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Suspicious Order Monitoring Solution
Todd LaBonte, CEO, Solution Architect
About Us
Founded in 1999 e-SupplyLink has been supporting the Life Sciences
Industry with innovative and efficiency-driven software solutions. In 2010
with the launch of SOMLink we presented one of the first Suspicious Order
Monitor (SOM) offerings on the market to assist our clients in complying with
the Controlled Substances Act and the DEA's “Know your customer” policy.
Other compliance solutions:
ComplyLink - B2B shipping system that bolts on to existing EDI or
Warehouse Management System.
McKesson fined $150M / Kaiser Permanente fined $850K (one
phamacist) / Safeway fined $3m
Over 12 million people in the US use prescription drugs for non-
medical purposes.
Approximately 15% of doctors and nurses self-medicate and
abuse prescription drugs.
There are 13,539 (1 every hour) newborns addicted to prescription
drugs each year in the US.
In 2009, Medicaid paid over $720M to cover the cost of treating
these drug-addicted babies.
It is estimated that opioid analgesic abuse results in over $72
billion in medical costs each year.
`
The Drug Abuse Problem
Who must comply with 21 CFR 1301.74b?
DEA Registrant Manufacturers, Distributors, Importers
& Exporters of any Controlled Substance (1301.11a)
“The registrant shall design and operate a system to
disclose to the registrant suspicious orders of
controlled substances.”
Suspicious Orders are described as “deviating substantially in
size, frequency, or pattern.”
Suspicious Order Monitoring
What is SOMLink?
SOMLink is a suite of tools that uses statistical analytics
that comply with the DEA 21 CFR 1301.74b regulations
which are designed to alert and flag suspicious orders
that flow through your order management system.
SOMLink also acts as a historical repository of your
investigative actions on orders of interest. This data is
easily accessible to defend against an DEA audit.
About SOMLink
⦿ Commercially available since 2010
⦿ Oversight from current DEA consultants and
statistical analysts.
⦿ Embedded Statistical and Comparative Engine.
⦿ NDC - Drug Family cross reference
⦿ Repository for recording investigation notes
⦿ Thresholds
● Analysis and loading of data - “Know your Customer “
⦿ Customizable
● Integration
● Extendable and scalable
● Comparison of pharmacies of similar size and volume in similar
geographic locations
● Affordable
SOMLink Environment
⦿Systems / Platforms
● Linux, Windows Servers, Series I*
● SQL Server, Oracle*,
⦿Order Management Integration
○ SAP
○ JD Edwards
○ Ross ERP
○ Others
SOMLink Features
⦿Available as software (behind firewall) or in the
Cloud
⦿Easy to use Dashboard
● Administrative Level
● Ability to address outstanding “Orders of Interest” quickly and
efficiently.
⦿Integration
● Database, XML, Web Service, Text Files.
● SSIS, Altova and others.
⦿Deployment
● Behind client's firewall: Secure, data stays in client’s control.
⦿Reporting
● XSLT Reporting
● Altova Stylevision
⦿Multi-Company / Multi-division support
SOMLink Performance
Please Note:
SOMLink performance varies depending on the following:
● Available Hardware
● How many validation tests are turned on
● Configuration settings, i.e. Peer Review, Threshold
● Total Number of Orders
● Total Number of Order Lines
Configurations
Total Number of Analytical Tests - 6
Thresholds : ON
Total Number of Orders : 665,696
Total Number of Order Lines : 13,986,273
Average Lines per order : 27.8
Platform
Windows 2008 Server
SQL 2008 R2 Standard Edition
Machine: Dual quad-Xeon (E5520, 2.27GHz), 24 Gigs of
RAM
Web Server: OC4J
SOMLink Audit Support
⦿Historical Repository - One place to go
● Notes - cannot be deleted once entered
● Attachments
○ emails
○ internal docs
○ correspondence with customer
⦿Historical Repository access
● Dashboard Search
○ Order
○ Customer/ DEA Registrant
○ Date
● Report engine - Altova XSLT Report Writer
Additional DEA/SOM Services
⦿ SOM Onsite Assessment
⦿ Pharmacy Site Reviews- Onsite or Longitude
⦿ SOP Review & Comment
⦿ Training
⦿ New Account Investigations
⦿ Best Industry Practices- “Know your customer”
Summary
⦿ Balanced oversight and support from both a
regulatory (current DEA consultants) and a
operational (statistical analysts) perspective.
⦿ Available in software or in the Cloud
⦿ Embedded Statistical and Comparative Engine.
