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Guidance British National Formulary Publications producer: Guidance British National Formulary, British product: National Formulary for Children Date: 29 August 2013 Version: 1.4 Accreditation Decision Report – for consultation British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 1 of 29 Contents Introduction ..................................................................................................................... 3 Accreditation recommendation ........................................................................................ 3 Reapplication for accreditation ........................................................................................ 6 Appendix A: NICE Accreditation analysis ........................................................................ 7 Appendix B: Bibliography .............................................................................................. 20 Appendix C: NICE Accreditation Advisory Committee, external advisers and NICE Accreditation team......................................................................................................... 27 British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 2 of 29 Introduction The NICE Accreditation Programme recognises organisations that demonstrate high standards in producing health or social care guidance. Users of the accredited guidance may therefore have high confidence in the quality of the information. Organisations can publicly display a seal of approval called an Accreditation Mark for 5 years after their processes have been accredited. The process for accrediting producers of guidance and recommendations for practice is described in the process manual. Accreditation recommendation It is proposed that the process used by British National Formulary Publications to produce the British National Formulary and British National Formulary for Children is not recommended for accreditation. This decision is subject to public consultation before a final decision is made. Background to the guidance producer The British National Formulary (BNF) is published by the British Medical Association (BMA) and the Royal Pharmaceutical Society (RPS), through the British Medical Journal (BMJ) Group and the Pharmaceutical Press. The British National Formulary for Children (BNFC) is published by the RPS, BMA, Royal College of Paediatrics and Child Health (RCPCH) and the Neonatal and Paediatric Pharmacist Group (NPPG). BNF Publications is a consortium of these organisations. Funding for the guidance is provided by the health services of the 4 home countries of the UK, and the contract is managed by NICE. BNF Publications also produce the Nurse Prescribers’ Formulary (NPF) which is a developed from a sub-set of the information in the BNF and BNFC. The process used to produce the NPF is the subject of a separate decision due to some key differences in the process, which are explained in that decision report. British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 3 of 29 The BNF and BNFC aim to provide prescribers, pharmacists and other healthcare professionals with accurate and up-to-date information about the use of medicines, including key information on selection, prescribing, dispensing and administration. This includes categorical information specific to individual medicines (termed ‘medicines information’ in this report), and more general information about conditions, classes of medicines and when it is appropriate to use them (termed ‘clinical information’ in this report). This information is advice designed to guide the decision making of prescribers, and is developed according to a standard process which can be assessed using the accreditation criteria. Summary The Accreditation Advisory Committee considered that the processes used by BNF Publications to produce the BNF and BNFC demonstrated compliance with 18 of the 25 criteria for accreditation, with 6 criteria not fully met, and 1 criterion not met. Overall the scope and purpose of the BNFC and BNFC are clear. The publications are based on a systematic search for evidence that takes into account the risks, benefits and side effects of different treatment options. The advice is presented clearly and a variety of support tools are available to aid implementation. Whilst the process has strengths, there are concerns about the lack of stakeholder involvement for some groups and the lack of a process for systematically assessing the strengths, weaknesses and areas of uncertainty in the evidence and communicating them to the end user. It is not clear that the process for peer review is external and the lack of involvement of particular groups of stakeholders may affect the suitability of the content for some users. In addition, the end user cannot tell when different sections were last updated or reviewed and the prices of medicines have not been updated since 2011. The assessment identified several areas where processes fall short of the required standard. The main improvement that must be made is: British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 4 of 29 to develop and implement a robust process to systematically and transparently assess the strengths, weaknesses and areas of uncertainty in the evidence base and communicate them to the end user. Further recommendations for improvement of the process include: continuing with the recruitment of lay members to the formulary committees and ensuring lay participation is meaningful involving all relevant stakeholder groups and target users including Community Practitioners and Nurse Prescribers in developing recommendations ensuring external peer review of the recommendations updating the prices of medicines in the publications ensuring the end user knows when each section was last updated or reviewed