Analysis and Consideration of Pediatric Medication in National Essential Medicine List （2018 Edition） / 中国药房

ABSTRACT

OBJECTIVE： To provide reference for improving pediatric medication of National Essential Medicine List （NEML） and establishing Chinese essential medicine list for children. METHODS： NEML （2018 edition） were compared with WHO Essential Medicines List for Children （WHO EMLc） in respects of target population， special symbols， categories and varieties， dosage form and specification. The related suggestions were put forward. RESULTS & CONCLUSIONS： WHO EMLc is specifically used for children under 12 years old， and defines specific age and body mass. NEML is applicable to all age groups （including children）. WHO EMLc includes 4 types of special symbols， i.e. “□” （the drug with the best efficacy and safety in the same kind of drugs， which matches the selection principle of NEML）， “a” （limited age or body weight， not found in NEML）， “*” （special dosage， specially emphasized indications and age not recommended for use， listing substitute drugs， not found in NEML）， “[c]” （placed next to a drug or a specification indicating that they are only used by children； and placed next to a supplementary list indicating that they need expert diagnosis， monitoring facilities， medical care for children， similar to the “Δ” in NEML）. NEML in China includes chemical drugs and biological products， Chinese patent medicines and TCM decoction pieces. Among them， there are 26 categories and 417 types of chemical drugs and biological products. Compared with WHO EMLc， NEML has no blood products and special drugs for newborns. As far as antimicrobial agents are concerned， WHO EMLc has strict limits and classifications. However， due to the lack of guidelines for special antimicrobial agents for children in China， the application of NEML antimicrobial agents in pediatrics is still difficult to define and classify. The number of coincident varieties in the 2 lists was 149， and the coincidence rate was 35.2％. In terms of drug dosage， WHO EMLc’s dosage form are more abundant and flexible， such as scored tablet， compressible fragments， intramuscular injections， and oral solutions suitable for children which are not included in NEML. In terms of drug specifications， 2 lists basically consider about the special needs of children taking small dosage and to some extent take into account the complementarity of dosage forms and specifications. The author suggests that the relevant departments in China should draw lessons from the mature experience of WHO EMLc， add new labeling symbols in NEML， expand drug dosage forms， implement classified management of antimicrobial drugs， and timely launch Chinese Essential Medicines List for Children so as to lay a solid foundation for further improving the accessibility and safety of essential medicines for children in China.