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Prospective cost-benefit analysis of a two-dimensional barcode for vaccine production, clinical documentation, and public health reporting and tracking : final report
  • Published Date:
    July 2012
  • Language:
Filetype[PDF-2.54 MB]

  • Description:
    According to the National Childhood Vaccine Injury Act (NCVIA) (1986), documentation for immunization must include manufacturer and lot number and the American Academy of Pediatrics (AAP) recommends recording the expiration date (AAP Committee on Infectious Diseases, 2012). Since 2004, the U.S. Food and Drug Administration (FDA) has required that vaccine product labels be printed with a linear barcode containing a product’s National Drug Code (NDC), which identifies the manufacturer, product name, and packaging information (FDA, 2004). Linear barcodes that could contain these data would be too large to appear on a label affixed to a 0.5 mL single-dose vial. Thus, barcodes appearing on vials, ampoules, and syringes of vaccines do not contain the lot number or expiration date.

    The intent of the FDA’s linear barcode rule was to enhance patient safety using machine- readable codes (FDA, 2004), but AAP (2010) noted that these barcodes are ineffective for patient safety because they omit lot number and expiration date. AAP has since assembled vaccine manufacturers, providers, public health groups (including the Centers for Disease Control and Prevention [CDC]), and other immunization stakeholders in an initiative to transition barcodes on unit-of-use vaccine containers from linear to two dimensional (2D).

    2D barcodes are capable of containing product, expiration date, and lot number on product labels (Figure ES-1). AAP cited changes since FDA’s 2004 rule was enacted, including decreasing costs of using 2D barcodes, changing immunization schedules, new vaccine products, and the prospect of meeting FDA’s safety goals in its initiative. The FDA (2011) agreed with AAP’s assessment and issued industry guidance in 2011 that stated it would grant vaccine manufacturers waivers to replace linear barcodes with 2D ones. A waiver is not necessary if both linear and 2D barcodes appear on a label.

    In October 2010, CDC’s Immunization Services Division contracted with RTI International, an independent, nonprofit research institute, to study the impacts 2D barcodes may have on vaccine production, clinical documentation, and public health reporting and tracking for stakeholders in the U.S. immunization system. The study included a prospective economic analysis and an information systems analysis. Stakeholders included in the study were vaccine manufacturers, vaccine users (e.g., immunization providers, immunization program managers), and immunization data users (e.g., immunization information systems [IIS], data exchange groups, vaccine-related tracking systems).

    Prepared for Immunization Services Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention by RTI International, RTI Project Number 0212793.

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