Independent and Supplementary Prescribing at a Glance
Edited by Barry Hill Aby Mitchell
Independent and Supplementary Prescribing at a Glance
Edited by Barry Hill
MSc Advanced Practice (ANP), PGC Academic Practice (PGCAP), BSc (Hons) Critical Care, DipHE/OA Dip Counselling Skills, Senior Fellow (SFHEA), Teaching English as a Foreign Language (TEFL), NMC Registered Nurse (RN), NMC Registered Teacher (TCH), NMC Registered Independent Prescriber (V300) Director of Education (Employability), Programme Leader and Senior Lecturer, Northumbria University, Newcastle, UK
Aby Mitchell
RGN, BA (Hons), MSc Advanced Practice (Healthcare Education), PGCAP, FHEA Professional Lead for Simulation and Immersive Technologies, Senior Lecturer Adult Nursing, University of West London, London, UK
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The contents of this work are intended to further general scientific research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting scientific method, diagnosis, or treatment by physicians for any particular patient. In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. While the publisher and authors have used their best efforts in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.
Library of Congress Cataloging-in-Publication Data applied for Paperback ISBN: 9781119837916
24 Principles of history taking and physical examination skills 52 25 Preparation for objective structured clinical examination 54 26 History taking for patients who lack mental capacity 58
Prescribing and the mental capacity act 60 28 Skin history taking and physical examination 62 29 Neurological history taking and physical examination 64 30 Head, ears, eyes, nose, and throat 66
Lymph node assessment 68 32 Endocrine history taking and physical examination 70 33 Respiratory 72
34 Cardiovascular history taking and physical examination 74
35 Abdominal history taking and physical examination for non-medical prescribers 76
36 Genitourinary system history taking and physical examination 78
37 Musculoskeletal history taking and physical examination 80
Part 4
Shared Decision-making 83
38 Equality, diversity, and inclusion 84
39 Concordance 86
40 Building relationships 88
41 Inclusive prescribing and informed choices 90
42 Medicine’s optimisation 92
43 Social prescribing 94
Part 5
Prescribing Practice 97
44 Adverse drug reactions 98
45 Frameworks and guidelines 100
46 Prescribing generic products 102
47 Medication calculations 104
48 Non-medical authorisation of blood components 106
49 Electronic prescribing 108
Part 6
Patient education and health promotion 111
50 Unlicensed medicines 112
51 Record-keeping and data management 114
52 Adherence 116
53 Patients recognising deterioration 118
54 Patients’ responsibility and self-management 120
References 122 Index 129
Contributors
Clare Allabyrne Chapter 26
Associate Professor and Programme Lead in Advanced Clinical Practice (Mental Health)
London South Bank University, London, UK
Emma L. Bennett Chapters 41, 47
Advanced Critical Care Practitioner (FICM Member)
University Hospital of Wales, Cardiff, UK
Jill Bentley Chapters 14, 21, 49
Lecturer in Advanced Clinical Practice, Non-Medical Prescribing and Adult Nursing, and Advanced Critical Care Practitioner (FICM member), Salford Royal Foundation Trust, Mancester, UK
Sebastian Birch Chapter 27
CAMHS Clinical Nurse Specialist and Senior Lecturer in Mental Health Nursing University of Roehampton, London, UK
Roberta Borg Chapter 24
Advanced Critical Care Practitioner (FICM Member)
Hampshire Hospitals NHS Foundation Trust, Hampshire, UK
Joanne Brown Chapter 32
Endocrine Clinical Nurse Specialist
Stockport NHS Foundation Trust, Society for Endocrinology Early Career Steering Committee and Nurse Committee Member, England, UK
Ashton Burden-Selvaraj Chapters 34, 35
Trainee Advanced Critical Care Practitioner and Collaborator
Equality, Diversity and Inclusion Working Group Intensive Care Society, London, UK
Edward Chaplin Chapter 26
Director
Head of the Scientific Committee European Association for Mental Health in Intellectual Disability,
London South Bank University, London, UK
Clare Cooper Chapters 6, 15
Advanced Clinical Practitioner and Senior Lecturer Advanced Practice
University of Northampton, Northampton, UK
Sian Cooper Chapter 25
Advanced Clinical Practitioner (ACP) in Psychiatry
NHS foundation trust Manchester, England, UK
Elizabeth Cray Chapter 19
Neurosurgical Advanced Clinical Practitioner
University Hospital Plymouth, Plymouth, UK
Anne Davidson Chapter 48
Education Lead
Patient Blood Management Practitioner Team
NHS Blood and Transplant, Newcastle, UK
Jo Delrée Chapter 26
Associate Professor and Head of Division
Mental Health and Learning Disability Nursing Institute of Health and Social Care
London South Bank University, London, UK
Simon Ross Deveau Chapter 44
Advanced Clinical Practitioner and Nurse Visiting Specialist University of Plymouth Torbay Hospital, Torquay, UK
Sadie Diamond-Fox Chapters 5, 7, 23, 24, 25, 48
Assistant Professor in Advanced Clinical Practice (ACP) & ACP Lead (Fellow HEA)
Advanced Critical Care Practitioner (FICM Member)
Regional Advancing Practice Supervision and Assessment Lead
Northumbria University Newcastle, UK
Newcastle upon Tyne Hospitals, UK
Health Education England, UK
Peter Dryden Chapter 46
Assistant Professor
Department of Nursing, Midwifery and Health
Northumbria University, Newcastle, UK
Laura Elliott Chapters 28, 53
Advanced Clinical Practitioner and Senior Lecturer Advanced Practice
University of Northampton, Northampton, UK
Karen Elton Chapter 46
Assistant Professor and Programme Leader, Senior Fellow (HEA) Northumbria University, Newcastle, UK
Annette Hand Chapters 3, 9, 12
Assistant Professor of Nursing (Clinical Academic) Northumbria University and Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK
Hayley Hassett Chapter 42
Senior Lecturer in Non-Medical Prescribing University of Hertfordshire (Fellow - HEA), Hertfordshire, UK
Colette Henderson Chapter 18
Programme Lead in MSc Advanced Practice and Deputy Programme Lead for Non-Medical Prescribing University of Dundee, Dundee, UK
Barry Hill Chapters 1, 16, 17, 29, 30
Director of Education (Employability), Programme Leader and Assistant Professor Northumbria University, Newcastle, UK
Lynne Hughes Chapter 22
Senior Lecturer in Adult Nursing University of Northampton, Northampton, UK
Tim Kuhn Chapter 34
Advanced Critical Care Practitioner (FICM Member) and Senior Lead Nurse
Critical Care and Critical Care Outreach Team, Croydon University Hospital, London, UK
Dorothy Kupara Chapters 45, 51, 54
Senior Lecturer and Course Leader for Learning Disabilities Nursing, HEA Fellow University of West London, London, UK
Hazel McPhillips Chapters 8, 38, 40 Lecturer School of Health and Social Care Edinburgh Napier University, Edinburgh, UK
Aby Mitchell Chapters 2, 39, 43, 52
Professional Lead for Simulation and Immersive Technologies and Senior Lecturer in Adult Nursing University of West London, London, UK
Tichaona Mubaira Chapter 11
Clinical Nurse Specialist in CRHTT West Berkshire Healthcare Foundation Trust; Associate Lecturer University of West London, London, UK
Kevin Murphy Chapter 4
Programme Lead for the Higher Apprenticeship in Specialist Practice District Nursing (HASPDN) and Assistant Professor in Adult Nursing (Fellow - HEA) Northumbria University
Reuben Pearce Chapter 11
Nurse Consultant in Crisis Resolution and Home Treatment Services
Berkshire Healthcare NHS Foundation Trust; Associate Lecturer University of West London, London, UK
Sam Pearson Chapters 10, 19
Non-Medical Prescribing Programme Lead and Senior Lecturer in Pharmacy Practice Edge Hill University, Ormskirk, UK
Ollie Phipps Chapter 50
Senior Lecturer and Course Director for Non-Medical Prescribing
