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The British National Formulary is a United Kingdom pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts
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Information on drug therapy Information on any aspect of drug therapy can be obtained from Regional and District Medicines Information Services. Details regarding the local services provided within your Region can be obtained by telephoning the following numbers.
England
London:
Wales
Scotland
Northern Ireland
Republic of Ireland
United Kingdom Medicines Information Pharmacists Group (UKMIPG) website www.ukmi.nhs.uk
Proprietary Manufacturers Telephone numbers and email addresses of proprietary manufacturers listed in BNF Publications are shown in the
UK Teratology Information Service Information on drug and chemical exposures in pregnancy.
www.uktis.org
UK Drugs in Lactation Advisory Service (UKDILAS) Information on the compatibility of drugs with breastfeeding.
www.ukmi.nhs.uk/ukdilas
Medicines in Dentistry Specialist Advisory Service Information on drug therapy relating to dental treatment.
Driver and Vehicle Licensing Agency (DVLA) Information on the national medical guidelines of fitness to drive is available from: www.gov.uk/government/publications/at-a-glance
Patient Information Lines
Poisons Information Services
www.toxbase.org
Sport ▶ Information regarding the use of medicines in sport is available from UK Anti-Doping: www.ukad.org.uk
ukad@ukad.org.uk UK Anti-Doping Fleetbank House
London
▶ Information about the prohibited status of specific medicines based on the current World Anti-Doping Agency Prohibited List is available from Global Drug Reference Online: www.globaldro.com/UK/search
Travel Immunisation Up-to-date information on travel immunisation requirements may be obtained from: ▶ National Travel Health Network and Centre (for
Friday (closed Wednesday afternoons and Bank
▶ Travel Medicine Team, Health Protection Scotland
www.travax.nhs.uk(for registered users of the NHS website Travax only) ▶ Welsh Government Switchboard English language
▶ Welsh Government Switchboard Yr laith Gymraeg
▶ Department of Health and Social Services (Belfast)
List of Registered Medical Practitioners Details on whether doctors are registered and hold a licence to practise medicine in the UK can be obtained from the General Medical Council.
www.gmc-uk.org/register
How to purchase
Stay up to date – sign up to the BNF
eNewsletter at www.bnf.org/newsletter
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
BNFC) are available. Discounted pricing is also available on
bulk sales.
PRINT SUBSCRIPTION
MOBILE
BNF app – Stay up to date anywhere with the BNF app
available for iOS, Android and Blackberry.
BNF eBook – Available as an ePDF via a range of
suppliers. See www.pharmpress.com/bnf.
BNF on MedicinesComplete – Now mobile responsive.
March –
September 2017
Preface
The BNF is a joint publication of the British Medical Association and the Royal Pharmaceutical Society. It is published under the authority of a Joint Formulary Committee which comprises representatives of the two professional bodies, the UK Health Departments, the Medicines and Healthcare products Regulatory Agency, and a national guideline producer. The Dental Advisory Group oversees the preparation of advice on the drug management of dental and oral conditions; the Group includes representatives of the British Dental Association and a representative from the UK Health Departments. The Nurse Prescribers’ Advisory Group advises on the content relevant to nurses and includes representatives from different parts 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. 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.
