European guideline on paediatric pharmacovigilance drafted
Better pharmacovigilance needed for children because they react
differently to drugs |
Pharmacovigilance over paediatric medicines is to be improved by the introduction of a European pharmacovigilance guideline specifically aimed at products for use in children up to 18 years of age.
The guideline (PDF 220K) is currently in draft form and has been put
out for six months’ consultation by the European Medicines Agency
(EMEA). This is the first EMEA guideline to focus specifically on issues
of medicines
safety in children. It covers both the reporting and recording of adverse
drug reactions and the possible need for studies to follow the long-term
safety of medicines in children.
The draft guideline says that paediatric pharmacovigilance needs special
attention because childhood disorders can be both quantitatively and
qualitatively different from their adult equivalents, with different
ADRs being seen because of the underlying processes of growth and development.
It adds that long-term treatment poses additional problems because the
susceptibility of child patients to ADRs may change as they grow and
develop. It also proposes the use of treatment registries to monitor
possible effects of medicines on skeletal, neural, behavioural, sexual
and immune maturation and development. |
The
Pharmaceutical Journal
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