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COMPARISON OF SAFETY REPORTS: HIGH-RISK VERSUS LOW-RISK PATIENTS
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| Author:
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JUNY SEBASTIAN, ALISHA BESTO, RINUSHAJI, , T VIJAYALAKSHMI, MELAMBHA SURONG, M RAMESH
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| Abstract:
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To determine the incidence, causality, severity, predictability, preventability, seriousness, predictors and direct cost
associated with the management of ADRs in high-risk and low-risk patients. The prospective study enrolled eligible
patients in to high-risk and low-risk categories as per the developed criteria. Required data were collected whenever
there was an ADR detected among the study population. Data was analyzed for incidence, causality (by Naranjo’s scale
and WHO scale), severity (by Modified Hartwig and Siegel scale), predictability, preventability (by Modified Shumock and
Thornton scale), seriousness (by ICH-GCP guidelines) and direct cost associated with the management of ADRs. The
incidence of ADRs in high-risk patients was 11.28% and that of low-risk patients was 10.44%. Majority (56.56%) of highrisk
patients who developed ADRs were females while 69.01% of low-risk patients who experienced ADRs were males.
Drugs most commonly implicated in ADRs among high-risk patients were insulin (8.94%) followed by tramadol (6.50%)
whereas among low-risk patients, ceftriaxone (15.06%) and insulin (10.95%) were the drugs implicated. Majority of the
reaction were ‘probable’ in their causality category in both high-risk (82.1%) and low-risk patients (82.19%). A total of
99% of ADRs were ‘not preventable’ in both high-risk and low-risk groups. The incidence of ADR was equal in both high
–risk and the low-risk group and there was no change in the severity and preventability of the reported ADRs.
Therefore, early detection and prevention of ADRs in any patients are essential to avoid adverse outcomes of ADRs.
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| Keyword:
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Adverse Drug Reactions, High-risk, Low-risk, Predictors of ADRs.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2018.10.03.008
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| Download:
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