At INTERPHEX, in March 2009, an expert panel convened to discuss the challenges facing the pharmaceutical industry in meeting the FDA's guidance regarding e-pedigree, and to address the larger global issues surrounding the implementation of RFID as part of a secure supply chain solution. Participating on the panel from the RFID Security Alliance (RFIDSA) were moderator, Louis Parks, President and CEO of Secure RF Corporation, Michael Pinney , Principal of Sixweight, Andrew Strauch, VP Marketing from Mikoh, Michael McCartney, Founder and Principal QLM Consulting and myself. The RFIDSA is a consortium of industry experts and stakeholders assembled to address security as it applies to the implementation of RFID technologies and systems. The Alliance aims to be a visible resource to the RFID community providing information and promoting collaboration through identifiable symbols, Web presence, and organizational involvement.. This article recaps our discussion on the key points and considerations that confront the pharmaceutical and biotech industry in adopting RFID as a solution to securing the Global Supply Chain (GSC).
Several essential considerations have emerged,including:
• Asset tracking – supply chain management
• Pedigree reporting
• Recalls and reverse logistics
Asset tracking is a broad term used for establishing track and trace capability within the supply chain. From API, excipient and component suppliers through to the pharmacies that dispense medications to patients, it is essential that a thorough system be put in place to provide visibility from beginning to end as the product moves through the supply chain. While establishing such a system may seem routine through distribution, including the pharmacies in this solution is a significant departure from historical practice. Similarly, these systems have been designed to provide information and not to ensure the integrity and the veracity of the information. These added factors drive up the complexity and broaden the scope of considerations when evaluating an asset tracking solution.
Much of the focus on GSC security centers on the issue of drug adulteration and counterfeiting. Although precise and detailed data on counterfeit medicines is difficult to obtain, estimates range from around 1 percent of sales in developed countries to over 10 percent in developing countries, according to the geographical area. Many countries in Africa, parts of Asia and Latin America have areas where more that 30 percent of the medicines on sale are counterfeit, while other developing markets have less than 10 percent overall (Source WHO). If these numbers are debatable, the impact of adulterated or counterfeited drugs is clear. Such added complexity is the genesis for the FDA's and industry's interest in the RFID solution. The 2006 FDA Anti-Counterfeiting Force document states: "We continue to believe that RFID is the most promising technology for implementing electronic track and trace in the drug supply chain." (Source: FDA Task Force Report: 2006 Update). The panel agreed with this assessment but emphasized that the strength of applying RFID lies in marrying the technology with a well-defined security strategy. The technology itself presents great flexibility: the capabilities within the RFID chip to verify and flag discrepant material are as well understood as are the counter measures to defeat them. Figure 1 captures a few of the ways an RFID chip solution can be compromised.
Securing the nation's food supply from contamination, as witnessed by the recent high-profile salmonella outbreaks, represents a parallel problem. Ensuring that product brought into the country has been processed properly and is in compliance with USDA and FDA regulations is of great concern, and the panel felt the challenges closely mirrored those of the pharmaceutical industry.
The issue of anti-diversion presents several degrees of urgency; the first being the financial impact of diverted product sold on the market. But, issues such as the potential damage to brand image and confidence in products were also discussed. From a track and traceability perspective, the dangers incurred by diversion are the same as for anti-counterfeiting.
Establishing a traceability report or drug "pedigree", detailing when and where all components of the product have been in the GSC is the central problem for the industry today. The FDA has issued its guidance and expectations with regard to a drug's pedigree. While largely technology-agnostic, the guidance makes reference to the application of RFID. To date, industry has been slow to respond to the guidance and the FDA has not been vigorous in its enforcement, making compliance somewhat of a back burner issue for pharma. Part of the dilemma is deciding how much is enough. The FDA is looking for security within the GSC and is leaving it to industry to implement a solution. Possible solutions range from a paper trail of documentation, as advocated by the International Pharmaceutical Excipients Council (IPEC), to individual serialization of every tablet manufactured. Many large pharmaceutical companies have implemented limited RFID for their high-value products, but it is unclear to what extent a thorough security strategy has been associated with the selected solution.
Part of the reluctance to embrace RFID has been the cost of implementation. While the cost of simple RFID chips has dropped significantly to approximately $0.05 for a simple chip, fully loaded chips capable of providing the level of verification required by pedigree implementations are closer to $0.60 at high volume. This is a healthy hit to the standard cost of many drugs today. Couple this with the escalating percentage of generic drug introductions (NB: the number of generic drug filings with the FDA has more than doubled since 2002.) and the pressure on profitability is a key consideration in implementation.
Recalls and Reverse Logistics
One key area where track and trace technology can assist organizations is in the event of a recall or market field action. A high level of visibility can afford a company immediate insight into product distribution and should reduce the costs and effort associated with product recall and recovery.
The challenge in implementing track and trace solutions in the healthcare arena can be attributed to the lack of standards. In January 2009 the GS1, an organization dedicated to establishing global standards in the supply chain, issued its traceability standards for the healthcare industry. Electronic Product Code (EPC) Global, also charged with establishing global standards for electronic coding, issued its standards for applying RFID in the supply chain. To date, our industry has not discussed adopting these standards as our path forward, nor has the FDA mandated this. In January, 2009, the FDA issued its own draft guidance in terms of serialization titled "Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages. " This guidance attempts to define the critical information required to establish a pedigree within the GSC. This is an excellent first step toward standardizing solutions across the industry. As a draft guidance, it is still open to comment from industry.
Security and Privacy
The application of RFID has had its share of high-profile issues. Most significant of these is the privacy issue surrounding sensitive information placed on an RFID tag. Many states are contemplating extending the pedigree into the pharmacy to ensure the security of the supply all the way to the patient. In a recent discussion forum it was clearly stated "Pharmacies need to be unimpeachable about the security and privacy of their customer's records."(Source: RFID in the Pharmacy: Q&A with CVS). The challenge, once again, centers on the security of the implementation of this technology. The issues can be distilled down to a trade-off between security and privacy with potentially large consequences to both patient safety and compliance with HIPAA.
Securing the GSC is a multifaceted undertaking and, like all complex analyses, one size does not fit all. Technology today has evolved to a point where a solution currently exists to fit the GSCs track and traceability needs. 2D and 3D bar codes are mature technologies that have been used across industries around the world. Their strengths and weaknesses are well understood. RFID has been employed in many facets of everyday life, from our "Fast Pass" bridge toll collection technology to our Passport information. Emerging technologies such as Physical Unclonable Functions (PUF) represent the latest breakthroughs in semiconductor security. PUF is a silicon "biometrics" technology, a type of electronic DNA or fingerprint technology for semiconductor ICs. PUF extracts unique "secrets" from each IC. These secrets are used to authenticate ICs, and enable a broad range of security applications. Nanotechnology has also crept into the field with several manufacturers providing the capability of individually serializing every tablet produced in a lot. Regardless of the technology evaluated, the effectiveness in securing the GSC can only be established through applying these solutions within the context of a detailed security strategy which factors in cultural, governmental and regional business practices in its overall solutions matrix.
The challenges facing securing the GSC are many in today's global market. Yet, significant progress has been made in moving to recognized standards to be used by the industry to establish a clear security roadmap. The trade-offs between technology and traceability must be made with all of the socio-technological issues related to privacy we are facing today. To do this effectively will require a holistic approach, in which security considerations are the primary factor in selecting technology and establishing a drug pedigree to demonstrate the safety of our products. If we can do this, our industry will fully leverage the opportunities present in emerging markets and do so with some immunity from adulteration, diversion and counterfeiting, which plague these marketplaces today.