A lead technologist of a transfusion service laboratory at a university hospital in Massachusetts reports that her staff issued a 4.8 mg vial of recombinant rFVIIa to the emergency room for treatment of a bleeding patient, only to have the vial returned unused and unopened five hours later. Since the drug was not refrigerated during the time that it was out of the blood bank's control, the blood bank staff were wondering what to do with the product. They are reluctant to discard the vial, since it costs about $5000 to replace. They contacted the drug manufacturer for guidance. The manufacturer provided written correspondence that strongly cautioned against using the drug, saying:

1. it does not recommend use of its products in any manner other than as described in its prescribing information
   
   
2. it does not recommend use of the drug when stored outside refrigerated conditions prior to reconstitution
   
   
3. the effects of administering improperly stored drug are unknown

However, the written correspondence implied that the estimated shelf life of the drug is reduced by approximately four months for each day of storage at 25C, while protected from light.

The inquiring colleague wonders if her lab should change the expiration date of the drug and shorten the shelf life of the vial by 4 months, or just discard the vial. What would others do?

The following comments have been received.

ADDENDA Mar. 27, 2007

1. A transfusion medicine physician in Detroit reports that she would discard the product. She comments "There are too many unknowns here to take a chance on the potency of the drug when it has been improperly stored. What if you were to later use this product and a patient had a reaction? Never mind whether it had anything to do with the storage of the product. With documentation that you had been advised by the manufacturer not to use the product and then done so, this would put you in a bad position." She suggests that the wastage of such an expensive drug be brought to the attention of the hospital administration and that it be investigated whether the financial loss can be charged to the responsible department!

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