Accreditation Decision Report for consultation

Guidance producer: British National Formulary Publications Guidance product: British National Formulary, British National Formulary for Children Date: 29 August 2013 Version: 1.4 Accreditation Decision 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 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. 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: 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 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. 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 The BNF 1 and BNFC 2 are produced according to a standard format 3,4,5. The aims of the publications are stated in prefaces and on the rear covers of the publications 1,2. Scope and purpose 1.2 The clinical, healthcare or social questions covered The BNF 1 and BNFC 2 aim to address high-level questions of drug safety, 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 format 3,4,5 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 seen in the BNF 1 and BNFC 2. 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 covers 1,2. The overall target population is broad given the variety of medicines covered, but specific populations are defined by the indications for each medicine 1,2. 1.4 Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances The standard format 3,4,5 of the BNF 1 and BNFC 2 and help to ensure 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 cautions 1,2, 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: Stakeholder involvement 2.1 Individuals from all relevant stakeholder groups, including patient groups, in developing guidance The document Standing Orders of the Formulary Committees of the British National Formulary 6 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 Not fully met example, who are also an audience for the publications as they are expected to refer to them when using the NPF 8. The publications 1,2 detail the membership of the committees and the contributing expert advisers. Page 8 of 29

Domain Criterion Evidence for meeting the criterion Accreditation decision 2.2 Patient and service user representatives and seeks patient views and preferences in developing guidance Some sources of evidence that the BNF 1 and BNFC 2 involve patients in the development of their guidance, as described in Standard reference sources 7. Patients are also involved in the development of cautionary and advisory warnings provided as appendix 3 of the BNF 1 and BNFC 2. There are no lay or patient representatives on the JFC or PFC however 6, 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. Not fully met 2.3 Representative intended users in developing guidance. The document Standing Orders of the Formulary Committees of the British National Formulary 6 details the composition of the JFC and the PFC. The committees include target users such as pharmacists and doctors, but do not include users of the NPF 8 who are also expected to refer to the publications. The publications 1,2 detail the membership of the committees and the contributing expert advisers. Not fully met Rigour of Does the guidance producer have a clear policy in place that: 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 Standard reference sources 7 and Journal allocation list 9 provide lists of 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 internal tracking spreadsheet 10. 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 Criteria for inclusion and exclusion of products in BNF and BNF for Children 11. 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 prescribed for use with medicines. The section of the BNF 1 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. 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 authoritative and reliable, however many other sources of evidence are included in the development of the BNF 1 and BNFC 2, so it is vital there is an appropriate process to appraise such evidence. The document Standard reference sources 7 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. Not met. 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 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 formulary committees of the British National Formulary 6 explains that consensus is used to reach decisions. Where consensus is not possible a voting system is used. Transcripts of conversations demonstrate this process in action 12. 3.5 Requires the guidance producers to consider the health benefits against the side effects and risks in formulating recommendations The BNF 1 and BNFC 2 present medicines information in a standard format 3,4,5 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 JFC or PFC following input from external advisers 13. The transcripts of these discussions 12 show consideration of the risks, benefits and side effects in reaching recommendations for both medicines and clinical information. 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 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. Not fully met 3.7 Describes the process of updating guidance and maintaining and improving guidance quality The BNF 1 and BNFC 2 are produced every 6 months in hard copy and are updated monthly online 15. The process states that medicines information is reviewed at least every 3 years, or sooner if new evidence becomes available 13. Clinical information is updated when new evidence becomes available through the systematic scanning of evidence sources. The BNF 1 and BNFC 2 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. Not fully met Clarity and Does the guidance producer ensure that: 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 which ensure the advice is clearly presented. Examination of the BNF 1 and BNFC 2 show that the recommendations are specific, unambiguous and clearly identifiable. 4.2 Different options for the management of the condition or options for intervention are clearly presented The standard format 3,4,5 of the BNF 1 and BNFC 2 ensures a range of medicines are presented where available, allowing the prescriber to the most appropriate medicine. Examination of the BNF 1 and BNFC 2 shows that the options for management or intervention are clearly presented. 4.3 The date of search, the date of publication or last update and the proposed date for review are clearly stated The BNF 1 and BNFC 2 are printed publications with a copyright statement on the first page containing the year of publication. The BNF displays the month and the year of publication on the front cover 1. The updating frequency for each publication is stated both in the process 13 and in the publications 12. 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. 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. Does the guidance producer routinely consider: The process 13 includes multidisciplinary committees 6 to help ensure the 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. Not fully met Applicability 5.1 Publishing support tools to aid implementation of guidance The BNF 1 and BNFC 2 are designed as succinct reference tools. They 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. 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 Both the BNF 1 and the BNFC 2 contain the section Taking medicines to 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 guidance 1,2, 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 research activities 17. The BNF 1 and BNFC 2 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: 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 source, but it would be impossible to ensure adequate professional stakeholder involvement without including a variety of health service employees in development of the BNF 1. 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 6,20. 6.2 Demonstrate transparency about the funding mechanisms for its guidance The funding source for the BNF 1 and BNFC 2 are the health services of the 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 health service 1,2. 6.3 Record and state any potential conflicts of interest of individuals involved in developing the recommendations The standing orders of the formulary committees 6, terms of reference for expert advisers 18 and declaration of interests form for expert advisers 20 provide comprehensive, appropriate policies for declaring and managing a range of conflicts of interest. BNF editorial staff are required to declare conflicts through the Royal Pharmaceutical Society register of interests 19. Both the policies and declarations are available upon request. 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 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. 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 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 BNFC Use Cases Scenarios demonstrating use 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 and BNFC Appendix 4: Example of expert adviser Discussions: JFC Use discussion over content 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 Appendix 9 - Cautionary patient information and advisory labels for dispensed medicines Appendix 8: BNF: latest User research findings user research Oct 2012 Appendix 9: BNF List of journal sources Page 20 of 29

