International Journal of Health & Allied Sciences

: 2017  |  Volume : 6  |  Issue : 4  |  Page : 247--248

Economic costs of adverse drug reaction: Concerns in methodology

Suhas Chandran, M Kishor 
 Department Psychiatry, JSS Medical College and Hospital, JSS University, Mysore, Karnataka, India

Correspondence Address:
Dr. Suhas Chandran
Department of Psychiatry, Mahatma Gandhi Road, Mysore - 570 004, Karnataka

How to cite this article:
Chandran S, Kishor M. Economic costs of adverse drug reaction: Concerns in methodology.Int J Health Allied Sci 2017;6:247-248

How to cite this URL:
Chandran S, Kishor M. Economic costs of adverse drug reaction: Concerns in methodology. Int J Health Allied Sci [serial online] 2017 [cited 2020 Oct 30 ];6:247-248
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Jisha[1] described an observational study regarding the economic impact and severity of adverse drug reactions (ADRs) in patients with mental illness in a tertiary care hospital in south India. We would like to acknowledge the authors for evaluation of this clinically relevant yet a largely unexplored area. However, we would like to highlight concerns regarding the casual manner in which the methodology was undertaken overlooking important confounding factors as well as the misleading interpretations.

In the study, there is a lack of consideration of significant confounding factors such as the presence of medical comorbidities and the role of the medications used for these disorders causing ADRs were not considered despite 23.3% of the subjects having at least one such comorbidity. Some of the ADRs reported such as constipation, abdominal pain, gastritis, diarrhea, myalgia, arthralgia, erectile dysfunction, and premature ejaculation can be a direct or an indirect consequence of the primary psychiatric disorder itself, such as substance use disorders (alcohol, nicotine, and cannabis), mood disorders, schizophrenia.[2],[3] There is no substantiation provided for excluding this before accepting the above as ADRs. Similarly, there are also gaps in fulfillment of the definition of ADRs. For example, reporting of delirium as an ADR of lorazepam use is very ambiguous keeping in mind that this benzodiazepine is one of the drugs commonly used for sedation/agitation management of delirium.[4] The study also reports sodium valproate causing diabetes mellitus as an ADR!! Are such claims substantiated? This study notes causal association of haloperidol to thrombophlebitis when the propensity of the intravenous route of administration of such drugs in acute conditions such as agitation can produce this rather than the intrinsic property of the haloperidol itself. Moreover, nine out of thirty drugs (30%) mentioned in [Table 3] as common drugs implicated in ADRs are not even psychotropic drugs!!!{Table 3}

There is no scientific data to support a large number of claims such as reporting that majority of the ADRs in the study are due to hepatocellular damage, which could have been because alcohol use disorders constitute a majority of the inpatient admissions and even otherwise relevant investigations to substantiate this is not mentioned. The study notes that the highest cost impact of ADRs was with quetiapine-induced bradycardia and QT prolongation!! How was the cost calculated? Is it cost of electrocardiogram or ECHO Cardiography? Unless it is Torsade De Pointes and Intensive Care Unit admission, the cost of management of these rare conditions is minimal; nothing of that nature is mentioned in the paper. The paper has consistently taken a presumptive approach in stating that the management of these ADRs has warranted a longer hospital stay and laboratory investigations without validating how these assessments were made. Hence, it is important that this paper should be considered with major limitations that readers should be made aware of, and future research in such areas should incorporate rigours methodology.

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Conflicts of interest

There are no conflicts of interest.


1Lucca JM, Varghese NA, Ramesh M, Ram D. Economic impact and severity of adverse drug reactions in patients with medical illness: A prospective observational study. Int J Health Allied Sci 2017;6:93-8.
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