ensuring the content, format and language is appropriate for all target users This draft decision is now going out for consultation, and the decision will be reviewed by the committee in the light of any feedback received before making a final recommendation. Professor Martin Underwood Chair, Advisory Committee August 2013 British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 5 of 29 Reapplication for accreditation Following a final decision in which accreditation has not been granted, guidance from the non-accredited producer will still be available on the NICE Evidence site but will not be identified by the accreditation mark graphic. Guidance producers that have not been awarded accreditation may reapply from 1 year after the previous assessment. The organisation should address any concerns highlighted in the original assessment before reapplying. The NICE Accreditation team will provide detailed feedback and advice on areas in which improvement is needed to meet the criteria in a future application. British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 6 of 29 Appendix A: NICE Accreditation analysis The Advisory Committee considered the following analysis of the guidance producer’s compliance with NICE Accreditation criteria, which covers 6 discrete domains. The full analysis leading to the accreditation decision is shown below. Domain Criterion Evidence for meeting the criterion Accreditation decision Does the guidance producer have a policy in place and adhered to that requires them to explicitly detail: 1.1 Overall objective 1 2 The BNF and BNFC are produced according to a standard format 3,4,5 . Criterion met The aims of the publications are stated in prefaces and on the rear covers 1,2 of the publications . 1 Scope and purpose 1.2 The clinical, healthcare or social questions covered 2 The BNF and BNFC aim to address high-level questions of drug safety, Criterion met effectiveness, appropriateness, dosage and adverse effects for all medications covered. Information relating to these key questions such as cautions, contraindications and side effects is provided in a standard 3,4,5 format for each medicine or class of medicine. Clinical questions outside the medicines information are answered through the clinical information found at the start of each chapter and section. This can be 1 2 seen in the BNF and BNFC . British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 7 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision 1.3 Population and/or target audience to whom the guidance applies The target audiences for BNF and BNFC are detailed on the rear Criterion met 1,2 covers . The overall target population is broad given the variety of medicines covered, but specific populations are defined by the indications 1,2 for each medicine . 1.4 Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances The standard format 3,4,5 1 2 of the BNF and BNFC and help to ensure Criterion met recommendations are given in reference to specific clinical or healthcare circumstances. Guidance is provided for individual medicines to treat specified conditions including indications, contraindications and 1,2 cautions , which cover the clinical circumstances in which a medicine is recommended or not. Does the guidance producer have a policy in place and adhered to that means it includes: 2.1 Stakeholder involvement Individuals from all relevant stakeholder groups, including patient groups, in developing guidance The document ‘Standing Orders of the Formulary Committees of the Not fully met 6 British National Formulary’ details the composition of the Joint Formulary Committee (JFC) and the Paediatric Formulary Committee (PFC). The committees include pharmacists and clinical representatives from a number of stakeholder groups, but do not include nurse prescribers for example, who are also an audience for the publications as they are 8 expected to refer to them when using the NPF . The publications 1,2 detail the membership of the committees and the contributing expert advisers. British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 8 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision 1 2.2 Patient and service user representatives and seeks patient views and preferences in developing guidance 2 Some sources of evidence that the BNF and BNFC involve patients in Not fully met the development of their guidance, as described in ‘Standard reference 7 sources’ . Patients are also involved in the development of cautionary and 1 2 advisory warnings provided as appendix 3 of the BNF and BNFC . There 6 are no lay or patient representatives on the JFC or PFC however , so some recommendations are developed without lay or patient input. The guidance producer has stated that recruitment of lay members to the JFC and PFC is underway, but lay members are not currently in place. 2.3 Representative intended users in developing guidance. The document ‘Standing Orders of the Formulary Committees of the Not fully met 6 British National Formulary’ details the composition of the JFC and the PFC. The committees include target users such as pharmacists and 8 doctors, but do not include users of the NPF who are also expected to refer to the publications. The publications 1,2 detail the membership of the committees and the contributing expert advisers. Rigour of Does the guidance producer have a clear policy in place that: British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 9 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision development 3.1 Requires the guidance producer to use systematic methods to search for evidence and provide details of the search strategy 7 9 ‘Standard reference sources’ and ‘Journal allocation list’ provide lists of Criterion met key sources of evidence which are scanned regularly for new medicines and clinical information. This includes updated summaries of product characteristics (SPC), drug safety updates (DSU), guidelines and journals. NICE also regularly notifies the guidance producer of any new relevant evidence it produces. This process is another systematic route to identify new evidence. Evidence of regular scanning of sources is provided by an 10 internal tracking spreadsheet . 