Professional, Legal, and Ethical prescribing
Overview
Prescribing can be seen as an advanced area of practice, with associated professional, clinical governance, legal, and ethical considerations. When you are legally able to prescribe, there is an onus to be aware of these and to be able to demonstrate at all times that you have fulfilled your duty of care. This duty is professional in working within your scope of practice, legal in being able to clearly articulate the logical basis of informed decision-making, and ethical in weighing up the risks, benefits, and autonomy of the people in your care.
This section provides:
links to the professional prescribing standards
a brief history of the laws underpinning prescribing;
information about continuing professional development
recommended reading
Professional: Links to prescribing standards
Each of the professional regulators have the legal authority to:
add new practitioners or qualifications to their register;
remove registrants from the register (in the case of professional breaches); and
set the educational standards for registrable qualifications, including prescribing.
This provides regulators with the authority to define the entry criteria for prescribing programmes, its content, assessment and practice assessment. For further detail around these standards, use the links to access the most up to date versions for your profession.
The NMC and HCPC have adopted the Royal Pharmaceutical Society's Competency framework for all prescribers as the foundation of their educational standards, whereas the GPhC has retained their own prescribing programme learning outcomes. All professionals are encouraged to map their practice experiences against the RPS (2021) competency framework as part of their ongoing CPD. The RAPID-CASE page has a workbook you can optionally use to undertake this mapping.
Prescribing laws
A brief history of prescribing
Prescribing for practitioners other than Doctors developed rapidly over the years. A series of changes in law were prompted by the Cumberlege review of community nursing services in 1986 (DHSS, 1986). The key legal developments to enable prescribing for nurses and midwives can be seen in the timeline illustrated in Figure 1. There are other dates of pertinence to Pharmacists and Allied Health Professionals and prescribing continues to expand.
Legal topics of pertinence to prescribing
Some of the core legal imperatives as a professional apply to prescribers, such as confidentiality and consent. Key legal topics that are covered on most prescribing courses include:
duty of care and negligence
confidentiality
consent and capacity
Gillick competence and Fraser Guidelines
prescribing laws and regulations
It is useful to stay attuned to new laws, as it is never a defence in court to claim you were unaware of a particular law. For example, it is important to sign up to the MHRA alerts and to note significant changes to medicines law, such as the Human Medicines Regulations.
Ethics and prescribing
Principles of bio-medical ethics
Seminal work by Beauchamp and Childress (2004) noted 4 principles of biomedical ethics that continue to underpin our clinical and prescribing decisions. A balance between acting in a way that is of benefit (beneficence), whilst avoiding harm (non-maleficence) and promoting informed decision-making (autonomy) requires examination. The final principle of justice, where we practice in a fair way, can be viewed through the lens of standardisation of care, for example, clinical guidelines and care protocols. Given the need for guidelines to include economic analysis, there can be conflict between the four principles which prompts the need for critical analysis.
Resource links are provided to help you explore this topic further.
Continuing professional development (CPD) and prescribing
Professionalism and CPD
Professional requirements entail a set number of participatory and other continuing professional development experiences. However, as a prescribing who is accountable for decisions, it is likely that more time is needed to keep up to date with research, guidelines, pharmacology and in growing your scope of practice. Continued learning is needed to fulfil your professional and legal duty of care, with a requirement to be able to explain the process by which decisions have been made.
One way to identify CPD needs is to consider the "Pieces" of information needed for safe clinical decision-making
The PIECES model for improving clinical decision-making
Growing scope of practice involves confidence in decision-making and an ability to apply key principles to a wider set of circumstances or conditions. The PIECES model has been developed to illustrate the continual process of justifying sound decision-making while identifying ongoing development needs. Having the skills and confidence to diagnose is essential to prescribing, but it is likewise important to always question the basis of decisions, be open to alternatives and to be self-aware of the influence of personal views or knowledge limitations. This model aims to prompt practitioners to stop and think about their consultations. Each part includes questions to self-assess decision-making processes and development needs.
PIECES
The PIECES for clinical decisions – key questions:
Pre-assessment:
Have I encountered a similar scenario before and is it within my scope of practice?
Do I have sufficient current knowledge to safely reach a working diagnosis and identify treatment options?
Am I self-aware of my limitations and learning needs?
Is referral or urgent action needed?
