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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary
K. Arnold Chan, MD, ScD, is a Senior Scientist at i3 Drug Safety and an Adjunct Associate Professor at the Harvard School of Public Health. He was the Director of the Harvard Pharmacoepidemiology Program from 2002 through 2005 and was elected a Fellow of the International Society for Pharmacoepidemiology in 2003. Dr. Chan has extensive experience in safety evaluation of pharmaceutical agents and vaccines and has conducted research sponsored by the NIH, FDA, and pharmaceutical companies.
Karen R. Cox, RN, PhD, is the Quality Improvement Coordinator in the Office of Clinical Effectiveness and a Senior Investigator in the Center for Health Care Quality at University of Missouri Health Care in Columbia. She is one of four Missourians who is a graduate of the Patient Safety Improvement Corp, a training partnership with the Agency for Healthcare Research and Quality and the Veteran’s Administration. Her areas of practice and research include population-based clinical outcomes improvement; health-care operations redesign; organizational culture change as it relates to patient safety; and faculty, student, and staff curriculum development and instruction in quality improvement, patient safety, and crew training. Beginning in 2000, the Office of Clinical Effectiveness oversaw the design and development of an internal, secure, web-based quality-of-care/patient safety event reporting system. The University of Missouri’s adverse event reporting system, implemented on January 1, 2002, is accessible for reporting by staff, physicians, patients, families, and visitors.
Francesca Cunningham, PharmD, is the Director of the Center for Medication Safety PSCI, National Center for Patient Safety (NCPS), and Program Director of Outcomes Research at the Department of Veterans Affairs (VA) Pharmacy Benefits Management/Strategic Healthcare Group (PBM/SHG). Dr. Cunningham was the driving force behind the successful effort of PBM/SHG to establish reliable methods for merging the VA prescription database with other large VA-related databases in order to evaluate the safe and appropriate use of medications in the veteran population. Her focus has been on assessing new agents where safety data is lacking and older drugs when a newly emerging danger requires evaluation. She designed the VAMedSAFE and PBM Drug Safety Quality Improvement (QI) program. Under her direction the program has become a major tool in the evaluation of drug safety in the VA and its role in the formulary decision process. Since her time in the VA, Dr. Cunningham has focused her research efforts in the area of drug safety. Her group has worked independently and with other researchers to perform several drug safety and pharmacoepidemiologic studies. She was awarded a