Knowledge Assessment: Paediatric Pharmacovigilance

The QPPV must personally review every paediatric case The QPPV must ensure visibility of significant issues and be able to challenge assessment, escalation and follow-up The QPPV should perform all specialist epidemiological analyses personally The QPPV should approve a separate paediatric procedure for every pharmacovigilance activity

Paediatric adverse events are always caused by underlying disease Many outcomes occur naturally in children and their frequency varies with age, disease and other factors Background rates are needed only for randomised clinical trials A signal is confirmed whenever the observed number of cases exceeds zero

Because paediatric cases are not subject to pharmacovigilance reporting requirements Because developmental stage can affect exposure, response, disease context and clinical presentation Because children cannot receive the same medicinal products as adults Because age is irrelevant once body weight has been recorded

Whether all cases should automatically be classified as intrinsic product toxicity Whether the concentration, labelling, device or instructions contributed to an administration error Whether spontaneous reports can be excluded because the events were preventable Whether the product should immediately be withdrawn without further assessment

The absolute dose alone The product name and indication only Dose in relation to body size, together with frequency, duration and formulation Whether the product was prescribed by a paediatrician

Assume the medicine caused the event because it occurred after treatment began Exclude the event because disease-related events are never reportable Assess disease natural history, baseline risk, timing, exposure and alternative explanations Attribute the event to the disease only because the condition is rare

Adult reference ranges always underestimate paediatric toxicity The alerts may include normal age-related values and obscure clinically relevant paediatric abnormalities Laboratory data should not be used in paediatric pharmacovigilance Statistical signal detection is invalid whenever children are included

Developmental outcomes may require time to emerge and may have substantial latency Children are never able to provide safety information immediately after exposure Long-term follow-up is required for every paediatric adverse event Short-term adverse events cannot be clinically assessed in children

Spontaneous reports contain no clinical information Under-reporting and selective reporting can distort both the apparent presence and frequency of associations Spontaneous reports are always more controlled than clinical trials Only adult cases can be reported spontaneously

It should be disregarded because it cannot inform pharmacovigilance for authorised use It should be treated as proof that the authorised indication is unsafe It should be assessed with the actual indication, dose, age, formulation and route clearly considered It should be included only if the medicine was used within the authorised age range