title: Prospective cost-benefit analysis of a two-dimensional barcode for vaccine production, clinical documentation, and public health reporting and tracking.
abstract: In the United States recording accurate vaccine lot numbers in immunization records is required by the National Childhood Vaccine Injury Act and is necessary for public health surveillance and implementation of vaccine product recalls. However, this information is often missing or inaccurate in records. The Food and Drug Administration (FDA) requires a linear barcode of the National Drug Code (NDC) on vaccine product labels as a medication verification measure, but lot number and expiration date must still be recorded by hand. Beginning in 2011, FDA permitted manufacturers to replace linear barcodes with two-dimensional (2D) barcodes on unit-of-use product labels. A 2D barcode can contain the NDC, expiration date, and lot number in a symbol small enough to fit on a unit-of-use label. All three data elements could be scanned into a patient record. To assess 2D barcodes' potential impacts, a mixed-methods approach of time-motion data analysis, interview and survey data collection, and cost-benefit analysis was employed. Analysis of a time-motion study conducted at 33 practices suggests scanning 2D-barcoded vaccines could reduce immunization documentation time by 36-39 s per dose. Data from an internet survey of primary care providers and local health officials indicate that 60% of pediatric practices, 54% of family medicine practices, and 39% of health departments would use the 2D barcode, with more indicating they would do so if they used electronic health records. Inclusive of manufacturer and immunization provider costs and benefits, we forecast lower-bound net benefits to be $310-334 million between 2011 and 2023 with a benefit-to-cost ratio of 3.1:1-3.2:1. Although we were unable to monetize benefits for expected improved immunization coverage, surveillance, or reduced medication errors, based on our findings, we expect that using 2D barcodes will lower vaccine documentation costs, facilitate data capture, and enhance immunization data quality.
authors.affiliation: RTI International, 3040 Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC 27709, USA. oconnor@rti.org
authors.forename: Alan C
authors.initials: AC
authors.lastname: O'Connor
authors.forename: Erin D
authors.initials: ED
authors.lastname: Kennedy
authors.forename: Ross J
authors.initials: RJ
authors.lastname: Loomis
authors.forename: Saira N
authors.initials: SN
authors.lastname: Haque
authors.forename: Christine M
authors.initials: CM
authors.lastname: Layton
authors.forename: Warren W
authors.initials: WW
authors.lastname: Williams
authors.forename: Jacqueline B
authors.initials: JB
authors.lastname: Amoozegar
authors.forename: Fern M
authors.initials: FM
authors.lastname: Braun
authors.forename: Amanda A
authors.initials: AA
authors.lastname: Honeycutt
authors.forename: Cindy
authors.initials: C
authors.lastname: Weinbaum
mesh_terms: D003362:Cost-Benefit Analysis; D003625:Data Collection; D004282:Documentation / Q000592:standards*; D004356:Drug Storage / Q000379:methods / Q000592:standards; D001330:Electronic Data Processing / Q000191:economics; D006801:Humans; D017589:Immunization Programs / Q000458:organization & administration*; D011356:Product Labeling; D011446:Prospective Studies; D011634:Public Health; D011786:Quality Control; D014481:United States; D014611:Vaccination; D014612:Vaccines / Q000191:economics* / Q000592:standards
chemical_list: D014612:Vaccines