BNF 78 September 2019 – March 2020 PDF

Medicines Information Services Information on drug therapy Medicines in Dentistry Specialist Advisory Service Information on any aspect of drug therapy can be obtained Information on drug therapy relating to dental treatment. from Regional and District Medicine...

Medicines Information Services Information on drug therapy Medicines in Dentistry Specialist Advisory Service Information on any aspect of drug therapy can be obtained Information on drug therapy relating to dental treatment. from Regional and District Medicines Information Services. Liverpool: (0151) 794 8206 Details regarding the local services provided within your region can be obtained by telephoning the following numbers. Driver and Vehicle Licensing Agency (DVLA) Information on the national medical guidelines of fitness England to drive is available from: Birmingham: (0121) 424 7298 www.gov.uk/government/publications/at-a-glance Bristol: (0117) 342 6655 Ipswich: (01473) 704 431 Medicines for Children Information Leaflets Leeds: (0113) 206 5377 Medicines information for parents and carers. Leicester: (0116) 258 6491 www.medicinesforchildren.org.uk Liverpool: (0151) 794 8113/7, or (0151) 794 8118 Patient Information Lines London: NHS Urgent Care Services 111. Guy’s Hospital (020) 7188 8750, or (020) 7188 3849, Poisons Information Services or (020) 7188 3855 UK National Poisons Information Service (for healthcare. Northwick Park Hospital (020) 8869 2761, professionals only) or (020) 8869 3973 Tel: 0344 892 0111 Newcastle: (0191) 282 4631 www.toxbase.org Southampton: (023) 8120 6908/9 Wales Sport Cardiff: (029) 2074 2979, ▶ Information regarding the use of medicines in sport is or (029) 2074 2251 available from UK Anti-Doping: www.ukad.org.uk Scotland Tel: (020) 7842 3450 Aberdeen: (01224) 552 316 [email protected] Dundee: (01382) 632 351, UK Anti-Doping or (01382) 660 111 Extn 32351 Fleetbank House 2-6 Salisbury Square Edinburgh: (0131) 242 2920 London Glasgow: (0141) 211 4407 EC4Y 8AE Northern Ireland ▶ Information about the prohibited status of specific medicines based on the current World Anti-Doping Belfast: (028) 9504 0558 Agency Prohibited List is available from Global Drug Republic of Ireland Reference Online: www.globaldro.com/UK/search Dublin: (01) 473 0589, or (01) 453 7941 Extn 2348 Travel Immunisation Up-to-date information on travel immunisation United Kingdom Medicines Information (UKMI) website requirements may be obtained from: www.sps.nhs.uk/ ▶ National Travel Health Network and Centre (for healthcare professionals only) 0845 602 6712 Monday and Friday: 9–11 a.m. and 1–2 p.m, Tuesday to Manufacturers Thursday: 9–11 a.m. and 1–3:30 p.m. Telephone numbers and email addresses of manufacturers ▶ travelhealthpro.org.uk/ listed in BNF Publications are shown in the Index of Travel Medicine Team, Health Protection Scotland manufacturers p. 1621 (0141) 300 1100 (2–4 p.m. weekdays) ▶ www.travax.nhs.uk(for registered users of the NHS website Travax only) UK Teratology Information Service ▶ Welsh Government Switchboard English language Information on drug and chemical exposures in 0300 0603300 (9 a.m.–5:30 p.m. weekdays only) pregnancy. ▶ Welsh Government Switchboard Yr laith Gymraeg Tel: 0344 892 0909 0300 0604400 (9 a.m.–5:30 p.m. weekdays only) www.uktis.org ▶ Department of Health and Social Services (Belfast) (028) 9052 2118 (weekdays) UK Drugs in Lactation Advisory Service (UKDILAS) Information on the compatibility of drugs with List of Registered Medical Practitioners breastfeeding. Details on whether doctors are registered and hold a Tel: (0116) 258 6491, licence to practise medicine in the UK can be obtained or (0121) 424 7298 from the General Medical Council. Email: [email protected] Tel: (0161) 923 6602 www.sps.nhs.uk/ukdilas www.gmc-uk.org/register 70 years supporting you to make effective decisions Since 1949 the British National Formulary (BNF) has been the UK’s most trusted and authoritative healthcare resource, helping to ensure the safe and effective use of medicines at the point of care. Now, as part of our anniversary celebrations, we want to showcase the rigorous editorial process that goes into creating the content that you rely on for your everyday practice. We will also go behind the scenes at the BNF in our ‘A day in the life’ articles. To find out more visit bnf.org We really appreciate the support you have given the BNF for our first 70 years. If you have a story to tell about how the BNF has been pivotal in your healthcare journey, we would love to hear about it on social media, just use hashtag #BNF70years Find out more about the BNF’s first 70 years at bnf.org  Access the BNF your way The British National Formulary (BNF) and BNF for Children are updated monthly online via MedicinesComplete, ensuring healthcare professionals always have the latest medicines information. ONLINE BNF on Evidence Search Search the BNF and BNF for Children alongside BNF on MedicinesComplete FormularyComplete other authoritative clinical Access BNF and BNF for Children Create, edit and manage your own and non-clinical evidence on MedicinesComplete and local formulary content built upon and best practice at receive the very latest drug the trusted prescribing advice of www.evidence.nhs.uk information through monthly the BNF and BNF for Children. IURP1,&( online updates. PRINT Eligible healthcare professionals will now receive one print copy a year – the September issue – to supplement RQOLQHDFFHVV,I\RXDUHHQWLWOHGWRDQ1+6FRS\SOHDVHUHIHUWRSDJHLLIRUIXOOGHWDLOVRQGLVWULEXWLRQ FDOORUHPDLO[email protected]. PRINT SUBSCRIPTION BNF subscription – Take advantage of our print subscription option. We will send you the new BNF as soon as the book is published. One or two year packages (including or excluding BNF for Children) are available. Discounted pricing is also available on bulk sales. MOBILE BNF app – Stay up to date anywhere with the BNF app available for iOS and Android. BNF eBook – Available as an ePDF. See www.pharmpress.com/bnf. BNF on MedicinesComplete – Now mobile responsive. How to purchase Buy direct from Pharmaceutical Press by Download mobile apps by visiting your visiting www.pharmpress.com/bnf appropriate app store. Available for iOS and For enquiries about the BNF or BNF for Android Children in print, contact For pricing information please visit the [email protected] website at www.pharmpress.com/bnf Tel: +44 (0) 1256 302 699 For international sales contact your local For enquiries concerning sales agent. Contact details at MedicinesComplete, FormularyComplete, www.pharmpress.com/Information-Help/ or bulk orders of the print edition, contact Bookseller-contacts/agents [email protected] Stay up to date - sign up to the BNF Tel: +44 (0) 20 7572 2266 eNewsletter at www.bnf.org/newsletter BNF 78 September 2019 – March 2020 Published jointly by In Wales, email: BMJ Group [email protected] Tavistock Square, London, WC1H 9JP, UK In Northern Ireland, email: and [email protected] Pharmaceutical Press About BNF content Pharmaceutical Press is the publishing division of the Royal The BNF is designed as a digest for rapid reference and it Pharmaceutical Society. may not always include all the information necessary for 66-68 East Smithfield, London E1W 1AW, UK prescribing and dispensing. Also, less detail is given on areas Copyright © BMJ Group and the Royal Pharmaceutical such as obstetrics, malignant disease, and anaesthesia since Society of Great Britain 2019. it is expected that those undertaking treatment will have specialist knowledge and access to specialist literature. BNF ISBN: 978 0 85711 351 1 for Children should be consulted for detailed information on ISBN: 978 0 85711 350 4 (NHS Edition) the use of medicines in children. The BNF should be interpreted in the light of professional knowledge and ISBN: 978 0 85711 352 8 (ePDF) supplemented as necessary by specialised publications and Printed by GGP Media GmbH, Pößneck, Germany by reference to the product literature. Information is also Typeset by Data Standards Ltd, UK available from Medicines Information Services. Text design by Peter Burgess Please refer to digital versions of BNF for the most up-to- date content. BNF is published in print but interim updates A catalogue record for this book is available from the British are issued and published in the digital versions of BNF. The Library. publishers work to ensure that the information is as accurate All rights reserved. No part of this publication may be and up-to-date as possible at the date of publication, but reproduced, stored in a retrieval system, or transmitted in knowledge and best practice in this field change regularly. any form or by any means, without the prior written BNF’s accuracy and currency cannot be guaranteed and permission of the copyright holder. neither the publishers nor the authors accept any responsibility for errors or omissions. While considerable Material published in the British National Formulary may not efforts have been made to check the material in this be used for any form of advertising, sales or publicity without publication, it should be treated as a guide only. Prescribers, prior written permission. 