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Cerebyx Errors

Dosage errors have been associated with fosphenytoin (Cerebyx) since its approval in 1996 and, despite label changes, seem to be continuing.
   Initially, the label displayed only the amount of Cerebyx per milliliter (50 mg PE/ml), and health care staff misread that measure as the amount of Cerebyx per vial. Because Cerebyx vials contain either 2 or 10 ml (100 or 500 mg PE/vial), this mistake led to two-fold and ten-fold overdoses, five deaths, and additional nonfatal overdoses. In 1999, the drug maker made prominent label changes and sent a “Dear Healthcare Professional” letter to help reduce the errors.
   Unfortunately, it seems that these efforts may not be solving the problem. According to the Institute for Safe Medication Practices (ISMP), MedWatch has recently identified seven more Cerebyx-related deaths involving 10-fold overdoses in children age 3 or younger. In at least four of the seven deaths, the drug was dispensed from an automated dispensing cabinet (ADC).
   To help reduce the risk of this fatal drug error, ISMP suggests double-checking your ADC screen, shelf labels, and printed requisitions to make sure they reflect the total amount of drug in the vial, not the amount of drug per milliliter. In other words, they should say 100 mg PE/2 ml or 500 mg PE/10 ml, not 50 mg PE/ml. Because massive overdoses seem to involve mainly the 10-ml vials, ISMP also suggests that pediatric facilities consider stocking only the 2-ml vials, that storage locations be limited, and that the number of vials available from ADCs be limited.


     
   

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