An Introduction to RAIN RFID Numbering Systems for the Pharmaceutical Industry
RAIN RFID encodings and numbering systems are complex and challenging in today’s pharmaceutical environments. As an industry leader in the RFID space, it’s our goal to shed light on this to help you better understand what you need to know, as we did in a recent blog about understanding ISO-based RFID encodings.
In today’s blog — the first in a series — our RFID Subject Matter Expert, Chris Brown, will look at numbering systems for use in the pharmaceutical industry and present an overview of the current situation. The general, pressing issue we are addressing is the familiar question: “What data should I encode to my tags?” Brown will present many key considerations, and also pose several unresolved questions. Despite several unresolved issues and questions, this article should expand your understanding of RAIN RFID numbering systems and encourage you knowing that various workgroups composed of informed experts are making progress on these questions.
7 Critical Considerations for Pharma RAIN RFID Numbering Systems
Here we will take a look at some of the issues that need to be considered and outline the critical considerations for RAIN RFID numbering systems in the pharmaceutical industry. In future blogs, we will go into more detail on which numbering systems are currently in use, the pros and cons of each, GS1’s role in the discussions, and finally where we may be headed in the future.
Let’s dig into some of the key issues that need to be considered.
- What is being tagged: First up is the issue of what are we trying to tag? What packaging level are we dealing with? The pharmaceutical industry and its stakeholders need to track items at various packaging levels. They work with packaging such as the “unit of use,” “unit of sale,” “logistics units,” and possibly other packaging levels we have not come across yet. Each packaging level is intertwined with its own applications, requirements, and stakeholders.
- Who is performing the tagging: Next comes the issue of who is doing the tagging and where? In a Utopian world many years from now, perhaps all pharma products will be tagged directly at the manufacturer, so-called “source tagging.” But in today’s world, only a small percentage of pharmaceutical products are tagged at the source. Currently, logistics entities, distributors, and end-users are also tagging products. Should they use different numbering systems? Can they all use the same numbering system?
- Regulatory bodies: Which regulatory authorities need to be considered? In the United States, the FDA and U.S. government requirements need to be considered. In Europe, the situation is even more complex with regulations both at the EU level (the EMA) and national levels. Of course, there are many additional jurisdictions outside of the U.S. and EU which can be relevant. And we must consider whether products need to be tagged for multiple jurisdictions.
- Security: Many pharmaceutical products are controlled or high-value substances. Security can be tackled at multiple levels and from multiple angles, but interoperable standards should be in place so that authorized stakeholders have access to needed data while unauthorized parties are locked out. Consider encrypted encodings, digital certificates and signatures, encrypted transmissions, “destructible” tags, etc.
- Sensor data: The rise of sensor chips is underway. These chips have either on-board sensors or a link to external sensors, and the sensor data can be captured and reported. For temperature-sensitive pharmaceutical products, sensor chips will probably play a key role in the future. Questions include, which sensor data should be captured? Where should the data be stored? How should the data be formatted?
- Technical considerations: We also have technical issues to consider. Which data elements should be stored directly on the chip versus in the Cloud or external database? Keep in mind that there are trade-offs in both directions. Will I need to efficiently read and filter large numbers of tags in moving or static populations? How much data I encode, in which memory banks, and with which data formatting all play a role in the technical feasibility of solutions.
- Affordability: And finally, there is a Catch 22 of what we want to encode versus what chips are commonly available on the market — and affordable. This issue cuts both ways because you want chips that support ideal encodings, but you also need to devise your encodings to support available, affordable chips.
As we stated at the beginning, for these key consideration areas we are dealing with many unanswered questions at this point. We hope these questions help you get your mental gears turning to think about your RAIN RFID numbering approach.
Stay tuned to our blog for our next post on this subject, where Brown will outline the numbering systems that are currently being used, the pros and cons of each, the issues of different numbering systems, and the issues of proprietary numbering systems.
You can also learn more about our RFID solutions on our website.