Did you know, that the FDA begins its planning period for interoperable data exchange standards in 2018? So what does this look like… We can learn from Europe.
In Europe, there are two specific supply chain security directives the Falsified Medicines Directive (FMD) and the E.U. Delegated Regulation (EUDR) that have manufacturers, wholesalers and pharmacies actively working on DSCSA-like processes and technology.
FMD/EUDR require submission of product data to the European Hub, a special repository setup by the non-profit European Medicines Verification Organization (EMVO) to fulfill specific data sharing requirements in the EUDR. The EMVO will then route data to national repositories. Pharmacies will actually use those national repositories to verify each drug before they are dispensed to a patient.
Many pharmacies are currently relying on wholesaler’s to provide DSCSA data. Others are using manual tracking systems such as Excel workbooks. The current standard in the US is to use an EDI (Electronic Data Interchange) format, which is a specific format used to communicate between “trading partners”, e.g. wholesalers to pharmacies, manufacturers to wholesalers, etc. These formats make exchanging data fairly seamless. If you are not currently utilizing these formats, you are likely making your work much harder, to comply with future DSCSA requirements, particularly submittal to national data hubs such as what is kicking off soon in Europe.
The great part about the EDI format standards, is that no matter how many companies your purchase product from, the data is in a format that it can later be shared to a repository. So if you have multiple wholesalers, or you change wholesalers secondary to GPO changes, or you by direct from several manufacturers, if you are using an EDI provider, such as RxTrail to handle your DSCSA data, you are prepared now and for the near future.
Don’t put off compliance with DSCSA. The amount of data and the level of detail you are required to maintain is quite significant. This year, manufacturer serialization kicks into FULL effect, with saleable units of product now required to have a Data Matrix barcode with serial numbers included. The data requirements gain complexity for you as a pharmacy, with this change, and again the AMOUNT of data is tremendous.
I encourage you to read more about these changes on our resources page.