Prescribing legally and ethically

Transcription

1 Prescribing legally and ethically A CPD open learning programme for non-medical prescribers DLP 153

2 Prescribing legally and ethically A CPD open learning programme for non-medical prescribers Copyright controller HMSO 2011

3 ii Acknowledgements Lead writer Louise Winstanley, non-medical prescribing project lead for CPPE, pharmacist independent prescriber CPPE programme developer Christopher Cutts, director Reviewers Margaret Stone, joint head of postgraduate pharmacy and CPD, School of Pharmacy, Faculty of Life and Health Sciences, De Montfort University Barry Strickland-Hodge, senior pharmacy lecturer and head of medicines management academic unit, School of Healthcare, University of Leeds This learning programme was piloted nationally by the following pharmacists: Danielle Gorman, Denise Morley, Pauline Park (nurse), Bina Patel and Diana Taylor CPPE reviewers Angela Brockbank, local pharmacy tutor Louise Cope, local pharmacy tutor Emily Wighton, local pharmacy tutor Thanks This learning programme has used materials from the CPPE Supplementary prescribing series (2004) and we thank all the writers that made a contribution to that resource. Production Outset Publishing Ltd, East Sussex Published in January 2011 by the Centre for Pharmacy Postgraduate Education, School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Oxford Road, Manchester M13 9PT

4 Contents iii About CPPE open learning programmes viii About this learning programme xi Section 1 Overview of the policy, context and legal basis 1 for prescribing 1.1 Background to non-medical prescribing 3 Controlled drugs Patient benefits from non-medical prescribing Government policy process for non-medical prescribing The laws dealing with non-medical prescribing 8 What changes have been made to allow for non-medical 8 prescribing? What were the subsequent amendments to the regulations? The introduction of independent prescribing Healthcare professionals who can prescribe 11 Nurse prescribing 11 Community practitioner nurse prescribers 11 Nurse independent prescribers 11 Nurse supplementary prescribers 12 Pharmacist independent prescribers 12 Pharmacist supplementary prescribers 12 Other NHS prescribers Clinical management plans for supplementary 12 prescribers 1.8 Clinical governance framework for non-medical 14 prescribers Patient safety and risk 14 Clinical effectiveness and evidence-based practice Future changes to non-medical prescribing 15 Exercises 4, 7, 13 Reflective questions 2, 6, 8, 10, 17 Summary and intended outcomes 16 Developing and maintaining your CPD portfolio 17 Suggested answers 18 References and further reading 21

5 iv C O N T E N T S Section 2 Consent and mental capacity Definition of consent Criminal law Civil law (negligence) Ethical basis of consent The standard of information provided Qualifications of the person seeking the consent A patient s capability to make an informed decision 29 Children and informed consent Mental capability and informed consent 33 Mental Health Act 1983 and amendments Code of Practice: Mental Health Act revised 34 Best interests decisions 34 The Mental Capacity Act Deprivation of Liberty 34 Safeguards (MCA DOL safeguards) Independent Mental Capacity Advocates and the 35 Safeguarding Vulnerable Groups Act Safeguarding vulnerable adults and children Consent to research procedures Related patient-centred considerations 41 Exercises 27, 42 Case study 1 Betty Hart 35 Case study 2 Sally Darting 38 Reflective questions 25, 30, 31, 36, 40, 44 Practice points 37, 41 Summary and intended outcomes 43 Developing and maintaining your CPD portfolio 44 Suggested answers 45 References 49 Section 3 Ethics and codes of practice Ethical principles 53 Principle 1: Respect for autonomy 53 Principle 2: Beneficence 54 Principle 3: Non-maleficence 54 Principle 4: Justice 54 Duty of care 55

6 C O N T E N T S v 3.2 Ethical frameworks Regulation of non-medical prescribers 61 Nursing and Midwifery Council (NMC) 61 General Pharmaceutical Council 61 Health Professions Council 62 General Optical Council Professional codes of ethics and standards 62 Nurses 62 Pharmacists 63 Nolan principles Professional discipline 68 Exercises 55, 65, 66 Case study 3 Sarah Price 56 Case study 4 Dennis Howard 58 Reflective questions 52, 53, 58, 61, 64, 68, 69, 71 Summary and intended outcomes 70 Developing and maintaining your CPD portfolio 71 Suggested answers 72 References 79 Section 4 Clinical negligence What is clinical negligence? A healthcare professional s legal duty of care Negligence claims Protection against litigation 88 Vicarious liability 88 The NHS Litigation Authority The basis of professional negligence law 89 The snail in the bottle (1932) 89 Hall v Brooklands Auto-Racing Club (1933) 90 The Bolam case: Bolam v Friern Hospital Management 90 Committee (1957) Summary of key points 91 Bolitho v City & Hackney Health Authority (1997) 91 Hunter v Hanley (1955) Standards for non-medical prescribers Practical application 93

7 vi C O N T E N T S 4.8 Clinical negligence cases that have developed the case law 95 Hucks v Cole (1968) 95 Wilsher v Essex Area Health Authority (1986) 96 Sidaway v Bethlem Royal Hospital Governors (1985) 96 Crawford v Board of Governors of Charing Cross 96 Hospital (1953) Whitehouse v Jordan (1980) 96 The Migril case: Dwyer v Roderick and others (1983) 97 The peppermint water case (1998) 97 Horton v Evans and Lloyds Pharmacy Ltd (2006) 97 Sheller v Lee (2009) 98 Exercises 83, 85, 97 Case study 5 Katie 94 Reflective questions 86, 89, 92, 95, 100 Practice points 82, 91 Summary and intended outcomes 99 Developing and maintaining your CPD portfolio 100 Suggested answers 101 References 104 Section 5 Medicines regulatory framework Legislative framework 106 Devices Commission on Human Medicines Role of the Medicines and Healthcare products 108 Regulatory Agency (MHRA) Safety information Summary of product characteristics (SPC) Controlled drugs 113 Supplementary prescribers 113 Independent prescribers Unlicensed medicines 113 Unlicensed products 114 Unlicensed or off-label use 114 Orphan drugs 115 Borderline substances Manufacture of medicines Exemptions for unlicensed medicines 118 Out of date practice 119 Imports 119

8 C O N T E N T S vii 5.9 Liability issues Patient information leaflets 121 Exercises 107, 109, 116, 117, 122 Case study 6 Jorge Zhadmiri 120 Reflective questions 105, 110, 118, 121, 123, 124, 125 Practice points 111, 112 Summary and intended outcomes 123 Developing and maintaining your CPD portfolio 124 Suggested answers 126 References 131 Figures Figure 1 Non-medical prescribing ethical framework 57

9 viii About CPPE open learning programmes About CPPE The Centre for Pharmacy Postgraduate Education (CPPE) is funded by the Department of Health and offers continuing professional development opportunities for pharmacists and pharmacy technicians providing NHS services in England. We are based in the University of Manchester s School of Pharmacy and Pharmaceutical Sciences. CPPE offers a wide range of learning opportunities for the pharmacy workforce. CPPE learning programmes will also be useful to other healthcare professionals. Our full learning portfolio is available on the internet at: We recognise that people have different learning needs and not every CPPE learning programme is suitable for every pharmacist or pharmacy technician. Some of our programmes contain core learning while others deliver more complex learning that is only required to support certain roles. So we have created three categories of learning CPPE and allocated each programme to an appropriate category. The categories are: Core learning (limited expectation of prior knowledge). Application of knowledge (assumes prior learning). Supporting specialisms (CPPE may not be the provider and will signpost you to other appropriate learning providers). This is a learning programme. Continuing professional development You can use this learning programme to support your continuing professional development (CPD). Activities Exercises We include exercises throughout this programme as a form of self-assessment. Use them to test your knowledge and understanding of key learning points. Practice points Practice points require you to undertake additional reading or activities to supplement the learning provided in this programme. The practice points in this programme are an essential component of the learning. They give you the opportunity to evaluate and analyse articles, debate the advantages and disadvantages of protocols and guidance, and apply your knowledge to your area of advanced practice. You may need to work with other healthcare professionals when undertaking some of these activities.

10 A B O U T C P P E O P E N L E A R N I N G P R O G R A M M E S ix Reflective questions These questions are included throughout this programme to give you an opportunity to pause and reflect on your current practice and skills. Thinking about these questions will help you to meet the objectives of the programme and will extend and reinforce your learning. Case studies Case studies are based on actual or simulated events and are a way of helping you to interpret protocols, deal with uncertainties and weigh up the balance of judgments needed to arrive at a conclusion. Case studies are designed to prepare you for similar or related cases that you may face in your own practice. Assessment There is no assessment related to this programme, but you may like to work through the e-assessment for non-medical prescribers, which you will find on the CPPE website: Reference sources and further reading Reference sources for all the books, articles, reports and websites mentioned in the text, together with a list of further reading to support your learning, can be found at the end of each booklet. References are indicated in the text by a superscript number (like this 3 ). Programme guardians CPPE has adopted a quality assurance process called programme guardians. A programme guardian is a recognised expert in an area relevant to the content of a learning programme who will review the programme every six months. Any corrections, additions, deletions or further supporting materials that are needed will be posted as an update to the programme on the CPPE website. We recommend that you refer to these updates if you are using this (or any other) learning programme significantly after its initial publication date. A full list of programme guardians is available on our website. You can your comments about this programme to them at: info@cppe.ac.uk

11 x A B O U T C P P E O P E N L E A R N I N G P R O G R A M M E S Brand names and trademarks CPPE acknowledges the following brand name and registered trademark which is mentioned in this programme: Sustanon External websites CPPE is not responsible for the content of any non-cppe websites mentioned in this programme or for the accuracy of any information to be found there. The fact that a website or organisation is mentioned in the programme does not mean that CPPE either approves of it or endorses it. Disclaimer CPPE recognises that local interpretation of national guidance may differ from the examples used in this learning programme and you are advised to check with your own relevant local guidelines. You are also advised to use this programme with other established reference sources. If you are reading this programme significantly after the date of initial publication you should refer to current published evidence. CPPE does not accept responsibility for any errors or omissions. Feedback We hope you find this learning programme useful for your practice. Please help us to assess its value and effectiveness by completing the online feedback form available on our website. Simply log on by visiting: and then choose my CPPE record from the menus, scroll down to find the learning programme title, and click on the Tell us what you think icon. CPPE may you a reminder to do this. You can also us direct if you feel your comments are urgent, using the address: feedback@cppe.ac.uk

12 About this learning programme xi Welcome to this open learning programme, Prescribing legally and ethically, which forms part of the CPPE continuing professional development (CPD) series for non-medical prescribers. For those of you who have already qualified as a nonmedical prescriber, then this CPD series will act as a refresher; much of the content should be familiar to you and will have been covered in your non-medical prescribing course. However, if you are not qualified or are in training to become a prescriber, we hope this programme supports your learning. To ensure you practise safely and legally you need to stay up to date with the changes that occur both to healthcare-related legislation and evidence-based practice. By working through this programme you will become familiar with current legal and ethical issues, and learn the best way to ensure you stay up to date. Throughout each section, as well as presenting the learning with the aim of refreshing your knowledge, we challenge you to think about your role as a nonmedical prescriber, to reflect on your own practice and the issues you should be considering. At the end of each section, we will ask you to consider three key learning points that you want to take forward in your practice and remind you to complete the relevant entries in your CPD portfolio. Equity and excellence: Liberating the NHS 1 In July 2010, the Government published the health White Paper, Equity and excellence: Liberating the NHS. This sets out the Government's vision for the future of the NHS. Many of the proposed changes outlined in the White Paper, are longterm in nature and subject to consultation. The main proposals contained within the White Paper can be summarised as follows: primary care trusts and strategic health authorities are to be abolished responsibility for commissioning will be devolved to GP commissioning consortia who will decide local priorities for purchasing healthcare within a framework established by a new NHS Commissioning Board the NHS Commissioning Board will be responsible for commissioning dentistry, community pharmacy and primary ophthalmic services, as well as national and regional specialised services. local authorities will take on responsibility for public health. This is only a brief summary of the proposed changes; read the document in full via the Department of Health website: (Gateway reference 14385). As many of the proposed changes are still at the consultation and planning stage, this programme describes the NHS structure as it is at the time of writing, but organisations and processes will be in a state of constant change as these reforms evolve. It is important that you keep yourself up to date with these changes and any revisions that occur. 1. Department of Health. Equity and excellence: liberating the NHS. London: The Stationery Office; Available online at: (Gateway reference 14385).

13 xii A B O U T T H I S L E A R N I N G P R O G R A M M E Legal and ethical issues are paramount for non-medical prescribers. The programme covers five key areas: legal and policy context for non-medical prescribing consent and mental capacity ethics and codes of practice clinical negligence regulation of medicines. This programme is one part of a three-part series; the content of the other two programmes in the series is summarised below. The influence of the NHS The influences of local committees and prescribing agreements The influence of clinical evidence on practice The influence of clinical guidelines and formularies The influence of patients The influence of the pharmaceutical industry Practical clinical governance Scope of practice Clinical effectiveness and clinical engagement Monitoring and evaluating prescribing outcomes Auditing prescribing Clinical supervision Learning styles and critical thinking Risk assessment and management Recording and reporting incidents and errors Writing prescriptions and prescription security Clinical record-keeping and documentation Caldicott, data protection and confidentiality Awareness of fraud, criminal behaviour and whistle-blowing

14 A B O U T T H I S L E A R N I N G P R O G R A M M E xiii Target audience This programme is aimed at all non-medical prescribers working in any area of practice, and is applicable to independent and supplementary prescribers. It may also help you if you are considering undertaking a prescribing course or are currently undergoing training. You may be: a qualified prescriber who uses their skills daily a qualified prescriber who uses their skills infrequently a qualified prescriber who wants to expand their skills or remit into a different clinical area a prescriber who has not prescribed since qualification. a student considering doing a prescribing course or already undertaking one. The programme is about giving you the confidence and ability to prescribe safely. Some sections will appear more relevant to you than others but we would encourage you to complete all the sections. You may think your knowledge is up-to-date in a specific area, but it is worth completing all the sections in case you have missed an important update since you qualified or since you last completed any CPD in this area. This programme is written about prescribing in England. Legislation, policy documents and guidelines are often different for Northern Ireland, Wales and Scotland. However, there is quite a lot of common ground and it is hoped that the programme will be of general relevance across the UK. Learning style adopted in this programme This programme considers how you can keep up to date with ethical, but especially legal issues as a non-medical prescriber and encourages you to develop your own system for doing so. You can work through the programme in its entirety or, if you prefer, use selected exercises, case studies and information to address specific learning needs that you have identified. This programme contains enough information to give you a comprehensive overview of legal and ethical issues. However, if you wish to deepen your understanding of the topics we suggest that you read selected references in full. Learning objectives Understand the policy background for non-medical prescribing and how it may be affected by future legislation. Describe the stages of the policy process and reflect on how these affect the implementation of non-medical prescribing in your local setting. Understand the concept of consent, when consent is required and how to identify when people are not able to give consent, and what to do in those situations. Understand the various ethical frameworks and how they affect decision-making in your prescribing practice.

15 xiv A B O U T T H I S L E A R N I N G P R O G R A M M E Reflect on the consequences of not prescribing to certain groups of people from an ethical perspective. Understand what constitutes clinical negligence and the legal implications for non-medical prescribing practice. Apply important principles of case law to your prescribing practice. Apply clinical governance principles and understand why record-keeping, the evidence base and risk assessment reduce your risk of being found clinically negligent. Working through this programme We would advise you to work flexibly with this programme to suit your style of learning. We have designed the programme for self-study, so you should complete all the exercises, practice points and case studies, and you should also find it useful to talk to colleagues about some issues as you work through the programme. Maintaining your CPD portfolio At the end of each section there is a prompt to take action to make an entry in your CPD portfolio, supporting advance of both practice and skills. Your portfolio has several purposes; to provide evidence of your competence, to help you to record your plans and actions, and to give you the opportunity for structured reflection and evaluation, therefore developing you as a prescriber. Your goal as a non-medical prescriber is safe, effective prescribing practice. You must be able to demonstrate that you have remained up-to-date with evidencebased practice and best practice guidelines. You need to be able to show that you fulfil all the competencies appropriate to your practice, so your portfolio needs to be robust and contain a wide range of documents as a continuous record of your CPD. To ensure you achieve and maintain competency in your role you could keep your CPD portfolio up to date, ideally following on from the portfolio you developed during your prescribing course and showing when and how you have met all the prescribing competencies. A comprehensive CPD portfolio is an indicator of good professional practice. There is no specific requirement regarding content or style, but it should contain records or copies of: audits clinical management plans courses attended evidence for the knowledge and skills framework (if you are employed by the NHS)* your personal or service formulary meetings with mentors other learning undertaken presentations or lectures given peer review or clinical supervision

16 A B O U T T H I S L E A R N I N G P R O G R A M M E xv reflection on practice significant events your personal development plan. (*Non-medical prescribers employed by the NHS will also need a folder relating to the knowledge and skills framework (KSF), so it makes practical sense for you to combine the two. The NHS KSF, on which the development review process is based, is designed to: identify the knowledge and skills that individuals need to carry out their role efficiently and effectively help guide their development provide a fair and objective framework provide the basis of pay progression in the service.) Throughout the programmes in this CPD series there are opportunities for taking action to support both the development of practice and skills. All of the programmes have adopted the National Prescribing Centre (NPC) prescribing competencies, developed for non-medical prescribers (see enabling practice and skills to work together and to provide a structure that helps the recording of and reflection on practice. You should also use your CPD portfolio as a tool to identify your learning needs throughout the programme, and to record evidence to demonstrate to yourself, your supervisor and your employer that your ongoing learning needs are being met. Your portfolio cannot be assessed by CPPE. It is your responsibility to use it and maintain it according to your needs. Successful completion of the programme will enable you to reflect on your practice and revalidate a range of competencies for non-medical prescribing, ensuring that you continue to be fit to practise. There are plans in place to integrate the National Prescribing Centre s work into NICE. (To keep up to date with changes to the roles and responsibilities of these organisations check their websites at: and The following documents provide further information about the CPD requirements for your profession: General Pharmaceutical Council. Standards for continuing professional development. London: GPhC; Available from the GPhC website at: professionaldevelopment/continuingprofessionaldevelopmentcpd/cpd standards/index.aspx Nursing and Midwifery Council. Guidance for continuing professional development for nurse and midwife prescribers. London: NMC; Available from the Nursing and Midwifery Council website at: Health Professions Council. Your guide to our standards for continuing professional development. London: HPC; Available from the Health Professions Council website at:

17 xvi A B O U T T H I S L E A R N I N G P R O G R A M M E Online resources Some of the references in this programme are to material which is only available online, and we assume that you have access to a computer connected to the internet. If you do not wish to retype all the web addresses into your browser you may find it helpful to download this programme from the CPPE website as a PDF document containing live web links. Log on to: openlearning select open learning portfolio, scroll down to find the learning programme title, and click the download icon. Where we think it will be helpful we have provided the URL to take you directly to an article or specific part of a website. However, we are also aware that web links can change (eg, the Department of Health links) so in some cases we have provided the URL for the organisation s home page only. If you have difficulty accessing any web links, please go to the organisation s home page and use appropriate key words to search for the relevant item. Note on NICE guidance: To find any of the NICE guidelines or technology appraisals mentioned in this programme visit the NICE website at: On their home page, click on Find guidance and then enter the relevant topic in Search NICE guidance. Note on articles: If you have difficulty locating an article on the internet, search via: by typing in the title, author, date and name of the journal. It can also be helpful if you add in, at the end of the search criteria, the website where you think the information may be, eg, dh.gov.uk You may prefer to use the NHS Evidence website to search at: Reflective questions Reflection Take a few minutes to answer these questions before working through the programme; they will help you identify your specific learning needs. 1. What is the legal standing of non-medical prescribing? 2. What are the main differences between supplementary and independent prescribing?

18 A B O U T T H I S L E A R N I N G P R O G R A M M E xvii 3. What are the legal requirements of a clinical management plan? 4. What is the Bolam test? 5. List the four principles of the common ethical framework? 6. Do all non-medical prescribers have the same regulator? 7. What are the key principles behind obtaining consent? 8. What is the Mental Capacity Act 2005? 9. What triggered the development of the Safeguarding Vulnerable Groups Act 2006?

19 xviii A B O U T T H I S L E A R N I N G P R O G R A M M E 10. What is the role of the Commission on Human Medicines? 11. What is the difference between unlicensed and off-label prescribing? 12. Can an independent non-medical prescriber prescribe unlicensed medicines? In attempting to answer these questions you should be able to assess any areas where you need to learn more. You will find the answers to these questions as you work through the programme. Return to this activity once you have completed the programme to see how much you have learnt; at that stage you should be able to answer all of the questions with confidence.

20 A B O U T T H I S L E A R N I N G P R O G R A M M E xix Reflective questions Planning Before moving on to the first section of this programme, use the questions below to develop an action plan. Are you confident in your approach to working legally and ethically? Was there an instance recently when you could have done better (legally and/or ethically)? Is there any aspect of the legal and ethical framework that you want to apply more rigorously in your day-to-day practice? What do you want to learn from this programme? Think about your specific learning needs in relation to this programme and how confident you felt when answering the questions set out above. Write down at least three topics that you want to learn more about as part of your continuing professional development. You will be able to return to this at the end of the programme to see whether you have been able to meet your learning needs

21 Section 1 Overview of the policy, context and legal basis for prescribing 1 Objectives On completion of this section you should be able to: apply a working knowledge of the triggers and policy background for non-medical prescribing describe the stages of the policy process anticipate how future legislation may affect non-medical prescribing be aware of the clinical governance framework that underpins nonmedical prescribing. As you work through this section use the objectives above to identify your learning needs, so that you can make notes in your CPD portfolio, recording evidence to demonstrate to yourself, your professional regulator and your employer that you are competent to prescribe. This first section provides the policy background and context for non-medical prescribing and reminds you of the relevant law. There are many policy documents and it can sometimes be difficult to know which are the most important, so in this section we have focused on the key documents, which are all available on the Department of Health website: All of the key documents are listed in the references at the end of this section. You may choose to read some of these at the beginning of your study, but they are also referenced throughout the section. This first section provides the policy background and context for non-medical prescribing and reminds you of the relevant law. In 2009 CPPE undertook a survey of non-medical prescribers (you can look at the results of the survey on our website: We asked you about the type of support you wanted and you said: Discussion about legal issues to ensure I m up to date, especially with regard to consent I would value and writing in medical notes. case-based scenarios to work through. I would like some guidance or support about how I can avoid losing my qualification or receive an update...

