Global pharmaceutical serialization mandates are largely driven by the need for a protected supply chain. Meaning no counterfeit product enters the supply chain, nor legitimate product is diverted from its intended destination. There are other intended benefits, such as expedited recall facilitation, better supply chain visibility and enhanced product tracking.
Serialization, however, is actually more about compliance at this point for most manufacturers. Packages need to be designed and implemented to accommodate the serialized data and barcodes. Serialization equipment and number management systems need to be installed and validated on packaging lines. Data needs to be integrated between enterprise, serialization, warehousing, channel partner and government systems. Serialization is a big project, with big capital equipment and labor investments and defined target dates for completion. With many equating “target” date with “end” date for the serialization “issue.”
In the United States, the Drug Supply Chain Security Act (DSCSA) serialization and tracing requirements go live for manufacturers this November. The DSCSA requires that every prescription drug package and homogeneous case have its own unique identifier in machine and human readable forms. The machine-readable form must be a 2D Datamatrix barcode that contains the following:
• National Drug Code
• Serial number
• Batch number
• Expiration date
Over and beyond packaging and serial number management, once the DSCSA is live, companies need to:
- Start responding to requests to verify drugs at the serial number level (this is new as soon as enforcement of the serialization requirement begins). DSCSA ‘Verification’ should not be confused with ‘barcode verification’, a distinctly different process;
- Retain records of serial number application to their drugs for six years, and be prepared to respond to requests for information to support investigations by state and federal agencies;
- Continue sending the same transaction documents (TI, TH, TS) to their customers, as they have been since 2015.
If a new or old manufacturer wants to introduce a new drug moving forward, these serialization requirements will be necessary Day 1 upon product introduction. If you work with Contract Manufacturers and/or Contract Packagers, it is still the brand’s responsibility to ensure compliance. They can certainly help, but brands need to own compliance.
Some key dates to be sure you are aware of:
- November 27, 2018: Item-level serialization mandated
- November 27, 2019: Wholesalers must buy/sell serialized drugs. Repackagers must serialize drugs
- November 27, 2020: Dispensers must buy/sell only serialized drugs
- November 27, 2023: Full enhanced drug distribution security in effect, unit-level traceability mandated.
With each new deadline, the DSCSA gets closer to its promise of a safer supply chain, while allowing investments to be spread across multiple budget cycles. Transaction data must be stored and retrievable for six years. The progress of time brings more information shared between trading partners and shorter response times when investigations are necessary. Finally, on November 27, 2023, the full “Enhanced Drug Distribution Security” vision will be in effect.
Meeting the DSCSA requirement is challenging for many pharmaceutical companies, particularly virtual pharma companies, who rely on contract manufacturing organizations (CMOs) and contract packaging organizations (CPOs). For some CMOs, getting serialized can be exponentially more difficult, as they need to consider each of their customers’ diverse set of requirements. This may involve great complexity in planning and implementation
How do we get there? Make this a repeatable process.
Whether you have one packaging line or 100, the basics of holistic project management will make this ongoing serialization project trouble free. This all begins with requirements gathering.
With the aforementioned deadlines coming our way, it may be appealing to just try to get this stuff done, and jump into a project running. Diving into a project like this without doing the proper amount of requirements gathering and analysis will set the project up for failure. Defects discovered in the requirements gathering phases of a project cost anywhere to from 50 to 100 times less to fix than defects that are found closer to rollout.
As projects move along, the cost to change increases dramatically as you get deeper in. Having the right stakeholders involved can help discover these design defects much earlier in the project – enabling the cost to fix them to be acceptable. Given the necessary validation of pharmaceutical solutions, fixing defects after validation (which would require a re-validation) is simply unacceptable.
Measure twice, cut once
Equally important to comprehensive requirements gathering is testing. We cannot emphasize enough to not cut corners when it comes to the testing phases of a serialization project rollout.
FAT (Factory Acceptance Tests) is an inspection that includes both static and dynamic exhaustive testing of systems or major system components to support the qualification a serialization system. The tests must verify that all functionality detailed in the User Requirements Specification (URS) is embodied and performs as specified. It is usually written by the manufacturers and executed by the client or client representative.
SAT (Site Acceptance Tests) is related to the FAT and also entails inspection and dynamic testing of systems or major system components to support the qualification of the serialization solution. This is written by the client and verifies that the installed functionality of the equipment meets or exceeds the operational requirements as specified in the equipment URS. The SAT is executed on completion of all commissioning tasks; but prior to the start of “go-live” execution.
Proper project time must be devoted to adequately performing FAT and SAT validations, and ensuring a compliant serialization implementation.
Stakeholders are critical. It takes a village
To be truly repeatable in a project, the necessary stakeholders associated with the project must be involved early on. Packaging, Legal, Marketing, Supply Chain, IT and Serialization Leads all have a “stake” in getting projects successfully to completion. NOT involving the right stakeholders is more dangerous and adds more risk to the project then bringing in too many possible stakeholders.
The serialization project sponsor will get the budget for the effort, and select the cross-functional project team assigned to get the project done. Organizations would be best served assigning a dedicated Serialization Project Lead to push the cross-functional effort forward. It is imperative for this team to truly represent the critical stakeholders involved.
Establishing the right project team is equally important to determining the proper requirements for the end solution. The requirements will never be implemented properly without the right team in place.
