Use of these drugs (antidotes) suggests a potential ADR occurred |
Naloxone |
Methadone |
Flumazenil |
Digoxin immune fab (“Digibind”) |
Protamine sulphate |
Activated charcoal |
Biperiden / promethazine / diazepam |
Sodium polystyrene (“Kayexalate”) |
Insulin with glucose |
Calcium gluconate |
Dextrose 10% |
Adrenaline (epinephrine) |
Systemic corticosteroid |
Diphenhydramine, prochlorperazine, promethazine, or any new antihistamine |
Antiemetics |
Oral vancomycin |
Granulocyte colony-stimulating factor |
Supratherapeutic drug concentration suggests a potential ADR occurred |
Digoxin > 1.5 nmol/L |
Theophylline > 110 μmol/L |
Lidocaine > 5 μg/L |
Phenytoin > 80 μmol/L |
Carbamazepine > 51 μmol/L |
Phenobarbital > 172 μmol/L |
Valproic acid > 700 μmol/L |
Gentamicin or tobramycin peak > 10 mg/L or 24 h trough > 2 mg/L |
Amikacin peak > 30 mg/L or 24 h trough > 2 mg/L |
Vancomycin trough > 25 mg/L or > 30 mg/L during continuous infusion |
Any other drug concentration reported as supratherapeutic |
Paracetamol concentration done (regardless of result) |
Laboratory result (other than TDM) suggests a potential ADR occurred |
Partial thromboplastin time (PTT) > 100 s |
International normalised ratio (INR) > 5 |
Anti-factor Xa ≥ 1.5 IU/mL |
Platelet count < 50 × 109/L |
White cell count < 3 × 109/L |
Haemoglobin < 8 g/dL |
Pancytopaenia |
Clostridium difficile positive stool after exposure to antibiotics |
Creatinine rising to above-normal range |
Hyponatraemia or Hypernatraemia |
Potassium < 3.5 mmol/L, in the absence of diarrhoea |
Potassium > 5.5 mmol/L |
Alanine transaminase (ALT) > three times upper limit of normal (ULN = 40 IU/L) in the presence of negative viral hepatitis screening test results |
Bilirubin > two times upper limit of normal (ULN = 21 μmol/L); if in a neonate, the neonate should also be on drugs |
Serum glucose < 3 mmol/L, outside the perinatal period |
Hyperlactataemia on antiretroviral therapy |
Clinical event suggests a potential ADR occurred |
Angioedema or lip swelling |
Rash or ulceration |
Mucositis or mucosal ulceration |
Pruritus |
Sudden onset wheezing |
Jaundice, new onset |
Dystonia, ataxia, torticollis, dyskinesia |
Retinopathy in premature infant on oxygen |
Hearing disturbance or hearing loss |
Seizure(s) |
Oversedation, lethargy, falls |
Decreased level of consciousness or pressure sores |
Delirium |
Fracture or osteoporosis |
Upper gastrointestinal bleed |
Arrhythmia, new |
Hypertension |
Nausea reported by parents / documented in file |
Constipation |
Biopsy of bone marrow, kidney, or liver |
Withdrawal symptoms |
Any other event suspected to be drug-related by doctor or nurse |
Unexplained medication stop |
Readmission to acute care unit within 14 days of discharge |
Readmission to intensive care unit within 48 h of transfer or discharge |
Require resuscitation in ward |
Death |