Assessment of adverse drug reactions identified in the outpatient department of psychiatry

Abstract

Context: Adverse drug reactions (ADRs) are “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or disease therapy.” Antipsychotics used for treating mental illnesses are highly vulnerable to ADRs due to the need for lifelong therapy. Early detection and regular monitoring of ADRs can minimize complications and improve patient's quality of life. Aims: The study aims to identify ADRs in patients with psychiatric disorders and determine the cause of ADRs. Settings and Design: A prospective cross-sectional study conducted in the outpatient department of psychiatry at a tertiary care teaching hospital. Materials and Methods: Patients were approached to identify ADRs at the psychiatry outpatient department. Informed consent was obtained from the participants before enrollment. Data collected from patients were documented in the patient data collection forms and suspected ADR reporting forms have been used to record ADRs. Statistical Analysis Used: Chi-square test was used for statistical analysis. Results: Among 190 recruited, 60 ADRs were reported from 39 outpatients. A significant multiple psychotropic drug usage was found in the patients (P ≤ 0.005). Both the genders showed an equal propensity toward ADRs. The antipsychotic drug sodium valproate held responsible for most of the ADRs. Tremor an extrapyramidal side effect was the most common adverse effect identified. Most of the patients required dose alteration to manage their symptoms. Conclusions: Regular observation is necessary for psychiatry patients to ensure safety and compliance with the therapy. Spontaneous reporting and regular monitoring are necessary to avoid ADR occurrence and its severity.

Keywords

• adverse drug reactions
• causality
• preventability
• probability
• psychiatry
• severity