Comparison Between Paediatric and Adult Suspected Adverse Drug Reactions Reported to the European Medicines Agency: Implications for Pharmacovigilance

Abstract

The present study applied a first-time approach to one of the largest databases worldwide of reported ADRs. It confirmed that reports of reactions in children were different to those in adults, not only in terms of reactions and drugs involved but also more concentrated around limited sets of reaction types and drugs. The possible causal association between a medicine or vaccine and the suspected ADR was not formally assessed in this study since the study analysed the characteristics of reported ADRs that were suspected and therefore not proven. However, the findings may help to identify pharmacovigilance activities that should be strengthened to reduce the burden of ADRs in children.

ADRs and Children: Knowledge and Methodological Standard in PASS (Post Authorization Safety Studies)

“…Family Pediatricians case reports mainly involve vaccines followed by frequency reports of pharmaceuticals used by children: antibiotics, antipyretics, inhaled corticosteroids, specific products for colds and some drugs belonging to the class of drugs on the gastrointestinal tract and metabolism. Most of the ADRs, observed in pediatric prospective studies, mainly effect the skin (rash, urticaria) and the gastrointestinal system (diarrhea, nausea and vomiting), but we can also observe systemic reactions and reactions connected to the central nervous system [1][2][3][4][5][6][7].…”

“…In this contest relevant proactive roles are being played by the FP-MCRN (family paediatricians-medicines for children research network) to develop new methodological approaches and optimise use of available resources, to enable the system to recognise issues of efficacy and safety reducing the health risks for such fragile populations for children as early as possible [1][2][3][4][5][6].…”

“…FPs (family pediatricians) have a close and elective involvement with children and their families establishing a very strong and close "pediatrician-parents" and "pediatrician-child" relationship. For this reason it becomes easier for the capacity to assess and involve outpatients in clinical trials and the possibility to give more accurate information on the correct use of pediatric drugs [1][2][3][4][5][6].…”

“…The differences such as pharmacokinetics, pharmacodynamics, epidemiology and co-medication between children and adults in general as well as between children of different age groups, the adverse event and ADR profiles may be different in children and adults. In addition most genetic and rare disease has a childhood onset which adds to the diversity of this population from the adult one [1][2][3][4].…”

“…label drugs increases the risk of adverse reactions and they should also try to pay much more attention when they administer drug therapies to their patient [1][2][3][4][5][6][7][8]. To address the issue of off-label and unlicensed prescribing in children, European regulations were issued with the scope of obliging pharmaceutical companies willing to register new compounds, or indications and formulations, for paediatric use, to submit "paediatric investigation plans" from January 2007 [9].…”