Is serialization enough? Probably not for global protection
The sad reality is that the counterfeit and gray markets for pharmaceuticals is far too lucrative for the issues to just stop with the onset of serialization. Several published studies state that the annual global trade in counterfeit medicines is approaching $200 billion. In an article titled “Keeping it Real – The Fight Against Fake Drugs”, an incredible example is given that shows that pharmaceutical counterfeiting is not going away anytime soon:
Did you know making counterfeit Viagra is up to 2,000 times more profitable than dealing hard drugs? In fact, a $1,000 investment in counterfeit prescription drugs can result in a $30,000 return, which is 10 times the profit rate of trafficking heroin. Pharmaceuticals are in high demand, and the punishment for fake pharmaceutical dealing is lower than for narcotics. It is no wonder the market for counterfeit pharmaceuticals continues to grow larger than many realize.
Serialization was introduced by governments as a mechanism to protect the pharmaceutical supply chain, as shown in the example just given. Whether it actually will, is up for debate. There is little doubt that serializing each and every salable unit of medications will be a good thing overall, however. But will it truly end counterfeiting and supply chain diversion? That answer is likely “no”. But is there a way to leverage this significant investment for greater value and protection?
Why doesn’t serialization work for product safety?
Serialized barcodes are easily copied. There is comprehensive data contained in serialized 2D barcodes, and when scanned can be utilized to find much more pertinent product information. Unfortunately, counterfeited products with a replicated barcode read the same and provide the same information as the legitimate item.
Additive and overt mechanisms like foils, seals and holograms are also easily available to the counterfeiter. With the profit margins seen in the counterfeit industry, along with the innovations and cost reductions in commercial printing technology, counterfeiters can spare no expense when it comes to making their illegitimate product look legitimate.
Authentication and Blockchain
One emerging method to ensure serialization programs truly meet supply chain safety goals is to utilize Blockchain.
Blockchain is the foundation for cryptocurrency like Bitcoin. It provides an immutable ledger which can manage and record the state, ownership, transfer, location, time stamping and other associated item and movement details. Having every event and transaction securely logged and managed for an item provides exactly what the supply chain needs for comprehensive safety. Nothing gets removed or edited from the ledger, any new information is added to the blockchain.
Blockchain is a completely digital platform. The supply chain exists in the physical world. Where shall the two meet?
We need to find a way to connect the previously unconnected pharmaceutical package to the connected world to take advantage of Blockchain.
The answer may lie in leveraging the existing investment pharmaceuticals have made in serialization. To derive from existing 2D serialized barcodes on packages unique identifiers (e-Fingerprints) that can be used for item authentication. Printing is a dynamic process. There are environmental factors such as line speed, humidity and substrate that create micro-differentiations in printed output. For example, you may have one million of the same printed UPC barcode on a product. With Systech’s UniSecure e-Fingerprinting solution, you can individually identify each and every product uniquely.
In pharma, you do have uniquely identified serialized products. But deriving an e-Fingerprint® with UniSecure creates a digital “signature” that can be leveraged to create trusted authenticity and protection from copied or fabricated 2D barcodes.
This solution will then leverage the power of smartphones and mobile networks to image these barcodes wherever the package is around the globe, and be able to authenticate that product immediately, connecting the product just like IoT examples. The non-additive nature of the technology also represents a substantial cost saving on capital purchase, artwork redesign and change management to additive solutions like RFID.
But wouldn’t you have to then authenticate each and every item individually throughout the supply chain? Obviously, that would not be a scalable solution. Pharmaceuticals could mirror what many are already doing with serialized product—leverage aggregation. Individual e-Fingerprinted items would be placed and scanned into a case, which would also be e-Fingerprinted. Multiple cases would be packed onto a pallet, which would also be e-Fingerprinted. One authenticated scan on the pallet label would be an authentication event for all cases and eaches on the pallet. This makes supply chain authentication simple.
So now we have a way to uniquely authenticate and trust the pharmaceutical package, without having to add anything to the package at all. Where does Blockchain fit in?
First and foremost, there are public and private blockchain networks. The most famous public blockchain based networks are cryptocurrency like Bitcoin. For the supply chain, we would likely use a private blockchain. In a private blockchain, all parties are not only known, but they are specifically invited to join. Unauthorized parties are simply not invited. When an entity is approved to join the private blockchain network they are granted a private key, that they control, and it represents them on the network for posting and unlocking transactions. This is another barrier for gray market infiltration or diversion, as all the players and assets are known in the blockchain.
Next, the very things that are necessary for safety and honesty in the supply chain are delivered by blockchain. Blockchain provides consensus—there can be no dispute in the chain regarding transactions because all participants on the chain agree to the same version of the ledger. Everyone on the blockchain can see the chain of ownership for drugs on the blockchain. Records on the blockchain cannot be erased which is critical for a secure and safe supply chain. Blockchain provides attestation—there is no dispute in the chain regarding the ownership, or the integrity, of the data.
For blockchain to work credibly to create safety and brand protection in the supply chain, we don’t just need assurance that the item is authentic, but a seamless and direct digital connectivity path for that product’s data. Connect to protect. Leveraging the existing 2D serialized barcode to read the product’s authenticated digital e-Fingerprint solves both those issues.
With its encryption, immutability and peer-to-peer visibility, blockchain provide a strong system to create and manage digital identity. Combining bulletproof digital identity with authenticated and trusted physical product identity makes the use of blockchain not only a revolutionary but essential resource in the fight for pharmaceutical supply chain safety.
Certainly we are advocating and know manufacturers are working hard to ensure compliance by this November’s serialization deadlines here in the US. However, it makes sense for manufacturers to think about leveraging this significant investment in serialization to do more.
About the author
Steve Tallant is Director Product Management and Marketing, at Systech International.