The Best Medicine: Protecting Pharmaceuticals From Counterfeiting with Radio Frequency Identification

Introduction

All across the landscape, both the mostly real one of trade show floors and in the virtual world of news-wires and blogs, there are mixed signals regarding the status of RFID (Radio Frequency Identification) in the American pharmaceutical market. There is pressure from the federal Food and Drug Administration (FDA) to implement the Prescription Drug Marketing Act, and yet, an injunction from a federal court that has stymied FDA efforts to require the use of track-and-trace systems – and legal analysts forecast this stay may remain in place for several years. There are proposals in Congress, including the Reducing Fraudulent and Imitation Drugs (RFID) Act, which will require the integration of counterfeit-resisting technologies into the packaging of all pharmaceuticals. Yet, states such as California and Florida have not waited on a federal solution, opting to take matters into their own hands and have state-level e-pedigree mandates for pharmaceutical tracking.

Successful Pilots

We’ve seen successful RFID pilots from drug manufacturers on highly susceptible target brands, including AstraZeneca (Diprivan), GlaxoSmithKline (Trizivir), Pfizer (Viagra), and Purdue Pharma (Oxycontin). Likewise, we’ve seen major pharmaceutical distributors, including AmerisourceBergen and Cardinal Health, have successful RFID track and trace pilots in their operations, which are central to the prescription drug supply chain in the US.

At the same time, there’s a battle emerging over which frequency level to use for tracking pharmaceuticals, with major forces lined-up supporting both UHF and HF systems, producing a real fear that there may not be one communications protocol for use in the pharmaceutical sector. There’s division between the pharmaceutical companies, the large and small pharmaceutical distributors, and retailers over not just the size of the investment needed to smarten the drug supply chain, but the very real question of which parties gain the benefits and which level will incur what costs as RFID tracking of pharmaceuticals rolls out.

Then, there’s the very real discussion of ROI, and how gains can be accurately measured and just how long the time horizons might be for RFID to pay-off.

The “Perfect Incubator” for RFID Applications

The pharmaceutical market has been characterized by analysts as the “perfect incubator for item-level RFID applications,” due to high-value, high-volume products it deals with and its absolute need for safety and compliance, making it easier for pharma supply chain actors to justify their auto ID technology investments. Yet, for all the touted benefits of integrating RFID into the pharmaceutical supply chain – for control, for management, for integration, for recall, for patient compliance – none exceeds the simple fact that RFID can help save lives by reducing the threat of counterfeit drugs around the world. As Robert Kashmer, vice president of Information Technology for the major drug wholesaler, H. D. Smith, recently observed: “To be honest, I get discouraged when I hear people in our industry talking constantly about “finding the ROI”. This is about patient safety! Increasing efficiency is a goal, but secondary.”