Chinese Journal of Pharmacovigilance ›› 2015, Vol. 12 ›› Issue (3): 175-177.

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Quality Analysis of Adverse Drug Reactions Reports in Zhongshan in 2013

LI Liang-hua,WEN Run-long*,LUO wan-ting   

  1. 1Adverse Drug Reaction Monitoring Center of Zhongshan, Guangdong Zhongshan 528437, China
  • Received:2014-12-01 Online:2015-03-08 Published:2015-07-28

Abstract: Objective To analyze the quality of adverse drug reaction(ADR) reports in Zhongshan in 2013, so as to improve the ability of ADR reporting and assessment. Methods By using the method of retrospective study, 155 ADR reports in 18 monitoring units were chosen at random to evaluate the authenticity, integrity and accuracy. We verified the original data of ADR reports on site and gave a mark according to the scoring criteria to assess the quality of ADR reports. Results All monitoring units established the ADR system of reporting and monitoring, some of which did not update and put it in place. All of ADR reports could be traced and proved to be true. The quality score of ADR reports was generally good, but it needs to be improved in reporting time, ADR process description, drug information and so on. Conclusion Regular quality evaluation of ADR reports is an important job for municipal monitoring organization. Improving the quantity and quality of ADR reports can provide the scientific basis for drug risk monitoring.

Key words: adverse drug reactions(ADR), quality assessment, verification, monitoring

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