Maxiom Group led a pharmaceutical client through an ePedigree Strategy project. The objectives included:
1. Understand the upcoming state regulations and how they would affect the company’s supply chain
2. Assess the client’s distribution partner’s ePedigree capabilities and strategy, as well as the implications of the distribution partner’s strategy on the client
3. Develop recommendations on a short-term action plan to meet near term customer and regulatory requirements
4. Develop recommendations for a strategy to meet longer term requirements
This pharmaceutical client has several commercial products, all of which are distributed and sold in the U.S., particularly California. At the time the project was initiated, new regulations were being discussed and passed on the state and federal level, including Indiana, Florida, and California. The client … Read more »
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The word on the street is that the California State Board of Pharmacy’s 2015 deadline for new regulations on drug product serialization and ePedigree will not be pushed back. How is your company preparing your supply chain to handle these new regulations?
The January 1, 2015 deadline requires that 50% of manufacturer’s drug product packages (at the smallest unit) be serialized and with ePedigree. The push for these regulations in recent years is primarily due to the increasing trend of counterfeit drugs entering the pharmaceutical … Read more »
No, not quite yet – but we are keeping track on the developments that are taking place. While many international countries already have pedigree and serialization legislation on the books (Brazil, China, Turkey, France), pharmaceutical manufacturers with US-only supply chains are still “on hold,” waiting for California in 2015 or the FDA to step in with a federal mandate.
Paul Thomas, Senior Editor of Pharmaceutical Manufacturing Magazine, asked this and other questions as a follow up to an article from last March, The Path to Epedigree: Manufacturers Chart Their Course, to see if anything had changed. The Q&A was published on its own (2011: Progress on the Pedigree Front?) and incorporated into a full length article. (Pedigree Adopters Play the Waiting Game) Paul finds that, though … Read more »
The brand integrity/product security world is heating up again, and not just for those focused on Brazil, China, Turkey and the global regulatory landscape. In June, the US White House released the “2010 Joint Strategic Plan on Intellectual Property Enforcement.” (A report by the IP Enforcement Coordinator, Victoria Espinel) Two key recommendations are:
• “Mandated Use of Electronic Track and Trace for Pharmaceuticals and Medical Products” including electronic pedigree based on unique identifiers (serialization)
• “FDA Notification Requirement for Counterfeit Pharmaceuticals and Other Medical Products” that requires companies to notify the FDA if and when a known counterfeit product is discovered in the supply chain.
As these are just recommendations, they will likely require congressional action before becoming enforceable. However, this is an additional step toward serialization and pedigree requirements … Read more »
Since we do a lot of pedigree-related work, and deal with many of the vendors in this space, we had an opportunity to get an early look at Oracle’s Pedigree and Serialization Manager (OPSM) solution. OPSM was designed to create and manage serial numbers, record and transmit serial number hierarchies and create pedigrees. OPSM was designed to comply with both document model (California) and centralized server (European) methods of pedigree reporting and to be extensible to meet future pedigree formats and data standards. Additionally, OPSM has an open web services architecture that should allow for additional features, such as product authentication, analytics and enhanced supply chain visibility.
In our experience, pedigree and serialization solutions require tight integration with ERP to ensure that serial numbers are generated … Read more »
Dirk Rodgers, formerly of SupplyScape and one of the foremost experts on track and trace/brand integrity, published what we’ve all been waiting for…realization that RFID is Dead (at the unit level for pharmaceuticals) on his RxTrace blog. I say “that we’ve all been waiting for” as, since the initial discussions of Florida’s pedigree law and certainly during the California pedigree debates, RFID has been mentioned as a “preferred method” by both governments and wholesalers. While debate has raged, my guidance to clients has been clear…RFID should be considered at the case and/or pallet level but not at the unit level unless there is a significant business case.
Dirk provides cost/benefit analyses of RFID and barcodes at each of the major stakeholders in the pharmaceutical supply chain … Read more »
On April 1, pharmaceutical Track-and-trace made it to the Op Ed page of the New York Times…and it wasn’t an April Fools’ joke!
Katherine Eban, of Dangerous Doses fame, and J. Aaron Graham, former chief security officer of Purdue Pharma, who launched one of the first RFID-enabled Track-and-trace pilots for OxyContin in 2004, teamed up to write a piece on the risks of illegal (counterfeit, diverted) pharmaceutical product and the benefits and costs of track and trace technologies designed to protect against such illicit activity. The Op-Ed was written in response to a $75 million theft of psychiatric drugs (Prozac, Cymbalta, Zyprexa) from Eli Lilly’s Enfield, CT warehouse.
Lilly’s response was to say that the American drug distribution system is “tightly controlled and monitored, making it extremely … Read more »