3.2 Requires the guidance producers to state the criteria and reasons for inclusion or exclusion of evidence identified by the evidence review High level inclusion and exclusion criteria are detailed in the document Criterion met ‘Criteria for inclusion and exclusion of products in BNF and BNF for 11 Children’ . Evidence about all prescription-only medicines licensed for use in the UK is included. ‘Specials’ (unlicensed medicinal products for individual patients) are excluded. There are additional inclusion criteria covering certain non-prescription medicines, and devices that may be 1 prescribed for use with medicines. The section of the BNF and BNFC 2 ‘How the BNF is constructed’ provides information on some of the inclusion criteria for evidence based upon the type and source of information. British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 10 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision 3.3 Describes the strengths and limitations of the body of evidence and acknowledges any areas of uncertainty Medicines information that comes explicitly and exclusively from SPCs is Not met. authoritative and reliable, however many other sources of evidence are 1 2 included in the development of the BNF and BNFC , so it is vital there is an appropriate process to appraise such evidence. The document 7 ‘Standard reference sources’ ranks sources of evidence according to how accurate and reliable the guidance producer considers the information from those sources to be, but there is no systematic process to appraise individual items of evidence from those sources. Ranks include large groups such as journals, and evidence from sources within the same rank appears to be considered of equivalent quality. The transcripts 12 of discussions by expert advisers, the JFC and PFC do not demonstrate systematic consideration of the strengths and weaknesses of the evidence. There is no process for communicating the strengths, weaknesses and areas of uncertainty in the evidence base to the end user. The publications indicate where medicines information deviates from an SPC and in some cases where clinical information comes from a specific guideline producer, but the strength of the information provided is unknown. British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 11 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision 3.4 Describes the method used to arrive at recommendations (for example, a voting system or formal consensus techniques like Delphi consensus) The process 13 states that content changes based on updated SPC or Criterion met DSUs are made by the editorial team. Any other evidence is first examined by the editorial team, then expert advisers who are practising clinicians, then the JFC or PFC. The document ‘Standing orders of the 6 formulary committees of the British National Formulary’ explains that consensus is used to reach decisions. Where consensus is not possible a voting system is used. Transcripts of conversations demonstrate this 12 process in action . 3.5 Requires the guidance producers to consider the health benefits against the side effects and risks in formulating recommendations 1 2 The BNF and BNFC present medicines information in a standard 3,4,5 format Criterion met that details contraindications and side effects. The clinical information also discusses the risks and side effects of classes of medicines for different conditions. Any amendments to this information, unless directly derived from SPCs or DSUs, requires discussion by the 13 JFC or PFC following input from external advisers . The transcripts of these discussions 12 show consideration of the risks, benefits and side effects in reaching recommendations for both medicines and clinical information. British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 12 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision 3.6 Describes the processes of external peer review Recommendations from the JFC and PFC are reviewed by editors who Not fully met work for BNF Publications with no prior involvement in assessing the evidence or developing the recommendations. A screenshot of an internal content change tracker 14 provides evidence of this process. It is not clear however that there is sufficient separation between different members of the editorial team for this to represent a process of external peer review. Expert advisers review entire chapters of the publications but this occurs post-publication and it is not stated that those advisers should not have had prior involvement in developing the recommendations. 3.7 Describes the process of updating guidance and maintaining and improving guidance quality 1 2 The BNF and BNFC are produced every 6 months in hard copy and are Not fully met 15 updated monthly online . The process states that medicines information is reviewed at least every 3 years, or sooner if new evidence becomes 13 available . Clinical information is updated when new evidence becomes available through the systematic scanning of evidence sources. The BNF 1 2 and BNFC clearly state how often they are updated in hard copy and online, but it is not clear to the end user when each section was last updated or reviewed. The prices of medicines have not been updated since 2011 due to an on-going change in process. Clarity and Does the guidance producer ensure that: British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 13 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision presentation 4.1 Recommendations are specific, unambiguous and clearly identifiable The format of information in the BNF and BNFC is governed by a number of style guides 3,4,5 Criterion met which ensure the advice is clearly presented. 