Disclaimer: The information and opinions expressed in this blog are based on the authors best understanding of the updates from HDA's 2017 Traceability Seminar and do not necessarily reflect the official policies or opinions of the industry in whole.
Blue Link was honored to sponsor and attend The Healthcare Distribution Alliance (HDA’s) 2017 Traceability Seminar November 8-10 in Washington, D.C. This year's event was a significant one for the Pharmaceutical industry as it was designed to bring together supply chain leaders, wholesalers, distributors, and manufacturers to discuss regulations, innovations and progress around the upcoming DSCSA implementation and milestone as the industry works toward the law’s 2023 finish line.
This seminar was a great opportunity for Blue Link to ensure that the functionality in our pharmaceutical ERP software, as well as functionality being developed, are in-line with current DSCSA requirements and the timelines set out. Blue Link was among key DSCSA solution providers for compliance and traceability in the industry and I am happy to say, that there were “no big surprises” coming from the conference that would require any deviation from our current development strategy. Specifically, Blue Link's timeline for implementation of the upcoming pharmaceutical wholesale distributor serialization requirement by November 2019 is in line with industry timeframes.
Key Takeaways
In General:
- Discussions were had on innovative approaches and lessons learned as distributors, manufacturers, and dispensers on how to implement serialization and traceability technologies, however many questions around specific requirements still linger.
- Guidance from the FDA is being provided but at a slower pace than hoped.
- The industry is moving forward but slower than expected as a result of the time that it is taking to procure, and install the hardware and software required to manage the functionality needed.
- Big players in the industry are involved but information is not being passed to downstream to their smaller supply chain partners as efficiently as it could be.
Deadlines:
- The requirement for Pharmaceutical Manufacturers and CMO’s to apply serial numbers on each item has not changed, however, due to delays in obtaining equipment and software to make this a reality the FDA has delayed enforcement of the law until Nov 2018 (previously November 2017).
- Re-Packagers are still required by law to serialize all products by Nov. 2018.
- Distributors are still required to ensure that all products they receive are serialized by Nov 2019.
- This means that anyone in the supply chain is expected to refuse shipments from manufacturers for products that are missing serialized information.
- If you accept returns from your customers after Nov 2019, you will be required to verify that the serial numbers returned are in fact valid.
Format of Data:
- During trials, the trend has been to use EPCIS GS1 standard for encoding of data.
- It is expected that when data is transmitted (via EDI, File Shares, File Downloads, E-Mails), the actual format of the data should be as stated in the EPCIS R1.2 Implementation Guideline.
Aggregations:
- Discussions were held around aggregation (case, tote, pallet) labeling and inference of the product information packaged.
- While aggregation is not a part of the law it is something that manufacturers and distributors realize will be vital to operational efficiency.
- Manufacturers who have been working to put together aggregation data warned that this data may not be 100% accurate due to human activities that occur after packaging such as sampling/testing from open cases. The verification of aggregation data is to 3 sigmas of accuracy (or 66,800 errors per million items packaged) - the industry realizes this error is too high and needs to be reduced.
Blue Link On-going Development
To help Pharmaceutical distributors manage their processes more efficiently, the 2018 release of Blue Link's Pharmaceutical ERP software will include the ability to receive purchase orders with serial numbers as well as lot information. With a link between the lot and serial data, this will make it easier to verify that products received are legitimate. Other functionality expected in the 2018 release include:
- Support for “aggregation data” to allow for faster PO receipt.
- For example, if you receive aggregation data from a supplier prior to receiving the PO in Blue Link, you will be able to scan a unique barcode on the case package that will look up the associated serial numbers from the aggregation data.
- A single scan of a case of 100 individual bottles, for example, would receive all 100 serial numbers with a single scan instead of having to open the case and scan 100 individual bottles.
- Verification will able to be performed against your own local database.
- For example, if you received the serial numbers into Blue Link and previously sold those serial numbers to the customer, on return you may verify against your local Blue Link database.
- If the serial number is not in your local database, then in order to accept the return you must verify the serial number against the manufacturer’s serial number database.
Development for future releases:
- Router service - If the serial number is not in your local database, then in order to accept the reuturn you will need to verify the serial number against the manufacturer's serial number database. The mechanism to perform this task will be performed through a router service.
- The router service is just a concept that has been piloted by some of the largest manufacturers and distributors.
- Blue Link intends to add support to our application for whatever the final router service happens to be, however, as of the conference there is no actual router service available.
Blue Link will continue to monitor what is happening in the Pharma Industry and attend conferences as applicable to better understand the needs of our pharma customers and to ensure our software is in line with requirements set out by the FDA/DSCSA/DEA. Blue Link’s current Pharmaceutical functionality includes:
- Lot Tracking (Traceability)
- DEA and State License Expiry Date Management
- Landed Cost Tracking
- Secure B2B Online Ordering Portal for convenient online ordering (including Schedule II)
- Serialization (expected summer 2018)
- Order Entry and Invoicing
- Revision Control
- Inventory Control
- AR/AP, GL, Bank Management etc.
- Track National Drug Codes (NDC#)
- Contact Management / CRM
- Suspicious Order Monitoring (SOM)
- Transaction History Management
- Controlled Substance Ordering System (CSOS)
