Abstract

BackgroundAdverse drug events (ADEs) detection and assessment is at the center of pharmacovigilance. Data mining of systems, such as FDA’s Adverse Event Reporting System (AERS) and more recently, Electronic Health Records (EHRs), can aid in the automatic detection and analysis of ADEs. Although different data mining approaches have been shown to be valuable, it is still crucial to improve the quality of the generated signals.ObjectiveTo leverage structural similarity by developing molecular fingerprint-based models (MFBMs) to strengthen ADE signals generated from EHR data.MethodsA reference standard of drugs known to be causally associated with the adverse event pancreatitis was used to create a MFBM. Electronic Health Records (EHRs) from the New York Presbyterian Hospital were mined to generate structured data. Disproportionality Analysis (DPA) was applied to the data, and 278 possible signals related to the ADE pancreatitis were detected. Candidate drugs associated with these signals were then assessed using the MFBM to find the most promising candidates based on structural similarity.ResultsThe use of MFBM as a means to strengthen or prioritize signals generated from the EHR significantly improved the detection accuracy of ADEs related to pancreatitis. MFBM also highlights the etiology of the ADE by identifying structurally similar drugs, which could follow a similar mechanism of action.ConclusionThe method proposed in this paper provides evidence of being a promising adjunct to existing automated ADE detection and analysis approaches.

Highlights

  • The main objective of pharmacovigilance involves the collection, monitoring, assessment and evaluation of adverse effects of medications and other biological products from healthcare providers and patients

  • The use of molecular fingerprint-based models (MFBMs) as a means to strengthen or prioritize signals generated from the Electronic Health Records (EHRs) significantly improved the detection accuracy of Adverse drug events (ADEs) related to pancreatitis

  • MFBM highlights the etiology of the ADE by identifying structurally similar drugs, which could follow a similar mechanism of action

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Summary

Introduction

The main objective of pharmacovigilance involves the collection, monitoring, assessment and evaluation of adverse effects of medications and other biological products from healthcare providers and patients. There are different Spontaneous Reporting System (SRS) databases, such as the FDA’s Adverse Event Reporting System (AERS) [1], the European Medicines Agency (EMA) [2] and the World Health Organization (WHO) international database [3] that have been designed to collect reports of suspected adverse drug events (ADEs) for these purposes. Despite their success and strengths they have some limitations [4]. Different data mining approaches have been shown to be valuable, it is still crucial to improve the quality of the generated signals

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