Canterbury Christ Church University; Advanced Clinical Practitioner Maidstone and Tunbridge Wells NHS Trust, Wells, UK
Jaclyn Proctor Chapter 20
Senior Clinical Practice Edge Hill University Medical School; Respiratory or Acute Medicine Advanced Clinical Practitioner and Non-Medical Prescriber Lancashire, UK
Claire Pryor Chapters 3, 9, 12
Subject Lead for Non-Medical Prescribing, Programme Lead and Assistant Professor Northumbria University, Newcastle, UK
Christina Rawlinson Chapter 25
Advanced Clinical Practitioner (ACP) in Psychiatry, NHS foundation trust, Mancester, England, UK
Anosha Sirpath Chapter 36
Senior Lecturer Course Leader or Module Leader for Independent and Supplementary Prescribing, Fellow - HEA University of West London, London UK
Sonya Stone Chapter 35
Assistant Professor of Advanced Clinical Practice (Advanced Clinical Practitioner) Faculty of Intensive Care Medicine (FICM) Clinical Lead for eICM, School of Health Sciences, University of Nottingham, Nottingham, UK
Maureen Wallymahmed Chapter 20
Programme Lead for Non-Medical Prescribing and Senior Clinical Practice Edge Hill University, Ormskirk, UK
Nicola Weston Chapter 31
Advanced Critical Care Practitioner (FICM Member) Department of Critical Care University Hospitals Sussex NHS Foundation Trust Brighton, UK
John Wilkinson Chapter 23 Anaesthetics Registrar Northern Deanery, UK
Lisa Williams Chapter 13
Advanced Clinical Practitioner Rotherham Foundation Trust (TRFT) Hospital at Night, England, UK
Joe Wood Chapter 33
Advanced Critical Care Practitioner, Physiotherapist, and Point of Care Ultrasound Educator Medway NHS Foundation Trust, Gillingham, UK
Nick Worth Chapter 37
North West Faculty for Advancing Practice HEE and Lecturer Non-Medical Prescribing University of Salford; Fellow of the Society of Musculoskeletal Medicine England, UK
RPreface
egistered nurses, registered midwives, physician associates, and healthcare professionals who want to become an independent prescriber within the United Kingdom (UK) must successfully complete a Nursing and Midwifery Council (NMC) or Health and Care Professions Council (HCPC) approved postregistration prescribing programme in order to meet the standards of proficiency necessary for an annotation to be made against an entry onto their professional register. Independent prescribers are practitioners responsible and accountable for the assessment of patients with previously undiagnosed or diagnosed conditions and for decisions about the clinical management required, including prescribing. They are recommended to prescribe generically, except where this would not be clinically appropriate or where there is no approved non-proprietary name.
Written by healthcare academics, this book provides an essential practical and theoretical resource for healthcare students related to independent and supplementary prescribing. Each part of this book is mapped against a recognised prescribing framework published by the Royal Pharmaceutical Society (RPS) for all registered healthcare professionals. This will be the newest and most up-to-date book of its kind in the UK aimed at those studying independent prescribing practice. This is the only book to address independent prescribing for all permitted healthcare professionals based on the RPS Prescribing Framework using literature from 2021 and addressing NMC and HCPC regulatory body requirements. This book is at a glance and it makes for the practising clinician; being only 150 pages, it is the perfect size for busy healthcare professionals. The snapshot figures and key points make this book accessible, appealing to a variety of learning styles,
and focused for busy healthcare professionals. Literature informing the book comes from the RPS and Royal College of Nursing (RCN) Guidance on Prescribing, Dispensing, Supplying and Administration of Medicines (2020), and RCN and RPS Professional Guidance on the Administration of Medicines in Healthcare Settings (2019), and has adopted the RPS Prescribing Competency Framework as well as the NMC’s standards of competency for prescribing practice. Each chapter is written in a format that will enable the reader to review the chapter as a complete unit, and therefore the reader can choose in which order they wish to read the book.
A multitude of professional bodies have updated guidance on undergraduate and postgraduate education programmes preparing students to become prescriber-ready. The NMC updated future nurse pre-registration programme standards, standards for nurses, standards for midwives, standards for nursing associates, and standards for post-registration programmes. Additionally, the HCPC now advocates the guidance for the same framework meaning that all registered healthcare professionals can use a UK standard of practice and this book facilitates the key points at a glance. This book follows the current at-a-glance series and provides information in a concise and comprehensive manner, which will engage readers by including full-colour images and graphics, as well as accurate and useful information, and a user-friendly overview of key prescribing topics utilising prescribing competency frameworks. The book is also available in a range of formats, including e-book, to increase accessibility.
Barry Hill and Aby Mitchell
Prescribing
Part 1
Chapters
1 Scope of Practice NMP 2
2 Professional, legal, and ethical issues 4
3 Independent and supplementary prescribing 6
4 Community practitioner nurse prescriber (V150/V100) 8
5 Critical thinking and clinical reasoning 10
6 Exploring interventions 12
7 Evidence-based diagnosis 14
8 Referring to other members of the multidisciplinary team 16
9 Clinical management plans 18
Scope of Practice NMP
Table 1.1 Who can become an NMP in the United Kingdom. Source: Based on HEE.1
Independent and supplementary prescribers
• Nurses/midwives
• Pharmacists
• Physiotherapists
• Podiatrists
• Paramedics
• Optometrists
• Therapeutic radiographers
Supplementary prescribers only
• Diagnostic radiographers
• Dieticians
Community practitioner prescribers
Nurses (health visitors and district nurses)
Table 1.2 A summary of what NMPs can prescribe. Source: RCN / Royal College of Nursing.5
Independent prescriberSupplementary prescriber
CDsYes – Schedule 2–5 CDs, except diamorphine, dipipanone,or cocaine for treatment of addiction
Unlicensed medicines
Off-label/off-licence prescribing
Yes – provided they are competent and take responsibility for doing so.May vary for nurse prescribers in Scotland
Yes – should only be prescribed where it is best practice to do so andmust take full clinical and professional responsibility for their prescribing
Private prescribingYes – for any medicine within their competence
Non-Medical Prescribing (NMP)
Doctors are by far the largest group of prescribers, who, along with dentists, can prescribe on registration. They have been joined by independent and supplementary prescribers from a range of other nonmedical healthcare professions, who are able to prescribe within their scope of practice once they have completed an approved education programme. This extension of prescribing responsibilities to other professional groups is likely to continue where it is safe to do so and where there is a clear patient benefit. NMP is the term used to describe any prescribing completed by a healthcare professional other than a doctor or dentist.1 Non-medical prescribers (NMPs) include nurses, midwives, and pharmacists, as well as other allied healthcare professionals who have completed an accredited prescribing course and registered their qualification with their regulatory body (Table 1.1). This enables them to prescribe medications as either community practitioner nurse prescribers (with a v150 or v100 course) or independent prescribers (with a v200 or v300 course) (Table 1.2).
