages 3 to 12 years poses neuropsychiatric adverse events in this age group (Shah, et al., 2007). Zantac, a drug used to treat gastroesophageal reflux, a condition that can be life-threatening in infants has its labelling changed. Other off label drugs that has their labelling changed for use in pediatric patients are Claritin (loratadine) syrup used to treat allergy and hives, a lower dose is required in patients 2 to 5 years. Duragesic (fentanyl) transdermal patch used to manage chronic pain, can be used in patients older than 2 years who have used opioid before (Food and Drug Administration, n.d.).  

In order to make off-label drug use safer for children, healthcare practitioner who prescribes these drugs are responsible for making decision on how safe the drugs are, what dosage to be prescribed, for what purpose and how to prevent or minimize the possible side effects in this population. This decision should be made on the basis of the information contained in the drug’s labeling (when available) or other data available to the prescriber. Promethazine that is mainly given over-the-counter to treat allergic symptoms in children. Another drug is phenobarbital that was introduced 90 years ago (Arcangelo, Peterson,  Wilbur & Reinhold, 2017). The drug should be taken with care because it increases the risk of adverse cognitive and behavioral events in children. Tetracycline is another drug in children introduced as an antibiotic, but research indicates it is not effective in treating hypoplasia and staining of the enamel of both primary and secondary teeth.  


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. 

Food and Drug Administration. (n.d.). Retrieved February 5, 2019, from Food and Drug Administration Web site: 


Sarganas, G., Zhuang, W., & Rascher, W. (2013). ‘Off-label medicine use in children and adolescents: results of a population-based study in Germany’. BMC Public Health2013. 

Shah, S. S., Hall, M., Goodman, D. M., Feuer, P., Sharma, V., Fargason Jr , C., . . . Slonim, A. D. (2017). Off-label Drug Use in Hospitalized Children. JAMA Network. 


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Week 11 Main Forum  


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Main Forum 

Less than half the medications used in the pediatric population are labeled for pediatric use there for the health care professional has to us its clinical judgment when prescribing these medications. Off label drug prescribing is a very important health topic especially among infants, young children, and children with rare diseases (American Academy of Pediatrics, 2014). Strategies to make off label medications safer for children infant to adolescent include knowing what disease or illness the child has, then patient specific data such as age, weight, and BSA, the child’s ability to metabolize other medication that the patient is currently taking as well as ability to excrete, and the child’s creatine clearance output, then decide the best route of drug therapy, dosing recommendations by reference or primary literature which includes equations using adult dosing or estimate based on pharmacokinetic properties (Arcangelo, Peterson, Wilbur, & Reinhold, 2017). 

When using off label drugs in children the benefit of use has to out weigh the risk of taking the drug. For example, when ciprofloxacin was placed on the contraindicated list for children because in juvenile animals it caused degenerative arthropathy but over the last 20 years there have been studies that have shown it safe to use in children especially with illness that is resistance to other drugs. When prescribing ADHS medications there have been case reports of sudden cardiac death especially in children with cardiac abnormalities as well as psychosis and mania-type reactions. Another medication that is used is anti-depressants which can cause a slight risk for suicide in children and adolescents although the risk of suicide in untreated patients is higher. Another drug class is inhaled steroids which can affect a patient’s height as much as 1 cm per year. Children given chemotherapy also have the potential to have long term side effect 2/3rd of the time, but again the benefits out way the risks (Arcangelo, Peterson, Wilbur, & Reinhold, 2017). 