22 2 S E C T I O N 1 We often consider that it is more important to be up-to-date clinically and the majority of your comments were about clinical skills and knowledge. This means we may overlook the fact that we are also bound by the law and clinical governance criteria. It is these areas of prescribing that this learning programme encourages you to think about more widely. In this section we introduce several themes which we go on to discuss in greater depth in all three parts of this CPD series. We start by looking back at some of the reasons for the introduction of non-medical prescribing, and then look at the legal framework for non-medical prescribing. We complete this section with a review of clinical governance issues in relation to non-medical prescribing. Reflective questions Reflect on your understanding of the legal and prescribing framework by answering the questions below. Can you summarise the similarities and differences between independent, supplementary, medical, and non-medical prescribing? Do you know the difference between supplementary prescribing, independent prescribing, the use of patient specific directions and the use of patient group directions? Which laws affect non-medical prescribing? What actions do you need to undertake to ensure you embed clinical governance principles into your practice?

23 O V E R V I E W O F T H E P O L I C Y, C O N T E X T A N D L E G A L B A S I S F O R P R E S C R I B I N G Background to non-medical prescribing The proposals to increase the authority to prescribe arose from the Cumberlege Report in 1986, 1 which considered the role of nurses working in the community. Legislative change for prescribing was achieved in 1992, 2 allowing certain trained district nurses and health visitors to prescribe from a limited range of products. This was followed by the first Crown Report in April 1993, 3 which introduced patient group directions for the supply and administration of medicines. In 1997 a further review was commissioned by the Department of Health, led by Dr June Crown, with a broader remit to look at the potential for extending prescribing to all healthcare professionals. The second Crown Report, 4 published in 1999, presented recommendations to extend prescribing to a wide range of healthcare professionals. The recommendations included pharmacists, as well as optometrists, podiatrists and physiotherapists, on the grounds that this would be of great advantage to many groups of patients. The other key recommendation was that the two types of prescribing should be treated separately, that is: independent prescribing, carried out by doctors and dentists; and dependent prescribing, renamed supplementary prescribing, carried out by other healthcare professionals, such as nurses and pharmacists. The outcome was the publication of the Health and Social Care Act which listed the professional groups who could prescribe. Once supplementary prescribing was in place, a consultation was undertaken in 2005 to examine options for the future of independent nurse prescribing. At the same time, a similar consultation examined options for the introduction of independent prescribing by pharmacists. Several options were put forward and the responses to both consultations were considered by a working group of the Committee on Safety of Medicines (CSM) and then agreed by the full CSM in October They recommended that suitably trained and qualified nurses and pharmacists should be able to prescribe any licensed medicine for any medical condition, within their own competence. Amendments to NHS Regulations put these changes into effect in England in May , 8 This meant that an alternative name was needed, in order to distinguish between doctors and dentists and other independent prescribers. The term non-medical prescriber was coined. The terms independent and/or supplementary non-medical prescriber continue to be used. The Committee on Safety of Medicines recommended that suitably trained and qualified nurses and pharmacists should be able to prescribe any licensed medicine for any medical condition, within their own competence. Supplementary prescribers are suitably qualified healthcare professionals who are able to prescribe any medicine (including controlled drugs), within the framework of a patient-specific clinical management plan, agreed with a doctor. Independent prescribers are able to prescribe both licensed and unlicensed medicines, with restrictions on controlled drugs. Changes were brought in on 21 December 2009 to allow independent prescribers to prescribe unlicensed medicines on the same basis as doctors and dentists. 9 The present working definitions are: Supplementary prescribing: A voluntary prescribing partnership between an independent prescriber and a supplementary prescriber, to implement an agreed patient-specific clinical management plan with the patient s agreement. 10

24 4 S E C T I O N 1 Independent prescribing: Prescribing by a practitioner (eg, doctor, dentist, nurse, or pharmacist) responsible and accountable for the assessment of patients with undiagnosed or diagnosed conditions and the clinical management required, including prescribing.within medicines legislation, the term used is appropriate practitioner. 11 We have chosen the term non-medical prescriber to use throughout this programme, as the most pragmatic term. Further changes to regulations, enabling prescribing of controlled drugs by nurse and pharmacist supplementary prescribers in primary care, came into effect on 14 April Controlled drugs Amendments to The Misuse of Drugs Regulations 2001, to enable nurse and pharmacist supplementary prescribers to prescribe controlled drugs, came into force in March The changes applied to all controlled drugs, except those listed in Schedule 1 to the 2001 Regulations, which are those not intended for medicinal use. These amendments enabled the supplementary prescribing of controlled drugs in secondary care. Further changes to regulations, enabling prescribing of controlled drugs by nurse and pharmacist supplementary prescribers in primary care, came into effect on 14 April Exercise 1 Visit the Department of Health website ( and gain a working knowledge of the documents listed below that relate most closely to your practice. Make some notes about the main changes that were proposed. Review of prescribing, supply and administration of medicines (second Crown report) 4 Shifting the balance of power within the NHS 14 The NHS plan: a plan for investment, a plan for reform 15 Pharmacy in the future. Implementing the NHS Plan: a programme for pharmacy in the National Health Service 16 The NHS plan: an action guide for nurses, midwives and health visitors 17 Liberating the talents: helping primary care trusts and nurses deliver the NHS plan 18 Meeting the challenge: a strategy for allied health professionals 19 Primary care, general practice and the NHS Plan 20 Supplementary prescribing by nurses, pharmacists, chiropodists/podiatrists, physiotherapists and radiographers within the NHS in England: a guide for implementation 21 Improving patients access to medicines: a guide to implementing nurse and pharmacist independent prescribing within the NHS in England 22

25 O V E R V I E W O F T H E P O L I C Y, C O N T E X T A N D L E G A L B A S I S F O R P R E S C R I B I N G 5 Turn to the end of the section for suggested answers. 1.2 Patient benefits from non-medical prescribing Non-medical prescribing benefits a wide range of patients, especially those with long-term conditions. Patients have quicker and easier access to medicines and more opportunities to discuss the details of their clinical management with the person looking after them. However, the paramount key principle is putting patients first, in terms of safe and effective healthcare. 23 Non-medical prescribers can support patients by: managing acute and long-term conditions monitoring and assessing illness improving the quality of service to patients without compromising patient safety giving advice on changes that make it easier for the patient to cope with treatment reviewing medication ensuring that the best formulation of the product is being offered to the patient making it easier for patients to get the medicines they need making better use of healthcare professionals skills contributing to the introduction of more flexible team working across the NHS communicating with patients to provide information about management and treatment of their health problems. Non-medical prescribing means that patients have quicker and easier access to medicines and more opportunities to discuss the details of their clinical management with the person looking after them.

26 6 S E C T I O N 1 Patients also benefit from convenience, greater choice in terms of who they can consult, and more direct access than many independent prescribers can offer. Non-medical prescribers offer greater opportunities for preventative healthcare, as well as direct therapeutic management of patients, for example, appointment-led hospital clinics, such as anticoagulation clinics. 24 Reflective questions You may already be a non-medical prescriber, or perhaps this is a role you plan to work towards for the future. Think about the implications of the role and answer the questions below. What are the benefits to my patients? How do I monitor safety? How do I measure the quality of my prescribing decisions? Much progress has been made with non-medical prescribing in improving the opportunities and choices that are safely available for patients. However, to really maximise the impact of non-medical prescribing, patients need to be aware of the choices available to them. A doctor may suggest to a patient that their care could be continued by a supplementary or independent non-medical prescriber, but the patient may choose to remain with their GP. In this situation the patient s choice should be recognised and respected.

27 O V E R V I E W O F T H E P O L I C Y, C O N T E X T A N D L E G A L B A S I S F O R P R E S C R I B I N G Government policy process for non-medical prescribing Government policy is developed and put into action in a structured way. The time taken between each stage depends on the agenda set by the government and the urgency of the policy. The key stages in the process for generating policy are summarised below. 1. Government wishes to introduce a new policy or amend existing policy, based on a fundamental belief. 2. The Queen announces the topics for the next session of Parliament. (The government gives her details of the intended topics.) 3. A preliminary paper outlining the new policy is issued (a Green Paper). 4. Political parties in the Houses of Commons and Lords debate the policy, with their respective ideologies and agendas; the policy may then be amended and finally agreed. 5. Political parties agree legislation to underpin and enable the new policy. 6. A paper outlining the aims and philosophy of the new policy is issued (a White Paper). 7. The enabling legislation is passed. 8. Additional working papers are produced detailing the implementation of the policy. Target organisations receive the policy (White Paper) and working papers, plus ongoing local authority circulars (LACs), health circulars (HCs), executive letters (ELs), press notes and publications. Organisations then interpret these to devise local policy. Exercise 2 Look through the second Crown Report 4 and consider whether the stages set out above were followed when non-medical prescribing was implemented. If not, where in the above list do you think the process began? Turn to the end of the section for suggested answers. It is worth noting that not all aspects of an act have to be implemented at the same time.

28 8 S E C T I O N 1 Reflective questions Look through the Health and Social Care Act at the list of potential prescribers, consider whether they have now all been enabled to prescribe, and make notes below. Once an act is passed, amendments, regulations and orders are then brought in to Once an act is passed, amendments, regulations and orders are then brought in to describe how the act should be implemented. An act is like a tree in winter. Amendments, regulations and orders are like putting the leaves on the tree, they give it form and definition, but mostly they fill in the blank spaces. All of these documents are legally binding. describe how the act should be implemented. 1.4 The laws dealing with non-medical prescribing There are several laws that deal with non-medical prescribing. These include: The Health and Social Care Act 2001 The Medicines Act 1968 (amendments) The Misuse of Drugs Regulations 2001 The NHS Act 1977 What changes have been made to allow for non-medical prescribing? Amendments to Section 63 of the Health and Social Care Act allowed for the extension of prescribing responsibilities to a wider range of healthcare professionals. It also enabled the introduction of different types of prescribing.

29 O V E R V I E W O F T H E P O L I C Y, C O N T E X T A N D L E G A L B A S I S F O R P R E S C R I B I N G 9 The extension of prescribing rights under the act meant that subsequent amendments to other acts and regulations were then necessary. Many of the healthcare professionals mentioned in the act have not yet been enabled to prescribe. What were the subsequent amendments to the regulations? Section 42 (England and Wales) and Section 44 (Scotland) of the National Health Service Act provided legislation for the dispensing of prescriptions written by healthcare professionals other than doctors or dentists (separate regulations govern provision in Northern Ireland). Section 63 of the Health and Social Care Act amends section 58 of the Medicines Act 1968, which governs the sale, supply and administration of prescription-only medicines. The definition of an appropriate practitioner under the Medicines Act 1968 was changed to allow inclusion of healthcare professionals other than doctors. A supplementary prescriber was specified as either a first level nurse or a pharmacist. In 2002 amendments were made to the POM Order, 26 to allow the introduction of prescribing of prescription-only medicines by supplementary prescribers (working either within or outside the NHS), as part of agreed clinical management plans relating to individual patients. An order is subsidiary to an act and provides the detail of the general powers described in the act, enabling the act to be put into practice. The amendment also proposed that P medicines (except for those that contained controlled drugs) and GSL medicines may be prescribed, and this amendment came into force on 4 April The amendment specified certain conditions to be met, in order for supplementary prescribing to take place, namely that: First level nurse A registered nurse who has completed a three-year programme of education, leading to a nursing qualification and an academic qualification (a degree or diploma). They were previously known by titles such as RGN (registered general nurse). An order is subsidiary to an act and provides the detail of the general powers described in the act, enabling the act to be put into practice. the independent prescriber must be a doctor or dentist the supplementary prescriber must be a registered nurse, midwife, pharmacist, physiotherapist, radiographer, optometrist or podiatrist there must be a written clinical management plan relating to a named patient, for a specific condition, agreed and signed by both prescribers the clinical management plan must specify the range of medicines that may be prescribed for the named patient by the supplementary prescriber, including the limits of variation within the range and when to refer back to the independent prescriber the clinical management plan must contain warnings about any known patient drug sensitivities and arrangements for notification of adverse drug reactions the clinical management plan must state the date of commencement of supplementary prescribing arrangements and date for review (which should not normally exceed one year) both independent and supplementary prescribers must share access to, consult and use the same common patient record. 26 These amendments to the regulations detail not only arrangements for nonmedical prescribing, but also the legal requirements for the content of a clinical management plan. 26 Failure to comply with the regulations is a criminal offence for any healthcare professional involved.

30 10 S E C T I O N 1 Changes to the Chemists Terms of Service 27 allow for the writing and dispensing of NHS prescriptions by supplementary prescribers within community pharmacies. Supplementary prescribing responsibilities were also extended to physiotherapists, optometrists, radiographers and podiatrists in The introduction of independent prescribing Similar amendments to the Health and Social Care Act were made to introduce independent prescribing. Then, in 2005, a joint Medicines and Healthcare products Regulatory Agency (MHRA)/Department of Health consultation was carried out to look at the future of independent nurse prescribing. It was felt that the original nurse prescribers extended formulary, introduced for independent nurse prescribers (V300) in 2001, was too complex. Experience had also shown that updating the formulary was difficult, with changes taking over a year to finalise. Also, it was not practical for supplementary prescribing (ie, prescribing supported by a clinical management plan) to be used in all settings where patients would benefit, as the clinical management plan could not be always be prepared in advance, for example, in emergency care. The proposals were designed to benefit patients by providing greater access to pharmacists knowledge and expertise, as well as a faster and more accessible service. At the same time, a similar consultation examined proposals for the introduction of independent prescribing by pharmacists. The proposals were designed to benefit patients by providing greater access to pharmacists knowledge and expertise, as well as a faster and more accessible service. A working group of the Committee on Safety of Medicines first considered the responses to both consultations in September Then, on 27 October 2005 the full Committee on Safety of Medicines decided to recommend that suitably trained and qualified nurses and pharmacists should be able to prescribe any licensed medicine for any medical condition, within their own competence, apart from controlled drugs. 6 The term non-medical prescribing was introduced at this stage to differentiate between types of independent prescribers, as there are legal differences between doctors and other medical prescribers and this new group of prescribers. Reflective questions Do you think the decision to allow independent prescribing was rushed through?

31 O V E R V I E W O F T H E P O L I C Y, C O N T E X T A N D L E G A L B A S I S F O R P R E S C R I B I N G 11 Do you think it would have been useful to fully evaluate the effects of supplementary prescribing on healthcare, before allowing independent prescribing? 1.6 Healthcare professionals who can prescribe Nurse prescribing There are two types of nurse prescribers: 1. community practitioner nurse prescribers V150/V100 (which includes district nurses and health visitor prescribers). The distinction between V150 and V100 practitioners is that V150 applies to nurses without a specialist practitioner qualification and is a stand-alone course, the V100 course is integrated with the specialist practitioner/specialist community public health nursing award. 2. nurse independent/supplementary prescribers V300 (previously known as extended formulary nurse prescribers). All nurse prescribers can prescribe any appliances or chemical reagents, but the medicines that they can prescribe differ according to their level of training, area of competency and qualifications. Community practitioner nurse prescribers Community practitioner nurse prescribers V100 and V150 are only entitled to prescribe from the nurse prescribers formulary for community practitioners. 22 The formulary has restrictions linked to particular products, eg, ibuprofen is limited to being prescribed as the 200 mg tablet or 100 mg/5 ml suspension. Nurse independent prescribers In May 2006, following the recommendation that was made by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulations were changed and the extended nurse prescribers formulary was no longer used. Any nurse who was an extended formulary nurse prescriber automatically became a nurse independent prescriber. A nurse independent prescriber must be a first level registered nurse, registered midwife or registered specialist community public health nurse whose name is held on the Nursing and Midwifery Council professional register, with an annotation signifying that the nurse has successfully completed an approved programme of preparation and training for nurse independent prescribing. Nurse independent prescribers are able to prescribe most licensed medicines for any medical condition within their competence, but only a limited number of controlled drugs for specific conditions. Nurse independent prescribers can prescribe any borderline substances and appliances, Nurse independent prescribers are able to prescribe most licensed medicines for any medical condition within their competence, but only a limited number of controlled drugs for specific conditions.

32 12 S E C T I O N 1 as well as medicines outside licence, or off-label, where it is accepted clinical practice (see Section 5, for definitions and further information). Department of Health guidance recommends that nurse independent prescribers restrict their prescribing to the substances on the Advisory Committee on Borderline Substances approved list, in part XV of the drug tariff. 29 Nurse supplementary prescribers Nurses can still qualify as supplementary prescribers and many have both independent prescribing and supplementary prescribing qualifications. As a supplementary prescriber they can prescribe any medicine that could be prescribed by a medical prescriber, providing they form part of a patient s clinical management plan, including any controlled drugs and unlicensed medicines. Initially some nurses trained as independent extended formulary nurse prescribers only, but since the change in regulation all nurses undertaking the V300 module will qualify with both independent and supplementary qualifications. Pharmacist independent prescribers are not currently permitted to prescribe controlled drugs. However, this restriction is currently being reviewed and it is anticipated that this will change. Pharmacist independent prescribers A pharmacist independent prescriber s authority to prescribe is very similar to nurse independent prescribers, except for controlled drugs. Pharmacist independent prescribers are not currently permitted to prescribe controlled drugs. However, this restriction is currently being reviewed and it is anticipated that this will change. Pharmacist supplementary prescribers Pharmacist supplementary prescribers can prescribe any medicine that could be prescribed by a medical prescriber, providing they form part of a patient s clinical management plan, including any controlled drugs and unlicensed medicines. Other NHS prescribers Optometrists, physiotherapists, radiographers and chiropodists/podiatrists are able to act as supplementary prescribers, in the same way as pharmacist or nurse supplementary prescribers. Optometrists can now train as independent prescribers. Changes are planned to extend independent prescribing to radiographers, physiotherapists and podiatrists. You can read more about the mechanisms of medicines supply in: Medicines matters. A guide to the mechanisms of prescribing, supply and administration of medicines Clinical management plans for supplementary prescribers A clinical management plan can be a fairly simple document and may make reference to established clinical guidelines or protocols that professionals working in NHS organisations may already be aware of. The Department of Health has published guidance notes for the development of clinical management plans. 31 Take a look at some examples of clinical management plans at:

33 O V E R V I E W O F T H E P O L I C Y, C O N T E X T A N D L E G A L B A S I S F O R P R E S C R I B I N G 13 Exercise 3 If you need to review your clinical management plans, use these questions to focus your learning. When do you need to use a clinical management plan? What should it look like? Where should it be kept? What details must it contain in order to fulfil legal requirements? If you are an independent non-medical prescriber, you may still need to use a clinical management plan. Why would this be? Who should sign the clinical management plan as the medical prescriber? What situations lend themselves to prescribing under a clinical management plan? Turn to the end of the section for suggested answers.

34 14 S E C T I O N Clinical governance framework for non-medical prescribers While clinical effectiveness is critical, there is an increasing focus on the quality of healthcare in the NHS. Everyone who uses the NHS should expect to receive care of the highest standard. This duty of quality is a legal requirement and is found in the Health and Social Care (Community Health and Standards) Act Clinical governance is an umbrella term that captures the range of activities needed to improve the quality of health services to patients. All NHS organisations need to have systems of accountability in place to monitor the quality of care they provide, so that they can continuously improve that care. In the past there have been examples of poor practice in the NHS, resulting in tragic consequences. The Bristol Heart Inquiry marked a turning point in the history of the NHS and resulted in the introduction of clinical governance processes in 1997, with the publication of: A first class service, 33 which placed quality improvement at the centre of health policy. Criminal activities by trusted healthcare professionals, eg, Harold Shipman, Beverley Allitt, have produced further changes in the way practice is governed. Standards are set down in national guidance from the Department of Health, and the National Institute for Health and Clinical Excellence (NICE) and in national service frameworks, and it is the duty of each NHS body to implement and maintain clinical governance arrangements. Clinical governance is the system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care, by creating an environment in which clinical excellence will flourish. 34 There are many elements that contribute to effective clinical governance, including patient involvement, research, clinical and cost-effectiveness, clinical audit, risk management, evidence-based practice, mechanisms to monitor the outcomes of care, systems for managing poor performance and lifelong learning among health professionals. Clinical governance also links improving care for individual patients with quality improvement for whole populations. An awareness of clinical governance issues is essential for your day-to-day practice and for your continuing professional development, and the collective benefit for professional practice outweighs any time implications. An awareness of clinical governance issues is essential for your day-to-day practice and for your continuing professional development, and the collective benefit for professional practice outweighs any time implications. Throughout this CPD series we will be looking at aspects of clinical governance in more detail, but here are some key issues to consider. Patient safety and risk There are risks involved in treating patients, managing staff and running hospitals and clinics. So, developing the essential practice competencies is the key to being 35, 36 able to deliver safe and effective healthcare. A significant number of contacts with patients result in harm to patients or staff and many of these adverse incidents are preventable. 37 In order to keep the level of risk to a minimum it is important to put risk management protocols in place to avoid clinical incidents, as well as near-misses, regardless of whether there is harm to the patient. There is also a cost implication for the NHS of adverse incidents, as a result of additional treatment, claims and litigation. Risk management processes and protocols help NHS organisations to manage and monitor health and safety, corporate and clinical risk in their organisation. Reporting and learning from

35 O V E R V I E W O F T H E P O L I C Y, C O N T E X T A N D L E G A L B A S I S F O R P R E S C R I B I N G 15 incidents is part of the risk management process and helps to protect the safety of patients, staff and visitors. The National Reporting and Learning Service (NRLS), established in 2003, enables patient safety incident reports to be submitted to a national database. This data is then analysed to identify hazards, risks and opportunities, to improve the safety of patient care. Since the NRLS was established, over four million incident reports have been submitted by healthcare staff, and the NRLS has used this data to issue alerts and reports, highlighting common themes and suggesting ways to improve patient safety. There are now plans in place to transfer the NRLS to a new NHS Commissioning Board. (To keep up to date with changes to the roles and responsibilities of this organisation check their website at: Since the NRLS was established, over three million incident reports have been submitted by healthcare staff. Clinical effectiveness and evidence-based practice The concept of clinical effectiveness emerged in the late 1980s. The NHS needed to account for its management, clinical efficiency and effectiveness and value for money and, as a result, introduced a range of quality improvement initiatives, whereby healthcare professionals developed measures to report on and assess the quality of clinical services. Clinical effectiveness initiatives include: evidence-based practice clinical audit to review current practice the development of clinical guidelines outcome measures and indicators. (Clinical audit evolved from medical audit in the late 1980s, as part of the process of implementing evidence-based practice in healthcare.) 1.9 Future changes to non-medical prescribing Lord Darzi s report, A year of progress towards high quality care for all 38 describes the achievements since the first Darzi report, High quality care for all 39 and looks at the future direction of the NHS. Future changes for prescribing are under consultation and, although they may not be as significant as previous changes, the Department of Health continues to have increasing expectations of all NHS professionals. 40 It is vital, therefore, to be aware of the impact of new laws on your practice so that you can continue to adapt and deliver new ways of working. The Quality, Innovation, Productivity and Prevention (QIPP) website contains resources designed to help clinical networks and NHS teams meet and deliver the QIPP challenge. It is available via the NHS Improvement website, or you can find it directly at: nhs.uk/qipp

36 16 S E C T I O N 1 Summary In this section we have set the scene for the rest of this programme, providing an overview of the legislation that has supported the development of non-medical prescribing. We have looked at the different groups of healthcare professionals who can prescribe and the benefits that this brings. However, with increased scope comes increased responsibility, governed by a regulatory framework, so we have also considered the place of clinical governance and the national approach to patient safety. Intended outcomes By the end of this section you should be able to: Can you? apply a working knowledge of the triggers and policy background for non-medical prescribing describe the stages of the policy process anticipate how future legislation may affect non-medical prescribing be aware of the clinical governance framework that underpins non-medical prescribing.

