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DEA suspends the license of another wholesaler over unmonitored shipments of controlled substances, including oxycodone
By means of a federal regulation (21 CFR 1301.74b) the US Drug Enforcement Administration is authorized to investigate wholesalers who do not sufficiently monitor their shipments of controlled substances. The latest company caught up in this regulation is Keystone Medical (Cincinnati), whose license was temporarily suspended, pending an administrative review, in early June. Keystone—an otherwise well-established legitimate wholesaler (the company has the Verified Authorized Wholesale Distributor, or VAWD, accreditation from the National Assn. of Boards of Pharmacy, and is a member of HDMA)—joins a string of other wholesalers, including all of the Big Three, who have been subject to DEA enforcement actions.
The CFR regulation requires wholesalers to “make a good faith inquiry” either with DEA or state agencies to ensure that customers are permitted to obtain the drug, and even to report directly to DEA “suspicious” levels of ordering. Wholesalers have complained that they’re being turned into de facto DEA agents; DEA’s response is that it’s more efficient for them to go after sources of drug shipments over the many dispensers (although enforcement occurs there as well).
The Big Three wholesalers and others caught up in DEA investigations have responded by developing “suspicious order monitoring” (SOM) systems, and now an IT vendor, eSupplyLink (Traverse City, MI; www.esupplylink.com) is seeking to fill that gap with SOMLink, a tailored IT solution. According to Ron McCreery, sales manager, SOMLink sits next to the order-entry system of the wholesaler, and performs ongoing statistical analysis of order receipts. Actions like sudden, unusually large orders, or orders from new customers, are flagged for further review.
Version 2.2 of SOMLink was introduced in July. McCreery says that it has been upgraded with user-controlled “threshold management,” which defines the parameters around which an order gets flagged. Up to 16 separate statistical analyses are performed. By purchasing a packaged solution, rather than customizing the functionality on an enterprise order-management system, McCreery says that costs can be cut by nearly an order of magnitude.
SOMLink is complementary to the online Controlled Substances Order System (CSOS) that DEA instituted to allow e-commerce to replace its Form 222, a paper-based system for recording controlled-substances orders (Pharmaceutical Commerce, Nov/Dec, 2010, p. 18). McCreery says that eSupplyLink has business relationships with Axway (Phoenix, AZ; www.axway.com) and Legisym (Temple, TX; www.legisym.com), two of the companies with validated CSOS systems available for retailers and wholesalers.