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Grouping the pharmacovigilance terms with a hybrid approach

Marie Dupuch, Laëtitia Dupuch, Amandine Perinet, Thierry Hamon, Natalia Grabar
2012 Studies in Health Technology and Informatics  
To achieve this, we combine two approaches: semantic similarity algorithms computed within structured resources and terminology structuring methods applied to a raw list of the MedDRA terms.  ...  The pharmacovigilance process benefits from the traditional statistical approaches and also from the qualitative information on semantic relations between close ADR terms, such as SMQs or hierarchical  ...  of the grouped terms R (sensitivity) number of relevant grouped terms as a percentage of the number of terms in the corresponding SMQ F (f-mesure) the harmonic mean of P and R with β = 1 Qualitative  ... 
pmid:22874187 fatcat:wuqnlagmxrhqvnioadffrgooeq

P14 Pharmacovigilance in pediatric patients: the challenge of identifying new signal

N Kronenfeld, S Gamsu, H Flor-Hirsch, N Agajani, R Sheinberg, L Ben-Nun, M Goldman, M Berkovitch
2019 Archives of Disease in Childhood  
During the study period (three months), the reporting rate increased dramatically. A new signal was reported; two neonates with apnea related to IVIG administration in the neonatology department.  ...  Steroids and antibiotics were responsible for various ADRs, but not for a new signal.ConclusionThere is one case report in the literature on apnea related to IVIG administration.  ...  Using this hybrid approach enabled the enrichment of the required volume by factor of 20.  ... 
doi:10.1136/archdischild-2019-esdppp.53 fatcat:ujclo4qfdnd5nm3or37plbpc3a

Harnessing social media data for pharmacovigilance: a review of current state of the art, challenges and future directions

Dimitra Pappa, Lampros K. Stergioulas
2019 International Journal of Data Science and Analytics  
(SNS) to pharmacovigilance, and a thorough review of this corpus was completed with a total of 100 articles reviewed.  ...  and the extraction of new insights in terms of potential for practical applications and future research directions in the area of pharmacovigilance.  ...  The framework proposed by Liu and Chen [71] employs a hybrid approach combining statistical machine learning methods and rule-based filtering with information from medical knowledge bases, and report  ... 
doi:10.1007/s41060-019-00175-3 fatcat:pbxbpcdihjfhrgm2nv3tomp3hm

Implementing a simple pharmacovigilance program to improve reporting of adverse events associated with biologic therapy in rheumatology: Preliminary results from the Calabria Biologics Pharmacovigilance Program (CBPP)

Caterina Palleria, Luigi Iannone, Christian Leporini, Rita Citraro, Antonia Manti, Maurizio Caminiti, Pietro Gigliotti, Rosa Daniela Grembiale, Massimo L'Andolina, Giuseppe Muccari, Maria Diana Naturale, Domenico Olivo (+8 others)
2018 PLoS ONE  
Aim of the present study is to report the preliminary data of a Regional (Calabria, Italy) Pharmacovigilance Program (CBPP) aimed at improving AEs' reporting associated with biologics use in rheumatology  ...  To test this approach, all consecutive patients undergoing treatment with one biologic agent at eight rheumatology centers during a two-years period were invited to participate.  ...  Acknowledgments This project has been funded by the Italian Medicine Agency (AIFA) and Regione Calabria, which are kindly acknowledged. Author Contributions  ... 
doi:10.1371/journal.pone.0205134 fatcat:2s7cm4f6fjgxllhqxstm7sqfs4

Utility of social media and crowd-intelligence data for pharmacovigilance: a scoping review

Andrea C. Tricco, Wasifa Zarin, Erin Lillie, Serena Jeblee, Rachel Warren, Paul A. Khan, Reid Robson, Ba' Pham, Graeme Hirst, Sharon E. Straus
2018 BMC Medical Informatics and Decision Making  
The methods varied widely, and some approaches yielded better results than others. Conclusions: Our results suggest that the use of social media conversations for pharmacovigilance is in its infancy.  ...  A scoping review to characterize the literature on the use of conversations in social media as a potential source of data for detecting adverse events (AEs) related to health products.  ...  Fatemeh Yazdi for helping with some screening and data extraction and Theshani De Silva for formatting the manuscript.  ... 
doi:10.1186/s12911-018-0621-y pmid:29898743 pmcid:PMC6001022 fatcat:yfqkea565jbpzetchxd34kcsl4

An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

Robert Carroll, Sreeram V. Ramagopalan, Javier Cid-Ruzafa, Dimitra Lambrelli, Laura McDonald
2017 F1000Research  
Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches.  ...  Borg JJ, Aislaitner G, Pirozynski M, et al.: Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.  ...  Studies using a combination of primary and secondary approaches were classed as employing a hybrid approach. Descriptive analysis was performed.  ... 
doi:10.12688/f1000research.12198.1 pmid:29188016 pmcid:PMC5698914 fatcat:zo2g62hi2jd2bb3mnsikwauobq

An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

Robert Carroll, Sreeram V. Ramagopalan, Javier Cid-Ruzafa, Dimitra Lambrelli, Laura McDonald
2017 F1000Research  
Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches.  ...  (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).  ...  Studies using a combination of primary and secondary approaches were classed as employing a hybrid approach. Descriptive analysis was performed.  ... 
doi:10.12688/f1000research.12198.2 pmid:29188016 pmcid:PMC5698914 fatcat:hrv5caddmfczznga7wh7ugyi54

How should you safely outsource pharmacovigilance to an Indian contract research organization?

