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Comparison of agreement and rational uses of the WHO and Naranjo adverse event causality assessment tools.

Mittal N, Gupta MC - J Pharmacol Pharmacother (2015 Apr-Jun)

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology, Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India.

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Sir, Causality assessment of adverse events (AEs) is the standardized and detailed assessment of individual case safety reports for the likelihood of involvement of the suspected drug/s in causing the particular AE... Methods for causality assessment of AEs can be broadly categorized as expert judgment/global introspection (GI), Bayesian methods and algorithms... Hence, according to the WHO, causality was labeled as possible in these cases... But, due to fulfillment of few other criteria, e.g., previous conclusive reports on the reaction, change in reaction severity with dose alteration, presence of an objective evidence and toxic drug concentrations in the blood (e.g., antiepileptics), these were able to attain a score compatible with probable association by the Naranjo algorithm... As per the WHO, ADR is labeled as probably caused by the suspected drug if all these criteria are met, i.e., reasonable time sequence to administration of the drug, unlikely to be attributed to concurrent disease or other drugs or chemicals and presence of a clinically reasonable response on withdrawal, i.e., a positive dechallenge... A similar scenario can be expected where an AE scores 1–4 on the Naranjo scale and, hence, is labeled as possibly caused by the particular drug... One reason for this disagreement might be subjective assessment in a few areas... For example, question no. 1 says: Are there previous conclusive reports on this reaction? This usually means “previous bibliographic description” and is based on judgment and needs clarification if there are few published case reports providing inconclusive evidence... Question no. 7 asks: Was the drug detected in the blood (or other fluids) in a concentration known to be toxic? Although this point is expected to give reproducible results with dose-related (type A) ADRs, the same does not stand true for type B reactions, where, in fact, it is inapplicable... Certain areas should be addressed, like type B (nondose related) ADRs, lack of efficacy/therapeutic failure as an AE and AEs arising as a result of drug interactions.

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Distribution of various adverse events. Miscellaneous included psychosis, renal and metabolic effects
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Figure 1: Distribution of various adverse events. Miscellaneous included psychosis, renal and metabolic effects

Mentions: For the present study, 200 ADR forms were included. The cases represented a wide spectrum of manifestations, the most common being cutaneous (28%) and gastrointestinal (22%) [Figure 1]. The mean age of the studied population was 35 ± 16 years, with more than 65% males (male/female: 133/67). The number of different branded/generic drugs suspected for causing ADRs was 173. A total of 34 (17%) ADRs were labeled as serious according to the WHO criteria. The use of concomitant medications was present in 108 (61%) cases. All the 200 AEs were probably or possibly caused by the suspected drugs. Causality was probable in 134 cases and possible in 42 cases with both methods. On the other hand, 24 cases were labeled as possible according to the WHO and probable according to the Naranjo algorithm. None of the cases was labeled as certainly/definitely or unlikely to be caused by the suspected drug/s. Full agreement between the two methods was seen in 88% (134 probable + 42 possible) cases while 12% (24) cases had partial agreement [Table 1]. Kappa analysis demonstrated a moderate to good agreement between the two scales (value of kappa coefficient = 0.701).


Comparison of agreement and rational uses of the WHO and Naranjo adverse event causality assessment tools.

Mittal N, Gupta MC - J Pharmacol Pharmacother (2015 Apr-Jun)

Distribution of various adverse events. Miscellaneous included psychosis, renal and metabolic effects
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4419255&req=5

Figure 1: Distribution of various adverse events. Miscellaneous included psychosis, renal and metabolic effects
Mentions: For the present study, 200 ADR forms were included. The cases represented a wide spectrum of manifestations, the most common being cutaneous (28%) and gastrointestinal (22%) [Figure 1]. The mean age of the studied population was 35 ± 16 years, with more than 65% males (male/female: 133/67). The number of different branded/generic drugs suspected for causing ADRs was 173. A total of 34 (17%) ADRs were labeled as serious according to the WHO criteria. The use of concomitant medications was present in 108 (61%) cases. All the 200 AEs were probably or possibly caused by the suspected drugs. Causality was probable in 134 cases and possible in 42 cases with both methods. On the other hand, 24 cases were labeled as possible according to the WHO and probable according to the Naranjo algorithm. None of the cases was labeled as certainly/definitely or unlikely to be caused by the suspected drug/s. Full agreement between the two methods was seen in 88% (134 probable + 42 possible) cases while 12% (24) cases had partial agreement [Table 1]. Kappa analysis demonstrated a moderate to good agreement between the two scales (value of kappa coefficient = 0.701).

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology, Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India.

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

Sir, Causality assessment of adverse events (AEs) is the standardized and detailed assessment of individual case safety reports for the likelihood of involvement of the suspected drug/s in causing the particular AE... Methods for causality assessment of AEs can be broadly categorized as expert judgment/global introspection (GI), Bayesian methods and algorithms... Hence, according to the WHO, causality was labeled as possible in these cases... But, due to fulfillment of few other criteria, e.g., previous conclusive reports on the reaction, change in reaction severity with dose alteration, presence of an objective evidence and toxic drug concentrations in the blood (e.g., antiepileptics), these were able to attain a score compatible with probable association by the Naranjo algorithm... As per the WHO, ADR is labeled as probably caused by the suspected drug if all these criteria are met, i.e., reasonable time sequence to administration of the drug, unlikely to be attributed to concurrent disease or other drugs or chemicals and presence of a clinically reasonable response on withdrawal, i.e., a positive dechallenge... A similar scenario can be expected where an AE scores 1–4 on the Naranjo scale and, hence, is labeled as possibly caused by the particular drug... One reason for this disagreement might be subjective assessment in a few areas... For example, question no. 1 says: Are there previous conclusive reports on this reaction? This usually means “previous bibliographic description” and is based on judgment and needs clarification if there are few published case reports providing inconclusive evidence... Question no. 7 asks: Was the drug detected in the blood (or other fluids) in a concentration known to be toxic? Although this point is expected to give reproducible results with dose-related (type A) ADRs, the same does not stand true for type B reactions, where, in fact, it is inapplicable... Certain areas should be addressed, like type B (nondose related) ADRs, lack of efficacy/therapeutic failure as an AE and AEs arising as a result of drug interactions.

No MeSH data available.


Related in: MedlinePlus