Rx-360 CEO, Mark Paxton, Featured in the World Korean Medical Journal

  1. Rx-360 is an international pharmaceutical supply chain consortium dedicated to protecting patient safety. Please explain Rx-360’s strategies, mission and activities to our readers.

Rx-360’s mission is to promote patient safety by sharing information and developing processes to improve the integrity of healthcare supply chains and the quality of materials moving in those supply chains.

To meet this mission, Rx-360 has pioneered a joint audit program for upstream suppliers, downstream distributors and others that are engaged in moving materials and products in commerce that must be properly qualified by manufacturers. In doing so, we manage audits of raw materials and basic chemicals, packaging materials, excipients, active pharmaceutical ingredients, wholesalers and common carriers by multiple sponsors who are each blinded from each other. In this way, we can lower the cost of the audits to each sponsoring manufacturer while simultaneously reducing the increasing audit burden on their trading partners.

In addition to the joint audit program, we have developed multiple white papers covering best practices for securing the integrity over the entirety of supply chains. We do this through internal work groups that are comprised of subject matter experts from our member companies. They have done a terrific job covering a myriad of programs and at any given time, we may have up to 15 active work groups operating at various stages.

  1. Your function and audit programs you offer are not only important for the patients but also for pharmaceutical companies as well. Can you explain about the benefits pharmaceutical companies would receive from working with Rx-360?

As noted above, the pharma companies benefit by sharing the costs of audits performed uncommon suppliers. They also are blinded from each other when they do so, so we can alleviate anti-competitive concerns that may otherwise exist. In addition, once an audit report is finalized, we make them available to purchase by third-party firms that did not participate in the audit. Those revenues are then used to provide credits to the original sponsoring firms that will offset the costs of future audits they need to perform –up to 100% of their original audit cost.

While these are clear benefits to finished product manufacturers, the benefits to the suppliers that are audited can be even more extensive. For suppliers that sell components and other materials to pharmaceutical and medical device companies, they are frequently under pressure to allow audits to their customers as part of the customers’ required vendor qualification programs. For suppliers that have hundreds of customers at a given site, the burden of audit requests is truly unsustainable. Consequently, our joint audit program helps to alleviate that burden.

Finally, under the new EU rules requiring manufacturers to qualify wholesalers and common carriers before distributing their products, those firms provide services to literally thousands of manufacturers. Therefore, they will absolutely require a joint audit firm like ours, along with a very robust licensing program to third parties, since they simply cannot and will not be able to withstand the avalanche of audit requests coming their way…

To read the article in its entirety download the publication by clicking the link below. Mark Paxton’s interview begins on page 22.

World Korean Medical Journal Issue 12