2016
DOI: 10.1016/j.jsps.2015.01.010
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Dilemmas of the causality assessment tools in the diagnosis of adverse drug reactions

Abstract: We suggest that there is a need to develop a high quality assessment tool which can meticulously establish suitable diagnostic criteria for ADRs with universal acceptance to improvise the fundamental aspect of drug safety and evade the impending ADRs with the motive to convert Pharmacovigilance into a state of art.

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Cited by 56 publications
(55 citation statements)
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“…Disproportionality analysis is subject to well‐known limitations, such as limited database quality inherent in voluntary reporting system, various confounding factors, and inability to provide actual denominator, ie, number of subjects who consumed drug of interest. These limitations might contribute to the occurrence of false signal of disproportionate reporting or alternatively true safety signals may appear without disproportional reporting . However, in the subset analysis, the presence of disproportionate reporting was associated with the update of section 4.4, implying serious events were probably often reported disproportionately …”
Section: Discussionmentioning
confidence: 94%
See 1 more Smart Citation
“…Disproportionality analysis is subject to well‐known limitations, such as limited database quality inherent in voluntary reporting system, various confounding factors, and inability to provide actual denominator, ie, number of subjects who consumed drug of interest. These limitations might contribute to the occurrence of false signal of disproportionate reporting or alternatively true safety signals may appear without disproportional reporting . However, in the subset analysis, the presence of disproportionate reporting was associated with the update of section 4.4, implying serious events were probably often reported disproportionately …”
Section: Discussionmentioning
confidence: 94%
“…In the subset analysis, however, both positive dechallenge and rechallenge were associated with update of section 4.8 (as opposed to update of section 4.4). This could be explained by the fact that clinically meaningful dechallenge and rechallenge, especially when combined with other aspects of the narrative, eg , information regarding medical history of the patient, time to onset, the use of concomitant drugs, etc, are strongly suggestive of causal association and therefore signals with reported positive dechallenge and rechallenge are more likely to result in update of section 4.8 . The presence of positive dechallenge and rechallenge was however not associated with update of section 4.4, probably because a well‐established causal association is neither sufficient nor necessary for inclusion of a warning for health care providers in section 4.4 of PI.…”
Section: Discussionmentioning
confidence: 98%
“…The underlying mechanisms of drug-induced hair colour changes are not clear and the relationship between drug intake and colour modification is often difficult to prove. In clinical practice, the widely used estimation tool to assess adverse drug reactions (ADRs) is the algorithm which consists of a series of queries, each with a defined score, in order to quantify the probability of a cause and effect correlation [2]. The algorithms are simple tools to assess causality, however, unfortunately, although they demonstrate good specificity, they also demonstrate poor sensitivity [3,4].…”
mentioning
confidence: 99%
“…21,22 Thus, expert judgment is typically based on the decisive factor on which algorithms are based so there is a need to develop a high quality assessment method which can accurately set up suitable diagnostic criteria for ADRs. 23 Although Naranjo scale is easily applied, yet in case reports or series of overdose patients, the Naranjo Scale has been stratified to evaluate the probability an event was caused by the ingested drug or therapeutic modality. This application of the Naranjo Scale is not scientifically valid and may lead to faulty derivations.…”
Section: Discussionmentioning
confidence: 99%
“…This application of the Naranjo Scale is not scientifically valid and may lead to faulty derivations. 24 The most abundantly applied algorithms for casuality assessment are the Naranjo algorithm, 13 WHO-UMC, [18][19][20][21][22][23][24][25] the Jones' algorithm, 26 the Karch algorithm, 27 RUCAM algorithm, 28 the Begaud algorithm, 29 the French algorithm, 30 the ADRAC, 31 and the Korean algorithm. 32 These algorithms of the ADRs and categorizes them as Definite, Probable, Possible and Doubtful (Table 1) 12,13 Data from 41 patients, who previously diagnosed as CADR, were evaluated to fit the category of probable or possible drug reaction as per Naranjo ADR probability scale.…”
Section: Discussionmentioning
confidence: 99%