⦿ NDC - Drug Family cross reference
⦿ Repository for recording investigation notes
⦿ Thresholds
● Analysis and loading of data - “Know your Customer “
⦿ Customizable
● Integration
● Extendable and scalable
● Affordable
⦿ Personalized Customer Service- Team execution to
insure efficiency and timely delivery
SOMLink
Suspicious Order Monitoring Solution
Questions / Next Steps
Call or email us to get started with e-SupplyLink
(231) 933-7212 or sales@e-supplylink.com
Todd LaBonte, CEO, Solution Architect

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SOMLink the Innovator in Suspicious Order Monitoring

  • 1. Suspicious Order Monitoring Solution Todd LaBonte, CEO, Solution Architect
  • 2. About Us Founded in 1999 e-SupplyLink has been supporting the Life Sciences Industry with innovative and efficiency-driven software solutions. In 2010 with the launch of SOMLink we presented one of the first Suspicious Order Monitor (SOM) offerings on the market to assist our clients in complying with the Controlled Substances Act and the DEA's “Know your customer” policy. Other compliance solutions: ComplyLink - B2B shipping system that bolts on to existing EDI or Warehouse Management System.
  • 3. McKesson fined $150M / Kaiser Permanente fined $850K (one phamacist) / Safeway fined $3m Over 12 million people in the US use prescription drugs for non- medical purposes. Approximately 15% of doctors and nurses self-medicate and abuse prescription drugs. There are 13,539 (1 every hour) newborns addicted to prescription drugs each year in the US. In 2009, Medicaid paid over $720M to cover the cost of treating these drug-addicted babies. It is estimated that opioid analgesic abuse results in over $72 billion in medical costs each year. ` The Drug Abuse Problem
  • 4. Who must comply with 21 CFR 1301.74b? DEA Registrant Manufacturers, Distributors, Importers & Exporters of any Controlled Substance (1301.11a) “The registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances.” Suspicious Orders are described as “deviating substantially in size, frequency, or pattern.” Suspicious Order Monitoring
  • 5. What is SOMLink? SOMLink is a suite of tools that uses statistical analytics that comply with the DEA 21 CFR 1301.74b regulations which are designed to alert and flag suspicious orders that flow through your order management system. SOMLink also acts as a historical repository of your investigative actions on orders of interest. This data is easily accessible to defend against an DEA audit.
  • 6. About SOMLink ⦿ Commercially available since 2010 ⦿ Oversight from current DEA consultants and statistical analysts. ⦿ Embedded Statistical and Comparative Engine. ⦿ NDC - Drug Family cross reference ⦿ Repository for recording investigation notes ⦿ Thresholds ● Analysis and loading of data - “Know your Customer “ ⦿ Customizable ● Integration ● Extendable and scalable ● Comparison of pharmacies of similar size and volume in similar geographic locations ● Affordable
  • 7. SOMLink Environment ⦿Systems / Platforms ● Linux, Windows Servers, Series I* ● SQL Server, Oracle*, ⦿Order Management Integration ○ SAP ○ JD Edwards ○ Ross ERP ○ Others
  • 8. SOMLink Features ⦿Available as software (behind firewall) or in the Cloud ⦿Easy to use Dashboard ● Administrative Level ● Ability to address outstanding “Orders of Interest” quickly and efficiently. ⦿Integration ● Database, XML, Web Service, Text Files. ● SSIS, Altova and others. ⦿Deployment ● Behind client's firewall: Secure, data stays in client’s control. ⦿Reporting ● XSLT Reporting ● Altova Stylevision ⦿Multi-Company / Multi-division support
  • 9. SOMLink Performance Please Note: SOMLink performance varies depending on the following: ● Available Hardware ● How many validation tests are turned on ● Configuration settings, i.e. Peer Review, Threshold ● Total Number of Orders ● Total Number of Order Lines Configurations Total Number of Analytical Tests - 6 Thresholds : ON Total Number of Orders : 665,696 Total Number of Order Lines : 13,986,273 Average Lines per order : 27.8 Platform Windows 2008 Server SQL 2008 R2 Standard Edition Machine: Dual quad-Xeon (E5520, 2.27GHz), 24 Gigs of RAM Web Server: OC4J
  • 10. SOMLink Audit Support ⦿Historical Repository - One place to go ● Notes - cannot be deleted once entered ● Attachments ○ emails ○ internal docs ○ correspondence with customer ⦿Historical Repository access ● Dashboard Search ○ Order ○ Customer/ DEA Registrant ○ Date ● Report engine - Altova XSLT Report Writer
  • 11. Additional DEA/SOM Services ⦿ SOM Onsite Assessment ⦿ Pharmacy Site Reviews- Onsite or Longitude ⦿ SOP Review & Comment ⦿ Training ⦿ New Account Investigations ⦿ Best Industry Practices- “Know your customer”
  • 12. Summary ⦿ Balanced oversight and support from both a regulatory (current DEA consultants) and a operational (statistical analysts) perspective. ⦿ Available in software or in the Cloud ⦿ Embedded Statistical and Comparative Engine. ⦿ NDC - Drug Family cross reference ⦿ Repository for recording investigation notes ⦿ Thresholds ● Analysis and loading of data - “Know your Customer “ ⦿ Customizable ● Integration ● Extendable and scalable ● Affordable ⦿ Personalized Customer Service- Team execution to insure efficiency and timely delivery
  • 13. SOMLink Suspicious Order Monitoring Solution Questions / Next Steps Call or email us to get started with e-SupplyLink (231) 933-7212 or sales@e-supplylink.com Todd LaBonte, CEO, Solution Architect