BNF for Children 2020-2021(British National Formulary)


BNF for Children 2020-2021

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 (‘BNFC’)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. BNFC 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 BNFC 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, BNFC 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.

BNFC 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. BNFC 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).

It is important to use the most recent BNFC information for making clinical decisions. The print edition of BNF for Children is updated in September each year. Monthly updates are provided online via the BNF Publications website Medicines Complete and the NHS Evidence portal. The more important changes listed under Changes p. xvii are cumulative (from one print edition to the next), and can be printed off each month to show the main changes since the last print edition as an aide memoire for those using print copies.

Overview

The BNF for Children (BNFC) 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 some digital formats. The most clinically significant updates are listed under Changes p. xvii.

BNFC is unique in bringing together authoritative, independent guidance on best practice with clinically validated drug information.

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.

Validation of information follows a standardised process. Where the evidence base is weak, further validation is 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 BNFC. 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 BNFC in the light of new 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

BNFC uses about 80 expert clinical advisers (including doctors, pharmacists, nurses, and dentists) throughout the UK to help with the clinical content. The role of these expert advisers is to review existing text and to comment on amendments drafted by the clinical writers. 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 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 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 including ‘non-active’ ingredients (BNFC 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 BNFC 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 manager; 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 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 (using tools based on SIGN methodology) 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.

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.

Consensus guidelines

The advice in BNFC is checked against consensus guidelines produced by expert bodies. The quality of the guidelines is assessed using adapted versions of the AGREE II tool. A number of bodies make drafts or pre-publication 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 Care Excellence (NICE), the All Wales Medicines Strategy Group

(AWMSG), 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.

Peer review

Although every effort is made to identify the most robust data available, inevitably there are areas where the evidence base is weak or contradictory. While the BNF has the valuable support of expert advisers and the Paediatric Formulary Committee, the recommendations made may be subject to a further level of scrutiny through peer review to ensure they reflect best practice.

Content for peer review is posted on bnf.org and interested parties are notified via a number of channels, including the BNF e-newsletter.

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 Human Medicines Regulations 2012.

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 are included in BNFC as are guidelines from bodies such as the Royal College of Paediatrics and Child Health.

Medicines and devices

NHS Prescription Services (from the NHS Business Services Authority) provides non-clinical, categorical information

(including prices) on the medicines and devices included in BNFC.

Comments from readers

Readers of BNFC are invited to send in comments. Numerous letters and emails are received by the BNF team. 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

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.

Market research

Market research is conducted at regular intervals to gather feedback on specific areas of development.

Assessing the evidence

From January 2016, recommendations made in BNFC have been evidence graded to reflect the strength of the recommendation. The addition of evidence grading is to support clinical decision making based on the best available evidence. The BNFC aims to revalidate all content over a rolling 3-to

4-year period and evidence grading will be applied to recommendations as content goes through the revalidation process. Therefore, initially, only a small number of recommendations will have been graded.

Grading system

The BNFC has adopted a five level grading system from A to E, based on the former SIGN grading system. This grade is displayed next to the recommendation within the text.

Evidence used to make a recommendation is assessed for validity using standardised methodology tools based on AGREE II and assigned a level of evidence. The recommendation is then given a grade that is extrapolated from the level of evidence, and an assessment of the body of evidence and its applicability.

Evidence assigned a level 1-or 2- score has an unacceptable

 


   



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