Better Practice

Nurse-led clinics:
Accountability and practice
Richard Griffith
Abstract
The numbers of nurse-led clinics are continuing to grow in primary and acute
care, and they provide timely intervention for patients. The clinics provide exciting
opportunities for nurse prescribers but also carry an increased risk of exposure
to liability. In this article, some of the key areas of accountability underpinning the
duty of care of nurse prescribers working in nurse-led clinics are discussed.

urse-led clinics will continue to

grow under the NHS reforms in
England, with commissioners being
actively encouraged to make better use of
non-medical prescribers to achieve their
strategic goals (Fittock, 2010). Research by
the RCN has shown the benefits of nurseled clinics and their role in the effective
operation of the modern NHS (Leary and
Oliver, 2010). Without these clinics, patients
would not be seen in a timely manner,
their conditions could worsen, and cost of
treatment would rise (Middleton, 2012).
Developments in the regulation of
nurse prescribing have enabled the
continued expansion of nurse-led clinics
in primary and acute care. On the whole,
nurse prescribers do an excellent job.
Warnings from doctors that nurse-led
clinics were a threat to safety and would
lead to patients being endangered by the
reckless expansion of nurse prescribing
have proved to be unfounded (Cressey,
2006). However, there is no room for
complacency. Medication errors remain
the second most common reported error
in the NHS, behind slips, trips, and
falls (National Health Service Litigation
Authority, 2012). Increased responsibility
for diagnosis and prescribing undertaken
in nurse-led clinics also leads to increased
exposure to liability. In January 2012, the
Richard Griffith is a Lecturer at Swansea
University specialising in healthcare and law
Email: richard.griffith@swan.ac.uk

196

Royal College of Nursing (RCN) changed

the terms of its indemnity scheme to
exclude practice nurses (RCN, 2012). The
RCN argued that the 4050 annual claims
relating to practice nurses, many of which
concerned medication errors, accounted
for 90% of its indemnity scheme budget
amounting to five million pounds.

Accountability

Accountability is fundamental to the

protection patients receiving care
and treatment in nurse-led clinics.
It is essential that nurse prescribers
clearly understand the scope of their
accountability, as it is the means by
which the law imposes standards and
boundaries on their practice. Nurse
prescribers working in nurse-led clinics
have a considerable amount of autonomy
to make decisions about the care and
treatment of patients, and this demands
the highest levels of probity and a duty to
act with honest and integrity at all times.
A nurse prescriber in a walk-in clinic
was recently suspended for six months
by the Nursing and Midwifery Council
(NMC) who found his fitness to practise
impaired when he prescribed fluconozole,
erythromycin and cocodamol for his sister
in contravention of standard 11.2 of the
Standards of proficiency for nurse and
midwife prescribers (NMC, 2012a).
Defining accountability
Lewis and Batey (1982) define
accountability as:

the fulfilment of a formal obligation to

disclose to reverent others the purposes,
principles, procedures, relationships,
results, income and expenditures for which
one has authority...
This definition reveals that
accountability has its basis in law with a
formal or legal relationship between nurse
prescribers and the higher authorities
that hold them to account. The extent of
the scrutiny goes beyond conduct and
encompasses competence and integrity. To
be accountable is to be answerable for your
acts and omissions. The NMC (2008a)
code states that:
You are personally accountable
for your practice. This means that
you are answerable for your actions
and omissions, regardless of advice or
directions from another professional.
To provide maximum protection
for patients in nurse-led clinics, four
areas of law are drawn together and
can individually or collectively hold
nurse prescribers to account. They are
accountable to:
Society through the public law
Patients through the law of negligence
The employer through the law
of contract
The profession through the provisions
of the Nursing and Midwifery
Order 2001
Falling below the standards imposed by
these four areas of law can result in action
being taken against the nurse prescriber.
The need to preserve public and patient
confidence in nurse-led clinics means that
any misconduct by a nurse prescriber is
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Better Practice

taken very seriously. Sanctions are not

mutually exclusive, and a nurse prescriber
can expect to be punished by more than
one area of law. A nurse prescriber who
received a community punishment after
pleading guilty to the theft of diazepam
tablets from his place of work was also
dismissed by his NHS trust and made
subject to an interim suspension order by
the NMC (2012b).

