Abstract

INITIATION AND EVALUATION OF PATIENT REPORTING ADRS IN OUT-PATIENT DEPARTMENT OF A TERTIARY CARE TEACHING HOSPITAL IN SOUTH INDIA

G R Pullagura, R Adepu*, Pranav V B Raju, P Rohith, U R Rakshith and Justin K

Abstract

To evaluate the efficacy of patient reporting of suspected ADRs, a 6 month prospective observational study was initiated in Medicine outpatient department of a South Indian tertiary care teaching hospital. Patients receiving medicines in outpatient department were explained about safe usage of their medication and were motivated to report telephonically to the investigators in case of any unpleasant experiences with their medicines. On receipt of the call, details about the event were collected and correlated for its causality. The collected data was analysed for causality, severity, outcome and fate of the suspected drug. Further an investigation was also done to assess the quality of report and barriers in reporting ADRs by patients. Descriptive statistics, T-test and Chi-Square test were applied to analyse the data. Among the 1125 enrolled patients, 128 patients called back to report 95 ADRs [response-rate 8.44%]. Mean age of the study population was 50.14%+/- 16.39 years. More number of reports were received from female patients [n=54(57%)] compared to males [n=41 (43%) (P =0.001)]. Highest number of reports were received from patients in age group of 40-60 [n=38 (40%)] and from graduates [38.8%]. Majority ADRs experienced were belonged to GI disorders [n=34 (35.78%)] and Skin & Appendages [n=22 (23.10%)]. Quality of patient reporting was found to be on par with physicians [T-test (0.986)]. Patient sensitization towards ADR reporting has shown an increased the number of reports.

Keywords: Patient reporting ADRs, quality of reports, sensitization, Pharmacovigilance, barriers.