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KMID : 1011320100030030101
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Journal of Pharmacoepidemiology and Risk Management
2010 Volume.3 No. 3 p.101 ~ p.112
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The Role of Consumers in the Spontaneous Adverse Drug Events Reporting
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Jin Xue-Mei
Kim Ye-Jee
Yang Bo-Ram
Song Hong-Ji
Choi Nam-Kyong
Park Byung-Joo
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Abstract
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In the early stage of the pharmacovigilance, the adverse drug reactions (ADR) were reported to the regulatory authority (RA) mainly by health professionals and pharmaceutical companies. However, spontaneous ADR reporting rate was low among health professionals. There have raised the need of reporting ADRs directly to the RA by consumers in the past decade. In this study, we assessed the pros and cons of consumer reporting and investigated the current status of spontaneous ADR reporting system to identify the level of participation of consumers in North America, Europe and Asia. Consumer reporting added values for pharmacovigilance in that it can raise the number of reports to speed up signal detection. Consumer reports contain more detailed and specific information and also describe how the ADRs affect their own life. However, consumer reports have lower quality than reports from health professionals and might increase the number of noise to distract signals. According to our review, consumer can report ADR to the RA directly in United States, Canada, United Kingdom, Denmark, Netherland, Sweden, Korea, China and Taiwan. While regulatory authorities in Japan, France and Germany do not receive ADR reports from consumers directly. The number of consumer reports is gradually increasing in North America and in Europe, but in Asian countries including Korea the level is still low. Effort for active education and public relation activities in the general public to raise awareness of ADR reporting system should be needed. In particular, education focused on how to report could be helpful for improving the quality of the consumer reports.
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KEYWORD
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Pharmacovigilance, Adverse drug reaction report, Spontaneous reporting system, Consumer
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