C4C - Paediatric pharmacovigilance: Methodological Considerations in Research and Development of Medicines for Children – A c4c Expert Group White Paper

Abstract

Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regards to, for example, drug response, growth and development, clinical presentation of adverse drug reactions (ADRs), how they can be detected and population specific factors (e.g. more frequent use of off-label/unlicensed drugs). In recognition of these challenges a group of experts has been formed in the context of the conect4children (c4c) project to support paediatric drug development. This expert group collaborated to develop methodological considerations for paediatric drug safety and pharmacovigilance throughout the life-cycle of medicinal products which is described in this article. These considerations include practical points to consider for the development of the paediatric section of the risk management plan (RMP), safety in paediatric protocol development and safety data collection and analysis. Furthermore, they describe the specific details of post-marketing pharmacovigilance in children using, for example, spontaneous reports, electronic health care records, registries and record-linkage, as well as the use of paediatric pharmacoepidemiology studies for risk characterisation. Next the details of the assessment of benefit-risk and challenges related to medicinal product formulation in the context of a Paediatric Investigation Plan (PIP) are presented. Finally, practical issues in paediatric signal detection and evaluation are included. This paper provides practical points to consider for paediatric pharmacovigilance throughout the life-cycle of medicinal products for RMPs, protocol development, safety data collection and analysis and PIPs.

Безопасность Назначения Лекарственных Средств Детям: Роль Врача И Фармацевта

“…КЛИНИЧЕСКАЯ МЕДИЦИНА И ФАРМАКОЛОГИЯ и нерешенные вопросы. К таким относится и ошибочные действия со стороны родителей, опекунов из-за неправильной оценки болезненного состояния ребенка, их боязнь возможных нежелательных реакций ЛС при применении препаратов, как и чрезмерная осторожность врачей при оценке соотношения польза/риск ЛС, когда излишняя предосторожность может привести к потере пользы ЛС для ребенка [13]. Особенно опасны случаи сознательного уменьшения дозировки антибактериальных средств или сокращения срока их приема для предупреждения «аллергизации» ребенка и вопреки инструкции для медицинского применения препарата, что, безусловно, ведет к фиаско в лечении бактериальных инфекций, и риску их осложнений и хронизации.…”