Duty of care

Nurse prescribers in nurse-led clinics owe

their patients a duty of care. The duty is
a legal obligation to be careful, to take
care, and it underpins the prescribers
accountability.
The standard expected of a skilled
professional, such as a nurse prescriber,
is based on the test established by Bolam
v Friern HMC (1957) confirmed by the
House of Lords in Sidaway v Bethlem
Royal Hospital (1985). It requires a
prescriber to act in accordance with
a practice accepted as proper by a
responsible body of professionals skilled in
that particular art. This standard rises the
more the professional puts themselves out
as an expert. A nurse prescriber employed
to treat patients in a nurse-led clinic
will be subject to a high standard when
discharging their duty of care than more
junior nurses working on wards or general
community settings.
Although the law is generally
content for the profession to establish
the standards expected of prescribers,
in Bolitho v City and Hackney Health
Authority (1998), the House of Lords held
that any expert evidence used to support
a prescribers acts or omissions must stand
up to logical analysis. Therefore, it is
essential that practice in a nurse-led clinic
is evidence based and up to date. Courts
will not condone practice where others
too are negligent or common professional
practice is slack (Reynolds v North
Tyneside Health Authority, 2002).
In England, common standards for
quality and safety have been established
under the Health and Social Care Act
2008 (Regulated Activities) Regulations
2010. The Care Quality Commission
(CQC) regulates health and adult social
care providers in England and imposes
16 essential standards for quality and
safety. Nurse-led clinics are required to
Nurse Prescribing 2013 Vol 11 No 4

contribute to the achievement of these

essential standards, and the CQC has farreaching powers to take action if the clinic
fails to meet those requirements.
The essential standards of quality and
safety include:
Care and welfare of people who
use services
Assessment and monitoring of the
quality of service provision
Safeguarding people who use services
Cleanliness and infection control
Management of medicines
Safety and suitability of premises
Safety, availability, and suitability
of equipment
Respecting and involving people who
use services
Maintaining nutritional needs
Privacy, dignity, and independence of
service users
Consent to care and treatment
Complaints
Records
Requirements relating to workers
Staffing
Supporting workers
Cooperating with other providers.
The standards are an essential yardstick
against which the clinic service is
measured.
Managing medicines is a regulated
activity under the Health and Social
care Act 2008 and nurse-led clinics have
a duty to protect service users against
risks associated with unsafe use and
management of medicines. To achieve this
standard nurse-led clinics must ensure
that the medicines given to service users
are appropriate and person centred by
taking account of the age, choice, lifestyle,
conditions, allergies and disabilities
of a person when prescribing and
administering medicines. Medicines must
not be prescribed or administered in the
same arbitrary way to every service user.
The most appropriate medicine, route and
form of the drug must be considered in
each persons case. Prescriptions must be
kept up to date, reviewed and changed as
the persons needs change and risks must
be managed through effective procedures
for medicines handling.
This includes procedures to be followed
for obtaining, safe storage, prescribing,

dispensing, preparation, administration,

monitoring, and disposal of medicines
(CQC, 2009).
Failure to comply can result in a
warning, fine, or even closure of the nurseled clinic.
The CQC has a memorandum of
understanding with the NMC and will
pass on evidence of poor practice to the
regulator for investigation of a nurses
fitness to practice if they believe the nurse
to be responsible for poor standards (CQC
and NMC, 2010). A recent review of a
nurse-led clinic led to CQC enforcement
action when an inspection found that the
clinic had failed to ensure that patients
were protected against the risk of unsafe
or inappropriate care and treatment due to
a lack of proper patient information. The
clinic was required to provide an action
plan for the improvement of this standard
to the CQC, who would then check to
ensure the improvements were made
before considering further enforcement
action (CQC, 2012).
Scope of duty of care
Lord Diplock in Sidaway v Bethlem Royal
Hospital (1985) defined the duty as a:
Single comprehensive duty covering
all the ways in which a you are called
on to exercise skill and judgement in the
improvement of the physical and mental
condition of the patient.
The scope of the duty is extremely
broad and covers all the direct and
indirect ways nurse prescribers provide
care and treatment for patients. It includes
direct care, history taking, diagnosis,
recordkeeping, advice giving, the standard
of prescribing including the standard of
handwriting as well as recognising the
limits to the scope of practice, and when
to seek more senior assistance (Gold v
Haringey Health Authority, 1987). The
duty arises when a nurse prescriber in a
nurse-led clinic agrees to take a case and
continues until the patient is discharged,
refuses further treatment or is hand over
into the care of another practitioner.

