Comparative Analysis of ADR on China's National Essential Medicines List (2015 Edition) and WHO Model List of Essential Medicines (19th Edition).

Objective: To explore the safety of the essential medicines recorded in China's list through the comparison of the list of essential medicines of China and the World Health Organization (WHO), as well as the analysis of the basic situation and characteristics of adverse drug reactions (ADRs) on the two essential medicines recorded in China's and WHO lists in order to provide a reference for the improvement of China's list.

Methods: A retrospective descriptive study was conducted, based on the database in Jiangsu Province ADR Monitoring Center from 2013 to 2015. A total of 266869 cases reports were collected within this period, comparing the differences between the two essential medicines recorded in China's and WHO lists, considering number of ADRs, type of report, and modes of administration. Compare the differences between the two groups of drugs in the presence of new, severe, and new severe adverse events using chi square test.

Results: Comparing the two essential medicines list, they have the same 117 species. When comparing ADRs in the two groups, most are antimicrobial, electrolytes, and acid-base balance drugs, regulate water, and are higher in China. In addition, with respect to the number of ADR types in the two groups, there is statistical significance (p<0.001) (total number is 68603 and 47515, new types are 12601 and 7262, the severe are 2714 and 7566, and the new severe are 820 and 716).

Conclusion: Compared to the WHO list of essential drugs, China's list is still to be improved.