Canadian Consensus Statement on Proposed Standards for Bar Codes on Vaccine Products

Automated Identification of Vaccines Projects Advisory Task Group

Introduction

In Canada, several million doses of vaccines are administered every year. Each time a dose of vaccine is administered, a health care provider must manually record details of the event in the patient’s health record. Studies have shown that between 5 and 15 percent of immunization records are missing important information and up to 24 percent contain errors, causing delays in the follow-up of adverse events following an immunization. The outcome is an increased cost to the health system and may result in adverse health outcomes for Canadians.

In light of these findings, the National Advisory Committee on Immunization (NACI) passed a resolution in 1999, recommending that bar codes be placed on all vaccine products to improve record keeping and the safe use of vaccines.

Background

The Public Health Agency of Canada initiated the Automated Identification of Vaccines Projects (AIVP) in response to the NACI recommendations. Between 2002 and 2005, the AIVP completed a number of initiatives including:

• A feasibility study for the bar coding of vaccine products conducted in consultation with vaccine manufacturers, international partners and other stakeholders;
• The design and development of the Vaccine Identification Database System (VIDS), a single, web based repository of comprehensive information on all vaccines licensed for use in Canada. VIDS is the link between the bar code and the information required to populate the client health record. When a health care worker scans the bar code on a vaccine product, the link to VIDS allows the population of the information on that specific vaccine product into the client health record; and,
• A pilot project implemented with front line providers of vaccines, demonstrated increased efficiency and accuracy of immunization information using bar codes instead of manual entry.

These initiatives were followed-up by a meeting with manufacturers in 2005 and the formation of the AIVP Advisory Task Group in 2007.

The AIVP Advisory Task Group (AIVP ATG) was established to provide leadership, direction, advice and support for the development and voluntary implementation of bar codes on vaccine products in Canada. The AIVP ATG is a collaborative effort between all stakeholder groups in the area of immunization and is co-chaired by the Public Health Agency of Canada (PHAC) and the vaccine industry with representation from: vaccine manufacturers, jurisdictions, health authorities, health professional associations, regulators, international standard setting agencies, EHR, and clinical management software developers.

The AIVP ATG developed a five-year strategic plan (2008-2013). One of the first tasks was to perform an independent cost benefit analysis for the adoption and implementation of bar codes on vaccine products. Six different implementation options varying in technical detail, the relative cost and benefits anticipated were selected by the AIVP ATG for consideration. The study unequivocally proved that bar codes on vaccine products would substantially benefit Canadians and that these benefits will increase over time as technology advances and new vaccines are introduced. It is clear that automated identification is advantageous in reducing overall cost to the Canadian health care system. More importantly, automated identification plays a pivotal role in ensuring up to date and accurate immunization records which will improve the safe and more effective use of vaccines.

A primary objective of the AIVP ATG is to develop Canadian recommendations for standard bar codes on vaccine products in Canada. The standards in this document have been agreed upon by all members of the AIVP ATG and will be implemented on a voluntary basis over the course of the next two years by manufacturers to maintain a high standard of quality of bar codes. Recognizing the importance of global standards, the AIVP ATG Advisory Task Group will continue to contribute to the development of global standards for bar coding of health products.

At the AIVP ATG annual meeting in February 2009, a consensus was reached on recommendation for Canadian bar code standards for vaccine products.

Recommendations

The Canadian bar code recommendations for vaccine products are:

• Two dimensional (2D) bar codes on the primary package which include the Global Trade Identification Number (GTIN) and the lot number. Including the expiry date in the bar code is optional as it can be determined through the lot number. Lot number and expiry date will continue to appear in human readable form on the primary packaging as per Canadian labeling requirements.
• 2D or linear (also known as 1D) bar codes on the secondary package that include GTIN and the lot number. Including the expiry date in the bar code is optional as it can be determined through the lot number. Lot number and expiry date will continue to appear in human readable form on the secondary packaging as per Canadian labelling requirements.

A 2D bar code (GS1 DataMatrix symbology) consists of printed squares or dots, spiralling outwards from the centre of the symbol. The main advantage of the 2D bar codes is the ability to provide a significant amount of information on a very small surface (for example on a vial or pre-filled syringe). In addition, they are easier to read on curved surfaces and are more resilient especially when handled multiple times and still maintain high scanning efficiency.

Example of a DataMatrix (2D bar code) ¹

 

The GS1 DataBar (formerly referred to as Reduced Space Symbology or RSS) is a family of bar code symbols that are both linear and 2D. The GS1 DataBar is also appropriate for vaccines as they are much smaller than EAN/UPC linear bar codes. They can carry additional information such as serial numbers, lot numbers and expiry dates.

Examples of a GS1 DataBar (2D bar code)

The GTIN-128 code (linear) structure has a fourteen data digit structure consisting of a packaging indicator, a company reference (company ID + product ID and a check digit value to ensure data integrity).

