Data matrix coding of vaccines on primary packaging

Data matrix coding of vaccines on primary packaging Aspired outcomes Opportunities and Aspired Outcomes Enhance utility of primary label coding via GS1 standards Enable EMR development via enhanced machine readable coding Unlock potential for additional end user benefits Enhance the patient experience

Opportunities Add value and utility to the product Use GS1 standards Leverage technology advancements at packaging site Enable systematic availability of key product data Establish primary pack coding competency ahead of potential compliance mandates Some markets will mandate it, some will simply aspire to it. Enable the provider community to aspire to better ways of working Enhance the patient experience

Aspired Outcomes Provider Enable EMR development Improve patient health record accuracy Improve Immunization Information Systems (IIS) and Vaccine Adverse Event Reporting System (VAERS) report accuracy Enable electronic inventory management Recall management and patient identification Less time on administrative tasks and more time for quality interaction with patients! Provider and Patient Right patient / right product Non-duplication of vaccinations Accurate and up-to-date medical records

The aspired outcome is to enable multiple technologies to help prevent medical error, increase the quality of recording/reporting, and to overall enhance the user experience and ways of working in the provider community Databases and secure transmission EMR Improved quality of medical care Logic systems Automatic ID bar coding

Small data carriers enabling BIG opportunities!

2D Vaccine Barcode Pilot 2013 GS1 Healthcare Work Group Forum April 8, 2013 Ken Gerlach, MPH, CTR Immunization Services Division Centers for Disease Control and Prevention (CDC) Bonni Kirkwood Deloitte Consulting, LLP 6 Immunization Services Division National Center for Immunization & Respiratory Diseases

Agenda Overview of CDC Purpose and Structure Vaccinations and Immunization Information Systems (IIS) The 2D Vaccine Barcoding Pilot Overview Design and Implementation Vaccine Information Statements EMR/IIS Functional Capabilities Next Steps 7

Centers for Disease Control and Prevention (CDC) A United States federal agency under the Department of Health and Human Services Works to protect public health and safety by providing information to enhance health decisions and promotes health through partnerships with state health departments and other organizations. CDC is the United States' national public health institute 8

Comparison of 20 th Century Annual Morbidity and Current Morbidity: Vaccine-Preventable Diseases Source: JAMA. 2007;298(18):2155-2163 Source: CDC. MMWR January 6, 2012;60(51);1762-1775. (provisional 2011 data) * Haemophilus influenzae type b (Hib) < 5 years of age. An additional 14 cases of Hib are estimated to have occurred among the 237 reports of Hi (< 5 years of age) with unknown serotype. 9

Immunization Information Systems (IIS) IIS are confidential, population-based, computerized databases that record all immunization doses administered by participating providers to persons residing within a given geopolitical area Clinical: provides consolidated immunization history for determining appropriate vaccinations Population: provides aggregate data for use in surveillance and program operations, and in guiding public health action to improve vaccination rates and reducing vaccine-preventable disease Work with EMR systems to exchange and relay vaccine information: e.g. histories, forecast decisions, alert notices, etc. 10

Agenda Overview of CDC Purpose and Structure Vaccinations and Immunization Information Systems (IIS) The 2D Vaccine Barcoding Pilot Overview Design and Implementation Vaccine Information Statements EMR/IIS Functional Capabilities Next Steps 11

2D Barcode Vaccine Pilot Objective: To assess the extent to which using 2D barcoded vaccines and scanners affect the completeness and accuracy of vaccine data collected by pilot sites. Part 1 Pilot Project to Implement 2D Barcodes on Vaccine Vials and Syringes (unit of use) Part 2 Incorporate 2D Barcodes onto Vaccine Information Statements (VIS) Part 3 Provide Technical Support and Guidance for Future Implementers 12

Pilot Vaccine and Information Flow Manufacture r Immunizer Record System IIS Add 2D barcode to primary packaging : Data Matrix barcode containing GTIN Expiration date Lot number Distribution to pilot participants via existing vaccine supply chain. Scan vaccine data: Entering vaccine into inventory Administering vaccine Record system types: Electronic medical records (EMR) Immunization Information Systems (IIS) Track GTIN, expiration date, and lot number Receive data from the immunizers record system: Acts as a source of evaluation for data accuracy and completeness 13

GS1 DataMatrix for Vaccines AAP / GS1 collaboration Barcode contains GTIN, Expiry Date and Lot Number GS1 DataMatrix symbology currently on multiple vaccines http://www2.aap.org/immunization/pediatricians/pdf/barcoding_guidance_manufacturers_022212.pdf 14

Pilot Participation 2 Vaccine Manufacturers Sanofi Pasteur, GlaxoSmithKline 217 Immunizers Public and Private Providers 10 Immunization Information Systems 2D Barcoded Vaccines Havrix Adult Menactra Pediatric DT Daptacel Adacel Tenivac Fluzone IPOL WA NYC CA OR NV ID UT AZ MT WY CO NM ND SD NE KS OK TX MN WI IA IL MO AR MS LA MI IN KY TN AL OH GA WV SC NC PA MD VA ME V N T H NY C MA T RI NJ DE HI AK FL Participating Immunization Awardee 15

