This article is the second instalment of a three-part Solidblog series written by Charles Young.
In my previous article I explained why QR Codes are the better choice for accessing electronic Patient Information, compared to Data Matrix barcodes. This is not controversial. It is easy to explain why this is the case, even though QR Codes are technically inferior to Data Matrix barcodes.
Data Matrix barcodes were designed principally for use in supply chain automation and electronic data interchange (EDI). QR Codes were designed to help consumers access information and services easily. All technical considerations serve to underline this difference in purpose, and all we need to do is to apply these different design philosophies to medicine safety in healthcare.
This illustrates the underlying reason for closely fought arguments in the field of medicine safety. Healthcare is fundamentally patient-orientated. However, it depends on a complex and highly regulated pharmaceutical supply chain to provide safe medicines on which patients rely. No wonder people argue about barcodes!
Let’s take a real-world example which is currently causing a lot of debate. Last year, a large and complex lower-middle income country introduced regulations requiring manufacturers of certain medicines to provide a means by which pharmacists, clinicians and patients can ‘verify’ packs digitally. Admittedly, the verification offers little protection against falsification. It simply allows users to access a defined set of attributes describing the medicinal product, the batch, and the license. Verification is not mandatory. There is no requirement to serialise packs and no mandated approach for barcoding.
The country has a large base of smaller, local pharmaceutical manufacturers. Some large global manufacturers would like to introduce verification based on unique pack identifiers. There is no regulatory barrier that prevents them from serialising packs today. They would naturally use Data Matrix barcodes and GS1 standards for this purpose. However, small manufacturers do not want to bear the additional costs of serialisation. Emphasising digital accessibility, they favour the use of QR Codes as a simple, cost effective and easily accessible means to direct patients to their websites where they can obtain the required information about the medicine pack.
Who is right? What is the best approach? Has the government missed a golden opportunity or wisely introduced a pragmatic stepping stone to support future evolution? Everyone has an opinion. The point is that the technical choices are not always clear-cut. A strong case can be made on both sides of this argument. The central issues are not technical, but commercial and regulatory, within the context of a specific national pharmaceutical landscape.
What we crave is a single and unique barcode on each pack that meets the broadest range of patient needs and regulatory requirements. We want that barcode to support verification and traceability of medicines within the supply chain. We want patients to use the same barcode to obtain safety information. We want the barcode to be cheap to produce, easy to use, widely accessible, compact, reliable, and flexible.
Unfortunately, we cannot always have what we want. No single barcode approach can fully meet all these requirements, and this is unlikely to change. Let’s look a little deeper at the issue.
Every time you scan a barcode, you embark on a journey from the barcode itself to the end-result of the scan. First, the barcode scanner decodes the pattern of dots or bars to obtain the ‘raw’ data. Then, it processes this data to check it has been read correctly. It then converts the data into the form that the barcode scanner transmits to your computer. Data Matrix barcodes support a wide range of technical options for this purpose. End users are not aware of this level of detail. QR Codes are technically simpler, but again, this is not obvious, except in terms of the size.
Once the scanner has completed its work and transmitted the processed data to your computer, the data is handled by a software application.
There are many possibilities at this stage, but let us consider some representative scenarios:
QR Codes and Data Matrix codes are broadly equivalent in terms of the data they can contain. They can be used in all the above scenarios and many more. The issue here is not the type of barcode, but the software we use and the actions we perform on the barcode data.
The reason QR Codes are better than Data Matrix barcodes for electronic Patient Information is that most smartphone camera applications are designed to scan QR Codes, detect if they contain a URL and, if so, display the website content to the end-user. They don’t support Data Matrix barcodes.
Could camera apps be extended to read Data Matrix barcodes? Yes. Could Data Matrix barcodes be used to provide URLs? Certainly, and the representation would be more compact and more reliable than for QR Codes. However, QR Codes have ‘won’ this battle. There is no incentive for software developers to extend camera apps in this way.
Within the pharmaceutical supply chain, we are often more interested in storing data records in the barcode. Consider verification of the authenticity of individual packs. We are interested in checking that the data printed by the manufacturer in the barcode, exactly matches a record that the manufacturer lodged electronically within a trustworthy on-line repository. The last thing we need is for the manufacturer to place a URL for the data repository within the barcode! In that case, anyone manufacturing falsified medicines could use the barcode to direct you to their own repository to falsely ‘authenticate’ the falsified product.
This illustrates the heart of the issue when considering a single barcode to meet the broadest range of requirements. The really important issue is not about barcode types or data representation. It is about the trustworthiness of the on-line services that support the actions we perform on scanned data. For electronic patient information, we can reasonably assume that the manufacturer provides the correct URL in the barcode to obtain up-to-date patient information. We trust the service specified by the URL. This is quite different to the example of verification provided above. In that case, we must not trust any URL provided by the manufacturer. We need access to an independent source of truth to verify the authenticity of the pack.
Of course, a medicine pack could be falsified. In that case, we must first verify the pack against an independent source of truth before we can trust the URL provided by the manufacturer to obtain patient information.
We could combine the data required for verification and the data required to access electronic patient information into a single barcode. Unfortunately, if we do this, not only does the barcode rapidly grow in size (a major problem for pharmaceutical packaging and reliable scanning), but we also lose the ability to scan the barcode using current smartphone camera apps. Those apps were not written specifically for the healthcare industry. They only understand URLs, and they expect QR Codes to contain URLs, only.
We could campaign to introduce wide support by smartphone camera apps for some standard that represents different data for different purposes within a single barcode. If that standard specified a URL field, camera apps could read that data field and use it to access on-line data or services.
GS1 provides a global standard for representing data records in barcodes. Their standard provides an ‘application’ (a combination of a data field identifier and a value) to support ‘extended packaging’. The idea is that this application provides a baseline URL which you combine with the product code, also stored in the barcode, to access a website for more information. Unfortunately, this approach is not very flexible and is not widely used. In any case, placing a URL in the barcode makes it significantly larger, which can cause problems. GS1 has recently announced that they will no longer support the use of the ‘extended packaging’ application in healthcare scenarios. Here is an example of a unique identifier barcode with extended packaging - the page does not exist, though!
What, then, is the way forward? The truth is that there isn’t a complete solution to the concept of a single barcode for multiple purposes in healthcare, but in the final article in this short series, we will discuss an approach which offers a partial solution.
European Commission Directorate-General for health and food safety see answer 2.12 and 2.16 GS1 General Specifications GS1 Standards in Healthcare QR Codes vs. Data Matrix for Patient Information
Solidsoft Reply is a leading technology company creating award-winning solutions utilising the Microsoft Azure cloud platform. As a globally acclaimed Microsoft AI Cloud Solutions Partner, we specialise in GS1 traceability systems worldwide, crucially ensuring the authenticity, legality, and safety of our customers’ products and services. Serving non-profits, NGOs, healthcare, and the pharmaceutical industries, we deliver technology for positive social impact. Your products, safe in our hands.