There has been an increase in concern regarding the drugs used to treat patients in pediatric care. The use of drugs is usually based on its approval by the provision of legal license (Mukattash et al., 2012). The existence of poor quality assessment mechanisms has created a loophole resulting in an increase in the proliferation of unlicensed drugs or treating a condition using a drug that is not specified or approved for that specific diagnosis. In this regard, this short excerpt addresses the concern of off-label drugs to treat children.
Children and Off-label Drug Prescription
According to Maria (2014), off-label drug prescription involves recommending or applying a drug for a condition, dosage, or age that is not in line with the listed characteristics during its approval. When children are diagnosed with a condition that requires treatment but the available drugs are meant for adults, it becomes necessary to consider how medication meant for adults could be used. In such a case, an evidence analysis should be carried out to determine the effectiveness and safety of the medication. Age, weight, and severity of the condition could lead to such a decision; however, the contraindications associated with the medication, the dosage, and possible post-treatment complications should be considered. The most commonly prescribed group of drugs as off-labels include antibiotics at 60% and those used to treat nervous system problems at 14% (Tefera et al., 2017). Cardiovascular drugs are prescribed in children as off-label at the rate of 8.6%. The common drugs include ceftriaxone 74, cloxacillin 83, and gentamycin 34. Moreover, paracetamol 5 is also common as off-label prescription children (Tefera et al., 2017).
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Making Off-Label Drug Usage Safe for Children
It is important to note that the lack of child-specific guidance about a drug does not imply that the drug has been prohibited in child care. However, a number of issues should be considered before a prescription is made. Practitioners are expected to conduct thorough research and scan the available evidence from reputable sources to determine the safety and effectiveness of the medication in children (Cuzzolin, Atzei, & Fanos, 2006). There are currently different sources that could offer reliable information about the use of a specific drug in children apart from the FDA publication and approval reports. Practitioners could check evidence from peer-reviewed journals, policy and practice frameworks, consensus statements, and other organizations such as the Cochrane Collaboration. Practitioners should equally use their experience to build on available data by sharing their outcomes. Indeed, it is important to share information with the family and discuss the drug provisions before reaching a decision. Practitioners are solely responsible for their decision. When dealing with off-label drugs, practitioners’ judgment also plays a key role in ensuring the safety of the child being treated (Conroy, Raffaelli, & Rocchi, 2000). On the other hand, it is also advisable to consider the risks involved by evaluating alternative options or the consequences in terms of health when there is no prescription made for the child. At the same time, other factors such as the insurance costs conditions defining the use of off-label drugs as well as the legal implications come into the picture.
Conclusion
The use of off-label prescription in children is a key concern across the globe. However, the health of children is equally a sensitive issue amid the limited drug testing for children. Nevertheless, practitioners are considered to be a position to make a favorable decision in line with the diagnosis made and according to available evidence or informed possibilities.
References
Conroy, S., Raffaelli, M. P., & Rocchi, F. (2000). Survey of unlicensed and off label drug use in pediatrics wards in European countries. Br Med J , 320, 79–82.
Cuzzolin, L., Atzei, A., & Fanos, V. (2006). Off-label and unlicensed prescribing for newborns and children in different settings: A review of the literature and a consideration about drug safety. Expert Opin Drug Saf , 5, 703–718.
Maria, L. B. (2014). Development of a Guideline on the Off Label-Use of Drugs . 1st February 2014.
Mukattash, T., Trew, K., Hawwa, A. F., & McElnay, J. C. (2012). Children’s views on unlicensed/off-label pediatric prescribing and pediatrics clinical trials. Eur J Clin Pharmacol , 68, 141– 148.
Tefera, Y. G., Gebresillassie, B. M., Mekuria, A. B., Abebe, T. B., Erku, D. A., Seid, N., & Beshir, H. B. (2017). Off-label drug use in hospitalized children: A prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia. Pharma Res Per , 5(2), e00304.
