Pharmacy & Therapeutics - June 2008 - (Page 361)

California e-Pedigree Rules (probably a wholesaler, although he doesn’t identify the partner). “This was the result of six-plus months of effort between solution providers, trading partners, and Pfizer,” Mr. McPhillips told the California Pharmacy Board in January 2008. He added that it was his “best estimate” that electronic serialization at the item level for the company’s entire product line would take his company five to seven years. The expense of the RFID tags—7 cents to 25 cents per tag, depending on the type (high frequency or ultra-high frequency) and the volume, in addition to some of the technological issues (such as the lack of intraoperable standards)—has forced many companies to use only two-dimensional (2D) bar codes on their packages. Biogen Idec is probably the first company that will be able to serialize all of its packages for its products (which number only two), by January 1, 2009, far ahead of any other firm. Biogen Idec is putting 2D DataMatrix bar codes on each package of vials and syringes of its two multiple sclerosis products—interferon beta-1a (Avonex) and natalizumab (Tysabri)—in part because the FDA has not approved RFID for use on packages of biologic agents. Bob Hamm, Executive Vice President of Pharmaceutical Operations and Technology at Biogen Idec, states: RFID is the ultimate solution. However, it is still unproven where biologics are concerned. Biogen Idec opted for 2D bar codes based on the information available when we were designing our solution.” Barbara Brungess, spokeswoman for AmerisourceBergen, says: While we strongly prefer that manufacturers embrace RFID because it offers the most efficient solution, we are willing to work with those who roll out 2D bar code serialization as an interim step. This is especially true for biotech manufacturers, as the industry still awaits the results of studies conducted by the FDA to determine what effect, if any, the scanning and reading of RFID tags has on biological products. “Biogen Idec is the first company to publicly announce itemlevel serialization for its entire product line,” says Kamal Mustafa, President of Secure Symbology (SSI, Inc.). SSI, a company in Wayne, New Jersey, is providing the bar code printing, product aggregation, and database operations that were installed at Catalent’s commercial packaging facility in Philadelphia, where both Avonex and Tysabri are packaged. Catalent is based in Somerset, New Jersey. It is the serialization of each item-level package that is the expensive part of the California e-Pedigree requirement, making previous packaging operations look like horse-and-buggy days. In the past, only the lot number and expiration date were printed in a large linear bar code. After the serialization is completed, creating and integrating the e-Pedigree down the distribution line, and authenticating it, are technically the more difficult parts of the process. SSI’s Mustafa claims that the cost of installing his “modules”—three on the Biogen Idec lines—can range anywhere from $100,000 to $400,000. In Biogen Idec’s case, the company is paying an incremental additional cost for every carton of product printed with a 2D bar code on the Catalent line, an incremental cost that basically reflects SSI’s capital costs. Costs are also a huge issue for wholesalers and pharmacies. Whereas RFID is the high-cost option for manufacturers, it is the low-cost option for wholesalers. When a Biogen Idec truck pulls up to an AmerisourceBergen warehouse in California, the guys working there must open each case of Avonex and Tysabri and pull out each carton to read the 2D DataMatrix bar code with the serial number. This task is incredibly laborintensive. Given their economies of scale and their small number of distribution centers, wholesalers will probably be much better able to handle the different serialization technologies that arrive on their doorsteps. Pharmacies face the same challenge, except that the costs will be a much larger percentage of revenues than for the wholesalers, and other workforce concerns will crop up in relation to e-Pedigree authentication. Typically, wholesaler “A” sends to each pharmacy a “tote”— a large sack of sorts—containing cartons of products from all the manufacturers with whom that wholesaler works. After the California requirement kicks in, each manufacturer may use one of a number of different serialization technologies, thereby creating an authentication nightmare for pharmacies. One retail pharmacy chain told the California Board of Pharmacy that it would take $54 million for one distribution center covering 591 pharmacies to achieve end-to-end serialization. David Wilcox of PharmKee thinks that independent pharmacists should be compensated for the costs associated with buying multiple scanning technologies. The estimated costs for a retail pharmacy to comply with e-Pedigree requirements are anywhere between $10,000 and $40,000. These expenses include obtaining the hardware and software as well as the staff training necessary to administer, monitor, and maintain the system, as required by law. Chain pharmacies estimate their initial per-store implementation costs at $25,000 to $35,000 and an additional $5,000 to $6,000 per year. The California Pharmacy Board is unlikely to balk again on the e-Pedigree requirement in January 2011. So the pitch is coming. Walgreens may have a big catcher’s mitt by then, but other pharmacies may have to settle for a long chest protector. I CALL FOR PAPERS P&T is now accepting article submissions from its readers. We welcome a wide variety of manuscripts, including drug class reviews, disease state management reviews, pharmacoeconomic analyses, strategies for coping with medication errors, outcomes research evaluations, DUEs, P&T committee experiences, commentaries, book reviews, and letters to the editor. We are also interested in receiving articles for both continuing education (CE) and continuing medical education (CME) credit. Articles to be considered for dual accreditation should provide an overview of topics that are directly relevant to health care practitioners. Please see our author guidelines at PTCommunity.com. You can contact the editor, Sonja Sherritze, via telephone: 267-685-2779, or e-mail: ssherritze@medimedia.com. Vol. 33 No. 6 • June 2008 • P&T® 361 http://PTCommunity.com

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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