TRAVERSE CITY, February 10, 2010
Small & Mid-Size Wholesale Distributors of Controlled Substances Weigh Options
Beginning in 2007 and continuing throughout 2008, the DEA made high profile examples of the “Big Three” in a renewed effort to bring CS registrants into compliance with Suspicious Order Monitoring (CFR 21 1301.74b). The DEA imposed strict sanctions and significant fines on Cardinal, McKesson and AmerisourceBergen;
Business Wire; Apr 25, 2007
AmerisourceBergen Receives DEA Order to Temporarily Halt Distribution of Controlled Substances from Its Orlando, Florida Facility.
U.S. Newswire; Oct 2, 2008
Cardinal Health Inc., Agrees to Pay $34 Million to Settle Claims That it Failed to Report Suspicious Sales of Widely-Abused Controlled Substances
U.S. Newswire; May 2, 2008
McKesson Corporation Agrees to Pay More Than $13 Million to Settle Claims That It Failed to Report Suspicious Sales of Prescription Medications
More recently, Cincinnati-based Masters Pharmaceutical was fined $500,000 for failing to report suspicious sales of controlled substances;
Business Courier of Cincinnati Monday, May 4, 2009:
A distributor of branded and generic prescription drugs . . . Masters Pharmaceutical, Inc. has agreed to pay $500,000 fine in a settlement with the Drug Enforcement Administration
Proactive, not Reactive: Registrants are required to place on hold, investigate, and disclose to the DEA all suspicious Orders of Controlled Substances- not suspicious Sales after the fact
False Positives: Industry experts recommend replacing traditional “order averaging” techniques with comprehensive, dynamic, computational analysis of each new Order entering the registrant’s business management system. Statistically defensible analysis of all Orders should flag only those having significant deviation in size, frequency, and pattern- without interrupting efficient distribution of critical medical products in Healthcare supply chains
SMB vs Big Three Budget: SMB Wholesale Distributors lacking the resources to develop custom SOM software applications will be relieved to know a robust, affordable SOM compliance toolset is scheduled for release in the first quarter of 2010- SOMLinkTM is designed specifically for Small and Mid-Size Wholesale Distributors of CS II-V
SOMLink integrates with any Financial/ERP to automatically review each new Order, apply multiple analytic tests, flag suspicious orders for verification by account managers, and maintain a permanent record of verification activities.
For more information, please visit: http://www.e-supplylink.com and click through to SOM
