IMPACT OF PERIODIC SAFETY UPDATE REPORTING SYSTEM IN A TERTIARY CARE TEACHING HOSPITAL OF SOUTHERN INDIA: A DELPHI STUDY

The process and functioning of newly implemented periodic safety update report system (PSUR) in the hospital were assessed using validated PSUR function assessment questionnaire (PFAQ) vetted by Delphi panel. Classical Delphi survey method was used to assess and validate the PFAQ in two successive review rounds with Delphi panel. Final validated PFAQ was circulated among health care practitioners (HCPs) to rate their responses. Responses were recorded for 2 phases of 9 months intervals each and assessed. Success factors and performance indicators listed in the PFAQ were successively added or deleted by the Delphi panel, in two successive rounds of revisions, yielding the final draft of PFAQ. One hundred sixty (160) PFAQs were circulated among HCPs in different wards of hospitals out of which 94 (58.75%) filled forms were received by the end of phase 2 study period. We observed a significant improvement in the visibility and functioning of PSUR system in the responses collated from the HCPs during phase 2 of the study, compared to the phase 1 responses. Majority of responses for each performance indicator for respective success factor were found shifting towards 1 (very good) and 2 (good) on Likert scale during phase 2 study period. This study illustrates the value of feasible and inexpensive ways to improve poorly designed pharmacovigilance system in India, which rely heavily on data from overseas. This study emphasizes how establishing a drug safety reporting network can helpfully fill-in country-specific data to assess the incidence and prevalence of ADRs of newer drugs.