Hello all!
Previously, I gave an overview of DSCSA current state. Well changes are coming that will impact dispensers!
Most of the requirements previously discussed will still be in place but there are some very important changes/modifications coming.
All transaction information MUST be handled in an interoperable manner. This basically means all data must be handled electronically. This would include tracking and tracing as well as communications for the tracking and tracing between trading partners. What does this look like? So to handle electronic communications, decisions and processes had to be made and agreed to by the FDA to ensure the intent is met. Nationally, changes of how data is to be transferred (or at least the form of that transfer) landed on the format called Electronic Product Code Information Services (EPCIS).
a. So, having the EPCIS standard is all well and good, but how does your site actually accept those data feeds? Well at a national level it was also decided that in order to receive the data feed it must be handled via use of the facilities global location number (GLN). These numbers are assigned to pharmacies by various methods: the wholesaler assigns one, a group pricing organization (GPO) assigns one, or the pharmacy communicates with the GS1 US® (a not-for-profit information standards organization) to establish their own.
So say the sight now has a GLN and can receive the EPCIS feed. Now what? How the site receives the EPCIS feed is greatly up to the site (that is if they so choose to accept that feed ). Most that go down the path of receiving the EPCIS feed will handle through a third party DSCSA solution much like I briefly discussed in the previous DSCSA blog. Those solutions can receive the EPCIS feed which will allow a very complete group of data points including all the TI data and the TS. With the changes coming to the flow of information there will no longer be the TH portion of the T3. These third party solutions also hold that data from the feed for at least the 6 year time frame required by DSCSA. These programs can be used to communicate very easily with trading partners and can assist with investigating suspect products.
This EPCIS feed will also contain all the data points noted on the 2d barcode of a medication which I discussed on the earlier blog. As a review that would be the Lot #, Expiration, NDC (most companies will use the GTIN which contains the NDC), and serial number.
b. What if your site does not want to use a third party solution to handle transaction information? One possible way is to check with your trading partner and ensure that they have an active "web portal". Web portals, FDA has stated, are a possible way to maintain electronic interoperability. All data would be stored on the web portal system that would have generally be fed visa EPCIS. If this is the route you choose, you must again ENSURE THAT YOUR TRADING PARTNER HAS A DSCSA COMPLIANT WEB PORTAL! You must also be able to respond to request for tracking and tracing from trading partners and regulatory bodies such as FDA or state inspectors. Remember, this data and its transmission MUST be handled in an electronic interoperable way as well!
NABP is currently working on a tool called the "Pulse" program. The goal of this tool is to assist in tracking and tracing and sending the tracking and tracing information from your facility to the requesting entity in an interoperable manner (in this case an email format). The plan is for these functionality of the Pulse program is to be free. They will also as an aside offer the ability for you to look up trading partners to verify licensure as well but this will be at an additional cost (at this time I am not familiar with that cost).
2. Tying back to the 2d barcode...remember the serial number? After November 27, 2023, all items will be required to be traceable to the SN! So if you are asked to trace it will have to be to that level.
3. One slight change to investigating suspect products is the idea of "verifying" the products after November 27, 2023. According to the FDA, the verification process entails evaluating the 2d barcode and comparing that data to the transaction information. The new standard will also require the following: when verifying you must "verify" 3 of the individual items or 10% of the total of the items (whichever number is greater). So, say for example you receive 100 bottles of drug A. You have serious questions as there are red flags indicating possible suspect product. You will be required to "verify" 10 bottles of the products in this scenario. I know I just raised a question for you regarding what are possible red flags for suspect products. Look for a future post going into this topic!
4. So we discussed verification above...there is another consideration of the idea of verification. This has to do with sending product back to your trading partner that you received the item from (ex. A wholesaler). DSCSA after November 27, 2023 will require that you verify that product and ensure that the EXACT same product you received from the trading partner gets back to them. Remember this is all the way to the SN! These situations will also complicate 340b as well!
As an important aside...
Currently Cardinal and McKesson are planning on testing the EPCIS feeds in the summer (at least that is what I understand. AmerisourceBergen is very soon going to start testing or has already started testing the feeds. It is hoped by November the big 3 will be ready for the feeds.
So as you can see there are some major changes in the VERY NEAR FUTURE! Be ready for it! Watch for other future post about DSCSA!
Jay G
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