Analysis of Labeled Items in Package Inserts of 51 Kinds of Ointment for External Use / 中国药房

ABSTRACT

OBJECTIVE:To provide reference for reasonably designing package inserts of ointment for manufacturers. METH-ODS:According to items included in Management Regulation for Package Insert and Label and Specification for Chemicals and Bi-ological Products for Treatment,labeled items in package inserts of 51 kinds of ointment for external use during Jan.-Jun. 2016 in our hospital were analyzed. RESULTS:Among the 51 kinds of ointment,39 were domestic varieties and 12 were imported variet-ies. In the package inserts of 39 domestic varieties,items with lower labeling rates were overdose,pharmacokinetics,use guid-ance,pharmacology and toxicology,with labeling rates of 2.6%,5.1%,15.4%,28.2%;while the labeling rates of imported vari-eties were 16.7%,83.3%,75.0%,100%. Compared with package inserts of imported ointment,composition,dosage and usage, adverse reactions,contraindications,precautions,drug interactions,medication for special populations were not enough detailed in domestic ointments. CONCLUSIONS:It is suggested that manufacturers consult medicine experts, list all auxiliary materials through Management Regulation for Drug Description and Label,refine and improve the labeling contents of dosage and usage,ad-verse reactions,precautions,medication for special populations,pharmacology and toxicology,overdose,etc. In addition,admin-istrative departments should strengthen the regulatory approval efforts.