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Hampshire If you would like to donate your copy email: RG24 8YJ [email protected] Tel: +44 (0) 1256 302 699 Fax: +44 (0) 1256 812 521 [email protected] or via our website www.pharmpress.com/ For all bulk orders of more than 20 copies: Tel: +44 (0) 207 572 2266 [email protected] The BNF is available as a mobile app, online (bnf.nice.org.uk/) and also through MedicinesComplete; a PDA version is also available. In addition, BNF content can be integrated into a local formulary by using BNF on FormularyComplete; see www.bnf.org for details. Distribution of printed BNFs In England, NICE purchases print editions of the BNF (September editions only) for distribution within the NHS. For details of who is eligible to receive a copy and further contact details, please refer to the NICE website: www.nice.org.uk/about/what-we-do/evidence-services/british- national-formulary. If you are entitled to a shared copy of the BNF, please call (0)1268 495 609 or email: [email protected]. In Scotland, email: [email protected]  BNF 78 iii Preface The BNF is a joint publication of the British Medical BNF Publications welcomes comments from healthcare Association and the Royal Pharmaceutical Society. It is professionals. Comments and constructive criticism should published under the authority of a Joint Formulary be sent to: Committee which comprises representatives of the two British National Formulary, professional bodies, the UK Health Departments, the Royal Pharmaceutical Society, Medicines and Healthcare products Regulatory Agency, and 66–68 East Smithfield a national guideline producer. The Dental Advisory Group London oversees the preparation of advice on the drug management E1W 1AW of dental and oral conditions; the Group includes [email protected] representatives of the British Dental Association and a representative from the UK Health Departments. The Nurse The contact email for manufacturers or pharmaceutical Prescribers’ Advisory Group advises on the content relevant companies wishing to contact BNF Publications is to nurses and includes representatives from different parts [email protected] of the nursing community and from the UK Health Departments. The BNF aims to provide prescribers, pharmacists, and other healthcare professionals with sound up-to-date information about the use of medicines. The BNF includes key information on the selection, prescribing, dispensing and administration of medicines. Medicines generally prescribed in the UK are covered and those considered less suitable for prescribing are clearly identified. Little or no information is included on medicines promoted for purchase by the public. Information on drugs is drawn from the manufacturers’ product literature, medical and pharmaceutical literature, UK health departments, regulatory authorities, and professional bodies. Advice is constructed from clinical literature and reflects, as far as possible, an evaluation of the evidence from diverse sources. The BNF also takes account of authoritative national guidelines and emerging safety concerns. In addition, the editorial team receives advice on all therapeutic areas from expert clinicians; this ensures that the BNF’s recommendations are relevant to practice. The BNF is designed as a digest for rapid reference and it may not always include all the information necessary for prescribing and dispensing. Also, less detail is given on areas such as obstetrics, malignant disease, and anaesthesia since it is expected that those undertaking treatment will have specialist knowledge and access to specialist literature. Similarly, little or no information is included on medicines for very rare conditions. BNF for Children should be consulted for detailed information on the use of medicines in children. The BNF should be interpreted in the light of professional knowledge and supplemented as necessary by specialised publications and by reference to the product literature. Information is also available from medicines information services, see Medicines Information Services (see inside front cover). It is important to use the most recent BNF information for making clinical decisions. The print edition of the BNF is updated in March and September each year. Monthly updates are provided online via Medicines Complete and the NHS Evidence portal. The more important changes are listed under Changes; changes listed online 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. The BNF Publications website (www.bnf.org) includes additional information of relevance to healthcare professionals. Other digital formats of the BNF—including versions for mobile devices and integration into local formularies—are also available.  iv BNF 78 Contents Preface page NOTES ON DRUGS AND PREPARATIONS Acknowledgements v How BNF publications are constructed viii 1 Gastro-intestinal system page 37 How to use BNF Publications in print x 2 Cardiovascular system 99 Changes xvi 3 Respiratory system 235 Guidance on Prescribing 1 4 Nervous system 300 Prescription writing 5 5 Infection 505 Emergency supply of medicines 7 6 Endocrine system 666 Controlled drugs and drug dependence 8 7 Genito-urinary system 776 Adverse reactions to drugs 12 8 Immune system and malignant disease 835 Guidance on intravenous infusions 16 9 Blood and nutrition 1010 Prescribing for children 18 10 Musculoskeletal system 1091 Prescribing in hepatic impairment 19 11 Eye 1158 Prescribing in renal impairment 19 12 Ear, nose and oropharynx 1194 Prescribing in pregnancy 23 13 Skin 1220 Prescribing in breast-feeding 23 14 Vaccines 1287 Prescribing in palliative care 25 15 Anaesthesia 1328 Prescribing for the elderly 30 16 Emergency treatment of poisoning 1359 Drugs and sport 31 APPENDICES AND INDICES Prescribing in dental practice 32 Appendix 1 Interactions 1373 Appendix 2 Borderline substances 1556 Appendix 3 Cautionary and advisory labels for dispensed medicines 1588 Appendix 4 Wound management products and elasticated garments 1591 Dental Practitioners’ Formulary 1615 Nurse Prescribers’ Formulary 1617 Non-medical prescribing 1620 Index of manufacturers 1621 Special-order Manufacturers 1626 Index 1628 Medical emergencies in the community inside back cover  BNF 78 v Acknowledgements The Joint Formulary Committee is grateful to individuals and organisations that have provided advice and information to the BNF. Contributors for this update were: K.W. Ah-See, M.N. Badminton, A.K. Bahl, P.R.J. Barnes, D. Bilton, S.L. Bloom, M.F. Bultitude, I.F. Burgess, D.J. Burn, C.E. Dearden, D.W. Denning, P.N. Durrington, D.A.C. Elliman, P. Emery, M.D. Feher, A. Freyer, B.G. Gazzard, A.M. Geretti, N.J.L. Gittoes, P.J. Goadsby, M. Gupta, T.L. Hawkins, B.G. Higgins, S.P. Higgins, S.H.D. Jackson, A. Jones, D.M. Keeling, J.R. Kirwan, P.G. Kopelman, T.H. Lee, A. Lekkas, D.N.J. Lockwood, A.M. Lovering, M.G. Lucas, L. Luzzatto, P.D. Mason, D.A. McArthur, K.E.L. McColl, L.M. Melvin, E. Miller, R.M. Mirakian, P. Morrison, S.M.S. Nasser, C. Nelson-Piercy, J.M. Neuberger, D.J. Nutt, R. Patel, W.J. Penny, A.B. Provan, A.S.C. Rice, D.J. Rowbotham, J.W. Sander, J.A.T. Sandoe, M. Schacter, S.E. Slater, J. Soar, S.C.E. Sporton, M.D. Stewart, S. Thomas, J.P. Thompson, A.D. Weeks, A. Wilcock, A.P.R. Wilson. Expert advice on the management of oral and dental conditions was kindly provided by M. Addy, P. Coulthard, A. Crighton, M.A.O. Lewis, J.G. Meechan, N.D. Robb, C. Scully, R.A. Seymour, R. Welbury, and J.M. Zakrzewska. S. Kaur provided valuable advice on dental prescribing policy. Valuable advice has been provided by the following expert groups: Advisory Committee on Malaria Prevention, Association of British Neurologists, British Association of Dermatologists’ Therapy & Guidelines Sub-committee, British Geriatrics Society, British Society of Gastroenterology, British Society of Paediatric Gastroenterology, Hepatology and Nutrition, Faculty of Sexual and Reproductive Healthcare, Neonatal and Paediatric Pharmacists Group, Royal College of Anaesthetists, Royal College of Obstetricians and Gynaecologists, Royal College of Psychiatrists, Vascular Society. The MHRA have provided valuable assistance. Correspondents in the pharmaceutical industry have provided information on new products and commented on products in the BNF. Numerous doctors, pharmacists, nurses, and others have sent comments and suggestions. The BNF team are grateful for the support and access to in- house expertise at Pharmaceutical Press and acknowledge the assistance of A. Lourie, J. Macdonald, N. Potter and their teams. M. D’Souza, D. Isaacson, A. Iqbal, N. Kaur, R.K. Khonsoorkh, I. Lowings, E. Richardson and T.T. Sham provided considerable assistance during the production of this update of the BNF.  vi BNF 78 BNF Staff BNF DIRECTOR Karen Baxter BSc, MSc, MRPharmS SENIOR EDITORIAL STAFF Kiri Aikman BPharm (NZ), PGDipClinPharm (NZ), ARPharmS Rebecca Luckhurst BSc, MSc Rebecca Bloor BPharm (NZ) Alexander McPhail MPharm, PGDipClinPharm Alison Brayfield BPharm, MRPharmS Claire McSherry BPharm (NZ), PGCertClinPharm (NZ) Robert Buckingham BSc, SRPharmS Claire Preston BPharm, PGDipMedMan, MRPharmS Catherine Cadart BPharm (AU), BA(Hons), Kate Towers BPharm (AU), GCClinPharm (AU) GradDipHospPharm (AU), MRPharmS Mahinaz Harrison BPharm, DipPharmPract, IP, MRPharmS EDITORIAL STAFF Lucía Camañas Sáez MPharm (ESP), PGDipClinPharm, Anna McLachlan BPharm (NZ), PGCertClinPharm (NZ) PGCertPsychTherap, MRPharmS Liliana Moreira Vilas Boas MPharm(PT), PGDipHPS(PT), Jacky Chan BPharm(Hons) (NZ), PGDipClinPharm (NZ) PGCertHSDM(PT), PGCertGPP, MRPharmS Kiran Cheema MPharm Merusha Naidoo BPharm (NZ), PGCertClinPharm (NZ) Kathleen Eager BPharm Hana Numan BPharm (NZ), PGDipClinPharm (NZ) Hannah Giles BPharm (NZ) Kere Odumah MPharm, PGCertClinPharm Holly Hayne BSc (Pharmacology) (NZ), BPharm (NZ) Barbara Okpala MPharm, PGDipHospPharm Sue Ho BPharm (AU), MRPharmS Catherine Pitt MPharm, PGDipClinPharm, MRPharmS Stephanie Jones MPharm, MSc (Genomic Medicine), Stephanie Powell MBioSci MRPharmS Rebekah Raymond BSc, DipPharmPrac, MRPharmS Elizabeth King MAPharmT Harpreet Sandhu MPharm, MRPharmS Marta Leon-Alonso MPharm (ESP), MRes (ESP), MSc Beejal Shah MPharm, PGDipClinPharm, IP, MRPharmS ClinPharm, MRPharmS Tadeh Tahmasi MPharm, MRPharmS David Lipanovic BPharm (NZ), PGCertClinPharm (NZ) Hannah Tan BPharm (AU) Jean MacKershan BSc, PgDip Jacob Warner BPharm (AU) John Martin BPharm, PhD, MRPharmS Julia Webb MPharm, PGCertPharmPrac Angela McFarlane BSc, DipClinPharm Hans Yu BPharm(Hons) (NZ), PGDipClinPharm (NZ) Deirdre McGuirk BComm, MPharm, MRPharmS SUPPORT STAFF Matt Bradbury BSc(Hons) Philip Lee BSc, PhD Darren Chan BSc, MSc Vicky Pollington BSc(Hons) Lauren Cheetham BA(Hons) Carina Redig de Campos Filsane Haji BSc, MSc Jannah Ryan BSc(Hons) Hannah Kitt BSc(Hons) Nikolaos Tsimplis BSc, MRes  BNF 78 vii Joint Formulary Committee Dental Advisory Group CHAIR CHAIR Derek G. Waller Sarah Manton BSc, MB BS, DM, FRCP BDS, FDSRCS Ed, FHEA, PhD, FDFTEd COMMITTEE MEMBERS COMMITTEE MEMBERS Andy Burman Rebecca Bloor CMgr, FCMI, FRSA, FIAM BPharm (NZ) Daniel Burrage Andrew K. Brewer BSc, MB BS, MSc, MRCP BSc, BchD, MFDS (Glas) Jo Lyn Chooi Alexander Crighton BMedSc, BM BS, FRCA BDS, MB, ChB, FDS, OM Carmel M. Darcy Hannah Giles BSc, MSc, IP, MPSNI, MRPharmS BPharm (NZ) Andrew Evans Michelle Moffat BPharm, MPH, DipClinPharm, MRPharmS BDS MFDS RCS Ed, M Paed Dent RCPS, FDS (Paed Dent) RCS Sue Faulding Ed BPharm, MSc, FRPharmS Barbara Okpala Tracy Hall MPharm, PGDipHospPharm BSc, MSc, Cert N, Dip N, RGN, DN, NIP, QN Wendy Thompson Brian Hawkins BSc(Hons), BDS(Hons), MJDF BSc, PhD, MRPharmS, FFRPS, IP Kate Towers Lynn Haygarth BPharm (AU), GCClinPharm (AU) BPharm, MEd, FFRPS, FRPharmS, FCMHP SECRETARY Simon Hurding Arianne J. Matlin MB, ChB, MRCGP MA, MSci, PhD Sandeep Kapur ADVICE ON DENTAL PRACTICE BSc(Hons), MB BS, MRCGP(Dist) The British Dental Association has contributed to the W. Moira Kinnear advice on medicines for dental practice through its BSc, MSc, MRPharmS representatives on the Dental Advisory Group. Mark P. Lythgoe MB BS, MRPharmS Louise Picton BSc, DipCommPharm, MSc, MRPharmS Bernadette Rae Nurse Prescribers’Advisory Pg Cert Ed, Fellow HEA, MSc Nursing, Pg CertANP, BSc(Hons), Grad Cert NMP, RGN Group Muhammad Magdi Yaqoob MD, FRCP CHAIR Molly Courtenay PhD, MSc, Cert Ed, BSc, RGN COMMITTEE MEMBERS Penny M. Franklin RN, RCN, RSCPHN(HV), MA, PGCE Matt Griffiths BA(Hons), FAETC, RGN, Cert A&E, NISP, PHECC Tracy Hall BSc, MSc, RGN, DN, Dip N, Cert N Penny Harrison BSc(Hons) Julie MacAngus BSc(Hons), RGN, RM, PGCE Joan Myers MSc, BSc, RGN, RSCN, Dip DN Fiona Peniston-Bird BSc(Hons), NIP, RHV, RGN Kathy Radley BSc, RGN Kate Towers BPharm (AU), GCClinPharm (AU)  viii BNF 78 How BNF Publications are constructed Overview Amendments to the text are drafted when the clinical writers The BNF is an independent professional publication that are satisfied that any new information is reliable and relevant. A addresses the day-to-day prescribing information needs of set of standard criteria define when content is referred to expert healthcare professionals. Use of this resource throughout the advisers, the Joint Formulary Committee or other advisory health service helps to ensure that medicines are used safely, groups, or submitted for peer review. effectively, and appropriately. Clinical writers prepare the text for publication and undertake a Hundreds of changes are made between print editions, and are number of validation checks on the knowledge at various stages of published monthly in a number of digital formats. The most the production process. clinically significant updates are listed under Changes p. xvi. Sources of BNF information The BNF is unique in bringing together authoritative, The BNF uses a variety of sources for its information; the main independent guidance on best practice with clinically validated ones are shown below. drug information. Validation of information follows a standardised process, reviewing emerging evidence, best-practice Summaries of product characteristics guidelines, and advice from a network of clinical experts. Where The BNF reviews summaries of product characteristics (SPCs) of the evidence base is weak, further validation is undertaken all new products as well as revised SPCs for existing products. The through a process of peer review. The process and its governance SPCs are the principal source of product information and are are outlined in greater detail in the sections that follow. carefully processed. Such processing involves: Joint Formulary Committee. verifying the approved names of all relevant ingredients The Joint Formulary Committee (JFC) is responsible for the including ‘non-active’ ingredients (the BNF is committed to content of the BNF. The JFC includes pharmacy, medical, nursing using approved names and descriptions as laid down by the and lay representatives; there are also representatives from the Human Medicine Regulations 2012); Medicines and Healthcare products Regulatory Agency (MHRA),. comparing the indications, cautions, contra-indications, and the UK Health Departments, and a national guideline producer. side-effects with similar existing drugs. Where these are The JFC decides on matters of policy and reviews amendments to different from the expected pattern, justification is sought for the BNF in the light of new evidence and expert advice. their inclusion or exclusion;. seeking independent data on the use of drugs in pregnancy and Dental Advisory Group breast-feeding; The Dental Advisory Group oversees the preparation of advice on. incorporating the information into the BNF using established the drug management of dental and oral conditions; the group criteria for the presentation and inclusion of the data; includes representatives from the British Dental Association and. checking interpretation of the information by a second clinical a representative from the UK Health Departments. writer before submitting to a content manager; changes Nurse Prescribers’ Advisory Group relating to doses receive a further check; The Nurse Prescribers’ Advisory Group oversees the list of drugs. identifying potential clinical problems or omissions and approved for inclusion in the Nurse Prescribers’ Formulary; the seeking further information from manufacturers or from expert group includes representatives from a range of nursing disciplines advisers; and stakeholder organisations.. constructing, with the help of expert advisers, a comment on the role of the drug in the context of similar drugs. Expert advisers The BNF uses about 60 expert clinical advisers (including doctors, Much of this processing is applicable to the following sources as pharmacists, nurses, and dentists) throughout the UK to help with well. clinical content. The role of these expert advisers is to review Literature existing text and to comment on amendments drafted by the Clinical writers monitor core medical and pharmaceutical clinical writers. These clinical experts help to ensure that the BNF journals. Research papers and reviews relating to drug therapy are remains reliable by: carefully processed. When a difference between the advice in the. commenting on the relevance of the text in the context of best BNF and the paper is noted, the new information is assessed for clinical practice in the UK; reliability (using tools based on SIGN methodology) and relevance. checking draft amendments for appropriate interpretation of to UK clinical practice. If necessary, new text is drafted and any new evidence; discussed with expert advisers and the Joint Formulary. providing expert opinion in areas of controversy or when Committee. The BNF enjoys a close working relationship with a reliable evidence is lacking; number of national information providers.. providing independent advice on drug interactions, prescribing In addition to the routine process, which is used to identify in hepatic impairment, renal impairment, pregnancy, breast- ‘triggers’ for changing the content, systematic literature searches feeding, children, the elderly, palliative care, and the are used to identify the best quality