BNFC.org

BNF for Children

BNF for Children: ENTER

How BNF for Children is constructed

BNF for Children (BNFC) is unique in bringing together authoritative, independent guidance on best practice with clinically validated drug information, enabling healthcare professionals to select safe and effective medicines for individual children.

Information in BNFC has been validated against emerging evidence, best-practice guidelines, and advice from a network of clinical experts. BNFC 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.

Hundreds of changes are made between editions, and the most clinically significant changes are listed at the front of each edition.

Paediatric Formulary Committee

The Paediatric Formulary Committee (PFC) is responsible for the content of BNFC. The PFC includes a neonatologist and paediatricians appointed by the Royal College of Paediatrics and Child Health, paediatric pharmacists appointed by the Royal Pharmaceutical Society of Great Britain and the Neonatal and Paediatric Pharmacists Group, doctors appointed by the BMJ Publishing Group, a GP appointed by the Royal College of General Practitioners, and representatives from the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK health departments. The PFC decides on matters of policy and reviews amendments to BNFC in the light of new evidence and expert advice. The Committee meets every 6 months and each member also receives proofs of all BNFC chapters for review before publication.

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.

Editorial team

BNFC staff editors are pharmacists with a sound understanding of how drugs are used in clinical practice, including paediatrics. Each staff editor is responsible for editing, maintaining, and updating specific chapters of BNFC. During the publication cycle the staff editors review information in BNFC against a variety of sources (see below).

Amendments to the text are drafted when the editors are satisfied that any new information is reliable and relevant. The draft amendments are passed to expert advisers for comment and then presented to the Paediatric Formulary Committee for consideration. Additionally, for each edition, sections are chosen from every chapter for thorough review. These planned reviews aim to verify all the information in the selected sections and to draft any amendments to reflect current best practice.

Staff editors prepare the text for publication and undertake a number of checks on the knowledge at various stages of the production.

Expert advisers

BNFC uses about 80 expert clinical advisers (including doctors, pharmacists, nurses, and dentists) throughout the UK to help with the production of each edition. The role of these expert advisers is to review existing text and to comment on amendments drafted by the staff editors. These clinical experts help to ensure that BNFC 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 areas where BNFC diverges from summaries of product characteristics;
  • advising on the use of unlicensed medicines or of licensed medicines for unlicensed uses (‘off-label’ use);
  • providing independent advice on drug interactions, prescribing in hepatic impairment, renal impairment, pregnancy, breast-feeding, neonatal care, palliative care, and the emergency treatment of poisoning.

In addition to consulting with regular advisers, BNFC calls on other clinical specialists for specific developments when particular expertise is required.

BNFC also works closely with a number of expert bodies that produce clinical guidelines. Drafts or pre-publication copies of guidelines are routinely received for comment and for assimilation into BNFC.

Sources of BNFC information

BNFC uses a variety of sources for its information; the main ones are shown below.

Summaries of product characteristics

BNFC receives 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, despite the ever-increasing volume of information being issued by the pharmaceutical industry. Such processing involves:

  • verifying the approved names of all relevant ingredients including ‘non-active’ ingredients (BNFC is committed to using approved names and descriptions as laid down by the Medicines Act);
  • 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 breastfeeding;
  • incorporating the information into BNFC using established criteria for the presentation and inclusion of the data;
  • checking interpretation of the information by two staff editors before submitting to a senior editor; changes relating to doses receive an extra check;
  • identifying potential clinical problems or omissions and seeking further information from manufacturers or from expert advisers;
  • careful validation of any areas of divergence of BNFC from the SPC before discussion by the Committee (in the light of supporting evidence);
  • 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.

Expert advisers

The role of expert clinical advisers in providing the appropriate clinical context for all BNFC information is discussed above.

Literature

Staff editors monitor core medical, paediatric, and pharmaceutical journals. Research papers and reviews relating to drug therapy are carefully processed. When a difference between the advice in BNFC and the paper is noted, the new information is assessed for reliability and relevance to UK clinical practice. If necessary, new text is drafted and discussed with expert advisers and the Paediatric Formulary Committee. BNFC enjoys a close working relationship with a number of national information providers.

Systematic reviews

BNFC has access to various databases of systematic reviews (including the Cochrane Library and various web-based resources). These are used for answering specific queries, for reviewing existing text and for constructing new text. Staff editors receive training in critical appraisal, literature evaluation, and search strategies. Reviews published in Clinical Evidence are used to validate BNFC advice.

Consensus guidelines

The advice in BNFC is checked against consensus guidelines produced by expert bodies. A number of bodies make drafts or prepublication copies of the guidelines available to BNFC; it is therefore possible to ensure that a consistent message is disseminated. BNFC routinely processes guidelines from the National Institute for Health and Clinical Excellence (NICE), the Scottish Medicines Consortium (SMC), and the Scottish Intercollegiate Guidelines Network (SIGN).

Reference sources

Paediatric formularies and reference sources are used to provide background information for the review of existing text or for the construction of new text. The BNFC team works closely with the editorial team that produces Martindale: The Complete Drug Reference. BNFC has access to Martindale information resources and each team keeps the other informed of significant developments and shifts in the trends of drug usage.

Statutory information

BNFC routinely processes relevant information from various Government bodies including Statutory Instruments and regulations affecting the Prescription only Medicines Order. Official compendia such as the British Pharmacopoeia and its addenda are processed routinely to ensure that BNFC complies with the relevant sections of the Medicines Act.

BNFC maintains close links with the Home Office (in relation to controlled drug regulations) and the Medicines and Healthcare products Regulatory Agency (including the British Pharmacopoeia Commission). Safety warnings issued by the Commission on Human Medicines (CHM) and guidelines on drug use issued by the UK health departments are processed as a matter of routine.

Relevant professional statements issued by the Royal Pharmaceutical Society of Great Britain are included in BNFC as are guidelines from bodies such as the Royal College of Paediatrics and Child Health.

BNFC reflects information from the Drug Tariff, the Scottish Drug Tariff, and the Northern Ireland Drug Tariff.

Pricing information

NHS Prescription Services provide information on prices of medicinal products and appliances in BNFC. BNFC also receives and processes price lists from product suppliers.

Comments from readers

Readers of BNFC are invited to send in comments. Numerous letters and emails are received during the preparation of each edition. Such feedback helps to ensure that BNFC provides practical and clinically relevant information. Many changes in the presentation and scope of BNFC have resulted from comments sent in by users.

Comments from industry

Each manufacturer is provided with a complimentary copy of BNFC and invited to comment on it. Close scrutiny of BNFC by the manufacturers provides an additional check and allows them an opportunity to raise issues about BNFC’s presentation of the role of various drugs; this is yet another check on the balance of BNFC advice. All comments are looked at with care and, where necessary, additional information and expert advice are sought.

Virtual user groups

BNFC has set up virtual user groups across various healthcare professions (e.g. doctors, pharmacists, nurses). The aim of these groups will be to provide feedback to the editors and publishers to ensure that BNF publications continue to serve the needs of its users.

Market research

Market research is conducted at regular intervals to gather feedback on specific areas of development, such as drug interactions or changes to the way information is presented in digital formats.

BNFC is an independent professional publication that is kept up-to-date and addresses the day-to-day prescribing information needs of healthcare professionals treating children. Use of this resource throughout the health service helps to ensure that medicines are used safely, effectively, and appropriately in children.

 

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