Considerations on Package Inserts in Force of Chinese Traditional Patent Medicine
- VernacularTitle:对现行中成药说明书的调查和思考
- Author:
Dongyu CHEN
- Publication Type:Journal Article
- Keywords:
Chinese traditional patent medicine;
Package insert;
Problem
- From:
China Pharmacy
2001;0(09):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To promote the standardization of the packing inserts of Chinese traditional patent medicine in the writing and printing. METHODS: A total of 106 package inserts of 5 common dosage forms of Chinese traditional patent medicine analyzed in accordance with the national standard. RESULTS: Problems were found in most of the package inserts of Chinese traditional patent medicine, which manifested as chaotic ranking of essential components, non-standard stating of actions and indications, unclear stating about dosage and administration, nonobjective in the labeling of adverse drug reactions, confusion between contraindication and precautions, lacking of research document on drug interactions, pharmacology & toxicology and pharmacokinetics. CONCLUSION:The drug surveilance agency should attach importance to and tighten control on the nonstandard writing and printing of packing inserts of Chinese traditional patent medicine.
