Analysis of the pediatric off-label use of medicines in 2012 edition of National Essential Medicine List / 中国药学杂志

ABSTRACT

OBJECTIVE: To investigate and study the 2012 edition of National Essential Medicine List chemical medicines and biological products off-label drug use in pediatrics, analyze the causes of off-label use of medications, provide the suggestion for off-label drug use in pediatrics. METHODS: To adopt questionnaire survey in different regions of the 10 third-grade class-A children's hospital off-label use of medications in 2012 edition of National Essential Medicine List chemical medicines and biological products of 309 types which excluded obstetrics and gynecology medication, family planning administration and national immunization programs with vaccine from 317 types. Excel 2007 software is used for data calculation and statistical analysis. RESULTS: CD20 categories, 22 dosage forms, which accounted for 80% of all drug categories are involved in off-label use of medications in 2012 edition of National Essential Medicine List. (2) Lack of children's dosage (62.95%) is mainly responsible for off-label of drugs. Off-label use of medications mainly manifest in off-labeling with pediatric indications (85.94%), of which labeling with pharmacological action without indication (45.63%) is the main type, and off-labeling with route of medication (66.96%). (3) 2013 edition of Chinese National Formulary (Chemical and Biological Products for Children) and 2010 edition of Chinese Pharmacopoeia of Clinical Medication Information are the main evidence for off-label drug use, account for 34.60% of the total number of cases. (4) 147 types of medicines which involved in off-label use are searched in a database named Micromedex. Indications have been approved by the the US Food and Drug Administration ( FDA) or not which labeling with children's dosage account for 27.10% of the total number of indications. CONCLUSION: Off-label drug use in the 2012 edition of National Essential Medicine List is an important public health issue for children. It reflects the lack of labeling with pediatric information. It is suggested that joint efforts should be paid by departments concerned and more support be provided to further improve the policy for children's medication.