CHAIR
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PRESENTER
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Joseph Tonning, FDA, United States
Anna Zhao-Wong is the Deputy Director of the MedDRA MSSO. She has led MedDRA development projects, such as the mapping of CTCAEv3.0 to MedDRA and ICD9CM to MedDRA and the expansion of medication error terms in MedDRA. Dr. Zhao-Wong received her M.D. from BMU and Ph.D. in Biochemistry from the USUHS.
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Linda Scarazzini, MD, AVP Risk Management at sanofi-aventis, is board certified in pharmacy and Internal Medicine. She has nine years of experience in Global Pharmacovigilance and Epidemiology and has coauthored publications on data mining, signal detection and quantitative benefit-risk methods.
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Dr. Fotsch is the CEO of PDR Network which distributes drug information, Alerts and warnings to all U.S. physicians in various formats including integration into EHRs. He has been frequently published in the area of health IT and is regularly quoted as an expert by the national press.
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Description
Recent, rapid advances in Health Information Technology (HIT), the ever-widening deployment of new electronic systems, as well as new FDA goals for EHRs now make it possible to both generate positive health outcomes at the point of care and identify important drug-related safety issues that may have previously gone undetected. Medication adherence can now be pursued using communication to both provider and patient using EHRs. Adverse Drug Event (ADE) reporting tools can now operate both independently and as components within existing EHR/EMR systems, and the data that they capture and generate can be combined with new tools and approaches to data mapping, safety analysis, and interoperability. With these new advancements comes the potential to improve the validation and correlation of safety signal data. As provider workflow evolves from a fragmented traditional approach into one that is more integrated and cohesive, EHR-centric systems are emerging as important pharmacovigilance tools which may prove crucial to the advancement of ADE reporting, early warning systems and safety signal detection.
Learning Objectives:
Identify EHR use adoption trends, incentives, workflow changes, opportunities for risk, regulatory and medication adherence engagement including key FDA goals
Analyze terminology interoperability using ICD-9-CM to MedDRA mapping
Assess how geo-mapping of ADE data, including that from EHRs, may bolster signal evaluation by identifying clues of genetic susceptibility, socioeconomic patterns, and areas for public health intervention.