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Purpose: To investigate adverse drug reactions (ADR) and causative drugs in the elderly 65 years of age or older,using Korean spontaneous reporting adverse events reporting database from June 2009 to December 2010. Methods: We estimated the association between ADRs and implicated medications by calculating a proportional reportingratio (PRR), reporting odds ratio (ROR), and information component (IC). We reexamined the most frequentlyimplicated medications and ADRs, and the seriousness of ADRs. Then, we assessed reports and concordant rate ofADRs due to medications designated as “high-risk” in elderly by 2012 healthcare effectiveness data and information set(HEDIS) or “potentially inappropriate” by 2012 American Geriatrics Society updated Beers criteria for potentially inappropriatemedications (PIMs). Results: Among 15,484 elderly reports, data-mining analysis by PRR, ROR and ICshowed that 421 drug-ADR pairs were detected as signals (3,189). The most frequently reported ADR and causativedrug were urticaria (470) and contrast media agents (647), respectively. One hundred eighty nine ADR cases weregraded as serious. Twenty-two kinds of high-risk medications were shown to be implicated in only 0.9% of ADRs. Only thirty-nine cases were consistent with 2012 Beers criteria or HEDIS. Conclusion: These results suggest that managementof the other medications including contrast media agents as well as close monitoring of PIMs are necessary forreducing ADRs in the elderly.

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