37 O V E R V I E W O F T H E P O L I C Y, C O N T E X T A N D L E G A L B A S I S F O R P R E S C R I B I N G 17 Developing and maintaining your CPD portfolio This section underpins the following National Prescribing Centre competencies: (taken from the NPC competency framework available at: Prescribing professionally Accepts personal responsibility for own prescribing and understands the legal implications of doing so. Understands how current legislation affects prescribing practice. The NHS in context Knows how local health service and partner organisations work and interact. Understands national NHS frameworks relevant to medicines use (eg, clinical governance, IT strategy). Understands the framework of supplementary prescribing and how it is applied in practice. Note: There are separate competency frameworks for the different professions, so some of the competencies listed may not be directly applicable to your own profession. Now make entries in your CPD portfolio to denote that you have undertaken CPD related to these competencies. Reflective questions What have you learnt so far? Think about all you have read and made notes about in this section. Write down three things you have learnt about legal issues that are relevant to your personal practice, or three changes you want to make in your future work

38 18 S E C T I O N 1 Suggested answers Exercise 1 (see page 4) Make some notes about the way that the documents you have accessed explain government policy and the rapid adoption of non-medical prescribing. Shifting the Balance of Power makes it clear that local people should be involved in financial and policy-making decisions, to develop a new and more patient-centred service. 13 The concept is based on the idea that local people are best placed to tailor resources efficiently, giving scope for the community to direct the local implementation of services. Local commissioning of services creates competition, ensuring that market forces result in cost-effectiveness. Services have been redesigned with an increasing focus on the patient, by breaking down the rigid demarcations between the professions and enabling non-medical prescribing. These changes reflect the view that the perceived balance of power laid with professionals, to the patient s detriment. The creation of independent healthcare regulators is a further indicator of the intention to make safeguarding the public of paramount importance, following poor practice and criminal activities of certain trusted healthcare professionals. The proposals from the Crown reports were rapidly adopted to bring about the extension of non-medical prescribing. It is worth noting that the rationale for change, better use of skills, breaking down professional barriers and greater access to patients, fits with the concept that access and equity are cornerstones of a reforming approach. The impact of the Crown reports continues to be far reaching. European Union directives also have to be incorporated into working practice, for example, junior doctor s working hours. Exercise 2 (see page 7) Look through the second Crown Report and consider whether non-medical prescribing was implemented following the stages set out above? If not, where in the above list do you think the process began? There was no specific debate or White Paper underpinning non-medical prescribing. In this case the Crown Report was commissioned, the proposals accepted by the government, and the process came in at point 5 in the list. Legislation was developed for non-medical prescribing because the recommendations from the Crown Report fitted the policy direction at the time; that is, it improves access for patients, it is patientcentred and it reduces vocational professional barriers.

39 O V E R V I E W O F T H E P O L I C Y, C O N T E X T A N D L E G A L B A S I S F O R P R E S C R I B I N G 19 Exercise 3 (see page 13) When do you need to use a clinical management plan? Before supplementary prescribing can take place, it is obligatory for an agreed clinical management plan to be in place (either written or electronic) relating to a named patient and relating to the patient s specific condition(s) that is to be managed by the supplementary prescriber. What should it look like and where should it be kept? The design of the clinical management plan is not important, provided it contains all the legal requirements; usually the Department of Health template is used and adapted. The agreed clinical management plan should be included in the patient record. What details must it contain in order to fulfil legal requirements? Regulations specify that the clinical management plan must include the following: the name of the patient to whom the plan relates the illness or conditions that can be treated by the supplementary prescriber the date on which the plan is to take effect, and when it is to be reviewed by the doctor or dentist responsible for developing the plan reference to the class or description of medicines, or types of appliances, which may be prescribed or administered under the plan any restrictions or limitations as to the strength or dose of any medicine which may be prescribed or administered under the plan, and any period of administration or use of any medicine or appliance which may be prescribed or administered under the plan relevant warnings about known sensitivities of the patient to, or known difficulties of the patient with, particular medicines or appliances the arrangements for notification of: a) suspected or known reactions to any medicine which may be prescribed or administered under the plan, and suspected or known adverse reactions to any other medicine taken at the same time as any medicine prescribed or administered under the plan, and b) incidents occurring with the appliance which might lead, might have led or has led to the death or serious deterioration of state of health of the patient the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the doctor or dentist responsible for developing the plan. 41 If you are an independent non-medical prescriber, you may still need to use a clinical management plan. Why would this be? You would only expect to be competent to independently diagnose and prescribe for a small range of conditions; however, you may be able to manage treatment for a wide range of other conditions as a supplementary prescriber, for example, long-term conditions such as diabetes, for which you would need to use a clinical management plan.

40 20 S E C T I O N 1 Who should sign the clinical management plan as the medical prescriber? The patient s usual GP or the doctor who is taking clinical responsibility. What situations lend themselves to prescribing under a clinical management plan? A clinical management plan can be developed for a wide range of conditions, but the patient must be part of an ongoing caseload. It would be inappropriate to develop a clinical management plan for a brief intervention; making supplementary prescribing unsuitable in this situation.

41 O V E R V I E W O F T H E P O L I C Y, C O N T E X T A N D L E G A L B A S I S F O R P R E S C R I B I N G 21 References 1. Department of Health and Social Security. Neighbourhood nursing a focus for care (Cumberlege Report). London: HMSO; Medicinal Products: Prescription by Nurses etc. Act Available online at: (accessed 1 February 2010). 3. Department of Health. Report of the advisory group on nurse prescribing (first Crown Report). London: HMSO; Department of Health. Review of prescribing, supply and administration of medicines (second Crown report). London: HMSO; Health and Social Care Act London: HMSO; Available online at: (accessed 1 February 2010). 6. Committee on Safety of Medicines. Summary of the Committee on Safety of Medicines meeting held on Thursday 27 October London: CSM; Available online at: committeedocument/con pdf (accessed 1 February 2010). 7. Department of Health. Improving patient s access to medicines: A guide to implementing nurse and pharmacist independent prescribing within the NHS in England. London: TSO; Available only online at: ionspolicyandguidance/dh_ (accessed 19 December 2010). 8. Secretary of State for Health. The National Health Service (Amendments Relating to Prescribing by Nurses and Pharmacists etc.) (England) Regulations SI 699. Internet version available online at: (accessed 4 February 2010). 9. The Medicines for Human Use (Miscellaneous Amendments) (No 2) Regulations SI 2009 No Available online at: (accessed 18 March 2010). 10. Department of Health web page. About supplementary prescribing (last modified 9 February 2007). Available only online at: Prescriptions/TheNon-MedicalPrescribingProgramme/ Supplementaryprescribing/DH_ (accessed 12 December 2009). 11. Department of Health. Mechanisms for nurse and pharmacist prescribing and supply of medicine Available only online at: PublicationsPolicyAndGuidance/DH_ (accessed 1 February 2010).

42 22 S E C T I O N Home Office. Explanatory memorandum to the misuse of drugs (amendment) regulations SI 2005/271. London: TSO; Available online at: (accessed 1 February 2010). 13. The Medicines for Human Use (Prescribing) Order SI 2005 No 765. Available online at: (accessed 1 February 2010). 14. Department of Health. Shifting the balance of power within the NHS. London: HMSO; Available online at: (accessed 1 February 2010). 15. Department of Health. The NHS plan: a plan for investment, a plan for reform. London: HMSO; Department of Health. Pharmacy in the future. Implementing the NHS Plan: a programme for pharmacy in the National Health Service. London: HMSO; Department of Health. The NHS plan: an action guide for nurses, midwives and health visitors. London: HMSO; Department of Health. Liberating the talents: helping primary care trusts and nurses midwives deliver the NHS plan. London: HMSO; Department of Health. Meeting the challenge: a strategy for the allied health professionals. London: HMSO; Department of Health. Primary care, general practice and the NHS Plan: information for GPs, nurses, other health professionals and staff working in primary care in England. London: HMSO; Department of Health. Supplementary prescribing by nurses, pharmacists, chiropodists/podiatrists, physiotherapists and radiographers within the NHS in England: a guide for implementation. London: HMSO; Gateway reference: Available online at: Department of Health. Improving patients access to medicines: a guide to implementing nurse and pharmacist independent prescribing within the NHS in England. London: HMSO; Gateway reference: Available online at: Nursing and Midwifery Council. Standards of proficiency for nurse and midwife prescribers. London: NMC; Available online at: (accessed 10 November 2010). 24. Yorkshire & Humber NHS Trust. High quality care for all, making the connections Available online at: nts/digitalasset/dh_ pdf (accessed 1 February 2010).

43 O V E R V I E W O F T H E P O L I C Y, C O N T E X T A N D L E G A L B A S I S F O R P R E S C R I B I N G National Health Service Act Available online at: _en_1 (accessed 18 March 2010). 26. Medicines and Healthcare products Regulatory Agency. MLX 284. Proposals for supplementary prescribing by nurses and pharmacists and proposed amendments to the Prescription Only Medicines (Human Use) Order Available online at: ations/mlxs/con (accessed 1 February 2010). 27. The National Health Service (Miscellaneous amendments relating to independent prescribing) Regulations SI 913. Available online at: (accessed 1 February 2010). 28. Department of Health web page. Summary of changes to regulations on supplementary prescribing. April Available only online at: Prescriptions/TheNon-MedicalPrescribingProgramme/Supplementary prescribing/dh_ (accessed 18 March 2010). 29. Department of Health web page. Nurse independent prescribing. Available only online only at: Prescriptions/TheNon-MedicalPrescribingProgramme/ Nurseprescribing/index.htm (accessed 9 February 2010). 30. Department of Health. Medicines matters. A guide to mechanisms for the prescribing, supply and administration of medicines. London: DH; Available only online at: PublicationsPolicyAndGuidance/DH_ (accessed 1 February 2010). 31. Department of Health web page. Clinical management plans (last modified 9 February 2007). Available only online at: Prescriptions/TheNon-MedicalPrescribingProgramme/ Supplementaryprescribing/DH_ (accessed 1 February 2010). 32. Health and Social Care (Community Health and Standards) Act Available online at: (accessed 1 February 2010). 33. Department of Health. A first class service: quality in the NHS. London: HMSO; Gateway reference: Available online at: Department of Health. Clinical governance quality in the new NHS HSC (1999/065). London: DH; Gateway reference: Available online at:

44 24 S E C T I O N National Prescribing Centre. Maintaining competency in prescribing. An outline framework to help nurse prescribers. Liverpool: NPC; Available online at: nurs.pdf (accessed 1 February 2010). 36. National Prescribing Centre. Maintaining competency in prescribing. An outline framework to help pharmacist prescribers. 2nd edition. Liverpool: NPC; Available online at: oct_2006.pdf (accessed 1 February 2010). 37. National Patient Safety Agency. Safety in doses. Improving the use of medicines in the NHS. London: NPSA; Available online at: (accessed 1 February 2010). 38. Professor the Lord Darzi of Denham KBE. A year of progress towards high quality care for all. London: Department of Health; Gateway reference: Available online at: Department of Health. Professor the Lord Darzi of Denham KBE. High quality care for all: NHS Next Stage Review final report. June Gateway reference: London: The Stationery Office; Available online at: Department of Health. Allied health professions prescribing and medicines supply mechanisms scoping project report. London: DH; Gateway reference: Available online at: Further reading Visit the Department of Health web pages shown below for further information about each area of prescribing: Supplementary prescribing Prescriptions/TheNon-MedicalPrescribingProgramme/ Supplementaryprescribing/index.htm Pharmacist independent prescribing Prescriptions/TheNon-MedicalPrescribingProgramme/Independent pharmacistprescribing/index.htm Nurse independent prescribing Prescriptions/TheNon-MedicalPrescribingProgramme/Nurseprescribing/ index.htm

45 Section 2 Consent and mental capacity 25 Objectives On completion of this section you should be able to: understand the concept of consent and discuss its place in the ethical framework of practice explain the underlying reasons for obtaining consent understand the situations when consent is required demonstrate and apply in practice how to identify when people are not able to give consent, and what to do in those situations. The principles and law relating to consent have been developed following the Nuremberg Code, (see page 40 for more details). It is important that you are familiar with these principles so that you know how and when to gain informed consent when you are consulting with patients. You also need to know how to treat patients who are not able to give consent and what else needs to be in place to support both you and them. Informed consent can be difficult to achieve, because it depends on the right conditions being met, the most important being your ability to get a response from your patients concerning your intentions. If informed consent has not been achieved it may be reflected by a patient not returning for a repeat appointment, or low adherence to your prescribing. It is essential that a patient gives their consent to procedures which involve them, even when risk is minimal, or when no personal contact is involved. The basis for the concept of informed consent lies in civil and criminal law, and in the ethical concept of autonomy. The area of consent is embedded in several pieces of legislation and while these provide a good guide, the subject can also seem fairly complex. Informed consent can be difficult to achieve, because it depends on the right conditions being met, the most important being your ability to get a response from your patients concerning your intentions. This section defines consent, shows where it fits with ethical principles and summarises the key legislation. Reflective questions How do you gain informed consent in your day-to-day practice?

46 26 S E C T I O N 2 List any situations where you have found it difficult to obtain consent, or where a patient has refused consent. 2.1 Definition of consent The Department of Health s Code of Practice to the Mental Health Act 1983 (revised 1999) gives the following definition of consent: 2 Consent is the voluntary and continuing permission of the patient to receive a particular treatment, based on an adequate knowledge of the purpose, nature, likely effects and risks of that treatment, including the likelihood of its success and any alternatives to it. Permission given under any unfair or undue pressure is not consent. Consent is necessary in any professional relationship between a patient and a healthcare provider. It seems obvious that a patient must freely consent to a surgical operation, because of the obvious dangers of the procedure and it is sometimes wrongly assumed that informed consent is necessary only for surgery or invasive procedures. Consent is necessary for all treatment, but it is often implied in the interaction, eg, in the normal health professional-patient relationship, where the patient seeks and accepts the advice of the health professional on treatment, when buying an over-the-counter (OTC) medicine, or when having a prescription dispensed. For major procedures or treatments involving risk to the patient, such as surgical procedures, it is usual for informed consent to be obtained in writing. For some services now being provided by health professionals, explicit consent is required. It is especially important where touching is concerned, for example, when a blood sample is taken. We have explained some of the terms in the above definition in more detail below. Explicit consent can be verbal or written. The steps involved in obtaining explicit consent could include adequately explaining the procedure and its risks, paying attention to whether or not the patient has understood the information provided and assessing whether the patient has the capacity to legally consent. Implicit or implied consent occurs when the patient agrees to the procedure simply by being a patient and by not objecting to therapeutic procedures about which they have received general information, for example, by holding out an arm for an injection.

47 C O N S E N T A N D M E N T A L C A P A C I T Y Criminal law It is unlawful to touch or even threaten to touch a person without their permission. Such a touch would constitute battery, that is, the unlawful deliberate touching of one person by another. Cases can be brought in civil and criminal courts by anyone who considers that they have been assaulted. Strictly speaking the term assault refers to the threat of physical harm; there is not even any need to prove that the touch caused any damage. So, treatments or investigations performed without consent constitute battery. Certain situations, such as emergency lifesaving procedures, would be exceptions to this rule. Strictly speaking the term assault refers to the threat of physical harm; there is not even any need to prove that the touch caused any damage. 2.3 Civil law (negligence) For an agreement to exist between the patient and the professional there has to be an element of consent; without consent there can be no agreement. Indeed, the first case brought by a patient claiming that he did not consent to the procedure took place in Consent must be based on adequate information being provided to the patient, especially about the risks. If inadequate information is given a patient may win a negligence claim. The word used in law for negligence is tort and its definition is: a wrongful act or an infringement of a right (other than under contract) leading to legal liability. 3 A court may regard any consent as invalid if it is based on inadequate information. Tort law Tort law is a branch of the law which covers civil wrongs. Under tort law, if someone suffers a physical, legal, or economic harm, they may be entitled to bring suit. If the suit is deemed valid, damages (remedies) may be awarded to Exercise 4 the plaintiff. Read about the case of Chatterton v Gerson [1981] 1 All ER on the UK Clinical Ethics Network website: Summarise the judgment in the case, and note down the court s definition of inadequate information. Remedies A legal remedy (or judicial relief) is the means by which a court of law, usually under civil, not criminal law, enforces a right, imposes a penalty, or makes a court order to impose its will. In legal philosophy and theory, there is a principle that for every right, there is a remedy. Lawmakers intend to provide appropriate remedies to protect rights. Turn to the end of the section for suggested answers.

48 28 S E C T I O N Ethical basis of consent It could be argued that consent forms the foundation for medical ethics: all of medical ethics is but a footnote to informed consent. 5 Informed consent reflects the ethical principle of patient autonomy, that is, the moral right to decide for oneself what is to happen to one s body. The principles of beneficence and non-maleficence also underpin the concept of consent. (We discuss ethical principles in more detail in Section 3 of this programme.) 2.5 The standard of information provided Generally, the amount of information given to the patient is at the discretion of the healthcare professional, provided he follows recognised good practice. Of course, any information provided needs to be accurate and any questions asked by the patient must be answered truthfully. However, the professional standard with regard to the provision of information was dealt with in two legal cases (listed below, but covered in more detail in Section 4 of this programme), and these cases have determined a guideline for what is commonly regarded as a weak disclosure. Bolam v Friern Hospital Management Committee Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital The judge in Sidaway said, a competent adult has a right to refuse treatment, for reasons which are rational or irrational, or for no reason. 6 To make an informed and valid consent a patient must be given the information relevant to the decision he is going to make. The case law indicates that this should be the information that a responsible body of professional opinion would consider necessary. The courts have said that patients should be told of risks that are so obviously necessary to an informed choice on the part of the patient that no reasonably prudent medical man would fail to make it Qualifications of the person seeking the consent Any healthcare professional involved in non-medical prescribing should make their profession clear to the patient at the outset. Consent is often given because the patient recognises the qualifications of the person seeking the consent, for example, hairdressers can easily gain consent to make contact with clients when a bus conductor would not. Some patients may assume that anyone who prescribes is a doctor, and therefore consent to accepting the prescription. They may feel differently about accepting a prescription from another healthcare professional. They may be even more concerned if they only find out about the status of the other healthcare professional after the event.

49 C O N S E N T A N D M E N T A L C A P A C I T Y 29 Any healthcare professional involved in non-medical prescribing should make their profession clear to the patient at the outset. If a clinical management plan is used, it might be a good opportunity to describe to the patient how it works and what access the healthcare professional will have to patient records. This knowledge might affect a patient s decision regarding consent. 2.7 A patient s capability to make an informed decision Consent is based on the assumption that the patient is capable of making an informed and voluntary decision. There are two aspects to this: the level of information provided about what is to happen, and the patient s ability to make a decision. There is an assumption that adult patients are usually competent to make decisions about their health, and therefore able to accept or refuse treatment. However, this presumption can be challenged in court, especially if the patient does not have the mental capacity to make reasoned decisions. We will look at mental capacity in more detail, later in this section. There is an eloquent statement relating to a patient s legal right to consent to treatment in American law: Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient s consent commits an assault, for which he is liable in damages. 7 The courts have suggested three tests to determine whether a person has the capacity to validly give consent: Did the patient understand what was said? Did they believe it? Did they consider the information, and balance needs and risks before reaching a decision? In the case law known as Re C [1994], 8 an elderly paranoid schizophrenic had delusions that he was a doctor. Nevertheless, the courts held that he was capable of refusing consent for an amputation to treat gangrene, because he understood the information about treatment. The case of Re C can be contrasted with that of Re T [1992], 9 where the courts found that a woman had been influenced by her Jehovah s Witness mother into refusing a necessary blood transfusion. The court declared that she had not been fully rational when she refused, due to the influence of her mother, and partly due to the medication received. However, Lord Donaldson said in this case : This right of choice is not limited to decisions which others might regard as sensible. It exists notwithstanding that the reasons for making the choice are rational, irrational, unknown or even non-existent. However, the capacity must be commensurate with the gravity of the decision purported to be made: The more serious the decision, the greater the capacity required. 9

50 30 S E C T I O N 2 Reflective questions Read through the following guidance relating to healthcare professionals seeking consent from patients and then answer the questions set out below. Department of Health. Reference guide to consent for examination or treatment, second edition London: DH; (Gateway reference: 11911). Available via their website at: and the General Medical Council guidance for doctors, Consent: patients and doctors making decisions together, available online at: What are the key issues for your personal practice? When do you need to record consent? What must be done to record consent? Do you have a form which you can use? Do you need to consider using different forms for different situations? You may want to look at the information about consent forms provided on the Department of Health website: (just enter consent forms into the search box) or use the internet to find other versions of consent forms. If you already have a consent form, you may want to check that it is up to date, by reading through the Department of Health guide mentioned above.

