One of the biggest challenges for companies in the U.S. pharmaceutical supply chain when the California pedigree law becomes operational after December 31, 2014 will be the need to maximize the efficiency of dealing with serial numbers on each drug package. One way to do that is to maximize the use of “inference” where the case serial number is read and the unit package-level serial numbers are “inferred” from the unit-to-case aggregation information supplied by the upstream trading partner (See my essays “Inference in the Pharmaceutical Supply Chain” and “Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!”).
But the problem with the use of inference is that you need to be able to rely on the accuracy of the aggregation information that your supplier provides to you. There is an element of trust in that—not just that you trust your supplier to be truthful with you but that you trust that your supplier’s case packing processes and systems will always accurately capture and document the unit-to-case hierarchy—or “aggregation”. You must be able to trust that the aggregation information your supplier provides to you will be 100% accurate. That’s a lot of trust.
If you trust that the aggregation information you were given by your supplier is 100% accurate, then you don’t need to take the time to explicitly read every unit package-level serial number on every unit packed inside each case. Instead, all you need to do is read the one serial number on the outside of each case. You would use that serial number to find the unit package serial numbers of all of the unit packages inside each case and then update the ePedigrees for those packages. Remember, ePedigrees are not maintained at the case-level, they are maintained at the unit package-level.
Inference saves time and physical system operation—especially if the serial numbers attached to each unit package are encoded in 2D barcodes, which appears to be the direction most pharma manufacturers are going for serialization for California (see my essay “RFID is DEAD…at Unit-Level in Pharma”).
Without the use of inference, companies would have to open every single case of pharmaceuticals they receive or ship, pull the contents out, scan the serial numbers on each package to capture exactly what they are receiving or shipping and then pack them all back up again and reseal the case. With the massive volume of drugs that pass through the large companies in the U.S. supply chain today, this would slow the movement of drugs and would cause distribution costs to skyrocket, not to mention opening the door to the introduction of new errors and theft (thus actually lowering the security of drugs in the supply chain).
The use of inference is critical to the successful operation of serialized drug ePedigree laws.
HOW INFERENCE WORKS
Manufacturers generally pack their serialized unit packages of drugs into shipping cases—themselves serialized—shortly after the packages are produced. That way they can stock them in their own distribution centers before they are shipped to their customers. When they ship cases of drugs to their customers they won’t want to open the cases either so even they would need to rely on their own unit-to-case aggregations to infer the unit serial number so they can create the unit-level ePedigrees at the time of shipment.
After drug distributors receive the cases from the manufacturer’s distribution center they open most cases and fulfill their customer orders by packing small quantities of unit packages in totes for delivery. Once the manufacturer’s case is opened by the distributor and individual packages are removed the case-level aggregation information is no longer needed. The distributor would typically read the unit-level serial numbers on each package as they are fulfilling customer orders and update the ePedigrees to reflect the shipment to the customer.
However, some customers order in quantities large enough for the distributor to simply deliver one or more entire cases of a drug. In that instance, the distributor doesn’t need to open the manufacturer’s case and so they would rely on the manufacturer’s aggregation information to know exactly which unit package serial numbers are being shipped to their customer and so that they can update and pass the correct unit-level ePedigrees to their customer. The distributor would pass on the manufacturer-supplied aggregation information to their customer for the cases that were shipped, along with the ePedigrees for the packages contained within them.
Since the distributor’s customer will also want to receive their shipment as efficiently as possible, they will likely make use of the aggregation information to update the ePedigrees that they received from the distributor so that they do not have to open every case and read the serial numbers on every package inside them.
Notice that in this scenario, the manufacturer distribution center, the distributor and the distributor’s customer are all relying on the accuracy of the aggregation information that was originally captured by the manufacturer at the time that the drug packages were packed into the cases.
BUT WHAT HAPPENS IF AGGREGATION INFORMATION IS NOT ACCURATE?
If the aggregation information is perfect every time, no problems ensue. But what if the information is incorrectly crossed between two cases? That is, the unit package-level serial numbers are attributed to the case serial number of a case that actually contains the serialized packages of another case, and vice versa. And now assume that one (not both) of those cases is received by the distributor’s customer in the example above.
In that instance, once the customer eventually opens the case and reads the serial numbers on the packages they will find that they do not have any record of those serial numbers, and they will not have a valid ePedigree for those packages. Without a valid ePedigree the drugs cannot be sold, returned or dispensed in California after the regulation goes into effect so these drugs cannot be used until the discrepancy is fixed.
And the same problem will occur at whatever company received the other case that was involved in the error. Both companies will need to work backward through their supplier until someone reaches the manufacturer where the error may be solvable. If the manufacturer agrees that a mistake has been made, they may be able to transmit the corrected ePedigrees to the distributor, who may then be able to update those updated ePedigrees to reflect their corrected shipment and pass it on to their customer who would then have to update the corrected ePedigree and thus finally allowing the customer to sell, return or dispense the drugs.
