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Table 1 Trigger list used to assist in identifying potential adverse drug reactions

From: Serious adverse drug reactions at two children’s hospitals in South Africa

CategoryTrigger
Use of these drugs (antidotes) suggests a potential ADR occurredNaloxone
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 occurredDigoxin > 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 occurredPartial 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 occurredAngioedema 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