Immunizer Demographics Immunizer Segments 1 71 145 Public Private Commercial Practice Specialties Public Private Commercial Family Practice 13 53 0 General Practice 7 2 0 Internal Medicine 0 4 0 Pediatric 4 84 0 Other 47 2 1 88 50 9 66 Family Practice General Practice Internal Medicine Pediatric Over 70% of Other are Public Health Depts. The single commercial practice is a commercial pharmacy that administers vaccinations 4 Other 16

AllScripts eclinical Works Medent EPIC Office Practicum Insight Netsmart NextGen RPMS Sage Intergy GE Centricity e-md e-addabbo Profiler (Unicare) SIS Mitchell & McCormick Cerner SuccessEHS Praxis Practice Partner Encounter Pro Amazing Charts NetPractice QS1 No EMR Number of Sites EMR Systems in Use at Pilot Sites Distribution of Pilot Sites by EMR Vendor 50 45 45 40 35 30 25 20 15 27 24 19 17 13 12 16 10 7 5 5 5 5 5 4 3 3 2 2 2 2 1 1 1 1 0 EMR Vendors (24 Total) Note: Sites with No EMR are IIS Only sites they report directly to the state registry 17

Configured Scanners with Pilot Sites EMR/IIS Systems Initial Findings Many EMR systems unable to capture GTIN (manufacturer and product name) from the barcode scan Use of drop down menus Necessary to tab to the data entry fields of lot number or expiration date to scan barcode Scanner configuration software tool allowed adjustments to address the software design (Motorola) Functional Capacities Findings 18

19 Vaccine Information Statement (VIS) Image

National Childhood Vaccine Injury Act Required by law. Prior to vaccine administration, provide a copy of the relevant Vaccine Information Statement (VIS) Vaccine Information Statement (VIS) Objective information on vaccine advantages and risks Intense scrutiny by panel of experts, updated periodically 20

Why Barcode VIS? Partners input: If you re going to put barcodes on vaccine vials and syringes what about the VIS? Record the VIS data more accurately Increase in completeness for data elements Simplify immunizer data entry Reduce the time spent by immunizers recording that the VIS was provided Ensure legal compliance Enhance record keeping for provider Promote use of barcoding technology 21

Decisions Use GS1 standards and tools Collaboration with GS1 Healthcare US Use GS1 data matrix 2D barcode Use GS1 Application Identifier (AI) - Global Document Type Identifier (GDTI) 22

23 VIS 2D Web-Page

Agenda Overview of CDC Purpose and Structure Vaccinations and Immunization Information Systems (IIS) The 2D Vaccine Barcoding Pilot Overview Design and Implementation Vaccine Information Statements EMR/IIS Functional Capabilities Next Steps 24

Functional Gaps 2D Barcodes exist on multiple vaccines and VIS statements. Most electronic medical record (EMR) and Immunization Information System (IIS) solutions are not designed to populate fields with information scanned from 2D barcoded vaccines. We are not aware of any EMR or IIS solutions that capture document type and edition date scanned from 2D barcoded VIS 25

Closing the Gaps 1-on-1 Interviews Collaborate with industry and EMR/IIS vendors to gain feedback and develop functional requirements for processing 2D barcoded vaccine and VIS information: Conduct 1-on-1 interviews with targeted EMR/IIS vendors Collect insight to challenges, opportunities, specific requirements, and path to incorporating 2D barcode data into existing software Share and collect feedback on functional requirement opportunities observed by the Pilot team Open Forum Interviews During HIMSS 2013 Conference, conducted open-forum work group discussions with EMR vendors: Invited EMR vendors to HIMSS 2013 Shared the future industry path identified during 1-on-1 interviews with EMR vendors Collected feedback and assessed input Functional Capabilities Report Detailed EMR/IIS 2D Barcode Functional Capabilities Report that will be available to the public 26

Agenda Overview of CDC Purpose and Structure Vaccinations and Immunization Information Systems (IIS) The 2D Vaccine Barcoding Pilot Overview Implementation - Unit of Use (Vials/Syringes) Vaccine Information Statements EMR/IIS Functional Capabilities Next Steps 27

Next Steps Educational Forum for immunization community: New Orleans - April 14 15, 2013 2D Vaccine Barcode Pilot Completion May 2013 2D barcodes on secondary packaging report June 2013 EMR/IIS Functional Requirements Report June 2013 Pilot data and analysis completion July 2013 Final Pilot Report issued Q3 2013 28

Key Takeaways 2D barcodes can contain more data More vaccine products with 2D barcodes are entering the supply chain EMR/IIS system capabilities to consume the 2D data are essential to adoption and use Guidance from the FDA on the use of barcoding will be beneficial 29

2dbarcodepilot.com http://www.2dbarcodepilot.com 30

Thank You-Happy Scanning For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. 31 National Center for Immunization and Respiratory Diseases Immunization Services Division