The Importance of Pedigree: Why Instituting RFID-Based Tracking of Pharmaceuticals Is Essential to Counteracting Counterfeiting and Maintaining Both the Health of the Public and the Potency of the American Drug Industry
Bibliographic record
Abstract
EXECUTIVE SUMMARY This article investigates the fast-growing problem of counterfeit prescription drugs, examining the toll being exacted by counterfeit medicines worldwide. The article also looks at the health concerns caused by the rising tide of fake pharmaceuticals. It then examines how leading pharmaceutical companies are seeking to protect their brands, bottom-lines, and patients through the use of RFID to ensure the integrity of their product. The article also provides an update on legislative efforts to improve pharmaceutical supply chain security. Finally, the article examines forecasts for growth in this area, with an analysis of the future of the pharmaceutical market for RFID. Keywords: RFID (Radio Frequency Identification), Pharmaceutical Industry, Supply Chain Security, Product Theft, Counterfeiting, Government Regulation INTRODUCTION Pharmaceuticals play a more prominent role in American health care than in any other nation. The North American market today comprises 47 percent of the global prescription drug market, which now exceeds half a trillion dollars, with Americans spending approximately $251.8 billion annually on pharmaceuticals. This is up significantly from a decade earlier, when American consumption represented approximately one-third of the world market (IMS Health, 2006a). America's insatiable demand for prescription drugs has led to serious cracks in the drug supply chain of the world's leading pharmaceutical market. This article examines the size and scope of the problem of counterfeit pharmaceuticals, both globally and in the United States. It looks at the impact this crisis is having both on public health and the pharmaceutical industry. Today, leaders in both the pharmaceutical industry and government are looking to more stringent regulations and RFID (radio frequency identification) tagging of pharmaceuticals as a way to head-off the problems associated with an increasingly leaky drug supply chain. This article outlines the steps being taken in the United States to help secure this vital supply chain. Finally, an analysis is given of the impact the shift to electronic pedigrees of pharmaceuticals will have both on the pharmaceutical and RFID marketspaces. THE GLOBAL EPIDEMIC OF COUNTERFEIT DRUGS The World Health Organization (WHO) estimates that as much as 10 percent of the global pharmaceutical market - a halftrillion-dollar marketplace - is counterfeit. In some countries, the WHO estimates that 25 percent or more of the entire drug supply is counterfeit. The New York City-based Center for Medicines in the Public Interest recently predicted that by 2010, counterfeit drug sales will reach $75 billion worldwide, almost doubling from the estimated counterfeit sales in 2005. The FBI (Federal Bureau of Investigation) estimates that the financial impact of counterfeit drugs on U.S. companies is $30 billion a year (Brooks, 2006; Eban, 2006). Today, the toll of counterfeit drugs is mounting worldwide: * Last year in Hamilton, Ontario, Canada, Abadir Nasr, a retail pharmacist, was arrested for dispensing counterfeit doses of Norvasc® to heart patients - pills filled with only talc. The local coroner investigated five patient deaths - all caused by a heart attack or stroke - that may have been brought about by the substitution of the counterfeit drug (Pitts, 2005). * Within the last year, counterfeit versions of three popular drugs - Lipitor® for cholesterol, Cialis® (for erectile dysfunction) and Reductil® (for obesity) have surfaced in England. One British expert, Graham Satchwell, has estimated that 100,000 counterfeit drug imports are dispensed by the National Health Service annually (Eban, 2006). * Lipitor® is a cholesterol reducing medication taken by more than 600,000 Americans, making it the most widely prescribed drug in the country. The U.S. Food and Drug Administration (FDA) announced on August 31, 2005 that it had busted a Lipitor counterfeiting ring that was trafficking almost $50 million worth of the drug (Gottlieb, 2005). …
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.025 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.004 | 0.006 |
| Scholarly communication | 0.009 | 0.009 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.005 | 0.005 |
| Insufficient payload (model declined to judge) | 0.009 | 0.003 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".