Table 1. List of triggers and process identified in children with adverse drug reactions (ADR).
Trigger | Process identified |
---|---|
Diphenhydramine, promethazine, or/and any other antihistamine | Hypersensitivity reaction or drug effect |
Systemic or localized topical corticosteroid* | Hypersensitivity reaction |
Vitamin K or fresh frozen plasma* | Over-anticoagulation with warfarin or drug-induced DIC |
Metoclopramide or other antiemetic* | Nausea or emesis related to drug use |
Antidiarrheals | Drug-induced diarrhea |
Sodium polystyrene | Hyperkalemia from renal impairment/drug effect |
Insulin with glucose* | Hyperkalemia from renal impairment/drug effect |
50% dextrose | Hypoglycemia (possibly with insulin) |
Flumazenil | Oversedation with benzodiazepines |
Naloxone | Oversedation or respiratory depression with narcotics |
Phenobarbitone statim or ≤ 24 hours* | Drug-induced seizure |
Diazepam stat or ≤ 24 hours* | Drug-induced seizure |
Adrenalin | Anaphylaxis /bronchospasm |
Biperiden* | Extrapyramidal effect to phenothiazine |
Atropine* | Extrapyramidal effect to phenothiazine |
Dopamine* | Drug-induced hypotension |
Cimetidine or other anti-ulcer agents* | Drug-induced gastritis |
Laboratory triggers | |
Potassium < 3.5 mmol/l | Hypokalemia due to loop diuretics |
PTT > 100 seconds | Over-anticoagulation with heparin |
WBC < 3000 × 106/µl | Neutropenia due to drug or disease |
ALT > thrice the normal* | Hepatotoxicity (possibly due to drug) |
Bilirubin > twice the normal* | Hepatotoxicity (possibly due to drug) |
Serum glucose ≤ 2.5 mmol/l | Hypoglycemia due to insulin |
Rising level of serial serum creatinine | Drug-induced renal insufficiency |
Event triggers | |
Oversedation, lethargy or fall | Related to overuse of medication |
Skin rash or ulceration | Drug-related adverse event |
Lip swelling and/or angioedema* | Drug-related adverse event |
Seizures and/or dizziness* | CNS adverse drug event, drug toxicity |
Dystonia, ataxia, torticollis and/or dyskinesia* | CNS adverse drug event, drug toxicity |
Altered level of consciousness (after excluding cerebral malaria)* | CNS adverse drug event, drug toxicity |
New bradycardia or tachycardia* | Drug-related cardiac event |
New onset of jaundice* | Drug-related hepatotoxicity |
New hypotension (defined by BP values relative to age)* | Drug-related vascular event |
New cardiac failure* | Drug-related cardiotoxicity |
Wheezing* | Allergic reaction |
Abrupt medication stop | Adverse event |
Transfer to PICU in another hospital* | Adverse event |
Event suspected to be drug-related* by doctor, nurse or parents | Suspected ADR |
Event added or modified from trigger event published by Rozich et al.26. Modification was based on pattern of drug therapy used at the Lagos State University Teaching Hospital and the available essential medicines in Nigeria. Some modifications were made to suit pediatric age group. DIC = disseminated intravascular coagulopathy; PTT = partial thromboplastin time; WBC = white blood cell count; ALT = alanine transaminase; PICU = pediatric intensive care unit; CNS = central nervous system. Serum toxic levels of drugs were excluded.