Document name Description Location journal allocation 11/2012 Appendix 10: Procedure Procedure for processing for processing SPCs SPCs Appendix 11: Example of processed SPC Processed SPC for Exembol [argatroban] Appendix 12: BNF SOP SOP for checking doses Checking doses Appendix 13: BNF and BNFC Advisors Terms of Reference Appendix 14: BNF Standing Orders of the Formulary Committees of the British National Formulary Appendix 15: Criteria for inclusion and exclusion of products in BNF and BNFC Appendices 16a-d: Email correspondence related to NYDA Appendix 17: BNF SOP Processing the Nurse Prescribers Formulary lists Terms of Reference for expert advisors Standing Orders of the Formulary Committees of the British National Formulary Information on what types of products are covered Email correspondence related to NYDA Information on how the list of medicines and devices in the NPF is arrived at Page 21 of 29

Document name Description Location Appendix 18: BNF SOP Information on how the list of Processing the Dental dental medicines in the BNF Practitioners Formulary and BNFC is arrived at lists 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 Appendix 22: BNF Sideeffects help guide Appendix 23: BNF ACBS Product placement decision guide Appendix 24: BNF ACBS Style guide Appendix 25: Google analytics of BNF website Appendix 26: Royal Pharmaceutical Society Register of Interests BNF Style guide BNFC Style guide BNFC Style guide BNFC Style guide Editorial guide Style guide Website statistics for BNF website Declaration of interests form for the RPS Page 22 of 29

Document name Description Location form Appendix 27: British Sample of evidence identified Society of Antimicrobial by searches Chemotherapy guidelines for the antibiotic treatment of endocarditis in adults 2012 Appendix 28: BNF BSAC Endocarditis BNF endocarditis analysis (2012) Appendix 29: BNF Standing orders Standing Orders of the Formulary Committees of the British National Formulary Appendix 30: BNF and Terms of reference BNFC Advisors Terms of Reference Appendix 31: Declaration of interests form Declaration of Interests Form Advisor Appendix 32: BNF SOP SOP for developing the NPF Creating content for the Nurse Prescribers Formulary for Community Practitioners Appendix 33: Extract of Sample of evidence identified NICE CG102: Bacterial by searches meningitis and Supplied Page 23 of 29

Document name Description Location meningococcal septicaemia in children: full guideline Appendix 34: BNFC Expert advisers review of Adviser questions evidence posted on pre-hospital antibiotics for meningitis Appendix 35: JFC JFC review of evidence paper on pre-hospital antibiotics for meningitis Appendix 36: PFC PFC review of evidence paper on pre-hospital antibiotics for meningitis Appendix 37: PFC PFC review of evidence paper on maximum dose of adenosine Appendix 38: PFC PFC review of evidence paper on lisinopril heart failure dose Appendix 39: PFC PFC review of evidence paper on the role of spironolactone in nephrotic syndrome Appendix 40: PFC PFC review of evidence paper on the nebulised dose of colistimethate sodium Appendix 41: JFC JFC review of evidence paper tiotropium Appendix 42: BNFC Expert advisers review of Page 24 of 29

Document name Description Location Adviser discussion on plasma concentration monitoring of colistimethate evidence Appendix 43: BNFC Expert advisers review of Adviser discussion on evidence benzylpenicillin dose in neonates Appendix 44: BNFC Expert advisers review of Adviser discussion on evidence intravenous infusion dose of metronidazole in neonates Appendix 45: UK Expert adviser review of BNF Ophthalmic Pharmacy chapter Group comments on chapter 11, BNF 64 Appendix 46: BNF and Terms of reference BNFC Advisors Terms of Reference Appendix 47: Drug Drug safety update Safety Update March 2013 vol. 6, issue 8 Appendix 48: BNF and Update of changes for BNF BNF for Children and BNFC update for health professionals Monthly important new Letter from NICE detailing information.pdf changes to medicines information of interest to the Page 25 of 29

Document name Description Location BNF 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 Consultant Locum Page 27 of 29

Dr Steve Hajioff General Practitioner and Public Health Consultant Ms Ruth Liley Assistant Director of Quality Improvement Professor Stuart Logan Professor of Paediatric Epidemiology Public Health England Marie Curie Cancer Care Peninsula College of Medicine & Dentistry Dr Edward Ng General Practitioner Ley Hill Surgery Sutton Coldfield Dr Carl Parker General practitioner North Tees and Hartlepool Foundation Trust Dr Mahendra Patel Senior Lecturer & Consultant Pharmacist Dr Karen Ritchie Head of Knowledge Management Ms Mandy Sainty Research and Development Manager Universities of Huddersfield and Bradford Healthcare Improvement Scotland College of Occupational Therapists Dr Pete Smith Vice President National Association of Primary Care Dr Sara Twaddle Head of Evidence & Technologies / Director of SIGN Professor Martin Underwood Head of Division of Health Sciences, Professor of Primary Care Research Dr Stephen Webb Consultant in Anaesthesia & Intensive Care Medicine Healthcare Improvement Scotland The University of Warwick Papworth Hospital NHS Foundation Trust Deputies Title Name Surname Role Organisation Deputising for Ms Josephine Kavanagh Research Officer Institute of Education 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 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 Page 29 of 29