evidence available to inform emergency treatment of poisoning. an update. Clinical writers receive training in critical appraisal, literature evaluation, and search strategies. In addition to consulting with regular advisers, the BNF calls on other clinical specialists for specific developments when Consensus guidelines particular expertise is required. The advice in the BNF is checked against consensus guidelines The BNF works closely with a number of expert bodies that produced by expert bodies. The quality of the guidelines is produce clinical guidelines. Drafts or pre-publication copies of assessed using adapted versions of the AGREE II tool. A number guidelines are often received for comment and assimilation into of bodies make drafts or pre-publication copies of the guidelines the BNF. available to the BNF; it is therefore possible to ensure that a Editorial team consistent message is disseminated. The BNF routinely processes guidelines from the National Institute for Health and Care BNF clinical writers have all worked as pharmacists or possess a Excellence (NICE), the All Wales Medicines Strategy Group pharmacy degree and a further, relevant post-graduate (AWMSG), the Scottish Medicines Consortium (SMC), and the qualification, and have a sound understanding of how drugs are Scottish Intercollegiate Guidelines Network (SIGN). used in clinical practice. As a team, the clinical writers are responsible for editing, maintaining, and updating BNF content. Reference sources They follow a systematic prioritisation process in response to Textbooks and reference sources are used to provide background updates to the evidence base in order to ensure the most clinically information for the review of existing text or for the construction important topics are reviewed as quickly as possible. In parallel of new text. The BNF team works closely with the editorial team the team of clinical writers undertakes a process of rolling that produces Martindale: The Complete Drug Reference. The BNF revalidation, aiming to review all of the content in the BNF over a has access to Martindale information resources and each team 3- to 4-year period.  BNF 78 ix keeps the other informed of significant developments and shifts Evidence used to make a recommendation is assessed for in the trends of drug usage. validity using standardised methodology tools based on AGREE II and assigned a level of evidence. The recommendation is then Peer review given a grade that is extrapolated from the level of evidence, and Although every effort is made to identify the most robust data an assessment of the body of evidence and its applicability. available, inevitably there are areas where the evidence base is Evidence assigned a level 1- or 2- score has an unacceptable weak or contradictory. While the BNF has the valuable support of level of bias or confounding and is not used to form expert advisers and the Joint Formulary Committee, the recommendations. recommendations made may be subject to a further level of scrutiny through peer review to ensure they reflect best practice. Levels of evidence Content for peer review is posted on bnf.org and interested. Level 1++ parties are notified via a number of channels, including the BNF High quality meta-analyses, systematic reviews of randomised e-newsletter. controlled trials (RCTs), or RCTs with a very low risk of bias. Statutory information. Level 1+ The BNF routinely processes relevant information from various Well-conducted meta-analyses, systematic reviews, or RCTs Government bodies including Statutory Instruments and with a low risk of bias. regulations affecting the Prescriptions only Medicines Order. Official compendia such as the British Pharmacopoeia and its. Level 1– addenda are processed routinely to ensure that the BNF complies Meta-analyses, systematic reviews, or RCTs with a high risk of with the relevant sections of the Human Medicines Regulations bias. 2012.. Level 2++ The BNF maintains close links with the Home Office (in relation High quality systematic reviews of case control or cohort to controlled drug regulations) and the Medicines and Healthcare studies; or high quality case control or cohort studies with a products Regulatory Agency (including the British very low risk of confounding or bias and a high probability that Pharmacopoeia Commission). Safety warnings issued by the the relationship is causal. Commission on Human Medicines (CHM) and guidelines on drug are issued by the UK health departments are processed as a matter. Level 2+ of routine. Well-conducted case control or cohort studies with a low risk of Relevant professional statements issued by the Royal confounding or bias and a moderate probability that the Pharmaceutical Society are included in the BNF as are guidelines relationship is causal. from bodies such as the Royal College of General Practitioners.. Level 2– Medicines and devices Case control or cohort studies with a high risk of confounding NHS Prescription Services (from the NHS Business Services or bias and a significant risk that the relationship is not causal. Authority) provides non-clinical, categorical information. Level 3 (including prices) on the medicines and devices included in the Non-analytic studies, e.g. case reports, case series. BNF.. Level 4 Comments from readers Expert advice or clinical experience from respected authorities. Readers of the BNF are invited to send in comments. Numerous letters and emails are received by the BNF team. Such feedback Grades of recommendation helps to ensure that the BNF provides practical and clinically. Grade A: High strength relevant information. Many changes in the presentation and NICE-accredited guidelines; or guidelines that pass AGREE II scope of the BNF have resulted from comments sent in by users. assessment; or at least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target Comments from industry population; or a body of evidence consisting principally of Close scrutiny of BNF by the manufacturers provides an studies rated as 1+, directly applicable to the target population, additional check and allows them an opportunity to raise issues and demonstrating overall consistency of results. about BNF’s presentation of the role of various drugs; this is yet another check on the balance of BNF’s advice. All comments are. Grade B: Moderate strength looked at with care and, where necessary, additional information A body of evidence including studies rated as 2++, directly and expert advice are sought. applicable to the target population, and demonstrating overall consistency of results; or extrapolated evidence from studies Market research rated as 1++ or 1+. Market research is conducted at regular intervals to gather feedback on specific areas of development.. Grade C: Low strength A body of evidence including studies rated as 2+, directly Assessing the evidence applicable to the target population and demonstrating overall From January 2016, recommendations made in BNF publications consistency of results; or extrapolated evidence from studies have been evidence graded to reflect the strength of the rated as 2++. recommendation. The addition of evidence grading is to support clinical decision making based on the best available evidence.. Grade D: Very low strength The BNF aims to revalidate all content over a rolling 3- to Evidence level 3; or extrapolated evidence from studies rated as 4-year period and evidence grading will be applied to 2+; or tertiary reference source created by a transparent, recommendations as content goes through the revalidation defined methodology, where the basis for recommendation is process. Therefore, initially, only a small number of clear. recommendations will have been graded.. Grade E: Practice point Grading system Evidence level 4. The BNF 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.  