TABLE 2.

Factors placing paediatric patients at increased risk for adverse drug reactions

Different and changing pharmacokinetic parameters between patients at various ages and stages of maturational development Need for calculation of individualized doses based on the patient’s age, weight (mg/kg), body surface area (mg/m2) and clinical condition Lack of available dosage forms and concentrations appropriate for administration to neonates, infants and children – frequently dosage formulations are extemporaneously compounded and lack stability, compatibility or bioavailability data Need for precise dose measurement and appropriate drug delivery systems Lack of published information or Food and Drug Administration approved labelling regarding dosing, pharmacokinetics, safety, efficacy and clinical use of drugs

Adapted from reference 17