Pharmacovigilance Project

 
 

Overview

 

The long-term objective of this project is to discover novel adverse drug events (ADEs) through use of automated methods involving natural language processing (NLP) and data mining methodologies on vast quantities of clinical data in electronic health records (EHRs) and the FDA's Spontaneous Adverse Event Reporting System (AERS). ADEs are major problems world-wide and cause hospitalizations, deaths, and incur a huge cost to health care. Therefore, continued post-marketing surveillance encompassing large and varied patient populations is crucial for patient safety. EHRs contain a comprehensive amount of clinical information, which if harnessed properly, would be invaluable for pharmacovigilance.

 

We have already demonstrated that we can accurately encode information in clinical reports using the NLP system MedLEE, and that we can accurately detect associations among clinical events using statistical methods that we developed. MedLEE will be used to map comprehensive clinical information in the EHR to codified data, and then statistical methods will be used to generate an extensive knowledge base of disease-symptom, disease-drug, drug-drug, and drug-symptom associations, which will be used to discover new ADEs. Additionally, we will also apply clinical knowledge and statistical methods to reduce confounding, which is a challenge when using the clinical record because there are many interdependencies in the data. We will also develop methods to map fine-grained concepts into higher level concepts, which could be important for optimizing the statistical methods. The performance of our discovery methods is evaluated by testing the methods using drugs currently in use with known ADEs, and also by using historical rollback. We are currently focusing on discovery of serious adverse events using inpatient records, and will then use the longitudinal outpatient record.

 

Funding

This project is supported by grants T15-LM007079, R01 LM010016, R01 LM010016-0S1, R01 LM010016-0S2, R01 LM008635, and R01 LM06910 from the National Library of Medicine.

 

Publications

  • Wang X, Hripcsak G, Markatou M, Friedman C. Active Computerized Pharmacovigilance using Natural Language Processing, Statistics, and Electronic Health Records: a Feasibility Study. J Am Med Inform Assoc2009 March 4. PMCID: PMC2732239.
  • Wang X, Hripcsak G, Friedman C. Characterizing environmental and phenotypic associations using information theory and electronic health records. BMC Bioinformatics 2009;10 Suppl 9; S13. PMCID:PMC2745684.
  • R, Haerian K, Chase HS, Friedman C. Mining multi-item drug adverse effect associations in spontaneous reporting systems. BMC Bioinformatics (in press).
  • Wang X, Chase HS, Li J, Hripcsak G, Friedman C. Integrating heterogeneous knowledge sources to acquire executable drug-related knowledge. Proc 2010 AMIA Annu Symp (in press).
  • Harpaz R, Haerian K, Chase HS, Friedman C. Statistical mining of potential drug interaction adverse effects in FDA’s spontaneous reporting system. Proc 2010 AMIA Annu Symp (in press).
  • Harpaz R, Haerian K, Chase HS, Friedman C. Mining electronic health records for adverse drug effects using regression based methods. Proc 1st ACM International Health Informatics Symposium (IHI 2010) (in press).
 
 
 

Members

 
Carol Friedman

Carol Friedman PhD

Project Director
Vice-Chair, Department of Biomedical Informatics
Professor of Biomedical Informatics

Email: friedman@dbmi.columbia.edu

 
George Hripcsak

George Hripcsak MD, MS

Chairman, Department of Biomedical Informatics
Vivian Beaumont Allen Professor of Biomedical Informatics
Director, Medical Informatics Services, NYP/Columbia

Email: hripcsak@columbia.edu

 
Herbert Chase

Herbert Chase MD, MA

Professor of Clinical Medicine (in Biomedical Informatics)

Email: herbert.chase@dbmi.columbia.edu

 
Lyudmila Shagina

Lyudmila Shagina

Sr. Programmer Analyst

Email: shagina@dbmi.columbia.edu

 
Feng Liu

Feng Liu

Sr. Programmer

Email: feng.liu@dbmi.columbia.edu

 
Xiaoyan Wang

Xiaoyan_Wang PhD

Predoctoral Trainee

Email: xiw7002@dbmi.columbia.edu

 
Rave Harpaz

Rave Harpaz

Postdoctoral Fellow

Email: rave.harpaz@dbmi.columbia.edu

 
Dowman P Varn

Dowman P Varn

Postdoctoral Fellow

Email: dowman.varn@dbmi.columbia.edu

 
Ying Li

Ying Li

Predoctoral Trainee

Email: ying.li@dbmi.columbia.edu

 
Krystl Haerian

Krystl Haerian

Postdoctoral Trainee

Email: Krystl.Haerian@dbmi.columbia.edu