So what are the main challenges in complying with the new regulatory framework? There are a number of major challenges that all parties in the supply chain need to address.
The first challenge I’ll address is: Who will bear the cost? I already hinted at this in the first article… There is no hard-and-fast rule here; rather, it’s a negotiation between the drug manufacturer and its partners regarding how to allocate the additional cost resulting from this new regulatory framework. This may mean that the manufacturer needs to adjust its prices, which would lead to price adjustments at every stage all the way to the user/patient. This could be difficult, as there are likely existing contracts already in place. I think we should look at how to streamline information management to keep costs down. This could become a competitive advantage over others.
The next challenge is handling the additional information required by the regulations! By “handling,” I mean creating, sending, receiving, storing, and tracking.
In this context, “creating” refers both to reusing existing information and, for the vast majority, to creating new information. One example of this is creating a unique ID on each medication package, consisting of a combination of the NDC (National Drug Code) and a unique serial number. This must be printed on each individual package; more on this later.
There must also be a solution that keeps track of which packages are packed into larger containers at all levels up to the shipping level.
As I mentioned above, more information needs to be included on medication packaging, and this could mean anything from redesigning labels to even having to use larger packages.
Sending the information involves first compiling all the information required by the regulations and then creating the documents where they belong—that is, in TI, TS, and TH. The medium used to send this information must be agreed upon by the parties involved in the information transfer. The recipient must be able to receive these documents in this format—whether on paper or in an electronic format (such as EDI or RFID). Different documents may be transmitted via different media if the parties agree to this. This also includes the requirement that the information must be stored for at least six years.
Tracking, therefore, requires access to all of this information. With high transaction volumes, this can amount to a considerable amount of data. But that’s not all—a robust architecture and effective reports are also necessary. So storing this information on paper is not ideal. Naturally, a digital solution is needed.