That’s a lot of very inefficient customer service interaction and in the mean time the drugs must sit on the shelf unusable. I hope you can see that for inference to work, there is a lot of reliance being placed on the accuracy of the aggregation information generated by the manufacturer.
IS IT EVEN POSSIBLE TO GENERATE 100% ACCURATE AGGREGATION INFORMATION?
Yes, it is possible. The way to always generate 100% accurate aggregation information is to use a special approach to the case packing operation. The key is to read the unit-level serial numbers only after the packages are bound together in a serialized grouping (inner-pack or full case grouping).
This is easy to do when the drug packages are serialized with RFID. Each drug package would have a unique RFID tag attached to it and the case packing operation can be done in any way that it is today—nothing special…no changes.
Then, after the cases are sealed and an RFID tag containing the case-level serial number is attached, the case would be run through an RFID reader where all of the unit-level serial numbers and the case-level serial number would be read and associated with each other to form the aggregation information for that case. Since the cases are already sealed, there is no chance of a mix-up of the contents between two cases, or some other discrepancy. If the RFID reader doesn’t pick up all of the expected serial numbers the case would be rejected for quality inspection and rework.
The reason this works is that RFID doesn’t require a “line-of-sight” to work. That is, the RFID reader can read directly through the cardboard case material and pickup all of the tags in a short time.
But, remember, I pointed out above that few, if any, companies are likely to put their unit package-level serial numbers into RFID tags and instead the vast majority of drugs will be serialized using 2D barcodes. Barcodes require “line-of-sight” to work. So how do you read the unit-level serial numbers only after the packages are bound together (remember, that’s the key to 100% accurate aggregation information) when the labels that contain the 2D barcode are on the side of the bottles? Once you bundle them together many of these labels will be covered and so the barcodes are no longer within a single “line-of-sight”.
A NEW IDEA SOLVES THE 100% ACCURACY WITH BARCODES DILEMMA
I don’t know who first thought of this idea, but the solution is out there and in use by multiple pharma manufacturers. It entails the use of a “temporary” 2D barcode that is inkjet printed onto the bottom of all empty bottles. This barcode contains a unique “bottle identification number”, or, bottle ID, that is unique for all of the bottles within the current batch of the drug being bottled. The purpose of this barcode is to keep track of the bottles within the packaging and case packing operation. I call the barcode “temporary” because it is only used within the packaging operation.
After the bottle ID barcode is printed on the bottom of each bottle the bottles are filled with the drug, capped and then the serialized drug label is applied. The drug label would have the unique serialized National Drug Code (sNDC) (and hopefully the drug lot and expiration date…see my essay “SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach”) encoded in a 2D GS1 DataMatrix barcode image.
Immediately following the label applicator is the traditional vision system camera that verifies that the barcode, lot and expiration date is readable. But in this new approach there would be a second camera that would simultaneously capture the bottom of the bottle to read the bottle ID barcode. The line management system would associate the sNDC in the DataMatrix barcode with the bottle ID. Since these two serial numbers are unique, the association is also unique.
Now the bottles can be bundled together into inner-packs that are wrapped in clear heat-shrink plastic film so that they are bound together in a single unit and an inner-pack serial number label applied to the top of the bundle. The sNDCs are not all visible, but the bottle ID on the bottoms of the bottles are all still visible. Because of the associations between the bottle IDs and the sNDCs, reading all of the bottle IDs in the bundle in a single image allows the line management system to know exactly which sNDCs are present in each bundle. Now the sNDCs of the bottles bound together in the inner-pack bundle can be reliably and accurately aggregated to the inner-pack serial number.
Multiple inner-packs can then be assembled into a case using an automated case packing machine that has 2D barcode imagers strategically placed to capture the inner-pack barcodes as they are being loaded into a pre- or simultaneously-serialized case. Now the case to inner-pack aggregation can be made accurately—100% of the time.
Again, the key to perfection is to capture the aggregation at each level only after the packages are already bound together.
WHERE CAN YOU BUY SYSTEMS THAT ARE BUILT AROUND THIS APPROACH?
In this essay I wanted to highlight the principle that allows RFID-based serial number aggregation to be so perfect, and which has recently been applied to 2D barcode-based serial number aggregation. I have not done an exhaustive search to find all of the system integrators or machine builders who offer systems based on this principle.
I am not promoting or recommending any specific company, but I will say that I first became aware of this approach being used in the pharma industry by actual pharma manufacturers who were using systems made by a collaboration of four companies known as 4Serialization (which includes Omega Design). I also know that Optel Vision has adopted the approach in systems. I would not be surprised if there were other companies using it (leave a comment below if you know of others). I have not worked with either of these organizations so I cannot vouch for the quality of their work.
Please do your own investigation before deciding which integrator is best for you. The Pharmapack trade show is coming up in May. That sounds like a great opportunity to talk with each vendor and find out what they’re capable of. Just make sure they are following this principle and your aggregations will be perfect every time!