Medication errors

Sharing or transferring the care of a

patient to another service or prescriber is
a situation where nurse-led clinics need
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Better Practice

to discharge their duty with particular

care. Medication errors at transitions in
care have been identified by the World
Health Organization (WHO) (2005) as
one of nine key patient safety areas that
must be improved. The WHO argues
that over 40% of medication errors occur
when prescriptions are issued on patient
admission or discharge and they urge
a system of medication reconciliation
to reduce these errors. This requires
prescribers in nurse-led clinics to ensure
they create a complete and accurate
list of all the medicinesincluding
prescription-only, over-the-counter, and
herbal medicinesthe patient is taking.
Keeping this list under review and up to
date to reflect changes in medication and
to communicate this list to the next care
provider to minimise error (Institute for
Healthcare Improvement, 2005).

Prescription-only drugs

Authority to authorise the supply of

prescription-only medicines can only
generally be given by an appropriate
practitioner under the provisions of the
Human Medicines Regulations 2012.
The Human Medicines Regulations
2012 were introduced in August 2012
and consolidate the wide range and
often piecemeal orders, regulations, and
European directives that had built up
over 40 years since the enactment of
the Medicines Act 1968. These are now
largely drawn together into a single
legal framework set out in the
2012 regulations.
Although medicines law generally
remains unchanged, the 2012 regulations
do make some provisions clearer and
extend the authority of non-medical
prescribers, including those who work in
nurse-led clinics.
Supplying prescription-only drugs
As a general rule, prescription-only
medicines must be supplied and
administered in accordance with the
directions of an appropriate practitioner
as set out in a valid prescription (Human
Medicines Regulations 2012: regulation
214(1)(a)).
This strict regime protects patients
from the harmful effects of medicines but
can delay treatment because of the need
to visit an appropriate practitioner or a
198

pharmacy before the medicine can be

supplied or administered.
To overcome this inflexible process
while still ensuring the safety of patients,
nurse-led clinics can take now take
advantage of amendments introduced by
the Human Medicines Regulations 2012
that allow prescription-only medicines to
be supplied for administration through
patient-specific directions (PSDs).
Patient-specific directions
PSDs are written instructions for
prescription-only medicines to be supplied
for administration to a named patient
without a prescription. PSDs have routinely
been used in hospitals through the patients
drug chart and administration record.
Prior to the introduction of the
2012 regulations the Prescription Only
Medicines (Human Use) Order 1997,
article 12 allowed any appropriate
practitioner, including non-medical
prescribers, to authorise the supply of a
prescription-only medicine in a hospital
for the purpose of being administered
(whether in the hospital or elsewhere) to a
specific person.
For other NHS settings article 12A of
the 1997 Order limited the exemption to
doctors and dentists. Nurse prescribers
could not authorise the supply of a
prescription-only medicines in nurse-led
clinics at a health centre, surgery, or other
community setting through a PSD, they
had to issue a prescription.
The Human Medicines Regulations
2012 remove that limitation for
independent nurse prescribers. Regulations
for the supply of a prescription-only
medicine do not apply to NHS bodies,
including community and primary care
trusts, where the product is supplied
for the purpose of being administered
to a person in accordance with the
written directions of doctor, dentist, or
independent non-medical prescriber.
A PSD differs from a prescription. To
be lawful, a prescription must meet the
requirements of the Human Medicines
Regulations 2012: regulation 217. In
contrast, a PSD is valid when it:
Is in writing
Relates to the particular person to
whom the medicine is to be supplied
for administration; and

Is issued by a person who is an

appropriate practitioner with authority
to issue a PSD in that setting.
Liability for harm rests with the
independent nurse prescriber who will
be accountable for the appropriateness of
the PSD and the appropriateness of any
delegation of the administration of the
medicine to another person.
The need for a prescription or a
PSD to be issued by an appropriate
practitioner with authority is also
a requirement of the Standards of
proficiency for nurse and midwife
prescribers and the Standards of
medicines management (NMC, 2006,
2008b). Failing to meet those standards
will call the nurse prescribers fitness to
practice into question and they will be
held to account. A nurse who worked
at several military health centres was
recently given an 18-month interim
suspension order by the NMC while
they conclude their investigation into
a series of incidents where he held
himself out to be a nurse prescriber
and prescribed medication to patients
when he was not a nurse prescriber
(NMC, 2012d). In another case, a
community matron was subject to an
18-month interim suspension order
by the NMC after investigations found
her to have written prescriptions in
advance of seeing patients and of issuing
prescriptions without assessing patients
(NMC, 2012c).

