Publication:

Adverse drug reactions: a retrospective review of hospitalized psychiatric patients at tertiary care hospital

Background Hospital data based monitoring of ADRs can shed light on their extensiveness and pattern of occurrence. Study is expected to enable us in obtaining information on the incidence and pattern of ADRs in the local population. The objective of this study was to do surveillance, detect incidence of ADR and to analyse the ADRs according to their demographic distribution, reporting, presentations and causality assessment scale.

Methods A retrospective study conducted from January 2011 to December 2014 and psychiatric hospitalized patients were analysed and ADR reports were assessed for probability, severity, psychotropic drugs involved, and preventability.

Results A total number of 101 ADRs were reported in 72 patients. Most common ADR were mainly tremor 14 (13.86%), salivation 11 (10.89%) followed by muscle rigidity 6 (5.94%) and slurring of speech 6 (5.94%). In majority of the instances, it was antipsychotic agents 41 (56.94%) followed by antidepressants 11(15.27%) and mood stabilizers 11 (15.27%). As per causality assessment, 95 (94.05%) cases were ‘possible’ in WHO-UMC criteria and 72 71.28%) cases were ‘possible’ in Naranjo scale respectively. As per Schumock and Thornton preventability assessment, 91(90.09%) of total ADRs were in the not-preventable category. As per Hartwig and seigle’s severity assessment, majority of ADRs 74 (73.26%) were mild in severity.

Conclusions ADRs were most commonly associated with antipsychotic drugs. Developing an on-going ADR reporting system with continuous motivation and creating awareness among the healthcare professionals for reporting suspecting ADR will help to continue reporting and improving the patient’s safety.