x BNF 78 How to use BNF Publications in print How to use the BNF of poisoning; or drug use related to a particular system of the body, such as Chapter 2, Cardiovascular. This edition of the BNF continues to display the Within each chapter, content is organised alphabetically fundamental change to the structure of the content that was by therapeutic use (e.g. Airways disease, obstructive), with first shown in BNF 70. The changes were made to bring the treatment summaries first, (e.g. asthma), followed by the consistency and clarity to BNF content, and to the way that monographs of the drugs used to manage the conditions the content is arranged within print and digital products, discussed in the treatment summary. Within each increasing the ease with which information can be found. therapeutic use, the drugs are organised alphabetically by For reference, the most notable changes to the structure of classification (e.g. Antimuscarinics, Beta 2-agonist the content include: bronchodilators) and then alphabetically within each. Drug monographs – where possible, all information that classification (e.g. Aclidinium bromide, Glycopyrronium relates to a single drug is contained within its drug bromide, Ipratropium bromide). monograph, moving information previously contained in Appendices, covering interactions, borderline substances, the prescribing notes. Drug monographs have also cautionary and advisory labels, and woundcare. changed structurally: additional sections have been added, Back matter, covering the lists of medicines approved by ensuring greater regularity around where information is the NHS for Dental and Nurse Practitioner prescribing, located within the publication. proprietary and specials manufacturers’ contact details, and. Drug class monographs – where substantial amounts of the index. Yellow cards are also included, to facilitate the information are common to all drugs within a drug class reporting of adverse events, as well as quick reference guides (e.g. macrolides p. 536), a drug class monograph has been for life support and key drug doses in medical emergencies, created to contain the common information. for ease of access.. Medicinal forms – categorical information about marketed medicines, such as price and pack size, continues to be Navigating the BNF sourced directly from the Dictionary of Medicines and The contents page provides the high-level layout of Devices provided by the NHS Business Services Authority. information within the BNF; and in addition, each chapter However, clinical information curated by the BNF team has begins with a small contents section, describing the been clearly separated from the categorical pricing and therapeutic uses covered within that chapter. Once in a pack size information and is included in the relevant chapter, location is guided by the side of the page showing section of the drug monograph. the chapter number (the thumbnail), alongside the chapter. Section numbering – the BNF section numbering has been title. The top of the page includes the therapeutic use (the removed. This section numbering tied the content to a running head) alongside the page number. rigid structure and enforced the retention of defunct Once on a page, visual cues aid navigation: treatment classifications, such as mercurial diuretics, and hindered summary information is in black type, with therapeutic use the relocation of drugs where therapeutic use had altered. titles similarly styled in black, whereas the use of colour It also caused constraints between the BNF and BNF for indicates drug-related information, including drug Children, where drugs had different therapeutic uses in classification titles, drug class monographs, and drug children. monographs.. Appendix 4 – the content has been moved to individual Although navigation is possible by browsing, primarily drug monographs. The introductory notes have been access to the information is via the index, which covers the replaced with a new guidance section, Guidance on titles of drug class monographs, drug monographs, and intravenous infusions p. 16. treatment summaries. The index also includes the names of branded medicines and other topics of relevance, such as Introduction abbreviations, guidance sections, tables, and images. In order to achieve the safe, effective, and appropriate use of Content types medicines, healthcare professionals must be able to use the BNF effectively, and keep up to date with significant changes Treatment summaries in the BNF that are relevant to their clinical practice. This Treatment summaries are of three main types; How to Use the BNF is key in reinforcing the details of the. an overview of delivering a drug to a particular body new structure of the BNF to all healthcare professionals system (e.g. Skin conditions, management p. 1220) involved with prescribing, monitoring, supplying, and. a comparison between a group or groups of drugs (e.g. administering medicines, as well as supporting the learning beta-adrenoceptor blockers (systemic) p. 147) of students training to join these professions.. an overview of the drug management or prophylaxis of common conditions intended to facilitate rapid appraisal Structure of the BNF of options (e.g. Hypertension p. 140, or Malaria, This BNF edition continues to broadly follows the high-level prophylaxis p. 607). structure of earlier editions of the BNF (i.e. those published before BNF 70): In order to select safe and effective medicines for individual Front matter, comprising information on how to use the patients, information in the treatment summaries must be BNF, the significant content changes in each edition, and used in conjunction with other prescribing details about the guidance on various prescribing matters (e.g. prescription drugs and knowledge of the patient’s medical and drug writing, the use of intravenous drugs, particular history. considerations for special patient populations). Monographs Chapters, containing drug monographs describing the Overview uses, doses, safety issues and other considerations involved In earlier editions (i.e. before BNF 70), a systemically in the use of drugs; drug class monographs; and treatment administered drug with indications for use in different body summaries, covering guidance on the selection of drugs. systems was split across the chapters relating to those body Monographs and treatment summaries are divided into systems. So, for example, codeine phosphate p. 454 was chapters based on specific aspects of medical care, such as found in chapter 1, for its antimotility effects and chapter 4 Chapter 5, Infections, or Chapter 16, Emergency treatment for its analgesic effects. However, the monograph in  BNF 78 xi chapter 1 contained only the dose and some selected safety range of adult 18 to 64 is applicable to a patient from the day precautions. of their 18th birthday until the day before their 65th birthday. Now, all of the information for the systemic use of a drug is All age ranges should be interpreted in this way. Similarly, contained within one monograph, so codeine phosphate when interpreting weight ranges, it should be understood p. 454 is now included in chapter 4. This carries the that a weight of up to 30 kg is applicable to a patient up to, advantage of providing all of the information in one place, so but not including, the point that they tip the scales at 30 kg the user does not need to flick back and forth across several and a weight range of 35 to 59 kg is applicable to a patient as pages to find all of the relevant information for that drug. soon as they tip the scales at 35 kg right up until, but not Cross references are included in chapter 1, where the including, the point that they tip the scales at 60 kg. All management of diarrhoea is discussed, to the drug weight ranges should be interpreted in this way. monograph to assist navigation. In all circumstances, it is important to consider the patient Where drugs have systemic and local uses, for example, in question and their physical condition, and select the dose chloramphenicol p. 568, 1173, 1196, and the considerations most appropriate for the individual. around drug use are markedly different according to the Other information relevant to Indication and dose route of administration, the monograph is split, as with The dose panel also contains, where known, an indication of earlier editions, into the relevant chapters. pharmacokinetic considerations that may affect the This means that the majority of drugs are still placed in the choice of dose, and dose equivalence information, which same chapters and sections as earlier editions, and although may aid the selection of dose when switching between drugs there may be some variation in order, all of the relevant or preparations. information will be easier to locate. The BNF includes unlicensed use of medicines when the One of the most significant changes to the monograph clinical need cannot be met by licensed medicines; such use structure is the increased granularity, with a move from should be supported by appropriate evidence and around 9 sections to over 20 sections; sections are only experience. When the BNF recommends an unlicensed included when relevant information has been identified. The medicine or the ‘off-label’ use of a licensed medicine, this is following information describes these sections and their uses shown below the indication and dose panel in the unlicensed in more detail. use section. Nomenclature Minimising harm and drug safety Monograph titles follow the convention of recommended The drug chosen to treat a particular condition should international non-proprietary names (rINNs), or, in the minimise the patient’s susceptibility to adverse effects and, absence of a rINN, British Approved Names. Relevant where co-morbidities exist, have minimal detrimental effects synonyms are included below the title and, in some on the patient’s other diseases. To achieve this, the Contra- instances a brief description of the drug action is included. indications, Cautions and Side-effects of the relevant drug Over future editions these drug action statements will be should be reviewed. rolled out for all drugs. The information under Cautions can be used to assess the In some monographs, immediately below the risks of using a drug in a patient who has co-morbidities that nomenclature or drug action, there