Friday, October 21, 2016
Forging Ahead to Secure Our Supply Chains Minimize

Forging Ahead to Secure Our Supply Chains

This year efforts to ensure the security of our pharmaceutical supply chain seem to be increasing across the globe – and recent illicit events have underscored the need for these increased efforts.  Examples this year include counterfeit Adderall®1 and counterfeit Avastin®2 discovered in the United States, and the production of unsafe capsules discovered in 254 capsule manufacturers in China3.

We sat down with Brian Johnson, Senior Director, Supply Chain Security, Pfizer and Tim ValkoExecutive Director, Operations Risk Management, Amgen, once again to learn more about what Rx-360 has been doing this year to help secure our supply chain since we last talked in January.  Johnson and Valko lead Rx-360’s Supply Chain Security Working Group, which takes a holistic look at the security of the supply chain - from raw materials to patients. They have brought together volunteers from across industry and regulatory bodies to help advance Rx-360’s global mission to assure the safety of patients.

When we last talked, the Supply Chain Security (SCS) group had recently kicked off four new initiatives and was focused on making significant changes swiftly. Over the past six months, this team has made significant headway.


Rx-360:  When we last spoke, the group had a lot of momentum going into 2012.  What has happened over the past six months?

Johnson: When we kicked off the Supply Chain Security Group in Rx-360, we started with four initiatives and committed to delivering on each of them. I’m pleased to share that in the past six months we have in fact delivered – we have published white papers, held webinars and provided tools at no cost to our colleagues across industry.

What’s great about the work we’re doing is that we’re making an impact – we’re not just a think tank. The white papers we have published, for example, were created in collaboration with multiple companies as well as input from regulatory observers.  These have been provided for the industry to use freely in order to set up their own programs. 

Rx-360 and Supply Chain Security

In the fourth quarter of 2011, Rx-360 kicked off a supply chain security (SCS) initiative with the goal of developing and sharing best practices to enhance the integrity of our supply chains and enhance patient safety. This initiative is looking at SCS holistically – which means working on processes to prevent, detect, and respond to the threats of theft, diversion, counterfeiting, and intentional adulteration across the entire supply chain (from raw materials to patients). 

The industry and its regulators, such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory bodies, are concerned that the drug supply chain is growing increasingly vulnerable to a variety of illegal activities that could have serious public health implications. Given this, Rx-360 member companies are paying increasing attention to the supply chain security of their operations and are collaborating to improve SCS in the industry to help support patient safety globally.

Valko: We’re really pleased with the progress our cross-functional and cross-company team has made in such a brief period of time. As Brian mentioned, the Supply Chain Security Steering Committee and its Working Groups recently delivered a series of white papers, practical tools and webinars on supply chain security all of which were very well received by industry, regulators, and other stakeholders.  Highlights include:

1) White Paper: Comprehensive Supply Chain Security Management System

This white paper, created by Rx-360 member company supply chain security experts, provides industry and other stakeholders with a comprehensive overview of fundamental elements that can be considered for a mature Supply Chain Security program, and provides an introduction to other key program elements that will be expanded on in subsequent white papers and guidelines.   

2) White Paper: Cargo Theft Risk Assessment

This white paper describes risk factors and risk mitigation strategies to prevent cargo theft by providing guidance on how to develop a comprehensive conveyance security program and compliments the new FDA Standard Operating Procedure for staff outlining how the FDA responds to cargo thefts.

3) Guidance and Toolkit: Threats and Monitoring Processes

This document provides a general overview of the definitions, sources, and distribution of Counterfeit, Unapproved and Diverted Drugs in the finished form, as well as a high level summary of Supply Chain Security (SCS) monitoring practices and tools that pharmaceutical companies can use to help detect, deter, and to establish appropriate control for these threats in the supply chain. 

4) White Paper and Toolkit: Audits and Assessments of Third Party Warehousing and Distribution Facilities

The white paper and toolkit developed by the Audits and Assessments team gives any pharmaceutical company the tools necessary to develop a Supply Chain Security program with external warehousing and distribution partners.  The tools were designed with an inclusive approach that captures the best of what all of the contributing members of the team are doing in their individual companies.  This type of approach underscores the true strengths of Rx-360 collaboration.

These white papers, webinar presentations, and other tools are available to anyone who might be interested and can be found on the Rx-360 website by clicking here.

Rx-360: What’s next for the SCS working groups?

Valko: The Steering Committee will continue to address stakeholder needs with the September launch of three new limited duration initiatives:  

1. Incident Notification.  This working group will outline best practices that companies use to elevate and manage supply chain security breaches internally and externally.  A white paper and webinar can be expected from this working group.

2. Illegal Diversion.  This working group will bring together experts to discuss and assess approaches to combating illegal diversion.  The group will deliver paper(s) and/or tools for industry use.  

3. Global Implementation of Serialization Discussion Group.  The objectives of this group will be to share companies' experiences and information regarding global implementation of serialization.  This will be a networking and knowledge/experience sharing initiative.  Specific papers, guidance, tools, etc., are not expected from this group.  

The Committee will also continue its development of a Management Systems Maturity Model.  

Johnson: We’re also continuing to promote more diverse participation in these working groups both geographically and functionally.  Our supply chains are global and we need representation from around the world.  Additionally, we need diversity in the functions represented in our workgroups so we have a good mix of quality, risk management, security, logistics, manufacturing, commercial, etc. and truly represent the broad supply chain.  

Rx-360:  It seems that there is a stronger focus from regulators on supply chain security issues.  How does that impact Rx-360?

Johnson: There is a stronger focus from all supply chain stakeholders, including regulators, as the threats continue to grow.  We are in this fight together.  We applaud the work of regulators around the world for their efforts and welcome their collaboration in the work Rx-360 is doing.  We currently have FDA working with us as observers in Rx-360 and would welcome additional regulatory agencies to participate.  

Rx-360: Where can readers go to get more information about the work you’re doing or to get more involved with the supply chain security working groups?

Johnson: We’ve made great progress so far this year, and we’re really just getting started. We’ve got much more to do and we encourage anyone who might be interested to get involved.

As we all know, the supply chain issues we’re working to prevent and mitigate are real – patients are at risk. The key for us now is to stay vigilant, and we’re doing that through Rx-360.  It’s an amazing opportunity to get involved and make a difference.  

Visit www.Rx-360.org or contact the Rx-360 team at:

Rx-360 at Drinker Biddle & Reath LLP
1500 K Street NW Suite 1100
Washington, DC 20005
Office Phone: 202-230-5189
e-mail: [email protected]


[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm305932.htm
[2] http://www.fda.gov/drugs/drugsafety/ucm291960.htm
[3] SecuringPharma: http://goo.gl/wfhUZ





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