Research and Analysis of 180 Package Inserts of Oral Chemical Prescription Drug / 中国药房

ABSTRACT

OBJECTIVE:To probe into the quality of the package inserts of oral chemical drugs to lay a foundation for the further standardization of drug package inserts.METHODS:180 package inserts of oral chemical drugs current on market were selected and subjected to inspection in accordance with the Regulatory Guidelines for the Package Inserts of Drugs announced by SFDA as well as other related references to find out the problems existing in the package inserts,and a statistical analysis was conducted on the typical problems.RESULTS:Among the 180 package inserts,109(60.56%)had problems(totaled 167 defects)predominantly in drug name,storage,usage and dosage.CONCLUSION:It is urgent to improve the quality of the package inserts.