When the Drug Quality and Security Act (DQSA) was passed in 2013, it mandated that full compliance with electronic data interoperability needed to be in place by 2023, enhancing and ensuring product serialization and traceability. Many of us involved in industry forums intended to help with the interpretation of the legislation, as well as what it would mean to implement a solution, thought – assumed, really – that a date so far off would inevitably mean that the requirements – if not the legislation itself – would be vastly different once that final milestone came about.
The example of the California Board of Pharmacies’ early effort to mandate the use of traceability for protecting medicinal product supply chains in that state came to mind: there had been several delays and postponements. Coupled with rapid changes in technology, it was easy to see the Board’s experience as an example of how difficult it would be to bring such a complex set of requirements to bear on an industry that – let’s face it – was not very enthusiastic about having to implement yet another complex capability in their supply chain. A capability that would inevitably impact the cost of goods sold.
That said: compliance with federal-level legislation makes its own business case, so we’ve seen and supported the work of the past nine years across the US supply chain – work that has gotten the US market close to fulfilling the vision of the DQSA.
DQSA in 2023
And while it may be to the surprise of many that the core objectives and mandates of the legislation remained essentially intact, the final milestone in the stipulated timeline for electronic product data exchange throughout the supply chain looms larger by the day: by late November 2023, every participant in the supply chain that serves to dispense medicinal products must be able to verify the authenticity of the product and be able to end the chain of custody for the serialized identifier affixed to it: for all intents and purposes, taking it “out of commission.”
That is a weighty responsibility for the vast group of retail pharmacies, physicians, specialty distributors, infusion clinics, etc. that become subject to DQSA on November 27, 2023, and it requires engaging with a complex technological exchange network that has no operational oversight from the FDA or any other US government agency.
Progress Towards the DQSA Deadline
Since 2013, there has been amazing progress made in the traceability solution market with Software as a Service (SaaS) offerings and mobile verification capabilities holding promise to reduce the burden (and cost) of enabling authentication down to the lowest salable unit.
But what of the burden of operational change on that vast network of participants, responsible under federal law for establishing the end state of a unique identifier? It was with that in mind that I asked my local pharmacist what she thought of the coming change, and if her national pharmacy chain had yet provided her with any preparation. Pat shared with a smile that she “… heard something about not needing to process replenishment orders manually anymore, that the numbers in the bar code would do that automatically …” She was unaware that the scanning action would allow her to confidently tell her customers that there was no risk that their prescriptions were anything other than what the doctor ordered. That it wasn’t tainted. That it wasn’t counterfeit.
And so, while that vision of serialization enabling “value beyond compliance” capabilities like automated inventory control is tantalizing, it can’t take shape without a solid foundation of dual capabilities: bullet-proof technical interoperability and informed engagement by thousands of participants.
There is reason for faith in the technical component. If Pat’s cheerful misunderstanding is an indicator, there is reason for worry on the human capital front. Without those both in place, there is more potential damage to the credibility of the US supply chain by false negative scans or commissioned serial numbers being retrieved from dumpsters by those with the intent – and capability – of putting those numbers on the packaging of any manner of adulterated product and selling them back into the supply chain.
At Clarkston, our team of serialization and traceability consultants remains deeply engaged with delivering brilliant serialization solution strategy, design, and implementation services to our clients, primarily around the technology and enterprise-level process requirements. But there is now also recognition that the most meaningful opportunity in the DQSA journey may also be the most challenging: making sure that Pat knows what it means when she scans that newly unboxed bottle of tablets, and how critical it is that she gets it right.
Those few feet from the delivery door out back to the dispensing desk up front will be the so-called Last Mile of DQSA, and they are the last and best chance to make good on the promise of the legislation.