Discussion Pharm #11 Assignment

Discussion Pharm #11 Assignment

Circumstances to Prescribe Off-Label Drugs for Children

Circumstances in which off-label drugs can be prescribed for children include the unavailability of the standard, safe and therapeutic alternatives for a specific condition or disease for children, as well as the absence of pediatric information in SmPC regarding a specific medication (Wimmer et al, 2015). In addition, off-label medications can be prescribed to children if the standard and FDA approved therapy is not effective, there are no optional forms of treatment for certain age groups, and also lack clinical trials for the pediatric population regarding specific medication (Mir & Geer, 2017). Therefore, off-label medication can be prescribed because the medication will provide better patient outcomes. Another reason why off-label medication can be prescribed is when there is convincing evidence regarding the safe use and efficacy of the medication in specific situations.  In addition, off-label drugs can be prescribed to the pediatric population if there is evidence supporting the medication use for a specific indication in a specific patient (Saiyed et al, 2015). The projected benefits and risks of the off-label medication, as well as alternative to the medication should be evaluated before prescribing an off-label medication to children. Nonetheless, it is important for the healthcare practitioner to ensure documentation of decision-making process to use an off-label medication in the medical record of the patient in order to reduce the risk of liability in case of poor outcome or adverse event (Mir & Geer, 2017). Discussion Pharm #11 Assignment


Strategies to Make the Off-Label Use and Dosage of Drugs Safer for Children

Designing improved formulations for children can help to ensure better compliance, improve drug metabolism, and also address reactions to medication use. For example, lack of availability of suitable pediatric formulations has led to some practitioners in using off-label medications by administering crushed tablets and this can result in medication errors (Parish & Cernak, 2015). Therefore, it is important to ensure the pediatric drugs are appropriate for children in terms of formulation, strength, and taste as well.

The second strategy is to have the off-label medications expected to have therapeutic benefits to children are tested and undergo pediatric clinical trials in order to prove their efficacy and safety as well (Saiyed et al, 2015).  In addition, due to is lack of gold standard clinical trials for most medications for the pediatric population, it is important for practitioners to consult various resources such as peer-reviewed journals, policy statements, medical databases, practice guidelines, and handbooks  in order to evaluate the quality of evidence-based drugs (Parish & Cernak, 2015).

In addition, pediatric-specific allometric techniques appropriate for calculating doses for children should be designed; the allometric technique should take into consideration various categories of body weight, age, as well as the body surface area of the pediatric population (Wimmer et al, 2015).

The clinical decision-making when it comes to prescribing medications for children should always be guided by the latest and best available evidence and should be to the best interests of the patient. Practitioners should apply professional competency and judgment to determine medication use in the pediatric population (Parish & Cernak, 2015).

Specific off-label medications requiring extra care and attention when used in pediatrics include Amphetamines and Alpha-Agonists which are approved for adult use but are used for the pediatric population as off-label; these medications are associated with adverse effects and hence require extra care when used in children. In addition, anticonvulsant mood stabilizers, antidepressants, as well as some antibiotics need extra monitoring due to the associated side effects (Wimmer et al, 2015). Discussion Pharm #11 Assignment


Mir A & Geer M. (2017). Off-Label Use of Medicines in Children. International Journal of Pharmaceutical Sciences and Research. 1(183).

Parish R & Cernak I. (2015). Creating a Distinct Medication-Use System for Children at the Point of Care: The Time is Now. Pharmacy (Basel). 3(3), 72–78.

Saiyed M, Lalwani T & Rana D. (2014). Off-Label Medicine Use in Pediatric Inpatients: A Prospective Observational Study at a Tertiary Care Hospital in India. International Journal of Pediatrics. 2014(6), 1-6.

Wimmer S, Nuebert A & Rascher W. (2015). The Safety of Drug Therapy in Children. Dtsch Arztebl Int. 112(46), 781–787.

Discussion Pharm #11 Assignment

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