Chinese Journal of Pharmacovigilance ›› 2015, Vol. 12 ›› Issue (3): 156-159.

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Study on Application of Electronic Healthcare Records in Pharmacovigilance in US and EU

WANG Ling   

  1. Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2015-02-28 Online:2015-03-08 Published:2015-07-28

Abstract: Objective To provide thought and references for the promotion of ADR monitoring in China. Methods Study on the current state and the practical application by using of data from electronic healthcare records for pharmacovigilance. The shortcomings were summarized and analyzed, suggestions on improving ADR monitoring and post-marketing clinical studies were put forward based on HIS. Results &Conclusion It can get data from the real world to carry out the ADR monitoring by using the HIS, improving the quality of ADR reporting at source and reducing the omission.To strengthen active surveillance can make up for the inadequacy of spontaneous reporting. It is a good way to improve the quality and the value of ADR monitoring. We should draw lessons from foreign advanced experience and technology, strengthen the HIS construction and information comprehensive utilization.

Key words: adverse drug reaction, electronic healthcare records, pharmacovigilance, hospital information system

CLC Number: