Open Access Pharmacovigilance Databases: Analysis of 11 Databases

Fouretier, Alice; Malriq, Alexia; Bertram, D. S.

doi:10.1007/s40290-016-0146-6

Cited by 11 publications

(7 citation statements)

References 5 publications

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“…In 2016, Fouretier et al [ 36 ] performed an analysis of 11 pharmacovigilance databases with open access to characterise the accessibility of the relevant data in those systems. In their study, the EV access was considered to be ‘medium’, mainly based on the fact that EV did not provide public access at the level of the individual cases in the ADR website.…”

Section: Discussionmentioning

confidence: 99%

“…The enhanced access to the data is also expected to trigger more engagement with academia. Up to November 2017, the information from EV publicly available could have been considered acceptable for patient use but not optimally for research purposes [ 36 ]. The extended access provides research institutions with a rich data source and there is therefore a unique opportunity to conduct research for public health.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection

Postigo¹,

Brosch²,

Slattery³

et al. 2018

Drug Saf

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The analysis of safety data from spontaneous reporting systems has a proven value for the detection and analysis of the risks of medicines following their placement on the market and use in medical practice. EudraVigilance is the pharmacovigilance database to manage the collection and analysis of suspected adverse reactions to medicines authorised in the European Economic Area. EudraVigilance first operated in December 2001, with access to the database being governed by the EudraVigilance access policy. We performed a literature search including data up to December 2016 to demonstrate how the data from EudraVigilance has been used in scientific publications. We describe the results, including by type of publication, research topics and drugs involved. In 50% of the publications, the data are used to describe safety issues, in 44% to analyse methodologies used in pharmacovigilance activities and in 6% to support clinical perspectives. We also outline a description of the use of the database by the European Union regulatory network. Driven by the full implementation of the 2010 pharmacovigilance legislation, EudraVigilance has undergone further enhancements together with a major revision of its access policy, taking into account the use of the new individual case safety report standard developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and the International Organization for Standardization. The aim of the broadened access is to facilitate more effective safety monitoring of authorised medicines, to make more data available for research and to provide better access to information on suspected adverse reactions for healthcare professionals and patients. In November 2017, the new full functionalities of EudraVigilance were launched, including the extensive web access to data on suspected adverse drug reactions and the possibilities for academic research institutions to request a more extensive dataset for the purposes of health research. The main objective of this article is to describe the new access to the database together with the opportunities that this new access can bring for research. It is intended to promote an appropriate use of the data to support the safe and effective use of medicines.Electronic supplementary materialThe online version of this article (10.1007/s40264-018-0647-1) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection

Postigo¹,

Brosch²,

Slattery³

et al. 2018

Drug Saf

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“…MedWatch provides information on voluntary and mandatory reporting. 27 The ADRs are reported online through 2 form 3500As or 3500Bs, which are reviewed by the Centre for Drugs Evaluation and Research or the Centre for Biologics Evaluation. The FDA introduced the Sentinel Initiative under the US FDA Amendments Act (2007) for the submission of adverse events mandatory for the manufacturers.…”

Section: Comparison Of Pv In Us Europe and Indiamentioning

confidence: 99%

Pharmacovigilance in India in Comparison With the USA and European Union: Challenges and Perspectives

Jose

Rafeek

2019

Ther Innov Regul Sci

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Pharmacovigilance (PV) is an integral part of the drug regulation system. PV plays an indispensable role in the identification, assessment, and publicizing of adverse drug reactions (ADRs) through various methods. ADRs account for serious harm to the patients and even lead to morbidity and mortality. The PV databases help in the promotion of safe drug use and protection of public health safety. This article compares the PV system in the USA, Europe, and India, highlighting the challenges and future perspectives to be adapted to widen the horizon of the existing PV structure in India. In India, PV programs are still at the dawning stage when paralleled to the other countries. The National Pharmacovigilance Program and the Pharmacovigilance Program of India are the most recent advancements in this field in the country. The USA and Europe have well-established PV systems in place thanks to technological progress and other resources. India is the largest producer of pharmaceuticals in the world and a major clinical research hub; hence, it requires a more stringent PV setup. With the increase in population and novel drugs in the market each day, there is a need for an effective PV system in India.

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“…Some of the ADME, potential drug-drug interaction (DDI) information and pharmacogenomics-related databases have been cited in a number of review articles (Ekins et al, 2005; Bauer-Mehren et al, 2009; Ekins and Williams, 2010; Sim et al, 2011; Peach et al, 2012; Wishart, 2014; Ayvaz et al, 2015; Zhang et al, 2015; Przybylak et al, 2018). Fouretier et al (2016) identified human drug safety data resources, or pharmacovigilance databases, specific to every country or subcontinent. The European Union's Innovative Medicines Initiative 2 Joint Undertaking (IMI 2) “Enhancing TRANslational SAFEty Assessment through Integrative Knowledge Management (eTRANSAFE)” project is developing an integrative data infrastructure to combine and utilise data resources, hence has stimulated the work described in this paper.…”

Section: Introductionmentioning

confidence: 99%

In Silico Toxicology Data Resources to Support Read-Across and (Q)SAR

et al. 2019

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A plethora of databases exist online that can assist in in silico chemical or drug safety assessment. However, a systematic review and grouping of databases, based on purpose and information content, consolidated in a single source, has been lacking. To resolve this issue, this review provides a comprehensive listing of the key in silico data resources relevant to: chemical identity and properties, drug action, toxicology (including nano-material toxicity), exposure, omics, pathways, Absorption, Distribution, Metabolism and Elimination (ADME) properties, clinical trials, pharmacovigilance, patents-related databases, biological (genes, enzymes, proteins, other macromolecules etc.) databases, protein-protein interactions (PPIs), environmental exposure related, and finally databases relating to animal alternatives in support of 3Rs policies. More than nine hundred databases were identified and reviewed against criteria relating to accessibility, data coverage, interoperability or application programming interface (API), appropriate identifiers, types of in vitro, in vivo ,-clinical or other data recorded and suitability for modelling, read-across, or similarity searching. This review also specifically addresses the need for solutions for mapping and integration of databases into a common platform for better translatability of preclinical data to clinical data.

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Open Access Pharmacovigilance Databases: Analysis of 11 Databases

Cited by 11 publications

References 5 publications

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection

Pharmacovigilance in India in Comparison With the USA and European Union: Challenges and Perspectives

In Silico Toxicology Data Resources to Support Read-Across and (Q)SAR

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