Blue Sphere Health

US drug serialization and traceability: not such a distant dream

The emergence of the Pharmaceutical Distribution Security Alliance (PDSA) as a growing force in the long running epedigree / track and trace / serialization saga was completed during a US Congressional hearing recently.  The whole hearing (which covered a variety of areas including Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain) can be heard again online but the highlights for our purposes are the opening presentation from Janet Woodcock of the Food and Drug Administration (FDA) and then “Panel III” on supply chain security from 2h 34m. The US industry consensus (manufacturers, distributors, pharmacists) is clearly aligning behind the PDSA suggestion (referred to as the “RxTEC proposal”) which calls for lot-level pedigree with unit-level pack coding.  This will entail mandatory peer-to-peer sharing of lot or batch information during the normal course of commerce, providing a lot-level transaction trail or pedigree as product moves through the supply chain.  Additionally, each individual pack will have a unique serial number which can be used for verification or other purposes but will not be part of the mandatory data set that must be passed during each transaction.  This avoids the need for many of the onerous, time-consuming and therefore expensive new processes that a full epedigree system would require.  For a fuller discussion of the various modes of traceability and their implications, see Dirk Rodgers’ excellent RxTrace blog. This hybrid model, which is either “pedigree-lite” or “serialization-plus” depending on your point of view,  has some key benefits. The first major advantage over previous attempts to implement traceability in pharma is that it is a pragmatic approach.  It is still a challenge but not an insurmountable one.  After years of meetings in Sacramento trying to persuade the California Board of Pharmacy to agree another stay of implementation of their pedigree requirement, this is a much more productive approach and probably the best shot at developing a federal solution that works. The second key step forward is that (unlike previous approaches) the RxTEC model seems to have the broad support of many of the stakeholders who will have to make it work (manufacturers, distributors and pharmacists). This gives it a fighting chance of actually happening. Thirdly, it is expandable to full pedigree as and when the capability or need is there.  Nothing in the PDSA proposition precludes a full epedigree environment in the future.  But if epedigree is like the Apollo programme, RxTEC is just taking the sensible step of testing components in Earth orbit first. Finally, global compatibility is made much easier by this new paradigm.  Blue Sphere Health does a lot of consultancy work with manufacturers on traceability in Europe, USA, India and elsewhere.  Our customers are wrestling with the problem of how to reconcile the needs of potential epedigree in the USA (because if you put systems in place for California, effectively you have to do it for your whole US supply chain) with the different system of end-to-end verification that is likely to be the model in Europe.  They also have to try to hit curve balls thrown by projects like the potential eTACT system being developed by the European Directorate on Quality of Medicines and the traceability systems in Brazil, Argentina, China, India etc. See for more on these stories. If the necessary legal language can be agreed and incorporated into the Prescription Drug User Fee Act  (PDUFA)  reauthorization process this year, which is the chosen tactic for rapid approval, then this lot-level system might happen soon (ie 2015).  It would replace the California law which has specific federal pre-emption clauses for this very purpose.  Anything which turns a state-level impasse into a pragmatic and achievable federal system deserves our backing.  Patient safety demands that we get this done. We specialize in advising clients on these issues.  Contact us for more details or email me personally at mark(dot)davison(at)bluespherehealth(dot)com.

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Pharmaceutical Anti-Counterfeiting

Combating the Real Danger from Fake Drugs has become a must-have primer on anti-counterfeiting and is widely used by drug companies, regulators and others. The book covers the legal, strategic and political issues as well as the technical counter-measures such as process control, digital serialisation and physical security.

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