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Section Two Section Two Section Two Section Two Secti
o
Section Two
Governance and Good Professional
Pharmaceutical Practice
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Chapter Eight
Clinical governance – an overview
Simon J. Tweddell
8
STUDY POINTS
*
Clinical governance, what it is and why it is
necessary
*
The use of standards for delivering quality services
*
The role of clinical governance in modern day
pharmacy
*
Regulation of pharmacists
*
How to deal with errors made by pharmacists
Introduction
Clinical governance is defined by the Department of
Health as ‘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’.
Clinical governance
Why is clinical governance
necessary?
Clinical governance was introduced following a series
of well publicized lapses in patient quality in the
1990s as part of a broader government agenda to
improve the quality of care delivered to patients by
the NHS. It is a set of processes that healthcare professionals are expected to work with in order to learn
from the successes and failures of both their own
practice and those of others and to promote an open
culture where experiences are shared to promote best
practice for their patients.
When was clinical governance
introduced?
The NHS document A First Class Service: Quality in
the New NHS (Department of Health 1998) intro-
duced the term ‘clinical governance’ stating that ‘for
the first time, the NHS will be required to adopt a
structured and coherent approach to clinical quality,
placing duties and expectations on local healthcare
organisations as well as individuals. Effective clinical
governance will make it clear that quality is everybody’s business’.
What is clinical governance?
The NHS publication Clinical Governance: Quality
in the NHS (1999) outlines four main components of
clinical governance. These are:
*
Clear lines of responsibility and accountability for
the overall quality of clinical care
*
A comprehensive programme of quality
improvement activities
*
Clear policies aimed at managing risks
*
Procedures for all professional groups to identify
and remedy poor performance.
The publication also provides examples of quality improvement activities, including:
*
Audit programmes (see Ch. 11)
*
Ensuring evidence-based practice (see Ch. 17)
SECTION TWO Governance and good professional pharmaceutical practice
*
Implementation of clinical standards
*
Continuing professional development
*
Monitoring of clinical care and high-quality record
into practice and a wider appreciation of the value of
preventing, analysing and learning fr om e rrors
becomes the norm.
keeping (see Chs 15 and 47)
*
Research and development to promote ‘an
evaluation culture’.
Clinical governance should underpin the practice of
allhealthcareprofessionalsastheystriveforthebest
quality of care for their patients and continually seek
improvement in their practice. Practising good clinical governance ensures a consistent approach to
decision making, minimizes risk and ensures that
patients are the pr iority and focus of the professional practice of pharmacists and all other healthcare
professionals.
Quality
Monitoring quality
Quality of care should be monitored through a process of clinical audits, clear policies aimed at managing
risks and involvement of patients and the public in an
open and transparent health service.
The audit cycle could include the following:
*
Decide criteria for ideal/best practice
*
Measure current practice
*
Feedback findings and set locally agreed targets
*
Implement change to move from current practice
to ideal
*
Re-audit practice after changes in place and provide
feedback to those involved
Standards for quality
*
Repeat audit cycle until practice meets agreed
targets.
Standards are set by clinical guidelines such as the
National Service Frameworks (NSFs). These are
documents that aim to guide decisions in a specific
area of health care, as defined by an authoritative ex-
Clinical governance and pharmacy
amination of current evidence. Decisions to prescribe
medicines should be evidence based. Evidence-based
medicine is defined as the use of clinical methods
and decision making that have been thoroughly
tested by properly controlled, peer-reviewed medical
research.
