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ASD Healthcare Deploys RFID Refrigerated Drug Cabinets

More than 50 hospitals are using the units, which monitor the quantity and temperature of refrigerated medicines that ASD provides on consignment.
By Beth Bacheldor
Sep 24, 2007ASD Healthcare—a division of AmerisourceBergen Specialty Group that distributes NovoSeven (a treatment for hemophilia) and other specialty life-saving pharmaceuticals—is now offering hospitals an RFID-enabled tracking service. This service automatically monitors the inventory of refrigerated medicines the company provides on consignment.

To date, more than 50 hospitals are using the consignment service, which relies on RFID-enabled Cubixx refrigerators developed by ASD (see Drug Distributor Uses RFID to Vend Meds) and manufactured by Helmer. The refrigerated cabinets are fitted with RFID antennas and interrogators to regularly receive data transmitted by active 433 MHz proprietary RF Code tags that ASD affixes to the shrink-wrap surrounding the drugs' packaging. Each tag contains a unique ID number associated with a specific medicine to which it is attached. The ID number and drug information, including the product's expiration date, is stored in a database maintained by ASD.

Blue Vector's Edge Manager intelligent appliances, installed on the top of each refrigerator, act as RFID middleware. The appliances are wired to the refrigerator's interrogator, as well as to a digital thermometer installed inside the unit. This enables the middleware to continually monitor the quantity and quality of each drug by collecting tag and temperature data. Software built into the appliances can filter out duplicate reads and execute rules governing business intelligence, to create events, alerts and RFID data that are securely transmitted via the Web to a Blue Vector Network Manager at ASD. The Network Manager controls all appliances out in the field, and also shares the data with ASD's customer service and fulfillment systems.

The RFID technology enables ASD to distribute the life-saving, high-cost medicines on consignment. Previously, the company was not able to offer them on consignment. The medicines must be stored at specific temperatures to maintain quality, and it was difficult for ASD to closely monitor the drugs' storage temperature and the length of time they were left outside the refrigerator, and to keep tabs on expiration dates. "Now we are able to offer this valuable service because we have very detailed, real-time information on all the pharmaceuticals, back here in our database," says Chad Herron, ASD's manager of business development. The distributor is currently tagging hundreds of unique products.


Henry Ames 2007-09-26 02:05:05 PM
FDA's Position of RF Use Around Biologics Dear Beth Bacheldor, FDA Compliance Policy Guide (CPG) Sec. 400.210, Nov 2004 “Radio Frequency Identification Feasibility Studies and Pilot Programs for Drugs” FDA excluded biological products (note: cold chain drugs are primarily biologic-based drugs) as eligible for RF pilot studies because there was - Insufficient information about the potential impact of radio-frequency (RF) on biologics. (CPG Sec. 400.210, Nov 2004, pg. 3, states: “The drugs involved will be limited to prescription or over-the-counter finished products. The drugs involved will not include those approved under a Biologics License Application or protein drugs covered by a New Drug Application.” On June 8, 2006, the FDA published the “FDA Counterfeit Drug Task Force Report: 2006 Update”. In this report, the FDA referenced the earlier 2004 CPG reiterating that they have not received sufficient information to change this policy. I believe that a major pharmaceutical manufacturer and the FDA have both begun studies with MIT to determine the potential affect RF may have (thermal and non-thermal) on biologic-based drugs but I do not beleive the findings have been published. Based on the material referenced above, could you please tell me how ASD Healthcare has obtained approval from the FDA for the use of the RFID-enabled Cubixx refrigerators? Is there some new FDA guidance that you can point me to? Have any new studies recently been published? Sincerely, Henry Ames

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