Yes – Schedule 2–5 CDs, except diamorphine, dipipanone, or cocaine for treatment of addiction
Yes – covered by the Clinical Management Plan (CMP)
Yes – covered by the CMP
Yes – for any medicine covered by the CMP
Royal Pharmaceutical Society (RPS)
In January 2019, the RPS and the Royal College of Nursing (RCN) co-created Professional Guidance on the Administration of Medicines in Healthcare Settings 2 The guidance was developed in response to the announcement of the withdrawal of the Standards for medicines management by the Nursing and Midwifery Council (NMC) and will be hosted on the RPS and RCN websites. Application of this guidance is a multidisciplinary responsibility. All staff groups involved in the administration of medicines should be involved in developing organisational policies and procedures. In addition to corporate and clinical governance responsibilities, registered healthcare professionals are personally responsible for putting patients first and for a commitment to ethics, values, principles, and improvement. They are also responsible for practising within their own scope and competence, using their acquired knowledge, skills, and judgement.
Scope of practice
The Health and Care Professions Council (HCPC) (2020)3 identifies scope of practice as the activities a healthcare professional carries out within their professional role. The healthcare professional must have the required training, knowledge, skills, and experience to deliver these activities lawfully, safely, and effectively. They must also have appropriate indemnity cover for their prescribing role. Scope of practice may be informed by regulatory standards, the professional body’s position, employer guidance, guidance from other relevant organisations, and the individual’s professional judgement.
The benefits of NMP
NMP has demonstrated patient care and economic benefits. Consequently, investing in NMP is seen as ‘an investment to save,’ and encouraging NMP capacity is seen as a vital upskilling priority and features as a key enabler in the planning and delivery of new care models and transforming care. NMP training can support role and career development by enabling practitioners to take on greater responsibilities for managing patient care. NMP enhances patient care by supporting patients’ timely access to treatment with medicines, enabling choice while helping to reduce waiting times and hospital admissions and maximising the wider skills of the healthcare team.
NMP healthcare professionals
The British National Formulary (BNF) and the National Institute for Health and Care Excellence (NICE) (2021)4 identify that to protect patient safety, the initial prescribing and supply of medicines prescribed should normally remain separate functions performed by separate healthcare professionals. However, there are several situations whereby simultaneous prescribing and administration or supply are required of the same practitioner, such as in the context of emergency situations.
Registered nurses
Nurse independent prescribers (formerly known as extended formulary nurse prescribers) can prescribe any medicine for any medical condition. Unlicensed medicines are excluded from the Nurse Prescribing Formulary in Scotland. Nurse independent prescribers can prescribe, administer, and give directions for the administration of Schedule 2, 3, 4, and 5 Controlled Drugs (CDs). This extends to diamorphine hydrochloride, dipipanone, or cocaine for treating organic disease or injury, but not for treating addiction. Nurse independent prescribers must work within their own level of professional competence and expertise.
Pharmacists
Pharmacist independent prescribers can prescribe any medicine for any medical condition. This includes unlicensed medicines subject to accepted clinical good practice. They can also prescribe, administer, and give directions for the administration of Schedule 2, 3, 4, and 5 CDs. This extends to diamorphine hydrochloride, dipipanone, or cocaine for treating organic disease or injury, but not for treating addiction. Pharmacist independent prescribers must work within their own level of professional competence and expertise.
Physiotherapists
Physiotherapist independent prescribers can prescribe any medicine for any medical condition. This includes ‘off-label’ medicines subject to accepted clinical good practice. They are also allowed to prescribe
the following CDs: oral or injectable morphine, transdermal fentanyl and oral diazepam, dihydrocodeine tartrate, lorazepam, oxycodone hydrochloride, or temazepam. Physiotherapist independent prescribers must work within their own level of professional competence and expertise.
Therapeutic radiographers
Therapeutic radiographer independent prescribers can prescribe any medicine for any medical condition. This includes ‘off-label’ medicines subject to accepted clinical good practice. Prescribing of CDs is subject to legislative changes. Therapeutic radiographer independent prescribers must work within their own level of professional competence and expertise.
Optometrists
Optometrist independent prescribers can prescribe any licensed medicine for ocular conditions affecting the eye and the tissues surrounding the eye, except CDs or medicines for parenteral administration. They must work within their own level of professional competence and expertise.
Podiatrists
Podiatrist independent prescribers can prescribe any medicine for any medical condition. This includes ‘off-label’ medicines subject to accepted clinical good practice. They are also allowed to prescribe the following CDs for oral administration: diazepam, dihydrocodeine tartrate, lorazepam, and temazepam. Podiatrist independent prescribers must work within their own level of professional competence and expertise.
Paramedics
Paramedic independent prescribers can prescribe any medicine for any medical condition. This includes ‘off-label’ medicines subject to accepted clinical good practice. Prescribing of CDs is subject to legislative changes. Paramedic independent prescribers must work within their own level of professional competence and expertise.
Prescribing supervisor
The prescribing supervisor is an independent supervisor who completes assessment and teaching in practice (previously known as a designated medical practitioner). The practice supervisor (PS) is a colleague in practice who must be able to provide guidance and supervision for your practice-based learning while you are on the course. The PS must be someone with whom you normally work, and they must meet specific criteria as outlined by the higher education institution. Support for the PS role is provided by the university NMP course leads and NMP leads in organisations.
Following completion of an NMP course
The newly qualified NMP must:
• Register with the relevant regulator, i.e. GPhC, NMC, or HCPC.
• Provide confirmation to their employers of their successful annotation.
• Complete any other local/employer requirements, e.g. scope of practice/formulary.
• Ensure they have appropriate indemnity arrangements.
• Maintain competence and undertake annual continuing professional development and revalidation as specified by their regulator.
• Ensure they have appropriate support to undertake their prescribing role.
Professional, legal, and ethical issues 2
Table 2.1 Legal, professional, and regulatory frameworks. Source: Adapted from Nuttall, 2020.
Prescription-Only-Medicines (POMs) (Human Use) Orders 1997 and Subsequent Statutory Instruments
NMC (http://www.nmc-uk.org)Medicines and Healthcare products Regulatory Agency (http://www.mhra. gov.uk)
Misuse of Drugs Act 1971General Pharmaceutical Council (http://www.pharmacyregulation.org)Drugs and Therapeutics Committees
Misuse of Drugs Regulations 2001
Human Medicines Regulations 2012 Human Medicines (Amendment) Regulations 2018
Health and Care Professions Council (http:///www.hcpc-uk.org)
General Optical Council’s Standards of Practice for Optometrists and Dispensing Opticians 2016 (http://www.optical.org)
UK Law for Medicines (https://www.gov.uk/guidance/eu-guidancedocuments-referred-to-in-the-human-medicines-regulations-2012#: ~:text=The%202020%20Regulations%20have%20been,and%20 advertising%3B%20and%20for%20pharmacovigilance.)