51 C O N S E N T A N D M E N T A L C A P A C I T Y 31 Often there will be no need for the patient to give written consent to you. However, you should always keep a record of any matters that have been discussed and any consent that has been given, especially if it relates to the risks of a particular treatment or course of action. The Department of Health guidance on non-medical prescribing states: Wherever it is proposed to manage a patient s condition through the use of non-medical prescribing, the principle underlying the concept of non-medical prescribing (ie, a prescribing partnership) must be explained in advance to the patient by the medical or non-medical prescriber and their agreement should be obtained. The agreement of the patient to the prescribing partnership should be recorded in the CMP (if appropriate) and patient record.without such agreement non-medical prescribing may not proceed. 10 You should always keep a record of any matters that have been discussed and any consent that has been given, especially if it relates to the risks of a particular treatment or course of action. The Department of Health clinical management plan templates include a space to note the date of agreement by the patient. Reflective questions Thinking about your own area of practice, which situations would you not need to gain written consent for? Children and informed consent The above cases concerned adults, however, children may also be considered competent to make decisions about their health. The Family Law Reform Act lowered the age of majority to 18 years and gave 16 and 17-year-olds the same right to consent to treatment as adults. Section 8(1) says:...the consent of a minor who has attained the age of sixteen...shall be as effective as it would be if he were of full age; and where a minor has...given an effective consent to any treatment it shall not be necessary to obtain any consent for it from his parent or guardian. The British Medical Association (BMA) guidance summarises the position as follows: competent adults have an absolute right to refuse treatment, but issues of consent are much more complex where children are concerned. Parents can consent to treatment on behalf of their children, but not if the treatment is against the child s best interests. Older children, if they can understand the treatment proposed, can consent on behalf of

52 32 S E C T I O N 2 themselves. But if the parent disagrees, the position is legally complex and the law of Scotland differs from that in England,Wales and Northern Ireland. For patients aged under 18, the courts may also take treatment decisions. 12 General information about consent for children can be found on the Citizens Advice Bureau website. General information about consent for children can be found on the Citizens Advice Bureau website. 13 The US courts use more memorable language and, in the case of Prince v Massachusetts (1944), the US Supreme Court said, Parents are free to become martyrs themselves. But it does not follow that they are free, in identical circumstances, to make martyrs of their children before they have reached the age of full and legal discretion when they can make that choice for themselves. 14 The Gillick v West Norfolk and Wisbech Area Health Authority (1985) 15 case, also known as the Fraser Ruling, established broad principles on the capacity of children aged under 16 to give consent to medical treatment. The parental right to determine whether a child below the age of 16 has medical treatment ceases if, and when, the child achieves sufficient understanding and intelligence to fully comprehend what is proposed. The court decided that parental rights did not exist, other than to safeguard the best interests of a child. In some circumstances a child could consent to treatment and in those circumstances a parent had no power to veto that treatment. 15 The parental right to determine whether or not a child below the age of 16 will or will not have medical treatment terminates if and when the child achieves sufficient understanding and intelligence to enable him to understand fully what is proposed. 15 Gillick competence relates to: A particular child and a particular treatment, so is not clear-cut and depends on the prescriber s professional judgment. There have been cases where a 17-year-old has been found insufficiently competent to refuse medical treatment, while in other cases much younger children have been deemed sufficiently competent. If a child is 16 or 17 either parent or child can consent to treatment independently (though neither can override the other or exercise a veto). The court can, however, override the wishes of both, where treatment is vital to the child s welfare. The Access to Health Records Act further complicates the picture by allowing a child under 16, deemed Gillick competent by a health professional, to veto the parent s access to medical information held by that doctor, even though the parent can consent to treatment which the child cannot veto. It is for the healthcare professional to decide whether or not an individual child is Gillick competent ; the courts are generally reluctant to do so. 17 Where a child is not of sufficient understanding, the consent of the parent, or a person with parental responsibility, is required. The Children Act 1989, 18 states that the child s welfare shall be the court s paramount consideration. The act gives young people under 16 a limited right to refuse certain treatments in circumstances connected with care orders. Where a child is of sufficient understanding, medical treatment may only be given with their consent (except in medical emergencies). It is for the doctor to decide whether the child is capable of giving consent. Where a child is not of sufficient understanding, the consent of the parent, or a person with parental responsibility, is required. Children of 16 and over can give their own consent. 18 The right to refuse

53 C O N S E N T A N D M E N T A L C A P A C I T Y 33 treatment is also limited by two judgments Re R and Re W, 19, 20 which challenge the Gillick ruling. In both cases the child s refusal to accept treatment was overruled and the parents wishes for treatment prevailed. The right to refuse to give consent has also been tested. Both in the United States and in the UK, courts have ordered necessary blood transfusions for a child whose parents objected because they were practising Jehovah s Witnesses. UK courts have also overridden the wishes of the parent in order to facilitate a procedure of benefit to the child, but which was refused by the parents. An interesting, but sad example of this is the case of Jodie and Mary B, conjoined twins. Their parents brought them to the UK for treatment, but as Catholics they steadfastly refused to agree to an operation in which one twin was almost certain to die. The courts overruled their objections and made the children wards of court. The outcome was that Jodie s best interests carried the greatest legal weight. 21 Healthcare professionals are most likely to encounter the issue of consent in relation to children seeking treatment when teenagers seek supply of emergency hormonal contraception (EHC). 2.8 Mental capability and informed consent It is often necessary to distinguish what is the best course of action from a medical point of view, from what is in the best interest of the patient all things considered. Of course, all healthcare professionals have a duty of care to their patients, but sometimes it is difficult to decide what is really in the patient s best interests. It is usual to assume that the patient is the best judge of what is best for them, provided they have been given adequate information to make an informed decision. Generally speaking a mentally competent patient has the right to refuse medical treatment, regardless of the consequences and regardless of how beneficial or necessary treatment may be. However, problems arise if a person is unable to understand what is happening to them. All healthcare professionals have a duty of care to their patients, but sometimes it is difficult to decide what is really in the patient s best interests. The Mental Capacity Act 2005, 22 sets out a clear legal framework to guide anyone caring for people who lack mental capacity by setting out key principles, procedures and safeguards. The act was fully implemented following the introduction of the Mental Health Act 2007, with further guidance presented in the Mental Capacity Act 2005: Code of Practice. 23 Mental Health Act 1983 and amendments 2007 The Mental Health Act amends the Mental Health Act 1983, the Mental Capacity Act 2005 and the Domestic Violence, Crime and Victims Act Over the last few years mental health services in England have experienced a period of unprecedented change, with evidence emerging about which practices are effective and which are not. The Mental Health Act 2007 sets out how a person should be treated if they have a mental illness, a learning disability or a personality disorder. It also sets out when a patient can be given treatment or taken into hospital against their will, what their legal rights are and what safeguards are in place to ensure that their rights are protected. 24

54 34 S E C T I O N 2 The Mental Capacity Act 2005 is underpinned by a set of five key principles set out in section 1: a presumption of capacity every adult has the right to make his or her own decisions and must be assumed to have capacity to do so unless it is proved otherwise the right for individuals to be supported to make their own decisions people must be given all appropriate help before anyone concludes that they cannot make their own decisions that individuals must retain the right to make what might be seen as eccentric or unwise decisions best interests anything done for or on behalf of people without capacity must be in their best interests; and least restrictive intervention anything done for or on behalf of people without capacity should be the least restrictive of their basic rights and freedoms. 22 Code of Practice: Mental Health Act revised 25 The Code of Practice provides guidance on how the Mental Health Act 1983 should be applied. The new code came into force on 3 November 2008 and reflects the changes made to the Mental Health Act 1983, by the Mental Health Act The British Psychological Society has produced guidance that supports the Code of Practice for the Mental Health Act and looks in more detail at the types of factors that might need to be considered when making a decision in someone s best interests. Best interests decisions Clearly, making a best interest decision on behalf of someone else needs to be done carefully. The British Psychological Society has produced guidance that supports the Code of Practice for the Mental Health Act and looks in more detail at the types of factors that might need to be considered when making a decision in someone s best interests. 26 In summary, the guidance suggests that the decision-making process should set out: the role of the decision-maker the process by which the decision-maker decides what is in the person s best interests when to refer to an independent mental capacity advocate what to record when to hold best interests meetings. 26 The Mental Capacity Act Deprivation of Liberty Safeguards (MCA DOL safeguards) The MCA DOL safeguards (formerly known as the Bournewood safeguards) are designed to protect the interests of an extremely vulnerable group of patients. 27 They were introduced into the Mental Capacity Act 2005 through the Mental Health Act The safeguards were implemented in April 2009 and apply to patients in hospitals and people in care homes that are registered under the Care Standards Act 2000 for anyone: aged 18 and over who suffers from a mental disorder or disability of the mind, such as dementia or a profound learning disability

55 C O N S E N T A N D M E N T A L C A P A C I T Y 35 who lacks the capacity to give informed consent to the arrangements made for their care and/or treatment, and for whom deprivation of liberty is considered in their best interests to protect them from harm, after an independent assessment is carried out. They are intended to: ensure people can be given the care they need in the least restrictive regimes prevent arbitrary decisions being made that could deprive vulnerable people of their liberty provide safeguards for vulnerable people provide vulnerable people with rights of challenge against unlawful detention. Independent Mental Capacity Advocates and the Safeguarding Vulnerable Groups Act 2006 The regulations that came into force on 12 October 2009 mean that Independent Mental Capacity Advocates (IMCAs) are a regulated activity for the purposes of the Safeguarding Vulnerable Groups Act The statutory IMCA service was launched across England and Wales in 2007 and sets out to help vulnerable people who are facing important decisions made by the NHS and local authorities about serious medical treatment and/or changes of residence. (Further information about the SafeguardingVulnerable Groups Act 2006 is provided below.) The role of the Independent Safeguarding Authority in relation to registration of IMCAs and other individuals and organisations is currently under consultation. Check the up-to-date situation by looking at the Independent Safeguarding Authority website at: Case study 1 Betty Hart You visit a care home to see Betty Hart, as the care staff think she is developing memory problems. The last time you saw her you had a satisfactory conversation with her and checked that she understood what you had discussed. However, on this occasion, she seems very different. She is tearful and doesn t remember you. What do you need to consider about her mental capacity?

56 36 S E C T I O N 2 Turn to the end of the section for suggested answers. Reflective questions Which is the easiest document to adopt as a working reference or guidance, which covers everything you need to know to do your job safely and within the law relating to the Mental Capacity Act 2005 and the Deprivation of Liberty Safeguards? Make a note of it here and also in your CPD portfolio. 2.9 Safeguarding vulnerable adults and children You have a duty of care to consider safeguarding issues with every patient in a vulnerable group who consults with you. In recent years there has been concern about the safety and welfare of children and vulnerable adults, due to reported cases of abuse and neglect. The main reason for this was the tragic death of Victoria Climbié. There are still many examples of child abuse cases reported in the media. Social services reviews have found that poor practice, inadequate training and lack of effective practice have continued to contribute to failures to prevent abuse. Following the death of Baby Peter in Haringey, a review of safeguarding arrangements in all 392 NHS organisations was carried out. You have a duty of care to consider safeguarding issues with every patient in a vulnerable group who consults with you. There have been many cases where healthcare professionals failed to act, when they should have intervened to help prevent serious outcomes.

57 C O N S E N T A N D M E N T A L C A P A C I T Y 37 Practice point Think about any patient who has consulted with you who may belong to a vulnerable group. Write down two or three questions you might ask if you are concerned about their welfare. Lord Laming in the Victoria Climbié Inquiry Report (2003) said: The support and protection of children cannot be achieved by a single agency... every service has to play its part. All staff must have placed upon them the clear expectation that their primary responsibility is to the child and his or her family. 29 Central government has defined safeguarding children as: The process of protecting children from abuse or neglect, preventing impairment of their health and development, and ensuring they are growing up in circumstances consistent with the provision of safe and effective care that enables children to have optimum life chances and enter adulthood successfully. 30 Safeguarding is defined by the Children Act 1989: Agencies (and organisations) working with children and young people take all reasonable measures to ensure that the risks of harm to the individual s welfare are minimised; and......where there are concerns about children and young people s welfare, all agencies (and organisations) take all appropriate actions to address those concerns, working to agreed local policies and procedures, working in partnership with other local agencies. 31 Legislation has been extended to include protection for vulnerable adults. A section of the Police Act 1997 states that a vulnerable adult is someone who is: Substantially dependent upon others in performing basic functions, or their ability to communicate with those providing services, or to communicate with others is severely impaired. 32 Some people may have a reduced ability to protect themselves from assault, abuse or neglect, as a result of learning or physical disability, reduction in physical or mental capacity, or simply because they are resident in a care home.

58 38 S E C T I O N 2 All healthcare professionals have a duty to raise and report any concerns about poor practice to the relevant authorities. Many instances of adult abuse, neglect, poor care and poor practice have been uncovered and continue to be found. Investigations in Cornwall Partnership NHS Trust, Sutton and Merton PCT, Maidstone and Tunbridge Wells NHS Trust, for example, revealed significant failings. These included abuse of people s money, use of outdated restraint techniques, poor training of staff, promotion of a climate of dependency and a lack of rapid action to tackle infection outbreaks. This has repercussions for prescribing practice and highlights that all healthcare professionals have a duty to raise and report any concerns about poor practice to the relevant authorities. Failure to do so could lead to you being considered negligent. Case study 2 Sally Darting Sally Darting was a very bright, nine-year-old child. She had a long-term condition which was managed by a team at the local hospital. She went to school as usual, but became ill one evening and was taken to hospital. She had a low level infection, but she insisted that her parents went home as she was quite comfortable and settled. She deteriorated overnight. Her parents were called and asked if there were any other health issues. The hospital was then told that both parents were HIV positive. Sally had an urgent HIV test which was positive, but she died of meningitis later that week. You will find useful guidance on these issues in: Department of Health, Department for Education and Skills. Children in need and bloodborne viruses: HIV and hepatitis. London: The Stationery Office; (Gateway reference: 3766) (available on the Department of Health website: or Local Safeguarding Children Board (Leicester, Leicestershire and Rutland). Child protection and HIV. Available online only at: protection_hiv.htm Why is this a safeguarding issue? Which law would apply?

59 C O N S E N T A N D M E N T A L C A P A C I T Y 39 Who could have intervened to protect her? What should they have done? Turn to the end of the section for suggested answers. The Safeguarding Vulnerable Groups Act 2006 was passed as a result of the Bichard Inquiry following the Soham murders in 2002, when the schoolgirls Jessica Chapman and Holly Wells were murdered by Ian Huntley. The act is available to download at: The inquiry questioned the way employers recruit people to work with vulnerable groups, and particularly the way background checks are carried out. The inquiry highlighted the need for an agency to vet all individuals who want to work, or volunteer to work, with children or vulnerable adults, in order to bar unsuitable people from doing so. The Independent Safeguarding Authority was set up in 2009 to fulfil this role, but their responsibilities are currently under consultation. Check the up-to-date situation by looking at the Independent Safeguarding Authority website at: Consent to research procedures Nowadays we are familiar with the concept of informed consent, particularly if a procedure or treatment is for research, rather than for the benefit of a patient; but this has not always been the case. In 2009 the Independent Safeguarding Authority was set up to vet all individuals who want to work, or volunteer to work, with children or vulnerable adults, in order to bar unsuitable people from doing so. Before the USA passed the Pure Food and Drug Act in 1906, 33 initiating the start of medicines control, there were no regulations in place regarding the ethical use of human subjects in research. Although the morality of using human subjects in research had been dealt with; for example, in 1865 Claude Bernard wrote: Morals do not forbid making experiments on one s neighbour or one s self... the principle of medical and surgical morality consists in never performing on man an experiment which might be harmful to him to any extent, even though the result might be highly advantageous to science, ie, the health of others. 34

60 40 S E C T I O N 2 Reflective questions Are there any circumstances when you may have prescribed for a patient in a research programme without being aware of it? What could you do to ensure that this does not happen? In 1948, as a result of events that took place in Germany during the Second World War, the Nuremberg Code was established. This was the first international document advocating voluntary participation in medical research and informed consent, containing the requirement the voluntary consent of the human subject is absolutely essential. 35 The Nuremberg Code was formulated during the Nuremberg trials and sets out conditions that must be met to justify research on human beings. It states that consent can only be voluntary if: participants are able to consent they are free from coercion they comprehend the risks and benefits involved. The Nuremberg Code was reflected in the Declaration of Human Rights, and accepted in principle by each of the 51 original signatories to the Charter of the United Nations. 36 In 1964 the World Medical Association produced a broader guidance document for doctors who are involved in research involving human subjects, known as the Declaration of Helsinki, which has since been revised a number of times. The latest version is from 2008 (sixth revision) and forms the basis of most good practice guides used in the medical research industry. 37

61 C O N S E N T A N D M E N T A L C A P A C I T Y Related patient-centred considerations The Dignity in Care campaign aims to end tolerance of indignity in health and social care services through raising awareness and inspiring people to take action. Lack of respect for an individual s dignity in care can take many forms, and can lead to abuse. Practice point Read the Dignity in Care challenge and consider if all ten of these challenges apply to your practice and if you are able to meet them. The information can be found on the Department of Health web page Dignity in care at: index.htm The Human Rights Act gives further legal powers to the European Convention on Human Rights. The act deals with the rights that each individual has in everyday life, and in matters of life and death. Your human rights are: the right to life freedom from torture and degrading treatment freedom from slavery and forced labour the right to liberty the right to a fair trial the right not to be punished for something that was not a crime when you did it the right to respect for private and family life freedom of thought, conscience and religion, and freedom to express your beliefs freedom of expression freedom of assembly and association the right to marry and to start a family

62 42 S E C T I O N 2 the right not to be discriminated against in respect of these rights and freedoms the right to peaceful enjoyment of your property the right to an education the right to participate in free elections the right not to be subjected to the death penalty. Each person is expected to respect other people s rights, and, if any of these rights and freedoms are breached, each person has a right to an effective solution in law, even if the breach is by someone in authority. The Human Rights Act is available at: and further information is available on the Directgov website at: responsibilities/dg_ Exercise 5 Jane Mellis, aged 15, comes to see you. She is pregnant and asks your advice about a termination. Her parents are against it and want the baby to be adopted. Which of the documents listed below cover the rights of Jane or her parents? Law Jane Jane s parents Comment Children Act 1989 Human Rights Act 1998 Criminal law Negligence law Mental Capacity Act 2005 Family Reform Act 1969 Declaration of Helsinki 2008 Deprivation of Liberty Safeguards (DOLS) Independent Mental Capacity Advocates and the Safeguarding Vulnerable Groups Act 2006

63 C O N S E N T A N D M E N T A L C A P A C I T Y 43 Law Jane Jane s parents Comment Mental Health Act 1983 and Amendments 2007 Health and Social Care Act 2008 The Safeguarding Vulnerable Groups Act 2006 Turn to the end of the section for suggested answers. Summary Providing sufficient information to your patients to allow them to make an informed decision about their healthcare is a vital part of your duty of care. You need to be aware of the legislation that sets down the criteria for the different types of consent and how to establish that a patient is able to give consent, ie, their mental capacity. However, all of your patients have rights set down in law and you need to ensure you work to consider and safeguard the rights of any patient who is vulnerable. Intended outcomes By the end of this section you should be able to: Can you? understand the concept of consent and discuss its place in the ethical framework of practice explain the underlying reasons for obtaining consent understand the situations when consent is required demonstrate and apply in practice how to identify when people are not able to give consent, and what to do in those situations.

64 44 S E C T I O N 2 Developing and maintaining your CPD portfolio This section underpins the following National Prescribing Centre competencies: (taken from the NPC competency framework available at: Establishing options Communicating with Prescribing The NHS in context The team and patients professionally individual context Accesses and interprets all Enables patients to make Accepts personal Knows how local health Recognises and deals relevant patient records to informed choices about responsibility for own service and partner with pressures that might ensure knowledge of the their management. prescribing and organisations work and result in inappropriate patient s management. understands the legal interact. prescribing. implications of doing so. Views and assesses the patient s needs holistically (eg, psychosocial, physical). Understands how current legislation affects prescribing practice. Now make entries in your CPD portfolio to denote that you have undertaken CPD related to these competencies. Reflective questions What have you learnt so far? Think about all you have read and made notes about in this section. Write down three things you have learnt about consent and mental capacity that are relevant to your personal practice, or three changes you want to make in your future work

65 C O N S E N T A N D M E N T A L C A P A C I T Y 45 Suggested answers Exercise 4 (see page 27) Summarise the judgment in the Chatterton v Gerson (1981) case, and note down the court s definition of inadequate information. The patient needed to prove that she had not given consent. The outcome of the case was that the patient had been informed of the nature of the treatment and had given her consent. The doctor s duty was to warn of any known risk in the procedure and he carried out his duty by doing this. The numbness in her leg was not a foreseeable risk of the operation, so the doctor was not under a duty to warn the patient of that possibility. The plaintiff s case was not upheld, as the information given was deemed to be adequate. Exercise 5 (see page 42) Which of the documents listed below cover the rights of Jane or her parents? Law Jane Jane s parents Comment Children Act 1989 Yes Yes Jane is protected Human Rights Act 1998 Yes Yes Jane and her parents both have rights Criminal law Yes Abortion Act 1967 Negligence law This law does not cover the rights of Jane or her parents Mental Capacity Act 2005 Yes Jane would be assumed to have capacity Family Reform Act 1969 Declaration of Helsinki 2008 Deprivation of Liberty Safeguards (DOLS) Independent Mental Capacity Advocates and the Safeguarding Vulnerable Groups Act 2006 Mental Health Act 1983 and Amendments 2007 Health and Social Care Act 2008 This law does not cover the rights of Jane or her parents This law does not cover the rights of Jane or her parents No unless Jane was assessed not to have capacity No unless Jane was assessed not to have capacity No unless Jane was assessed to have a mental illness This law does not cover the rights of Jane or her parents The Safeguarding Vulnerable Groups Yes Jane has rights under the law Act 2006

66 46 S E C T I O N 2 In the absence of further information the likely general outcome of this case, would be that Jane would be deemed to have mental capacity and therefore her rights need to supersede those of anyone else. She should therefore be able to decide the outcome for herself and exclude her parents if she chooses to do so. Jane s parents could choose to go to court if they wish, but would be unlikely to succeed in overturning Jane s decision. Case study 1 Betty Hart (see page 35) What do you need to consider about her mental capacity? Staff in the care home are legally required to apply the Mental Capacity Act 2005: Code of Practice when acting in relation to a person who lacks, or who may lack, mental capacity. The MCA code of practice states that you should always start from an assumption of capacity. However, doubts as to a person s capacity to make a particular decision can occur because of the way a person behaves, their circumstances, or concerns raised by someone else. So, capacity must be assessed at every occasion when any kind of intervention takes place, as a person may have capacity on some occasions but not on others. There are two questions to ask if you are assessing a person s capacity: 1. Is there an impairment of, or a disturbance in the functioning of the person s mind or brain? 2. Is the impairment or disturbance sufficient to cause the person to be unable to make that particular decision? This two-stage test must be used, and you must be able to show that it has been used. Most people will be able to make most decisions, even when they have been diagnosed with a condition that may seem to imply that they cannot. This is a general principle that cannot be stressed enough. The assessment process should include family and carers, and needs to be clear and accountable. Where there is no family or carer or other person authorised to make decisions for that person, an independent mental capacity advisor may be assigned if there is an important decision about certain medical treatment to be made, or if a change of accommodation is needed. Any assessment of a person s capacity must consider: whether they are able to understand the information whether they are able to retain the information related to the decision to be made whether they are able to assess that information as part of the decision-making process. So, if a person is deemed to be capable of making a decision that will affect them they need to be able to do all three things understand, retain, and assess the information and they have to be able to communicate that decision. Communication could include sign language, blinking an eye, or squeezing a hand, when verbal communication is not possible.

