Extent of Under Reporting of Adverse Drug Reactions (ADRs) in India: Evaluation using Logistic Regression Analysis (LRA) Model

Mala Kharkar Suresh Bowalekar

doi:10.4172/2167-0870.1000155

Abstract

Objective: 1. To determine a. Statistically, the Knowledge, Attitude and Practice (KAP) related variables responsible for underreporting of ADRs in India, using Logistic Regression Analysis (LRA) Model, b. Extent of under reporting of ADRs at the current KAP levels of Medical Practitioners (MPs). 2. To recommend measures at National level to reduce underreporting of ADRs Methods: The results of survey on KAPs of MPs in India towards underreporting of ADRs were published. In the survey, the information was provided on number of ADRs observed during medical practice and number of ADRs reported to ADR monitoring center by 116 MPs. MPs reported less than 25% of ADRs was assumed to contribute to underreporting. Thus, dependent variable ‘underreporting’ was measured on binary scale as ‘Yes’ or ‘No’. Similarly, six independent variables were also measured on a binary scale as ‘Yes’ or ‘No’. The six 2×2 contingency tables were prepared with ‘underreporting’ as dependent variable and each of the 6 independent variables. However, contingency table assumes the levels of all other independent variables to be the same, which is unrealistic and thus fails to estimate the true odds ratio. Hence, Logistic Regression Analysis was used to analyze the data. Results: 2×2 contingency tables revealed that each independent variable was significantly associated with ‘underreporting’. The odds ratio was statistically significant with all six variables. Stepwise LRA applied to data of 116 MPs, picked up 4 variables as statistically significant (P<0.05). Conclusion: At the current level of KAP of MPs, there is high probability of continuing the problem of underreporting of ADRs. To reduce the rate of underreporting it is recommended to develop appropriate training modules at National level to create awareness among all healthcare professionals and design simple ADR forms and procedures for ADR reporting.

Highlights

Voluntary Adverse Drug Reaction (ADR) reporting schemes are in operation since the early sixties in many Western countries [1]
A voluntary reporting system of ADRs is fundamental to drug safety surveillance but under-reporting was its major limitation [4]
National Pharmacovigilance Program for India - sponsored by World Health Organization (WHO) and funded by World Bank was made operational from 1 January 2005

Summary

Introduction

Voluntary Adverse Drug Reaction (ADR) reporting schemes are in operation since the early sixties in many Western countries [1]. These surveillance systems enable physicians and pharmacists to report suspected ADRs and act as a tool to identify new ADRs and risk factors predisposing to recognized ADRs. Monitoring of adverse drug reactions started in India about two decades ago (1982) [2]. Other studies [5] identified, a significant and widespread under-reporting of ADRs to spontaneous reporting systems including serious or severe ADRs. National Pharmacovigilance Program for India - sponsored by World Health Organization (WHO) and funded by World Bank was made operational from 1 January 2005

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Conclusion