Consistency between Causality Assessments Obtained With Various Scales and Their Agreement for Adverse Drug Events Reported in Pediatric Population

Rana, Devang; Bhadiyadara, Sunilkumar Nagjibhai; Shah, Heena; Malhotra, Supriya; Patel, Varsha J.

doi:10.5530/jyp.2015.2.6

Cited by 11 publications

(7 citation statements)

References 10 publications

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“…The study shows that incidence rate of ADRs was found to be more for males when compared to females. Our findings were similar to the study conducted by Devang Ashwinkumar Rana et al [3] and Dilip et al [4]. The study also showed that the incidence rate for geriatrics to be higher than adults and pediatrics.…”

Section: Discussionsupporting

confidence: 92%

Spontaneous Adverse Drug Reaction Reporting in a Tertiary Care Hospital in Calicut

Sundaran¹,

Abhijith²,

Alex³

et al. 2018

Asian J Pharm Clin Res

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Objective: The study was conducted to assess the adverse drug reactions (ADRs) reported in a tertiary care hospital in Calicut.Methods: Spontaneous ADR reporting method was followed for the study. The ADRs reported by the health-care professionals, or the patients were confirmed with the physician-in-charge. Further, the assessments of type, severity, and preventability of reported ADRs were done using Wills and Brown classification, modified Schumock and Thornton severity scale, and modified Hartwig and Siegel preventability scale.Results: A total of 30 ADRs were reported. A study found that the incidence of ADRs was more in males (1.14%) when compared to females (0.79%). Geriatric patients showed more incidences of ADRs (1.04%) when compared to pediatrics (0.69%) and adults (1.02%). More number of ADRs was associated with antibiotics (23.33%) and anticonvulsants (23.33%) than another category of drugs. Based on type or mechanism involved 80% of ADRs were pharmacologically related (Augmented) ADRs. Severity assessment showed that 50% were mild, 46.67% were moderate, and 3.33% were severe. Assessment of preventability showed that 63.33% of ADRs were not preventable, 30% were preventable, and 6.67% were probably preventable.Conclusion: The study was useful in finding the age category and drugs that were more prone to ADRs. This will render precautions and monitoring in the future. The importance of ADR monitoring unit and aid of clinical pharmacist in the monitoring and assessment were very well considered during the study.

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Section: Discussionsupporting

confidence: 92%

Spontaneous Adverse Drug Reaction Reporting in a Tertiary Care Hospital in Calicut

Sundaran¹,

Abhijith²,

Alex³

et al. 2018

Asian J Pharm Clin Res

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“…Rana et al . [ 14 ] also found poor agreement (Cohen's κ =0.014) between the WHO-UMC scale and the Naranjo algorithm. In this study, only 36 ADRs were analyzed, all belonging to the pediatric age group.…”

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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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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“…However, the Cohen's kappa coe cient (κ) statistical test, demonstrated that there was no agreement between the WHO and Naranjo Causality Scales. Studies conducted by other research groups also yielded similar results, with the kappa coe cient statistical test demonstrating low agreement between the WHO and Naranjo Causality Scales [33,41,42]. Given these ndings, developing a gold standard evaluation scale is essential to improve the quality and reliability of future causality assessments.…”

Section: Variations In Resultsmentioning

confidence: 63%

A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore’s Traditional Chinese Medicine clinics.

Ng,

Zhao,

Wang

et al. 2023

Preprint

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Background This study aimed to investigate the rates and causality of patient-reported adverse events (AEs) associated with concomitant Chinese Herbal Medicine (CHM) and Western Medicine prescription drug (WMPD) consumption through active surveillance in Singapore’s Traditional Chinese Medicine (TCM) clinics. Methods A cross-sectional study was conducted at five TCM clinics across Singapore from 8th May till 8th July 2023. Patients were screened to determine rates of CHM and WMPD consumption, and then interviewed if an AE was reported. An expert committee assessed the AE reports to determine causality. Along with descriptive statistics, odds ratios were calculated to determine AE occurrence likelihoods for patients who consumed both CHM and WMPD compared to CHM consumption alone. Results 1028 patients were screened and 62.65% of them reported concurrent CHM-WMPD consumption. Patients who consumed CHM and WMPD were 3.65 times more likely to experience an AE as compared to CHM consumption alone. 18 AE reports were adjudicated, with most AEs deemed unlikely due to CHM consumption. Conclusions A large proportion of patients consumed CHM and WMPD concurrently, thus increasing their risk of experiencing AEs compared to those consuming CHM only. Active surveillance is feasible for detecting AEs, collecting data for causality assessment, and analysis.

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Consistency between Causality Assessments Obtained With Various Scales and Their Agreement for Adverse Drug Events Reported in Pediatric Population

Cited by 11 publications

References 10 publications

Spontaneous Adverse Drug Reaction Reporting in a Tertiary Care Hospital in Calicut

Spontaneous Adverse Drug Reaction Reporting in a Tertiary Care Hospital in Calicut

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

A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore’s Traditional Chinese Medicine clinics.

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