Table 2.2 Prescribing governance
The patientPrescribing practice
Circumstances and current medication
A thorough knowledge of the medicine to be prescribed, its therapeutic action, side effects, and interaction
Current patient medication and any potential interactions with new medications
Past medical historyA thorough knowledge of alternatives to prescribing
Current and anticipated health status
Previous drugs the patient has taken and full medical history
Frequency of the use of drug and dosage, adherence to current medications, and patient’s perception of health
Table 2.3 The British Pharmacological Society’s 10 principles of good prescribing – 2021. Source: Adapted from The British Pharmacological Society, 2021.
Be clear about the reasons for prescribing
Consider the patient’s medication history before prescribing
Consider factors that might alter the benefits and risks of treatment
Consider the patient’s ideas, concerns, and expectations
Select effective, safe, and costeffective medicines
Adhere to national guidelines and local formularies where appropriate
Ensure prescriptions are written on the correct documentation
Monitor the beneficial and adverse effects
Communicate and document prescribing decisions and rationale
Prescribe within the limitations of your knowledge, skills, and experience
Prescribers should establish an accurate diagnosis whenever possible and be clear what the patient is likely to gain from the prescribed medicines
Obtain a list of current and recent medications
Ask the patient/carer about any over-the-counter medications, adverse drug reactions, and drug allergies
Consider individual factors, e.g. physiological changes with age, pregnancy, or impaired kidney, liver, or heart function
Values-based prescribing is a collaborative approach to prescribing whereby the practitioner takes into account the wishes, values and principles of the patient when prescribing medication
Consider if the effect of medicines outweighs the extent of potential harms
Review published evidence
Choose the best formulation, dose, frequency, route of administration, and duration of treatment
Select medicines with regard to cost and needs of other patients (healthcare resources are finite)
Access and use reliable and validated sources of information, e.g. The British National Formulary
Be aware of common factors that cause medication errors and how to mitigate risk factors
Identify how beneficial and adverse effects can be assessed
Understand how to alter prescriptions because of information
Knowledge of how to report adverse drug reactions (via the Yellow Card scheme)
Communicate effectively with patients, carers, and colleagues
Use the health record to document prescribing decisions accurately
Be prepared to seek advice and support
Make sure appropriate prescriptions are checked
The United Kingdom (UK) prescribing law is ever changing; therefore, it is important that prescribers consistently update their knowledge of legislation. There are several legal, professional, and regulatory frameworks to support prescribing practice (see Table 2.1). For prescribers, the virtues of openness, transparency, and duty of candour are imperative and hence these should be embedded into clinical practice.
All prescribers are required to work within their own professional boundaries and standards of conduct to provide high-quality healthcare. Nurse prescribers’ practice is grounded by the professional code of practice that guides the prescribing with rules and standards. The introduction of the Royal Pharmaceutical Society (RPS) Prescribing Competency Framework 2016 has ensured that high standards are maintained and that capabilities are synonymous between disciplines. Prescribing accountability is coincident with the components of ‘governance’ and prescribers are held accountable for assuring quality standards are met on the delivery of care. The Nursing and Midwifery Council (NMC) recognises clinical governance is essential to continuously improve quality and maintain standards of care. Nurse prescribers practise autonomously within the code of the ethical principles of non-maleficence, deontology, and paternalism. Prescribing demands a higher degree of professional responsibility and accountability ensuring that the prescriber is responsible for someone or something and willing to take the consequences of actions or inactions.
Prescribing governance
The RPS Prescribing Competency Framework is structured in two key domains, i.e. prescribing governance and the consultation with the patient at the centre. Prescribing governance refers to prescribing safely and focuses on the need to reduce risk and maintain patient safety. As part of the role, nurse prescribers are expected to work at an advanced clinical level demonstrating competence in professional prescribing with evidence of accountability for clinical decisions within legal, professional, and professional boundaries. Legal and professional accountability requires prescribers to provide a rationale for prescribing for:
• What is prescribed?
• When are over-the-counter products recommended?
• When are decisions made not to prescribe or recommend a product?
In addition, prescribers are expected to have knowledge and competence in patient assessment within certain contexts (see Table 2.2).
To appropriately prescribe, it is essential that prescribers have a good knowledge and understanding of pharmacology in relation to the drugs prescribed; this includes:
Pharmacokinetics and pharmacodynamics: Pharmacokinetics involves the changes in the serum concentration of a drug in the body over a set period of time. Absorption, distribution, metabolism, and excretion of the drug bring this about. The last two processes also account for the elimination of the drug from the body. Pharmacodynamics is the term to describe what a drug does to the body, including therapeutic and adverse effects.
Safety and efficacy remain the key objectives for prescribing. All prescribes are required to work within the boundaries of their own standards of conduct and scope of practice. In gaining a prescribing qualification, a practitioner must be fully conversant with their codes of practice. Prescribers must:
• Only prescribe within their scope of practice and recognise own limitations in knowledge and skill.
• Have a good understanding about common types of medication errors and how to prevent and avoid these.
• Identify potential risks associated with remote prescribing, e.g. over the telephone/by a third party, and minimise risk factors.
• Develop and adhere to the process that supports safe prescribing practice, e.g. transfer of information and repeat prescriptions.
• Keep up to date with prescribing practice and be aware of emerging safety concerns relevant to prescribing.
• Report prescribing errors, near misses, and critical incidences, and review to prevent recurrence.
In order to ensure safe prescribing and the effective use of medicines, all practice should be underpinned by the principles provided in Table 2.3.
The prescriber must inform the patient: what to expect when taking the medicine and how to take it; the duration of time they will be on the medication and what effects and improvements they are likely to see; and the efficacy of the medication and any precautions or likely side effects.
Independent and supplementary prescribing 3
Table 3.1 Prescribing rights and medicines entitlements by profession
ProfessionGoverning bodySupplementary prescriber
Independent prescriber, excluding controlled drugs Independent prescriber, including some controlled drugs
Figure 3.1 The supplementary prescribing partnership
Table 3.2 Comparison of supplementary prescribing and independent prescribing roles and responsibilities
Prescriber type
SupplementaryIndependent
Accountable for patient initial assessment and diagnosis x√
Assess the patient As part of the CMP√
Make a diagnosisx√
Prescribe√√
Types of medication that can be prescribed
Any medication or class of medications within the agreed CMP and permitted by professional relevant legislation
Any that are permitted by professional relevant legislation
This chapter focuses specifically on two types of prescribing –independent prescribing and supplementary prescribing (v300 qualification). Chapter 4 details prescribing for nurses who have undertaken the community practitioner nurse prescribing (v100/v150) qualification.
Following a formal review of prescribing practice in the United Kingdom, the Crown Report (1999)1 recommended that there should be two types of nurse prescribers – independent and dependent (where dependent later termed supplementary). Changes to Section 63 of the Health and Social Care Act 2001 enabled the government to extend prescribing responsibilities to other health professions and the introduction of supplementary prescribing. Amendments to the Prescription Only Medicines Order and National Health Service (NHS) regulations allowed supplementary prescribing by suitably trained nurses from April 2003. Amendments to ‘The Misuse of Drugs Regulations 2001’ enabled the prescribing of controlled drugs by some supplementary prescribers (SPs) since April 2005 in line with their regulatory body stipulations.
