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Track-and-Trace Technology Seminar
Wednesday, November 9–Friday, November 11, 2011
Gaylord National Resort & Convention Center
National Harbor, Md.
"Track-and-Trace Technology" Seminar Highlights
Last week more than 140 healthcare distribution industry leaders convened just outside of Washington, D.C., for HDMA’s "Track-and-Trace Technology" seminar. In its third year, the seminar explored important legislative, regulatory and industry issues surrounding the use of track-and-trace technologies in the healthcare supply chain.
Seminar highlights included perspectives from FDA on its initiatives to combat the threats and vulnerabilities of counterfeit drugs in the supply chain. Karen Rothschild, Esq., of the Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, discussed a number of FDA’s supply chain initiatives supporting the use of technology to help further secure the drug supply and enhance patient safety. She provided a summary from the Track and Trace Public Workshop that took place on February 15–16, 2011, and initiatives moving forward. Rothschild also provided an overview of recent organizational changes in the Office of Compliance. A copy of Ms. Rothschild’s presentation is available here.
Virginia Herold, California Board of Pharmacy, joined the seminar by webcast to provide a regulatory overview and emphasize the importance of securing the drug distribution system to sustain and increase confidence in the authenticity of prescription drugs in California. Herold shared the Board’s expectations for the industry as the state’s deadline for track-and-trace implementation approaches in 2015.
With continued discussions about the impact of California pedigree, potential federal legislation and international marketplace drivers, Julie Kuhn of Cardinal Health, Inc., said that serialized product in the U.S. marketplace is not far off. Kuhn’s presentation focused on the challenges of obtaining and recording serialized data and showed what kind of data has become available for Cardinal to use and assess internally.
Margot Drees of Global Healthcare Exchange (GHX) talked about her company's work on a prototype of a track-and-trace system. Such a system would provide a flexible framework that leverages the GHX Exchange and GS1 Standards and would allow pharmaceutical trading partners to enhance patient safety, meet regulatory compliance mandates and derive additional business benefits. GHX will be piloting various scenarios that could be used to help comply with California requirements beginning in 2015.
HDMA would like to extend special appreciation to the American Society of Health-System Pharmacists, the Generic Pharmaceutical Association and the Health Industry Distributors Association for partnering to provide this timely seminar to its members. This seminar also would not have been possible without the support of our sponsors: Acsis, Inc., Axway, Inc., OM HealthCare Logistics and Seidenader Vision.
Stay tuned to HDMA’s website for the latest education updates and 2012 seminars to be announced later this year.
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