title: Monitoring of adverse drug reactions in psychiatry outpatient department of a Secondary Care Hospital of Ras Al Khaimah, UAE.
abstract: BACKGROUND
  Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality, resulting in increased healthcare cost. Association of psychotropic medications with ADRs is common. Pharmacovigilance can play a vital role in alerting the healthcare providers from the possible ADRs and thus protecting the patients receiving psychotropic medications.
  
  
  OBJECTIVE
  To monitor and report the incidence and nature of ADRs in psychiatry outpatient department (OPD).
  
  
  METHODS
  A prospective observational study was carried out in the psychiatry OPD. All the patients attending psychiatry outpatient and satisfying the inclusion criteria were monitored for ADRs. The causality, severity and preventability assessment of documented ADRs was done. Chi-square test was done to identify the association between ADRs and sociodemographic, disease and treatment-related variables. Paired Student's t-test was carried out to compare the significance difference in the weight of the patients who reported weight gain to psychotropic medications.
  
  
  RESULTS
  The incidence rate of ADR was found to be 10.2%. A total of 112 ADRs were documented. Weight gain 18 (16.07%) followed by somnolence 8 (7.14%) was the most commonly reported ADR. Atypical antipsychotics 37 (33.0%) were the most common class of psychotropic drugs implicated in ADRs. Escitalopram 16 (14.28%) followed by quetiapine 14 (12.5%) were associated with a maximum number of ADRs. No significant association (P > 0.05) documented between demographic and treatment-related variables with number of ADRs.
  
  
  CONCLUSIONS
  Study revealed a moderate incidence of ADRs in patients attending the psychiatry OPD. Majority of the ADRs reported during the study were mild in nature and not preventable type.
authors.affiliation: Department of Clinical Pharmacy and Pharmacology, RAK College of Pharmaceutical Sciences, RAK Medical and Health Sciences University, Ras Al-Khaimah, UAE.
authors.forename: Sathvik Belagodu
authors.initials: SB
authors.lastname: Sridhar
authors.affiliation: Department of Clinical Pharmacy and Pharmacology, RAK College of Pharmaceutical Sciences, RAK Medical and Health Sciences University, Ras Al-Khaimah, UAE.
authors.forename: Sura Saad Faris
authors.initials: SS
authors.lastname: Al-Thamer
authors.affiliation: Department of Psychiatry, Ibrahim Bin Hamad Obaidallah Hospital, Ras Al-Khaimah, UAE; Department of Psychiatry, RAK Medical and Health Sciences University, Ras Al-Khaimah, UAE.
authors.forename: Riadh
authors.initials: R
authors.lastname: Jabbar
keywords: Adverse drug reaction; adverse drug reaction monitoring; pharmacovigilance; psychiatry outpatients; psychotropic medications