are a number of cross are also included in the Cautions for that drug—if a safer references or flags used to signpost the user to any alternative cannot be found, the drug may be prescribed additional information they need to consider about a drug. while monitoring the patient for adverse-effects or This is most common for drugs formulated in combinations, deterioration in the co-morbidity. Contra-indications are far where users will be signposted to the monographs for the more restrictive than Cautions and mean that the drug individual ingredients (e.g. senna with ispaghula husk p. 63) should be avoided in a patient with a condition that is or for drugs that are related to a drug class monograph (see contra-indicated. Drug class monographs, below). The impact that potential side-effects may have on a Indication and dose patient’s quality of life should also be assessed. For instance, User feedback has highlighted that one of the main uses of in a patient who has difficulty sleeping, it may be preferable the BNF is identifying indications and doses of drugs. to avoid a drug that frequently causes insomnia. Therefore, indication and dose information has been The Important safety advice section in the BNF, delineated promoted to the top of the monograph and highlighted by a by a coloured outline box, highlights important safety coloured panel to aid quick reference. concerns, often those raised by regulatory authorities or The indication and dose section is more highly structured guideline producers. Safety warnings issued by the than in earlier editions, giving greater clarity around which Commission on Human Medicines (CHM) or Medicines and doses should be used for which indications and by which Healthcare products Regulatory Agency (MHRA) are found route. In addition, if the dose varies with a specific here. preparation or formulation, that dosing information has Drug selection should aim to minimise drug interactions. been moved out of the preparations section and in to the If it is necessary to prescribe a potentially serious indication and dose panel, under a heading of the combination of drugs, patients should be monitored preparation name. appropriately. The mechanisms underlying drug interactions Doses are either expressed in terms of a definite frequency are explained in Appendix 1, followed by details of drug (e.g. 1 g 4 times daily) or in the total daily dose format (e.g. interactions. 6 g daily in 3 divided doses); the total daily dose should be Use of drugs in specific patient populations divided into individual doses (in the second example, the Drug selection should aim to minimise the potential for drug patient should receive 2 g 3 times daily). accumulation, adverse drug reactions, and exacerbation of Doses for specific patient groups (e.g. the elderly) may be pre-existing hepatic or renal disease. If it is necessary to included if they are different to the standard dose. Doses for prescribe drugs whose effect is altered by hepatic or renal children can be identified by the relevant age range and may disease, appropriate drug dose adjustments should be made, vary according to their age or body-weight. and patients should be monitored adequately. The general In earlier editions of the BNF, age ranges and weight principles for prescribing are outlined under Prescribing in ranges overlapped. For clarity and to aid selection of the hepatic impairment p. 19, and Prescribing in renal correct dose, wherever possible these age and weight ranges impairment p. 19. Information about drugs that should be now do not overlap. When interpreting age ranges it is avoided or used with caution in hepatic disease or renal important to understand that a patient is considered to be 64 up until the point of their 65th birthday, meaning that an age  xii BNF 78 Typical layout of a monograph and associated medicinal forms * 1 Class Monographs and drug monographs In most cases, all information that relates to an individual drug Class monograph * 1 f is contained in its drug monograph and there is no symbol. Class monographs have been created where substantial amounts of information are common to all drugs within a drug class, these CLASSIFICATION * 2 are indicated by a flag symbol in a circle: f eiii F 1234i Drug monographs with a corresponding class Drug monograph * 1 * 3 01-Jun-2016 monograph are indicated by a tab with a flag symbol: ! F 1234 (Synonym) another name by which a drug may be known The page number of the corresponding class monograph is l DRUG ACTION how a drug exerts its effect in the body indicated within the tab. For further information, see How to use BNF Publications l INDICATIONS AND DOSE Indications are the clinical reasons a drug is used. The * 2 Drug classifications dose of a drug will often depend on the indications Used to inform users of the class of a drug and to assist in Indication finding other drugs of the same class. May be based on ▶ ROUTE pharmacological class (e.g. opioids) but can also be associated ▶ Age groups:[Child/Adult/Elderly] with the use of the drug (e.g. cough suppressants) Dose and frequency of administration (max. dose) SPECIFIC PREPARATION NAME * 4 * 3 Review date Indication The date of last review of the content ▶ ROUTE ▶ Age groups: [Child/Adult/Elderly] * 4 Specific preparation name Dose and frequency of administration (max. dose) If the dose varies with a specific preparation or formulation it DOSE ADJUSTMENTS DUE TO INTERACTIONS dosing appears under a heading of the preparation name information when used concurrently with other drugs DOSES AT EXTREMES OF BODY-WEIGHT dosing information for patients who are overweight or underweight DOSE EQUIVALENCE AND CONVERSION information around the bioequivalence between formulations of the same drug, or equivalent doses of drugs that are members of the same class PHARMACOKINETICS how the body affects a drug (absorption, distribution, metabolism, and excretion) POTENCY a measure of drug activity expressed in terms of the concentration required to produce an effect of given intensity l UNLICENSED USE describes the use of medicines outside the terms of their UK licence (off-label use), or use of medicines that have no licence for use in the UK IMPORTANT SAFETY INFORMATION Information produced and disseminated by drug regulators often highlights serious risks associated with the use of a drug, and may include advice that is mandatory l CONTRA-INDICATIONS circumstances when a drug should be avoided l CAUTIONS details of precautions required l INTERACTIONS when one drug changes the effects of another drug; the mechanisms underlying drug interactions are explained in Appendix 1 l SIDE-EFFECTS listed in order of frequency, where known, and arranged alphabetically l ALLERGY AND CROSS-SENSITIVITY for drugs that carry an increased risk of hypersensitivity reactions l CONCEPTION AND CONTRACEPTION potential for a drug to have harmful effects on an unborn child when prescribing for a woman of childbearing age or for a man trying to father a child; information on the effect of drugs on the efficacy of latex condoms or diaphragms BNF 78 xiii l PREGNANCY advice on the use of a drug during pregnancy * 5 Evidence grading l BREAST FEEDING g advice on the use of a drug during Evidence grading to reflect the strengths of recommendations breast feeding h * 5 will be applied as content goes through the revalidation process. l HEPATIC IMPAIRMENT advice on the use of a drug in A five level evidence grading system based on the former SIGN hepatic impairment grading system has been adopted. The grades h i j k l RENAL IMPAIRMENT advice on the use of a drug in renal l are displayed next to the recommendations within the text, impairment and are preceded by the symbol: g l PRE-TREATMENT SCREENING covers one off tests required For further information, see How BNF Publications are to assess the suitability of a patient for a particular drug constructed l MONITORING REQUIREMENTS specifies any special monitoring requirements, including information on * 6 Legal categories monitoring the plasma concentration of drugs with a P This symbol has been placed against those preparations narrow therapeutic index that are available only on a prescription issued by an l EFFECTS ON LABORATORY TESTS for drugs that can appropriate practitioner. For more detailed information see interfere with the accuracy of seemingly unrelated Medicines, Ethics and Practice, London, Pharmaceutical Press laboratory tests (always consult latest edition) l TREATMENT CESSATION specifies whether further a b c d e m These symbols indicate that monitoring or precautions are advised when the drug is the preparations are subject to the prescription requirements of withdrawn the Misuse of Drugs Act l DIRECTIONS FOR ADMINISTRATION practical information on the preparation of intravenous drug infusions; general For regulations governing prescriptions for such preparations, advice relevant to other routes of administration see Controlled Drugs and Drug Dependence l PRESCRIBING AND DISPENSING INFORMATION practical information around how a drug can be prescribed and Not