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On June 5, 2009, over 125 global attendees, representing some 70 organizations from across pharmaceutical, biotechnology, and generic drug manufacturing industries, along with their suppliers, professional trade associations and regulatory agencies, came together at the Ronald Reagan Building and International Trade Center in Washington, DC to officially launch Rx-360 as a legal, nonprofit entity.
The Rx-360 advisory committee organized the launch meeting in an effort to increase awareness, solicit membership, pressure-test share audit models, and collect feedback from attendees. Topics at the meeting explored the global impact of counterfeits and the legal considerations and challenges of creating a consortium like Rx-360. As a volunteer, member-driven organization, the Rx-360 advisory committee saw the meeting as an important opportunity to hear attendees’ opinions on Rx-360. Participants were polled electronically regularly during the meeting with the help of handheld voting devices.
In an overwhelming show of support, 100% of participants said they thought there was a need for an organization like Rx-360 during one of the first polls of the meeting.
The consortium will have four distinct functions that can best be done collectively. The four functions are as follows:
1) Adopting Standards and Best Practices: the consortium will scan external sources for the best available standards today that will assist in improving the performance of the supply chain. The goal will be to prompt consortium members to adopt best practices with a sense of urgency. Then after implementation, the consortium will look to identify any gaps in the standards, aimed at improving on these standards.
2) Technology Development: The consortium will work with research organizations, such as Massachusetts Institute of Technology (MIT) and University of California at Berkeley, and research institutions in Europe to develop new technologies that will secure the supply chain and to detect if there has been tampering with the supply chain.
3) Monitoring: The consortium will act as a clearinghouse for suspicious supplier and supply-chain information that might impact patient safety such as suspected tampering, contamination or adulteration of materials or the signs of a disruption in the supply chain causing a shortage that could lead to unethical individuals to take advantage of the shortage to counterfeit or adulterate materials for economic gain at the expense of patient safety. Consortium members will report suspicious events to the consortium, which will disseminate the initial information, evaluate the impact of the information on its members and then develop potential proactive solutions for its members to consider adopting.
4) Shared Supplier Audits: The consortium will provide for a wide range of auditing services such as GMP, GDP, EHS and supply chain security. The consortium will develop a system that will make audits broader and more thorough, and allow firms to share audit findings and corrective actions making the system more effective and efficient. The concept will reduce the number of audits at a particular supplier but increase the effectiveness of the audits performed. Each manufacture will then take this information and make their own independent assessments on the appropriateness of a supplier based on its own company policies and product needs.
The majority of attendees at the June meeting indicated that of the four Rx-360 functions, they were most interested in shared audits.
There are many noble initiatives around the world, attempting to solve this complex global problem. Rx-360 will attempt to bring these various initiatives together, leveraging the strength of each initiative rather than trying to compete with these initiatives. If we fail to leverage the strengths of each initiative through coordination and collaboration, the end result will be a system and supply chain with a higher risk profile that could lead to more patient deaths and a lack of consumer confidence in their medications.
I strongly urge everyone to work collaboratively to solve this complex global problem, putting aside individual interest, so that we can put global systems, procedures and practices in place that will effectively and efficiently protect and serve patients. To this end, the ISPE (International Soc. for Pharmaceutical Engineering), IPEC (International Pharmaceutical Excipients Council), EFCG (European Fine Chemical Group), SOCMA (Synthetic Organic Chemical Manufacturers Assn.), NIPTE (The National Institute for Pharmaceutical Technology and Education), BIO International and others have agreed to work collaboratively with Rx-360 such that the missions of all organizations are served.
For more information on the consortium, details on the actual presentations and polls conducted, and membership opportunities, go to www.Rx-360.org. PC
ABOUT THE AUTHOR
Martin van Trieste is the Advisory Committee leader of Rx-360, and also Vice President, Quality, Commercial Operations, at Amgen.