Table 1.
Table 1 ADE Surveillance Rules
| Rule Description |
|---|
| Amikacin > 35 Post |
| Anti-Xa laboratory test result > 2 |
| Carbamazepine > 14 |
| Clostridium difficile infection |
| Digoxin > 2.5 |
| Flumazenil administered |
| Gentamicin > 40 and cystic fibrosis; gentamicin > 15 all other patients |
| Gentamicin trough > 3 |
| Hepatotoxicity: elevated liver function test (2.5x ULN) |
| Hyperkalemia: potassium > 6.5 and age > 1 yr |
| Hyperphosphatemia: phosphorus > upper limit of normal |
| Hypocalcemia: calcium < 8.6 with drug cause |
| Hypoglycemia: glucose < 40 and insulin |
| Hypokalemia: potassium < 3 |
| Hypomagnesemia: Mg2+ < 1.6 |
| Hyponatremia: sodium < 135 with drug cause |
| Hypophosphatemia: phosphorus < lower limit of normal |
| INR > 4.5 |
| Metabolic acidosis: anion gap > 11 with drug cause |
| Naloxone administered |
| Nephrotoxicity: (Scr 2× increase over past 2 days) or (Scientific Review > 1.5x ULN) |
| Neutropenia: ANC < lower limit of normal |
| Pancreatitis: elevated pancreatic enzymes (1.5x ULN) |
| Phenobarbital > 50 |
| Phenytoin > 18 and <= 20 and albumin < 3.3 |
| Phenytoin > 20 |
| Seizures (as indicated by admin. Of lorazepam or diazepam) |
| Tacrolimus > 20 |
| Thrombocytopenia (HIT): platelets > 100,000 with 50% decline from baseline |
| Tobramycin > 40 and cystic fibrosis; tobramycin > 15 all other patients |
| Tobramycin trough > 3 |
| Vancomycin trough elevated > 25 |
ADE = adverse drug event; INR = international normalized ratio; ULN = upper limit of normal.