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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

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