SOMLink V 2.2- New Tech Tools Upgrade DEA Compliance Target Illegal Drug Diversion
TRAVERSE CITY, Michigan
Pharmaceutical manufacturers and distributors of oxycodone and similar Schedule II controlled substances are using new technology to comply with strict DEA mandates for preventing diversion of these potentially addictive drugs to illicit and unethical markets.
First introduced in December 2010, SOMLink™ analytic software monitors all orders of CS II-V drugs entering a supplier's order management system. The software application analyzes each new order in accordance with DEA 21 CFR 1301.74b requirements to identify and place on hold all orders having a significant deviation in order size, frequency and pattern, commonly referred to as "Suspicious Order Monitoring."
Developers of SOMLink announce today the release of version 2.2, with user-driven enhancements to analytic processes and user interface upgrades.
"Early adopters of the product had the opportunity to make recommendations for functionality, user interaction, and reporting features to be incorporated in subsequent releases," according to Ron McCreery, Sales Manager at e-SupplyLink, the Michigan-based software company that was originally contracted to develop SOMLink.
Version 2.2 adds "Thresholds Management" to a suite of analytic and comparative processes that includes; 16 statistical validation tests, NDC / Item Family analysis, and Peer Group analysis. Thresholds Management enables users to set quantity and time parameters for specific products and ship-to locations. Note: DEA requires each ship-to destination to have a valid, unique Registrant License that is the same as the purchase order received by the supplier.
As new orders enter the supplier's order management system, SOMLink compares relevant data from each order against 24 months sales order history. SOMLink applies rigorous statistical analysis to each line item to identify orders deviating substantially in size, frequency and pattern. If a customer does not have sufficient order history to run the validation tests, Thresholds and Peer Group analysis may be used until adequate history is acquired.
"Orders of interest" are placed on hold pending administrative resolution. SOMLink user interface automatically notifies designated account managers of flagged orders, and provides a permanent repository to record the activities of investigation and final resolution, including reports for notification of the appropriate DEA office. The permanent repository provides an audit trail for each flagged order that is readily accessible for DEA or internal review.
"Manufacturers have different order fulfillment and compliance issues than wholesale distributors. And within each of those large groups, there are many unique requirements," says Todd LaBonte, CEO and SOMLink project leader. "Our designers are using state-of-the art development tools that allow us to adapt SOMLink to industry trends quickly. We are currently anticipating new CS distribution requirements from DEA, and industry regulatory affiliations such as VAWD."
SOMLink is the only commercially available validation and resolution toolset that is universally applicable and locally adaptable for diverse pharma supply chain users. To date, the only alternatives to licensing SOMLink are to build custom SOM applications in-house, or contract with custom program developers.
About e-SupplyLink: e-SupplyLink is a group of experienced, innovative supply chain solutions developers with over 10 years successful integration to hundreds of Automotive, Retail / CPG and Pharmaceutical order fulfillment applications.
Suspicious Order Monitoring & Management
SOMLink™ is a suite of analytic and order management tools designed to automate suppliers' compliance with DEA 21 CFR 1301.74b. SOMLink™ integrates with a Manufacturers' or Distributors' Financial / ERP system to automatically review each order, applying analytic tests and comparisons with the buyer's order history to flag any orders that meet the criteria for being suspicious. Once flagged, suspicious orders are placed on hold pending an investigation by customer service.
Benefits of SOMLink™ include seamless integration to suppliers' existing Financial / ERP system via XML and automatic notification of flagged orders via e-mail including notice of cause. The SOMLink™ application permanently maintains records for reporting verification activities, updates, and status of flagged orders. The SOMLink™ record archive is supplier-managed and in compliance with DEA mandates.
e-SupplyLink works closely with suppliers to adapt and optimize the SOMLink™ template to their specific needs. If your company could benefit from Suspicious Order Management or if you have additional order management needs, please contact sales@e-SupplyLink.com or call 877-998-3645 toll free, or 231-933-7214.
What is Suspicious Order Monitoring and DEA 21 CFR 1301.74b?