Mission Critical: Aggregation Done Right

The Drug Supply Chain and Security Act requires electronic tracing of certain prescription drugs at the lot, unit and package levels by November 27, 2023. Image courtesy of Omega Design Corporation.

The Deadline is Approaching for Aggregation of Packed Prescription Pharma Products

By Chris Siegele, Sales & Marketing Specialist for Omega Design Corporation

Tick, tock. The countdown to November 2023 continues – and so far – the data isn’t encouraging.

With aggregation compliance deadlines per the U.S. Food and Drug Administration’s Drug Supply Chain and Security Act (DSCSA) less than a year away, it’s officially crunch time. We are fast approaching the point at which establishing parent-child relationships between units of prescription pharma packaging – such as cartons, bottles and vials– goes from an optional value-add to a mission-critical must.

By November 2023, the DSCSA will require electronic tracing of certain prescription drugs at the lot, unit and package levels. Ultimately, the FDA aims to create a secure supply chain where prescription drugs can be traced through every stage of the manufacturing and distribution process.

For many pharma brand owners and contract packagers, the result is something akin to a bad sequel. Often, the same folks who muddled through the decade-long process of incorporating unit-level serialization – the DSCSA’s initial hurdle – are now scrambling to aggregate. And like serialization before it, aggregation can be a tricky, trial-and-error process that requires fine-tuning lest it hamper the pace and flow of overall production.

The pharma industry is still ironing out aggregation’s wrinkles – and that’s putting it kindly. More than 25% of aggregation data coming into distributors during their aggregation pilot programs was found to be inaccurate.

Twenty-five percent. A full one-fourth. It’s a jarring figure, and hopefully it’s enough to wake us up. Because as an industry, we need to get this right or drugs will not reach consumers, will not save lives, and will not provide shareholders value.

When out of compliance, prescription drugs are more than a drag; they are utterly worthless. Without accurate aggregation data, your product’s value will go to zero after spending millions to create it. Was expected return on investment baking in a loss of a quarter of your product sales? Were your investors anticipating a 25% earnings shortfall?

Do we need to ask any more rhetorical questions before getting aggregation done right?

A simple upstream strategy – one that places codes where they will be visible to a camera after product packing – enables this secure aggregation method during case aggregation. Image courtesy of Omega Design Corporation.

Un-trackable is untraceable

Distributors have continued to be unified and clear in their messaging to trading partners, and cannot accept un-trackable prescription drugs.

The quantity of products passing through prominent distributors requires inferring the contents of a case or shipment from its label. If a label isn’t accurate, then the drugs’ path through the supply chain will be disrupted, delaying or even entirely denying their arrival at pharmacies, doctors’ offices and, of course, patients. Distributors require high integrity aggregation data to infer case contents with certainty.

The industry is improving the quality of data that accompanies valuable products in the supply chain. It’s been a process, and now we have some best practices to share.

The pack first, then inspect strategy

First and foremost, to achieve accurate data packagers need to design a data-oriented packing process. The most secure data-oriented processes create a pack first, then inspect its contents.  Such a ‘Pack First, Then Inspect’ strategy reduces risks and protects earnings.

Some companies will be able to afford expensive, fully automatic case packing solutions to automatically create aggregated cases. With full automation, fail-safes integrated into the machine design can catch insufficiently aggregated product before it leaves the facility.

The FDA aims to create a secure supply chain where prescription drugs can be traced through every stage of the manufacturing and distribution process. Image courtesy of Omega Design Corporation

However, nearly half of all packaging lines in the United States involve manual packing operations. By using semi-automatic technologies, it is possible to achieve aggregation compliance while maintaining manual case packaging operations. However, with manual operators an additional strategy is required to produce accurate data. This is done by placing them on an electronic path within the system itself.

A coordinated, back-and-forth exchange between operator and machine keeps products on an electronic path toward securely aggregated cases. This action-reaction process involves an operator initiating the packing cycle by preparing a case, the machine signaling the operator to begin packing, and the operator triggering a camera to read product codes. A case label is automatically applied, and a camera automatically triggered to maintain operational speed.

In the background, the contents in the case will be associated to the automatically applied case label code in the database. The data duet continues, with the machine confirming a case is complete and the operator pushing it through the sealer, sealing the product and the correct data along with it. Through a series of handoffs, then, the operator and machine produce the required result.

A simple upstream strategy – one that places codes where they will be visible to a camera after product packing – enables this secure aggregation method during case aggregation. Case packing is the last time you’ll see a code before your customers do. Do it the right way and keep product flowing forward through the supply chain.

The stakes are high to bridge the gap

Both the stakes and the gap to bridge are clear: distributors require perfect aggregation data, and the pharma industry is currently nowhere close to providing it. Pharma brand owners and contract packagers must do better – and quickly – to ensure neither business continuity nor patient health is compromised.

Luckily, whether packaging via fully automated or semi-automatic procedures, there are clear paths toward a workable aggregation strategy. Unsurprisingly, the delicate data dance aggregation requires is a little trickier with partially manual setups, but tried and true best practices are emerging that can help packagers comply with DSCSA without unacceptable equipment investment or production slowdown.

About the Author

Chris Siegele is Sales & Marketing Specialist for Omega Design Corporation, a global provider of innovative packaging solutions for the pharmaceutical, nutraceutical and consumer healthcare industries. The company specializes in the design, manufacture, service, and support of a broad range of container handling and packaging equipment systems, as well as coding, vision and case packing modules supporting serialization and aggregation. Learn more at  www.omegadesign.com.

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