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Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.
Supply chain security and quality group Rx-360 driven by patient safety.
Following the recall by FDA in 2008 of heparin due to contamination of raw material from China, the pharmaceutical industry realized that greater management and control of the supply chain was needed to properly protect patient safety. The result: creation of the Rx-360 Consortium, an industry group focused on sharing information and developing processes to enhance the integrity of the healthcare supply chain that complements the efforts of regulatory agencies. Five years later, Rx-360 has established itself as a resource for the industry by providing valuable information and tools related to supply chain security and quality. The organization is currently working to expand its efforts to pharmaceutical markets in developing regions of the world.
The biggest success for the Rx-360 Consortium, according to Rx-360 chair Brian Johnson, who is also senior director of supply chain security at Pfizer, is that the group is viewed as an industry thought leader in supply chain safety and patient safety. He notes that the group has established a very effective mechanism for raising awareness of counterfeiting, product diversion, theft, and other harmful activities and is now seen as a key source of supply chain intelligence. In addition, Rx-360 has published numerous white papers and developed other supply chain security tools that it shares for free on its website. The Consortium also hosts free training webinars on key supply chain security topics. “Our goal is to help everyone in the supply chain increase their ability to protect the integrity of the supply chain,” Johnson says.
A key accomplishment for the group has been the development of the Joint Audit program, which allows multiple companies working with the same business partner to participate in a standardized audit without sacrificing product or process confidentiality. “The program is designed to significantly reduce audit costs, standardize the audit scope, expand the number of audits conducted, and ultimately reduce supplier audit fatigue while maintaining a high quality standard,” observes Johnson. “With this program,” he adds, “it is possible for pharmaceutical companies to more effectively allocate their limited resources and achieve greater reach into the supply chain.” In June 2014, Rx-360 announced a strategic partnership with BSI Supply Chain Solutions to streamline the audit process and ensure supplier compliance with quality and security standards through verification audits.
These various initiatives are, however, only part of the reason Rx-360 is viewed as a thought leader by both industry members and regulators, according to Johnson. The Consortium’s commitment to sharing and communication of information is just as crucial. “Rx-360 was founded on a culture of transparency and openness, and our activities are all driven by the need to ensure patient safety. It is necessary to be inclusive, transparent, and open, and to communicate about all issues so that problems can be identified and resolved. Patient safety is not a competitive advantage,” he asserts.
Diverse range of projects
Recent projects either completed or initiated by Rx-360 cover numerous aspects of supply chain security and involve various approaches to providing information and assistance. White papers made available on the website are written by subject-matter experts and provide tips and suggestions for dealing with challenging issues. One recent example focuses on responding to the problem of cargo theft, which has been an issue for pharmaceutical manufacturers in Italy. The thefts generally involve organized crime and hijacking. The white paper discusses steps that companies can take to reduce their exposure to these types of incidents. Also in 2014, a white paper describing tools and techniques for managing the supply chain and maintaining supply chain integrity was published. According to Johnson, two to three such papers are prepared each year.
Back in the US, Rx-360 pursued an educational campaign targeting the medical community on why purchasing drugs from known, validated sources is critical. Counterfeit, substandard, and diverted medicines represent a serious patient safety risk and can enter the legitimate supply chain via healthcare providers purchasing from unknown sources, according to Johnson. The issue was clearly highlighted when fake Avastin was found in the United States on two separate occasions in 2012. “Education and awareness within the medical community about safe buying practices is an important part of the battle against fake medicines,” he notes. Also in September 2014, the Consortium announced its support for FDA’s “Know Your Source” campaign, which encourages healthcare professionals to verify the source of their prescription drugs and utilize suppliers licensed in-state.
In Africa, Rx-360 has been working to provide information on effective pharmaceutical distribution practices. “It is often a significant challenge to get safe medicines to people in need in Africa due to the lack of proper distribution infrastructure and awareness of the storage and handling needs of many drugs. We have developed materials on good distribution practices (GDP) and are providing them to pharmaceutical companies and distributors through a series of GDP Workshops in Africa in order to help address the shortcomings and increase the likelihood that key medicines will be delivered safely,” he explains.
In the serialization space, Rx-360 is focusing on issues that are not being addressed by other groups. In particular, a working group has been established to look at potential data architectures for serialization that will enable the smooth movement of drug products from one market to another. The Traceability Data Exchange Architecture Work Group, established in August 2014, is a collaborative work group set up to support serialization and track and trace legislation that is evolving globally. “The focus of the group,” says Johnson, “is to develop conceptual models for the interoperable exchange of information needed to comply with global regulations.” The group is expected to have a white paper available by the end of 2014 for discussion at industry forums. The workgroup is tri-chaired by Lloyd Mager of AbbVie, Peggy Staver of Pfizer, and Brian Rezach of Actavis.
With the numerous successes that Rx-360 has achieved in its first five years, Johnson believes the group is positioned to expand its efforts in a variety of ways. He first notes that globalization has led to increasing complexity in the supply chain, with raw materials manufactured in one part of the world, drug substance produced in another, final drug products packaged in a third and then distributed globally. “As a group, Rx-360 was initially focused on the US and European Union, but we do realize that emphasizing markets that are already highly regulated will not solve the problem. Therefore, we are increasing our efforts around the world, with the ultimate goal of covering the entire globe,” comments Johnson.
The first initiative was launched in 2013 when the Asia Working Group was established in China. This group is doing a lot of the same work that Rx-360 is doing in the US, but from an Asia/China perspective and with the hopes of influencing supply chain integrity in the region, according to Johnson. The Consortium is also in the process of establishing a similar working group in India. Rx-360 is in discussions with a number of stakeholders and is building momentum for achieving the critical mass needed to formally launch the group.
The Consortium is also focused on expanding participation in the organization by groups involved in the pharmaceutical supply chain other than drug manufacturers and their direct suppliers. “There are a lot of people involved in the supply chain, including distributors, carriers, service providers, and others, and we want to engage with all of these groups in order to be able to evaluate supply chain security issues in a truly holistic manner,” Johnson states.
Driving volume in its Joint Audit program is another major goal for Rx-360. With a larger number of companies participating in the program, the number of available audit reports will increase. As a result, pharmaceutical manufacturers will be able to rely on the joint audit program for lower risk audits of reliable suppliers, and focus their resources on higher risk sources, according to Johnson. “We want this program to be as successful as possible for the industry, and thus we are committed to increasing the volume of audits,” he says.
Finally, Rx-360 is also looking to expand its user base and leverage its knowledge of supply chain security for the benefit of related industries. One of the first efforts is the Medical Device Initiative, which was launched in May 2014 to identify and address the supply chain quality and security needs of medical device companies. The Medical Device Working Group was created to integrate the goals and priorities of the medical device industry into the existing supply chain security programs of Rx-360, according to Johnson.