all monographs include all possible sections; sections dispensed including details of when brand prescribing is are only included when relevant information has been necessary identified l HANDLING AND STORAGE includes information on drugs that can cause adverse effects to those who handle them before they are taken by, or administered to, a patient; advice on storage conditions l PATIENT AND CARER ADVICE for drugs with a special need for counselling l PROFESSION SPECIFIC INFORMATION provides details of the restrictions certain professions such as dental practitioners or nurse prescribers need to be aware of when prescribing on the NHS l NATIONAL FUNDING/ACCESS DECISIONS details of NICE Technology Appraisals, SMC advice and AWMSG advice l LESS SUITABLE FOR PRESCRIBING preparations that are considered by the Joint Formulary Committee to be less suitable for prescribing l EXCEPTION TO LEGAL CATEGORY advice and information on drugs which may be sold without a prescription under specific conditions l MEDICINAL FORMS Form CAUTIONARY AND ADVISORY LABELS if applicable EXCIPIENTS clinically important but not comprehensive [consult manufacturer information for full details] ELECTROLYTES if clinically significant quantities occur ▶ Preparation name (Manufacturer/Non-proprietary) Drug name and strength pack sizes P * 6 Prices Combinations available this indicates a combination preparation is available and a cross reference page number is provided to locate this preparation  xiv BNF 78 impairment can be found in drug monographs under Hepatic Medicinal forms impairment and Renal impairment (e.g. fluconazole p. 595). In the BNF, preparations follow immediately after the Similarly, drug selection should aim to minimise harm to monograph for the drug that is their main ingredient. the fetus, nursing infant, and mother. The infant should be In earlier editions, when a particular preparation had monitored for potential side-effects of drugs used by the safety information, dose advice or other clinical information mother during pregnancy or breast-feeding. The general specific to the product, it was contained within the principles for prescribing are outlined under Prescribing in preparations section. This information has been moved to pregnancy p. 23 and Prescribing in breast-feeding p. 23. The the relevant section in the main body of the monograph Treatment Summaries provide guidance on the drug under a heading of the name of the specific medicinal form treatment of common conditions that can occur during (e.g. peppermint oil p. 48). pregnancy and breast-feeding (e.g. Asthma, acute p. 240). The medicinal forms (formerly preparations) section Information about the use of specific drugs during pregnancy provides information on the type of formulation (e.g. tablet), and breast-feeding can be found in their drug monographs the amount of active drug in a solid dosage form, and the under Pregnancy, and Breast-feeding (e.g. fluconazole p. 595). concentration of active drug in a liquid dosage form. The A section, Conception and contraception, containing legal status is shown for prescription-only medicines and information around considerations for females of controlled drugs, as well as pharmacy medicines and childbearing potential or men who might father a child (e.g. medicines on the general sales list. Practitioners are isotretinoin p. 1270) has been included. reminded, by a statement under the heading of “Medicinal Administration and monitoring Forms” that not all products containing a specific drug When selecting the most appropriate drug, it may be ingredient may be similarly licensed. To be clear on the necessary to screen the patient for certain genetic markers or precise licensing status of specific medicinal forms, metabolic states. This information is included within a practitioners should check the product literature for the section called Pre-treatment screening (e.g. abacavir p. 647). particular product being prescribed or dispensed. This section covers one-off tests required to assess the Details of all medicinal forms available on the dm+d for suitability of a patient for a particular drug. each drug in BNF Publications appears online on Once the drug has been selected, it needs to be given in MedicinesComplete. In print editions, due to space the most appropriate manner. A Directions for administration constraints, only certain branded products are included in section contains the information about intravenous detail. Where medicinal forms are listed they should not be administration previously located in Appendix 4. This inferred as equivalent to the other brands listed under the provides practical information on the preparation of same form heading. For example, all the products listed intravenous drug infusions, including compatibility of drugs under a heading of “Modified release capsule” will be with standard intravenous infusion fluids, method of available as modified release capsules, however, the brands dilution or reconstitution, and administration rates. In listed under that form heading may have different release addition, general advice relevant to other routes of profiles, the available strengths may vary and/or the administration is provided within this section (e.g. fentanyl products may have different licensing information. As with p. 458). earlier editions of the BNF, practitioners must ensure that After selecting and administering the most appropriate the particular product being prescribed or dispensed is drug by the most appropriate route, patients should be appropriate. monitored to ensure they are achieving the expected As medicinal forms are derived from dm+d data, some benefits from drug treatment without any unwanted side- drugs may appear under names derived from that data; this effects. The Monitoring section specifies any special may vary slightly from those in previous BNF versions, e.g. monitoring requirements, including information on sodium acid phosphate, is now sodium dihydrogen monitoring the plasma concentration of drugs with a narrow phosphate anhydrous. therapeutic index (e.g. theophylline p. 274). Monitoring may, Patients should be prescribed a preparation that in certain cases, be affected by the impact of a drug on complements their daily routine, and that provides the right laboratory tests (e.g. hydroxocobalamin p. 1026), and this dose of drug for the right indication and route of information is included in Effects on laboratory tests. administration. When dispensing liquid preparations, a In some cases, when a drug is withdrawn, further sugar-free preparation should always be used in preference monitoring or precautions may be advised (e.g. clonidine to one containing sugar. Patients receiving medicines hydrochloride p. 145): these are covered under Treatment containing cariogenic sugars should be advised of cessation. appropriate dental hygiene measures to prevent caries. In earlier editions, the BNF only included excipients and Choice and supply electrolyte information for proprietary medicines. This The prescriber and the patient should agree on the health information is now covered at the level of the dose form (e.g. outcomes that the patient desires and on the strategy for tablet). It is not possible to keep abreast of all of the generic achieving them (see Taking Medicines to Best Effect). Taking products available on the UK market, and so this information the time to explain to the patient (and carers) the rationale serves as a reminder to the healthcare professional that, if and the potential adverse effects of treatment may improve the presence of a particular excipient is of concern, they adherence. For some medicines there is a special need for should check the product literature for the particular product counselling (e.g. appropriate posture during administration being prescribed or dispensed. of doxycycline p. 564); this is shown in Patient and carer Cautionary and advisory labels that pharmacists are advice. recommended to add when dispensing are included in the Other information contained in the latter half of the medicinal forms section. Details of these labels can be found monograph also helps prescribers and those dispensing in Appendix 3, Guidance for cautionary and advisory labels medicines choose medicinal forms (by indicating p. 1588. As these labels have now been applied at the level of information such as flavour or when branded products may the dose form, a full list of medicinal products with their not be interchangeable (e.g. diltiazem hydrochloride p. 157), relevant labels would be extensive. This list has therefore assess the suitability of a drug for prescribing, understand been removed, but the information is retained within the the NHS funding status for a drug (e.g. sildenafil p. 813), or monograph. assess when a patient may be able to purchase a drug In the case of compound preparations, the prescribing without prescription (e.g. loperamide hydrochloride p. 66). information for all constituents should be taken into account.  