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KMID : 1011320090020010052
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Journal of Pharmacoepidemiology and Risk Management
2009 Volume.2 No. 1 p.52 ~ p.59
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Application of Internationally Standardized Classification System for Data Management on Adverse Events with Health Functional Food and Suggestion for Improvement
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Shin Ju-Young
Choi Nam-Kyong
Park Byung-Joo
Jung Sun-Young
Lee Jin-Ho
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Abstract
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Objective: To investigate the current adverse event (AE) classification code with health functional food and suggest possible solutions for data management on AEs with health functional food.
Methods: We investigated the essential elements for standardized classification to review the the current AE classification code with health functional food. The AE reporting system and classification code (WHO-ART and MedDRA) of the USA, Canada, UK were investigated and compared for efficient coding collected AEs with health functional food. Finally we made a suggestion for improvement and developed checklist for reporting and coding convenience.
Results: Essential elements as standardized classification system were following: completeness, comprehensiveness, multiple hierarchies, simplicity, version control, etc. Considering the essential elements, current AE classification system with health functional food was not appropriate for coding and reporting AEs. For coding collected AEs, the USA, Canada, UK applied internationally standardized classification system, WHO-ART or MedDRA. All 3 countries had a integrated health product vigilance system covering pharmaceutical drugs, health functional food, medical device, etc. Also, AEs were reported in a free-text. As a suggestion for improvement, WHO-ART was selected for AE data management and classification. To develop a checklist for reporting AEs, 29 AEs were selected to report and code efficiently. Finally, the development of guideline for coding AEs with health functional food were suggested.
Conclusion: For the high quality of AE data management toward active health product vigilance, appropriate checklist for reporting AEs are necessary. Also, internationally standardized classification system should be applied to facilitate the recognition of terms and communicate the information efficiently.
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KEYWORD
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Health functional food, Spontaneous adverse event reporting system, Internationally standardized classification system, Health product vigilance
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