BNF Publications welcomes comments from healthcare professionals. Comments and constructive criticism should be sent to:
British National Formulary, Royal Pharmaceutical Society,
London
editor@bnf.org
The contact email for manufacturers or pharmaceutical companies wishing to contact BNF Publications is manufacturerinfo@bnf.org
Acknowledgements v How BNF publications are constructed ix How to use BNF Publications in print xii
BNF Staff
Karen Baxter BSc, MSc, MRPharmS
HEAD OF CONTENT Kate Towers BPharm (AU), GCClinPharm
CONTENT MANAGERS Thomas F. Corbett BScPharm (IRL), MPharm (IRL)
Kristina Fowlie MPharm, CertPharmPract, MRPharmS
Claire McSherry BPharm (NZ), PGCertClinPharm (NZ)
Heenaben Patel MPharm, DipClinPharm, MRPharmS
QUALITY AND PROCESS MANAGER Angela M.G. McFarlane BSc, DipClinPharm
CLINICAL WRITERS Abby Calder BPharm (NZ), PGCertClinPharm (NZ)
Naimah Callachand MPharm
Angela L. Kam BPharm (NZ), PGDipPharmPrac (NZ), PGCertPharmPres (NZ)
Philip D. Lee BSc, PhD
Kirsty Luck BPharm (AU)
Kere Odumah MPharm
Paridhi K. Prashar MPharm, MRPharmS
Jacob M. Warner BPharm (AU)
Sharyn Young BPharm (NZ), PGDipClinPharm (NZ)
CLINICAL ASSISTANTS Elizabeth King
EDITORIAL ASSISTANTS Hima Bhatt BSc, MA
Jaya Venkitachalam BSc, MRes
SENIOR BNF ADMINISTRATOR Heidi Homar BA
MANAGING DIRECTOR, PHARMACEUTICAL PRESS Alina Lourie B.Ed, MSc
SENIOR MEDICAL ADVISER Derek G. Waller BSc, MB, BS, DM, FRCP
Joint Formulary
Committee 2016– 2017
Derek G. Waller BSc, MB BS, DM, FRCP
DEPUTY CHAIR Alison Blenkinsopp BPharm, PhD, FRPharmS, OBE
COMMITTEE MEMBERS Julie Beynon MB ChB, FRCA, FFPM
Carmel M. Darcy BSc, MSc, IP, MPSNI, MRPharmS
Sue Faulding BPharm, MSc, FRPharmS Tracy Hall BSc, MSc, Cert N, Dip N, RGN, DN
Simon Hurding MB, ChB, MRCGP
W. Moira Kinnear BSc, MSc, MRPharmS
Mark P. Lythgoe MB BS, MRPharmS
Louise Picton BSc, DipCommPharm, MSc, MRPharmS
Michael J. Stewart MB ChB, MD, FRCP(Ed), FRCP
Esther Wong BSc, MPharm, MSc, DipEthics, DipPharmPract, IP, MRPharmS
LAY MEMBERS Andy Burman
Elaine Keen
EXECUTIVE SECRETARY Heidi Homar BA
Dental Advisory Group
2016 – 2017
Sarah Manton BDS, FDSRCS Ed, FHEA, PhD
COMMITTEE MEMBERS Karen Baxter BSc, MSc, MRPharmS Andrew K. Brewer BSc, BchD Lesley P. Longman BSc, BDS, FDSRCS Ed, PhD Michelle Moffat BDS, MFDS RCS Ed, M Paed Dent RCPS, FDS (Paed Dent) RCS Ed
SECRETARY Arianne J. Matlin MA, MSc, PhD
EXECUTIVE SECRETARY Heidi Homar BA
ADVICE ON DENTAL PRACTICE The British Dental Association has contributed to the advice on medicines for dental practice through its representatives on the Dental Advisory Group.
How BNF Publications are constructed
The BNF is an independent professional publication that addresses the day-to-day prescribing information needs of healthcare professionals. Use of this resource throughout the health service helps to ensure that medicines are used safely, effectively, and appropriately. Hundreds of changes are made between print editions, and are published monthly in a number of digital formats. The most clinically significant updates are listed under Changes p. xix. The BNF is unique in bringing together authoritative, independent guidance on best practice with clinically validated drug information. Validation of information follows a standardised process, reviewing emerging evidence, best-practice guidelines, and advice from a network of clinical experts. 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.
The Joint Formulary Committee (JFC) is responsible for the content of the BNF. The JFC includes pharmacy, medical, nursing and lay representatives; there are also representatives from the Medicines and Healthcare products Regulatory Agency (MHRA), the UK Health Departments, and a national guideline producer. The JFC decides on matters of policy and reviews amendments to the BNF in the light of new evidence and expert advice.
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.
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.
doctors, pharmacists, nurses, and dentists) throughout the UK to help with 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 the BNF 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; . providing independent advice on drug interactions, prescribing in hepatic impairment, renal impairment, pregnancy, breast-feeding, children, the elderly, palliative care, and the emergency treatment of poisoning.
In addition to consulting with regular advisers, the BNF calls on other clinical specialists for specific developments when particular expertise is required. The BNF works closely with a number of expert bodies that produce clinical guidelines. Drafts or pre-publication copies of guidelines are often received for comment and assimilation into the BNF.