ADHD medications first line of treatment is stimulants which inhibit the reuptake of dopamine and norepinephrine which increase concentrations in the presynaptic clefts. They come in extended release and immediate release. Contraindications include existing cardiovascular disease, moderate to severe hypertension, hyperthyroid, and history of substance abuse. Methylphenidate should not be given to patients with anxiety, tension, or agitation, glaucoma, or history of tics or Tourette syndrome. Common side effects include sleep disturbances, appetite suppression which leads to weigh loss, agitation and nervousness (Arcangelo, Peterson, Wilbur, & Reinhold, 2017). The second line of treatment is non-stimulants which “inhibits the reuptake of norepinephrine by inhibiting presynaptic norepinephrine transporter” (Arcangelo, Peterson, Wilbur, & Reinhold, 2017). Nonstimulants should not be taken with MAO inhibitors and should not be given to patients with narrow-angle glaucoma. Nonstimulants can lead to high blood pressure and should not be given to patients with cardiovascular abnormalities, cardiomyopathy, uncontrolled hypertension, and patients with heart rhythm abnormalities (Arcangelo, Peterson, Wilbur, & Reinhold, 2017). Third line of treatment is bupropion which is an antidepressant, but it works by “inhibiting the reuptake of norepinephrine and dopamine but does this less intensely” (Arcangelo, Peterson, Wilbur, & Reinhold, 2017). Its contraindications are it lowers seizure threshold and should not be given to patients with a seizure disorder as well be avoided in those who are stopping alcohol suddenly and can be associated with suicidal thoughts. Adverse effects of bupropion include risk of seizures, use with caution in people with anxiety disorder because it can worsen anxiety (Arcangelo, Peterson, Wilbur, & Reinhold, 2017). 


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 

American Academy of Pediatrics. (2014, February 4). AAP makes recommendations on use of off-label drugs for children. Retrieved from 

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Marie Lucien  

Off-Label Drug Use in Pediatrics  


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Off-Label Drug Use in Pediatrics 

            Off-label drug use in pediatrics is described as the prescription use of a medicine in a way that is different from the labeling approved by the Food and Drug Administration (FDA). This means that the medication is used for a different disease or medical condition, given in a different route, or provided in a different dose other than the required on the standard label. Today, off-label prescribing in pediatric patients is widespread; however, the magnitude is considerably lower than previously thought. Off-label prescribing should be evidence-based, and further studies should address the need for adequate dosing guidelines for such prescribed medicines. It is necessary not only for pediatrics but in general for every sick individual that need medication to relieve their discomfort and suffering (de Souza et al., 2016). 

Concerns Regarding off-label Drugs Use in Pediatrics 

            Off -label drug use in pediatrics is not that famous around the world; many questions are pending on the efficacity and service rendered in the pediatric population.  According to Magalhães et al. (2015), off-label and unlicensed prescribing is widespread among the hospitalized pediatrics population worldwide, there is no consensus on a definition of off-label and unlicensed drugs, and preterm newborns receive most off-label and unlicensed drugs. By skinning new light on off-label drug prescribing, these findings will hopefully contribute to engendering new, more operational knowledge about the pediatric population’s need for eminence drugs that are both harmless and worthwhile. 

            It should not happen that off-label drugs are prescribing to justified such as life-saving efforts, or for treating conditions where no drugs have been approved for pediatric use due to lack of research. In such cases, off-label prescribing is not just warranted but is also unavoidable. It should, however, be defensible, justifiable, and showing good reason for using it (Aagaard, 2015).  The benefits must always out-weight the risks of the medication. Recently, the new policy statement from the American Academy of Pediatrics on off-label prescribing recommended that “the use of a drug, whether off or on the label should be based on sound scientific evidence, expert medical judgment, or published literature whenever possible.”  (Ghinea, Lipworth, & Kerridge, 2015).  This policy statement should guarantee better safety while prescribing to children from neonates to adolescents. 

Most Off-Label Drug Used 

            The therapeutic drug categories most commonly used off-label in hospital care were analgesics and antibiotics. Some of the most common drugs used off-label in pediatric hospital care were morphine, Tylenol, Proventil, caffeine, and heparin. Another area with a high proportion of off-label drug use was that of cardiovascular drugs. In primary health care, antibiotics for systemic use were among the most commonly prescribed drugs used off-label, as well as anti-asthmatic drugs. However, in most studies, the highest proportion of off-label drug use in children in primary health care was among topically administered drugs such as dermatological and eye drops (de Souza et al., 2016). Most patients do not wish to be exposed to such treatment and are particularly reluctant to have their children exposed to it. In case of severe side effects, half of the patients would sue doctors who had prescribed the off-label therapy (Ćurković, & Gorjanski, 2018). Therefore, it is essential that the provider explains to parents all the risk they are facing when using off-label medications. 