Brian Edwards
2008 Indian Journal of Pharmacology  
Acknowledgments The author wishes to acknowledge that ideas and inspiration for this article came from presentations by Dr Arun Bhatt  ...  We must not forget that a short-term attitude and a healthy approach to safety are often incompatible.  ...  a hybrid of a CRO and a site management organization.  ... 
pmid:21369409 pmcid:PMC3038519 fatcat:g7s2iz6ngvfqnof6omgon6lxi4

Text mining for pharmacovigilance: Using machine learning for drug name recognition and drug–drug interaction extraction and classification

Asma Ben Abacha, Md. Faisal Mahbub Chowdhury, Aikaterini Karanasiou, Yassine Mrabet, Alberto Lavelli, Pierre Zweigenbaum
2015 Journal of Biomedical Informatics  
For DDI-Extraction, our hybrid system combining a feature-based method and a kernel-based method was ranked second in the DDI-Extraction-2011 challenge, and our two-step system for DDI detection and classification  ...  Pharmacovigilance (PV) is defined by the World Health Organization as the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug-related  ...  Two-step approach for DDI detection and classification Our second DDI extraction approach is basically a considerable improvement (in terms of results obtained for DDI extractions) on our hybrid approach  ... 
doi:10.1016/j.jbi.2015.09.015 pmid:26432353 fatcat:byu5sg2npzfkpb3b7gmzvzxjoi

Mechanisms, Methods of Detection and Causality Assessment of Adverse Drug Reactions

Akshay Sadhotra, Anshu Gupta, Rani Walia, Nidhi Sharma
2016 Indian Journal of Pharmacy and Pharmacology  
approach algorithm.  ...  to a central authority (Central Drugs Standard Control Organization -CDSCO in India).  Prescription Event Monitoring-represents a method which is hybrid of spontaneous reporting with aspects of formal  ... 
doi:10.5958/2393-9087.2016.00005.4 fatcat:pzam7fu3lrhg3kh5sl6otiza2q

Hybrid Semantic Analysis for Mapping Adverse Drug Reaction Mentions in Tweets to Medical Terminology

Ehsan Emadzadeh, Abeed Sarker, Azadeh Nikfarjam, Graciela Gonzalez
2018 AMIA Annual Symposium Proceedings  
Our approach, which we call Hybrid Semantic Analysis (HSA), sequentially employs rule-based and semantic matching algorithms for mapping user-generated mentions to concept IDs in the Unified Medical Language  ...  However, because of the non-standard nature of social media language, automatically extracted ADR mentions need to be mapped to standard forms before they can be used by operational pharmacovigilance systems  ...  We compared two semantic similarity techniques: LSA and a proposed hybrid approach (HSA). The hybrid approach shows improvement over a single similarity technique (LSA).  ... 
pmid:29854133 pmcid:PMC5977584 fatcat:cjw37ut535f6tgwp7uuo2n3taq

The tools of globalization: ways of regulating and the structure of the international regime for pharmaceuticals

David Demortain
2015 Review of International Political Economy  
This happens incrementally, through gradual changes and hybridization of the existing regime, much more than all-out replacement of the regime.  ...  Focusing on international pharmacovigilance, it recounts the history of the World Health Organization programme for the international drug monitoring, to shed light and explain the concomitant rise of  ...  ACKNOWLEDGEMENTS I would like to thank Christian Bonah, Soraya Boudia, Jean-Paul Gaudilli ere, Boris Hauray, Emmanuel Henry, Nils Kessel, Anne Rasmussen and David Vogel, with whom the present study was  ... 
doi:10.1080/09692290.2015.1066695 fatcat:lezwah26gzh53eaelnhshe4s7q

Social Media Listening for Routine Post-Marketing Safety Surveillance

Gregory E. Powell, Harry A. Seifert, Tjark Reblin, Phil J. Burstein, James Blowers, J. Alan Menius, Jeffery L. Painter, Michele Thomas, Carrie E. Pierce, Harold W. Rodriguez, John S. Brownstein, Clark C. Freifeld (+2 others)
2016 Drug Safety  
There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance.  ...  Results In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA Ò ) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared  ...  Carrie Pierce, Harold Rodriguez, John Brownstein, Clark Freifeld, and Nabarun Dasgupta are employees of or contractors to Epidemico, Inc., a technology company intending to commercialize the software platform  ... 
doi:10.1007/s40264-015-0385-6 pmid:26798054 fatcat:mqdp3c7vxjdvjm3lu6kqwg6uwe

A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports

Xiao Liu, Hsinchun Chen
2015 Journal of Biomedical Informatics  
To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States.  ...  In this study, we develop a research framework with advanced natural language processing techniques for integrated and highperformance patient reported adverse drug event extraction.  ...  Acknowledgements This material is based upon work supported by a subcontract from Caduceus Intelligence Corporation with grant funds provided by the United States National Science Foundation (IIP-1417181  ... 
doi:10.1016/j.jbi.2015.10.011 pmid:26518315 fatcat:53nu3jrxfbdmxe2yqpaaqyrija

Comparisons of Food and Drug Administration and European Medicines Agency Risk Management Implementation for Recent Pharmaceutical Approvals: Report of the International Society for Pharmacoeconomics and Outcomes Research Risk Benefit Management Working Group

Yvonne Lis, Melissa H. Roberts, Shital Kamble, Jeff J. Guo, Dennis W. Raisch
2012 Value in Health  
Of these, there were 29 drugs (11 biologics and 18 new chemical entities) with EMA RMPs. REMS and RMPs are similar in objectives, with comparable toolkits.  ...  RMP requirements are increased pharmacovigilance and risk minimization activities. We compared these requirements for drugs requiring both REMS and RMPs.  ...  Supplemental Material Supplemental material associated with this article can be found in the online version at http://dx.doi.org/10.1016/j.jval.2012.06.019.  ... 
doi:10.1016/j.jval.2012.06.019 pmid:23244814 fatcat:hcgjnfdygvf2dmnz72ewsbes3m
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