BNF clinical writers have all worked as pharmacists or possess a pharmacy degree and a further, relevant post- graduate qualification, and have a sound understanding of
how drugs are used in clinical practice. As a team, the clinical writers are responsible for editing, maintaining, and updating BNF content. They follow a systematic prioritisation process in response to updates to the evidence base in order to ensure the most clinically important topics are reviewed as quickly as possible. In parallel the team of clinical writers undertakes a process of rolling revalidation,
Amendments to the text are drafted when the clinical writers are satisfied that any new information is reliable and relevant. A set of standard criteria define when content is referred to expert advisers, the Joint Formulary Committee or other advisory groups, or submitted for peer review. Clinical writers prepare the text for publication and undertake a number of validation checks on the knowledge at various stages of the production process.
The BNF uses a variety of sources for its information; the main ones are shown below.
Summaries of product characteristics The BNF reviews summaries of product characteristics (SPCs) of all new products as well as revised SPCs for existing products. The SPCs are the principal source of product information and are carefully processed. Such processing involves:
. verifying the approved names of all relevant ingredients including ’non-active’ ingredients (the BNF is committed to using approved names and descriptions as laid down by
. 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 the BNF 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 and pharmaceutical journals. Research papers and reviews relating to drug therapy are carefully processed. When a difference between the advice in the BNF 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 Joint Formulary Committee. The BNF 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 the BNF 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 the BNF; it is therefore possible to ensure that a consistent message is disseminated. The BNF routinely processes guidelines from the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the Scottish Intercollegiate Guidelines Network (SIGN).
Reference sources Textbooks and reference sources are used to provide background information for the review of existing text or for the construction of new text. The BNF team works closely with the editorial team that produces Martindale: The Complete Drug Reference. The BNF 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 Joint 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 The BNF routinely processes relevant information from various Government bodies including Statutory Instruments and regulations affecting the Prescriptions only Medicines Order. Official compendia such as the British Pharmacopoeia and its addenda are processed routinely to ensure that the BNF complies with the relevant sections of the Human
The BNF 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 are 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 the BNF as are guidelines from bodies such as the Royal College of General Practitioners.
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 the BNF.
Comments from readers Readers of the BNF are invited to send in comments. Numerous letters and emails are received by the BNF team. Such feedback helps to ensure that the BNF provides practical and clinically relevant information. Many changes in the presentation and scope of the BNF have resulted from comments sent in by users.
Comments from industry Close scrutiny of BNF by the manufacturers provides an additional check and allows them an opportunity to raise issues 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 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.
publications 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.
recommendations as content goes through the revalidation process. Therefore, initially, only a small number of recommendations will have been graded.
Grading system 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. 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.
unacceptable level of bias or confounding and is not used to form recommendations.
Levels of evidence
. Level 1++ High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias. . Level 1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias. . Level 1– Meta-analyses, systematic reviews, or RCTs with a high risk of bias. . Level 2++ High quality systematic reviews of case control or cohort studies; or high quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal. . Level 2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal. . Level 2– Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal. . Level 3 Non-analytic studies, e.g. case reports, case series. . Level 4 Expert advice or clinical experience from respected authorities. Grades of recommendation . Grade A: High strength NICE-accredited guidelines; or guidelines that pass AGREE II assessment; or at least one meta-analysis, systematic
target population; or a body of evidence consisting
target population, and demonstrating overall consistency of results.
How to use BNF Publications in print
How to use the BNF
This edition of the BNF continues to display the fundamental change to the structure of the content that was
consistency and clarity to BNF content, and to the way that the content is arranged within print and digital products, increasing the ease with which information can be found. For reference, the most notable changes to the structure of the content include:
. Drug monographs – where possible, all information that relates to a single drug is contained within its drug monograph, moving information previously contained in the prescribing notes. Drug monographs have also changed structurally: additional sections have been added, ensuring greater regularity around where information is located within the publication. . Drug class monographs – where substantial amounts of information are common to all drugs within a drug class
created to contain the common information.
. Medicinal forms – categorical information about marketed medicines, such as price and pack size, continues to be sourced directly from the Dictionary of Medicines and Devices provided by the NHS Business Services Authority. However, clinical information curated by the BNF team has been clearly separated from the categorical pricing and pack size information and is included in the relevant section of the drug monograph. . Section numbering – the BNF section numbering has been removed. This section numbering tied the content to a rigid structure and enforced the retention of defunct classifications, such as mercurial diuretics, and hindered the relocation of drugs where therapeutic use had altered. It also caused constraints between the BNF and BNF for Children, where drugs had different therapeutic uses in children.
drug monographs. The introductory notes have been replaced with a new guidance section, Guidance on
Introduction
In order to achieve the safe, effective, and appropriate use of medicines, healthcare professionals must be able to use the BNF effectively, and keep up to date with significant changes in the BNF that are relevant to their clinical practice. This How to Use the BNF is key in reinforcing the details of the new structure of the BNF to all healthcare professionals involved with prescribing, monitoring, supplying, and administering medicines, as well as supporting the learning of students training to join these professions.
