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BNF for Children aims to provide prescribers, pharmacists,
and other healthcare professionals with sound up-to-date
information on the use of medicines for treating children.
A joint publication of the British Medical Association, the
Royal Pharmaceutical Society, the Royal College of
Paediatrics and Child Health, and the Neonatal and
Paediatric Pharmacists Group, BNF for Children is published
under the authority of a Paediatric Formulary Committee
which comprises representatives of these bodies, the
Department of Health for England, and the Medicines and
Healthcare products Regulatory Agency.
Many areas of paediatric practice have suffered from
inadequate information on effective medicines. BNF for
Children addresses this significant knowledge gap by
providing practical information on the use of medicines in
children of all ages from birth to adolescence. Information in
BNF for Children has been validated against emerging
evidence, best-practice guidelines, and crucially, advice from
a network of clinical experts.
Drawing information from manufacturers’ literature where
appropriate, BNF for Children also includes a great deal of
advice that goes beyond marketing authorisations (product
licences). This is necessary because licensed indications
frequently do not cover the clinical needs of children; in
some cases, products for use in children need to be specially
manufactured or imported. Careful consideration has been
given to establishing the clinical need for unlicensed
interventions with respect to the evidence and experience of
their safety and efficacy; local paediatric formularies, clinical
literature and national information resources have been
invaluable in this process.
BNF for Children has been designed for rapid reference
and the information presented has been carefully selected to
aid decisions on prescribing, dispensing and administration
of medicines. Less detail is given on areas such as malignant
disease and the very specialist use of medicines generally
undertaken in tertiary centres. BNF for Children should be
interpreted in the light of professional knowledge and it
should be supplemented as necessary by specialised
publications. Information is also available from Medicines
Information Services (see inside front cover).
Overview
The BNF for Children is an independent professional publication
that addresses the day-to-day prescribing information needs of
healthcare professionals involved in the care of children. Use of
this resource throughout the health service helps to ensure that
medicines are used safely, effectively, and appropriately.
Hundreds of changes are made between print editions, and are
published monthly in a number of digital formats. The most
clinically significant updates are listed under Changes p. xviii.
BNF for Children is unique in bringing together authoritative,
independent guidance on best practice with clinically validated
drug information.
Information in BNF for Children has been validated against
emerging evidence, best-practice guidelines, and advice from a
network of clinical experts. BNF for Children includes a great deal
of advice that goes beyond marketing authorisations (product
licences or summaries of product characteristics). This is
necessary because licensed indications frequently do not cover
the clinical needs of children; in some cases, products for use in
children need to be specially manufactured or imported. Careful
consideration has been given to establishing the clinical need for
unlicensed interventions with respect to the evidence and
experience of their safety and efficacy.
Validation of information follows a standardised process.
Where the evidence base is weak, further validation may be
undertaken through a process of peer review. The process and its
governance are outlined in greater detail in the sections that
follow.
Paediatric Formulary Committee
The Paediatric Formulary Committee (PFC) is responsible for the
content of BNF for Children. The PFC comprises pharmacy,
medical, and nursing representatives with a paediatric
background, and lay representatives who have worked with
children or acted as a carer of a paediatric patient; there are also
representatives from the Medicines and Healthcare products
Regulatory Agency (MHRA) and the Department of Health for
England. The PFC decides on matters of policy and reviews
amendments to BNF for Children in the light of new complex or
contentious evidence and expert advice.
Dental Advisory Group
The Dental Advisory Group oversees the preparation of advice on
the drug management of dental and oral conditions; the group
includes representatives from the British Dental Association and
a representative from the UK Health Departments.
Nurse Prescribers’Advisory Group
The Nurse Prescribers’ Advisory Group oversees the list of drugs
approved for inclusion in the Nurse Prescribers’ Formulary; the
group includes representatives from a range of nursing disciplines
and stakeholder organisations.
Expert advisers
BNF for Children uses representatives from expert groups
(professional societies and advisory bodies) to provide expert
advice on clinical content. These expert advisers are practice-
based healthcare professionals (including doctors, pharmacists,
nurses, and dentists), and are regarded as specialists in their field.
The role of these expert advisers is to provide independent advice
on their area of expertise by reviewing existing text and
commenting on amendments drafted by the clinical writers.
These clinical experts help to ensure that BNF for Children
remains reliable by:
. commenting on the relevance of the text in the context of best
clinical practice in the UK;
. checking draft amendments for appropriate interpretation of
any new evidence;
. providing expert opinion in areas of controversy or when
reliable evidence is lacking;
. advising on the use of unlicensed medicines or of licensed
medicines for unlicensed uses (‘off-label’ use).
BNF for Children may also call on other clinical specialists for
specific developments when particular expertise is required.
BNF for Children works closely with a number of expert bodies
that produce clinical guidelines. Drafts or pre-publication copies
of guidelines are often received for comment and for assimilation
into BNF for Children.
Editorial team
BNF for Children clinical writers have worked as pharmacists or
possess a pharmacy degree and many have a further, relevant
post-graduate qualification; they therefore have a sound
understanding of how drugs are used in clinical practice. A
number of the clinical writers have specific experience of
paediatric practice. As a team, the clinical writers are responsible
for editing, maintaining, and updating BNF for Children content.
They follow a systematic prioritisation process in response to
updates to the evidence base in order to ensure the most clinically
important topics are reviewed as quickly as possible. In addition,
review of content is carried out proactively, with the aim of
considering all recommendations for review every 3 to 4 years.
Amendments to the text are drafted when the clinical writers
are satisfied that any new information is reliable and relevant. A
set of standard criteria defines when content is referred to expert
advisers, the Paediatric Formulary Committee or other advisory
groups, or submitted for peer review.
Clinical writers prepare the text for publication and undertake a
number of validation checks at various stages of the content
creation process.
Sources of BNF for Children information
BNF for Children uses a variety of sources for its information; the
main ones are shown below.
Summaries of product characteristics
BNF for Children reviews the summaries of product
characteristics (SPCs) of all new products as well as revised SPCs
for existing products. The SPCs are a key source of product
information and are carefully processed. Such processing
involves:
. verifying the approved names of all relevant ingredients
including ‘non-active’ ingredients (BNF for Children is
committed to using approved names and descriptions as laid
down by the Human Medicines Regulations 2012);
. comparing the indications, cautions, contra-indications, and
side-effects with similar existing drugs. Where these are
different from the expected pattern, justification is sought for
their inclusion or exclusion;
. seeking independent data on the use of drugs in pregnancy and
breast-feeding;
. incorporating the information into BNF for Children using
established criteria for the presentation and inclusion of the
data;
. checking interpretation of the information by a second clinical
writer before submitting to a content approver; changes
relating to doses receive a further check;
. identifying potential clinical problems or omissions and
seeking further information from manufacturers or from expert
advisers;
. constructing, with the help of expert advisers, a comment on
the role of the drug in the context of similar drugs.
Much of this processing is applicable to the following sources as
well.
Literature
Clinical writers monitor and process various sources of
information on a regular basis. When a difference between the
advice in BNF for Children and the source is noted, the new
information is assessed for reliability (using tools based on SIGN
methodology if appropriate) and relevance to UK clinical practice.
If necessary, new text is drafted and discussed with expert
advisers and the Paediatric Formulary Committee. BNF for
Children enjoys a close working relationship with a number of
national information providers.
In addition to the routine process, which is used to identify
‘triggers’ for changing the content, systematic literature searches
are used to identify the best quality evidence available to inform
an update. Clinical writers receive training in critical appraisal,
literature evaluation, and search strategies.