67 C O N S E N T A N D M E N T A L C A P A C I T Y 47 Any assessment of capacity should also include assessing the person s: general intellectual ability memory attention and concentration reasoning information processing how a person interprets what they are told verbal comprehension and all forms of communication cultural influences social context ability to communicate. For further information see The Mental Capacity Act 2005: Code of Practice, 23 (This is a long document, so you may want to just dip into certain sections of it, as you feel necessary.) The article which can be accessed at the web address shown below explores the subject of mental capacity assessment further (Church M and Watts S. Assessment of mental capacity: a flow chart guide. Psychiatric Bulletin, 2007; 31: ): Case study 2 Sally Darting (see page 38) Why is Sally s case a safeguarding issue? Sally has a long-term condition, but no-one was aware that her parents were both HIV positive. Even though she died of meningitis, by not disclosing that they were HIV positive, the parents were not acting in the best interests of the child, as Sally s safety should override any other considerations. Which law would apply? Children Act Section 1 the welfare of the child is paramount Section 47 the need for child protection enquiry by the relevant authority Children Act Section 11 the duty of a professional to share information to safeguard a child There may also be local safeguarding children procedures regarding blood-bourne viruses, as there were in this case. You can find examples of these in the document produced by the Department of Health and the Department for Education and Skills, Children in need and blood-borne viruses: HIV and hepatitis. Gateway reference: London: DH; 2004, available on the Department of Health website at: or on the Leicester, Leicestershire and Rutland Local Safeguarding Children Board web page on Child protection and HIV at:

68 48 S E C T I O N 2 Who could have intervened to protect her? The HIV team at the acute trust were the only people who held this information, apart from the parents. What should they have done? They should have tried to elicit whether Mr and Mrs Darting had any children, and then they should have been aware of Sally s rights under the Children Act The parents should have been counselled about the legal requirements of testing Sally. Then, if they did not agree to the child being tested, the local authority should have been involved and an application made to the court for a child assessment order so that Sally could be tested and ultimately treated for HIV. This is a real case. Both parents were known to the HIV department in the same trust and were being actively treated for HIV. When diagnosed, they had both been advised to have Sally tested, but they refused. It was also the same trust where Sally was being treated for her long-term condition, but this service was not aware of the parents HIV status. When the parents were diagnosed, they also requested that their GP was not informed. The HIV service was not aware of Sally s rights, so, when the parents did not consent to her being tested for HIV, they did not refer Sally to paediatric services. One of the parents was a healthcare professional.

69 C O N S E N T A N D M E N T A L C A P A C I T Y 49 References 1. World Health Organization. The Nuremberg code turns 60. Geneva: WHO; Available online at: (accessed 9 February 2010). 2. Department of Health. Code of Practice to the Mental Health Act 1983 (revised 1999). London: The Stationery Office; Oxford English dictionary online. Web page for tort. Available online only at: gb (accessed 3 December 2010). 4. Chatterton v Gerson [1981] 1 All ER Kuczewski, MG. Reconceiving the family:the process of consent in medical decision-making. Hastings Centre Report 1996; 26(2): Reprinted as Medical decision-making: A role for the family? The Responsive Community 1998; 8(2): Sidaway v Board of Governors of the Bethlem Royal and the Maudsley Hospital (1985), 1 All ER, Schloendorff v The Society of the NewYork Hospital. (1914). Available online at: (accessed 1 February 2010). 8. Re C [1994] 1 WLR Re T [1992] 4 All ER Department of Health web page. About supplementary prescribing (last modified 9 February 2007). Available online only at: Prescriptions/TheNon-MedicalPrescribingProgramme/Supplementary prescribing/dh_ (accessed 1 February 2010). 11. The Family Law Reform Act Available online at: 46_en_1 (accessed 9 February 2010). 12. British Medical Association. Consent, rights and choices in health care for children and young people. London: BMJ Books; Citizens Advice Bureau web page: NHS patients rights. Available online at: rights.htm#consent (accessed 1 February 2010). 14. Prince v Commonwealth of Massachusetts. No 98. [1944]. Available online at: invol=158 (accessed 1 February 2010). 15. Gillick v West Norfolk and Wisbech Area Health Authority and another [1986] Available online at: (accessed 1 February 2010).

70 50 S E C T I O N Access to Health Records Act Royal College of Nursing. The role of school nurses in providing emergency contraception services in educational settings. London: RCN; Available online at: data/assets/pdf_file/0005/78665/ pdf (accessed 1 February 2010). 18. Children Act Available online at: (accessed 1 February 2010). 19. Re R (A Child) [2006] EWCA Civ Available online at: (accessed 1 February 2010). 20. Re W (A Child) [2005] EWCA Civ Available online at: (accessed 1 February 2010). 21. BBC News web page. Siamese twins, the judgement. 22 September Available online only at: (accessed 1 February 2010). 22. Mental Capacity Act (accessed 1 February 2010). 23. Department for Constitutional Affairs. Mental Capacity Act 2005: Code of practice. London: The Stationery Office, Available online at: (accessed 1 February 2010). 24. Mental Health Act Available online at: (accessed 1 February 2010). 25. Department of Health. Code of Practice: Mental Health Act 1983 revised May London: The Stationery Office; British Psychological Society. Best interests. Guidance on determining the best interests of adults who lack the capacity to make a decision (or decisions) for themselves. Leicester: BPS; Available online at: DFD0-7E4B-5FA0B872E9C1&ext=pdf (accessed 1 February 2010). 27. Department of Health web page. The Mental Capacity Act Deprivation of Liberty Safeguards (MCA DOL safeguards). Available online at: Capacity/MentalCapacityActDeprivationofLibertySafeguards/index.htm (accessed 1 February 2010). 28. The Safeguarding Vulnerable Groups Act Available online at: (accessed 1 February 2010).

71 C O N S E N T A N D M E N T A L C A P A C I T Y House of Commons Health Committee. TheVictoria Climbié Inquiry Report. London: HMSO; Available online at: cmselect/cmhealth/570/570.pdf (accessed 1 February 2010). 30. Department for Education and Skills. Working together to safeguard children A guide to interagency working to safeguard and promote the welfare of children. London: The Stationery Office; Available online at: IG00060/ (accessed 1 February 2010). 31. Children Act Available online at: (accessed 1 February 2010). 32. Police Act Available online at: (accessed 1 February 2010). 33. Federal Food and Drugs Act of United States of America. 34. Claude Bernard quotation online information. Available online only at: (accessed 1 February 2010). 35. Augsburg College (US) web page. The Nuremberg Code. Available online only at: (accessed 1 February 2010). 36. United Nations. Department of Public Information web page. Charter of the United Nations Available online only at: (accessed 1 February 2010). 37. World Medical Association web page. Declaration of Helsinki Available online only at: (accessed 1 February 2010). 38. Human Rights Act Available online at: (accessed 14 December 2010).

72 52 Section 3 Ethics and codes of practice Objectives On completion of this section you should be able to: describe the four basic ethical principles, as established by Beauchamp and Childress use the code of ethics of your own profession for guidance about non-medical prescribing apply a specific code of ethics to decision-making in your prescribing practice give examples of people for whom, from an ethical point of view, you should not prescribe reflect upon the consequences of not prescribing to certain groups of people from an ethical perspective. A competent prescriber is able to consciously recognise all the influences on them and apply them during their consultations and decision-making. Ethics, or moral philosophy, explores the concept of good and bad, right and wrong. The application of ethics involves deciding how moral outcomes can be achieved in specific situations. So, ethics form the basis for critical thinking. A competent prescriber is able to consciously recognise all the influences on them and apply them during their consultations and decision-making. However, to do this requires skill and is something that needs to be developed over a period of time; you need to be committed and determined to work at it. You will be aware of ethical discussions that appear almost on a daily basis in the news media, as well as examples of situations where ethical principles have been misapplied. Thinking through these as they arise is a good way of reflecting on and developing your own ethical principles. In this section we will look at four ethical principles and encourage you to consider your personal ethical framework by working through some case studies and reflective questions. Reflective questions Make a list of the ethical issues you have faced in the last month and reflect on how you dealt with them.

73 E T H I C S A N D C O D E S O F P R A C T I C E 53 What discussions have you had with colleagues about ethical dilemmas related to prescribing? 3.1 Ethical principles In your role as a non-medical prescriber you will need to make decisions, many of which are not straightforward. Your approach to the decision-making process will depend on your ethical standpoint, and will develop and change in the light of your experience. However, in your professional role you need to apply certain standards and protocols in your dealings with patients; so it is important that you use a common ethical framework. The four principles that should inform your decisions, according to Beauchamp and Childress 1 are: respect for autonomy beneficence non-maleficence justice In your professional role you need to apply certain standards and protocols in your dealings with patients; so it is important that you use a common ethical framework. Principle 1: Respect for autonomy This is the principle of self-determination and applies both to patients and to your personal practice. As individuals we all have the capacity to think, decide and take action and make reasonable, informed choices. Each individual has their own beliefs and rights, which must be respected. As a healthcare professional you need to understand the law that relates to autonomy, in order to apply it correctly. From a patient s perspective, a lack of mental capacity means no autonomy. Reflective questions How does the law on mental capacity influence your day-to-day practice?

74 54 S E C T I O N 3 Do you need to do anything differently in your practice in the light of the laws on mental capacity? Read the documents below and try to find out how your employer (if applicable) carries out their responsibilities under these acts. Links to these documents can be found at the end of this section. Mental Capacity Act Department of Health Mental Capacity Act 2005 online information page 3 Code of Practice for the Mental Capacity Act Mental Capacity Act: Deprivation of liberty safeguards 5 Principle 2: Beneficence Beneficence is our ethical obligation to act in a way that benefits the patient. It has been argued that healing should be the sole purpose of healthcare. However, healthcare brings a wide range of benefits, some of which are not aimed at healing, for example, palliative care. We must also be able to balance the benefits of treatment against the risks and costs of that treatment. Principle 3: Non-maleficence This principle means that we will avoid harming the patient. In practice, all treatments carry risks, even if these are small, but the risks should not be out of proportion to the benefits of the treatment. The assessment and communication of risk become crucial factors in non-maleficence. The patient must be your only concern. We must not presume to know what is best for the patient and, in some cases, not taking account of their views may be considered harmful. Principle 4: Justice Justice means that patients have a right to be treated fairly and proportionately; patients in similar situations should be treated in a similar manner. Healthcare resources, including benefits, risks and costs, should be allocated in a fair way. Justice is also dependent on the first three principles. Any major inequity in the way healthcare is delivered is contrary to the ethics of justice in healthcare.

75 E T H I C S A N D C O D E S O F P R A C T I C E 55 Exercise 6 It has been suggested that three more principles should be added to the four above: truth-telling confidentiality preservation of life. Do you consider these are new principles, or do you think they are implied in the four principles above? Please give a rationale for your choice. Turn to the end of the section for suggested answers. Duty of care A legal duty of care is an obligation to work to a reasonable standard of care while not doing anything that could forseeably harm others. 6 You also carry a moral duty of care to act in the best interests of the patient and not doing so can, in some cases, be considered negligent. You need to report any incidents of negligence that you encounter in your day-to-day practice to your employer. (We look at clinical negligence in more detail in Section 4.)

76 56 S E C T I O N 3 Case study 3 Sarah Price Sarah Price is 83 years old and has mild dementia. She needs to go into hospital for a vital operation. If she does not have the operation done, there is an 80 percent chance that she will die. The operation has a 95 percent success rate. Some of the time Mrs Price has a good quality of life, as it is mainly her memory that is poor. She has stated clearly that she does not want to have this operation because she is afraid of hospitals. She currently lives at home with her sister, who is trying to convince her to go into hospital for the operation and asks if it can be done without her agreement. Consider all the arguments in this case, using the four ethical principles, to identify both Sarah Price s needs and your own possible approaches to this situation. Autonomy Beneficence Non-maleficence Justice Turn to the end of the section for suggested answers.

77 E T H I C S A N D C O D E S O F P R A C T I C E Ethical frameworks As a professional with some years of experience, you will be aware of the right thing to do. Your knowledge and awareness will have developed based on a number of factors. The first influence on you is your vocational calling and the second is your ethical principles of autonomy, beneficence, non-maleficence and justice. These principles affect all your professional activities and guide you to work for your patients best interests, putting their interests before your own. Also, if we focus on non-medical prescribing, there is a responsibility, accountability and ethical imperative to maintain competence in your chosen area of expertise for prescribing. You need topic-specific knowledge to ensure safety, and an acceptable level of competence. Finally, your knowledge and how you deal with that knowledge is shaped by your personal and professional experience. All these things make up the person you are and have an impact on the actions you take. Your patients will also have an ethical framework that affects their decisions and actions. The skill lies in understanding your own framework and that of your patient and making them work together. The skill lies in understanding your own ethical framework and that of your patient and making them work together. FIGURE 1 Non-medical prescribing ethical framework Source: Adapted from Griepp s model of ethical decision making. Griepp, ME;

78 58 S E C T I O N 3 Reflective questions Look at the non-medical prescribing ethical framework in Figure 1 and think about whether you were aware that these are the main factors that influence you. Can you think of anything else that influences your ethical practice? The next case study encourages you to consider all the possible ethical options you face as a non-medical prescriber, using the framework described in Figure 1. Case study 4 Dennis Howard You are a non-medical prescriber working in a clinic for patients with type 2 diabetes. Dennis comes in and asks to see you. He explains that he feels the metformin he has recently been prescribed as first-line treatment is not working. You determine that this is due to his reaction to a metallic taste in his mouth. You also feel that he believes that the medicine has been prescribed to increase the iron in his blood. You know that metformin has a unique mechanism of action and that it is the current drug of choice for uncomplicated, overweight patients with type 2 diabetes. The implication of this side-effect on his medicines adherence prompts an ethical dilemma. a. Look at each of the areas of the non-medical prescribing ethical framework (Figure 1) to develop a rationale for how you might proceed. We have provided a suggested answer for Area 1 below as an example to give you an idea of how to proceed. Area 1: Professional vocational view I am a professional with a vocation and have a calling to use my knowledge to the benefit of patients. If it all goes wrong I will be judged by my peers according to the actions of the average practitioner. Ethically I may decide that the issues of adherence are so great that a change of medicine (to a sulphonylurea) may be warranted. If it goes wrong, I will have gone against national and local guidance and my actions may be viewed unfavourably by the profession and my colleagues.

79 E T H I C S A N D C O D E S O F P R A C T I C E 59 Area 2: Non-maleficence and justice view Area 3: Responsibility and accountability Area 4: Knowledge of the specific area of prescribing Area 5: Professional and personal experience Area 6: You

80 60 S E C T I O N 3 b. Now consider this scenario from Dennis s perspective, as the patient, using the patient s ethical framework (Figure 1). Area 1: Health expectations Area 2: Learned roles Area 3: Personal experience Area 4: The whole person (holistic view) Turn to the end of the section for suggested answers. Having worked through the case study you need to think about the way that these ethical options relate to your day-to-day practice. To practise ethically, you must give priority to a patient s views over your own. So, the success of your consultations depends on your awareness of the influences on your patient.

81 E T H I C S A N D C O D E S O F P R A C T I C E Regulation of non-medical prescribers As a result of the enquiries following the Bristol Royal Infirmary case, Beverley Allitt, Harold Shipman and others, the regulatory framework for all healthcare professions has been modernised to ensure and safeguard patient safety. The days when healthcare professionals were trusted to work to the highest standards without supervision have gone. There needs to be open accountability and public confidence in healthcare professionals, which the government believes can only be delivered with regulation. This means that an appropriate balance needs to be struck between measurable standards of ethics and care, and fitness to practise and inspection. 8 There needs to be open accountability and public confidence in healthcare professionals, which the government believes can only be delivered with regulation. Reflective questions While you will be familiar with your own professional regulator, it is worth spending some time thinking about how other healthcare professionals are regulated. Nursing and Midwifery Council The Nursing and Midwifery Council (NMC) exists to safeguard the health and well-being of the public, whose remit is set out in The Nursing and Midwifery Order The NMC is the regulator for all nurses, including those who are non-medical prescribers. It registers all nurses and midwives and ensures that they are properly qualified and competent to work in the UK. It sets the standards of education, training and conduct that are needed to deliver consistent high quality healthcare. The NMC is also responsible for ensuring that nurses and midwives keep their skills and knowledge up to date and uphold the standards of their professional code, by setting rules for their practice and supervision. General Pharmaceutical Council The publication in 2007 of the White Paper: Trust, assurance and safety the regulation of health professionals in the 21st century, 10 meant that the separation of the regulatory and professional bodies for pharmacy was necessary. So, in 2010 a new professional body for pharmacy was established the General Pharmaceutical

82 62 S E C T I O N 3 Council (GPhC). The GPhC is now the regulatory body for pharmacists and pharmacy technicians in England, Scotland and Wales. Its primary role is the protection of the public and the regulation of professional standards for pharmacists and pharmacy technicians. Health Professions Council The Health Professions Council (HPC) is the regulator for most other nonmedical prescribers, except optometrists. It was set up to protect the public and keeps a register of healthcare professionals who meet the HPC standards for training, professional skills, behaviour and their own health, so that none of these impair a professional s fitness to practise. They currently regulate 14 allied health professions: arts therapists, biomedical scientists, chiropodists/podiatrists, clinical scientists, dietitians, occupational therapists, operating department practitioners, orthoptists, paramedics, physiotherapists, practitioner psychologists, prosthetists/orthotists, radiographers and speech and language therapists. General Optical Council The General Optical Council (GOC) regulates dispensing opticians and optometrists. The GOC s main aims are to protect the public and promote high standards of professional conduct and education among opticians. All of the professions mentioned above have professional titles that are protected by law. This means, for example, that anyone using the titles physiotherapist or nurse or any of the other protected professions must be registered with their respective regulatory body. Healthcare professionals must abide by their own regulatory practice standards and guidance, specific to non-medical prescribing. 3.4 Professional codes of ethics and standards Healthcare professionals must also abide by their own regulatory practice standards and guidance, specific to non-medical prescribing. These vary slightly between the different professions. Those for nurses and pharmacists are summarised below. Nurses The mandatory professional standards and good practice guidance for nurse or midwife non-medical prescribers have been laid out under The Code: Standards of conduct, performance and ethics for nurses and midwives. 11 The people in your care must be able to trust you with their health and wellbeing. To justify that trust, you must: make the care of people your first concern, treating them as individuals and respecting their dignity work with others to protect and promote the health and wellbeing of those in your care, their families and carers, and the wider community provide a high standard of practice and care at all times be open and honest, act with integrity and uphold the reputation of your profession. Each of these criteria is then underpinned by more detail and standards.

83 E T H I C S A N D C O D E S O F P R A C T I C E 63 Pharmacists The mandatory professional standards and good practice guidance for pharmacists are set out below. As a pharmacy professional, you must: 1. Make patients your first concern 2. Use your professional judgement in the interests of patients and the public 3. Show respect for others 4. Encourage patients and the public to participate in decisions about their care 5. Develop your professional knowledge and competence 6. Be honest and trustworthy 7. Take responsibility for your working practices. 12 The codes of ethics and standards for allied healthcare professions 13 and optometrists 14 are very similar. Nolan principles In 1995 the Nolan Committee carried out an inquiry into standards in British public life. The seven principles they developed have been accepted by the NHS and as such also apply to prescribers. 15 The seven principles are: 1. Selflessness 2. Integrity 3. Objectivity 4. Accountability 5. Openness 6. Honesty 7. Leadership. As you work through the activities presented in the rest of this section think about the best way to embed ethical principles into your personal ethical framework.

84 64 S E C T I O N 3 Reflective questions Look through the code of ethics for your own profession, the Nolan Principles and the code of ethics for one other profession, and compare and contrast them. Are there any additional principles that you feel you should adopt? Are there any other areas of guidance given in the code of ethics for your profession that you feel specifically relate to your practice as a nonmedical prescriber?

85 E T H I C S A N D C O D E S O F P R A C T I C E 65 Exercise 7 Look through your code of ethics or conduct for your profession and identify any requirements particularly relating to: continuing professional development provision of advice accountability reporting of adverse drug reactions confidentiality and consent clinical governance risk management Turn to the end of the section for suggested answers.

86 66 S E C T I O N 3 Exercise 8 Listed below are some ethical issues that will affect you as a non-medical prescriber. You may already have encountered some of them. If not, how will you react to these situations? Is it legal to prescribe for myself? Is it legal to prescribe for family and friends? Can I prescribe repeat medicines for a patient that I have never prescribed for before, if he/she has run out? Can I prescribe a few more days of an antibiotic if a patient tells me they are still not quite right yet, despite finishing a course of medicines from another prescriber? Should I change the medicine to a different brand rather than the patient s regular medicine if it is more cost-effective?

87 E T H I C S A N D C O D E S O F P R A C T I C E 67 If I am an independent prescriber, does that mean I no longer need to use a clinical management plan? How responsible am I if I do not write the prescription, but I change a repeat medicine on the patient record? Can I prescribe and dispense in full for the same patient? Should I discuss the porcine origin of a medicine in case the patient is of the Muslim or Jewish faith? Does my ethical framework conflict with the prescribing of emergency hormonal contraception? Turn to the end of the section for suggested answers.

88 68 S E C T I O N 3 Reflective questions Thinking about everything you have read about so far in this section, are there any areas of practice that you need to strengthen in relation to ethical working? How will you go about this and who will you involve? Would your clinical records provide information about the ethical principles you have applied for every patient you see? If not, write a plan to help you achieve this. 3.5 Professional discipline It is crucial for all non-medical prescribers to be aware of their codes of practice and other standards or guidance, but equally it is important to be aware of current practice issues. Negligence is a serious offence and is dealt with by the courts. (We look at clinical negligence in more detail in Section 4.) However, poor practice which does not constitute negligence is dealt with by the regulatory bodies. If a healthcare professional is found guilty of misconduct they can, as an ultimate sanction, be removed from the register. Appropriate conduct is judged by referring to the healthcare professional s code of ethics, as discussed in the previous section. However, some sections of the codes can be very broad in nature and may provide a basis for an allegation. So, when considering the detail, the regulatory body will reflect on what is accepted proper practice. It is crucial for all non-medical prescribers to be aware of their codes of practice and other standards or guidance, but equally it is important to be aware of current practice issues. Practice changes over time, and what was once common is often no longer considered good practice. For example, current guidance now requires patient data to be password-protected, but this was not common practice a few years ago.

