In the last blog, we discussed the Drug Supply Chain Security Act. Today we want to discuss the change that is effective on 11/27/2023, the Enhanced Drug Distribution Security (EDDS). We will review what is in place today and how that will change as part of EDDS.
Where we are today concerning the EDDS
Today, you order your prescription drugs from an authorized trading partner (ATP). The ATP will send you transaction data before or at delivery. This data includes transaction information (TI), transaction history (TH), and the transaction statement (TS). The transaction data could be in any format, including but not limited to:
- Paper
- Fax
- EDI
The pharmacy must maintain this information for at least six (6) years. Pretty simple unless you have multiple ATPs you are ordering from, but regardless, it’s a mindless activity.
The obvious issue with any of these methods is the sheer number of files, emails, and pieces of paper you would need to sort through in an audit, verification request, or investigation from the State, FDA, accreditation organizations, or PBMs. If you have multiple ATPs, you will probably have several formats (hardcopy and electronic) that you will need to consider and filter through. If the bottle is still on your shelf, that should be pretty simple if you are placing the stickers that came from the ATP on the bottle. If not, which ATP sent you that bottle? You may need to run reports (if available from your ATP), pour over invoices, and, as a last resort, try to go through the transaction data (TI, TH, and TS) to validate the information for the auditor. All of this is required today. And fortunately, most independent pharmacies have not seen one of these audits yet, which has also led to pharmacies not thinking about their DSCSA compliance. But, things are changing. Over the past six months to a year, we have received questions from several pharmacies about requests for their transaction data.
Where will we be on and after 11/27/2023
On 11/27/2023, we will see all trading partners (including pharmacies) required to follow the Enhanced Drug Distribution Security (EDDS) requirements of the DSCSA. EDDS requires the transaction information (TI), now including the product identifier (serial number, NDC, lot number, and expiration date), and the transaction statements (TS) to be exchanged in a secure, interoperable, and electronic manner. The transaction history (TH) requirement will sunset. This means you will receive a file from your ATPs, most likely in a format called Electronic Product Code Information Services, or EPCIS for short. The file will be delivered before or at the time of product delivery. Although you can physically read the file, that is not the intent. This file format is designed to be read electronically. So, while the overall amount of data will be the same, you will now receive an electronic file with the required information.
These EPCIS files lead to another issue. How will you organize, read, and search through these files? You could rely on your wholesalers with an information maintenance agreement, which, though not ideal, is workable if you have only one or two ATPs. Even if you do have an information maintenance agreement, you are still the entity that will be legally responsible for providing the transaction data when requested.
If you have multiple ATPs (as most pharmacies do), it will make sense to have a service provider utilizing specialized software to collect these EPCIS (or alternative) files from your ATPs and place them in one repository that enables you to review, confirm (as necessary), search, and maintain. Ultimately, having a service provider is something all independent pharmacies need to consider. A complete service provider can also help you with other aspects that will assist you with DSCSA compliance, such as obtaining a Global Location Number (if utilizing EPCIS files), your Standard Operating Procedures, and employee training.
Since there is a deadline of 11/27/2023, timing is the next thing to consider. If you are using a service provider, that service provider will need to reach out to all of your ATPs (wholesalers and manufacturers) to request the receipt of the EPCIS data. As of now, this is taking anywhere from a few days to several months. If you do not want to get caught in the backlog of requests for access to the EPCIS data from your ATPs, you need to consider your options today. As we get closer to the deadline, we predict a further slowdown with EPCIS data requests as the sheer number of pharmacies requesting access overwhelms the ATPs, which may be short-staffed already in today’s environment.
EDDS and Saleable Returns
The last area to consider is the returns process to your ATPs for saleable products. You (and your ATP) will need to be able to associate the product you are returning with the transaction data (TI and TS) from when you received the products. Your ATPs (primarily wholesalers in this case) will only be able to accept returns for products they sold to you, and they are not just looking at the NDC. The wholesaler will look at the unique Product Identifier (serial number, NDC, Lot number, and expiration date) that identified the unit level bottle.
Stay Tuned
In the next few weeks, PRS will be providing additional information on a program to ensure your pharmacy is in full compliance with the 11/27/2023 EDDS requirements. The solution will give you access to the DSCSA database and allow you to quickly and easily:
- Conduct the verification of receipt of the correct unit level package
- Communicate with trading partners when you have a suspect product
- Receive alerts when you receive an incorrect, suspect, or illegitimate product
- Provide the necessary information when you want to return products
- Respond to FDA and trading partners
- Notify the FDA
- And more
We will release a series of short blogs over the next few months to better educate pharmacies on the existing and upcoming DSCSA requirements.
Please sign up here to ensure you receive information on PRS’s and our Partner’s EDDS solution and general updates regarding the DSCSA requirements.
How can PRS help today?
For your compliance needs today, PRS offers the DRUGSUPPLYTrack Program. The DRUGSUPPYTrack Program provides policies, procedures, forms, and employee training to ensure you comply with today’s DSCSA requirements. If you have any questions, don’t hesitate to contact us at 1-800-338-3688.