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A Q&A with Brian Johnson, senior director of supply chain security at Pfizer, moderated by Patricia Van Arnum. Part of a special Ingredients issue.
This article is part of PharmTech's supplement on Ingredients, Excipients, and Manufacturing 2011.
PharmTech: On an overall industry basis, what would you identify as the most significant issues facing pharmaceutical companies in terms of supply-chain security?
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Johnson: Globalization and the resulting complexity in our supply chains are resulting in increased threats for product theft, diversion, economic adulteration, and counterfeiting. Where companies buy raw materials, manufacture products, and sell products is rapidly changing. On a global basis we are seeing increased criminal activity in all of these threat categories. This is necessitating changes in how we operate. Relying on traditional GMP [good manufacturing practices] and GDP [good distribution practices] alone are not enough. We are in a war against the criminals who are risking patient safety for financial gain.
Brian Johnson, senior director of supply chain security at Pfizer
PharmTech: Issues such as product theft, product diversion, economic adulteration, and counterfeit goods are areas of concern for pharmaceutical companies. On an industry wide basis, what would you identify as the significant initiatives or programs in place or under consideration to address supply-chain security, first looking at the United States?
Johnson: There is a lot of work being done by pharmaceutical companies, suppliers, government, law enforcement, and distributors to address supply-chain security threats in the US market. It is going to take cooperation by all components of the supply chain to be successful. The weakest link in the supply chain will be exploited by the criminals.
FDA recently published a strategic plan, "Pathway to Global Product Safety and Quality" (1). It outlines four FDA focus areas that include: increased global regulatory cooperation, improved information sharing, improved intelligence and information-technology capability, and allocating agency resource using risk-management principles. Foundational to these efforts is engagement and cooperation with all supply-chain stakeholders. FDA recognizes that we are in this together.
There also are a number of trade organizations, consortiums, and coalitions working on various aspects of this global problem. Many of these are cooperative efforts between industry, government, and law enforcement. Some examples are: the Pharmaceutical Security Institute (PSI) and the Partnership for Safe Medicines (PSM) , which are working on counterfeiting; the Pharmaceutical Cargo Safety Coalition (PCSC), which is working on cargo theft; and the recently formed Supply Chain Safety Consortium, which is working on track and trace. Rx–360, an international pharmaceutical supply-chain consortium, is a great example of a consortium where these efforts are coming together to look at supply-chain security holistically. All of these organizations are doing great work.
PharmTech: On an industry wide basis, what would you identify as the significant initiatives or programs in place or under consideration to address supply-chain security in Europe?
Johnson: The European Union's Directive on Falsified Medicinal Products will drive a number of supply-chain security enhancements when implemented (2). Some key focus areas include: unit level authentication, tamper evidence , increased regulation of Internet pharmacies, enhanced controls around importation of APIs and excipients, and increased penalties for supply-chain security crimes. There are also a number of trade organizations, consortiums, and coalitions working on various aspects of the problem in Europe, including some of those previously mentioned. I think we are getting closer to a broad recognition that supply-chain security is a global issue for a global market requiring better collaboration and harmonization.
Other international efforts
PharmTech: How do these initiatives in the US and EU connect with activities in Asia (such as in China and India) and other international programs?
Johnson: Both the FDA strategic plan and the EU directive recognize international cooperation among regulators as a key to success in our new global marketplace. The International Conference on Harmonization (ICH), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and the World Health Organization's International Medical Products Anti-Counterfeiting Taskforce (WHO–IMPACT) are examples of where this is happening. Law enforcement also collaborates internationally on supply-chain security issues through organizations such as Interpol.
Many of the organizations that I previously mentioned (i.e., Rx–360, PSI, and PSM) also recognize the global nature of the supply-chain security problem and are working to pull international stakeholders together. As an example PSM just created an Indian chapter, and Rx–360, which is already an international consortium, is working hard to increase engagement in Asia.
PharmTech: Counterfeit goods are a concern not only in terms of revenue loss, but also in the misdirection of consumers believing they are taking a drug that may or may not be effective or even potentially harmful. What types of technologies and strategies can a pharmaceutical company use to authenticate its drug product to the consumer?
Johnson: Pfizer has a broad range of technologies that it uses to authenticate drug products with the consumer, such as color-shifting inks, radio frequency identification, and 2D barcodes. These examples are primarily overt technologies, meaning they are typically adapted to the end user that will be performing the authentication. Track-and-trace initiatives around the world are driving the need for standardization of technologies, and the use of 2D barcodes for authentication is becoming the technology of choice.
PharmTech: Are there specific approaches in place at Pfizer that you would like to discuss in terms of drug-product authentication or other anticounterfeiting approaches? Can you provide best practices or examples of specific programs in place at Pfizer to achieve supply-chain security?
Johnson: Pfizer typically has used a risk-based approach for determining the authentication needs for our drug products. In other words, we address the need for anticounterfeiting and authentication measures on an individual product basis and based on the market/regions where the product is sold. We are implementing a life-cycle approach to help us formalize the process for choosing when and what to use and also when to discontinue use over the life cycle of the products.
I think the key to Pfizer's approach to supply-chain security was the development of a "One Pfizer" strategy across the company. We recognized that the threats were increasing, our business was rapidly changing, and we could improve our collaboration/alignment across the different functional groups involved in protecting our supply chains. We defined the supply chain as starting with raw materials that we use in our products until the finished product is delivered to our patients. We are focusing on strengthening processes across the supply chain.
To provide leadership and governance, we created a supply-chain security function and a standing cross-functional team. Some of the functional groups represented on this team include quality, global security, procurement, commercial trade, global logistics and supply, external supply, packaging technology, and public affairs.
1. FDA, "Pathway to Global Product Safety and Quality" Report (Rockville, MD, July 7, 2011).
2. EC Directive 2011/62/EU, Directive on Falsified Medicinal Products (Brussels, June 2011).