89 E T H I C S A N D C O D E S O F P R A C T I C E 69 The National Clinical Assessment Service helps healthcare managers to understand, manage and prevent performance concerns (for more information, visit their website at: ). Their aim is to get involved early and to restore safe and valued practice where possible, offering: advice from experts with backgrounds in clinical practice, healthcare and human resources management specialist interventions, including facilitation, mediation, performance assessment, action planning and back-to-work support shared learning from case experience, evaluation and research. Additionally, professional bodies usually provide services to support healthcare professionals who may be under scrutiny or suspension from their employer, or have had a complaint made against them. Support is also provided for people whose personal problems are affecting their work. Reflective questions Look at the fitness to practise information provided by your regulatory body and find any information that helps you to distinguish between misconduct and negligence. General Pharmaceutical Council Nursing and Midwifery Council Health Professions Council General Optical Council to_make_a_complaint/the_investigation_process.cfm You can also read about fitness to practise hearings and documents relating to individual cases (which make very sober reading) by visiting the following web pages: Nursing and Midwifery Council Hearings General Optical Council Past hearings Health Professions Council Hearings

90 70 S E C T I O N 3 Summary This section considers the basic ethical principles and reflects on the way that these affect non-medical prescribing. While there are generic principles that apply to all healthcare professionals, each profession also has its own code of ethics. Also, we need to be aware of our own ethical principles and ensure we consider those of our patients. All of these will influence our decision-making as a non-medical prescriber. Intended outcomes By the end of this section you should be able to: Can you? describe the four basic ethical principles, as established by Beauchamp and Childress use the code of ethics of your own profession for guidance about non-medical prescribing apply a specific code of ethics to decision-making in your prescribing practice give examples of people for whom from an ethical point of view, you should not prescribe reflect upon the consequences of not prescribing to certain groups of people from an ethical perspective.

91 E T H I C S A N D C O D E S O F P R A C T I C E 71 Developing and maintaining your CPD portfolio This section underpins the following National Prescribing Centre competencies: (taken from the NPC competency framework available at: Communicating with patients Prescribing professionally The team and individual context Listens to and understands patients beliefs, Makes prescribing decisions, based on the Recognises and deals with pressures that ideas, concerns and expectations. needs of patients and not the personal might result in inappropriate prescribing. considerations of the prescriber. Understands the cultural and religious implications of the diagnosis/prescribing. Undertakes the consultation in an appropriate setting and adapts to meet the needs of different patients (eg, language, level of understanding, physical impairments). Deals sensitively with patients emotions and concerns. Now make entries in your CPD portfolio to denote that you have undertaken CPD related to these competencies. Reflective questions What have you learnt so far? Think about all you have read and made notes about in this section. Write down three things you have learnt about ethics and your professional code of practice that are relevant to your personal practice, or three changes you want to make in your future work

92 72 S E C T I O N 3 Suggested answers Exercise 6 (see page 55) Do you consider these are new principles, or do you think they are implied in the four principles above? Please give a rationale for your choice. Truth telling We offend against the principle of autonomy if we do not tell the truth. A patient has a right to the correct information on which to base decisions; the patient s perspective has to be taken seriously. Truth telling is implicit in the first principle. 16 Confidentiality If we share confidential information then we destroy trust, but the exception would be when keeping certain information confidential could jeopardise someone, for example, in the case of possible child abuse. Maintaining confidentiality means acting in a beneficent and also non-maleficent way for the benefit of the patient in a way that will not lead to harm. The risk of the harm that may be caused by disclosure needs to be balanced against the likely benefit. Preservation of life, eg, euthanasia This is a complex area of ethics in today s society; however, preservation of life is implicit in all four principles. Exercise 7 (see page 65) There are no right or wrong answers here. The codes of ethics are all very different, although as we might expect there is a great deal of common ground. Continuing professional development Healthcare professionals must ensure that their knowledge, skills and performance are up-to-date, evidence-based and relevant to their field of practice. They must ensure that they undertake CPD relevant to their professional duties and submit documents to their regulatory body on request for review. Any CPD recorded should pertain to their role as a prescriber. Provision of advice Healthcare professionals must be ready and able to provide information and advice about any medicine supplied by them or under their authority. If they give advice to other prescribers, patients or anyone else, they must be able to demonstrate competence and knowledge of medicines within the relevant therapeutic class. They must keep appropriate written records, review prescribing regularly, explain to patients why they have selected a particular course of action, and record this.

93 E T H I C S A N D C O D E S O F P R A C T I C E 73 Accountability Healthcare professionals must ensure that all the activities they undertake are covered by professional indemnity insurance. They are accountable for all their prescribing and should prescribe only where they have the knowledge of the patient s medical history and medicines they are prescribing. They should only prescribe where there is a genuine need for treatment. Reporting of adverse drug reactions (ADRs) Healthcare professionals must be alert to potential adverse drug reactions and drug interactions and respond accordingly. They must ensure that they report any suspected adverse drug reactions to the relevant authorities, using the yellow card system. Confidentiality and consent Healthcare professionals must ensure that the confidentiality of information acquired in the course of their professional activities is respected and protected, and is disclosed only with the consent of the individual, other than in defined circumstances. Healthcare professionals must ensure that the requirements of data protection legislation for data collection and use are complied with. They must obtain consent for everything that they do, in either verbal or written form. They can only breach confidentiality when there is real danger of harm or they are legally obliged to do so (eg, a court order). Clinical governance and risk management Healthcare professionals must continually review the skills and knowledge required for their field of practice, identifying those skills or knowledge most in need of development or improvement, and audit their performance as part of that review. They must use adequate equipment and facilities, have up-to-date knowledge, give clear instructions, undertake audit and keep an audit trail, using evidence-based practice. Healthcare professionals must implement procedures to minimise risk, incorporating checks to reduce special risks associated with treatment or management. Exercise 8 (see page 66) Listed below are some ethical issues that will affect a non-medical prescriber. You may already have encountered some of them. If not, how will you react to these situations? Is it legal to prescribe for myself? Although there is nothing in law to prevent this, you should not prescribe for yourself. It may be difficult to remain objective about treatment and there would be no second check in case of an error in prescribing, or if the medicine prescribed was not the best treatment. Also, should you come under scrutiny for your prescribing decisions (especially, for example, where controlled drugs are involved), you would have no third party as defence. The General Medical Council (GMC) directs doctors that they are illadvised in prescribing for themselves and their families. Non-medical prescribers should also follow this advice.

94 74 S E C T I O N 3 Is it legal to prescribe for family and friends? It is strongly recommended that you do not prescribe for close friends or family members. Objective assessment, clinical examination, or clinical judgment may be difficult in such situations and while you would not be breaking any laws, you would be not be acting in an ethical way. Can I prescribe repeat medicines for a patient that I have never prescribed for before, if he/she has run out? This would depend on your level of competence. If you are a supplementary prescriber and you can agree a clinical management plan for the patient, or if you are an independent prescriber and the medicine is one for which you are competent to prescribe, then it would be a reasonable thing to do. Can I prescribe a few more days of an antibiotic if a patient tells me they are still not quite right yet, despite finishing a course of medicines from another prescriber? This is the same as above, although it would be less likely to be a safe approach, due to the manner in which infections resolve and the mode of action of antibiotics. Should I change the medicine to a different brand rather than the patient s regular medicine if it is more cost-effective? If there is a valid reason to change the medicine, then, provided the patient is able to give informed consent based on the information you have given, it would be a reasonable approach to take. If I am an independent prescriber, does that mean I no longer need to use a clinical management plan? If you only prescribe medicines within your independent prescribing formulary, then you would not need to use a clinical management plan. However, if you wish to prescribe other medicines for which you have a lower level of competence, you still need to use a clinical management plan. This rule also currently applies to controlled drugs for pharmacist independent prescribers and some controlled drugs for nurse independent prescribers too. The legislation relating to the prescribing of controlled drugs is expected to change in the near future. How responsible am I if I do not write the prescription, but I change a repeat medicine on the patient record? The legal responsibility is with the prescriber who signs the repeat prescription. However, you are still fully responsible for your actions and should consider how you record the decision you have made. If a patient died and it was found to be as a result of your change, blame would be apportioned in court. The Horton v Evans and Lloyds Pharmacy case, mentioned in Section 4, provides an example of this situation (see page 97 for more information). Can I prescribe and dispense in full for the same patient? Separating dispensing from prescribing is intended to minimise risk. You may consider that non-medical prescribing by pharmacists contradicts this ideal, especially where community pharmacist non-medical prescribers are concerned. However, where feasible, it is still recommended to keep the role of prescribing and dispensing separate. Dispensing doctors have worked in this way for many years.

95 E T H I C S A N D C O D E S O F P R A C T I C E 75 However, with supplementary prescribing, where the prescribing healthcare professional is working to clearly defined protocols within a clinical management plan, then it is not as critical to keep the prescribing and dispensing separate. In this situation though it is even more important that there is an objective check by another individual, for example, another healthcare professional or trained pharmacy technician working to a standard operating procedure (SOP). In other words, clear accountability arrangements must be in place to ensure patient safety and probity. Should I discuss the porcine origin of a medicine in case the patient is of the Muslim or Jewish faith? Yes, you should always take cultural needs into consideration. Does my ethical framework conflict with the prescribing of emergency hormonal contraception? Your opinion about whether to prescribe emergency hormonal contraception and similar issues will be influenced by your own ethical framework. You can choose not to prescribe, but you would have an ethical duty to signpost the patient to another prescriber to access the prescribed medicine. Healthcare professionals can refuse to supply or treat patients on moral or religious grounds, for example, emergency hormonal contraception or contraception, but only if they can refer the patient to another healthcare provider within an appropriate time frame; this presents an ethical/moral dilemma and there is guidance from the GPhC advising employers and employees how to handle the situation. 17 Case study 3 Sarah Price (see page 56) Consider all the arguments in this case, using the four ethical principles, to identify both Sarah Price s needs and your own possible approaches to this situation. Autonomy Autonomy is not an all or nothing concept. Sarah may or may not be legally competent to refuse treatment, but either way her views should be considered and respected, as far as possible. She has expressed her wishes clearly. Provided she has been given sufficient information she will be able to make an informed autonomous decision, but this may not be the correct objective decision from everyone s point of view. However, in this situation Sarah may not have been given sufficient information and it may not have been presented in a way that she could understand. If this is the case then further attempts should be made to discuss all the relevant factors with Sarah; she only has mild dementia, which may mean that on occasion she is quite lucid. Beneficence In this circumstance the principle of beneficence clashes with the principle of respect for autonomy, as Sarah has made a decision that is not in her own best interests. The healthcare professionals involved in her care need to consider both the long-term and short-term effects of overriding Sarah s views. In the short-term Sarah is frightened of being in hospital. This may lead her to be frightened of other healthcare professionals in the future. In the long term the benefit of overriding Sarah s decision is that without treatment she is likely to die.

96 76 S E C T I O N 3 It is worth noting that the wishes of a competent patient would never be overridden in their best interests. Non-maleficence This ethical principle guides healthcare professionals to do no harm to the patient. Sarah may be harmed by forcing her into hospital and her dementia may worsen. On the other hand if she is not treated now she may soon die. Which course of action would result in the greatest harm? Any decision would need to rely on assumptions, for example, how successful is the operation likely to be, how likely is it that her dementia will worsen, how long would she live without the operation? Justice Sarah must be treated fairly, by considering the cost-effectiveness of the treatment options for her. The impact of her decision may lead to her needing to go into a care home, which may also affect her life expectancy. Case study 4 Dennis Howard (see page 58) Do bear in mind that these are just suggested answers and yours may be different. Area 1: Professional vocational view A suggested answer has already been provided for this section. Area 2: Non-maleficence and justice view Dennis thinks the metformin is harming him (because of the metallic taste). You need to be honest about the side-effects of metformin and explain the risks of not receiving treatment for diabetes. He has a right to be treated, so you also need to consider other options with him, eg, diet, sulphonylureas. You are directed by the ethical principle of autonomy to respect the patient s desire for a change in his treatment. You would not want to intentionally maintain him on a drug that is causing distress (ie, non-maleficence). However, you need to balance this with your need to do the right thing for the patient. In this situation, pharmacologically, the best choice is to continue with the drug as it is the drug of choice and in a short time Dennis will develop tolerance to the metallic taste. You need to explain all the options to the patient so that he understands the implications. Area 3: Responsibility and accountability You will be responsible and accountable for your understanding of the situation, as it will be recorded in the patient s notes and may be scrutinised at a later date. You should know that the metallic taste is not harmful and will disappear with time, so that you can reassure the patient and give him the right choices. Area 4: Knowledge of the specific area of prescribing Metformin is recommended first-line treatment for diabetes and is supported by national guidelines from NICE. Metformin needs to be started at a low dose and gradually increased to minimise any side-effects and this should have been explained to Dennis when it was first prescribed. Metformin MR may have a better side-effect profile and may be a preferred option before sulphonylureas.

97 E T H I C S A N D C O D E S O F P R A C T I C E 77 One way of reassuring the patient is to use your clinical experience; having dealt successfully with a number of side-effect related difficulties. Perhaps you have had an interest in the area of diabetes for several years and have followed the NICE guidelines successfully in the past, supporting patients to achieve good control as indicated by HbA1c improvements. Area 5: Professional and personal experience Metformin is widely prescribed and is a very safe drug. Dose titration and clear explanations will really help Dennis to feel differently about taking the medicine. Diarrhoea can be much more of a problem. You may find that you can empathise with the patient, for example, you may have had a course of metronidazole and forgotten to put the tablets at the back of your throat which would meant the taste in your mouth may have affected your enjoyment of food, and made you feel very uncomfortable. Area 6: You You may decide to ask him to persevere for a few more days, and offer him a regular follow up. If you bring all your knowledge, thoughts and experiences to the discussion with the patient then you should be able to develop your negotiation skills, and use this opportunity to educate the patient and hopefully reach an agreement for action. Case study 4 Dennis Howard continued (see page 60) Now consider this scenario from Dennis s perspective, as the patient, using the patient s ethical framework (Figure 1). Some assumptions have been made for the purposes of illustrating the case, and we have made the notes as if Dennis had written them. Area 1: Health expectations I have been diagnosed with type 2 diabetes. I want it to be cured, but I m not even sure they ve got it right, as I don t seem to have any symptoms. I expect a health service to be staffed by people who know their business and I expect them to use their skills to fix me up to the best of their abilities. I want to know as much as possible and to be able to make up my own mind. I want to know that my wishes are taken account of and that I am seen as an individual, not just another patient. I want an expert a consultant to deal with me, at the very least a doctor, and I do not know what any other healthcare professional has to do with my treatment. Area 2: Learned roles I m pretty sure that the medicine they have given me is to increase the amount of iron in my blood and that because I can taste it, it must mean that there is now enough in there and it is starting to poison me. I know that to receive a treatment I have to follow the system and be good, and not make too much fuss, but the metallic taste can t be right. They must have given me the wrong medication and won t own up to it. I m in their hands now, but I m not feeling well and want someone to acknowledge my difficulty in coming to grips with my situation. I want a different medicine. I m not sure about seeing a nurse or a pharmacist they are not as well trained; my doctor knows me best.

98 78 S E C T I O N 3 Area 3: Personal experience My experience with the medical profession has not been great. Several members of my close family have died in hospital and I suspect some would have lived longer if they had avoided the place. I have asked other diabetics about this drug metformin; nobody else seems to have suffered as I have. I don t really believe I need the drug in the first place as I was quite well before the blood test. I think I have been harmed by this medicine. I don t like people nagging me, especially as I don t feel well. Area 4: The whole person (holistic view) I m very reluctant to speak to another healthcare professional, but it seems as if this might be my only route for resolving my problem. I m really hoping he will refer me to the consultant. I don t think I have a problem with diabetes it s only a mild form my problem is with the crowbar in my mouth!

99 E T H I C S A N D C O D E S O F P R A C T I C E 79 References 1. Beauchamp TL, Childress JF. Principles of biomedical ethics. 5th edition. Oxford: OUP; Mental Capacity Act Available online at: (accessed 1 February 2010). 3. Department of Health information web page. The Mental Capacity Act Available only online at: Capacity/MentalCapacityAct2005/index.htm (accessed 1 February 2010). 4. Department for Constitutional Affairs. Mental Capacity Act 2005: Code of Practice. London: The Stationery Office; Available online at: (accessed 10 February 2010). 5. Mental Capacity Act Deprivation of Liberty Safeguards. Capacity/MentalCapacityActDeprivationofLibertySafeguards/index.htm (accessed 18 March 2010). 6. UNISON. The duty of care. London: UNISON; Available online at: (accessed 1 February 2010). 7. Griepp, ME. Griepp s model of ethical decision making. Journal of Advance Nursing 1992; 17: Department of Health web page. Professional regulation (last modified 20 November 2007). Available online only at: bills/healthandsocialcarebill/dh_ (accessed 10 February 2010). 9. The Nursing and Midwifery Order Statutory Instrument 2002 No Internet version available online only at: (accessed 10 February 2010). 10. Department of Health. Trust, assurance and safety: the regulation of health professionals in the 21st century. London: The Stationery Office; Available online at: (accessed 18 March 2010). 11. Nursing and Midwifery Council web page. The Code. Available online only at: (accessed 6 December 2010). 12. General Pharmaceutical Council. Standards of conduct, ethics and performance. London: GPhC; (Available online at: quality/conductethicsandperformance/index.aspx

100 80 S E C T I O N Health Professions Council. Standards of conduct, performance and ethics. London: HPC; Available online at: performanceandethics/ (accessed 1 February 2010). 14. General Optical Council. Code of conduct for members, advisers and visitors. July 2006 (amended 2009). Available online only at: code_of_conduct_for_members_advisers_visitors_april_ pdf (accessed 1 February 2010). 15. HM Government. Summary of the Nolan Committee s first report on standards in public life. London: HMSO; Available online only at: nolan.htm (accessed 1 February 2010). 16. BBC web page. Ethics guide: lying and medical ethics. Available online only at: (accessed 1 February 2010). 17. General Pharmaceutical Council. Guidance on the provision of pharmacy services affected by religious and moral beliefs. London:GPhC; Available online at: guidancev13.pdf (accessed 14 December 2010).

101 Section 4 Clinical negligence 81 Objectives On completion of this section you should be able to: understand what constitutes clinical negligence be aware of the Clinical Negligence Scheme for Trusts (CNST) and how risk management standards apply to your practice understand the legal implications of specific case law in non-medical prescribing practice apply key principles of case law to your prescribing practice, especially with regard to the cases of Bolam and Bolitho understand why record-keeping, the evidence base and risk assessment reduce your risk of being found clinically negligent. You may assume that you are already working within the law, but are you absolutely certain that you are? You should know which laws apply to your practice and be able to think through the complexities, in order to demonstrate to your organisation and your professional body that you practise within the law. This will be difficult and demanding and is not helped by the legislation itself, which often seems contradictory. The extension of your rights as a non-medical prescriber offers you new challenges, and yet may raise concerns about how you apply the law in practice, how you use your own professional judgment and about liability and indemnity should something untoward happen. As a healthcare professional and not a lawyer, you will rarely read the primary legislation. Instead it is likely that you will rely on reading updates, and also on your organisation or professional body to support you in this knowledge, through policy and training. However, it is only by accessing the documents that you can begin to get a feel for the complexity, scope and power that the law encompasses. This section aims to give you a better understanding of the sheer volume of the law that has now been passed relating to prescribing, and what it contains. We are also going to look at how the law deals with negligence and more specifically, clinical negligence. We review the key case law, showing the importance of considering your actions when prescribing. Trust and confidence in non-medical prescribing has taken years to build up, but could be destroyed very quickly if clinical negligence cases begin to appear. Safety concerns have been much discussed since non-medical prescribing was introduced, but so far these concerns have been unfounded. However, there is no room for complacency and prescribers should do everything in their power to maintain this excellent record. You will also have an opportunity to work through some case studies to help you think through the implications for your practice. Trust and confidence in nonmedical prescribing has taken years to build up, but could be destroyed very quickly if clinical negligence cases begin to appear.

102 82 S E C T I O N 4 Practice point Consider how a case against a close colleague citing possible negligence might affect your practice. Think specifically about ways that you ensure that you work within the law, how you avoid potential errors and how your profession as a whole could be affected. Try to make notes in response to the following: How do I know that I am acting within the law? What will happen if something goes wrong? Will I be liable? How will my profession view what I am doing?

103 C L I N I C A L N E G L I G E N C E 83 None of us wish to break the law, although most of us recognise that the law does not always dovetail exactly with day-to-day practice. What counts is what it says; not what we think it says. 4.1 What is clinical negligence? The law of negligence is based on the concept that individuals owe each other a duty of care. Clinical negligence is a term used to describe medical accidents, which may include a missed diagnosis, treatment that has fallen below an acceptable standard, or an omission in a patient s care, as a result of which they have suffered harm and/or financial loss. A healthcare professional is negligent if their treatment of a patient under their care has fallen below the minimum standard that the profession regards as acceptable. The effect of this is that there are no absolute standards against which to assess medical negligence and a healthcare professional will be judged in court by standards of average competence (see the Bolam test on page 90), assessed on the basis of what was known or should have been known at the time of the alleged negligence. A healthcare professional is negligent if their treatment of a patient under their care has fallen below the minimum standard that the profession regards as acceptable. Exercise 9 Many clinical negligence cases attract national coverage. Here are a few examples of what can happen. Read the following cases and see how many factors contributed to the incident. 1. Mr D was assaulted and suffered an injury to his right eye. He was admitted to the accident and emergency department of a local hospital where he was reviewed by a locum who prescribed eye drops, advising him to return after the weekend. Mr D had suffered a very serious eye injury which required immediate treatment. Over the course of two days his eyesight deteriorated and by the time he returned to hospital as instructed, the doctors were too late to save his vision. Mr D was already blind in one eye and therefore suffered total loss of vision as a result of the negligence. 2. Mr E, aged 69 at the date of the negligence, received clinical negligence compensation following the mismanagement of a leg ulcer by practice nurses employed by his GP. The leg ulcers became infected and the infection spread to his artificial knee joint, which required removal. 3. Mr F, a delivery driver, fell from the back of a lorry and sustained a serious injury to his wrist. The hospital said it was a sprain, but in fact there was a fracture and by the time the fracture was diagnosed it was too late to operate. The driver was paid clinical negligence compensation as he lost the full use of his hand.