Nursing and Midwifery Council (NMC) registered nurses and midwifes may undertake qualification in both supplementary prescribing and independent prescribing. This includes the prescribing of controlled drugs if it is within their scope of competence, confidence, and practice area. Conversely, the Health and Care Professions Council (HCPC)2 makes clear differentiation between medicines entitlements of their registered professionals and if they can become both independent and SPs, or SPs only. In addition, the HCPC specifies which prescribers may prescribe specific controlled drugs. These differences are governed by both law and professional registration. As such, they must be adhered to.
For all prescribers, it is paramount that they are aware of these differences and only prescribe within their permitted entitlements. These entitlements and considerations are shown in Table 3.1. (community practitioner nurse prescribing is detailed in Chapter 4.)
Independent prescribing
Independent prescribing is undertaken by independent prescribers (IPs). It is important to recognise that the terms are not the same; one relates to the activity and the other relates to the type of prescriber performing that activity.
The Joint Formulary Committee (2021) defines IPs as:
‘. . .practitioners responsible and accountable for the assessment of patients with previously undiagnosed or diagnosed conditions and for decisions about the clinical management required, including prescribing. . .’
Joint Formulary Committee (2021)3 para 2
IPs take responsibility for the assessment and diagnostic process that leads to the generation of a prescription (or not). This makes them responsible not only for the assessment, diagnosis, and prescribing decisions, but also for follow-up and review of any prescribing activity and patient care. IPs need to have advanced clinical assessment skills to assess their patients safely and comprehensively. They make informed decisions about the patient care and treatment based on their own appraisal. Central to this is the ability to provide a clear rational for the decisions that have been made. For some IPs, this may include assessing previously undiagnosed conditions and initiating care (including prescribing new medications).
In summary, independent prescribing is based upon the principles of:
1 Safe and appropriate assessment.
2 The prescribing for diagnosed and potentially undiagnosed conditions.
3 The inclusion of sound decision-making management planning and consideration of issuing a prescription (or not).
(Nuttall and Rutt-Howard 2020)4
Supplementary prescribing
As with independent prescribing, supplementary prescribing is intended to provide patients with quicker and more efficient access to medicines.
Supplementary prescribing is defined as:
‘a partnership between an independent prescriber (a doctor or a dentist) and a supplementary prescriber to implement an agreed Clinical Management Plan for an individual patient with that patient’s agreement’
Joint Formulary Committee (2021)3 para 3
One of the main differences between independent prescribing and supplementary prescribing is that the SP is not responsible for the initial assessment or diagnosis of the patient. Supplementary prescribing also provides a move away from the supply and administration under group protocols, which are intended to treat groups of patients, to allow for a greater flexibility over the choice and range of products for an individual patient.
Once a diagnosis has been established for an individual patient by an IP, the responsibility for clinical management can be transferred from the IP (a doctor or a dentist) to another suitably qualified health professional who may complete follow-up assessments and reviews, including prescribing from a pre-agreed range of medications within stipulated parameters and situations (detailed on the legal clinical management plan [CMP]).
In this situation, the prescribing of medicines by the second clinician is defined as supplementary prescribing.
Historically, it was felt that supplementary prescribing would be most useful for patients with complex long-term conditions, where the diagnosis was usually made by a specialist doctor, but the patient then needed continuing care. An SP could provide this continuing care by prescribing from within a defined CMP that was developed following clinical guidelines, or continuing established treatments by issuing repeat prescriptions, with the authority to adjust the dose or dosage form according to the patient’s needs.
The supplementary prescribing process
1 An IP (a doctor or a dentist) makes a formal diagnosis and identifies that a specific patient may benefit from supplementary prescribing.
2 A discussion occurs between the IP, the SP, and the patient to agree to this process.
3 At this stage, the doctor (or the dentist) becomes formally the named IP, and the SP is also named individually; Figure 3.1 shows this partnership.
4 The named IP and named SP agree which medicines may be prescribed by the SP under an individual patient CMP.
5 The SP is responsible for managing and prescribing for the condition(s) and medication(s) listed within the agreed CMP according to patient need (Department of Health, 2005),5 but is not able to prescribe any other medications.
6 The IP and the SP must maintain communication on an ad hoc basis while the SP is reviewing and prescribing for the patient.
7 It is recommended that a joint formal clinical review should be carried out with the IP, the SP, and the patient within a maximum of 12 months since the start of the CMP. Or earlier depending on the condition or medication being prescribed.
An outline of the differences between independent prescribing and supplementary prescribing is shown in Table 3.2.
Supplementary prescribing involves an agreement between a named IP and an SP or a named patient. The IP or SP cannot change without redrafting the clinical management plan.
drafted for that individual.
Community practitioner nurse prescriber (V150/V100)
Registered nurses who successfully complete a Nursing and Midwifery Council (NMC) registered community practitioner nurse prescribing course (also known as v100/v150) can prescribe from the Nurse Prescribers’ Formulary (NPF). The NMC recognises the qualification as a community practitioner nurse prescriber (CPNP) and annotates this on the individual’s NMC record once successful completion of the course has been done.1 As of March 2021, there are currently 41,301 registered CPNPs, increasing minimally over the previous five years, potentially reflective of the decreasing numbers of registered district nurses and health visitors2 (see Figure 4.1). Community nurses are recognised as the first group of nurses in the United Kingdom (UK) that can prescribe independently from a list of restricted products in the NPF (see Figure 4.2).
Significant legislative and policy reforms have formed the landscape for current nurse prescribing practice. Although the Cumberlege Report (1986)3 recommended that community nurses can prescribe from a limited range of products, it wasn’t until 1998 that nurses got access to the first restricted prescribing formulary. Prescribing is an integral part of contemporary community nursing practice, with many nurses not only appearing to highlight the benefits to patient to validate their prescribing, but also due to the inherent need to provide patient centred care. Previously seen as an activity purely exclusive to medical colleagues (with only doctors and dentists being able to prescribe until the 1990s), the strengthening of the professional role of nurses through safe and effective prescribing has provided more job control and enhanced status and credibility.
Although the qualification is recognised equally by the NMC, there are two different categories of CPNP qualification. V100 refers to an NMC module approved as part of an integrated programme of learning, such as the district nursing specialist practitioner (DNSP) or the specialist community public health nurse (SCPHN) qualification, previously known as health visitors. This is also often included in school nurse (SN) and sexual health advisor (SHA) programmes of learning. V150 refers to a stand-alone prescribing course for those who have not undertaken the V100 qualification as part of an integrated programme and yet wish to be able to prescribe from the NPF. This can be undertaken by all registered nurses working in appropriate clinical settings with support from their employer and in line with specific university entry requirements.
All nurses undertaking the V100 and/or V150 prescribing course need to demonstrate competence in numeracy skills and drug calculations. Nurses need to undertake 10 theory days at an approved university as well as observed and supported clinical practice days, working alongside appropriately qualified and experienced prescribing practitioners. Community nurses previously required an experience of two years in their current area of practice to be able to undertake this qualification; however, recent standard changes from the NMC (2018)4 have stated that this can be undertaken from the point of qualification as a registered nurse. Despite this, initial NMC consultation feedback regarding the proposed changes showed that 65% of 706 responders disagreed with newly qualified nurses undertaking prescribing prior to completion
of a preceptorship programme. For non-medical V300 prescribing, a minimum of one-year post-registration experience is required.