This BNF edition continues to broadly follows the high-level structure of earlier editions of the BNF (i.e. those published
Front matter, comprising information on how to use the BNF, the significant content changes in each edition, and guidance on various prescribing matters (e.g. prescription writing, the use of intravenous drugs, particular considerations for special patient populations). Chapters, containing drug monographs describing the uses, doses, safety issues and other considerations involved in the use of drugs; drug class monographs; and treatment summaries, covering guidance on the selection of drugs. Monographs and treatment summaries are divided into chapters based on specific aspects of medical care, such as
of poisoning; or drug use related to a particular system of the
Within each chapter, content is organised alphabetically by therapeutic use (e.g. Airways disease, obstructive), with the treatment summaries first, (e.g. asthma), followed by the monographs of the drugs used to manage the conditions discussed in the treatment summary. Within each therapeutic use, the drugs are organised alphabetically by
bronchodilators) and then alphabetically within each classification (e.g. Aclidinium bromide, Glycopyrronium bromide, Ipratropium bromide). Appendices, covering interactions, borderline substances, cautionary and advisory labels, and woundcare. Back matter, covering the lists of medicines approved by the NHS for Dental and Nurse Practitioner prescribing, proprietary and specials manufacturers’ contact details, and the index. Yellow cards are also included, to facilitate the reporting of adverse events, as well as quick reference guides for life support and key drug doses in medical emergencies, for ease of access.
The contents page provides the high-level layout of information within the BNF; and in addition, each chapter begins with a small contents section, describing the therapeutic uses covered within that chapter. Once in a chapter, location is guided by the side of the page showing the chapter number (the thumbnail), alongside the chapter title. The top of the page includes the therapeutic use (the running head) alongside the page number. Once on a page, visual cues aid navigation: treatment summary information is in black type, with therapeutic use titles similarly styled in black, whereas the use of colour indicates drug-related information, including drug classification titles, drug class monographs, and drug monographs. Although navigation is possible by browsing, primarily access to the information is via the index, which covers the titles of drug class monographs, drug monographs, and treatment summaries. The index also includes the names of branded medicines and other topics of relevance, such as abbreviations, guidance sections, tables, and images.
Content types
Treatment summaries are of three main types;
. an overview of delivering a drug to a particular body
. a comparison between a group or groups of drugs (e.g.
. an overview of the drug management or prophylaxis of common conditions intended to facilitate rapid appraisal
In order to select safe and effective medicines for individual patients, information in the treatment summaries must be used in conjunction with other prescribing details about the drugs and knowledge of the patient’s medical and drug history.
administered drug with indications for use in different body systems was split across the chapters relating to those body
for its analgesic effects. However, the monograph in chapter
precautions. Now, all of the information for the systemic use of a drug is contained within one monograph, so codeine phosphate
advantage of providing all of the information in one place, so the user does not need to flick back and forth across several pages to find all of the relevant information for that drug.
management of diarrhoea is discussed, to the drug monograph to assist navigation. Where drugs have systemic and local uses, for example,
use are markedly different according to the route of administration, the monograph is split, as with earlier editions, into the relevant chapters. This means that the majority of drugs are still placed in the same chapters and sections as earlier editions, and although there may be some variation in order, all of the relevant information will be easier to locate. One of the most significant changes to the monograph structure is the increased granularity, with a move from
included when relevant information has been identified. The following information describes these sections and their uses in more detail.
Monograph titles follow the convention of recommended international non-proprietary names (rINNs), or, in the absence of a rINN, British Approved Names. Relevant synonyms are included below the title and, in some instances a brief description of the drug action is included. Over future editions these drug action statements will be rolled out for all drugs. In some monographs, immediately below the nomenclature or drug action, there are a number of cross references or flags used to signpost the user to any additional information they need to consider about a drug. This is most common for drugs formulated in combinations, where users will be signposted to the monographs for the
or for drugs that are related to a drug class monograph (see Drug class monographs, below).
