6521 Week 11 Pediatric Off Label Prescribing Narrative Instructions
Construct a 1-page narrative that addresses the following: (this must be cited by a minimum of 3 scholarly sources. I provided some that I researched but you may use others at your need. Additionally, I have included at the end of this instruction sheet an EXAMPLE only of a narrative that contains some ideas of what is required; however, I find it too long and not very well written! Please be very mindful of plagiarism.)
Introduction
Briefly define and summarize off label use of medications in the pediatric population. Include main risks vs benefits when put into practice by a provider. End with a strong purpose statement that encompasses the following requirements listed under the headings.
Appropriate Use of Off-Label Drugs in Pediatrics
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples. (The reference to use for ADHD is fine but please include other classes of drugs and there circumstances of use as well)
Safety Strategies
Explain strategies to making off-label use and dosage of drugs safer for children from infancy to adolescence.
Use with Caution
Descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. Be specific.
Conclusion
A comprehensive summary of the narrative with all key points represented.
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 Therapeutics, 20(4), 316–328. https://doi.org/10.5863/1551-6776-20.4.316
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. https://doi.org/10.5863/1551-6776-22.6.423
Rosenthal, L. D., & Burchum, J. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2nd ed.). Elsevier. (Chapter 9 pg 58-60)
Yackey, K., & Stanley, R. (2019). Off-label prescribing in children remains high: A call for prioritized research. Pediatrics, 144(4). https://doi.org/10.1542/peds.2019-1571
Yackey, K., Stukus, K., Cohen, D., Kline, D., Zhao, S., & Stanley, R. (2019). Off-label medication prescribing patterns in pediatrics: An update. Hospital Pediatrics, 9(3), 186–193. https://doi.org/10.1542/hpeds.2018-0168
EXAMPLE NARRATIVE
Arcangelo and Peterson (2013) cautioned prescribers about prescribing and administering drugs to the pediatric population. The ongoing maturation and development process, the short and long-term effects that the prescribed drug will have on the growth and development, and the effects of underlying congenital, chronic, and current diseases should be considered. The pediatric body’s composition and proportions and the small liver and kidneys can affect the pharmacokinetics of drugs. It is therefore important that clinicians who prescribe drugs to pediatrics, be very knowledgeable of all drugs prescribed, including off-label drugs.
The off-label use of a drug is when a drug is prescribed against the monograph (a label with specifics of ingredients, directions, conditions of use, and the contraindications). Regarding off-label prescriptions in pediatrics, Corny, Lebel, Bailey, and Bussières (2015), stated that off-label drugs are those drugs that have not been tested on pediatrics but may be legislatively allowed to be prescribed in the pediatric population. Off-label use of a drug in pediatrics can expose both clinicians and patients to delays, costs, and risks. As stated by Corny, Lebel, Bailey and Bussières (2015), authorities have established various strategies and regulations to oversee and promote clinical research in children and hopefully decrease both unlicensed and off-label drug use. Meanwhile, as prescribers, we need to understand the circumstances under which we can prescribe off-label drugs, their safety, and those drugs that require extra attention/care especially in the pediatric population.
Prescribing Off-Label Drugs to Children
There are circumstances that would require prescribing off-label drugs to children. An article by Panther et al., (2017) described a situation where off-label drugs were prescribed to children under the age of 5 to treat ADHD. Such drugs included clonidine; an alpha agonist used to treat many conditions including hypertension in adults. Panther et al., (2017) stated that 91.4% of prescriptions were off label for children aged 3-5 years. This was because there were no available approved drugs for ADHD treatment for patients under that age of 6. The question would be, what circumstances would warrant prescribing an off-label drug to a pediatric patient? As a practitioner, I would weigh the benefits against the risks while considering any underlying diseases and any other medications that child might be taking. According to panther et al., (2017), the American academy of pediatrics and the American academy of child and adolescent psychiatry both recommend behavioral therapy as first-line treatment for children 3 to 5-years old. However, if medication is indicated, methylphenidate (Ritalin) is the treatment of choice for young children. Treatment with methylphenidate should be initiated at a small dose and titrated up slowly. For those young children who do not respond well to methylphenidate, treatment alternatives such as alpha agonists can be used.
Strategies for off-label Drug Safety
Panther et al., (2016) stated that the purpose of off-label use is to benefit the individual patient. The term “off-label” does not imply an improper, illegal, contraindicated, or investigational use. Therapeutic decision-making must always rely on the best available evidence, the practitioner’s best professional judgment, and the benefit for the individual patient. For example, the FDA recommends weight-based dosing for drugs such as Ritalin for children. The recommendation is that most children under the age of 5 years should not receive doses higher than 25 mg/day. Other measures that should be taken into consideration are drug formulations. For example, in pediatric patients, it would be safer to administer an oral drug in liquid form, for accurate measurement, than a tablet that need to be split. According to Mir and Geer (2016), the FDA advocates good medical practice that requires providers to use legally available drugs and biologicals according to their best knowledge and judgment. Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) have collectively resulted in an improvement in rational prescribing for children in USA. The BPCA and the PREA are two complementary federal laws that have substantially increased clinical evaluation and labelling of drugs in children both by the pharmaceutical industry and through government-sponsored trials. The PREA mandates that almost all new drugs and certain approved drugs must be studied in children for approved use. The application for new drug approval include the results of adequate pediatric studies unless the studies are deferred or waived by the FDA.
Off-label Drugs Requiring Extra Attention
Larkin, Ang, Avorn and Kesselheim (2014) stated that all antidepressant and antipsychotic drugs pose substantial safety risks for children, including increased rates of suicide and other adverse effects. For example, the FDA, according to Larkin, Ang, Avorn and Kesselheim (2014), has not approved the use of paroxetine (Paxil) in pediatrics, either because is showed side effects or the risks outweigh the benefits. Other off-label drugs that would require extra attention would be the use of alpha agonists such as clonidine as mentioned by Panther et al., (2017) due to its side effects, such as dizziness and insomnia. Mir and Geer (2016) stated that the most commonly used off-label drugs reported were anti-infectives, such as ceftriaxone (Rocephin), drugs of the respiratory system such as dextromethorphan, Chlorpheniramine, and antianxiety medications such as lorazepam (Ativan) due to their side effects.:
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