As the November 2018 deadline for the next phase for the Drug Supply Chain Security Act (DSCSA) compliance approaches, many still find themselves facing significant hurdles when it comes to serialization. The Adents Serialization Innovation Summit in Philadelphia brought together industry experts to share the new technologies that are empowering life science companies to improve and perfect their track-and-trace solutions.
Some parts of the conversation sounded familiar—things like cold chain and thermal validation and the push toward digitalization are not new concepts. However, there was certainly fresh insight on these topics. And some things, like the concept of process simulation and the need for better transparency along the supply chain, all the way to the patient’s bedside generated some new interest.
Speakers from various stations along the pharmaceutical supply chain from software architects to those in distribution to end users showed up to present at the summit. Highlighting the different hands a drug will pass through on its way to a patient was appropriate at an event about serialization, particularly because, as the summit progressed, a trend calling for the breakdown of silos and communication barriers along the manufacturing and supply chain began to emerge.
Breaking Down Walls
The issue of transparency and communication began early in the program with Microsoft Health Business Leader Desmond Creary addressing some of the effects that the lack of transparency in the supply chain can have. He presented some startling numbers that demonstrate the severity of the industry’s counterfeit drug problem.
According to Creary, 15 percent of drugs on the market right now are thought to be counterfeit. Helping sustain that percentage most likely are some of the 50,000 online pharmacies, 95 percent of which are noncompliant with simple regulations.
The most startling figure that Creary presented was 700,000—the number of lives lost annually due to counterfeit drugs.
While those numbers might be surprising to many, a focus of the remaining talks, and in many ways the solution to this and other supply chain challenges, won’t be: digitalization.
Que the ever-present elephant in the room: blockchain. Tianna Umann, Microsoft software architect, explained how, when used within an already existing end-to-end solution, blockchain can improve communication by storing and sharing product transaction and check-point status along the manufacturing process and supply chain in a single, fixed ledger.
Using a sequence diagram for blockchain for transparency in the pharmaceutical supply chain, Umann explained that everyone involved in the transaction would have a copy of the blockchain ledger, and as the product goes from manufacturer to carrier one, to carrier two, and so on, it is validated each time it goes through new ownership via sensors that scan for certain properties.
As this happens, those with access to the ledger can see the product’s location and validation status according to properties in the ledger established by the manufacturer. All carriers and trading partners will be alerted immediately if the product violates any of the parameters put into place, allowing for quicker intervention.
A New Perspective
The mere fact that David Aguero and Dennis A. Tribble participated in the summit speaks to this trend of breaking down some of the significant communication barriers that plague the industry. Aguero, manager of systems and informatics at St. Jude Children’s Research Hospital and Tribble, director of healthcare industry operations at Becton Dickinson, both are pharmacists by trade, and their unique perspectives on the drug supply chain offered a crucial insight into some of its biggest challenges.
Both brought up the challenge of tracing in situations where patient doses are prepared in the pharmacy. Tribble commented, “Sometimes I make IVs. Now I’ve got a mixture going up to the patient care unit. Traceability at this point becomes very difficult, if not completely lost.”
Additionally, both pointed out that any serialization regulations on the agenda to take effect in November do not address track-and-trace within hospital walls. As Tribble said in his talk, the point of dispense “is where the iron curtain descends on the process.”
Compounding the issue of traceability once a product reaches a hospital, Tribble informed the audience that hospitals trade drugs amongst themselves, in a program called borrow-loan. “So, as a pharmacist, I become a packager and a labeler. Oh, and by the way,” he added, “there are no good laws to regulate how I repackage it.”
And why is traceability so important on the streets and in hospitals? According to Tribble, the current lack of traceability as a drug moves throughout a hospital can have serious consequences. While many hospitals scan barcodes and many patient-care units have automated medicine cabinets that will only dispense a certain drug if a patient’s electric medical record indicates it has been prescribed, there still are serious issues involving missing medication. Furthermore, it is a problem that is almost impossible to measure.
Caregivers who become addicts are very creative when it comes to stealing controlled substances. They will substitute the real medication with saline, preventing the patient who needs it from receiving their drug, and of course, contaminating the content, which in some cases has led to the spread of hepatitis C.
Tribble claims that only about 1 percent of the people at hospitals who take such illegal action ultimately are identified and found. He added that more still needs to be done and more tools need to be developed to meet the DSCSA standards of true traceability. Tribble ended his talk by saying, “We need to try to bring that level of traceability into the healthcare system so we can better manage our inventory.”
Aguero provided a real-life example of how hard it can be for a dispensary to find out crucial serialization information. When he noticed something that seemed slightly “off” about a nicotine patch, it took him an entire month to find out where this patch came from and why it didn’t look exactly like previous versions of the product. It turns out that a merger had taken place, resulting in a minor packaging change. In this case, the difference proved harmless, but unfortunately, these discrepancies, when overlooked, can lead to devastating results.
From audience reaction to the Aguero and Tribble presentations, it appears that manufacturers currently know little about the dispensing of medication, but at least the conversation about such drug visibility has begun, an important step that reminds us of what truly is at stake—the health and well-being of the patient.
Digitized Pharm: What’s Ahead
Taking the conversation a step further, process simulation will become the future of digitalization, according to Todd Lybrook, life science director at Siemens. Technology that enables an entire production process to be simulated digitally allows R&D and manufacturing to work collaboratively when developing a process flow and production line for a product, which is one key way to break down walls between R&D and manufacturing.
Sorin Haias, president and founder of Lives International, addressed serialization within the cold chain. Use of biologics requiring temperature regulation and other forms of stability already is increasing and can be expected to rise. As this happens, easier and more accurate ways of ensuring that the drug has not been compromised at each check point along the supply chain will be needed.
Haias’s company has developed data loggers and thermal validation systems that use Adents Prodigi to generate unique serial numbers. A tracker is then placed in the package with the product. When the tracker is scanned by each carrier, real-time property information is made accessible and notifications and alarms are sent to the user to indicate a compromised product.
Real-time trackers that use geo location have the potential to provide visibility and certainty in previously uncertain situations, such as the length of time a temperature-sensitive product remains in an unplugged container on an airport tarmac beneath the scorching sun.
The summit’s presenters offered those in attendance a lot to consider. During much of the summit, the feel of the room was a combination of excitement and concern—excitement about the new solutions and technologies that have been developed and are continuing to improve and evolve, and concern about the approaching DSCSA deadline and those areas of the supply chain that remain untouched by reliable and regulated serialization.
One thing that became increasingly clear is that many in the industry are looking for more than compliance. In fact, despite the pharma industry’s rocky past with regulatory agencies, many speakers expressed a desire for increased standardization and regulation in certain areas within manufacturing and the supply chain.
As the summit wrapped up, many were left feeling that there is a lot to look forward to in the field of serialization, and as November gets ever closer, we will begin to see how companies intend to utilize these solutions to improve manufacturing downtime, ROI, and most importantly, patient safety.