User feedback has highlighted that one of the main uses of the BNF is identifying indications and doses of drugs. Therefore, indication and dose information has been promoted to the top of the monograph and highlighted by a coloured panel to aid quick reference. The indication and dose section is more highly structured than in earlier editions, giving greater clarity around which doses should be used for which indications and by which route. In addition, if the dose varies with a specific preparation or formulation, that dosing information has been moved out of the preparations section and in to the indication and dose panel, under a heading of the preparation name. Doses are either expressed in terms of a definite frequency
divided into individual doses (in the second example, the
Doses for specific patient groups (e.g. the elderly) may be included if they are different to the standard dose. Doses for children can be identified by the relevant age range and may vary according to their age or body-weight. In earlier editions of the BNF, age ranges and weight ranges overlapped. For clarity and to aid selection of the correct dose, wherever possible these age and weight ranges now do not overlap. When interpreting age ranges it is
All age ranges should be interpreted in this way. Similarly, when interpreting weight ranges, it should be understood
weight ranges should be interpreted in this way. In all circumstances, it is important to consider the patient in question and their physical condition, and select the dose most appropriate for the individual.
The dose panel also contains, where known, an indication of pharmacokinetic considerations that may affect the choice of dose, and dose equivalence information, which may aid the selection of dose when switching between drugs or preparations. The BNF includes unlicensed use of medicines when the clinical need cannot be met by licensed medicines; such use should be supported by appropriate evidence and experience. When the BNF recommends an unlicensed medicine or the ‘off-label’ use of a licensed medicine, this is shown below the indication and dose panel in the unlicensed use section.
The drug chosen to treat a particular condition should minimise the patient’s susceptibility to adverse effects and, where co-morbidities exist, have minimal detrimental effects on the patient’s other diseases. To achieve this, the Contra- indications, Cautions and Side-effects of the relevant drug should be reviewed. The information under Cautions can be used to assess the risks of using a drug in a patient who has co-morbidities that are also included in the Cautions for that drug—if a safer alternative cannot be found, the drug may be prescribed while monitoring the patient for adverse-effects or deterioration in the co-morbidity. Contra-indications are far more restrictive than Cautions and mean that the drug should be avoided in a patient with a condition that is contra-indicated. The impact that potential side-effects may have on a patient’s quality of life should also be assessed. For instance, in a patient who has difficulty sleeping, it may be preferable to avoid a drug that frequently causes insomnia. Clinically relevant Side-effects for drugs are included in the monographs or class monographs. Side-effects are listed in order of frequency, where known, and arranged alphabetically. The frequency of side-effects follows the regulatory standard:
administrations of a drug
administrations of a drug
administrations of a drug
of a drug
a drug
. Frequency not known An exhaustive list of side-effects is not included, particularly for drugs that are used by specialists (e.g. cytotoxic drugs and drugs used in anaesthesia). The BNF also omits effects that are likely to have little clinical consequence (e.g. transient increase in liver enzymes). Recognising that hypersensitivity reactions can occur with virtually all medicines, this effect is generally not listed, unless the drug carries an increased risk of such reactions,
l (^) HEPATIC IMPAIRMENT advice on the use of a drug in hepatic impairment
l RENAL IMPAIRMENT advice on the use of a drug in renal impairment
l PRE-TREATMENT SCREENING covers one off tests required to assess the suitability of a patient for a particular drug
l MONITORING REQUIREMENTS specifies any special monitoring requirements, including information on monitoring the plasma concentration of drugs with a narrow therapeutic index
l EFFECTS ON LABORATORY TESTS for drugs that can interfere with the accuracy of seemingly unrelated laboratory tests
l TREATMENT CESSATION specifies whether further monitoring or precautions are advised when the drug is withdrawn
l DIRECTIONS FOR ADMINISTRATION practical information on the preparation of intravenous drug infusions; general advice relevant to other routes of administration
l PRESCRIBING AND DISPENSING INFORMATION practical information around how a drug can be prescribed and dispensed including details of when brand prescribing is necessary
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 PARENT 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 and SMC 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
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
(always consult latest edition)
a b c d e m These symbols indicate that the preparations are subject to the prescription requirements of the Misuse of Drugs Act
For regulations governing prescriptions for such preparations, see Controlled Drugs and Drug Dependence
Not all monographs include all possible sections; sections are only included when relevant information has been identified
when the information is included under Allergy and cross sensitivity. The Important safety advice section in the BNF, delineated by a coloured outline box, highlights important safety concerns, often those raised by regulatory authorities or guideline producers. Safety warnings issued by the Commission on Human Medicines (CHM) or Medicines and Healthcare products Regulatory Agency (MHRA) are found here. Drug selection should aim to minimise drug interactions. If it is necessary to prescribe a potentially serious combination of drugs, patients should be monitored appropriately. The mechanisms underlying drug interactions
interactions.