104 84 S E C T I O N 4 4. Mr G worked as a hospital porter. He was told by his GP he may have lung cancer and was referred to hospital for tests. The hospital told him there was nothing to worry about. The GP was correct and Mr G developed lung cancer two years later. By then it was too late to operate and he died. His widow made a clinical negligence claim and received substantial damages from the hospital. 5. Miss H, a nurse, developed complications after a routine gynaecological operation. The problems were not detected before a lot of harm was done and to compensate for being unable to have children, she received clinical negligence compensation. 6. Mr J s gallbladder operation went badly wrong when the common bile duct was severed. He received clinical negligence compensation for the pain and suffering of the additional operations he had to undergo to deal with the mistake. He also won the right to go back to court for further awards if he developed complications in the future, requiring more major surgery or even a liver transplant. 7. Mr L, a retired railway engineer, was admitted to hospital with a suspected heart attack. Treatment was started, but he received a massive drug overdose which caused fatal brain damage. The hospital admitted liability and an outof-court settlement was reached for his widow. 8. Infant M, a one-year-old child who became drowsy with a temperature, was taken to an accident and emergency department over a bank holiday. Tests were done which decided that there were no symptoms of meningitis and they sent her home with a sponge so that the parents could take a urine sample. Next morning they came back with the sample, but by then she was pale, unresponsive and had a temperature. Within a short space of time she developed a classic meningitis rash and was rushed into recovery. It was too late and she suffered widespread brain damage. She was awarded clinical negligence compensation to pay for the care she would need for the rest of her life. 9. Lieutenant N served in the royal navy and suffered a fracture to his right ankle. The fracture was misdiagnosed as a sprain, for a period of some six months. He did eventually undergo surgery to repair the fracture when it was discovered but, due to the delay, he developed secondary arthritis and was medically downgraded and discharged from the navy. The clinical negligence compensation reflected pain, suffering, loss of earnings and loss of promotion prospects within the navy. 10. A young mother, Mrs P, died as a result of a GP s failure to diagnose a deep vein thrombosis. She died when a clot travelled into her lung and blocked the supply of her blood to her heart. Her husband and two children received clinical negligence compensation.

105 C L I N I C A L N E G L I G E N C E 85 Exercise 9 continued Complete the table below noting the outcomes and the factors that contributed towards the clinical negligence claims. Case Injury Death Poor surgery Poor execution Poor decision- Poor follow-up Poor number or treatment of tests making or safety net communication Note the cases and choose one of them to write a brief description of something that could have been done differently to change the outcome. Turn to the end of the section for suggested answers. 4.2 A healthcare professional s legal duty of care Whenever a healthcare professional/patient relationship is established, a healthcare professional has a duty to: possess the knowledge and skills required of a reasonably competent practitioner working in the same area of practice exercise the care in the application of that knowledge and skill, that would be expected of a reasonably competent healthcare professional working in the same area of practice use the professional judgment in the exercise of that care required of a reasonably competent healthcare professional in the same area of practice. 1 To bring a claim of negligence the claimant must show that on the balance of probabilities the healthcare professional was negligent. This means that the patient (or their representative) has to show that the standard of care fell below what could reasonably have been expected. To bring a claim of negligence the claimant must show that on the balance of probabilities the healthcare professional was negligent.

106 86 S E C T I O N 4 The four elements in a claim are duty, damage, causation, and negligence, ie: 1. the defendant owed a duty of care to the claimant 2. a breach of that duty occurred, ie, negligence 3. some damage was sustained 4. the breach caused the damage. Reflective questions Think about your duty of care to your patients. 1. First, create a detailed list of incidents that you may come across in your work, for example, lack of dignity, inappropriately administered prescribed medicines, poor nutritional support. 2. Would you class them as negligent? 3. Thinking about situations that you have encountered recently, did you do the right thing? Did you report the incident? Did you record the concern?

107 C L I N I C A L N E G L I G E N C E Do you know about any cases of medical negligence or any of the principles which were established as a result? List the cases you have already read about. Write down any principles that have been established in law. 4.3 Negligence claims The evidence is that claims against healthcare professionals are increasing. We live in an increasingly litigious society, and healthcare professionals make mistakes just like anyone else. However, the consequences of our actions can be very serious and injury or death can follow, both with and without negligence. A small percentage of patients treated every year in the NHS or privately may become the victim of a medical accident. When that accident can be attributed to incompetent care or lack of judgment, it may be possible to bring a claim for compensation. When a claim is made against the NHS, whether large or small, it will be alleged that clinicians have failed to work to a suitably professional standard and that as a consequence, the patient has suffered injury and/or loss. This is known as the Bolam/Bolitho test. The time limit for making a claim is three years from the date of injury, but it can be longer if: the patient is a child (then the three year period only begins on his/her 18th birthday) the patient has a mental disorder within the meaning of the Mental Health Act 1983, which makes them incapable of managing their own affairs (in this case the three-year period does not apply) there was an interval before the patient realised or could reasonably have found out that they had suffered a significant injury possibly related to their treatment a court is persuaded that it is fair overall to allow a longer period. When a claim is made against the NHS, whether large or small, it will be alleged that clinicians have failed to work to a suitably professional standard and that as a consequence, the patient has suffered injury and/or loss.

108 88 S E C T I O N Protection against litigation You are usually protected against litigation through your employment. However, the basic level of insurance cover that your employer holds may not offer complete cover, so non-medical prescribers should ensure that they have sufficient indemnity insurance, eg, either via a professional body, or purchased privately. It is also important to protect yourself against litigation by acting within a robust clinical governance framework (see Section 1, page 14). You would be able to justify your decisions in a court of law far more effectively if, for example, you set yourself strict criteria for prescribing outside the evidence base, rather than putting yourself in a situation where you could not produce the evidence base for your prescribing. This argument would also apply to a wide range of clinical governance issues, including audit, record-keeping, risk assessment, using a formulary and undertaking regular training updates. Vicarious liability is a legal doctrine that assigns liability for an injury to a person who did not cause the injury, but who has a particular legal relationship to the person who did act negligently. Vicarious liability Employers are vicariously liable for negligent acts or omissions by their employees in the usual course of their work. Vicarious liability is a legal doctrine that assigns liability for an injury to a person who did not cause the injury, but who has a particular legal relationship to the person who did act negligently. Courts sometimes distinguish between an employee s detour or frolic. For instance, an employer will be held liable if it is shown that the employee had gone on a mere detour in carrying out their duties. Employers are not liable where an employee goes off on a frolic of their own. 2 The NHS Litigation Authority The NHS Litigation Authority (NHSLA) handles negligence claims and works to improve risk management practices in the NHS. They are also responsible for resolving disputes, giving advice to the NHS on human rights case law and handling equal pay claims on behalf of the NHS. In 2008/2009, 6,080 claims of clinical negligence and 3,743 claims of non-clinical negligence were received against NHS bodies. 3 The Clinical Negligence Scheme for Trusts (CNST), administered by the NHSLA, provides insurance to members and their employees in respect of clinical negligence claims arising from events which occurred on or after 1 April It is funded by contributions from NHS trusts. According to the NHS Litigation Authority annual report for 2008/2009, around 37,890 cases paid out 809 million for claims which either went to court or were settled without a trial. 4 Most claims refer to surgical procedures, but a proportion relate to medicines or prescribing. Finally, one recent disturbing trend not only in this country, but worldwide is the move towards bringing criminal charges against individual healthcare professionals, for issues previously only considered as torts in civil court (see Section 2, page 27 for more information about tort; and the Sheller v Lee case on page 98).

109 C L I N I C A L N E G L I G E N C E 89 If you are involved in a claim, your role as a non-medical prescriber will be crucial. The NHSLA may need to know: what you did the reasoning behind any decision you made what your notes say. 4.5 The basis of professional negligence law Several key cases form the basis of the case law with regard to negligence and we look at these in a little more detail below. The snail in the bottle (1932) The existence of a duty of care was established in 1932, in the case of Donoghue v Stevenson, known to all lawyers as the snail in the bottle case. A man bought a bottle of lemonade from a shop and gave it to his friend. There was an unseen decomposed snail in the bottle, and after drinking the lemonade the friend became ill. The manufacturer was held liable in negligence. The judge said: you must take reasonable care to avoid acts or omissions which you can reasonably foresee would be likely to injure your neighbour. 5 Neighbour here means any person who is so closely and directly affected by the act that he or she ought reasonably to be borne in mind when considering the act. There can be no doubt that the relationship between a healthcare professional and the patient fits into this definition, and therefore a clear duty of care is owed to the patient. 5 Reflective questions Read a short account of the Donoghue v Stevenson case which can be found at: or What is the importance of this case to your practice?

110 90 S E C T I O N 4 Hall v Brooklands Auto-Racing Club (1933) When a case relating to possible negligence is brought to court the court tends to apply objective tests to determine what the standard of care should be. In most situations the standard required will be that of the ordinary or average prudent man often referred to as the man on the Clapham omnibus. 6 The case that brought this phrase into common use is described below. It may not immediately appear that it is related to prescribing, but it provides useful background information. Mr Hall paid to go to a race track to watch car racing, on a track owned and managed by Brooklands Auto-racing Club. Mr Hall was severely injured when two cars collided near the barrier between the spectators and the track. The club was held liable to pay damages by a jury who found that they had not taken reasonable precautions to protect spectators. The racing club appealed and it was held that there was no evidence to find that they had not taken reasonable precautions and that there was no obligation to ensure safety in all circumstances, provided reasonable precautions were taken. The defendant s case was upheld. (You can read about this case online at: Professional negligence cases often depend on the view taken by the court of the professional s standard of care, ie, whether it was the correct professional standard. However, when the law is being applied to professionals then the required standard of skill is usually higher. Professionals are considered to possess particular skills and so the standard expected will be that usually met by other professionals. Professional negligence cases often depend on the view taken by the court of the professional s standard of care, ie, whether it was the correct professional standard. So, when healthcare professionals are writing a prescription they must use the standard of skill usually required by other healthcare professionals. Non-medical prescribers would not be categorised as the man on the Clapham omnibus, and the Bolam case sets this out. The Bolam case: Bolam v Friern Hospital Management Committee (1957) In the Bolam case a patient was given electroconvulsive therapy (ECT) without the use of either relaxant drugs or any manual restraint, and he sustained fractures. Medical opinion at the time was divided over the use of drugs and restraint. One group of specialists favoured relaxant drugs, another did not. There were also two views about the use of manual restraint when no drugs were used. According to this case a doctor is not negligent if he is acting in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art. This is so even if there is a body of such opinion that takes a contrary view. In this case the judge said: the test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill it is well established in law that it is sufficient if he exercises the ordinary skill of the ordinary competent man exercising that particular art. 7 What is being stated here, quite simply, is that the law does not expect healthcare professionals to work to an unrealistic ideal. What is expected of them is that they work as any other competent, reasonable healthcare professional would. Opinion often differs over the proper action to be taken by a healthcare professional.

111 C L I N I C A L N E G L I G E N C E 91 However, following the Bolam case, it is a valid defence to show that the treatment or action was in accordance with the views of a responsible body of professional opinion. To prove negligence the Bolam test can be applied, whereby there has to be a situation in which no reasonable healthcare professional, acting competently, would have dealt with things in the same way. 7 Summary of key points Healthcare professionals are expected to have higher than average skills and abilities, due to their qualifications and expertise. The prescriber must do what a reasonable non-medical prescriber would do in the same circumstances. There has to be a responsible body of opinion. Practice point The Bolam case is a key case, so is worth reading more about. We have provided one website address below, but there are many examples of the Bolam case online, so you might want to read the transcript or Wikipedia, or search for another site. Bolitho v City & Hackney Health Authority (1997) The Bolitho case created a watershed in terms of what could be deemed to be an acceptable standard of care, as far as the law is concerned. The Bolitho case stated that where it could be demonstrated that the professional opinion was illogical, then the judge can hold that opinion unreasonable. As a result of the Bolitho case, practitioners will not be able to rely solely on the Bolam test, ie, that the same practice was followed by a responsible body of professional opinion. Following this case there have been others where the courts, although accepting a practice was approved by a responsible body of opinion, have themselves judged such practice to be negligent. In summing up this House of Lords appeal case Lord Browne-Wilkinson said: The use of these adjectives responsible, reasonable and respectable all show that the court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis. In particular in cases involving, as they so often do, the weighing of risks against benefits, the judge, before accepting a body of opinion as being responsible, reasonable and respectable, will need to be satisfied that, in forming their views, the experts have directed their minds to the question of comparative risks and benefits and have reached a defensible conclusion on the matter... the court may reject a body of professional opinion in the very rare case where it can be shown that the opinion in question is not logically supportable at all. 8 Read about the case at: boli01.htm

112 92 S E C T I O N 4 Hunter v Hanley (1955) This was another key case where the doctor was alleged to have fallen below the standard regarded as reasonable by a relevant body of medical opinion. To establish liability three facts had to be established. First, it must be proved that there is a usual and normal practice. Secondly, it must be proved that the doctor has not adopted that practice, and thirdly (and this is of crucial importance) it must be established that the course the doctor adopted is one which no professional man of ordinary skill would have taken if he had been acting with ordinary care. Compliance with, or deviation from, a clinical guideline is unlikely to prove conclusive in a medical negligence action, unless it can be shown that the guideline is so well established that no responsible doctor acting with reasonable skill would fail to comply with it. 9 Established guidelines will provide evidence of what common (and best) practice is, although they will not be decisive. The Bolam test will remain crucial. You can read more about this case at: Hunter%20v%20Hanley.doc Reflective questions Having read about these cases, you may feel that these events could easily have happened to you. How can you reduce the risks to yourself? Is your practice of a standard that would be regarded as reasonable? How could you prove this if asked? Do you keep a record of the clinical guidelines you use? Do you keep a record of the clinical evidence base that you use?

113 C L I N I C A L N E G L I G E N C E 93 Have you recently read or reviewed the key clinical and professional guidance relating to your practice? Write a plan to ensure that you do this. 4.6 Standards for non-medical prescribers The extent of a healthcare professional s duty of care when undertaking new roles has not been determined in court. It is certain that it extends to all the traditional activities checking prescriptions, administering medicines, giving advice and not giving misleading advice. Similarly, it extends to activities that affect the patient indirectly, for example, advising others, making changes before another prescriber signs the prescription. As new roles are adopted, the duty of care will encompass those new roles. Some writers have argued that the standard expected of healthcare professionals undertaking new tasks, including non-medical prescribing, will be high. Healthcare professionals will be expected to have high levels of understanding about the general characteristics of a medicine, its profile of risks and benefits, and its potential for interacting with other medicines. In the future, we can expect arguments about clinical negligence to rely more on the evidence, and less on opinion. Expert witnesses are likely to cite systematic reviews and other rigorous sources of evidence more frequently, and their own views rather less. This reinforces how important it is to keep up to date and, wherever possible, to prescribe within the evidence base. Although there may be an overlap of function in some circumstances, it is important to remember that it is not the standard of a doctor which is important, but the standard of a non-medical prescriber. The non-medical prescriber would not be held to a doctor s standard. Rather, the standard will be the Bolam test, that is, that of a reasonable non-medical prescriber. Specialised experience within a particular area may also raise the expectations for the level of care given, for example, in diabetes or hypertension. 4.7 Practical application We have looked at the background to clinical negligence claims, but now you need to think about the implications for your day-to-day practice. As you work through the case study below bear in mind the information provided in Section 3 of this programme, in particular how your ethical framework will influence your decisionmaking. The non-medical prescriber would not be held to a doctor s standard. Rather, the standard will be the Bolam test, that is, that of a reasonable nonmedical prescriber.

114 94 S E C T I O N 4 Case study 5 Katie Katie, aged 26 had a personality disorder. She was not terminally ill, but she was very depressed. She had taken an overdose and called an ambulance. However, when the ambulance arrived, they found that she had written a living will saying that she wanted to be allowed to die. This was an advance directive that had been witnessed by a solicitor. She called the ambulance to be taken to the hospital, because she did not want to die alone and in pain. The hospital staff feared that they would be sued in law and be found negligent if they treated her against her wishes and so they did not. She died. Her parents sued the medical team for negligence as they said that she was not in a fit state to make a decision. What are your thoughts about this case? Make some notes under the headings of each of these ethical principles; then answer the questions set out below. Autonomy Beneficence Non-maleficence Justice Which law would the medical staff have been sued under? Would you have known what to do in this case? What does the law say with regard to living wills and suicide?

115 C L I N I C A L N E G L I G E N C E 95 Turn to the end of the section for suggested answers. Reflective questions Could you find yourself in this situation? Are there any other similar issues that you need to consider and possibly prepare yourself for? 4.8 Clinical negligence cases that have developed the case law The cases summarised below do not all relate directly to non-medical prescribing, but may help you to understand how case law has developed over time and how future clinical negligence cases may be viewed in court. Hucks v Cole (1968) The Hucks v Cole case looked at the question What is a responsible body of opinion? and established that for any professional practice to be legal it has to be supported by current professional knowledge. This can, of course, work both ways; for example, the practice of keeping patient records is now so widespread that courts will expect healthcare professionals to keep comprehensive records and failure to do so could be considered negligent. It is also worth noting that the law does not allow for a learning curve; no exception is made for beginners. 10

116 96 S E C T I O N 4 You can read about the case on the swarb.co.uk law forum web page on Professional negligence , available at: Wilsher v Essex Area Health Authority (1986) Even where a person is shown to have been negligent the claimant still has to establish causation, ie, that the negligence was responsible for the damage. This case also looked at the extent to which the standard required of a trainee doctor should be the same as that of anyone else holding that particular post. 11 Read about the case on the swarb.co.uk law forum web page on Professional negligence , available at: Sidaway v Bethlem Royal Hospital Governors (1985) In the Sidaway case, a patient sued both the surgeon and the hospital for battery and negligence, alleging that she had not been told about all the risks involved in her spinal operation. 12 Read about this case on the Lawyers Collective website at: Crawford v Board of Governors of Charing Cross Hospital (1953) One concern among practitioners relates to the level of knowledge they are expected to have. Once again, the law will consider what is reasonable for the practitioner to know in terms of evidence-based practice. It has long been accepted in law that while a clinician has to keep up to date with practice, that does not extend to reading every article or innovation which would be impractical and in the legal sense unreasonable. 13 A healthcare professional must keep up to date, but the courts understand that new practices and views are taken up by a profession over time. Failure to have read a single recent article will not be considered negligent, but disregarding a series of warning articles in the professional press might be. There are few sources available online for this case, but try the Medical Law Portal for the UK website at: The cases below all relate to prescribing, and involve doctors. Whitehouse v Jordan (1980) This case considered whether an error of judgment is equivalent to negligence, in the legal sense. In this case the judge said An error of judgement may, or may not, be negligent; it depends on the nature of the error. If it is one that would not have been made by a reasonably competent professional professing to have the standard and type of skill that the defendant held himself out as having, and acting with ordinary care, then it is negligent. If, on the other hand, it is an error that a man, acting with ordinary care, might have made, then it is not negligent. 14

117 C L I N I C A L N E G L I G E N C E 97 The Migril case: Dwyer v Roderick and others (1983) Usually more than one healthcare professional is involved in the supply of medicine, ie, the prescriber and the pharmacist. The courts may find that both have contributed to a situation that has caused damage, and apportion blame and damages between them. That was the outcome of the Migril case, one of the few negligence cases that specifically deals with pharmacy. 15 You can read more on the British Medical Journal website, in the article entitled Writing a wrong (Mullan K. BMJ, 1988; 297: ) at: The peppermint water case (1998) This case established that although the healthcare professional who is supervising takes professional responsibility, other staff in the pharmacy may be held accountable. 16 You can read more on the BBC website, on their news page Chemists fined after baby death (1 March 2000), at: Horton v Evans and Lloyds Pharmacy Ltd (2006) This case makes it clear that the duty of care requires rather more than just spotting obvious prescribing errors. 17 You can read more on the Chemist and Druggist web page Professionalism and duty of care (Wingfield J; June 2008) at: _SHARED_articleId=769898&CMPI_SHARED_CommentArticleId= &CMPI_SHARED_ImageArticleId=769898&CMPI_SHARED_Tools ArticleId=769898&CMPI_SHARED_articleIdRelated= Exercise 10 What are the key points about prescribing raised by the Horton v Evans and Lloyds Pharmacy case? You may also want to reflect on how your practice meets these standards. Turn to the end of the section for suggested answers.

118 98 S E C T I O N 4 Sheller v Lee (2009) Locum pharmacist, Elizabeth Lee, was given a suspended sentence in April 2009 after dispensing propranolol instead of prednisolone to Carmel Sheller, aged 72, who later died, of a cause unrelated to the error. It was a one-off, non-deliberate error which was considered to be a criminal offence. It was a concern that healthcare professionals would no longer report dispensing errors for fear of prosecution. As a result of campaigns by healthcare professionals, the law is to be changed. This case will probably now pass into case law. 18 The background to the case can be read on the link below, together with a GP s opinion, which gives it a different perspective. Read about the case in this British Journal of Clinical Pharmacy article Are dispensing errors and jail sentences inevitable? (Brown P, British Journal of Clinical Pharmacy, 2009:1) available at: or, on the Chemist and Druggist web page The personal cost of the Elizabeth Lee case (Gosney, M; June 2010) at: _SHARED_articleId= &CMPI_SHARED_ImageArticleId= &CMPI_SHARED_CommentArticleId= &CMPI_SHARED_ToolsA rticleid= &cmpi_shared_articleidrelated=

119 C L I N I C A L N E G L I G E N C E 99 Summary In this section we have looked at the way that case law has developed in relation to claims for negligence. It is important that you become familiar with the key cases highlighted in this section, so that you have a greater understanding of the way that the law affects professional practice. This understanding and awareness will help you to put clinical governance systems in place to reduce the risks of being found clinically negligent. Intended outcomes By the end of this section you should be able to: Can you? understand what constitutes clinical negligence be aware of the Clinical Negligence Scheme For Trusts (CNST) and how risk management standards apply to your practice understand the legal implications of specific case law in non-medical prescribing practice apply key principles of case law to your prescribing practice, especially with regard to the cases of Bolam and Bolitho understand why record-keeping, the evidence base and risk assessment reduce your risk of being found clinically negligent.

