A PROSPECTIVE ANALYSIS OF ADVERSE DRUG REACTIONS IN PSYCHIATRIC PATIENTS

Abstract

The overall incidence of ADRs in patient with mental disorders was 37.6%. The system organ class most commonly affected was gastrointestinal system [n=225 (22.7%)] while dry mouth (n=101) and weight gain (n=81) were the commonly reported ADRs. Antidepressants [n=415 (42%)] and antipsychotics [n=405 (41%)] were the class of drugs frequently implicated in ADRs, whereas escitalopram [15.9% (n=158)] and olanzapine [12.1% (n=120)] were the most commonly implicated individual medications. About one half (51.6%) of the ADRs were probable in their causal relationship and 76.6% of the ADRs were mild in their severity, while majority (94.6%) of ADRs were non serious in nature. In 76.7% (n=760) of the cases, ADRs were predictable and 81.2% (n=804) of ADRs were not preventable . Female gender (p=0.002), patients presented with co morbid conditions (p=0.001) and drug- drug interactions (p=0.000) were the predictors of both short-term and long-term ADRs. The incidence of ADI with respect to the total number of patients with DDIs was 12%. Pharmacodynamic interactions accounted for the majority [n=98 (68.5%)] of ADIs. Approximately one-half of the ADIs were caused by moderate DDIs. Majority (64.7%) of ADIs were probable in their causal relationship. Patients receiving gt5 drugs were found to have six times higher risk of developing ADIs than the patients receiving lt5 drugs [OR 7.024 95% CI; 2.745-17.976; p=000]. The total and average direct cost associated with the management of ADRs was INR 114731.00/- and INR 482/- respectively. newlineThis prospective surveillance study provides a representative data of safety profile of the psychotropic agents likely to be encountered in Indian psychiatric patients.ADRs and ADIs are important cause of increased burden of disease and unnecessary healthcare expenditure. Constant vigil in early detection and reporting of ADRs and subsequent management can make the therapy with psychotropic agents safer and effective and decreases cost. Clinical pharmacist can play a vital role in the detec