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Pediatric Adverse Events in MedDRA

The document discusses the Pediatric Adverse Events List in MedDRA. It was developed to support pharmacovigilance activities and monitoring of adverse drug events in the pediatric population. Adverse events may differ in pediatric patients compared to adults due to developing systems. The list identifies preferred terms specific to pediatrics by searching for relevant roots/words in MedDRA and reviewing the hierarchy. Inclusion criteria are terms that exclusively or commonly relate to pediatrics, like conditions impacting fetuses or newborns. Exclusion criteria remove terms for adult-only or non-adverse conditions.

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121 views2 pages

Pediatric Adverse Events in MedDRA

The document discusses the Pediatric Adverse Events List in MedDRA. It was developed to support pharmacovigilance activities and monitoring of adverse drug events in the pediatric population. Adverse events may differ in pediatric patients compared to adults due to developing systems. The list identifies preferred terms specific to pediatrics by searching for relevant roots/words in MedDRA and reviewing the hierarchy. Inclusion criteria are terms that exclusively or commonly relate to pediatrics, like conditions impacting fetuses or newborns. Exclusion criteria remove terms for adult-only or non-adverse conditions.

Uploaded by

rr48843
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Pediatric Adverse Events in MedDRA

1.

Uses of the Pediatric Adverse Events List

One of the key drivers for development of the Pediatric Adverse Event Terms List is
to support pharmacovigilance activities in surveillance of adverse events in the
pediatric population. Medicinal products may affect physical and cognitive growth
and development, and adverse event profiles may differ in pediatric patients.
Because developing systems may respond differently than mature adult organs,
some adverse events and drug interactions that occur in pediatric patients may not
be identified in adult studies and therefore need specific monitoring. In addition,
dynamic processes of growth and development may not manifest adverse events
acutely, but at a later stage of growth and maturation.
For aggregate data analysis of adverse drug events observed in the pediatric
population, it is recommended that the relevant age groups provided in the Individual
Case Safety Reports (ICSRs) be taken into account. When no age information is
available, the Pediatric Adverse Event Terms List can facilitate overall monitoring of
adverse events in this population.
The Pediatric Adverse Event Terms List is intended as recommendation only,
providing a basis for a common understanding of pediatric adverse event terms and
leaving organizations the option to modify the list either adding terms or deleting
terms according to their own organization specific needs.

2.

Development of the Pediatric Adverse Event Terms List

The preparation of the Pediatric Adverse Event Terms List consisted of identifying
the MedDRA Preferred Terms (PTs) that are specific to the pediatric population.
Initially, all PT terms in MedDRA with the following roots/words were identified:
Pediatric Roots/Words
Accel
Adolescen
Behavi
Child
Develop
Embry
Foet

Gestat
Grow
Inborn
Infant
Juvenile
Matur
Neona
Newborn

Paedia
Perinat
Pubert
Retard
Toddl
Young
Youth

The retrieved PT terms were then reviewed by an MSSO physician and the list
completed by drilling up and down into the MedDRA hierarchy. The list was
additionally reviewed by external pharmacovigilance experts (the EudraVigilance
Expert Working Group and the EMEA Paediatric Committee).
The inclusion criteria are:

Terms that relate exclusively to the pediatric population.


e.g., PT Neurotic disorder of childhood
Terms for conditions that could occur in the non-pediatric population but are
characteristic or more common in the pediatric age group.
e.g., PT Varicella
Terms for maternal disorder(s) that directly impact the fetus or newborn.
e.g., PT Maternal hypertension affecting foetus
The exclusion criteria are:
Terms for conditions that occur exclusively (or nearly exclusively) in the adult
population e.g., PT Parkinson's disease
Pregnancy-related terms (including placental and amniotic conditions) that do
not necessarily result in a harm to the fetus or newborn e.g., PT Retained
placenta or membranes
Pediatric terms that are not typically adverse events/adverse drug reactions.
Such terms are found primarily in SOC Social circumstances, e.g., PT
Childhood

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