Abstract
ObjectiveWe analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions.MethodsAdverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary’s teaching hospital, Daejeon, Korea) from 2010–2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton’s preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed.ResultsOf 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001), and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001). Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001) but not among contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization–Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001).ConclusionsWe found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse reactions. The World Health Organization–Uppsala Monitoring Centre and Naranjo algorithm causality evaluation afforded similar results.
Highlights
According to the World Health Organization (WHO), an adverse drug reaction (ADR) is a noxious, unintended, and often unavoidable response to normal therapeutic doses of a medicine [1]
We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse reactions
D-ADRs were defined as adverse reactions induced by other drugs except contrast media (CM)
Summary
According to the World Health Organization (WHO), an adverse drug reaction (ADR) is a noxious, unintended, and often unavoidable response to normal therapeutic doses of a medicine [1]. The hospital admission rate due to ADRs is over 10% in some countries, and is associated with marked socioeconomic loss [2,3]. Detecting and establishing preventive measures against ADRs is essential for patient safety. An automatic or spontaneous reporting system is necessary to uncover ADRs [1]. Several ADR reporting and monitoring systems, including computerized surveillance systems, have encouraged the monitoring of ADRs at in-hospital regional PV centers, and could promote the early identification or prevention of ADRs with properly designed ADR detection methods [4,5]. Periodical evaluation and analysis of reported ADRs filed during PV enhances the understanding of the ADR magnitude and patterns
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