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BNF for Children 2011-2012

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<strong>BNF</strong>C <strong>2011</strong>–<strong>2012</strong>How <strong>BNF</strong> <strong>for</strong> <strong>Children</strong>is constructed<strong>BNF</strong> <strong>for</strong> <strong>Children</strong> (<strong>BNF</strong>C) is unique in bringing togetherauthoritative, independent guidance on best practicewith clinically validated drug in<strong>for</strong>mation, enablinghealthcare professionals to select safe and effectivemedicines <strong>for</strong> individual children.In<strong>for</strong>mation in <strong>BNF</strong>C has been validated against emergingevidence, best-practice guidelines, and advice froma network of clinical experts. <strong>BNF</strong>C includes a great dealof advice that goes beyond marketing authorisations(product licences or summaries of product characteristics).This is necessary because licensed indicationsfrequently do not cover the clinical needs of children;in some cases, products <strong>for</strong> use in children need to bespecially manufactured or imported. Careful considerationhas been given to establishing the clinical need <strong>for</strong>unlicensed interventions with respect to the evidenceand experience of their safety and efficacy.Hundreds of changes are made between editions, andthe most clinically significant changes are listed at thefront of each edition.Paediatric Formulary CommitteeThe Paediatric Formulary Committee (PFC) is responsible<strong>for</strong> the content of <strong>BNF</strong>C. The PFC includes aneonatologist and paediatricians appointed by theRoyal College of Paediatrics and Child Health, paediatricpharmacists appointed by the Royal PharmaceuticalSociety of Great Britain and the Neonatal andPaediatric Pharmacists Group, doctors appointed bythe BMJ Publishing Group, a GP appointed by theRoyal College of General Practitioners, and representativesfrom the Medicines and Healthcare products RegulatoryAgency (MHRA) and the UK health departments.The PFC decides on matters of policy andreviews amendments to <strong>BNF</strong>C in the light of newevidence and expert advice. The Committee meetsevery 6 months and each member also receives proofsof all <strong>BNF</strong>C chapters <strong>for</strong> review be<strong>for</strong>e publication.Dental Advisory GroupThe Dental Advisory Group oversees the preparation ofadvice on the drug management of dental and oralconditions; the group includes representatives fromthe British Dental Association.Editorial team<strong>BNF</strong>C staff editors are pharmacists with a sound understandingof how drugs are used in clinical practice,including paediatrics. Each staff editor is responsible<strong>for</strong> editing, maintaining, and updating specific chaptersof <strong>BNF</strong>C. During the publication cycle the staff editorsreview in<strong>for</strong>mation in <strong>BNF</strong>C against a variety of sources(see below).Amendments to the text are drafted when the editorsare satisfied that any new in<strong>for</strong>mation is reliable andrelevant. The draft amendments are passed to expertadvisers <strong>for</strong> comment and then presented to the PaediatricFormulary Committee <strong>for</strong> consideration. Additionally,<strong>for</strong> each edition, sections are chosen from everyixchapter <strong>for</strong> thorough review. These planned reviews aimto verify all the in<strong>for</strong>mation in the selected sections andto draft any amendments to reflect current best practice.Staff editors prepare the text <strong>for</strong> publication and undertakea number of checks on the knowledge at variousstages of the production.Expert advisers<strong>BNF</strong>C uses about 80 expert clinical advisers (includingdoctors, pharmacists, nurses, and dentists) throughoutthe UK to help with the production of each edition. Therole of these expert advisers is to review existing textand to comment on amendments drafted by the staffeditors. These clinical experts help to ensure that <strong>BNF</strong>Cremains reliable by:. commenting on the relevance of the text in thecontext of best clinical practice in the UK;. checking draft amendments <strong>for</strong> appropriate interpretationof any new evidence;. providing expert opinion in areas of controversy orwhen reliable evidence is lacking;. advising on areas where <strong>BNF</strong>C diverges from summariesof product characteristics;. advising on the use of unlicensed medicines or oflicensed medicines <strong>for</strong> unlicensed uses (‘off-label’use);. providing independent advice on drug interactions,prescribing in hepatic impairment, renal impairment,pregnancy, breast-feeding, neonatal care, palliativecare, and the emergency treatment of poisoning.In addition to consulting with regular advisers, <strong>BNF</strong>Ccalls on other clinical specialists <strong>for</strong> specific developmentswhen particular expertise is required.<strong>BNF</strong>C also works closely with a number of expert bodiesthat produce clinical guidelines. Drafts or pre-publicationcopies of guidelines are routinely received <strong>for</strong>comment and <strong>for</strong> assimilation into <strong>BNF</strong>C.Sources of <strong>BNF</strong>C in<strong>for</strong>mation<strong>BNF</strong>C uses a variety of sources <strong>for</strong> its in<strong>for</strong>mation; themain ones are shown below.Summaries of product characteristics <strong>BNF</strong>Creceives summaries of product characteristics (SPCs)of all new products as well as revised SPCs <strong>for</strong> existingproducts. The SPCs are a key source of product in<strong>for</strong>mationand are carefully processed, despite the everincreasingvolume of in<strong>for</strong>mation being issued by thepharmaceutical industry. Such processing involves:. verifying the approved names of all relevant ingredientsincluding ‘non-active’ ingredients (<strong>BNF</strong>C iscommitted to using approved names and descriptionsas 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 <strong>for</strong> their inclusion orexclusion;. seeking independent data on the use of drugs inpregnancy and breast-feeding;

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