국외 약물감시기관의 시판 후 약물유해사례 보고자료 공개 현황 = The Status of Public Access to Postmarketing Adverse Event Reporting Data in Foreign Pharmacovigilance-related Organizations

다국어 초록 (Multilingual Abstract)

Objective: For establishing effective pharmacovigilance (PV) system, it is important to not only detect signal and assess adverse drug reactions (ADRs), but also communicate with ADR reporters and provide safety information to the public. We identified the situation of foreign PV-related organizations in public access to post-marketing adverse event (AE) reporting data. And we would provide valuable resources in determining the public access policy for AE report data. Methods: We investigated the current status of public access to AE reporting data in foreign PV-related organizations; WHO-Uppsala Monitoring Center (Sweden), U.S. Food and Drug Administration (US), Medicines and Healthcare Products Regulatory Agency (UK), Health Canada (Canada), Therapeutic Goods Administration (Australia), Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration (China). Results: Among the foreign PV-related organizations, we identified there were three types of public access to AE reporting data; providing statistical analysis like annual reports, detected signals from AE reports, and individual case safety reports. Conclusion: Public access policy concerning AE reporting data in foreign PV-related organizations can be used as a good reference in developing the appropriate method and accessing levels in disclosing Korea Adverse Event Reporting System (KAERS) data.

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