Adverse Drug Events in Patients with Mental Disorder in an Ambulatory Setting.

BACKGROUND

Although adverse drug events (ADEs) among inpatients occur frequently and are widely studied, few data are available on ADEs among outpatients with mental disorders.

AIMS

To determine the rates, types, and severity of ADEs in patients with mental disorder.

MATERIALS AND METHODS

Cross-sectional survey of patients with mental disorder attending outpatient department. Data were collected over a period of 6 months.

RESULTS

A total of 400 patients (217 schizophrenia patients, 127 bipolar affective disorder patients, and 56 patients of depression) with a mean age of 32.1 ± 9.7(±standard deviation) participated in the study. Patients suffering from schizophrenia and all nonadherent patients reported significantly more ADEs ( < 0.05). Out of 343 patients (86%) who reported at least one ADE, majority (87%) reported central nervous system ADEs followed by weight gain (48%), gastro-intestinal (28%), skin (4%), cardiovascular (1%), and sexual dysfunctions (0.3%). Out of 673 ADEs reported, sedation (41%) and weight gain (25%) were reported most commonly. Most ADEs reported (76%) were mild; however, there were no life-threatening, fatal, or serious ADEs. The medication classes most frequently involved in ADEs were antipsychotics (72%) followed by sedatives (44%), antimanic drugs (32%), and antidepressants (27%). Patients on atypical antipsychotic drugs reported significantly more body weight gain ( < 0.05). More than three drugs were prescribed in 49% of patients who reported ADEs.

CONCLUSION

The study data indicate high prevalence of ADEs in the outpatients on psychotropic medications.