Off-label drugs that require attention 

             Many off-label drugs require extra care and attention when used in pediatrics. Therefore, recent pediatric drug studies have resulted in the addition of pediatric information to the labeling for more than 80 drugs. The drug labeling delivers advice for doctors and other healthcare providers on how to use a drug. Here are examples of several changes that are considered significant for dosing and risk such as Claritin (loratadine) syrup – used to treat allergy and hives. Patients ages 2 to 5 years require a lower dose (5 milligrams) compared to a 10-milligram dose in older children and adolescents. Duragesic (fentanyl) transdermal patch – used to manage chronic pain. It is now only to be used in patients older than 2 years who have been on opioids and are used to them. This medication is administered through a patch placed on the skin. Luvox (fluvoxamine maleate) tablets – treats obsessive-compulsive disorder. The dose of the drug may need to be increased to the recommended adult dose in adolescents, but girls ages 8 to 11 years may need lower than the recommended dose. Midazolam hydrochloride syrup and injection – used as a sedative (de Souza et al.,2016). 

            Furthermore, the following drugs were shown to have a higher risk of critical and deadly adverse events for children with congenital heart disease and pulmonary hypertension. According to de Souza et al. (2016), the research identified the need to begin therapy with doses at the lower end of the dosing range to prevent respiratory problems in this particular pediatric population. Neurontin (gabapentin) capsules, tablets, and oral solution – used as adjunctive therapy in the treatment of partial seizures in pediatric patients ages 3 to 12 years. Neuropsychiatric adverse events were identified in 3 – to 12-year-olds. Pepcid (famotidine) tablets, injection, and oral suspension – used to treat gastroesophageal reflux disease. Patients up to 3 months of age require a lower dose because their ability to get rid of the drug is less than that of older children and adults. Ultane (sevoflurane) volatile liquid for inhalation – used in general anesthesia. Pediatric studies revealed rare reports of seizures in pediatric patients given this drug (de Souza et al.,2016). 

Steps to Follow when Prescribing Off-Label drugs 


            When prescribing off-label drugs in pediatrics, a common approach has been to use data from adults and adjust the dose according to a child’s weight. Experimenting over the years has taught providers to use many drugs in children safely and effectively. But this trial-and-error approach has also resulted in tragedy, indicating that adult experiences with a prescription aren’t always a reliable predictor of how children will react. For example, in the past, the antibiotic chloramphenicol was widely used in adults to treat infections resistant to penicillin. But many newborn babies died after receiving the drug because their immature livers couldn’t break down the antibiotic. Experience has shown us that we need to study drugs in children because they aren’t small adults. It’s not just about smaller weight; there are dynamics of growth and maturation of organs, changes in metabolism throughout infancy and childhood, changes in body proportion, and other developmental changes that affect how drugs are metabolized (de Souza et al.,2016). 


            The pediatrics population lives are so fragile, and sometimes providers want to do the impossible to save it. It is essential to do more extensive research to evaluate the patterns of unapproved drug use. It could help identify global needs and solutions regarding pediatric drug research and registration. Using such prescribing patterns, specific protocols to facilitate interdisciplinary collaboration could also be implemented, as close communication between pharmacists and physicians is needed to increase the effectiveness of the unapproved medication use. It is understanding that sometimes the time window to make a decision is crucial but when the like hood is too high a second thought is more beneficial. It is necessary that parents and caregivers give the chance to weight the risk that they are putting them in medical a condition that not responding to most of the medications prescribed. 


Aagaard, L. (2015). Off-Label and Unlicensed Prescribing of Medicines in Pediatric Populations: Occurrence and Safety Aspects. Basic & Clinical Pharmacology & Toxicology, 117(4), 215–218. 

Ćurković, M., & Gorjanski, D. (2018). Knowledge and attitudes of patients in primary care on off-label treatment. International Journal of Risk & Safety in Medicine, 29(3/4), 181–192. 

de Souza, A. S., Jr, Dos Santos, D. B., Rey, L. C., Medeiros, M. G., Vieira, M. G., & Coelho, H. L. L. (2016). Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study. BMC Pediatrics, 16, 13. 

Ghinea, N., Lipworth, W., & Kerridge, I. (2015). Evidence, regulation and “rational” prescribing: the case of gabapentin for neuropathic pain. Journal of Evaluation in Clinical Practice, 21(1), 28–33. 

Magalhães, J., Rodrigues, A., Roque, F., Figueiras, A., Falcão, A., & Herdeiro, M. (2015). Use of off-label and unlicensed drugs in hospitalized pediatric patients: a systematic review. European Journal of Clinical Pharmacology, 71(1), 1–13. 



