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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.