FDA Proposes Unit-of-Dose Packaging and Bar Coding to Reduce Errors; Agency's Guidelines Will Be Hot Topics at Upcoming WestPack Show.

Business Editors

WestPack 2003

LOS ANGELES--(BUSINESS WIRE)--Nov. 20, 2002

There is growing concern about the frequency of medication dose errors in the U.S. health care system. The Institute of Medicine reported in 1999 that nearly 770,000 drug events which result in either injury or death -- the majority of which are attributed to preventable errors -- occur in the nation's hospitals each year.

Health care organizations have employed barcode-enabled point-of-care (BPOC) systems as a way of combating errors -- a process that has resulted in significant documented decreases. The Food and Drug Administration (FDA) is now considering a dramatic expansion of this effort, through a rule that would require that all human drugs and biological products be packaged and bar-coded in single dosages. The prospect of this new regulation is generating some controversy within the packaging industry. Although it seems to offer patients better protection against miscalculated doses, manufacturers are understandably concerned about the retooling costs required to comply with its provisions.

FDA has postponed its decision until the end of the year, which means that the first major discussion of its implementation and impact will occur at February's WestPack trade event on the West Coast. Taking place at the Anaheim Convention Center, February 19-21, 2003, the show's technical conference will feature three major sessions addressing bar code technologies, including:

--  Bar Coding Unit Doses and Patient Strategy -- This presentation
    will cover package labeling, technology and industry standards
    being applied in the health industry supply chain to enhance the
    quality of patient care, improve the efficiency of staff, and
    reduce the overall cost of healthcare.

--  Unit Dose Bar Coding: Bar Coding and HUD/OTC In-Line Printing --
    This presentation offers a detailed overview of the entire
    production process from the initial art design to the manufacture
    of the printing plate to the final in-line printing.

--  Unit Dose Bar Coding: Coding Standards, Symbologies, Printing
    Processes, and Data Capture Technologies -- This session will
    review printing options and provide an overview of various data
    capture technologies. Effective bar coding in an open system
    environment requires the use of standardized data, data carriers
    and data capture technologies. Established EAN.UCC system and
    HIBCC healthcare standards are the foundation of unit dose bar
    coding today and any possible FDA-mandated bar coding regulation
    is expected to build on one or both of these standards.

"To speak at WestPack is a great honor. This conference allows us to go beyond meeting with the manufacturers and provides an opportunity to meet with those actually involved in packaging design," said Frank Kilzer, Director Material Resources at St. Alexius Medical Center in Bismarck, North Dakota, speaking on the Bar Coding Unit Doses and Patent Strategy session. "Using real life experiences and a hands-on approach, attendees will gain valuable insights into the important role package design has in improving the quality of patient care and streamlining business processes in a healthcare organization."

Additional WestPack conference session titles include: "Cosmetic & Personal Care Packaging," "Food, Beverage, and Supplement Packaging Trends," "Medical Packaging Design," and "Medical Packaging Management and Operations."

Produced and managed by CANON COMMUNICATIONS LLC, WestPack is part of CANON'S worldwide family of trade events. Information about the show can be found at www.westpackshow.com, or by calling 310/445-4200.