KMID : 0869620170340040422
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Journal of Korean Society of Hospital Pharmacists 2017 Volume.34 No. 4 p.422 ~ p.432
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A Methodological Approach for Detecting Adverse Drug Reactions in the Surgical Intensive Care Unit
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Shin Jin-A
Ryu Su-Hyun Sa Eun-Young Lee Eun-Ji Suh Sung-Yun Cho Yoon-Sook Cho Yoon-Sook Han Hyun-Joo Lee Jin Son Hye-Ryeon Kang Dong-Yoon Kang Hye-Ryun
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Abstract
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Background : The prevalence of adverse drug reactions (ADRs) in critically ill patients is estimated to be high due to several reasons such as the severity of their underlying diseases, the use of multidrug agents, and the changes in pharmacokinetic parameters. The objectives of this study were to understand the status of ADRs that occurred in the surgical intensive care unit (SICU) and to suggest an optimal monitoring method.
Methods : We studied adult patients who were hospitalized in the SICU of the Seoul National University Hospital, a tertiary care hospital in South Korea, between August 3, 2015 and September 11, 2015. ADRs were detected by prospective monitoring, retrospective monitoring, and signal monitoring and assessed by a pharmacist in terms of causality, severity, preventability, seriousness, recovery, and types. The sensitivity of each monitoring method and the positive predictive value (PPV) of the signals were also calculated.
Results : A total of 96 ADRs (36.6%) was identified from prospective monitoring (n=56), retrospective monitoring (n=74), and signal monitoring (n=17). Most ADR cases were either possible or probable, and 56 (58.3%), 29 (30.2%), 11 (11.5%) cases were mild, moderate, and severe, respectively. Only one case was detected by any of the monitoring methods and there was little overlap between the ADR cases found by each of the monitoring strategies. Among the 206 alerts generated by the signal monitoring, 25 were found to be associated with ADRs and the overall positive predictive value was calculated as 0.12.
Conclusion : The incidence of ADRs was 36.6% in 262 patients hospitalized in the SICU. According to the monitoring methods, there was a difference in the detection of ADRs that occurred in critically ill patients, suggesting that prospective, retrospective, and signal monitoring are complementary.
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KEYWORD
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Drug-related side effects and adverse reactions, Adverse drug reaction reporting systems, Intensive care units, Critical care, Postoperative care
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