Clinical pharmacologists are physicians, pharmacists, and scientists whose focus is developing and understanding new drug therapies.

The objective of this study was to analyze information on pediatric use in Korean drug product labels and compare it with that in US Food and Drug Administration (FDA) labeling information. Prescription information on pediatric use contained in the commonly used drugs’ product labels approved by Korean government was compared with that approved by the FDA. Among the top 50 commonly prescribed drugs, 20 drugs were deemed to have insufficient prescribing information in Korean drug labels. Pediatric prescribing information regarding indication, approved age, formulations, and safety was insufficient in Korean drug labels compared with those in the FDA. Most important, the adverse events frequently reported in Korean children were not sufficiently presented in drug labels. In conclusion, this study highlights the urgent need for the Korean regulatory agency to encourage and accelerate research and development to increase the extent of pediatric prescribing information to be added to drug labels to promote appropriate drug prescribing for children.

Drug labeling should provide science-based prescribing information to give healthcare professionals the information they need to prescribe drugs safely and effectively for their approved indications. However, due to the lack of evidence or regulatory delays in labeling updates, recommendations for pediatric drug use are often missing. This may expose children to a higher risk for side effects, unwanted drug reactions, and medication errors.

In the past decade, significant attention and effort have been made to overcome gaps in prescription drug labeling by major policy changes and innovations in the field of pediatric pharmacotherapy in developed countries. The adoption of pediatric regulatory initiatives in the United States and then in European Union (EU) has led to more pediatric studies and labeling with both requirements and incentives for pediatric studies of drugs. The US Food and Drug Administration (FDA) pediatric labeling rule of 1994, the FDA Modernization Act of 1997, companion legislation of the Best Pharmaceuticals for Children Act in 2002, and Pediatric Research Equity Act (PREA) of 2003 have led to significant advances in the field of pediatric labeling information.The EU pediatric regulation enacted in 2007 also intended to encourage development of suitable medicinal products for children, thereby prioritizing children's real therapeutic needs by promoting high-quality research and improving information available on the use of medicines in children. The results of all pediatric studies were to be submitted to the appropriate authority, and included in the product labels, independent of whether the pediatric indications concerned were approved by the appropriate authority. The ultimate aim of these pharmaceutical policy initiatives is to provide additional data on safety, efficacy, and dosing of currently available medicines and to stimulate routine testing that may lead to pediatric labeling at the time of the initial drug approval.

Thanks and Regards,

Robert Her.