The Research of Patient Direct Reporting in Pharmacovigilance

Abstract

Abstract: Objective To introduce the implementation of direct reporting of patients in pharmacovigilance, in order to provide references for our patient reporting. Methods Analyze the importance, operation and international experience of patient direct reporting by literature and make recommendations combined with China's national conditions accordingly. Results and Conclusion Patient reporting has the advantages of rich qualitative description with more details, increasing the number of ADR reports and new ADR symptoms, helping early detection of ADR and so on. It provides the evidence for regulatory decision-making as an important complement to the reporting system. In China, the level of patient reporting is still very low. Particularly in the implementation process, there are still many problems. Therefore, we should actively carry out the research of reporting routes, forms and coding based on the existing situation. We should widely publicize the importance of patient reporting, timely provide patient education, and increase the public awareness of the reporting.

Key words: adverse drug reaction monitoring, patient direct reporting, international experience

CLC Number:

R951

BIAN Lei ,ZHAO Pin ,YANG Yue . The Research of Patient Direct Reporting in Pharmacovigilance [J]. Chinese Journal of Pharmacovigilance, 2013, 10(10): 609-613.

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