NMC consultations regarding the incorporation of prescribingrelated content in pre-registration academic programmes have highlighted potential to increase cost-efficiency and time benefits for employers. However, increasing the number of NMP prescribers will impact the levels of support and resources required across services, already highlighted as a challenge due to the ongoing implications of the COVID-19 pandemic. V100/V150 prescribers have been shown to reduce National Health Service (NHS) costs and improve efficiency across the multi-disciplinary team (MDT) as well as improving outcomes for patients, families, and carers (Griffiths, 2020)5 Patients have reported that they are able to start treatments sooner, which reduces waiting times and complications and increases rates of healing and improvement (McIntosh et al., 2016)6
The NPF contains a range of medications and products relevant to community settings, including 13 prescription-only medicines (POMs), dressings, pharmacy (P), general sales list (GSL), and a range of appliances. CPNPs will also be able to prescribe a range of products not stipulated in the NPF, including catheters and catheter equipment, compression garments, and socking application apparatus. NHS-employing organisations will often produce a local formulary for nurses to prescribe from, recommending products based on the latest evidence base and considering cost-effectiveness. Many trusts have taken this further, now holding centralised stores of stock equipment, such as dressings (Smith et al., 2018)7. These schemes have reduced the need for many prescribing nurses to prescribe, therefore influencing prescribing patterns. There is an association between the confidence to prescribe and prescribing rates; confidence is only likely to emerge if nurses have regular opportunity to prescribe in their area of competence (see prescription example in Figure 4.3).
Although the V100/V150 offers evidenced benefits, there is a clear need to review its contemporary effectiveness. Some community nurses will need the ability to prescribe using a wider range of available products with less restrictions on what can be prescribed. Currently, the majority of CPNP prescribing is related to wound-management products. Although the formulary is limited, prescribers should always work within the limitations of their knowledge and skill. The Nurse Prescribers’ Advisory Group includes representatives from a range of nursing disciplines and oversees the list of drugs approved for inclusion in the NPF. Many nurses perceive prescribing decisions to be highly complex, with learning to prescribe being one of the most personally challenging areas of professional development.
Equipped with the history-taking and assessment skills obtained through an NMC-approved V100/V150 programme, nurses will need to consolidate this learning in clinical practice. Prescribing is an ongoing learning process, requiring practitioners to keep up to date with the contemporary evidence base to best support prescribing decisions. CPNPs should engage with their prescribing leads and become involved in prescribing supervision to ensure clinical effectiveness and opportunity for professional development.
Critical thinking and clinical reasoning
Figure 5.1 The elements involved in clinical reasoning, underpinned by a knowledge of basic and clinical sciences. Source: Frain and Cooper9 / John Wiley & Sons.
Figure 5.2 Traditional findings versus evidence-based method of diagnosis. A textbook presents 15 traditional physical findings of pneumonia (left), along with the assumption that each finding has similar diagnostic weight. The EBD method (right), based upon studies of actual patients, shows that five findings accurately increase probability of pneumonia, and only one decreases it.
Source: Frain and Cooper7 / John Wiley & Sons.
Fever
Tachypnoea
Tachycardia
Reduced oxygen saturation
Grunting respirations
Cyanosis
Asymmetric chest excursion
Percussion dullness
Diminished breath sounds
Crackles
Aegophony
Bronchophony
Whispering pectoriloquy
Bronchial breath sounds
Pleural rub
Presenting complaintAllow the patient to describe their presentingsymptom(s)
Consider three or more hypotheses relating to diagnosis
Refine the diagnosis
Physical examination
Relevant investigations
5 findings increase probability
Asymmetrical chest excursion
Aegophony
Bronchial breath sounds
Percussion dullness
Oxygen
1 finding decreases probability
Consider the following:
• The patient’s presenting symptom(s) and basic demographics (age, gender, etc.)
• Key features of each of the three hypotheses
• Distinguishing features of each of the hypotheses
• Formulate a primary hypothesis
• Formulate a differential diagnosis or diagnoses
• Consider what findings are expected given the hypothesis and look for them
• Relevant positives and negatives should refine the hypothesis
• Consider diagnostic testing if required
• Will the investigation confirm or alter your hypothesis? If not, is it necessary?
Table 5.1 The clinical reasoning process within a consultation. Source: Based on Ross et al.6
Clinical reasoning is a multifaceted and complex construct (Figure 5.1), the understanding of which has emerged from multiple fields outside of healthcare literature, primarily the psychological and behavioural sciences. Clinical reasoning does not present us with a simple ‘yes/no’ answer to the presence or absence of a disease, rather it challenges the probability of the presence or absence; thus, it is not a black-and-white process.
The application of clinical reasoning is central to the nonmedical prescribing role; not only is it embedded within the Royal Pharmaceutical Society (RPS) framework (2021),1 but it is also essential because complex patient caseloads with undifferentiated and undiagnosed diseases are now a regular feature in healthcare practice. It is also vital for improving evidence-based diagnosis (EBD) and subsequent effective care planning, moving the clinician away from the traditional finding method (Figure 5.2).
Clinical reasoning may be defined as ‘a complex ability, requiring both declarative and procedural knowledge, such as physical examination and communication skills’.2 A plethora of literature exists surrounding this topic, with a recent systematic review identifying 625 papers, spanning 47 years, across the health profession.
A diverse range of terms are used to refer to clinical reasoning within the healthcare literature, which can make their influence somewhat challenging on their use within the clinical practice and educational arenas. The concept of clinical reasoning has changed dramatically over the past four decades. What was once thought to be a process-dependent task is now considered to present a more dynamic state of practice, which is affected by complex, non-linear interactions between the clinician, the patient, and the environment.
Cognitive and metacognitive processes
Multiple themes surrounding the cognitive and metacognitive processes that underpin clinical reasoning have been identified (Table 5.1). Central to these processes is the practice of critical thinking. Much like the definition of clinical reasoning, there is also diversity with regard to definitions and conceptualisation of critical thinking in the healthcare setting. Critical thinking has been described as ‘purposeful reflective judgement’ that consists of six discrete cognitive skills: analysis, inference, interpretation, explanation, synthesis, and self–regulation.3
Critical thinking positively correlates with academic success, professionalism, clinical decision-making, wider reasoning, and problem-solving capabilities. Patient outcomes and safety have been directly linked to critical thinking skills. There are nine discrete cognitive steps that may be applied to the process of critical thinking, which integrates both cognitive and metacognitive processes4:
1 Gather relevant information.
2 Formulate clearly defined questions and problems.
3 Evaluate relevant information.
4 Utilise and interpret abstract ideas effectively.
5 Infer well-reasoned conclusions and solutions.
6 Pilot outcomes against relevant criteria and standards.
7 Use alternative thought processes if needed.
8 Consider all assumptions, implications, and practical consequences.
9 Communicate effectively with others to solve complex problems.
There are a number of widely used strategies to develop critical thinking and EBD. These include simulated problem-based learning platforms, high-fidelity simulation scenarios, case-based discussion forums, reflective journals as part of continuing professional development (CPD) portfolios, and journal clubs.
