Audit to evaluate the completeness of adverse drug reporting in an ADR monitoring centre in Tamilnadu

Abstract

Abstract Objectives The study was aimed to evaluate the completeness of suspected adverse drug reaction (ADR) forms in order to identify the areas lacking complete information, to assess the proportion of the ADR forms received with incomplete data and to evaluate the completeness score of the individual case safety reports. Methods This cross sectional study was done as an audit using data in the ADR forms collected and Individual Case Safety Reports (ICSRs) submitted in VigiFlow in the previous two years from January 2015 to December 2016 at our ADR Monitoring centre (AMC). Results The total number of ADR forms audited was 1650. Seriousness, action taken and outcomes and concomitant drugs were three areas identified to be lacking complete information. The mean completeness score was 0.95 for 2015 and 0.97 for 2016, indicative of a high completeness score of the ICSRs uploaded in Vigiflow maintained by the AMC. Conclusion The audit has analyzed various parameters of ADRs reported for completeness and has demonstrated that, though some improvement in completeness of reporting is evident in the year 2016 compared to 2015, there is an obvious need for increasing the awareness on reporting of ADRs with complete information amongst reporters.