Pharmacovigilance of Psychotropics among Patients in A Mental Health Institution of Eastern India

Introduction

Polypharmacy, use of narrow therapeutic index drugs and clinical co-morbidities make the patients administered with psychotropics vulnerable to Adverse Drug Reactions (ADRs) and hence, awareness about it is essential for diagnosis and prevention. Objective of this study is to analyze and report ADRs in Mental Health Institution of a tertiary care teaching hospital.

Materials and Methods

This pharmacovigilance investigation was carried out to report 377 ADRs of 180 psychiatric patients (aged 10-80) administered with psychotropic drugs for duration of 8 months through active surveillance and spontaneous reporting following approval from institutional ethics committee. ADRs were assessed as per their demography along with World Health Organization Uppsala Monitoring Center (WHO UMC) causality assessment, Schumock and Thornton preventability and Modified Hartwig Severity Scale and statistically analyzed by chi-square test.

Results

ADRs were majorly noticed through active surveillance (64.4%) in male patients (60%) aged 19-29 (32.6%) suffering from Schizophrenia, schizotypal and delusional disorders (37.7%). Majority of the reactions were augmented in nature (68.2%), owing to the pharmacological properties of the psychotropics acting on neurotransmitters. Psychotropics primarily affect the nervous system accounting for 63.9% of ADRs. Antipsychotics were responsible for the highest number of ADRs (59.7%), with tremors observed in 54.6% of patients. Most of ADRs i.e., 53% were classified as ‘possible’ and 89% ADRs were ‘predictable’. In addition, 38% of patients experienced a level 2 severity, indicating less severe nature of psychotropics under use.

Conclusion

Primary detection of ADRs improves management and reduces useless healthcare expenditure; hence health service providers must take accountability for minimizing ADRs.