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 (P < 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 (P < 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.