Adverse Drug Monitoring in the Psychiatry Outpatient Department in a Tertiary Care Hospital-A Pilot Study

Abstract

Background: Psychotropic medications, used at normal therapeutic or maintenance doses, have been associated with Adverse drug reactions (ADRs). Multiple studies have noted the high burden of ADRs caused by psychiatric medications. Hence, reporting of likely ADRs is warranted as pharmacovigilance data will help health care professionals to provide reliable, balanced information for the effective assessment of the risk/benefit profile of medicines. Methodology: Necessary approval from the Institutional Ethics Committee will be obtained before initiating the study. It is a prospective, observational, single centre pilot study. 30 patients attending the Psychiatry OPD in MGM Hospital, Kamothe, and experiencing ADRs were enrolled in the study. Results: People who experienced an ADR had a median age of 43±16.23 yrs. A total of 35 ADRs were noted in 30 patients on psychiatric medications. Therapeutic Failure (57%) was observed to be the most common ADR followed by gastric reflux (22%). Benzodiazepines (19%) and SSRIs (17%) seems to be the most common class of drugs, while Trihexyphenydyl (14%) was noted to be the most common drug, causing ADRs. Conclusion: Therapeutic Failure (57%) was observed to be the most common ADR and benzodiazepines (19%) seems to be the most common drug class causing ADR. Under reporting of ADRs is an issue that arises from the lack of awareness amongst patients as well as healthcare professionals. Hence, pharmacovigilance in psychiatry units alerts the physicians and protects the patients from ADRs that can be avoided.