BNF 78 xv Prices in the BNF conditions. Classified sections on foods for special diets and Basic NHS net prices are given in the BNF to provide an nutritional supplements for metabolic diseases are also indication of relative cost. Where there is a choice of suitable included. preparations for a particular disease or condition the relative Wound dressings cost may be used in making a selection. Cost-effective A table on wound dressings in Appendix 4, Wound prescribing must, however, take into account other factors management products and elasticated garments p. 1591, (such as dose frequency and duration of treatment) that allows an appropriate dressing to be selected based on the affect the total cost. The use of more expensive drugs is appearance and condition of the wound. Further information justified if it will result in better treatment of the patient, or about the dressing can be found by following the cross- a reduction of the length of an illness, or the time spent in reference to the relevant classified section in the Appendix. hospital. Advanced wound contact dressings have been classified in Prices are regularly updated using the Drug Tariff and order of increasing absorbency. proprietary price information published by the NHS dictionary of medicines and devices (dm+d, www.nhsbsa.nhs. Other useful information uk/pharmacies-gp-practices-and-appliance-contractors/ Finding significant changes in the BNF dictionary-medicines-and-devices-dmd). The weekly updated dm+d data (including prices) can be accessed using the dm+d. Changes, provides a list of significant changes, dose browser of the NHS Business Services Authority (apps.nhsbsa. changes, classification changes, new names, and new nhs.uk/DMDBrowser/DMDBrowser.do). Prices have been preparations that have been incorporated into the BNF, as calculated from the net cost used in pricing NHS well as a list of preparations that have been discontinued prescriptions and generally reflect whole dispensing packs. and removed from the BNF. Changes listed online are Prices for extemporaneously prepared preparations are not cumulative (from one print edition to the next), and can be provided in the BNF as prices vary between different printed off each month to show the main changes since manufacturers. In Appendix 4, prices stated are per dressing the last print edition as an aide memoire for those using or bandage. print copies. So many changes are made for each update of BNF prices are not suitable for quoting to patients seeking the BNF, that not all of them can be accommodated in the private prescriptions or contemplating over-the-counter Changes section. We encourage healthcare professionals to purchases because they do not take into account VAT, regularly review the prescribing information on drugs that professional fees, and other overheads. they encounter frequently; A fuller explanation of costs to the NHS may be obtained. Changes to the Dental Practioners’ Formulary, are located from the Drug Tariff. Separate drug tariffs are applicable to at the end of the Dental List; England and Wales (www.ppa.org.uk/ppa/edt_intro.htm),. E-newsletter, the BNF & BNFC e-newsletter service is Scotland (www.isdscotland.org/Health-Topics/Prescribing-and- available free of charge. It alerts healthcare professionals Medicines/Scottish-Drug-Tariff/), and Northern Ireland (www. to details of significant changes in the clinical content of hscbusiness.hscni.net/services/2034.htm); prices in the these publications and to the way that this information is different tariffs may vary. delivered. Newsletters also review clinical case studies, provide tips on using these publications effectively, and Drug class monographs highlight forthcoming changes to the publications. To sign In earlier editions of the BNF, information relating to a class up for e-newsletters go to of drugs sharing the same properties (e.g. tetracyclines www.bnf.org. p. 564), was contained within the prescribing notes. In the. An e-learning programme developed in collaboration with updated structure, drug class monographs have been created the Centre for Pharmacy Postgraduate Education (CPPE), to contain the common information; this ensures such enables pharmacists to identify and assess how significant information is easier to find, and has a more regularised changes in the BNF affect their clinical practice. The structure. module can be found at For consistency and ease of use, the class monograph www.cppe.ac.uk. follows the same structure as a drug monograph. Class monographs are indicated by the presence of a flag f (e.g. Using other sources for medicines information beta-adrenoceptor blockers (systemic) p. 147). If a drug The BNF is designed as a digest for rapid reference. Less monograph has a corresponding class monograph, that detail is given on areas such as obstetrics, malignant disease, needs to be considered in tandem, in order to understand the and anaesthesia since it is expected that those undertaking full information about a drug, the monograph is also treatment will have specialist knowledge and access to indicated by a flag eiii i (e.g. metoprolol tartrate F 1234 specialist literature. BNF for Children should be consulted for p. 154). Within this flag, the page number of the drug class detailed information on the use of medicines in children. monograph is provided (e.g. 1234), to help navigate the user The BNF should be interpreted in the light of professional to this information. This is particularly useful where knowledge and supplemented as necessary by specialised occasionally, due to differences in therapeutic use, the drug publications and by reference to the product literature. monograph may not directly follow the drug class Information is also available from medicines information monograph (e.g. sotalol hydrochloride p. 108). services. Evidence grading The BNF has adopted a five level evidence grading system (see How BNF Publications are constructed p. viii). Recommendations that are evidence graded can be identified by a symbol appearing immediately before the recommendation. The evidence grade is displayed at the end of the recommendation. Other content Nutrition Appendix 2, Borderline substances p. 1556, includes tables of ACBS-approved enteral feeds and nutritional supplements based on their energy and protein content. There are separate tables for specialised formulae for specific clinical  xvi BNF 78 Changes Monthly updates are provided online via Medicines reports of disabling and potentially long-lasting or Complete and the NHS Evidence portal. The changes listed irreversible side effects [MHRA/CHM advice]. below are cumulative (from one print edition to the next).. Gabapentin p. 315 (Neurontin ®) and risk of abuse and Significant changes dependence: new scheduling requirements from 1 April Significant changes that appear in the print edition of BNF [MHRA/CHM advice]. 78 (September 2019 — March 2020):. Gemtuzumab ozogamicin p. 869 for untreated acute. Abemaciclib p. 967 with an aromatase inhibitor for myeloid leukaemia [NICE guidance]. previously untreated, hormone receptor-positive,. Heavy menstrual bleeding p. 753: updated HER2-negative, locally advanced or metastatic breast recommendations for the use of ulipristal acetate. cancer [NICE guidance].. Hydrocortisone p. 1216 muco-adhesive buccal tablets:. Alemtuzumab p. 857 (Lemtrada ®): restriction of use due to should not be used off-label for adrenal insufficiency in serious safety concerns [MHRA/CHM advice]. children due to serious risks [MHRA/CHM advice].. Anthrax vaccine p. 1297: updated guidance in-line with. Immunisation schedule p. 1296: updated National flu Public Health England recommendations. immunisation programme in-line with Public Health. Attention deficit hyperactivity disorder p. 346: updated England recommendations. guidance on management.. Influenza vaccine p. 1301: updated guidance in-line with. Belimumab p. 845 (Benlysta ®): increased risk of serious Public Health England recommendations. psychiatric events seen in clinical trials [MHRA/CHM. Ipilimumab p. 871 (Yervoy ®): reports of cytomegalovirus advice]. (CMV) gastrointestinal infection or reactivation. Benralizumab p. 266 for treating severe eosinophilic [MHRA/CHM advice]. asthma [NICE guidance].. Irinotecan hydrochloride p. 926, liposomal formulations. Breast cancer p. 942: updated guidance on management. (Onivyde ®): reports of serious and fatal thromboembolic. Brentuximab vedotin p. 864 for treating CD30-positive events [MHRA/CHM advice]. cutaneous T-cell lymphoma [NICE guidance].. Japanese encephalitis vaccine p. 1302: updated guidance. Brigatinib p. 971 for treating ALK-positive advanced non- in-line with Public Health England recommendations. small-cell lung cancer after crizotinib [NICE guidance].. Lenvatinib p. 987 for untreated advanced hepatocellular. Carbimazole p. 771: increased risk of congenital carcinoma [NICE guidance]. malformations; strengthened advice on contraception. Liposomal daunorubicin with cytarabine p. 900 for [MHRA/CHM advice]. untreated acute myeloid leukaemia [NICE guidance].. Carbimazole p. 771: risk of acute pancreatitis [MHRA/CHM. Malaria, prophylaxis p. 607: updated country