Vaishali K. Patadia

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In the last 5 years, regulatory agencies and drug monitoring centres have been developing computerised data-mining methods to better identify reporting relationships in spontaneous reporting databases that could signal possible adverse drug reactions. At present, there are no guidelines or standards for the use of these methods in routine(More)
The EU-ADR project aims to exploit different European electronic healthcare records (EHR) databases for drug safety signal detection. In this paper we report the preliminary results concerning the comparison of signal detection between EU-ADR network and two spontaneous reporting databases, the Food and Drug Administration and World Health Organization(More)
Data mining is receiving considerable attention as a tool for pharmacovigilance and is generating many perspectives on its uses. This paper presents four concepts that have appeared in various professional venues and represent potential sources of misunderstanding and/or entail extended discussions: (i) data mining algorithms are unvalidated; (ii) data(More)
The safety profile of a drug evolves over its lifetime on the market; there are bound to be changes in the circumstances of a drug's clinical use which may give rise to previously unobserved adverse effects, hence necessitating surveillance postmarketing. Postmarketing surveillance has traditionally been carried out by systematic manual review of(More)
Pharmacovigilance experts devote considerable effort to post-marketing surveillance of adverse drug reactions (ADRs). Although the prepared mind of the pharmacovigilance expert remains the cornerstone of this process [1], statistical algorithms, also known as data mining algorithms (DMAs), are being promoted as supplementary tools for safety reviewers.(More)
BACKGROUND The growing interest in using electronic healthcare record (EHR) databases for drug safety surveillance has spurred development of new methodologies for signal detection. Although several drugs have been withdrawn postmarketing by regulatory authorities after scientific evaluation of harms and benefits, there is no definitive list of confirmed(More)
A prospective pharmacovigilance signal detection study, comparing the real-world healthcare data (EU-ADR) and two spontaneous reporting system (SRS) databases, US FDA's Adverse Event Reporting System and WHO's Vigibase is reported. The study compared drug safety signals found in the EU-ADR and SRS databases. The potential for signal detection in the EU-ADR(More)
Background Electronic reporting and processing of suspected adverse drug reactions (ADRs) is increasing and has facilitated automated screening procedures. It is crucial for healthcare professionals to understand the nature and proper use of data available in pharmacovigilance practice. Objectives To (a) compare performance of EU-ADR [electronic healthcare(More)