Drug selection should aim to minimise the potential for drug accumulation, adverse drug reactions, and exacerbation of pre-existing hepatic or renal disease. If it is necessary to prescribe drugs whose effect is altered by hepatic or renal disease, appropriate drug dose adjustments should be made, and patients should be monitored adequately. The general principles for prescribing are outlined under Prescribing in
avoided or used with caution in hepatic disease or renal impairment can be found in drug monographs under Hepatic
Similarly, drug selection should aim to minimise harm to the fetus, nursing infant, and mother. The infant should be monitored for potential side-effects of drugs used by the mother during pregnancy or breast-feeding. The general principles for prescribing are outlined under Prescribing in
Treatment Summaries provide guidance on the drug treatment of common conditions that can occur during
Information about the use of specific drugs during pregnancy and breast-feeding can be found in their drug monographs
A section, Conception and contraception, containing information around considerations for females of childbearing potential or men who might father a child (e.g.
When selecting the most appropriate drug, it may be necessary to screen the patient for certain genetic markers or metabolic states. This information is included within a
This section covers one-off tests required to assess the suitability of a patient for a particular drug. Once the drug has been selected, it needs to be given in the most appropriate manner. A Directions for administration section contains the information about intravenous
provides practical information on the preparation of intravenous drug infusions, including compatibility of drugs with standard intravenous infusion fluids, method of dilution or reconstitution, and administration rates. In addition, general advice relevant to other routes of administration is provided within this section (e.g. fentanyl
After selecting and administering the most appropriate drug by the most appropriate route, patients should be monitored to ensure they are achieving the expected benefits from drug treatment without any unwanted side- effects. The Monitoring section specifies any special monitoring requirements, including information on monitoring the plasma concentration of drugs with a narrow
in certain cases, be affected by the impact of a drug on
information is included in Effects on laboratory tests. In some cases, when a drug is withdrawn, further monitoring or precautions may be advised (e.g. clonidine
cessation.
The prescriber and the patient should agree on the health outcomes that the patient desires and on the strategy for achieving them (see Taking Medicines to Best Effect). Taking the time to explain to the patient (and carers) the rationale and the potential adverse effects of treatment may improve adherence. For some medicines there is a special need for counselling (e.g. appropriate posture during administration
advice. Other information contained in the latter half of the monograph also helps prescribers and those dispensing medicines choose medicinal forms (by indicating information such as flavour or when branded products may
assess the suitability of a drug for prescribing, understand
assess when a patient may be able to purchase a drug
In the BNF, preparations follow immediately after the monograph for the drug that is their main ingredient. In earlier editions, when a particular preparation had safety information, dose advice or other clinical information specific to the product, it was contained within the preparations section. This information has been moved to the relevant section in the main body of the monograph under a heading of the name of the specific medicinal form
The medicinal forms (formerly preparations) section provides information on the type of formulation (e.g. tablet), the amount of active drug in a solid dosage form, and the concentration of active drug in a liquid dosage form. The legal status is shown for prescription-only medicines and controlled drugs, as well as pharmacy medicines and medicines on the general sales list. Practitioners are reminded, by a statement under the heading of “Medicinal Forms” that not all products containing a specific drug ingredient may be similarly licensed. To be clear on the precise licensing status of specific medicinal forms, practitioners should check the product literature for the particular product being prescribed or dispensed. Details of all medicinal forms available on the dm+d for each drug in BNF Publications appears online on MedicinesComplete. In print editions, due to space constraints, only certain branded products are included in detail. Where medicinal forms are listed they should not be inferred as equivalent to the other brands listed under the same form heading. For example, all the products listed under a heading of “Modified release capsule” will be available as modified release capsules, however, the brands listed under that form heading may have different release profiles, the available strengths may vary and/or the products may have different licensing information. As with earlier editions of the BNF, practitioners must ensure that the particular product being prescribed or dispensed is appropriate. As medicinal forms are derived from dm+d data, some drugs may appear under names derived from that data; this may vary slightly from those in previous BNF versions, e.g. sodium acid phosphate, is now sodium dihydrogen phosphate anhydrous. Patients should be prescribed a preparation that complements their daily routine, and that provides the right dose of drug for the right indication and route of administration. When dispensing liquid preparations, a