Focused Pharmacovigilance of Neuropsychiatry Drugs in A Tertiary Care Hospital, India

Background: Adverse drug reactions (ADRs) to neuro-psychiatry drugs are frequent and add to patient suffering in terms of health and cost. These ADRs often overlap with the clinical picture, necessitating differentiation of disease symptoms and ADRs. Moreover, with the recent development of newer drugs, the pattern of ADRs has continuously evolved, making their monitoring and reporting vital. Materials and Methods: This was a prospective, observational study including both outpatients and inpatients reporting ADRs to neuropsychiatric drugs in a tertiary care hospital in northern India over a 3-month period. ADR characteristics such as seriousness, outcomes, severity and causality were noted. Descriptive statistics were used to analyze the results. Results: Out of the 124 ADRs reported by 102 patients, 98 (96%) were outpatients, 60 (59%) were males, and 44 (43%) were aged 29–39 years. Slightly more than half (56%) of the patients were taking 1-2 drugs. The majority (89, 87%) reported a single ADR. Most ADRs (118 (95%)) were type A. Epilepsy was the most common neurological diagnosis (13 (45%)), whereas depression (31 (42%) predominated in psychiatry. The most common ADR for neurology drugs was sleepiness (9, 26%), whereas dizziness (16, 18%) was common in psychiatry. In neurology, phenytoin and sodium valproate (4 (14% each) were the main culprits, whereas paroxetine (13 (18%) was the offending agent in psychiatry. Most of the ADRs observed during the study were nonserious [114 (92%)], and almost half of the patients recovered 63 (51%). Most ADRs (86 (69%) were of moderate severity and their causality was probable (89 (72%). Conclusion: Our findings suggest that ADRs are quite common in patients receiving neuro-psychiatry medications. Young people of the male gender have a higher ADR reporting rate. Most of the reported ADRs were Type A. Anti-epileptics and anti-psychotics were the main neuro-psychiatric medications implicated in causing ADRS, even though most of the ADRSs had recovered and were not serious. The current study adds to the knowledge database, highlighting a varying pattern of presentation of ADRs. However, further research involving targeted pharmacovigilance activity or active surveillance could strengthen the database.