Guarding the Rx supply chain
Isincerely appreciated your editorial (“Unnecessary compromise,” June 10, p. 18). The article thoroughly outlined the underlying points and background of the developing pharmaceutical supply chain security discussion. The article mentions the Pharmaceutical Distribution Security Alliance (PDSA) and its support of federal legislation, especially the pre-emption of state bills, California SB 1307 particularly, which require tracking of units through the supply chain. While their objection is represented as seeking common standards instead of a patchwork of state regulations, it is the itemlevel track in supply chain, which is absent in federal legislation, that provides the greatest challenge and the loudest objections.
I’ve been involved in evaluating the developing legislation in Congress since early last year (H.R 1919 and S. 957). I was one of the seven industry panelists that addressed the House Energy and Commerce Committee on April 25. While all of the witnesses were in support of improving pharmaceutical supplychain security, not all saw the merit in itemlevel tracking for containers in transit from manufacturer through the pharmacy.
Based upon the opening statements from the lawmakers and their follow-up questions to testimony, one would have concluded that they were of a like mind and that we were heading toward a more robust law consistent at least with the California legislation already on the books. Sadly, the revised bill was weak and in no way represented the comments we heard on the 25th. It is shocking that public safety has taken a backseat to politics.
We have continually noted to legislators that tracking units and reading the item-level codes is the most critical part of supply chain security, in particular the read at the point of dispense in pharmacy, not simply at receipt. There are too many documented instances of pharmacy-introduced counterfeits, diverted product (Internet product), dispense of returned product and even dispense of outdated product. Only when we check at dispense will these events be prevented.
While it is unlikely this current legislation will include the scan at point of dispense, there may be another path to achieve this level of security. We’ve been promoting the concept that insurers (pharmacy benefit managers, healthcare providers, the CMS, etc.) could and should require the standardized numeric identifier (SNIs) for reimbursement of prescriptions. By requiring this number and verifying it against an industry-managed database, we will thwart bad actors in pharmacy who may introduce counterfeit or substandard products. Prescription fraud was a key driver for the introduction of serial- ized pharmaceutical containers in several European countries.
While the current Senate bill does establish serialization as an early step, which is commendable, it fails to require active checking of that serial number in transit as recommended by the Food and Drug Administration, and, most critically, at dispense in pharmacy. This will relegate the SNI to being a tool for investigating why a problem occurred instead of preventing the introduction of counterfeit and substandard drugs. That this legislation seems to ignore the recommendation of the FDA, the very entity charged with safeguarding the pharmaceutical supply chain, is troubling to say the least.
The bill ultimately fails to complete supply chain security, which would end with the scan in pharmacy at dispense. The pieces are here but they are not being used in concert to achieve the goal of a safe supply chain. Without this last scan, all the work along the way is virtually useless. There have been too many instances where pharmacy introduced counterfeits, grey market product and even dispensed returned/recalled product.
The rest of the world is moving steadily toward a serialized supply chain for pharmaceuticals. As China, India, Turkey, Brazil, Argentina and numerous others tighten security and we continue to languish, you have effectively painted a target on the U.S. supply chain making it a haven for global counterfeiters. Without track and trace in transit and most importantly without verification at dispense in pharmacy we lose the benefit of serialization. By failing to track and failing to verify at dispense we’ve reduced serialization to a tool for forensic analysis of what went wrong. “Why did this bad drug end up being ingested by this patient?”
Walter Berghahn President, SmartRmeds for Life Executive director, Healthcare Compliance Packaging Council, Bon Air, Va.