The NHS document Clinical Governance in Com-
munity Pharmacy (Department of Health 2001)
first introduced clinical governance into community
pharmacy, although it was not part of the contract at
that time. Clinical governance facilitators were introduced at a local level, whose role was to inform
Delivering quality
and educate community pharmacists on the primary
care organizations’ policies for good clinical gover-
Quality health care should be delivered by well
trained and motivated healthcare professionals
who are well managed and are commi tted to selfdevelopment through continuing professional
development (CPD; see Ch. 10). NHS staff should
communicate openly with o ther healthcare professionals and should be encouraged to share best practice. Errors, service failures or ‘near misses’ should
be recorded, reflected upon and shared among
others so they are not repeated and a ‘no-blame’
culture should be adopted for mistakes. NHS staff
should be regularly appraised on their performance and poor performance identified and remedied. The NHS document Organisation with a
Memory (Department of Health 2000) requires that
mechanisms are introduced for ensuring that, where
lessons are identified, the necessary changes are put
nance. The new contract for community pharmacists was launched in April 2005 with the inclusion
of clinical governance as an essential component of
the terms of servic e. The new contract requirements on clinical governance include the following
areas:
*
Patient and public involvement
*
Clinical audit
*
Risk management including the implementation of
standard operating procedures (SOPs)
*
Clinical effectiveness programmes, e.g. practising
evidence-based pharmaceutical care
*
Staffing and staff management
*
Education, training and CPD
*
Use of information, for example storing patient
information confidentially.
82
Clinical governance – an overview CHAPTER 8
Professional governance
Professional governance in the pharmacy profession
forms part of clinical governance, the aim of which is to:
*
Ensure that pharmacists work to accepted
standards of personal and professional conduct, put
their patients’ needs before their own and behave
with integrity and probity.
Professional governance in pharmacy could be defined as:
*
The process by which the pharmacy profession
works with its members to ensure that patients
receive an optimal standard of pharmaceutical care
and maintains confidence in the profession.
Duty of care
Pharmacists have a duty of care to the public and
their patients imposed by law to ensure that the
public is protected. The law would expect that pharmacists practise pharmacy to a level of competence
expected by the profession and indeed practised by
the average pharmacist. Pharmacists are expected to
exercise reasonable care when supplying the public
and patients with medicines and pharmaceutical and
other professional advice. In their practice, pharmacists are subject to criminal law (e.g. Medicines
Act, Misuse of Drugs Act), administrative law
(e.g. contractual agreements with the primary care
organizations), civil law and the Code of Ethics of
the Royal Pharmaceutical Society of Great Britain
(RPSGB).
Mistakes or errors do happen. However, the vast
majority of these are relatively minor and are usually
quickly and easily rectified without concern. Unless
a pharmacist causes deliberate harm to a patient it is
unlikely that he or she would be subject to criminal
charges; however, this is a possibility. In fact, a pharmacist and pre-registration trainee were initially
charged with manslaughter following the incorrect
dispensing of a supply of peppermint water that
caused the death of a 3-week-old baby in 1998.
The charge of manslaughter was later dropped
in favour of prosecution u nder the Medicines Act
instead.
Negligence
If the mistake by a pharmacist does lead to resulting da mag es then a more likely charge of negligence
may be pursued in a civil court. For a breach in a
duty of care to be proven then the prosecution
must prove that a duty of care exists, that this duty
of care has been breached and that the patient has
suffered damages resulting from the breach. Often
an expert witness from the pharmacy profession
would be called to explain how a ‘standard’ or ‘normal’ member of the profession would have act ed in
this case.
The Code of Ethics
Pharmacists are also subject to the RPSGB Code of
Ethics (see later) and should a pharmacist act in a
manner that falls below the standards expected of
members of the profession, then he or she may be
subject to internal investigations conducted by the
RPSGB.
Professional governance and regulation procedures in pharmacy
You may remember that one of the key components
of clinical governance is that there must be ‘Procedures for all professional groups to identify and remedy poor performance’. This role in the governance of
the professional is vital to ensure that patients are
protected and confidence in the profession is maintained. This role currently falls within the remit of
the RPSGB; however, by 2010, parliamentary time
permitting, this role will be undertaken by a new
regulatory body for pharmacists and pharmacy technicians. The new independent General Pharmaceutical Council (GPhC) was proposed in the government
White Paper entitled Trust, Assurance and Safety and
will be approved in 2009 ready to take on the substantive functions of the GPhC in 2010. It is proposed
that the GPhC will:
*
Set standards for pre-registration and postregistration education and training
*
Set standards for the conduct and ethics expected
of registrants
*
Set standards for practice and performance
*
Set standards for the content and frequency of
monitoring of CPD
*
Approve courses, institutions and qualifications
*
Maintain registers of pharmacists, pharmacy
technicians and premises
83
SECTION TWO Governance and good professional pharmaceutical practice
*
Determine initial fitness to practise of potential
registrants
*
Investigate impaired fitness to practise and
adjudicate fitness to practise cases.
