Title: NURS 6521 Week 11: Pediatrics<\/strong><\/h2>\n\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f 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.<\/span>\u00a0<\/span><\/p>\nCircumstances for Off-Label Drug Use<\/span><\/b>\u00a0<\/span><\/h2>\n\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f 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 \u201coff-label\u201d 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).\u00a0<\/span>\u00a0<\/span><\/p>\nStrategies to Promote Safe Use of Off-Label Drugs<\/span><\/b>\u00a0<\/span><\/h2>\n\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f <\/span><\/b>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).<\/span>\u00a0<\/span><\/p>\nName and Descriptions of Off-Label Drugs<\/span><\/b>\u00a0<\/span><\/h2>\n\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f <\/span><\/b>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\u202f(Aagaard, 2015).<\/span>\u00a0<\/span><\/p>\nConclusion<\/span><\/b>\u00a0<\/span><\/h2>\n\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f\u202f <\/span><\/b>In conclusion, prescription of medications for diseases and age groups not approved by the US FDA is considered \u201coff-label\u201d 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.\u00a0<\/span>\u00a0<\/span><\/p>\n\u202f<\/span>\u00a0<\/span><\/p>\nReferences<\/span><\/b>\u00a0<\/span><\/h2>\nAagaard, L. (2015). Off-LAbel and Unlicensed Prescribing of Medicins in the Paediatric Populations: Occurrance and Safety Aspects. <\/span>Basic Clinical Pharmacology<\/span><\/i>, 215-218.<\/span>\u00a0<\/span><\/p>\nChidambaran, V., Costandi, A., & D’Mello, A. (2015). Propofol: A review of its Role in Pediatric Anesthesia and Sedation. <\/span>CNS Drugs<\/span><\/i>, 543-563.<\/span>\u00a0<\/span><\/p>\nde 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. <\/span>BMC<\/span><\/i>, 1-12.<\/span>\u00a0<\/span><\/p>\nPanther, 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. <\/span>Pediatric Pharmacy and Therapeutics<\/span><\/i>, 423-429.<\/span>\u00a0<\/span><\/p>\nA Sample Answer 3 For the Assignment: NURS 6521 Week 11: Pediatrics<\/strong><\/h2>\nTitle: NURS 6521 Week 11: Pediatrics<\/strong><\/h2>\nOff 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).\u202f<\/span>Off-label drug use remains a significant public health issue, especially for infants, young children, and children with rare diseases.<\/span> The Pediatric Research Equity Act and\u202f<\/span>Best Pharmaceuticals for Children Act\u202f<\/span>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).\u202f<\/span>Most drugs prescribed for children have not been tested in children<\/span>\u00a0<\/span><\/p>\nThe 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).<\/span>\u00a0<\/span><\/p>\nIbuprofen, 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).<\/span>\u00a0<\/span><\/p>\nReference<\/span>\u00a0<\/span><\/h2>\n