Monday, October 24, 2016
Ensuring Patient Safety Across the Supply Chain: Rx-360 Supply Chain Security Working Group Minimize

Ensuring Patient Safety Across the Supply Chain:
Rx-360 Supply Chain Security Working Group


The following interview with Rx-360’s Supply Chain Security Working Group leaders, Brian Johnson, Senior Director, Supply Chain Security, Pfizer and Tim Valko, Executive Director, Operations Risk Management, Amgen, highlights the exciting new work being done with Rx-360 to ensure patient safety.  The new group is looking at supply chain security holistically – from raw materials to the patient.


Rx-360: Before we get started, can you explain what supply chain security is specifically?


Johnson: Supply Chain Security are the systems and processes,  from “materials to patients,”  that we use to prevent, detect and respond to economic adulteration, theft, illegal diversion, fraud, and counterfeiting.   

It begins with components and continues through manufacturing, packaging, warehousing, distribution, returns of samples and finished goods; and ends with the consumption by the patient or upon final destruction.

Recent examples of supply chain issues include: a heist from a Lilly warehouse which resulted in $75 MM of stolen medicines; cases of economically motivated adulteration in Heparin, infant formula, pet food, and cough syrup; and fake anti-malaria drugs which kill an estimated 100,000 Africans a year (World Trade Organization).


Rx-360: Why did you decide to create this working group?

Johnson:  Crime involving the combined threats of cargo theft, diversion, counterfeiting and economically motivated adulteration is on the rise around the world.  With this and Rx-360’s mission in mind - “to enhance patient safety by developing a global quality system that helps members ensure product quality and authenticity throughout the pharmaceutical supply chain” – we knew a more comprehensive approach to this problem was needed to protect patients.  

We began assessing the work currently being done across the industry, and we discovered that while certain pieces of supply chain security were being addressed, no organization was looking at the issue holistically.   

Up until now, Rx-360 has been focusing on affecting significant change in the audit space.  Tim and I recognized the opportunity to expand the work Rx-360 is doing and got approval to initiate this working group in October of this year.  Our group is looking at issues in the supply chain and tackling them holistically. We’re partnering with existing organizations and leveraging the work being done in the industry and filling the gaps, creating that comprehensive look at supply chain security.

Valko: And this is all aligned with what we feel is the next area of focus for Rx-360.  We’re excited to be able to leverage the consortium and benefit from the previous work and administration of Rx-360 to advance on the topic of patient safety.

Rx-360: What is the group focused on achieving?


Valko: Our objectives are to develop and share best practices and information on key supply chain security processes and to enhance collaboration among supply chain stakeholders on issues of supply chain security.


The scope of our work focuses on counterfeiting, theft, adulteration, fraud, and illegal product diversion, and includes key processes to prevent, detect, and respond; advocacy and education/awareness; materials, manufacturing (internal/external), transportation, warehousing, distribution, market monitoring, consumers, and reverse logistics.


At the end of the day, we’re focused on making significant changes as quickly as possible – specifically through delivering best practice documents, position papers, surveys and benchmarking, emerging crisis or threat response, and intelligence sharing. 


Rx-360: There appears to be a lot of momentum and opportunity with this group – what are you focused on right now?

Valko: We have kicked off four limited-duration teams to start with:


1) Supply Chain Security (SCS) Management System


The objective is to develop a simple, standard management system rooted in best practices that drive measurable and sustainable improvements to a firm’s SCS program. Through an open sharing of these practices across the industry, our goal is that SCS will become a widely adopted system of protection for all patients.


One of the ways we’re doing this is through developing a “maturity model” approach with Supply Chain Security – establishing different levels of maturity, with initiating on one end of the spectrum, and best-in-class on the other end.  Under this model we’re developing specific detail around terms and the actions we’ll be taking.


2) Supply Chain Security Audits & Assessments - Third Party Provider Locations


The main defense against threats is a robust security program with minimum standards conveyed via contracts, assessments and audits. Our goal with this team is to complete Key Deliverables and develop consensus among industry professionals.


The initial focus of this team is to develop tools and techniques used in auditing logistic service providers.  This could eventually lead to us to look at sharing audits or conducting joint audits like the GMP work streams.


3) Conveyance Security Risk Management

This team looks at the security measures we take to protect goods when they are moved around the world.  The objective of this team is to benchmark risk management thinking and approaches that different companies are using and develop a “points to consider” document that can be shared broadly across the industry to help companies develop, compare, or enhance their programs.  The study will be aimed at developing these points to consider for risk modeling parameters.  Our goal is to strengthen the overall supply chain by sharing our best thoughts.

Supply Chain Security Market Monitoring Charter

The team is looking at how can we scan, analyze and mine data to see signals describing threats in the market place. This team is also developing an understanding of how many companies are utilizing active programs in internet monitoring and market signal detection, and understanding the technologies existing and emerging that are being employed by pharmaceutical manufacturers.  We’re working on developing guidance on adoption and deployment of these tools for best results and effectiveness.

We’re currently developing shared practices and will be determining where and how we will publish these.


Rx-360: This topic of supply chain security is one that has been of particular importance to regulators recently.  How are you aligning with regulatory expectations?


Valko: It’s true – just this summer the FDA announced that its Center for Drug Evaluation and Research (CDER) was creating a new office called the Office of Drug Security, Integrity & Recalls (ODSIR), to “take the lead in dealing with issues such as supply chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls,” (as stated by Dr. Janet Woodcock, CDER Director).


In an effort to align with the work being done in the FDA, our team recently met with this group on the topic and they were supportive of the work we are doing.   


Rx-360: What do you find to be the most exciting aspects, and the biggest opportunities, for this group?

Johnson: What is exciting for us is that through this new working group, Rx-360 is the only organization that has now pulled together the entire supply chain picture under its mandate.  There are so many opportunities for companies to collaborate in the interest of patient safety.  As an industry we generally do more competing and less collaborating – but this is an issue where we are all in it together against the criminals.  

Valko: Having the ability to benchmark and share how we’re addressing makes good business sense too - by collecting better information faster, we’re all learning and getting broad visibility to how firms manage SCS.  We’re establishing a network.  

One recent example involved an Rx-360 company looking to implement a new GPS tracking device. They were able to contact another Rx-360 company to learn how to best conduct their implementation. 

This is a space that we’re all benefitting from and it benefits the patient.

As other Rx-360 members have commented before, patient safety is not a competitive advantage. We’re all in this together and protecting patients is something we can do together. 


Rx-360: What is your vision for this team?


Johnson:  Our vision for this workstream and Rx-360, is that it be made up of a broad spectrum of supply chain participants.  In addition to manufacturers and suppliers that are already Rx-360 members, we need to add other supply chain partners such as carriers, distributors, logistic service providers, brokers, pharmacies, and law enforcement.  Collaborating across the supply chain is the only way we will succeed.  Additionally, recognizing that we are working in a truly global marketplace we need broader representation from other regions of the world such as Asia and Latin America.




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