A Prospective Observational Study to Evaluate the Prevalence of Adverse Drug Reactions and its Impact on Quality of life in Psychiatric Patients at a Tertiary Care Teaching Hospital

Abstract

Background: In recent times, emphasis on pharmacovigilance (PV) is elevated due to increased cases of adverse drug reactions (ADRs) coming into notice. Psychotropic medications that are the mainstay of treating psychiatric patients are linked to various adverse drug reactions. The given study lays accentuation on determining the pattern of ADRs due to the use of antipsychotics and antidepressants. Objectives: In this study, we aim to determine the incidence of ADRs and their effect on the quality of life (QOL) of the patients after the ADR (s). Methodology: This is a prospective observational study of a total of 300 subjects receiving antipsychotics and/or antidepressants. They were screened for possible ADRs. Possible risk factors for the development of ADRs were also assessed. The difference in the pattern of ADRs in patients prescribed with Antidepressants (ADs) and/or Antipsychotics (APs) was observed. The average number of APs and/or ADs per prescription was calculated. The causality and severity assessment of the observed ADRs was done by the World Health Organization-Uppsala Monitoring Center (WHO-UMC) scale, Naranjo’s algorithm, and Hartwig–Siegel scale, respectively. Lastly, the impact of ADRs on the QOL of the patients receiving APs and/or ADs was evaluated. Results: The prevalence of ADRs in patients receiving APs and/or ADs is 24.33%. Olanzapine is the most commonly prescribed AP while sertraline is the most commonly prescribed AD. Olanzapine and sertraline are responsible for the highest number of ADRs as AP and AD, respectively. Females are found to be at higher risk for developing ADRs. Multiple comorbidities and polypharmacy are also considered to be possible risk factors. The average number of APs and/or antidepressants per prescription is 1.94 drugs. APs are found to be responsible for a higher number of ADRs in comparison with ADs. The maximum number of ADRs falls into the possible criteria of causality assessment by the WHO-UMC scale and Naranjo’s algorithm. All the observed ADRs fall into the mild and moderate category of severity by the Hartwig–Siegel scale. The ADRs have a significant impact on the physical health and psychological domain of QOL assessment. Conclusion: The need for PV is highlighted by the results obtained in this study. Intense monitoring and increased awareness can help improve the rate of ADR (s) occurrence in patients receiving psychotropic medications. As a result, the impact of ADRs on the QOL of the patients can also be reduced.