Off-Label Drug Use in Pediatrics.

Off-Label Drug Use in Pediatrics.


Lack of government approval and specific information on pediatric drugs for on-label prescribing leaves most clinicians to prescribe drugs off-label. To address this gap in practice, the AAP (American Academy of Pediatrics) developed a policy statement on off-label use of drugs in children. AAP describes off-label use as using a drug not approved or labeled by the FDA for pediatrics (American Academy of Pediatrics, 2015). This excludes investigational, improper, and illegally contraindicated use. According to this statement, off-label use does not require clinicians to have informed consent especially if there is anecdotal and scientific evidence that is not investigational to support decisions to prescribe specific medications.Off-Label Drug Use in Pediatrics.


Circumstances to Prescribe Drugs for Off-Label Use in Pediatrics

The most likely clinical scenario that clinicians can practice off-label prescribing is when managing pediatric conditions that do not have approved drugs for management and when saving a life. In such instances, the prescriber should have good, justifiable, and defensible reasons (Arcangelo et al, 2017).  Clinicians can also write off-label prescriptions when an off-label drug serves the patient’s best interest, and its benefits outweigh the risks.Off-Label Drug Use in Pediatrics.

Strategies to Make Off-Label Drug Use and Dosage Safer

According to Tefera et al (2017), one of the best strategies that clinicians can use to make off-label prescribing safer for children is using guidance from evidence-based findings on specific off-label drugs. However, these findings should be available, published, and include any negative findings. Alternatively, clinicians can use practice guidelines, scholarly sources, and policy statements on pediatric off-label drug use provided by the AAP (Tefera et al, 2017). During off-label prescribing, clinicians should adequately educate patients and families about the off-label drug, and share the research recommendations for prescribing the drug. Off-Label Drug Use in Pediatrics.

The most important drugs that clinicians must be cautious when prescribing to pediatric populations are antidepressants, opioids, and psychostimulants. Psychostimulants are particularly used to manage ADHD and some of its adverse effects are psychosis and mania (Arcangelo et al., 2017). On the other hand, antidepressants have been associated with increased suicidal risks and the risk is even higher among children with untreated depression.Off-Label Drug Use in Pediatrics.