Evaluation of pattern, predictability, severity and preventability of adverse drug reactions in the department of psychiatry at a tertiary care hospital in bengaluru – a five years experience


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6

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2

Abstract :

Objective Psychotropics are known to cause number of adverse drug reactions (ADRs) which often results in either nonadherence or discontinuation of therapy. Present study aimed to analyze the pattern as well as causality, preventability, severity and predictability of occurrence of ADRs in psychiatry. Materials and Methods This retrospective cohort study was conducted to analyze the ADRs reported spontaneously from the Department of Psychiatry at a tertiary care hospital, Bengaluru to the ADR monitoring centre, Bangalore Medical College & Research Institute. Causality of ADR was assessed by WHO-ADR probability scale, preventability was assessed using Modified Schumock & Thornton scale and severity was assessed using Hartwig and Siegel criteria. Beer’s criterion was used to identify the potentially inappropriate drugs among elderly that caused ADRs. Descriptive statistics was used for analysis. Results 40.7% of ADRs were observed among patients aged between 31-40 years. Higher frequencies of ADRs were noted among patients diagnosed with depression (34.5%), followed by schizophrenia (28.3%). Central Nervous System (58%) was affected predominantly. Headache (12.3) was the most commonly observed ADR followed by dystonia (11.1%) and drowsiness (9.9%). Patients receiving antidepressants (48%) and antipsychotics (37%) experienced more ADRs. Fluoxetine (17%) accounted for majority of ADRs followed by risperidone (12.3%). 85% of the ADRs were of ‘probable causality and predominantly predictable (95.1%). 9% of the ADRs were definitely preventable. 44% of ADRs required additional medical treatment. 96.3% of patients recovered completely. Conclusions 5% of ADRs were severe, no mortality was noted which highlights the appropriate management of ADRs at our centre. Regular intensive monitoring of ADRs in psychiatry outpatient department will help to improve to the quality of care.
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