Neither the Drug Supply Chain Security Act (DSCSA) in the United States, nor the Falsified Medicines Directive (FMD) in the European Union explicitly mandates the capture or use of aggregation data (see “Aggregation –> Chargeback Accuracy –> ROI” and “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary“). In this instance, “aggregation data” is data that documents the serialized packaging containment hierarchy of drug products—also known as “parent-child relationships”. It is well established that companies are not required by law to capture it, but for the smooth operation of pharma supply chains under a serialization, tracing and/or verification regulation, high quality aggregation data will be necessary. But there are warning signs that a significant percentage of drug manufacturers are not going to meet that bar by the deadlines.
The Healthcare Distribution Alliance (HDA) published a report last fall with industry readiness data they collected earlier in 2017. One of the questions they asked drug manufacturers was:
“Is your company planning to aggregate-data (unit to case)?”
Seventy percent of the respondents said they planned to have aggregation data by November 27 of 2018.
About the same time as the HDA survey, GS1 Ireland and Enterprise System Partners (ESP) conducted a similar survey to assess the readiness of drug manufacturers for meeting the FMD. In their survey they asked:
“Do you plan to include aggregation as part of your strategy for EU FMD?”
Only 56% of their respondents said ‘Yes’. Considering the volume of product in both of these supply chains, these percentages are not encouraging. Neither survey asked if the aggregation data would be collected manually, or with some kind of automation.
It isn’t enough to just capture aggregation data manually, using hand-held barcode readers. To achieve aggregation data with enough accuracy to make it usable, you have to have at least some automation assistance (see “Pharma Aggregation: How Companies Are Achieving Perfection Today“). Pharmaceutical machine-builders have been offering cost-effective, manual, automation-assisted packing stations specifically for capturing high quality aggregation data for several years now, so there’s really no excuse anymore for using fully manual methods. For higher volume products, a fully automated solution may be necessary.
If you are capturing aggregation data using hand-held barcode readers for anything other than a few cases-worth of product, you might as well not bother. When downstream wholesale distributors and large dispensers receive your aggregation data, they will use it for various purposes. In the US, that includes saleable returns verification, and they will pass your data on to their customer for their use when they sell full-case quantities. In 2023, aggregation data accuracy will be even more critical in the US.
Next year in the EU your aggregation data will be used to mass verify and decommission full case, full pallet and maybe even full shipment quantities whenever drugs are exported, converted to samples, stolen or damaged (see “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary“). Hospitals and pharmacy chains in the EU may use your aggregation data to verify and decommission everything in all of their incoming shipments, to avoid having to verify/decommission at the time of dispense. Although, admittedly, if everything gets decommissioned via aggregation data, and nothing is actually scanned and decommissioned at dispensed, then these problems will go undetected. But then, what’s the point of a Point of Dispense (PoD) authentication regulation? It’s certainly not patient safety if everyone does mass decommissioning for everything!
If your data accuracy doesn’t approach six sigma, customer service problems may arise daily. Aggregation-triggered problems will prove to be very complex to resolve. Odds are, you will be forced to take good product back and destroy it because its serial number(s) is(are) not accurately reflected in your aggregation data. Your costs for resolving these problems over time could exceed the cost to install aggregation data capture automation in the first place.
Aggregation data is the only thing that will ease the burden of compliance for downstream trading partners in a serialized world. But if the data is not consistently accurate, aggregation data will become a curse for everyone and the Achille’s Heel of supply chain operation. If you are not planning to collect it, or you plan to collect it manually without automation assistance, I urge you to reconsider.
11 thoughts on “Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation”
It may be too late for regulatory agencies to demand aggregation as part of the milestones leading towards 2023. I wonder whether (all of?) the nodes of the supply chain will choose to demand aggregation as part of their Quality Agreements. It would be a work-around to the actual regulations.
That would be a good idea, but they should do that sooner rather than later. Adding aggregation capability to a single packaging line takes some thought and some time, even when it is only semi-automated.
Some of us have been preaching the same song for some time to as many companies as possible. Some have listened.
Exactly. Keep up the great work you’ve been doing.
Thanks for this Dirk.
Timely. There are many packaging lines serialized, but not yet aggregated.
You make a valid point about the necessity of aggregation data being consistently accurate.
This secure and reliable aggregation has been a centralized part of Omega Design’s end-of-line semi-automatic case aggregation modules all along. This design keeps the operator on a mission to properly aggregate all cases. Unless the case is securely aggregated, the case cannot be sealed. The “system” will not allow it.
This ensures that only secure and reliably aggregated cases leave the packaging line … and move into the supply chain and to valuable trading partners.
This is important. And it alleviates the chance for the aggregation becoming the “Achilles Heel” that you so accurately warn about.
There are proven solutions.
Dirk – thanks for the essay. Yes, we have been bringing this message of aggregaton accuracy for some time. I would go further though- it’s not enough to have an automated aggregation line – you need six sigma accuracy on the entire information chain that manages serialization data. This includes the internal data management system, how you interface with 3PLs, how you manage exceptions, etc. One weak area and you will have trouble that is very tough to unravel. Proactive companies will come out ahead in this regard.
I agree with you. And with the advent of serialization, companies are going to find that it will be inefficient to skimp on solutions like aggregation and internal data management systems. In the end, inefficiency equals lower quality and therefore, lower profits.
I think today’s semi-automatic case aggregation systems are particularly well designed and well worth the costs.
I agree Dirk with your comments!
I always find the conversation interesting when we talk about the downstream trading partners demanding aggregation. Especially when it is between a manufacturer and drug wholesaler.
The law requires that a manufacturer provide a list of serial numbers in the TI; effectively give me a list of SNs for all units and cases that are shipped to a customer.
I make the argument that, without aggregation, there’s a larger burden on the manufacturer, selling full cases, to open every homogeneous case & scan each and every individual unit.
Depending on the distribution model, 80-90% of ABC’s receipts are full cases and only 5-10% of our sales are full cases. When you look at it that way.. I’d say a manufacturer’s own distribution center or 3PL should be demanding aggregation!
All that said, I hope we don’t wait until 2023 to start upgrading non-aggregated lines… we have enough to figure out by then and we should tackle what’s known.
Well said Matt. I would only clarify your comment about the law in your second paragraph. You are referring to what the DSCSA says for after November 27, 2023. I share your hope that drug manufacturers not wait until then to offer aggregation to their customers. When do you think wholesale distributors will offer aggregation data for their shipments to their customers? November 2023 or earlier than that?
Comments are closed.