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Lindsey Steele  

Main- L. Steele Discussion week 11  


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Treatment of pediatric patients with rare conditions and diseases can cause issue with prescribing medications as treatment due to the lack of research conducted on the safety and efficacy of the drugs (AAP, 2014). While a drug may not be specifically labeled for use in an age group for any specific condition does not necessarily contraindicate use of the drug by that age group for the condition. What it does indicate is that the drug has not met the evidence requirement by law to be approved by the FDA for labeling purposes. For medications known to be unsafe or ineffective in pediatrics, medications will have the contraindications and warnings indicated on the label. With clinical trials and studies not being available for many medications, the use of expert opinion on the age group being treated or on the evidence obtained from a different population.  

With the passing of the FDA Modernization Act in 1997 and the Best Pharmaceuticals for Children Act in 2002 there has been a minimal effect on the use of medication of label in pediatrics. While there has been some improvement with a small increase of drugs being studied in pediatrics, there is still a significant number of medications prescribed off-label (Corny et al, 2015). An example of a medication commonly used off-label in pediatrics is albuterol in children under the age of four. Albuterol is a bronchodilator used to relax airway muscles to improve air flow to the lungs (, 2018). The medication is approved to be prescribed from age four to adult. While the approval is for ages four and above, the medication is commonly given to infants in the acute setting with bronchiolitis (Condella et al, 2018). In one study, infants were given a dose of albuterol prior to hospitalization for bronchiolitis was anywhere between 23-84% dependent upon which of the 17 settings were being evaluated. Whether the use of the medication had any correlation with the admission to the acute setting or whether it was the initial infection resulting in hospitalization is unknown. What is known is that the AAP has guidelines indicating that the use of this medication in infants is advised against. Additional studies with use of albuterol in infants should include age, documentation of prior wheezing before administration, and prior use of bronchodilators to fully address the use of this medication in infants.   

Another medication that used to be commonly prescribed in pediatrics was promethazine. The use of this medication in children under two years of age is now contraindicated due to respiratory depression. The medication was commonly prescribed for nausea and vomiting in children but now has a black box warning (Hampton, 2005). The drug is often used for its antihistamine, antiemetic, and sedative effects. It is a histamine and alpha-adrenergic receptor antagonist. Promethazine is metabolized by the liver cytochrome P450 enzymes (Buck, 2010). This medication can cause not only the respiratory depression but hallucinations, seizures, dystonic reactions, agitation, and over sedation especially in children (Starke, 2005). This medication is still sometimes prescribed to children but not as often as it once was.  

While it may be common place for medications to be prescribed to pediatric population off-label, it may not be safe for a number of reasons. As children’s bodies develop, they may not have the ability to break down a drug in the way that an adult’s body is capable. Without studies indicating the safety of a medication to back it, a provider would be ill advised to prescribe any medications off-label (Arcangelo et al, 2017). That being said, the lack of studies on drugs in the pediatric population limits the amount of medications that can be prescribed. If a provider were to have significant data backing the choice of prescribing a medication off label, it should be done so carefully with intensive monitoring of the patient.  

AAP (2014). Off-label use of drugs in children. American Academy of Pediatrics. 133(3):563-567 

Arcangelo, V., Peterson, A., Wilbur, V., and Reinhold, J. (2017) Pharmacotherapeutics for advanced practice: A practical approach (4th ed.). Ambler, PA: Lipincott Williams and Wilkins 

Buck, M. (2010). Promethazine: Recommendations for safe use in children. Pediatric Phramacotherapy. 16(3): Retrieved from: 

Corny, J., Lebel, D., Bailey, B., and Bussieres, J. (2015). Unlicensed and off-label drug use in children before and after pediatric government initiatives. The Journal of Pediatric Pharmacology and Therapeutics. 20(4): 316-328 

Condella, A., Mansbach, J., Hasegawa, K., Dayan, P., Sullivan, A., Espinola, J., and Camargo, C. (2018). Multicent study of albuterol use among infants hospitalized with bronchiolitis. Western Journal of Emergency Medicine. 19(3): 475-483 (2018). Albuterol inhalation. Retrieved from: 

Hampton, T. (2005). Promethazine warning. JAMA. Retrieved from: 

Starke, P. (2005). Boxed warning added to promethazine labeling for pediatric use. The New England Journal of Medicine. Retrieved from: 

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