Proper reporting and analytics are important to every company, but even more for businesses in regulated industries where compliance involves submitting reports to governing bodies and “downstream” to your customers. This includes requirements set forth by the DEA and FDA in the pharmaceutical wholesale and distribution industry. Not only does proper reporting ensure that supply chain partners are adhering to regulations, but it helps keep the supply chain safe from illegitimate products, reduces the number of items that make it into the black market, and gives customers peace of mind that the products they receive are legitimate and safe. Blue Link’s pharmaceutical distribution system includes robust functionality for managing reporting and analytics, including the many standard reports for all businesses and then additional reports based on the categorization of products you buy and sell. We’ve broken down some of these reports below.
Transaction Reports (T3 Reporting)
A Transaction Report or T3 is a report that tracks the “Transaction Information” (physical transaction between the seller and buyer), “Transaction History” (Pedigree of the product) and “Transaction Statement” (statement by the seller that the products being sold are legitimate) of each unit of a product along the supply chain. Every time product changes ownership, the new owner is added to the Transaction History which is included with the specific product information. Each unit of a product/lot has its own history.
Originally set forth by the Drug Supply Chain Security Act (DSCSA), the regulations around T3 reporting dictates that all trading partners including manufacturers, re-packagers, wholesale distributors, and dispensers cannot accept pharmaceutical products unless the trading partner they receive the product from can provide specific information about the product – including a Transaction Report or T3. This allows each trading partner in the supply chain to verify that the product is legitimate and legal.
Want to learn more about the information included as part of the Transaction Report? Check out this blog post: Drug Supply Chain Security Act (DSCSA) Transaction Report (T3).
The Controlled Substances Act outlined in 1970 requires that all manufacturers and distributors report their controlled substance transactions to the DEA. To monitor the movement of controlled substances along the supply chain, ARCOS (or the Automation of Reports and Consolidated Orders System) was established, which tracks transactions involving controlled substances from their point of manufacture through commercial distribution channels to the consumer (through use at hospitals, via practitioners, through sales at pharmacies, etc.). The DEA requires submission of ARCOS by the distributor after the sale of any controlled substance. ARCOS reporting includes information from DEA Form 222, which is submitted by a customer (such as a pharmacy, hospital, specialist, practitioner, etc.) that wants to purchase Schedule II drugs from their supplier. Submission of Form DEA 222 by the customer dictates that they have the authority to purchase the product based on their licenses and helps to track the movement of Schedule II product along the supply chain. The information from DEA Form 222 submitted by the customer is then included in the ARCOS report which must be submitted by the distributor selling the product.
The point of ARCOS is to accumulate transactions of controlled substances so that Federal and State government agencies can identify and address any diversion of product into illicit channels of distribution.
Reporting with Blue Link
Blue Link recognizes the importance of proper reporting for pharmaceutical distribution businesses and has developed specific features to meet all the above reporting requirements.
- Blue Link ERP includes functionality that captures all the information required in a T3 for each product/lot and stores the information in the system. This data can then be automatically turned into a report and sent to other members of the supply chain or used for other reporting purposes.
- Blue Link includes CSOS functionality as part of its B2B Online Order Portal, which allows customers to electronically submit orders containing Schedule II drugs with their suppliers. This eliminates the need for customers to manually submit DEA Form 222 through mail or courier, which can be expensive and time-consuming.
- Blue Link includes functionality that automatically captures and stores relevant ARCOS and/or CSOS information which allows businesses to then automatically generate reports that can be uploaded to the DEA site.