Dual process theory and cognitive bias in diagnostic reasoning
A lack of understanding of the interrelationship between critical thinking and clinical reasoning can result in cognitive bias, which can in turn lead to diagnostic errors. Embedded within our understanding of how diagnostic errors occur is dual process theory –system 1 and system 2 thinking.
Although much of the literature in this area regards dual process theory as a valid representation of clinical reasoning, the exact causes of diagnostic errors remain unclear and require further research. The most effective way in which to teach and also learn critical thinking skills in healthcare settings remains unclear; however, a five-step strategy has been proposed based on well-known educational theory and principles, which they have found to be effective for teaching and learning critical thinking within the ‘high-octane’ and ‘high-stakes’ environment of the intensive care unit. This is arguably a setting that does not always present an ideal environment for learning given its fast pace and constant sensory stimulation. However, it may be argued that if a model has proven to be effective in this setting, it could be extrapolated to other busy clinical environments and may even provide a useful aide-memoire for self-assessment and reflective practices.
Integrating the clinical reasoning process into the clinical consultation
The clinical consultation has been described as ‘the practical embodiment of the clinical reasoning process by which data are gathered, considered, challenged, and integrated to form a diagnosis that can lead to appropriate management’.5 The application of the previously mentioned psychological and behavioural science theories is intertwined throughout the clinical consultation via the following discrete processes:
1 The clinical history generates an initial hypothesis regarding diagnosis, and said hypothesis is then tested through skilled and specific questioning.
2 The clinician formulates a primary diagnosis and differential diagnoses in order of likelihood.
3 Physical examination is carried out, aimed at gathering further data necessary to confirm or refute the hypotheses.
4 A selection of appropriate investigations, using an evidencebased approach, may be ordered to gather additional data.
5 The clinician (in partnership with the patient) then implements a targeted and rationalised management plan, based on best available clinical evidence.
Table 5.1 details a useful framework of how the abovementioned methods can be applied to the process of undertaking the clinical consultation process. In Chapter 7, we discuss how the principles of clinical reasoning are embedded within the practices of formulating an EBD.
Exploring interventions
Example monograph from the BNF. Source: Ross1 / John Wiley & Sons.
Figure 6.1
Scoping of key issues to be reviewed
Topic Referral
Development of Key aims and literature search
Surveillance & Updating
Publication
Once an indication for treatment has been established, responsible clinicians must consider the options available to them. Supplementing existing knowledge and clinical skills with expertly sourced and up-to-date information pertaining to evidence-based recommended treatments will aid safe and justifiable decision-making. There is a vast array of resources available, and these primarily fall into two main categories: formularies and guidelines.
Formularies
The British National Formulary (BNF) consists of a comprehensive list of medications licensed for use within the United Kingdom (UK). Reference is given to each medication’s indication, cautions, contraindications, side effects, dosages, and relative cost in a single monograph – see Figure 6.1. Content also includes medicationrelated legal and professional guidelines, guidance on drug management of common conditions, and a comprehensive list of known drug interactions. The BNF and the BNF for Children are valuable information sources for prescribers in the UK, and it is advisable to become familiar with their use and content. Access is readily available with the online (https://bnf.nice.org.uk/) version updated monthly and paperback versions are updated and published every 6 months.
Local formularies are often the result of local collaboration between commissioners and primary and secondary care providers. They usually consist of an agreed subset of medications from the national formulary that is tailored to address the needs of the local community, support the rapid access to cost-effective medication, reduce variations in clinical care, and ultimately increase medication safety.
Personal formularies are advocated by the World Health Organization as a means of increasing safety within one’s own prescribing practice. The process of reviewing the efficacy and risks associated with medications regularly encountered can be timeconsuming and often not practical at the patient’s bedside.
Consultation with stakeholders
Revision in response to stakeholders and Quality Assurance
Therefore, conducting these reviews, prior to patient contacts makes for safer and more efficient clinical decision-making.
Guidelines
Clinical guidelines are a key component of modern healthcare practice globally. Systematic evaluation of the best available evidence is used to generate consensus statements which aid practitioners with decisions pertaining to assessment and/or management of specific clinical presentations. The widespread application of these guidelines is linked to their affinity for improved care quality and standardised practice, in addition to safer and economical decision-making.
The National Institute for Health and Care Excellence (NICE) is responsible for the development and production of national clinical guidelines in the UK, with the Scottish Intercollegiate Guidelines Network (SIGN) conducting similar work in Scotland. Both organisations ensure that clinical guideline developments are subject to rigorous, transparent, and evidence-based methodology (Figure 6.2), as such practitioners can have confidence in the recommendations made. Guidelines produced by NICE are available for many aspects of care pertaining to a vast array of clinical presentations; these are easily accessible online at www.nice.org.uk. Local guidelines tend to be based on their national counterparts, but consider specific local needs, such as local antibiotic sensitivities and availability of resources/services.
It is worth noting that whilst clinical guidelines arguably aid practitioner’s decision-making, they should not be followed without due consideration. Guidelines are generic guides, and you must be conscious that ‘one size does not fit all’ and be able to recognise the instances when an individual’s clinical requirements cannot be met by the relevant guideline. In such cases, it is justifiable to offer alternative recommendations for that individual, provided the prescriber has conducted the appropriate risk–benefit assessment and can appropriately evidence the decision (see Chapter 15).
Evidence-based diagnosis
Figure 7.1 A two-by-two square. Source: McGee.5 With permission of Elsevier. Table 7.1 (Continued)
Actual status of the individual:
Disease present/ Individual has the condition
Finding/sign/test = positive A True positive
Disease absent/ Individual does not have the condition
(Number of patients that have the finding/sign or tested positive and have a disease) B
Finding/sign/test = negative C False negative
False positive
(Number of patients who have the finding/sign or tested positive and do not have a disease)
(Number of patients who did not have the finding/sign or tested negative, but have a disease) D
Column determines sensitivity N1
•Total number of patients with disease (A+C)
True negative
(Number of patients who did not have the finding/sign or tested negative and do not have a disease)
Column determines specificity N2
•Total number of patients without disease (B+D)
TermMeaning
PPV
Row entries used to determine positive predictive value (PPV)
Row entries used to determine positive negative predictive value (NPV)
Table 7.1 Statistical terms pertaining to evidence-based diagnosis
TermMeaning
True positive
True negative
False positive
False negative
Sensitivity
Specificity
• Column A
• People with the target condition who have a positive test result
• Column D
• People without the target condition who have a negative test result
• Column B
• People without the target condition who have a positive test result
• Colum C
• People with the target condition who have a negative test result
• Proportion of patients with the diagnosis who have the physical sign or a positive test result
• Calculation: A ÷ (A + C)
• Proportion of patients without the diagnosis who lack the physical sign or have a negative test result
• Calculation: D ÷ (B + D)
NPV
Likelihood ratio (LR)
Positive likelihood ratio
• Proportion of patients with disease who have a physical sign divided by the proportion of patients without disease who also have the same sign
• Calculation: A ÷ (A + B)
• Proportion of patients with disease lacking a physical sign divided by the proportion of patients without disease also lacking the sign
• Calculation: D ÷ (C + D)
• Finding/sign/test results’ sensitivity divided by the false-positive rate.
