The risk of adverse drug reaction is high in off-label use compared to approved medication. The risk is even higher for outpatients compared to hospitalized patients due to limited monitoring. Off label, medication requires maximum monitoring since they have not been previously tried on children thus the pediatricians are uncertain of reactions. Safety strategies include administering of label medication to inpatients only to maximize monitoring of the adverse effect. Secondly, physicians should report adverse reactions of off label medication as required by their professional code for purposes of documentation thus reference in subsequent cases (Tanemura, Asawa, Kuroda, Sasaki, Iwane & Urushihara, 2019).
Other strategies include use of electronic health systems to improve the quality of prescribing by integrating parameters such as age, weight, body surface area and renal function status in complex dosage calculations, which is essential in off-label medication. electronic health records facilitates correct dosage and putting of precaution on negative drug interactions by sharing patients medical information to all additional participants in the treatment process (Corny, Lebel, Bailey & Bussières, 2015).
Another strategy is increasing access to evidence-based information regarding off label children medication and integrating pharmacists in pediatric wards for consultation in decisions regarding pediatric prescription of off label medication.
One of the off-label drugs that require extra care and attention when used in pediatrics is Budesonide. It is an inhaled corticosteroid used for asthma treatment. The children’s inability to use inhalers poses a danger of overdose of the drug. Other asthma drugs like mometasone and ciclesonide are new in the market therefor there lacks existing evidence on the implications of their use on children. They should therefore be cautiously prescribed for pediatric use.
References
Corny, J., Lebel, D., Bailey, B., & Bussières, J. F. (2015). Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. The Journal of Pediatric Pharmacology and Therapeutics, 20(4), 316-328.
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