Example of a GS1-128 (linear bar code)

Data Structure Sample:

 

Bar Code Sample:

 

GTIN – Global Trade Item Number

The GTIN is a global product identification standard that has been adopted across the majority of products worldwide from oranges to operating room equipment. The GTIN is recommended for use instead of the Drug Identification Number because it is a global e-commerce number and not a number that is unique to Canada. In addition, the GTIN is unique by packaging hierarchy (e.g. pallet, case, primary package) whereas the DIN is not.

Including the lot number enables product traceability; increased efficiency in electronic record keeping, as it prevents users from having to select the lot from a drop down list or using other work around solutions to uniquely identify the product; and is especially important from a patient safety perspective, as it is used for recalls and the follow up of adverse events following an immunization.

The Benefits

Fully unique product identification on both the primary and secondary packages encourages efficient and complete electronic health record keeping by the immunizer or clerical staff; reduces the number of immunization errors through improved completeness and accuracy of records; and expedites the follow up of adverse events following immunization. Additional benefits include improved inventory management and forecasting throughout the vaccine supply chain and improved record keeping resulting in accurate coverage rates.

Next Steps for the AIVP ATG

In 2009-2010 the AIVP ATG will conduct a comprehensive assessment of the state of readiness of public health, private health and hospitals to use bar code technology. The assessment results will help inform the way forward as industry continues to work towards implementing the standards for bar coding on vaccine products.

Members of the Automated Identification of Vaccine Projects Advisory Task Group

Federal Co-Chair

Lisa Belzak, Manager, Assessment and Immunization Information, Centre for Immunization and Respiratory Infectious Diseases, Infectious Disease and Emergency Preparedness Branch, Public Health Agency of Canada

Stakeholder Co-Chair

Louis Lamarche, Public Health Manager, Vaccine Division, Merck Frosst Canada Limited

Project Team

Amanda Jane Diniz, Program Evaluation Officer, Centre for Immunization and Respiratory Infectious Diseases, Infectious Disease and Emergency Preparedness Branch, Public Health Agency of Canada

Vanessa Wilson, Project Officer, Centre for Immunization and Respiratory Infectious Diseases, Infectious Disease and Emergency Preparedness Branch, Public Health Agency of Canada

Members

BIOTECanada
Graeme Fraser, Director, Health Policy

Canadian Immunization Registry Network
Dr. Monika Naus, Associate Director, Epidemiology Services

Canadian Nurses Coalition on Immunization
Cathy O’Keefe, Director, Disease Control, Public Health, Government of Newfoundland and Labrador, Health and Community Services

Canadian Paediatric Society
Marie Adèle Davis, Executive Director

Information Technology Association of Canada
Brendan Seaton, President, Health Division

Canadian Medical Association (CMA)
Dr. Jay Mercer, Senior Medical Advisor, Office of the Chief Technology Officer

GlaxoSmithKline (GSK)
Brian D. Wigle, Sr. Manager, Public Vaccines Portfolio

GS1 Canada
Alicia Duval, Vice-President, Healthcare Sector

GS1 Canada
Rob Bell, Director Healthcare

Health Canada
Luna Al-Khalili, Patient Safety Specialist, Patient Safety Section, Marketed Health Products Directorate, Health Products and Food Branch,

Health Canada
Julie Wallace, Unit Head, Blood, Tissues, Organs & Vaccines Division, Biologics and Genetics Therapies Directorate, Health Products and Food Branch

Health Canada
Hershey Cleofas, Policy Analyst, Policy and Promotion, Office of Policy and International Collaboration, Biologics and Genetic Therapies Directorate, Health Products and Food Branch

Institute for Safe Medication Practices Canada (ISMP Canada)
Sylvia Hyland, Vice-President

Merck and Co., Inc.
Stephen Hess, Executive Director of Packaging Technology, Merck Manufacturing Division

Novartis Vaccines
John Tracey, Operations Manager, Novartis Vaccines

Sanofi Pasteur Limited
Mesfin Zeme, Deputy Director, Formulations, Filling and Packaging

Sanofi Pasteur Limited
Rob Van Exan, Director, Immunization Policy, Public Affairs

Solvay Pharma Inc.
Noelle Byrne, Manager, Corporate Affairs, Solvay Pharma Inc.

Vaccine Vigilance Working Group
Jean Nkanza, Vaccine Safety Officer, Canadian Adverse Events Following Immunization Surveillance System, Vaccine Preventable Diseases and Vaccine Safety, Center for Immunization and Respiratory Infectious Diseases, Infectious Disease and Emergency Preparedness Branch, Public Health Agency of Canada

Vaccine Supply Working Group
Louis Dimitracopoulos, Manager, Strategic Services and Contract Management, Corporate and Direct Services Division, Supply and Financial Services Branch

Wyeth Pharmaceuticals
Chris Todd, Associate Product Manager, Vaccines, Public Health

Liaison Members

Sanofi Pasteur Limited
Charles Listigovers, Senior Director, Global Manufacturing Technology, Filling and Packaging, Discovery Drive

American Academy of Pediatrics
Elizabeth Sobczyk, Manager, Immunization Initiatives, Vision of Pediatric Practice

Special Acknowledgements

GS1 International
NHS England

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¹ All bar code images have been enlarge for display purposes