120 100 S E C T I O N 4 Developing and maintaining your CPD portfolio This section underpins the following National Prescribing Centre competencies: (taken from the NPC competency framework available at: Prescribing safely Knows the limits of own knowledge and skill, and works within them. Prescribing professionally Accepts personal responsibility for own prescribing and understands the legal and ethical implications of doing so. Understands the need for and makes accurate, clear and timely records and clinical notes. Now make entries in your CPD portfolio to denote that you have undertaken CPD related to these competencies. Reflective questions What have you learnt so far? Think about all you could do to avoid being clinically negligent. Write down three things you have learnt about ethics and your professional code of practice that are relevant to your personal practice, or three changes you want to make in your future work

121 C L I N I C A L N E G L I G E N C E 101 Suggested answers Exercise 9 (see page 83) Complete the table below noting the outcomes and the factors that contributed towards the clinical negligence claims. Case Injury Death Poor surgery Poor execution Poor decision- Poor follow-up Poor number or treatment of tests making or safety net communication 1 Y Y Y Y 2 Y Y Y 3 Y Y Y Y 4 Y Y Y 5 Y Y 6 Y Y 7 Y Y 8 Y Y Y Y 9 Y Y Y Y 10 Y Y Y Y In the majority of these cases, there was more than one opportunity for the negligence to be minimised or avoided. Interestingly, poor communication was not often a factor; poor follow-up, decision-making or testing were much more common. Exercise 10 (see page 97) What are the key points about prescribing raised by this case? 1. The risks to the prescriber as well as the patient, of using as directed as a direction. This is well known, but is still found. 2. Records, if available, should always be consulted. 3. The risks to the prescriber of prescribing from a label. 4. The duty of care to query a high dose of a high-risk medicine. 5. The expectation that you will recognise potential risks and intervene to prevent harm to the patient. 6. The responsibility for checking that the dose is correct for that patient falls completely to the healthcare professionals. Legally, the patient has no responsibility for spotting that the dose is different. You may also want to reflect on how your practice meets these standards.

122 102 S E C T I O N 4 Case study 5 Katie (see page 94) Apply the ethical principles laid out in Section 3. Autonomy At the inquest, it was determined that Katie had been able to make an autonomous decision. Although she had a personality disorder, this was not recognised under the Mental Health Act However, the act was amended in 2007 to include personality disorder. Also, if she had been assessed at the time of making the advance directive, it may have been considered that she did not have the mental capacity to make that decision. Beneficence The ambulance team had a duty to act to save her life. Non-maleficence Katie could have been harmed if she had been treated because her views would have been ignored. However, in this circumstance the ambulance team were right because they did not harm her by ignoring her wishes. Justice Justice in this situation means that all people who attempt suicide should be treated in the same way by healthcare professionals, so that all possible life-saving interventions are used to preserve that person s life. Did the ambulance crew treat Katie differently to anyone else they had been called to help? This was probably a completely new situation for them. Which law would the medical staff have been sued under? They may have been sued for common assault. Would you have known what to do in this case? It is unlikely that you would have known what to do, unless you had thought this type of situation through beforehand, or had clear guidance. What does the law say with regard to living wills and suicide? Section 9.9 of the Code of Practice attached to the Mental Capacity Act 2005, includes provision for dealing with people with obvious suicidal intentions. It warns that medical staff may have particular concerns about the capacity of someone with a history of suicide attempts or suicidal thoughts who has made an advance decision. It goes on: If the person is clearly suicidal, this may raise questions about their capacity to make an advance decision at the time they made it. This is a real case, although the names have been changed. Katie killed herself by poisoning, as she was depressed about not being able to have children. Emergency services and medical staff could have saved Katie s life. They did not do so, because they feared that they might have been prosecuted for assault under the Mental Capacity Act The act was intended to enable terminally ill patients to have a degree of autonomy over their medical treatment; to allow those who were dying, or who knew

123 C L I N I C A L N E G L I G E N C E 103 that their condition could only end in their death, to refuse medical treatment so that nature could take its course. An inquest heard how the 26-year-old had drawn up a legal declaration, in the presence of a solicitor, stating that she did not want doctors to intervene to save her life. After drinking the substance she called an ambulance to take her to hospital but made it clear this was only because she did not want to die alone and in pain. Medical staff feared that administering life-saving treatment against her wishes would have constituted assault. The coroner found that Katie had full knowledge of what she was doing and said that it would have been unlawful for medical staff to intervene. Her parents, David and Julia, were convinced that their daughter, who had a history of self harm, was in no state to make a reasoned decision. The family brought a civil case against the hospital, which they did not win.

124 104 S E C T I O N 4 References 1. UNISON. The duty of care. London: UNISON; Available online at: 2. The free dictionary web page. Definition of vicarious liability. Available online only at: (accessed 1 February 2010). 3. National Health Service Litigation Authority. Clinical negligence reporting guidelines. 5th edition; Available via the Clinical Negligence Scheme for Trusts web page at: (accessed 1 February 2010). 4. National Health Service Litigation Authority. Report and accounts London: The Stationery Office; Available online at: 16D4D6/0/NHSLAannualreportandaccounts2009.pdf (accessed 1 February 2010). 5. Donoghue v Stevenson [1932] AC Hall v Brooklands Auto-Racing Club (1933), or the man on the Clapham omnibus. Available online at: html (accessed 1 February 2010). 7. Bolam v Friern Hospital Management Committee [1957] 1 WLR Bolitho v. City and Hackney Health Authority [1997] 4 All ER 771. Available online at: boli01.htm (accessed 1 February 2010). 9. Hunter v Hanley 1955 S.C Hucks v Cole [1993] 4 Med LR Wilsher v Essex Area Health Authority [1986] 3 All ER 801; [1987] 2WLR Sidaway v Board of Governors of the Bethlem Royal and the Maudsley Hospital (1985), 1 All ER, Crawford v Board of Governors of Charing Cross Hospital. Times 8th December Whitehouse v Jordan [1981] 1 All ER 267: 15. Dwyer v Roderick and others (1982). 16. Pharmaceutical Journal. The peppermint water case. Pharmaceutical Journal 2002; 268: 7185; Horton v Evans and Lloyds Pharmacy Ltd (2006) EWHC 2808 (QB). 18. Sheller v Lee (2009).

125 Section 5 Medicines regulatory framework 105 Objectives On completion of this section you should be able to: understand the processes involved in licensing medicines employ the relevant legislation, eg, the Medicines Act 1968 and subordinate legislation in your prescribing practice distinguish situations when you can prescribe medicines off label determine whether you can prescribe unlicensed medicines and when it is appropriate to do so. The first four sections of this programme have focused on how the law specifically affects you and your patients. We will now look at the other key aspect in nonmedical prescribing how the law affects medicines. The medicines licensing system safeguards public health by ensuring medicines meet quality, safety and efficacy criteria. It is important that you have a working knowledge of the medicines licensing system and how it affects your practice. Substances and devices which are not licensed are often found in practice, and clinical trials are also closely controlled, so an understanding of the legislation is critical to ensure you practise safely and within the law. This section will bring you up to date with current legislation relating to medicines licensing, and will help you to identify the medicines that you can legally prescribe. It deals with the broad legislative framework regarding medicines, the licensing process and the advisory committees, and provides definitions of some of the relevant terms. The final part of this section deals with some of the exceptions to licensing that you may encounter in practice. You can read about local policies and national guidance in more detail in the next part of this CPD series: Influences on you as a prescriber. This section deals with the broad legislative framework regarding medicines, the licensing process and the advisory committees, and provides definitions of some of the relevant terms. Reflective questions Why do you think you need to know about the Medicines Act 1968, and EU directives and regulations?

126 106 S E C T I O N 5 Will this knowledge help you to do your job better? Have you ever prescribed an unlicensed medicine, either intentionally or unintentionally? Write down what you think you need to know regarding medicines regulation, in order to do your job safely and within the law. You already have a working knowledge of a significant amount of the Medicines Act 1968 without realising it, as it has been used in your training as a healthcare professional. However, it is also important for you to understand how medicines legislation applies to non-medical prescribing, so that you can adapt as new laws come into effect. The case study that you will work through later in this section will highlight the importance of this. 5.1 Legislative framework The guiding principle of European and UK medicines legislation is to ensure the quality, safety and efficacy of medicinal products, with the overall aim of safeguarding public health. Medicines in the UK are controlled through the system of licensing, with conditional exemptions from licensing laid down in EU legislation, amendments to the Medicines Act and in various Regulations and Orders. There are also controls on the sale, distribution and advertising of medicines. A marketing authorisation (formerly called a product licence) is needed before a medicine can be prescribed. Under the Medicines Act a company may only market (that is advertise and sell their product) in the UK if they hold a marketing

127 M E D I C I N E S R E G U L A T O R Y F R A M E W O R K 107 authorisation for that product. 2 Also, the therapeutic or diagnostic purposes for which the product can be marketed are limited by the terms of the authorisation. This would mean, for example, that a product licensed only for the treatment of gastric ulcers may not be marketed for the treatment of indigestion. Devices CE marking certifies that a product has met EU consumer safety, health or environmental requirements. Manufacturers are obliged to ensure that their devices are safe and fit for their intended purpose before they are CE marked and placed on the market, in any EU member state. The CE mark is a declaration by the manufacturer that the device conforms to essential requirements as laid out in directives and is fit for purpose. It also means that the device can be marketed anywhere in the EU. 3 The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices within the UK. The CE mark is a declaration by the manufacturer that the device conforms to essential requirements as laid out in directives and is fit for purpose. Further information about the regulation of medical devices can be found on the MHRA website at: Exercise 11 Which are the best websites to help you keep up to date with legislation? Do an internet search using human medicines regulation as your search criteria. List below any that you already know about, as well as any others that you come across which you think will prove helpful. Turn to the end of the section for suggested answers.

128 108 S E C T I O N Commission on Human Medicines The Commission on Human Medicines is a committee of the Medicines and Healthcare products Regulatory Agency (MHRA). It was formed in October 2005 by the union of the Medicines Commission and the Committee on Safety of Medicines. The Commission on Human Medicines advises the government on matters relating to human medicinal products, gives advice in relation to the safety, quality and efficacy of human medicinal products, and promotes the collection and investigation of information relating to adverse reactions to human medicines. 4 Section 3 of the Medicines Act 1968 established the Medicines Commission to provide advice on general matters of policy relating to medicines control. In certain circumstances it also considers applications for licences. It reports to the licensing authority, which must take account of its report in determining an application. The specific duties of the Medicines Commission are set out in the act. The commission has a duty to: 1. make recommendations as to the constitution and functions of the other committees to be set up under the Medicines Act recommend people to serve on those committees 3. review the functions of the committees 4. receive representations, in certain cases, from applicants for licences or certificates 5. act as an advisory committee if no other committee is set up specifically to deal with the problem 6. direct the preparation of publications, such as the British Pharmacopoeia. 5.3 Role of the Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines and medical devices work, and are acceptably safe. They ensure that any benefits gained from medicinal products justify any potential risks. They keep watch and take prompt, necessary action to protect the public if there is a problem. They encourage everyone to tell them about any problems with a medicine or medical device, so that they can investigate and take any necessary action. The MHRA website contains information about current and historic alerts, messages, advice and guidance. Safety information No product is ever risk free. Some of the risks are known about when a medicine is first licensed or when a medical device is first used. However, some information only comes to light later, as more people use the products. The MHRA website contains information about current and historic alerts, messages, advice and guidance. You can also report a safety problem about a product directly to them, under the yellow card system. The black triangle scheme is also provided by the MHRA.

129 M E D I C I N E S R E G U L A T O R Y F R A M E W O R K 109 Exercise 12 Think about the MHRA yellow card and the black triangle schemes, and answer the queries below. What is the purpose of the yellow card scheme? What is the black triangle scheme? What reasons might you have for not reporting suspected concerns about medicines? Turn to the end of the section for suggested answers.

130 110 S E C T I O N 5 The MHRA operates a range of regulatory systems which aim to ensure that: design of clinical trials is of a high standard products are only allowed onto the market with a licence if there is enough evidence that the potential benefits will outweigh the likely risks they receive enough reliable information about adverse events with medicines and devices that are in use products are withdrawn or have their use restricted if the evidence shows that this is necessary new information about an adverse effect of a product is shared widely if a medicine or medical device is being inappropriately or incorrectly used, or is inadequately maintained, sterilised or tested, that information about this is shared widely the availability of a medicine is appropriate to the risks it poses the supporting information for professionals and the public about a medicine or medical device is appropriate, readable and fit for purpose advertising or marketing claims for medicines are justified and targeted at appropriate audiences pharmaceutical companies and device manufacturers meet their legal obligations the supply of unauthorised or counterfeit medicines is stopped as far as is possible. information in relation to MHRA decisions is made available to the public. Reflective questions Have you ever completed a yellow card? Think about the last time you sent one in. What was the reason? If you have never sent in a yellow card, reflect on why this might be.

131 M E D I C I N E S R E G U L A T O R Y F R A M E W O R K 111 List all the situations when you should send in a yellow card. Are you aware of the black triangle scheme? Have you recently prescribed a black triangle drug? Access the MHRA web page Black triangle scheme via the link below and click on current drugs under intensive surveillance (Black Triangle List) : Reportingsuspectedadversedrugreactions/Healthcareprofessional reporting/blacktrianglescheme/index.htm Practice point Access the MHRA web page Healthcare reporting: how to report via the link below and consider registering onto the system as a healthcare professional, so that you can log in to the site quickly and also receive updates: Reportingsuspectedadversedrugreactions/Healthcareprofessional reporting/howtoreport/index.htm Decide on a system you could put in place to ensure you are aware of black triangle drugs when you are prescribing, so that you never unknowingly prescribe a black triangle drug. Suggested ideas are: print off the black triangle list of medicines every month or save it onto your computer desktop clearly highlight the black triangle drugs in your BNF use a personal formulary that you review regularly.

132 112 S E C T I O N 5 The SPC should provide details about dosage, method and route of administration, shelf-life, storage precautions and the results of clinical trials and tests. 5.4 Summary of product characteristics (SPC) It is a requirement of the licensing process that each drug or product is accompanied by a summary of product characteristics (SPC), previously known as the datasheet, which contains certain required information about the therapeutic indications, contraindications and side-effects. It must contain the most up-to-date information available about a specific drug. It should provide details about dosage, method and route of administration, shelflife, storage precautions and the results of clinical trials and tests. It should also contain information about any monitoring that may be needed, and is a key document for prescribers. You can find all the SPCs at: Practice point Consider signing up to receive a newsletter from the National electronic Library for Medicines (visit the registration page on their website at: ). You will be able to register for a daily newsletter containing alerts, and any changes to SPCs. Access an SPC for a medicine you prescribe frequently and have not read recently. Make notes about anything that has changed or that you were not aware of.

133 M E D I C I N E S R E G U L A T O R Y F R A M E W O R K Controlled drugs Supplementary prescribers Nurse, pharmacist, chiropodist/podiatrist, physiotherapist, radiographer and optometrist supplementary prescribers can prescribe any controlled drugs listed under Schedules 2-5 for any condition within their competence, as part of a patient-specific, written clinical management plan (CMP) agreed with a doctor. 5 Independent prescribers Nurse independent prescribers are restricted by current legislation to independently prescribe only certain controlled drugs solely for specified medical conditions (see BNF Nurse Prescribers Formulary Nurse Independent Prescribing). Pharmacist independent prescribers are not yet able to independently prescribe any controlled drugs. Optometrist independent prescribers cannot prescribe controlled drugs Unlicensed medicines There are two categories of unlicensed medicines: 1. Unlicensed product 2. Unlicensed use also known as off-label use The two are often confused, so use the diagram below to help you: Is the medicine licensed? Does it have an SPC, or is it in the BNF? Yes It is a licensed product No It is an unlicensed product Is it being used for an indication named in the SPC or licence? Yes This is a licensed use No This is unlicensed or off-label use

134 114 S E C T I O N 5 Unlicensed products As we mentioned above, under European medicines legislation (Directive 2001/83/EC) a manufactured medicinal product placed on the market has to hold a marketing authorisation. Medicines without marketing authorisations are unlicensed products. Unlicensed medicines may only be used when no pharmaceutically equivalent licensed product or suitable licensed alternative is available for use. A designated healthcare professional (a doctor) is also able to commission the manufacture of an unlicensed product for a patient under his direct responsibility. Changes to regulations to enable nurse and pharmacist supplementary prescribers to prescribe unlicensed medicines (products), came into effect on 14 April Anyone prescribing an unlicensed product needs to be aware that it carries increased risk, and that they are personally responsible and professionally accountable for their judgment when they do this. Prescribers have a duty in common law to take reasonable care and to act in a way consistent with the practice of a responsible body of their peers of similar professional standing (as described in Section 4). This applies particularly to the prescribing of unlicensed medicines. Anyone prescribing an unlicensed product needs to be aware that it carries increased risk, and that they are personally responsible and professionally accountable for their judgment when they do this. In the case of adverse events they may be called upon to justify their actions, and in serious cases, they could be accused of negligence. Supplementary and independent non-medical prescribers need additional indemnity insurance to protect them in these circumstances. Provided the unlicensed medicines are prescribable by a doctor or dentist (a medical prescriber) at NHS expense, and they are referred to in the patient s clinical management plan, then supplementary prescribers are able to prescribe them. Supplementary prescribers are also able to prescribe unlicensed medicines that are part of a clinical trial, provided they have a clinical trial certificate or exemption. Independent non-medical prescribers can prescribe an unlicensed medicine for any condition within their clinical competence. However, the responsibility when prescribing an unlicensed medicine is greater than when prescribing a licensed medicine within the terms of its licence. Prescribers should pay particular attention to the risks associated with using unlicensed medicines, or licensed medicines off-label. Unlicensed or off-label use Unlicensed use is also known as off-label use of a medicine and refers to prescribing which is outside a product s licensed indication. The licence details are found in the medicine s summary of product characteristics (SPC) and a product cannot be marketed for any use outside the licence conditions. Unlicensed use might be due to: dose age group route therapeutic indication condition. An SPC is specific to the particular brand or manufacturer of that medicine.

135 M E D I C I N E S R E G U L A T O R Y F R A M E W O R K 115 Many medicines prescribed for children are prescribed and used off-label. This is because clinical trials are rarely carried out on children, especially very young children, so the licensed use is restricted to those groups of patients where clinical trials have been carried out. A medicine is used outside its licence when: the licensed indications do not reflect established current knowledge the licensed indications do not include well proven uses of a drug the licensed uses are at variance, for example, one branded product of a medicine has two licensed uses but a second branded product of the medicine only has one licensed use. In exceptional circumstances, a non-medical prescriber may use a medicine outside its licensed indication if the use is supported by current best practice, for example, national NHS guidance. Healthcare professionals prescribing medicines outside the terms of the product licence must accept full professional, clinical and legal responsibility for that prescribing. When a prescriber chooses to do this, the product liability passes to the prescriber. Before prescribing outside the licensed indications, the prescriber must ascertain that a reasonable body of medical opinion would support the use of the product in that way, as in Bolam/Bolitho (described in Section 4 above). NHS policies may set a different standard and some organisations may not allow off-label prescribing under any circumstances. Provided medicines can be prescribed by a doctor or dentist (a medical prescriber) at NHS expense, and they are referred to in the patient s clinical management plan, supplementary prescribers are able to prescribe licensed medicines for use outside their licensed indications (ie, off-label prescribing), black triangle drugs, and drugs marked less suitable for prescribing in the BNF. However, once again, the prescriber must accept full professional, clinical and legal responsibility. It is worth noting that this has not yet been tested by the courts. 7 In 2009 the MHRA provided advice about off-label or unlicensed use of medicines and prescribers responsibilities. 8 It is available at: Before prescribing outside the licensed indications, the prescriber must ascertain that a reasonable body of medical opinion would support the use of the product in that way. Orphan drugs There tends to be less pharmaceutical research carried out on rare diseases or disorders, because the numbers of patients affected, and therefore the potential market for new drugs, is also small. The medicines for these rare diseases are known as orphan drugs. A rare disease is one that occurs in fewer than five per 10,000 individuals in the European Union. Government regulatory agencies in the European Union have therefore taken steps to encourage manufacturers to license these medicines, so that medicines are developed for rare diseases. 9

136 116 S E C T I O N 5 Borderline substances The Advisory Committee on Borderline Substances (ACBS) is the committee responsible for advising on the prescribing of certain foodstuffs and toiletries. Borderline substances are mainly foodstuffs, such as enteral feeds and foods that are specially formulated for people with medical conditions, but also include some toiletries, such as special sun blocks that are used by people with conditions that are light sensitive. 10 Exercise 13 Can independent non-medical prescribers prescribe borderline substances/off-label medicines/unlicensed medicines? Can supplementary non-medical prescribers prescribe borderline substances/off-label medicines/unlicensed medicines? Turn to the end of the section for suggested answers. You need to be really clear in your mind about both the legal aspects and the personal aspects of prescribing in these categories, as it can be very easy during the day-to-day hustle and bustle to put these considerations to one side for the sake of practicality, which could have serious consequences. The exercise below offers you some further practice in making these decisions.

137 M E D I C I N E S R E G U L A T O R Y F R A M E W O R K 117 Exercise 14 Using the flowchart on page 113, identify whether these medicines are licensed, used outside licence (off-label), or unlicensed. Name of medicine and dose Indication Licensed, unlicensed, or off-label Sodium valproate Methylprednisolone acetate depot Testosterone enantate injection Naproxen suspension Erythromycin suspension Benzylpiperazine Simvastatin liquid Manic episodes associated with bipolar disorder Suppression of inflammation in joints Breast cancer Osteoarthritis Gastric motility Anthelmintic Prevention of cardiovascular events Turn to the end of the section for suggested answers. 5.7 Manufacture of medicines In 2008, the MHRA revised Guidance Note 14, The supply of unlicensed relevant medicinal products for individual patients. The document provides guidance to manufacturers about the conditions under which they may manufacture and supply specials and their legal obligations. 11 It states: The conditions are that there is a bona fide unsolicited order, the product is formulated in accordance with the requirement of a doctor or dentist registered in the UK, and the product is for use by their individual patients on their direct personal responsibility. If a special is manufactured in the UK, the manufacturer must hold a manufacturer s (specials) licence issued by the MHRA. A special may not be advertised and may not be supplied if an equivalent licensed product is available which could meet the patient s needs. Essential records must be kept and serious adverse drug reactions reported to the MHRA. Supplementary prescribers can request that specials are ordered according to the guidance. 10 The MHRA has put in place changes to medicines regulations to enable mixing of medicines prior to administration in clinical practice, effective from 21 December These changes enable: doctors and dentists, who can already mix medicines themselves, to direct others to mix nurse and pharmacist independent prescribers to mix medicines themselves and to direct others to mix