Happy Martin Luther King Jr. Day!
As someone who often attempts to explain truth and reality through writing, I can really appreciate the writing skill of Rev. Dr. Martin Luther King Jr. (see “Celebrating Martin Luther King Jr.”). I’ve learned that the best writing has to come from your heart just as much as it does from your head, but I still make mistakes that I don’t expect to see in Dr. King’s writing. Last week is an example. By attending the Healthcare Distribution Alliance’s (HDA’s) Verification Router Services (VRS) Task Force meeting in Crystal City, Virginia, I learned more about HDA’s intentions for the design of the VRS. The result is, I have now made some corrections to last week’s RxTrace essay, “DSCSA: Saleable Returns Verification”.
The corrections came from the fact that HDA intends the VRS to be a standardized collection of verification services offered by drug manufacturers that are reachable only through a centralized router. That router would only use a GS1 Global Trade Item Number (GTIN) to figure out which drug manufacturer(s) to send each verification request to. The thing that threw me off was how to handle the real-world problem of Mergers and Acquisitions (M&A) when ownership of a single product line is transferred (sold) from one manufacturer to another. In those situations, there is almost always some period of time when it is hard for trading partners to know exactly which of the two manufacturers should be equipped to verify any given instance of a drug in that product line. There are many ways to solve this problem. I thought they would solve it one way, but it is now clear to me, that is not the way the HDA is likely to go.
My way required the VRS to have a list of Standardized Numerical Identifiers (SNIs)—which are composed of an NDC and a unique serial number (see “Anatomy Of An FDA SNI”)—and a single pointer to the verifying manufacturer for each one. That’s a bad design for what HDA is trying to accomplish. Instead, the service they are pursuing would take a different approach, although the exact approach has not yet been defined.
The purpose of this meeting was primarily to collect business requirements for a workable VRS and collect feedback on a few high-level ideas for the design. The meeting was structured similar to the way the FDA structures their public meetings (see “The 2014 FDA DSCSA Workshop”), with a few prepared presentations followed by breaking the attendees into table-sized groups and asking them to discuss a list of pre-defined questions for reporting out at the end.
Based on what I heard at the meeting, it is clear that wholesale distributors will need to prepare to receive the list of serial numbers for each shipment along with the product, and prepare to work with the VRS. That’s because some drug manufactures have already announced that they will not collect aggregation data (which is necessary to use when generating the list of serial numbers included in a given shipment), and others will almost certainly not implement the VRS on time. If any wholesale distributors plan to mandate one or the other of HDA’s approaches to solving their 2019 saleable returns problem (see last week’s essay), they had better do it soon so drug manufacturers have time to make the right plans and investments.
It is hard to tell what the HDA will do next, but given the little time before a VRS would need to begin operating, they will need to move aggressively toward a technical design, and the funding and governance models. In my view, very soon, HDA needs to figure out that last part and create it first. Once the funding and governance is figured out, only then should that new organization proceed with the technical design and development of the service. The wrong way to do it is to expect a group of stakeholders to work out a technical design based on the requirements collected, and afterward, figure out the funding and governance. There isn’t time for that approach, and the technical design should not come from a disparate group of IT people representing the companies that will use the service. This one will be interesting to watch because if it’s going to work, it’s going to have to move fast.