California Board of Pharmacy weighs in on RxTEC proposal15-May-2012
The California Board of
Pharmacy in the US has written an open letter to Representative
Henry Waxman calling for a federal approach to pharmaceutical
traceability that provides the same or greater protection to the
public as its electronic pedigree system due to come into effect
between 2015 and 2017.
The letter to Waxman - who serves as ranking member of the House Energy and Commerce Committee - also takes a swipe at the Pharmaceutical Traceability Enhancement Code (RxTEC) system enshrined in the Securing Pharmaceutical Distribution Integrity Act of 2012, saying that it is a "less robust, and less secure, supply chain infrastructure."
RxTEC has emerged from the Pharmaceutical Distribution Security Alliance (PDSA) - a consortium of pharmaceutical manufacturers, distributors, pharmacists and technology providers which is reminiscent of the stakeholder group set up in Europe to promote a point-of-dispense verification model.
The RxTEC model would provide item-level serialization of medicine packs using 2D datamatrix codes - in accordance with the FDA's 2010 guidance on serialised numerical identifiers (SNIs) - and this would allow each item to be associated with a lot numbers and the quantity of units within each lot.
Traceability would only be applied to the lot level, and rather than providing full chain-of-custody pedigree as per the California model, would identify only the previous and next owner/handler of the shipment.
The PDSA insists this goes far enough to secure the supply chain without the additional costs and technical hurdles associated with unit-level traceability.
The CBP begs to differ, however, saying in its letter to Waxman that RxTEC is not an effective equivalent to its ePedigree approach and would pre-empt its own system if adopted at the federal level.
Specifically, the CBP is concerned that the deadline for rollout of RXTEC could mean the measures are not fully implemented until 2020, and could be further delayed by legislative wrangling. It also takes issue with the "non-utilisation of serialised numeric identifiers", arguing that while these are added to packs of medicines "frankly it does not require much to be done with those data carriers or the associated data".
Lot level traceability via data carrier "would be entirely duplicative of the human-readable lot numbers that are already printed on individual units," it argues.
Also, the CBP does not like the fact that RxTEC specifies 2D datamatrix codes as the data carrier. The California ePedigree system makes no ruling in this area leaving the door open to alternative carriers such as radiofrequency identification (RFID) tags, which may become a feasible option if prices drop and have certain advantages such as no need for line-of-sight reading.
Among the other sticking points is the lack of a routine verification step for individual medicine packs, that could be used to automatically detect counterfeits or otherwise illegal products not carrying a valid SNI, and what the CBP says is a "practical inability" to trace suspect product.
The PDSA argues that lot traceability can be used to prevent counterfeit, diverted, stolen or otherwise illegal product entering the supply chain, with unit-level serialisation allowing regulatory and enforcement bodies to validate suspect product on an as-required basis.
Traceability absent from PDUFA drafts
Regardless of the arguments on both sides, chances that there will a federal pronouncement on a track-and-trace system for the US - at least in the near-term - appear to be diminishing.
RxTEC has been hoping to gets its model incorporated in the broad bundle of legislation going through alongside the latest incarnation of the Prescription Drug User Fee Act (PDUFA V), which could be passed within the coming weeks. PDUFA IV is due to expire on September 30.
However, the wording of the April drafts under consideration by the US Senate and House of Representatives included no mention of medicine traceability, dashing hopes of a federal ruling that would supersede state-led initiatives such as California's e-pedigree requirement, although recent reports suggest it may still be on the table.
The critical consideration for drugmakers wondering how to push forward with traceability in a regulatory vacuum is to focus on the most likely elements of any system, i.e. the use of serialised codes at one or more pack levels, likely delivered via 2D datamatrix and in compliance with GS1 standards.
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