Conclusions

Nurse-led clinics allow patients to

receive timely care from specialist
nurse prescribers and their numbers
are set to expand under the NHS
reforms in England. The clinics offer
nurse prescribers an opportunity to
develop advanced practice and manage
a caseload of patients with relative
autonomy. With this autonomy comes
increased accountability and exposure to
the risk of liability. To ensure maximum
protection for patients, nurse-led clinics
are subject to legal and professional
standards that hold the service and its
practitioners to account for the quality
of care delivered in the clinic and the
discharge their duties in law. Failing to
meet the standards imposed by the law
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Better Practice

will result in nurse prescribers in nurseled clinics being held to account and called
to justify their actions. It is essential that
nurse prescribers in nurse-led clinics
are aware of the legal and professional
standards expected of them and that they
discharge those standards when caring for
patients in their clinics. In this way, they
will ensure the safety of their patients and
the continued development of their nurseled clinic.
Bolam v Friern HMC (1957) 1 WLR 582
Bolitho v City and Hackney Health Authority (1998)
AC 232
Care Quality Commission (CQC) (2009) Essential
standards of quality and safety. CQC, Newcastle
Care Quality Commission (CQC) (2012) Review of
compliance at University Hospitals Bristol NHS
Foundation Trust Central Health Clinic. CQC,
London
Care Quality Commission (CQC) and Nursing and
Midwifery Council (NMC) (2010) Memorandum
of understanding between the Care Quality

Commission and Nursing and Midwifery

Council. CQC and NMC, London
Cressey D (2006) Nurse prescribing a threat to
safety. Pulse October 5th: 1
Fittock A (2010) Non-medical prescribing by nurses,
optometrists, pharmacists, physiotherapists,
podiatrists and radiographers. A quick guide for
commissioners. National Prescribing Centre,
Liverpool
Gold v Haringey Health Authority (1987) 1 FLR 125
Health and Social Care Act 2008 (Regulated
Activities) Regulations 2010 (SI 2010/781)
Human Medicines Regulations 2012 (SI 2012/1916)
Institute for Healthcare Improvement (2005) The case
for medicine reconcilliation. Nursing Management
September 22nd: 22
Leary A, Oliver S (2010) Clinical nurse specialists:
Adding value to care. Royal College of Nursing,
London
Batey MV, Lewis FM (1982) Clarifying autonomy and
accountability in nursing service: part I. J Nurs
Adm 12(9): 138
Middleton J (2012) Recognising the value of all roles
in nursing. Nurs Times November 27th: 1
National Health Service Litigation Authority
(NHSLA) (2012) NHSLA risk management

Key Points
Nurse-led clinics will continue to grow under the NHS reforms in England
Increased responsibility for diagnosis and prescribing undertaken in nurse-led
clinics also leads to increased exposure to liability
Nurse prescribers working in nurse-led clinics must act with the highest levels
of probity and have a duty to act with honest and integrity at all times
Nurse-led clinics must meet the essential standards for quality and safety
imposed by the Care Quality Commission
Human Medicines Regulations 2012 now allows independent nurse prescribers.
In nurse-led clinics in health centres and community setting to issue patient
specific directions for the supply and administration of prescription-only medicines

standards 201213 for NHS trusts providing

acute, community, or mental health and learning
disability services and non-NHS providers of
NHS care. NHSLA, London
Nursing and Midwifery Council (NMC) (2006)
Standards of proficiency for nurse and midwife
prescribers. NMC, London
Nursing and Midwifery Council (NMC) (2008a) The
code: Standards of conduct, performance and
ethics for nurses and midwives NMC, London
Nursing and Midwifery Council (NMC) (2008b)
Standards for medicines management. NMC,
London
Nursing and Midwifery Council (NMC) (2012a)
Conduct and Competence Committee substantive
hearing on 8 and 9 November 2012. NMC,
London
Nursing and Midwifery Council (NMC) (2012b)
Conduct and Competence Committee substantive
hearing on 8 and 9 November 2012 at the NMC
Aldwych, London, WC2B 4EA. NMC, London
Nursing and Midwifery Council (NMC) (2012c)
Investigating Committee interim order hearing
on the 28 February 2012 at 85 Tottenham Court
Road, London, W1T 4TQ in respect of Dawn
Elizabeth Williams. NMC, London
Nursing and Midwifery Council (NMC) (2012d)
Investigating Committee new interim order
hearing on the 1 August 2012 at the NMC, 61
Aldwych, London, WC2B 4EA in respect of
David Maxwell Mwenitete. NMC, London
Nursing and Midwifery Order 2001 (SI 2002/253)
Reynolds v North Tyneside Health Authority (2002)
Lloyds Rep Med 459
Royal College of Nursing (RCN) (2012) A briefing
from the Royal College of Nursing on changes to
its indemnity scheme. RCN, London
Sidaway v Bethlem Royal Hospital (1985) AC 871
World Health Organization (WHO) (2005)
Collaborating Centre for Patient Safety: Nine lifesaving patient safety solutions. WHO, Geneva

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