Impact of periodic safety update reporting system: A preliminary trial in a tertiary care teaching hospital of southern India

Alkesh K Lokhande ,Mukhyaprana Prabhu ,Surulivelrajan Mallayasamy ,P Girish Thunga ,Mazhuvancherry Kesavan Unnikrishnan

doi:10.7324/japs.2018.81213

Abstract

The objective of this study was to assess impact of implemented periodic safety update report (PSUR) system in our hospital via PSUR function assessment questionnaire (PFAQ) vetted by Delphi panel and by comparing frequency and rate of adverse drug reaction (ADR) reporting for three highly prescribed drugs. A PFAQ was validated by Delphi panel, in two successive rounds of revision and used to record responses on Likert scale. Drugs with well-known ADR profiles in published literature were considered reliable markers of the impact of PSUR system implementation. Pre-PSUR retrospective data retrieved from medical records for nine months and compared with the trend of frequency and rate of ADR reporting post-PSUR system implementation. Frequency and rate of ADR reporting for selected drugs rose by 68% post PSUR system implementation. Participation of wards in ADR reporting and reporting of unexpected/unreported ADRs was also seen increased. Numbers of PFAQ responses for each performance indicator corresponding to the respective success factors were seen shifting favorably on the Likert scale in phase 2 study period. This study illustrates how drug safety reporting network can be established by reallocating existing resources, with minimal expenses on training/human resources and to improve poorly designed pharmacovigilance system in India that relies heavily on data from overseas.

Highlights

The World Health Organization (WHO) defines pharmacovigilance (PV) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects of drugs
The objective of this study was to assess the impact of implemented periodic safety update report (PSUR) system in our hospital via PSUR function assessment questionnaire (PFAQ) vetted by Delphi panel and by comparing frequency and rate of adverse drug reaction (ADR) reporting for three highly prescribed drugs
Frequency and rate of ADR reporting for selected drugs rose by 68% post-PSUR system implementation

Summary

Introduction

The World Health Organization (WHO) defines pharmacovigilance (PV) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects of drugs. In 2013, India’s share in globally reported ADRs was only 2%. ADRs reported per million almost doubled in the last few years to 40 but remains far less than in developed nations. The ADRs entail the unjustified hospital admissions, worsen the hazards from the prevailing shortage of trained health professionals, increase the preventable health hazards, diminish the quality of life, and waste both resources and money. International data revealed that 4.1% of the non-elderly hospital admissions were ADR-related, while it was four times higher for elderly (16.6%) (Beijer and De Blaey, 2002)

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Conclusion