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Controlled Substances Ordering System (CSOS)

Controlled Substances Ordering System (CSOS). A Case Study – April 18, 2007. Agenda. CSOS History and Overview Benefits and Challenges to Adoption CSOS Current Status Ongoing Challenges Moving Forward. History of CSOS.

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Controlled Substances Ordering System (CSOS)

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  1. Controlled Substances Ordering System (CSOS) A Case Study – April 18, 2007

  2. Agenda • CSOS History and Overview • Benefits and Challenges to Adoption • CSOS Current Status • Ongoing Challenges • Moving Forward

  3. History of CSOS • DEA tasked under the Controlled Substances Act of 1970 to regulate controlled substances • Purchasers (pharmacies and distributors) of controlled substances have historically used a controlled paper DEA Form 222 to place their orders • Industry requested DEA provide a provision to enable electronic orders for controlled substances to integrate with their existing electronic orders for non-controlled substances • An allowance to existing regulations, not a mandate

  4. Concept of Operations

  5. The Benefits of CSOS • Improved customer service • The Regulations provide allowances for new business processes such as centralized ordering from a single location for all stores within a chain • Reduced manual effort • Manually prepared paper order forms will be replaced by electronically generated orders • Paper order form is limited to ten line items per order; No limit on the number of line items on electronic orders • Reduced errors • Paper order form requires handwritten product description • Electronic orders will identify the product by its National Drug Code (NDC) • Improved security measures • Order originator authentication • Order content integrity • Non-repudiation of involvement by parties to a transaction

  6. CSOS Milestones • Initiation Phase began 1999 • Industry Pilot conducted 2002 through 2005 • Final Rule published June 2005 • CSOS launched August 8, 2005 • Obtained WebTrust for Certification Authorities (CA) April 14, 2006 • FBCA Cross-Certification awarded July 2006

  7. Software Challenges Facedby Industry • Subscribers may hold multiple certificates – one for each location for which they are ordering. Software needed to select which location and use appropriate certificate • Integrating PKI into existing ordering software systems across multiple and diverse platforms

  8. Success Factors • DEA worked extensively with industry groups: • Early engagement with Healthcare Distribution Management Association (HDMA), National Association Chain Drug Stores (NACDS) and many other major pharmacies, distributors, and manufacturers • 3-Year CSOS Pilot to demonstrate proof of concept • Test platform to provide industry with suite of test certificates • Commercial software vendors to CSOS-enable software • Assisted industry with technical challenges • HDMA EDI 850 Working Group extend the 850 Purchase Order transaction set to accommodate digital certificates • Incorporated DEA authorization information (schedules, authorized shipping location, etc.) into X.509 v3 extensions to replace DEA Form 222 data

  9. Electronic Order (Example) Business Activity Code Registrant Information Order Line Elements

  10. Certificate Extensions Containing DEA Form 222 Information Microsoft Certificate Viewer DEA Extension Information Registrant Information printed on DEA 222 form

  11. Results! • Several commercial CSOS software packages now available to industry • 33,569 certificates issued to 12,333 Registered DEA locations to date – majority of these have been smaller independent pharmacies • Larger chains have indicated a readiness to adopt in 2007

  12. CSOS Ordering Trend To date – there have been 2,211,151 transactions (order line items) ordered electronically, providing significant savings in processing costs to the Pharma industry

  13. Ongoing Challenges • Educating others on CSOS’ unique role as a Credential Service Provider (CSP) to industry • Signed B2G transactions are not required by DEA • Certificates only used in B2B transactions between supply chain partners within a regulated industry

  14. Ongoing Challenges • Ensuring that systems not under DEA governance are compliant with performance standards specified in updated 21 CFR • DEA requires external audit of system to ensure that FIPS 140-2 and 21 CFR requirements are met • DEA Diversion Investigator’s Toolkit developed so that DEA can audit and analyze electronic transactions in the field

  15. Ongoing Challenges • Industry cannot be required to operate on a specific platform • Minimal support for SHA-256 and RSA 2048 algorithms presently available • Software development time • Commercial vendors and industry require sufficient lead time to update software in accordance with changes to the Regulations or NIST algorithms • Educating Pharma community about PKI

  16. Moving Forward • Successfully completed second WebTrust for CA audit • Readying for increased adoption rates as chain pharmacies come on board • Working with industry to prepare them for new NIST algorithms

  17. Questions? www.deaecom.gov 1-877-332-3266 1-877-DEA-ECOM

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