Abstract
Background: Children are recognized as “therapeutic orphan” in many parts of the world, one expression of this is the lack of adequate pediatric labeling information. Some research studies have been done to investigate the pediatric labeling condition in the U.S. and other countries, but no national studies had been carried out in China. This survey was conducted aiming to inquire the current situation of pediatric labeling in China.Methods: We investigated 6020 child-applied medicines from 15 representative Chinese hospitals, and analyzed the information according to the dosage forms, therapeutic category, and label information integrity.Results: Among all these medicines, only 238 (3.95%) are pediatric products, the rest are adult formulations with an extended use in children. The major pediatric formulations were injection (45.95%), tablet (23.69%), and capsule (4.93%), respectively. Alimentary tract/metabolism medicine (24.70%) and infections medicines (20.60%) had the most species. In prescription drugs, only 210 of 5187 (4%) medicines had adequate pediatric labeling information. The main cause of this deficiency was lack of evidence derived from pediatric clinical trials.Conclusion: The dilemma of “therapeutic orphan” requires significant attention. Inadequate labeling information and lack of pediatric clinical trials were two prominent issues in China. It calls for more efforts from pharmaceutical industries, regulatory agencies, and legislature in China to collaborate and find solution to improve the situation.
Highlights
Forty years ago, after the tragedy of fetal malformation from maternal ingestion of thalidomide, Dr Harry Shirkey first pointed out the dilemma of pediatric therapy and raised the concept of “therapeutic orphan” [1, 2]
MATERIALS AND METHODS This study investigated the pediatric labeling in 15 top-ranked Chinese medical facilities by questionnaire, including the basic condition of pediatric drugs in each facility, their dosage forms, therapeutic category, and label information integrity
The child-specific proportion is low, and the phenomenon of adult products off-label use in pediatric population is serious in China, especially in prescription drugs
Summary
After the tragedy of fetal malformation from maternal ingestion of thalidomide, Dr Harry Shirkey first pointed out the dilemma of pediatric therapy and raised the concept of “therapeutic orphan” [1, 2]. In 1975, Wilson investigated the US Physicians’ Desk Reference (PDR) and discovered only 22% of drug labeling had adequate pediatric information [5]. The phenomenon of lack of labeling information in children is a critical issue in China, yet very few studies have been carried out nationwide [7]. This study was undertaken aiming to investigate the current pediatric medicine labeling situation with the intension that it may help to promote the collaborative efforts among pharmaceutical industry, the regulatory agencies of the country, and legislature professionals to provide child-friendly formulations and adequately label the medicines for infants and children. Children are recognized as “therapeutic orphan” in many parts of the world, one expression of this is the lack of adequate pediatric labeling information. Some research studies have been done to investigate the pediatric labeling condition in the U.S and other countries, but no national studies had been carried out in China.This survey was conducted aiming to inquire the current situation of pediatric labeling in China
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