Rx-360 Advances Supply-Chain Security

Rx-360, a pharmaceutical industry supply-chain consortium, is advancing approaches between pharmaceutical companies, suppliers, and contract manufacturers as a means to better secure the pharmaceutical supply chain. Pharmaceutical Technology discussed the group’s recent activities and upcoming goals with Brian Johnson, chair of Rx-360 and senior director of supply-chain security at Pfizer.

PharmTech: Can you outline the key accomplishments of Rx-360 during the past year and what is planned in the near term?

Johnson: We continue to see headlines around the world where criminals are putting patient safety at risk to make money through counterfeiting, product diversion, theft, and intentional adulteration. Substandard drugs with little or no active ingredient are being found at very high levels in the legitimate supply chains of many poor countries. Most experts and published data show that the problem is getting worse, not better. Globalization and increasing supply-chain complexity are contributing to the problem. It is time to take action and Rx-360 is leading the way. Rx-360 is a global nonprofit consortium of more than 80 companies and organizations with a mission to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain. Rx-360 accomplishes its mission through education, sharing information, promoting best practices, and sharing audits. A few highlights from the past year demonstrate our commitment to action.

Education. Rx-360 believes that educating stakeholders on supply chain risks and, more importantly, solutions is key for the industry to be successful. A great example is Rx-360’s recent “Protect Your Patients - Know Your Suppliers” campaign targeted at educating healthcare practitioners on the risks of product diversion. Rx-360 also conducted six free educational webinars for the industry this past year providing solutions and best practices for other supply-chain threats.

Sharing information. Supply-chain security is not a competitive advantage. Rx-360 believes that freely sharing information, such as alerts on potential supply-chain threats, is vital to the industry’s success. Over the past year, Rx-360 issued 14 alerts, including a potential heparin shortage, use of ‘gutter oil’ in China, toxins in glycerin, reports on Hurricane Sandy, and Avastin (bevacizumab). [Gutter oil is a term used in China to describe illicit cooking oil, which has been recycled from waste oil collected from various sources, such as restaurant fryers, drains, grease traps, and slaughterhouse waste; improper use of gutter oil involves its use in excipient manufacture.] Rx-360 also published 80 summaries of new guidances, legislation, and regulations.

Promoting best practices. It is not enough to talk about the risks; the industry needs to develop and share best practices. Over the past 18 months, Rx-360 developed and published seven white papers that contain the industries best thinking on various supply-chain security topics such as: preventing cargo theft; risks of drug shortages; tools for product diversion; auditing logistics service providers (LSPs); comprehensive supply-chain security programs; incident management processes; and monitoring the marketplace for threats--these examples are real solutions to real problems.

Sharing audits. Industry collaboration on sharing audit information and jointly conducting audits is crucial to improving the transparency of our increasingly complex and global supply chains. Rx-360 has completed and published almost 100 audits to date, and in 2013, we are on pace to double the number of audits completed in 2012, so we are quickly gaining momentum. Helping drive this initiative was the recent completion of a lean six sigma analysis of our audit programs and making modifications in the process to make it easier, quicker, and more cost effective for companies to use. Our new database is also coming online, which takes a manual process and automates it, leading again to a simpler, more efficient process for all involved. We are also launching a pilot to conduct good distribution practice (GDP) audits, which we believe will help Rx-360 meet an important industry need. Finally, over the past year, we have been promoting the licensing of Rx360 audits by making it easy to purchase an audit already conducted by Rx-360 and helping to defer costs that sponsors of the original audit incurred. This approach allows companies sponsoring an audit to put proceeds towards future audits, thereby, increasing capacity and lowering costs.

For more information on Rx-360, including free tools and resources, see www.rx-360.org~.