Pharmacy & Therapeutics - June 2008 - (Page 360)

TECHNOLOGY California e-Pedigree Rules Pose Challenges for Pharmacies Will the FDA Follow in the Golden State’s Footsteps? Stephen Barlas N othing has united the sometimes fractious players in the pharmaceutical industry like California’s e-Pedigree requirement for prescription drugs. The e-Pedigree law states that all drug packages must contain a serialized number for tracking the movement of pharmaceuticals through the supply chain to combat counterfeit or adulterated products. California was the first state to set a deadline for e-Pedigree compliance—for January 1, 2009. However, generic and brand-name manufacturers; wholesalers; purchasing cooperatives; and community, chain and hospital pharmacies pressed the California Board of Pharmacy to delay the deadline. On March 25, 2008, the Board moved the date back by two years to January 1, 2011. The prospect of the looming 2009 deadline had conjured up nightmare scenarios in the pharmacy sector. It is the pharmacies, more than the manufacturers or the wholesalers, that have the more complex technical task and that face the higher cost hit, based on percentage of revenues. The big revenue hit would come from the need to purchase various types of bar code readers, radiofrequency identification (RFID) chip readers, and software and database upgrades so that pharmacies will be able to authenticate each individual package from the bar code or the RFID chip (or both) attached to each package label. Underlying that pyramid of costs is the unpalatable fact that no single, intraoperative e–Pedigree technology exists, nor is one likely to appear—even by the beginning of 2011. The two-year delay might seem as if it is giving the participants a lot of time, but it is not. Some pharmacies anticipate that they will be able to conquer the technical conundrums and costs related to e-Pedigree, but Walgreens’ boast in September 2007 that it was preparing a “very big catcher’s mitt” to catch the variety of serialization technologies likely to cross its plate sparked a perturbed retort from PharmKee, Inc., a group of 10 pharmacies serving rural areas in California. David Wilcox, president of PharmKee, replied that he could afford only a very small mitt and that he was likely to get hit, figuratively and financially, in some delicate places come January 1, 2011. The e-Pedigree requirement is likely to knock the wind out of many pharmacies. In response to the Board’s March 25 decision to reset the deadline to 2011, Bruce Roberts, RPh, Executive Vice President and Chief Executive Officer of the National Community Pharmacists Association (NCPA), said this: While we certainly support the concept of using Track-andTrace technology to limit the fraud and abuse of prescription drugs, the 2009 deadline was a logistical impossibility that lacked specificity for the affected parties. We hope the delay will allow those lingering issues to be addressed, including providing financial relief for community pharmacies that would be required to buy the expensive equipment for this unfunded mandate. Those “lingering issues” are momentous; they resonate not only for pharmacies, manufacturers, and wholesalers doing business in California but also for industry participants nationally. Other state legislatures, most notably New York, are in the process of following in California’s footsteps. Maybe, more importantly, there is a chance that the Food and Drug Administration (FDA) will adopt its own, national e-Pedigree requirement, one that might parallel California’s—or it might not. In the FDA Amendments Act (FDAAA) that was passed last September, Congress included a section that requires the FDA to develop a standardized numerical identifier … no later than 30 months after the date of the enactment of FDAAA. This … identifier is to be applied to a prescription drug at the point of manufacturing and repackaging at the package or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription drug. Stephen Barlas is a freelance writer based in Washington, DC, who covers issues inside the Beltway. The FDAAA doesn’t appear to have set a deadline for the FDA to actually require application of that “identifier” to the drug package; however, the FDA has been concerned for the past decade about counterfeit drugs. In February 2004, the FDA’s Counterfeit Drug Task Force issued a report mentioning that the agency expected widespread adoption of RFID tagging of drugs in 2007, based on what technology suppliers and drug companies were saying at that time. That advance never happened. In fact, even now, in mid-2008, few companies are placing RFID tags on product containers beyond ver y limited pilot projects. Ever yone talks about Pfizer’s tagging of sildenafil (Viagra) coming from France; this has been going on for about a year. But even in this most celebrated case of RFID tagging, some matters have not been resolved. Tom McPhillips, Vice President of the U.S. trade group at Pfizer, says that in December 2007, the company began to exchange pedigree information with only one trading partner Accepted for publication May 6, 2008. Disclosure: The author has no commercial or financial relationships to report in regard to this article. 360 P&T® • June 2008 • Vol. 33 No. 6

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - June 2008

Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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