1 2 Examination of the BNF and BNFC show that the recommendations are specific, unambiguous and clearly identifiable. 4.2 4.3 3,4,5 1 2 Different options for the management of the condition or options for intervention are clearly presented The standard format of the BNF and BNFC ensures a range of The date of search, the date of publication or last update and the proposed date for review are clearly stated The BNF and BNFC are printed publications with a copyright statement Criterion met medicines are presented where available, allowing the prescriber to the 1 2 most appropriate medicine. Examination of the BNF and BNFC shows that the options for management or intervention are clearly presented. 1 2 Criterion met on the first page containing the year of publication. The BNF displays the 1 month and the year of publication on the front cover . The updating frequency for each publication is stated both in the process 13 and in the 12 publications . This also informs users of the period of new evidence taken into account in the new edition compared to the previous edition (6 months for the BNF, 1 year for the BNFC, and monthly for the BNF and BNFC online). This is an appropriate alternative to a single date of search as the publication relies on regular searching of many evidence sources. British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 14 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision 4.4 The content of the guidance is suitable for the specified target audience. If patients or service users are part of this audience, the language should be appropriate. The process 13 6 includes multidisciplinary committees to help ensure the Not fully met content is suitable for the target audience, but some sections of the target audience are not represented, for example community practitioner nurse prescribers. Therefore there are some gaps in the process for ensuring the content is suitable for the target audience. Does the guidance producer routinely consider: 5.1 Applicability Publishing support tools to aid implementation of guidance 1 2 The BNF and BNFC are designed as succinct reference tools. They Criterion met include guidance on how to write prescriptions, prescribing for particular groups, and details of major changes since the last edition. Online versions of the BNF and BNFC are available 15 to subscribers or those with an NHS Athens account that contain recent updates and provide a quick way to find medicines information. The BNF is also available as an application for smart-phones 16 which may assist prescribers who do not have access to a hard copy whilst working. British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 15 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision 5.2 Discussion of potential organisational and financial barriers in applying its recommendations 1 2 Both the BNF and the BNFC contain the section ‘Taking medicines to Criterion met best effect’ that provides advice for prescribers in overcoming barriers to adherence of a medicines regimen. The section ‘Controlled drugs and drug dependence’ explain the organisational and legislative barriers to prescribing controlled drugs along with the requirements for prescriptions. Positive or negative NICE technology appraisals are indicated in the 1,2 guidance , which may indicate to prescribers that NHS funding might not be available for certain drugs. 5.3 That their guidance is current, with review criteria for monitoring and/or audit purposes within each product. There are processes to monitor usage of the BNF through market 17 1 Criterion met 2 research activities . The BNF and BNFC all contain MHRA ‘yellow cards’ for reporting suspected adverse reactions to medicines. This demonstrates a form of monitoring included within the guidance product as yellow cards are important for monitoring medicines in the marketplace. Editorial Does the guidance producer: British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 16 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision independence 6.1 Ensure editorial independence from the funding body The health services of the 4 home countries of the UK are the funding Criterion met source, but it would be impossible to ensure adequate professional stakeholder involvement without including a variety of health service 1 employees in development of the BNF . In practice the NHS employees who sit on the committees are not responsible for purchasing the BNF. BNF Publications is also independent of the pharmaceutical industry and receives no funding from them. The publications do not include adverts for any products. All committee members and external advisers are required to declare any conflicts of interest 6.2 Demonstrate transparency about the funding mechanisms for its guidance 1 6,20 . 2 The funding source for the BNF and BNFC are the health services of the Criterion met 4 home countries of the UK, and the contract is managed by NICE. The BNF and BNFC include a statement that they are funded by sales to the 1,2 health service . 