Chinese Journal of Pharmacovigilance ›› 2015, Vol. 12 ›› Issue (5): 271-274.

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Comparison and Analysis on Instructions for Foreign and Domestic Aspirin Enteric-coated Tablets

ZENG Jing1,2 ,ZHUO Lin1 ,ZHAN Si-yan1   

  1. 1.Department of Epidemiology and Biostatistics, Health Science Center, Peking University, Beijing 100191, China;
    2.Department of Epidemiology, Institute of Geriatrics, Chinese PLA General Hospital, Beijing 100853, China
  • Received:2014-12-18 Published:2015-06-08

Abstract: Objective To improve the domestic instructions by summarizing evidence of the criterion and accuracy of aspirin enteric-coated tablet instructions. Methods Systematic review was applied to identify instructions through foreign and domestic web/databases. Aspirin enteric-coated tablet instructions classified as OTC and produced during 2002-2013 were included. Results 82 copies were eligible and divided into low or high dose type according to the usage and specifications. In terms of domestic instructions, incorrect label of basic items was mainly in the non-safety information, contraindications and precautions, and low-dose instructions were not unified in indications, usage and dosage, etc. As for safety information, we found that two types all had inconsistency in indications, dosage and suitable crowd, and the difference in low dose was more obvious. Conclusion The quality of basic items in domestic instructions was acceptable, but the low-dose safety information was poorly administrated. Compared with others, domestic instructions lacked local researches and we should attach more importance to pediatric use.

Key words: aspirin, drug instruction, comparison

CLC Number: