by Drew Meek, WHO/QSS; Sheila Cattell, IFPMA; and Joanie Robertson, PATH
In the packaged food and consumer products industries, barcodes have become a way of life. Most large supermarkets around the world use barcode scanners at the checkout counter, and an average smartphone can now scan barcodes. Barcodes make it easy to track the flow of goods from their point of origin to their final destination, to recall products that may pose a safety hazard, and to link a product with a great deal of information such as where it was made, where it has been, ingredient lists, and instruction manuals in multiple languages. Given the ubiquity and utility of barcodes, why are they not widely used on vaccines?
In fact, barcodes are included on the labels of some vaccines sold in industrialized countries. Without information systems and hardware in developing-country immunization programs to scan and use barcode information and without a global barcode standard to follow for vaccine products, the application of barcodes on vaccine products destined for developing countries is happening much more gradually.
The need for global barcode standards
Global standards make it easier to correctly implement and interpret barcodes coming from any number of suppliers in different countries of origin. In the absence of global standards, the national regulatory agencies of individual countries are forced to manage multiple different standards on different products or to come up with their own standard which leads to barcode information that is not compatible with systems in other locations.
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GS1 is a nonprofit entity leading the design and development of global standards for supply and demand chains, and their standard appears to be emerging as the leading global solution for product information. Their standard product numbering schema, called the Global Trade Item Number®, identifies the manufacturer and product. From there, depending on the type of barcode used, it is likely that vaccine lot numbers and/or expiry dates would be included in the barcode, and in higher-capacity barcodes perhaps other data as well. Most importantly, using a global standard identification barcode allows different countries and entities to link the product to a record in a product database containing all the information they need and ensures that the identification number will be unique.
Obtaining global agreement on a standard for the type of information that should be included, the type and format of barcode to use (one dimensional versus two dimensional), and the levels of packaging on which it should be included is a difficult but critical hurdle to overcome before a really useful system of barcoding for vaccines can be adopted.
Because most vaccines destined for low-income countries are prequalified by the World Health Organization and procured through the United Nations Children’s Fund, these organizations have a powerful role to play in proposing a global standard for barcodes on all public-sector vaccines. The Vaccine Presentation and Packaging Advisory Group of the World Health Organization has initiated a discussion around the concept of primary-label barcodes and is gathering information from regulatory agencies for guidance, including the United States Center for Disease Control and Prevention. The additional complexity of placing a barcode on primary labels is the limited amount of available label space and the need for specific placement to compensate for vial curvature for some code formats. The goal is to contribute to the current global discussion on barcodes for vaccines and ensure that the anticipated needs of developing countries are considered alongside the needs of industrialized countries.
Country readiness for barcodes
Another major hurdle is the fact that most developing countries are not yet ready for barcodes on vaccines. Existing information management systems in most countries are not equipped to take full advantage of the added value and benefits of barcodes. Many countries are starting to build more sophisticated systems within their immunization programs as an increasing number of cost-effective software and hardware solutions are becoming available along with technical capability to support implementation and long-term management. In the short term, however, demand for vaccine barcodes in developing countries is still quite low.
A handful of countries have begun to demonstrate the value of barcodes on vaccines. For example, Health Canada is in the process of adopting GS1 standards for vaccine product identification and recently recommended piloting a two-dimensional format with information on lot number and expiry dates on both primary and secondary packaging. This effort will make it possible for Health Canada to develop complete electronic health records, reduce immunization errors, improve inventory management and forecasting, and maintain more accurate immunization coverage rates.
If a similar effort was successfully deployed in developing countries, barcodes could also help facilitate lot recalls, allowing the health system to identify specific children that were vaccinated with a particular lot and determine where leftover stock is sitting. Barcodes linked to a database could also be used to provide relevant information about the vaccine, proper administration, and safety warnings in local languages to users. All of this is possible with barcodes but only if the necessary systems and infrastructure are in place and functional enough to support proper use.
Over the next decade, as more and more developing-country governments become interested and are ready to implement barcode tracking systems in their immunization systems, it will be critical for vaccine products with barcodes to be ready in the public-sector supply chain. For this to happen, both global- and national-level decision-makers can take positive steps toward a future where barcodes are an essential component of vaccination programs.
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