Inquiry / investigation:
Have I actively listened and attended to the person’s concerns and priorities?
Have I considered diversity, equity, and inclusion?
Am I aware of the possible influence of my own personal characteristics or beliefs?
Have I investigated areas of unfamiliarity or uncertainty?
Expertise:
Have I judiciously applied my knowledge and experience?
Have I elicited the person’s understanding of their health issue(s) and possible solutions?
Have I collaborated with, or sought advice from others?
Critical thinking:
Have I used a systematic approach (e.g. RAPID-CASE) to the assessment, leading to a defensible outcome?
Have I considered alternative conclusions and asked myself “what else could it be”?
Can I articulate a logical basis to decisions?
Evidence:
Has up-to-date research, expert opinion, or guidelines, informed my assessment, working diagnoses, treatment options and advice?
Can I justify adherence to or deviation from guidelines?
Have I provided sufficiently detailed information, at a suitable level, to promote understanding and shared decision-making?
Summary:
Have I elicited the person’s understanding?
Can I logically explain the decision-making and safety-netting?
Have I reflected on or re-visited this episode of care to evaluate outcomes, my knowledge, skills, or learning needs?
References and recommended reading
- Beauchamp, T. L., & Childress, J. F. (2019). Principles of biomedical ethics. 8th Edition
- Bolam v Friern HMC [1957] 1 WLR 582
- Bolitho v City & Hackney Health Authority [1997] A.C. 232
- Care Quality Commission (2018) Nigel's surgery 8: Gillick competency and Fraser guidelines Available at: https://www.cqc.org.uk/guidance-providers/gps/nigels-surgery-8-gillick-competency-fraser-guidelines
- Care Quality Commission (CQC) (2019) Nigel's surgery 19: Patient Group Directions (PGDs) / Patient Specific Directions (PSDs) Available at: https://www.cqc.org.uk/guidance-providers/gps/nigels-surgery-19-patient-group-directions-pgds-patient-specific-directions
- Carey N., Courtenay M (2010) An exploration of the continuing professional development needs of nurse prescribers and nurse supplementary prescribers who prescribe medicines for patient with diabetes. Journal of Clinical Nursing 19(1-2): 208-21
- Cavanagh S (2020) An introduction to PGDs: definitions and examples of use; Specialist Pharmacy Services Available at: https://www.sps.nhs.uk/articles/what-is-a-patient-group-direction-pgd/
- Cumberlege, J. (2020) “First Do No Harm” Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege Available at: https://www.immdsreview.org.uk/Report.html
- Department for Constitutional Affairs (2007) The Mental Capacity Act 2005 Code of practice Issued by the Lord Chancellor on 23 April 2007 in accordance with sections 42 and 43 of the Act. [Online] Available at: https://www.gov.uk/government/publications/mental-capacity-act-code-of-practice
- Emrich‐Mills, L, Collier, P, West, J. (2019) The role of nurse prescribers in memory services and their continuing professional development: A review of the literature. J Clin Nurs. 2019; 28: 1422–1432. https://doi.org/10.1111/jocn.14796
- Professional, legal and ethical dimensions of prescribing: part 2: legal and ethical.
