From: Serious adverse drug reactions at two children’s hospitals in South Africa
Category | Trigger |
---|---|
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 |