Abstract

Pattern of Adverse Drug Reactions (ADRs) Reported with Neuropsychiatric Drugs in a Teaching Hospital of North Karnataka: An Observational Study

Purpose: Adverse Drug Reactions (ADRs) to neuropsychiatric drugs are common and can lead to noncompliance. As patients with neuro or psychiatric illness need long-term therapy with psychotropic medications and the pharmaceutical companies utilize this opportunity to influence the prescribing habits of the treating physician. If the patients receive polypharmacy, they will be predisposed to an array of side effects. Hence, the treating physician needs to consult the safety profile and cost of the therapy before prescribing any psychotropic medications. If the patient discontinues the therapy due to adverse effects, it can lead to the recurrence of the symptoms or disease relapse. Over the last few years, atypical (Second generation) antipsychotics have been increasingly used to treat schizophrenia and other related neuropsychiatric disorders. Along with that, the safety profile of few newer atypical antipsychotic agents and other drugs used in neuropsychiatric illnesses has not been elucidated completely. To determine the pattern of ADR’s caused by these medications and the methods used to prevent an ADR related morbidity, this study has been undertaken. Methods: All the spontaneously reported ADR’s between Aug 2015 to Sep 2017, to an ADR monitoring center in Vijayapura, after the administration of drugs effective in the treatment of neuropsychiatric illnesses, were collected and entered into the suspected ADR form designed by the IPC (Indian Pharmacopoeia Commission). The data gathered was assessed for causality by using, World Health Organization-Uppsala Monitoring Centre (WHOUMC) causality assessment system. Similarly, the severity and preventability were assessed by using standard prevalidated scales. Results: A total of 177 ADRs were identified from 104 patients, and the vast majority of those patients who had an ADR belong to the age group of 21-40 years. Among the total, 84 (80.8%) patients had to Type A ADRs. Nausea being the commonest ADR reported and the System Organ Class (SOC) which got affected was neurological disorders as coded in the MedDRA. Psycholeptics were predominantly involved in the causation of ADRs. The ADRs were mostly mild to moderate in severity and only 2 patients had severe cutaneous reactions with Antiepileptics. 48.07% of the ADR’s were preventable according to the Schumock criteria. Conclusion: The present study adds to the existing information on the safety of the medications used in the treatment of neuropsychiatric illnesses especially in South Indian patients. Still incomplete because of underreporting by the Health care providers. Hence, further research by targeted pharmacovigilance activity or active surveillance is needed to strengthen the database.

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