6.3 Record and state any potential conflicts of interest of individuals involved in developing the recommendations 6 The standing orders of the formulary committees , terms of reference for expert advisers 18 and declaration of interests form for expert advisers Criterion met 20 provide comprehensive, appropriate policies for declaring and managing a range of conflicts of interest. BNF editorial staff are required to declare 19 conflicts through the Royal Pharmaceutical Society register of interests . Both the policies and declarations are available upon request. British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 17 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision 6.4 Take account of any potential for bias in the conclusions or recommendations of the guidance The process of evidence identification is systematic. Funding is Criterion met transparent, editorial independence from the funding source is achieved, and there is a comprehensive policy for declaring and managing conflicts of interest 6,18,19,20 . Together these steps help to ensure the possibility of bias is reduced. British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 18 of 29 Domain Criterion Evidence for meeting the criterion Accreditation decision 1 British National Formulary 2 British National Formulary for Children 3 BNF style guide 4 BNFC style guide 5 Style guide for hepatic, renal, pregnancy, and breast-feeding messages in BNF and BNFC 6 Standing Orders of the Formulary Committees of the British National Formulary 7 Standard reference sources 8 Nurse prescribers’ formulary 9 Journal allocation list 10 logs of systematic searches 11 Criteria for inclusion and exclusion of products in BNF and BNF for Children 12 transcripts of discussions by expert advisers, the JFC and PFC 13 Creating content for referential (human readable) BNF and BNFC 14 screenshot of an internal content change tracker 15 Online versions of the BNF and BNFC 16 BNF application for smart-phones 17 User research report 18 BNF and BNFC Advisors Terms of Reference 19 Royal Pharmaceutical Society register of interests 20 Declaration of Interests Form – Advisor British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 19 of 29 Appendix B: Bibliography Appendix B lists the additional information taken into account in the analysis and considered by the committee. Document name Description Location Appendix 1: BNF and Scenarios demonstrating use supplied BNFC Use Cases of the BNF Appendix 2: When to Explains when expert seek expert input on advisers and committees are clinical issues used Appendix 3: Creating Process document for content for referential creating BNF and BNFC (human readable) BNF content supplied supplied and BNFC Appendix 4: Example of expert adviser Discussions: JFC Use discussion over content supplied of aminoglycosides with ototoxic diuretics Appendix 5: Recruiting Procedure for recruiting a new adviser expert advisers Appendix 6: Standard List of sources and quality reference sources criteria used by the BNF Appendix 7: Readability Demonstrates patient Testing report for BNF involvement in developing supplied supplied supplied Appendix 9 - Cautionary patient information and advisory labels for dispensed medicines Appendix 8: BNF: latest User research findings supplied List of journal sources supplied user research Oct 2012 Appendix 9: BNF British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 20 of 29 Document name Description Location journal allocation 11/2012 Appendix 10: Procedure Procedure for processing supplied for processing SPCs SPCs Appendix 11: Example of processed SPC supplied SOP for checking doses supplied Appendix 13: BNF and Terms of Reference for supplied BNFC Advisors Terms expert advisors Processed SPC for Exembol [argatroban] Appendix 12: BNF SOP Checking doses of Reference Appendix 14: BNF Standing Orders of the Standing Orders of the Formulary Committees of the Formulary Committees British National Formulary supplied of the British National Formulary Appendix 15: Criteria Information on what types of for inclusion and products are covered supplied exclusion of products in BNF and BNFC Appendices 16a-d: Email correspondence Email correspondence related to NYDA® supplied related to NYDA® Appendix 17: BNF SOP Information on how the list of Processing the Nurse medicines and devices in the Prescribers’ Formulary NPF is arrived at supplied lists British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 21 of 29 Document name Description Location Appendix 18: BNF SOP Information on how the list of supplied Processing the Dental dental medicines in the BNF Practitioners’ Formulary and BNFC is arrived at lists BNF Style guide supplied BNFC Style guide supplied BNFC Style guide supplied Appendix 22: BNF Side- BNFC Style guide supplied Appendix 19: BNF Style guide Appendix 20: BNFC Style guide Appendix 21: Style guide for hepatic, renal, pregnancy, and breastfeeding messages in BNF and BNFC effects help guide Editorial guide supplied Style guide supplied Appendix 25: Google Website statistics for BNF supplied analytics of BNF website Appendix 23: BNF ACBS Product placement decision guide Appendix 24: BNF ACBS Style guide website Appendix 26: Royal Declaration of interests form Pharmaceutical Society for the RPS supplied Register of Interests British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 22 of 29 Document name Description Location Appendix 27: British Sample of evidence identified supplied Society of Antimicrobial by searches form Chemotherapy guidelines for the antibiotic treatment of endocarditis in adults 2012 supplied Appendix 28: BNF BSAC Endocarditis BNF endocarditis analysis (2012) Appendix 29: BNF Standing orders supplied Terms of reference supplied Declaration of interests form supplied SOP for developing the NPF Supplied Appendix 33: Extract of Sample of evidence identified supplied NICE CG102: Bacterial by searches Standing Orders of the Formulary Committees of the British National Formulary Appendix 30: BNF and BNFC Advisors Terms of Reference Appendix 31: Declaration of Interests Form – Advisor Appendix 32: BNF SOP Creating content for the Nurse Prescribers’ Formulary for Community Practitioners meningitis and British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 23 of 29 Document name Description Location Appendix 34: BNFC Expert advisers’ review of supplied Adviser questions evidence meningococcal septicaemia in