• A test of no value has an LR of 1. Therefore, the test would have no impact upon the patient’s odds of disease
• Proportion of patients with disease who have a positive finding/sign/test, divided by proportion of patients without disease who have a positive finding/sign/test
Calculation: (A ÷ N1) ÷ (B ÷ N2) or sensitivity ÷ (1 –specificity)
• The more positive an LR (the further above 1), the more the finding/sign/test result raises a patient’s probability of disease
• Thresholds of ≥4 are often considered to be significant when focusing a clinician’s interest on the most pertinent positive findings, clinical signs, or tests
Negative likelihood ratio
• Proportion of patients with disease who have a negative finding/sign/test result, divided by the proportion of patients without disease who have a positive finding/sign/test
• The more negative an LR (the closer to 0), the more the finding/sign/test result lowers a patient’s probability of disease
• Thresholds <0.4 are often considered to be significant when focusing clinician’s interest on the most pertinent negative findings, clinical signs, or tests
Prevalence
Post-test probability
Pre-test probability
Pre-test odds
• Equal to the pre-test probability
• The probability of the presence of a condition after a diagnostic test is performed
• The probability of the presence of a condition prior to a diagnostic test is performed
Using the principles underlying critical thinking and clinical reasoning, there is potential to make a significant contribution to diagnostic accuracy, treatment options, and overall patient outcomes. Clinical reasoning and evidence-based diagnosis go hand in hand. Much like consultation and clinical assessment, the process of the application of clinical reasoning and evidence-based diagnosis was once seen as solely the duty of a doctor; however, the non-medical prescribing (NMP) role crosses those traditional boundaries. A recent systematic review of health professionals’ understanding of diagnostic information and the accuracy metrics of specific diagnostic tests demonstrated that confusion often surrounds this subject due to its complexity.1 This chapter aims to simplify the fundamental principles.
The application of evidence-based practice and diagnosis is central to the NMP role and is embedded within the Royal Pharmaceutical Society Prescribing Competency Framework.2 As explored in Chapter 5, the principles of clinical reasoning are embedded within the practices of formulating an evidence-based diagnosis.
Evidence-based diagnosis quantifies the probability of the presence of a disease using diagnostic tests. Three pertinent questions to consider in this respect are:
1 ‘How likely is the patient to have a particular disease?’
2 ‘How good is this test for the disease in question?’
3 ‘Is the test worth performing to guide treatment?’
Evidence-based diagnosis gives a statistical discriminatory weighting to update the probability of a disease to either support or refute the working and differential diagnoses, which can then determine the appropriate course of further diagnostic testing and treatments.
Bayes’ theorem
As with clinical reasoning, evidence-based diagnosis does not present us with a simple ‘yes/no’ answer when questioning the presence or absence of a disease, rather it challenges the probability of the presence or absence; thus, it is not a black-and-white process. The processes underlying clinical reasoning are complex and require an array of underpinning knowledge of not only the clinical sciences, but also psychological and behavioural science theories.
In order to practise evidence-based diagnosis effectively, we need to apply the process of formal probabilistic reasoning. Such reasoning requires use of Bayes’ theorem, which is a technique named after Thomas Bayes (1701–1761) which is used to calculate the conditional probability of events using a simple mathematical formula. Conditional probability is the probability of an event happening, given that it has some relationship to one or more other events. For example, your probability of getting a parking space, prior to commencing a clinical shift in an inner city National Health Service hospital car park, is connected to start time of your shift, whether the said car park is shared with patients’ visitors and whether you are awarded a staff permit. Bayes’ theorem is applied within the clinical sciences to assess diagnostic accuracy through the use of a 2 × 2 contingency table.
2 × 2 contingency table
The construction of a 2 × 2 (two-by-two) contingency table (Figure 7.1) allows the accuracy of pertinent points of a patient history-taking exercise, a finding/sign on physical examination, or a test result to be weighted. Calculation of several statistical weightings can then be determined from this construct (Table 7.1). There are various online statistical calculators that can aid in the above calculations, such as the BMJ Best Practice statistical calculators, which may be used as a guide (https://bestpractice. bmj.com/info/toolkit/ebm-toolbox/statistics-calculators).
The inaccuracies of diagnostic accuracy
Diagnostic accuracy refers to how positive or negative findings change the probability of the presence of disease. Unfortunately, on occasion, bias and variability in the reporting of research concerning diagnostic testing has been reported in studies, particularly in studies within which a new or alternative test is being evaluated against a clinical reference or ‘gold’ standard. This has been reported to be due to researchers omitting vital reporting information, such as those detailed within the Standards for Reporting Diagnostic Accuracy Studies (STARD) statement.3, 4
STARD statement
The STARD checklist was developed to improve the quality of reporting of diagnostic accuracy studies. It contains 30 essential items that should be included in every report of a diagnostic accuracy study. It may also be used to report other studies, which evaluate the performance of tests, such as studies that report prognostication data. The STARD research team have become part of an international initiative (EQUATOR) that seeks to improve the value of published health research. Multiple toolkits from writing your own research to guidance on reporting clinical trials and evaluation data can be found on their website: https:// www.equator-network.org/.
Clinical scoring systems
Evidence-based literature supports the practice of determining clinical pre-test probability of certain diseases prior to proceeding with a diagnostic test. There are numerous validated pre-test clinical scoring systems and clinical prediction tools that can be used in this context and accessed via various online platforms, such as MDCalc (https://www.mdcalc.com/#all). Such clinical prediction tools include:
• 4Ts score for heparin-induced thrombocytopenia.
• ABCD2 score for transient ischaemic attack
• CHADS₂ score for the risk of atrial fibrillation stroke.
• Aortic dissection detection risk score.
Referring to other members of the multidisciplinary team
SBAR Process Dos Don’ts
S Situation
Introduce yourself and where you are calling from/based.
State who/what you are calling/seeking advice about.
Say why you are calling/seeking advice about this situation.
B Background
A Assessment
R Recommendation(s)
Pertinent information: reason for admission, past medical history, events leading up to this call/situation, medication, and allergies.
Most recent information: observations, Glasgow Coma Scale (GCS), trends, most probable differential diagnosis, treatment so far and the results of this.
What you would like from this referral: help/advice/assessment etc.
Speakclearly.
Clarify you are speaking to the right person.
Apologiseforcalling.
State your immediate concern.
Make it clear early on if the referral/advice required is urgent.
Provide this in an organised fashion.
Ensure that this information is clear and succinct.
Repeat back any information that you are given and aim to have the other person clarify they have understood the information provided.
Thanktheperson.
7 Cs of Referral
Calm Stay calm, even if you do not receive the answer or outcome you expect.
Provide information that is not relevant to the issue/situation that you are referring.
Usejargon. Provide a long list of differentials.
Fail to clarify any points/advice/information that you are unsure of.
Clear Speak clearly and introduce yourself and why you are referring. Be clear about your reason for referral.
Clarity Seek clarity around any information or advice you are unsure of.
Concise Keep the referral concise, provide only pertinent information.
Confirm Confirmanyadvicegivenanddocumentthis.
Courteous Be polite, referrals rely on good communication and relationships.
Coordinated Ensure the information is offered in a logical and coordinated manner.
