The Considerations Chapter also covers the roles and responsibilities of the Marketing Authorisation Holders, applicants for marketing authorisation, and the EMA Paediatric Committee (PDCO) and the Pharmacovigilance Risk Assessment Committee (PRAC).
The last part of the Considerations Chapter covers various EU plans such as the paediatric investigation plan and the risk management plan in the EU.
Specific paediatric pharmacovigilance issues
The paediatric population is the part of the population between birth and 18 years. Adverse reactions in the paediatric population may differ from adverse reactions occurring in the adult population. There can be differences in terms of frequency, nature, severity and presentation.
Medicinal products are often prescribed to minors in different patterns and the medicinal products are often used off-label.
The new Considerations Chapter IV provides that the five pharmacovigilance aspects specific to the paediatric population are: i) the paediatrics’ population susceptibility to adverse reactions, ii) the limited numbers of subjects in paediatric clinical trials iii) errors when providing medication to minors, iv) off-label use of adult medicinal products on minors and v) different signs and symptoms between paediatric patients compared to adults.
Structures and processes
GVP Module V and the Guidance on the format of the risk management plan (RMP) in the EU contain specific considerations for paediatric populations. The considerations identify and describe particularly important aspects for paediatric patients. Example given are “the effects on bone and cartilage during the paediatric growth phase” or “age related shifts in the interaction of the medicinal product with its target organs or tissues”.
The Considerations further describe the management and reporting of adverse reactions, the recording of the patient’s age information and other information that is relevant to the paediatric population. Other information relevant to the paediatric population include, as an example, the pharmaceutical form and strength of the active substance in the medicinal product.
The Considerations also provide guidance regarding Periodic Safety Update Reports (PSUR), Post-authorisation Safety Studies (PASS), safety communication and signal management.
Safety communication and accompanying risk minimisation measures (RMM) should include targeting specific audiences such as paediatricians and parents while involving the child as appropriate considering the child’s age.
Authored by Elisabethann Wright and Alexander Wenzel