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Informaticists on the Drug Supply Chain Security Act 

by 

SOPIT Track and Trace Workgroup 

Track and Trace, as it is fondly referred to, has been a game of hide-and-seek at times as Pharmacy Purchasing Agents and Pharmacy Managers have struggled with innovative ways to facilitate compliance.  Several software products are on the market currently, as other pharmacies have developed their own home grown processes to facilitate ways to capture and store data. 

Third party vendors offer an organized, electronic solution for receiving, cataloging and searching for 3Ts (in the form of electronic Advance Ship Notices (ASNs)) by establishing Electronic Data Interchange (EDI) with trading partners.  Some considerations when determining whether you can achieve and maintain compliance with a third party vendor are:

1. An EDI does not equal “hands off.”  Even with an EDI, delivery records may be incomplete if the National Drug Codes (NDC) purchased are not tailored in or are missing from the vendor’s NDC master file.  In these cases, the NDC master file will need to be updated and the transaction record re-sent.  Also, ASNs for drop shipments may not be sent electronically despite an EDI with a wholesaler or manufacturer (depending on their EDI configuration).
2. Not all trading partners establish EDI with third party vendors so 3Ts for these transactions must be manually maintained, either by uploading and documenting them in the vendor software or archiving them externally.  Some trading partners may send ASNs for direct shipments and not for drop shipments depending on the EDI message enabled.
3. The time commitment needed for ongoing success can be substantial.  Understand and support realistic labor requirements for processes such as establishing new trading partner connections, maintaining the NDC master file database, addressing delivery transaction failures, contacting trading partners for “paper” 3Ts, and manually archiving “paper” 3Ts when needed. 

Alternatively, many organization are choosing not to pursue a vendor initially and instead are relying on alternative processes are workflows to ensure that their product tracing information is retained in a readily reviewable manner. Some considerations when determining whether you can achieve and maintain compliance without an external vendor are:

1. Prior to developing an acceptable workflow for your organization, it is imperative that you understand how all products are procured and how vendors are providing product tracing information for each purchase.
2. Once this information is fully understood, you can take steps to ensure you are capturing all the required information. Potential methods to do so are outlined below:
   1. Purchases from a Prime Vendor: Many wholesalers will retain transactional information for their customers free of charge. This information can be accessed by the customer through the wholesaler’s online portal. If pursuing such an arrangement, it is recommended that the entity have a contract with the wholesaler indicating what sites the wholesaler will retain this information for and outlining the ownership of this information in the event an entity choses to end a business relationship with a particular wholesaler. 
   2. Direct Purchases/Dropship Purchases: Various vendors provide transactional information in different formats. The most common include providing this information printed on packaging slips included with the product and or transmitting this information electronically.
3. Subsequently, it is recommended that the organization develop a policy outlining how transactional information is received from various vendors. This policy may indicate that this information is stored in the cloud for purchases from your prime vendor/wholesaler but is stored electronically for all other vendors (e.g., archived PDF files, etc.) These electronic files can be scanned copies of packing slips that are received as well as scanned copies of transactional information printed from third party vendors that a pharmaceutical company relies on to provide this information. 

1. Loan-Borrow Processes
2. Product On-Boarding (particularly if relying on an external vendor to retain transactional information)
3. 340B Contract Pharmacy

So, with that being said, ready or not, Track and Trace, here we come!

*The ASHP SOPIT WG on Track and Trace is looking to share your experiences with other pharmacists who are struggling with ways to meet this fast approaching deadline.  If you are interested, please consider filling out the online survey using this link: Link: http://ashp.az1.qualtrics.com/SE/?SID=SV_06rDXE1wSHTC245.  The SOPIT WG intends to assimilate this information and provide tips for improving compliance! 

**For additional information and resources to support implementation of the DSCSA please see ASHP's DSCSA Resource Center at: http://www.ashp.org/DSCSA