Global Track & Trace Solution — Compliance Applications Layer
As part of the Axway Healthcare Platform, Axway brings best-in-class Compliance Applications to the GTT Solution, including solutions for CSOS (Controlled Substances Ordering Systems), ePedigree and region-specific compliance needs, including Turkey Compliance. To learn more about the components of the GTT Compliance Applications Layer, click on the colored boxes below.
Axway’s CSOS Solution
The DEA enforces the Controlled Substances Act with regulations that provide a framework for the legal distribution of controlled substances. Form 222, the DEA’s paper-based form for ordering controlled substances, must be filled out in triplicate and costs an estimated $30 per form to complete and track. Cost control, heightened security, and greater visibility into transactions have driven the healthcare industry to adopt an electronic alternative to Form 222: the e222. Working with pharmaceutical manufacturers, distributors, and purchasers, the DEA created the Controlled Substance Ordering System (CSOS) with the express purpose of:
- Reducing paperwork and manual effort
- Speeding transaction time
- Lowering costs per transaction
- Accelerating access to historical documents
- Enhancing security measures
- Improving system integrity
CSOS outlines the procedures and requirements to secure, report, and retain the e222 form for ordering and distributing controlled substances. In addition, CSOS serves as a catalyst to modernize a number of existing ordering, tracking, and supply chain functions.
Synchrony™ CSOS won the Healthcare Distribution Management Association’s iBusiness Award for its ability to deliver increased security, cost control, and greater visibility into transactions, end-to-end, while ensuring compliance with DEA regulations. Synchrony™ CSOS leverages pre-configured profiles for its existing customers, such as all of the Big Three Pharma distributors, 70% of regional distributors, and top manufacturers and retailers, making interaction throughout the supply chain easier.
Synchrony™ CSOS leverages the ubiquity of Axway’s market leading business-to-business connectivity platform to deliver the following advantages:
- Easily connects to the DEA and supply chain partners.
- Automates manual order processes to increase order frequency and reduce order cycle time.
- Delivers real-time visibility for improved order tracking end-to-end.
- Reduces supplier’s burden to verify buyer DEA status.
- Makes it easy to deploy to large communities to manage orders.
- Increases security over conventional processes.
- Automatically archives and recalls orders in human readable formats.
- Fully complies with CSOS requirements (e.g., reporting and auditing).
- Works with existing IT infrastructures via an open, extensible framework.
For more information about the Axway CSOS Solution, please visit www.axway.com.
Axway’s ePedigree Solution
Combating counterfeit drugs is a focus of many government regulators and the pharmaceutical supply chain because of the obvious risks to patient safety. Manufacturers of high cost, high value pharmaceuticals are also concerned about the impact of counterfeit drugs incidents to their brand and revenue. However, despite regulatory and product security efforts across the supply chain, the problem of counterfeit drugs continues to grow. Drug industry analysts estimate that nearly 10% of drugs worldwide are counterfeit. Also, the World Health Organization estimates that US$32 billion in legitimate corporate sales are lost each year due to the sale of counterfeit drugs. This number is expected to grow to US$75 billion by 2010.
To help combat the growing problem of counterfeit drugs, state and federal regulators in the United States require pharmaceutical supply chain constituents to provide drug pedigrees, or custodial histories. These pedigrees trace each drug’s chain of ownership from the pharmacy back to the manufacturer. While some states allow this to be a manual paper-based process, it requires significant effort from the various supply chain participants to maintain complete records, and has questionable success. Most regulators are looking for a tighter, more secure process than manual tracking. In many states, legislation requires or will require electronic pedigrees to be exchanged. This makes the tracking and retrieval of Pedigree easier for all members of the supply chain, and for regulators.
Axway’s award-winning Synchrony™ ePedigree automates the creation, transmission, tracking, and retrieval of electronic pedigrees to help prevent counterfeiting and safeguard the drug supply. It ensures compliance to regulatory mandates by various states and supports the recommendations by the U.S. federal government. Built on reliable, market-tested platforms used by many manufacturers, wholesalers, and retailers, Synchrony™ ePedigree guarantees the authenticity of origin and demonstrates possession as pharmaceutical drugs move through the supply chain. It delivers a clear trail of ownership—with signed and stored forms—at each step of the process. As a result, it enables:
- Support for both serialized and non-serialized data in compliance with all state and federal ePedigree mandates
- Complete visibility into the custodial history of a particular drug, drug lot, or item serial number
- Security and integrity to assure product integrity and patient trust
- Comprehensive archiving, reporting, and alerting for regulatory compliance and exception management
- Continuous alignment with the evolving electronic product code (EPC) and RFID standards
- Title 21 CFR Part 11 compliance for electronic records and digital signatures
- Safer drug supply
For more information about the Axway ePedigree Solution, please visit www.axway.com.
Axway’s Turkey Compliance Solution
Supply chain fragmentation has driven a number of changes within the industry over the last ten years including consolidation of wholesale distribution in the U.S. and growth of pan-European distributors in the European Union (EU). It has increased the number of intermediaries managing a vast network of distribution points and a rapidly expanding specialty market. As a result, transparency of the pharmaceutical distribution supply chain has decreased. Meanwhile, labor shortages, unequal access and quality concerns continue to plague the system. Combined, these factors increase the economic incentives for counterfeiting, diverting pharmaceuticals, and reimbursement fraud.
Throughout the world, Track & Trace technology is intended to trace the chain of custody and/or ownership of a product all the way back to the manufacturer. Many pharmas making decisions about technology for compliance are moving towards global solutions instead of specific solutions for a geographic region. Turkey is leading the way in requiring companies to implement track and trace solutions driving pharma companies to make a decision not only about the immediate need to comply with Turkey requirements but to also address their long term strategy for global compliance and the implementation of a global track and trace solution.
Axway’s Synchrony™ Compliance solutions allows companies to meet not only the directives put out by the Turkish Ministry of Health but also prepares a company for all future track and trace initiatives across the globe. Axway’s solution for Turkey compliance provides:
- Trading Partner defined in Axway
- Generate and allocate serial numbers
- Extract data from customer’s back-end system (manual or scheduled)
- XML output—extract data formatted and published
- Transports file and receives ACK from recipient
- Updates correlation engine (links ACK to records for audit purposes)
- Query engine to support TMOH queries and data requests
For more information about the Axway Turkey Compliance Solution, please visit www.axway.com.