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Off-Label Drug Use in Pediatrics

 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 interactive media piece in this week’s Resources and reflect on the types of drugs used to treat pediatric patients with mood disorders.
• 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.
By Day 5 of Week 11
Write a 1-page narrative in APA format that addresses the following:
• Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
• 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.

Please include introduction with purpose statement and conclusion.
Please use a heading for each major part of the assignment



Off-Label Drug Use in Pediatrics


Off-label drug use entails drugs that are prescribed and used outside the normal licensed indications as far as the dosage, age, indication or route is concerned. Institute of Medicine et al. (2012) point out that because of inadequacy of drugs that are specifically designed and marketed for small children, off-label use of drugs is commonly used in pediatric drug treatment. This paper looks at situations under which children can be prescribed drugs for off-label use.

Circumstances under which children should be prescribed drugs for off-label use

According to Lenk (2012) off-label use refers to situation where a drug is used for a disease or medical condition which is not approved by the relevant authority. There are a number of circumstances that lead to off-label use of drugs. Among the common reasons is the non-availability or absence of standardized, licensed and safe therapeutic options for certain types of diseases or conditions for children (Lenk, 2012). According to Lenk (2012), sometimes there is inconsistency in pediatric information regarding specific diseases.  From the FDA perspective, once it approves a drug, healthcare providers are permitted to prescribe a drug for an approved use when it is medically judged that it is appropriate for the patient I(nstitute of Medicine, et al., 2012). In some situations, all the drugs that are approved may have been tried yet the results are not positive. An approved drug for an approved use can be used to treat the disease or medical condition (Institute of Medicine, et al., 2012).

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

Off-label use medication is an essential part of medical practice because it enables clinicians to become highly knowledgeable regarding alternative treatments (Zhang Lingli, Youping, Linan Z, et al., 2012). To make the off-label use and dosage safer for children, the prescription of approved drugs must be based on the diagnostic and approved treatment practices. It is also the responsibility of medical institutions to take responsibility for the regulation and monitoring use of the innovative off-label medication. There is need for management guidelines for off-label medication use (Zhang Lingli, Youping, Linan Z, et al., 2012). Basically, any off-label medication use need to be in the context of study where informed consent is provided with an approval by an Institutional Board. The following principles should guide the process;

  • Primary consideration should be given to the patient
  • Physicians should self-monitor their prescribing practices
  • Off-label prescribing must meet ethical obligations to both the patient and the general society (Zhang Lingli, Youping, Linan Z, et al., 2012).
  • Pharmacotherapy Committee of a hospital should provide expedited services to urgent patient care issues.


In conclusion, it is evident that off-label drug use has both its rationality and significance. Though the possible risks cannot be ignored, it is a legally recognized national guideline that has a wide scope of application. If well used, the concept can be of great help to the children. It is also essential that the targeted pediatric education and training of healthcare professional regarding off-label drug use should be enhanced to ensure that clinical practice and guidelines are improved and adhered to.



Institute of Medicine, et al. (2012). Safe and Effective Medicines for Children: Pediatric Studies         Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research     Equity Act. Washington DC: National Academies Press.

Lenk C. (2012). Off-label drug use in paediatrics: a world-wide problem. Curr Drug             Targets. 2012;13(7):878–884. doi: 10.2174/138945012800675759.

Zhang Lingli LI, Youping LI, Linan Z, et al. (2012). Evidence-based evaluation on off-label drug use policies in 15 countries. Chin J Evid-Based Med. 2012;12(4):426–435.

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