Adverse drug reaction profile at psychiatry outpatient department of a tertiary care centre

Abstract

Background: Monitoring adverse drug reactions (ADRs) helps in alerting physicians and developing strategies to prevent and minimize the risk of developing ADRs. Data regarding pattern of ADRs due to psychotropic medications is scanty. Hence, the study was planned to assess ADRs among psychiatry outpatients of a tertiary care hospital in Maharashtra.Methods: A prospective, observational study was conducted in psychiatry outpatient department of a tertiary care centre for 3 months. Cases were enrolled by active and passive surveillance after obtaining informed consent. Demographic details, adverse event details, history of medications were recorded. Pattern of ADRs was studied according to demographic parameters, drug class, organ system affected, causality (WHO - Uppsala Monitoring Centre Scale) and severity (modified Hartwig and Siegel Scale).Results: Out of total 1200 patients screened, 77 qualified the inclusion and exclusion criteria and 92 ADRs were reported; overall incidence rate of 6.41%. Maximum ADRs were reported in the age group of 31- 40 years. 63.63% subjects received more than 2 psychotropic drugs. Among 24 types of ADRs observed, tremor (13.04%) was the commonest, closely followed by somnolence. Antipsychotics (45.65%) were most frequently incriminated and central nervous system (46.73%) the most often affected. Trifluoperazine (11.96%) was the commonest drug, followed by olanzapine and haloperidol (10.53% each). Causality analysis yielded 66 ADRs as “probable” and on severity analysis 80.43% were mild.Conclusions: The study provides an insight into pattern of ADRs in psychiatry outpatients. It is prudent to communicate this to treating physicians as well as counsel patients (and caregivers). Initiatives and concerted efforts involving all stakeholders in healthcare can go a long way in decreasing drug-related morbidity and health costs.

Drug therapy problems in patients with schizophrenia: A cross-sectional study

“…In our study, an undesired effect occurred in 14 (15.9%) participants and this was higher than the study done in India and UAE, where 6.41% and 10.2% of the study participants, respectively, were reported to develop undesired effects. 11,12 In contrast, our finding was lower than two studies done in India, where the undesired effect rate was reported to be 20.4% and 43.5%, respectively. 13,14 The reason for the lower rate could be under documentation in medical records and/or the method of data collection as in the case of prospective and retrospective studies.…”

“…10 DTPs are hence a major public health concern that could occur anywhere in the globe with no limit for a boundary. 11 Studies revealed that 5-10% of hospital admissions are associated with DTPs 12 and treatment adherence has also been used as one of the seven categories under DTPs that could affect patients proper drug therapy. 13…”

“…10 DTPs are hence a major public health concern that could occur anywhere in the globe with no limit for a boundary. 11 Studies revealed that 5-10% of hospital admissions are associated with DTPs 12 and treatment adherence has also been used as one of the seven categories under DTPs that could affect patients proper drug therapy. 13 Treatment satisfaction is also a related factor that affects treatment outcomes and largely the preparedness of the psychosocial aspect of the patients to deal with their treatment.…”