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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
Whenever a drug is taken from a Cubixx unit, its removal is documented, thanks to an electric switch in the refrigerator door, which activates the RFID interrogator each time the door is opened and closed. This, explains John Beans, Blue Vector's VP of marketing, triggers the device to read all tags on the pharmaceuticals within the unit. Each reading compiles an inventory of all that is stocked in the refrigerator. Customers are only charged for drugs that have been removed from the refrigerators and kept out for at least three hours, unless state pedigree laws require an instant transaction. The service also regularly records temperatures within the refrigerators via a digital temperature gauge inside each unit.

Because each tag ID number is associated with the drug's expiration date, the RFID service helps keep tabs on a product's remaining shelf life. The system alerts ASD six months before a specific medicine is about to expire, Herron says, enabling ASD to call the hospital consigning that drug and request that hospital staff move it to the front of the refrigerator to make sure it is used first. Another expiration alert is triggered at the three-month mark, at which time ASD asks the hospital to return the pharmaceuticals to the distributor. ASD also replenishes the original customer's supply with a new batch. According to Herron, products stored at correct temperatures generally have a shelf life of two to three years.

ASD tracks the drugs from the time they leave ASD's distribution center to the point of arrival at the customer's site. The pharmaceuticals are then placed within the RFID-enabled refrigerators. "One of the big differences between what we do with our consignment program and what others are doing," Herron states, "is we can offer 100 percent, iron-clad pedigrees for all our products. We track each pharmaceutical from the time it is shipped to our distribution centers, and we buy only direct from manufacturers and authorized distributors, so we can make sure they are cold-chain-compliant, and that product integrity is being upheld."

ASD began testing the service late last year, and started rolling out a commercial service in June. The company provides the RFID-enabled Cubixx refrigerators and access to a secure Web-enabled site, where customers can view inventory data for free, as part of its consignment service.


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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