children: full guideline posted on pre-hospital antibiotics for meningitis Appendix 35: JFC JFC review of evidence supplied PFC review of evidence supplied PFC review of evidence supplied PFC review of evidence supplied PFC review of evidence supplied PFC review of evidence supplied JFC review of evidence supplied Expert advisers’ review of supplied paper on pre-hospital antibiotics for meningitis Appendix 36: PFC paper on pre-hospital antibiotics for meningitis Appendix 37: PFC paper on maximum dose of adenosine Appendix 38: PFC paper on lisinopril heart failure dose Appendix 39: PFC paper on the role of spironolactone in nephrotic syndrome Appendix 40: PFC paper on the nebulised dose of colistimethate sodium Appendix 41: JFC paper tiotropium Appendix 42: BNFC British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 24 of 29 Document name Description Adviser discussion on evidence Location plasma concentration monitoring of colistimethate Appendix 43: BNFC Expert advisers’ review of Adviser discussion on evidence supplied benzylpenicillin dose in neonates Appendix 44: BNFC Expert advisers’ review of Adviser discussion on evidence supplied intravenous infusion dose of metronidazole in neonates Appendix 45: UK Expert adviser review of BNF Ophthalmic Pharmacy chapter supplied Group comments on chapter 11, BNF 64 Terms of reference supplied Drug safety update supplied Appendix 48: BNF and Update of changes for BNF supplied BNF for Children and BNFC Appendix 46: BNF and BNFC Advisors Terms of Reference Appendix 47: Drug Safety Update March 2013 vol. 6, issue 8 update for health professionals Monthly important new Letter from NICE detailing information.pdf changes to medicines supplied information of interest to the British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 25 of 29 Document name Description Location BNF British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 26 of 29 Appendix C: NICE Accreditation Advisory Committee, external advisers and NICE Accreditation team NICE Accreditation Advisory Committee The Accreditation Advisory Committee operates as a standing advisory committee of the Board of the National Institute for Health and Care Excellence (NICE). The Committee provides advice to NICE on a framework for accrediting sources of evidence that should be recognised as trusted sources of information for the NHS. The chair of the Committee is appointed by the NICE Board and the meetings are conducted by the chair, or in his/her absence the vice chair. The current Chair is Martin Underwood. A full list of the Advisory Committee membership is available on the NICE website. Members are appointed for a period of 3 years. This may be extended by mutual agreement for a further 3 years, up to a maximum term of office of 10 years. The decisions of the Committee are arrived at by a consensus of the members present. The quorum is set at 50% of committee membership. The Committee submits its recommendations to the NICE Guidance Executive which acts under delegated powers of the NICE Board in considering and approving its recommendations. Committee members are asked to declare any interests in the guidance producer to be accredited. If it is considered that there is a conflict of interest, the member is excluded from participating further in the discussions. Committee members who took part in the discussions for this accreditation decision are listed below. Title Name Surname Role Organisation Dr Adrian Brown Principal Screening Advisor NHS England Professor Ann Caress Professor of Nursing University of Manchester Ms Joyce Epstein Lay member Lay member Dr Elvira Garcia Public Health Medicine Locum Consultant British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 27 of 29 Dr Steve Hajioff General Practitioner and Public Public Health England Health Consultant Ms Ruth Liley Assistant Director of Quality Marie Curie Cancer Care Improvement Professor Stuart Logan Professor of Paediatric Peninsula College of Medicine & Epidemiology Dentistry Dr Edward Ng General Practitioner Ley Hill Surgery Sutton Coldfield Dr Carl Parker General practitioner North Tees and Hartlepool Foundation Trust Dr Mahendra Dr Karen Patel Ritchie Senior Lecturer & Consultant Universities of Huddersfield and Pharmacist Bradford Head of Knowledge Healthcare Improvement Scotland Management Ms Mandy Dr Sainty Pete Smith Research and Development College of Occupational Manager Therapists Vice President National Association of Primary Care Dr Sara Twaddle Head of Evidence & Healthcare Improvement Scotland Technologies / Director of SIGN Professor Martin Underwood Head of Division of Health The University of Warwick Sciences, Professor of Primary Care Research Dr Stephen Webb Consultant in Anaesthesia & Papworth Hospital NHS Intensive Care Medicine Foundation Trust Deputies Title Ms Name Josephine Surname Kavanagh Role Research Officer Organisation Institute of Education Deputising for Professor Sandy Oliver External Advisers for this application Dr Andrea Hilton, Lecturer and practising pharmacist, University of Hull, UK Dr Marlies Ostermann, Consultant in Critical Care and Nephrology, Guy's & St Thomas' Hospital, London, UK British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 28 of 29 Adrian Palfreeman, Consultant Physician University Hospitals Leicester, UK Adrian Reyes-Hughes, Clinical Consultant, Clinical Strategy & Health Information Services, UK NICE Accreditation team for this application James Stone, Accreditation Technical Analyst, National Institute for Health and Care Excellence, Manchester, UK Stephanie Birtles, Accreditation Technical Analyst, National Institute for Health and Care Excellence, Manchester, UK British National Formulary Publications: British National Formulary, British National Formulary for Children: Accreditation Report for consultation Page 29 of 29