Blue Sphere Health

Safeguarding America’s Pharmaceuticals Against Counterfeiting and Diversion

September 22nd, 2011 saw the introduction of HR 3026 or the ‘Safeguarding America’s Pharmaceuticals Act of 2011’ into the US House of Representatives. Itself an update of an earlier bill, the document contains some interesting elements that could have big repercussions. Taking the Fifth… First of all, let me give the standard caution that most bills don’t make it out of the committee stage so this is a long way from being law. However, assuming for a moment that it represents current Democrat thinking, let’s examine what it would mean if passed. Pedigrees The bill is based on the ‘pedigree’ model, with (broadly) every transaction recorded for every pack as items travel through the supply chain from Authorised Distributors of Record (ADRs) or manufacturers right through to pharmacists. This is in contrast to the likely model in Europe, where end-to-end verification is favoured as a more workable option. In the latter, so-called ‘bookend’ systems, the pack is coded and checked at the manufacturing or packaging step and again at the pharmacy before dispensing but all intermediate code checks during distribution are optional. Big Pack, Little Pack, Cardboard Box Pedigree imposes a much higher burden on the supply chain, partly because the most practical coding technology is visible printed codes – usually in a two-dimensional matrix format. These codes require line-of-sight: the scanner must be able to ‘see’ the code optically with no intervening opaque packaging. This is an obvious problem when packs are aggregated into shipping case and pallets. It is simply not feasible for distributors to unpack, scan and repack large volumes of material, so a workaround known as ‘aggregation’ is used. In this process, the unit pack codes that go into a larger box are associated together in a database together with a secondary code that is applied onto the bigger container. The process is repeated as necessary up to pallet level. Mongrels Thus by scanning a single code on the pallet, an operator can (in theory) find out the codes on all of the unit packs contained within. This all works well. Until it doesn’t. The pharmaceutical distribution process is complex and for many reasons shipments are broken down, mixed with other products and reaggregated before being sent onwards. There are multiple opportunities for someone to fumble the ball and when they do the whole consignment could become unsaleable due to lack of a viable pedigree. Return-to-Sender Encouragingly, the returns process is also addressed in the Bill and included in the pedigree requirement. The ‘reverse logistics’ operation of returning expired or unwanted goods back up the supply chain has been vulnerable to fraud in the past. Code but no Enigma Standardized numerical identifiers will be needed for a coherent coding and tracking system and this is also addressed although FDA thinking on this has been provided already. The danger of a non-globally-aligned numbering format seems to have passed and any implemented system is likely to be a GS1-harmonised structure based on existing National Drug Codes. California, USA The timetable for applying codes to packs is pretty much that of the existing California pedigree deadlines, i.e. starting on 1 January 2015, and (sensibly) any Federal regulations would automatically supersede state provisions. So no shocks there on timing but a much bigger scale of challenge to comply nationally on the same timescale. This timeline also ties in broadly with the anticipated schedule for the implementation of traceability provisions in the EU Falsified Medicines Directive. SWOT Team The Bill also calls for a study into threats, technology choices and gaps in current government processes. This is to include ‘consultation with technology developers, drug manufacturers and other interested parties’. Time to make your thoughts heard. Conclusions This is just my initial reading of a Bill that may well not come to pass. There are no easy ways through this serialization / pedigree problem but we owe it to patients to try to seal the supply chain against fake drugs. Any traceability system will be complex, but I think going for a full pedigree model in one step is not the way to go. It is technically feasible, but it will be needlessly expensive and risky compared to the alternative model. Next steps If your company is struggling with these issues and you need some advice on strategy, technology choice or other aspects, then contact Blue Sphere Health. We help customers to solve these traceability challenges cost-effectively and in a way that adds value rather than just raising costs. For a fuller discussion of supply chain issues, authentication and other elements of the fight against counterfeit drugs, see my new book “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs” (Wiley, 2011) reviewed here.

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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.

Pharmaceutical Anti-Counterfeiting book