Partnering with Clinical Pharmacologists to Improve Medication Use in Children

By: Shogo John Miyagi, Edwin Lam, Sonya Tang Girdwood

Posted on: December 15, 2020

Partnering with Clinical Pharmacologists to Improve Medication Use in Children

American children receive on average 3.5 prescriptions annually, with 62%-85% used off-label.1,2 Lack of formulations suitable for children is a major reason for off-label and unlicensed use of medications.3 Although this practice does not imply improper, illegal, contraindicated, or investigational use, it often lacks substantial evidence of effectiveness and/or safety from adequate and well-controlled studies. The passage of legislation (Best Pharmaceuticals for Children Act in 2002, the Pediatric Research Equity Act in 2003, the Food and Drug Administration Safety and Innovation Act in 2012; and the Food and Drug Administration Reauthorization Act in 2017) has helped to change >500 labels to include pediatric indications, yet 59% of drug labels still do not contain pediatric information.