A Study of Agreement between WHO-UMC Causality Assessment System and the Naranjo Algorithm for Causality Assessment of Adverse Drug Reactions Observed in Medical ICU of a Tertiary Care Teaching Hospital

Acharya, Tejas; Trivedi, DN; Joshi, Krupal; Chhaiya, Sunita B.; Mehta, Dimple S.

doi:10.13005/bpj/1863

Cited by 17 publications

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“…The difference in the values found in the study done by Mittal et al . [ 17 ] and Acharya et al .,[ 18 ] and this study can be attributed to the smaller sample size of the study (200) and observer bias. The study done by Rehan et al .…”

Section: Discussionmentioning

confidence: 85%

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Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions

Shukla

Jhaj

Misra

et al. 2021

Journal of Family Medicine and Primary Care

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Background: The Pharmacovigilance Program of India recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, while many clinicians prefer the Naranjo algorithm for its simplicity. In the present study, we assessed agreement between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm. Materials and Methods: In this study, 842 individual case safety reports were randomly selected from 1000 spontaneously reported forms submitted to the ADR Monitoring Center at a tertiary healthcare Institute in Central India between 2016 and 2018. Two well-trained independent groups performed the causality assessment. One group performed a causality assessment of the 842 ADRs using the WHO-UMC criteria and the other group performed the same using the Naranjo algorithm. The agreement between two ADR causality scales was assessed using the weighted kappa (κ) test. Results: Cohen's kappa coefficient (κ) statistical test was applied between the two scales (WHO-UMC scale and Naranjo algorithm) to find out the agreement between these two scales. “No” agreement was found between the two scales {Kappa statistic with 95% confidence interval = 0.048 ( P < 0.001)}. Conclusion: There was no agreement found between the WHO-UMC criteria and the Naranjo algorithm in our study.

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Section: Discussionmentioning

confidence: 85%

“…Acharya et al . [ 18 ] found moderate agreement (Cohen's κ =0.6) between the WHO-UMC system and the Naranjo algorithm. In this study, sample size was only 59 and both assessments were done by the same teams.…”

Section: Discussionmentioning

confidence: 99%

Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions

Shukla

Jhaj

Misra

et al. 2021

Journal of Family Medicine and Primary Care

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“…The moderate level agreement which was implicated in this study aligns with the studies done by Thaker SJ (kappa=0.69) [17] and Tejas. A. Acharya (kappa=0.60) [11]. But lower kappa values were found in other studies like Rehan et al…”

Section: Discussionmentioning

confidence: 65%

“…This parallelism in both the scales is in agreement with the earlier studies done by Tejas. A. Acharya et al [11], Roy et al [12] and Nitti Mittal et al [13], where the probable category was the highest in both the tools. In contrast to this, many studies show that the "Possible" criteria to be prominent, as seen in Behelkar MN et al [14] and Lei et al [15].…”

Section: Discussionmentioning

confidence: 93%

A Study of Agreement Between Who-Uppsala Monitoring Centre Criteria, Naranjo Algorithm, and Liverpool Algorithm for Causality Assessment of Adverse Drug Reactions

Sunitha

Parvathy

2021

Int J Pharm Pharm Sci

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Objective: A standard causality assessment tool of an adverse drug reaction (ADR) is essential to compute the risk-benefit assessment of the medication taken by the patient and categorize its relationship likelihood. It should be reproducible and should not differ with the background and experience of the evaluator. Though there are a large number of causality assessment tools, none is unanimously accepted worldwide. So, this study was done to assess the agreement between three frequently used methods of causality assessment, the World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) system, the Naranjo’s algorithm, and the Liverpool algorithm. Methods: 172 ADR forms from the pharmacovigilance unit were randomly selected for the study. Causality assessment was done using three different methods, the WHO-UMC system, Naranjo’s algorithm, and the Liver pool algorithm. Cohen’s Kappa statistics was applied to look for agreement between the causality assessment methods. Results: The agreement between the WHO-UMC criteria and Naranjo’s algorithm was the highest (136), with a Kappa value of 0.511, suggesting a moderate level of agreement. A maximum number of disagreements were noted between the WHO-UMC system and the Liverpool algorithm method (110). Conclusion: A moderate agreement exists between the WHO-UMC system and the Naranjo algorithm. There is poor agreement between the Liverpool algorithm and the other two scales. Therefore, it is recommended that both the WHO-UMC system and the Naranjo algorithm be used for causality assessment of ADRs.

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“…A recently published analytical study reported a moderate agreement when comparing causality assessment between the WHO-UMC and Naranjo scales. 16 However, the WHO-UMC scale is likely prone to subjective variations due to differences in clinical knowledge and expertise from the scorer; the Naranjo scale is designed to reduce this impact, and is therefore considered to have a low sensitivity. The presence of “possible” Naranjo scores associating SPS with all events uncovered in our study, while in the setting of this anticipated lower sensitivity for causality, substantiate the higher rates of serious adverse events seen.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Sodium Zirconium Cyclosilicate to Sodium Polystyrene Sulfonate in the Inpatient Management of Acute Hyperkalemia

Joyce,

Corpman

2023

Journal of Pharmacy Practice

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Background Oral potassium binders have a role in the management of acute hyperkalemia among hospitalized patients. However, with therapeutic additions to this class, there is insufficient evidence between potassium binders to support a standard of care recommendation for use in this acute setting. Objective The purpose of this study was to compare the acute potassium lowering effects of sodium zirconium cyclosilicate (SZC) and sodium polystyrene sulfonate (SPS). Methods A retrospective review of admitted patients who received SZC or SPS was conducted after exemption from the Institutional Review Board. Patients with baseline potassium values less than 5.1 mmol/L or factors contributing to potentially false report of serum potassium were excluded. The primary outcome was the average change in potassium from baseline to 24 hours following potassium binder administration. Secondary outcomes compared changes to potassium from baseline to various time periods after administration, presence of electrolyte changes, and documentation of serious adverse events. Results A total of 246 patients were included, with 128 receiving SZC and 118 receiving SPS. Mean change in serum potassium (mmol/L) at 24 hours was not significant between binders (−.78 vs −.91; P = .22). Secondary efficacy and safety outcomes were also similar between groups. A total of 5 serious adverse events were reported, occurring only in the SPS group. Conclusion SZC and SPS have comparable effects in acute potassium reduction, with serious gastrointestinal adverse events documented only in SPS patients. Health systems may consider this data in determining medication formularies or during order set development.

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A Study of Agreement between WHO-UMC Causality Assessment System and the Naranjo Algorithm for Causality Assessment of Adverse Drug Reactions Observed in Medical ICU of a Tertiary Care Teaching Hospital

Cited by 17 publications

References 0 publications

Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions

Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions

A Study of Agreement Between Who-Uppsala Monitoring Centre Criteria, Naranjo Algorithm, and Liverpool Algorithm for Causality Assessment of Adverse Drug Reactions

Comparison of Sodium Zirconium Cyclosilicate to Sodium Polystyrene Sulfonate in the Inpatient Management of Acute Hyperkalemia

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