- Gould J, Bain H (2022) The professional, legal and ethical dimensions of prescribing. Part 1: professional. Primary Health Care. doi: 10.7748/phc.2022.e1773
- Gould J, Bain H (2022) The professional, legal and ethical dimensions of prescribing. Part 2: legal and ethical. Primary Health Care. doi: 10.7748/phc.2022.e1774
- Griffith R. and Tengnah C. (2011) Legal issues surrounding consent and capacity: the key to autonomy British Journal of Community Nursing Vol 16, No 12 Available at: https://www.ncbi.nlm.nih.gov/pubmed/22413407
- Griffith R. and Tengnah C. (2012) Consent to care: patients who demand or refuse treatment British Journal of Community Nursing Vol 17, No 3 Available at: https://www.ncbi.nlm.nih.gov/pubmed/22398872
- Griffith, R. (2020) Law & professional issues in nursing . 5th edition. London : Learning Matters
- Griffith R (2008) Consent and children: The law for children under sixteen British Journal of School Nursing Vol. 3, No. 6
- Griffith R. (2012) Medicines law overhaul with Human Medicines Regulations 2012. Br J Community Nurs. 2012 Sep;17(9):445-7 Available at: https://doi.org/10.12968/bjcn.2012.17.9.445
- Griffith R (2018) Neglect by carers British Journal of Community Nursing August 2018 Vol 23, No 8
- Hall K. and Picton C. (2020) Analysing the Competency Framework for all Prescribers Journal of Prescribing Practice 2020 2:3, 122-128
- McKenna, B. (2020) Impact of COVID-19 on prescribing in English general practice: March 2020. [online] May 20 2020. Available from: https://ebmdatalab.net/covid19-prescribing-impact/
- Medicines for Human Use (Prescribing) (miscellaneous amendments order) [2006]
- Medicines Healthcare Products Regulatory Agency (MHRA) (2014) Rules for the sale, supply and administration of medicines for specific healthcare professionals [Online] Available at: https://www.gov.uk/government/publications/rules-for-the-sale-supply-and-administration-of-medicines/rules-for-the-sale-supply-and-administration-of-medicines-for-specific-healthcare-professionals
- Medicines Healthcare Products Regulatory Agency (MHRA) (2017) Patient group directions (PGDs): Who can use them https://www.gov.uk/government/publications/patient-group-directions-pgds/patient-group-directions-who-can-use-them
- Medicines Healthcare Products Regulatory Agency (MHRA) (2019) The Yellow Card Scheme: guidance for healthcare professionals. Medicines and Healthcare products Regulatory Agency Available at: www.mhra.gov.uk
- Medicinal Products: Prescription by Nurses etc. Act 1992 (c. 28) Available at: https://www.legislation.gov.uk/ukpga/1992/28/contents
- Misuse of Drugs regulations [2001]
- Montgomery vs Lanarkshire Health Board [2015] Available at: https://www.supremecourt.uk/cases/uksc-2013-0136.html
- National Institute of Health and Care Excellence (NICE) Medicines and prescribing https://www.nice.org.uk/about/nice-communities/medicines-and-prescribing
- Nursing and midwifery Council (2018b) Future Nurse: Standards of proficiency for registered nurses Available at: https://www.nmc.org.uk/standards/standards-for-nurses/standards-of-proficiency-for-registered-nurses/
- Nursing and midwifery Council (2018c) Realising professionalism: Standards for education and training Part 3: Standards for prescribing programmes [Online] Available at: https://www.nmc.org.uk/standards/standards-for-post-registration/standards-for-prescribers/standards-for-prescribing-programmes/
- Nursing and Midwifery Council (2019) High level principles for good practice in remote consultations and prescribing Available at: https://www.nmc.org.uk/standards/standards-for-post-registration/standards-for-prescribers/useful-information-for-prescribers/
- Nursing and Midwifery Order [2001] Article 19(6)
- Royal College of Nursing (2020) “Prescribing safely under COVID-19” https://www.rcn.org.uk/clinical-topics/medicines-management/covid-19-remote-prescribing
- Royal Pharmaceutical Society (RPS) (2021) Competency framework for all prescribers Available at: https://www.rpharms.com/resources/frameworks/prescribers-competency-framework
- Royal Pharmaceutical Society (RPS) Medicines optimisation hub https://www.rpharms.com/resources/pharmacy-guides/medicines-optimisation-hub
- The Human Medicines Regulations [2012] Available at: https://www.legislation.gov.uk/uksi/2012/1916/contents/made
- The King’s Fund (2017) Social prescribing Available at: https://www.kingsfund.org.uk/publications/social-prescribing
- The Misuse of Drugs Regulations 2001 (SI 2001/3998) Available at: https://www.legislation.gov.uk/uksi/2001/3998/contents/made
- The Misuse of Drugs (Amendment No.2) (England, Wales and Scotland) Regulations [2012] Available at: https://www.legislation.gov.uk/uksi/2012/973/made
- The Prescription Only Medicines (Human Use) Order [1997] Available at: https://www.legislation.gov.uk/uksi/1997/1830/contents
- Weglicki RS, Reynolds J, Rivers PH. (2015) Continuing professional development needs of nursing and allied health professionals with responsibility for prescribing. Nurse Education Today. 2015;35(1):227–231. https://doi.org/10.1016/j.nedt.2014.08.009
- World Health Organisation (WHO) (2017) Global Patient Safety Challenge ‘Medication Without Harm’ WHO: Geneva, Available at: https://www.who.int/patientsafety/medication-safety/en/