Despite the lack of firm evidence of safety and efficacy in children, of medicines licensed for use in adults, such medicines may well be used when treating children, especially where no licensed alternatives exist.
SUSPECTED ADRS IN CHILDREN
There
has been significant public interest expressed in the safety of medicines used
in children; particular concern surrounds the safety of medicines which are
not specifically licensed for use or are used ‘off label’ (i.e. for unlicensed
indications) in this patient group (Wells, 1996). Despite the lack of firm
evidence of safety and efficacy in children, of medicines licensed for use in
adults, such medicines may well be used when treating children, especially
where no licensed alternatives exist. Safety and efficacy in chil-dren cannot
be assumed simply based on data from studies in adults; for instance, children
differ from adults in terms of their pharmacokinetics (Leeder, 1996; Reed,
1996). It is possible that the adverse reaction profile of a medicine in
children may differ from that in adults, and it is therefore particularly
important to collect suspected ADR reports in this area. However, it is notable
that under-l8-year-olds make up around 20% of the population, but that the
proportion of Yellow Card reports received for this age group was somewhat
lower in 1997 and 1998 (approximately 8%).
To
investigate whether unlicensed or ‘off label’ use of medicines in children was
leading to adverse reac-tions, and whether such reactions were being reported,
a pilot Scheme to stimulate reporting of suspected ADRs in children was set up
in the Trent NHS region in September 1998; this Scheme targeted paediatri-cians
and hospital pharmacists.
An
analysis by the MHRA of this pilot Scheme, two years following its
introduction, showed that there was an increase in the absolute numbers of
hospital reports of suspected ADRs in children received from the Trent region.
Since the time covered by this analysis overlapped significantly with the
nationwide meningitis C vaccination campaign, it was perhaps not surprising
that the majority of reports received were of suspected ADRs associated with
this vaccine. However, when reports for meningitis C vaccine were excluded, it
was notable that the underlying rate of paediatric reporting in the Trent
region had remained relatively static between 1994 and 2000, and was comparable
with national reporting rates for suspected ADRs in children; additionally a
relatively low proportion (less than 30%) of reports related to serious
reactions.
As
a separate initiative, the MHRA collabo-rated with the British Paediatric
Surveillance Unit (BPSU) (now the Royal College of Paediatrics and Child
Health) on their ‘Orange Card’ reporting Scheme, where consultant
paediatricians report partic-ular disorders under surveillance in children to
the BPSU (Verity and Preece, 2002). In order to improve the availability of
medicines licensed for use in chil-dren and to seek ways of improving reporting
of paediatric ADRs, the CSM established a Paediatric Medicines Working Group in
July 2000. A move towards improving the safe use of medicines in children was
also undertaken in Europe and in Decem-ber of the same year a Council
Resolution called on the European Commission to find solutions to the issue of
inadequate medicines for children. In Septem-ber 2004, the Commission adopted
the proposal for a regulation of the Council and the European Parliament on
medicinal products for paediatric use, with the overall objective of improving
the health of children in Europe by increasing research, development and
authorisation of medicines for paediatric use. As part of the proposal,
measures to increase the robustness of pharmacovigilance for paediatric
medicines will be put forward and a Paediatric Working Party within the
European Medicines Agency (EMEA) will be established.In recent years, the
proportion of Yellow Cards received by the MHRA in under-l8-year-olds has
increased marginally to 10% of all UK ADR reports received in 2004, perhaps
influenced by the introduction of nurse reporting and a general increased
knowledge about the Scheme. There is still room for improvement, but with the
advent of the European paediatric regulation and the introduction of patient
reporting in the United Kingdom, it is likely that paediatric ADR reporting
will continue to increase.
Related Topics
TH 2019 - 2024 pharmacy180.com; Developed by Therithal info.