To complicate matters in the meantime, the RPSGB
has had to implement new fitness to practise committees in 2007 following the publication of the Pharmacists and Pharmacy Technicians Order 2007. The
order came into force on 7 February 2007 and new
fitness to practise rules came into force on 30 March
2007 (see later). The order established three new
statutory committees:
*
Investigating Committee (replaces Infringements
Committee)
*
Health Committee (new committee)
*
Disciplinary Committee (replaces Statutory
Committee).
Under the old rules the RPSGB was only able to
consider allegations of misconduct and had limited
sanctions available to it. Under the new scheme the
RPSGB is able to consider a wider range of allegations
including those relating to a registrant’s health, and
has a number of new sanctions including imposing
conditions on registration and suspensions from the
registers of up to 1 year, as well as the power to direct
removal of the registrant’ s name from the appropriate
registers.
Investigating Committee
*
Issue a warning to the person concerned and advice
to any other person or other body involved in its
investigation of the allegation
*
Give a direction that the person’s registration shall
be suspended for a period not exceeding 12 months
*
Give a direction that the person’s registration shall
be conditional upon compliance with specified
requirements that the committee thinks fit to
impose for the protection of the public or in the
person’s own interests.
Disciplinary Committee
The Disciplinary Committee determines whether or
not the fitness to practise of the person of whom the
allegation is made is impaired based on allegations that
are not normally health related. If the committee
finds that fitness to practise is impaired it may:
*
Issue a warning to the person concerned and advice
to any other person or other body involved in its
investigation of the allegation
*
Give a direction that the person concerned be
removed from the register
*
Give a direction that the person’s registration shall
be suspended for a period not exceeding 12 months
*
Give a direction that the person’s registration shall
be conditional upon compliance with specified
requirements that the committee thinks fit to
impose for the protection of the public or in the
person’s own interests.
The Investigating Committee receives an ‘allegation’
and determines in the first instance whether that allegation should be referred to either the Disciplinary
Committee or the Health Committee. If referral is
unnecessary then it may issue:
*
A warning or advice to the person concerned in
connection with any matter arising out of or related
to the allegation
*
Advice to any other person or other body involved
in its investigation of the allegation on any matter
arising out of or related to the allegation.
Health Committee
The Health Committee determines whether or not
the fitness to practise of the person of whom the
allegation is made is impaired based on the health of
the person. If the committee finds that fitness to
practise is impaired it may:
84
When things go wrong
Pharmacists are only human and, despite best intentions and safeguards, mistakes do happen. It is how
mistake s are dealt with an d whether or not lessons
are learned from them that will normally determine whether incidents are referred for further investigation.
When a dispensing error occurs the pharmacist is
ideally placed to determine the potential risk to the
patient. When dealing with dispensing or prescribing
mistakes it is vital that pharmacists place the welfare
of the patient first and seek immediate medical attention if necessary. An investigating committee would
take a very dim view of pharmacists covering up a
mistake, not assessing the risk of a mistake to the
health of a patient or repeated mistakes where they
have clearly not taken remedial action in preventing
errors from recurring.
Clinical governance – an overview CHAPTER 8
Dealing with errors
While this is not a comprehensive checklist it may be
helpful to consider the following when an error
occurs:
*
Is there any risk to the welfare of the patient? If yes
refer to GP/Accident and Emergency, phoning
ahead if necessary
*
Who do I need to inform? e.g. patient’sGP,
superintendent pharmacist, family member of
patient, RPSGB inspector, primary care trust
(PCT) personnel. It is better for you to proactively
raise the error with these stakeholders rather than
them to hear of it from the patient, patient’s
solicitor, etc.
*
How did the mistake happen?
*
Could I have prevented it from occurring?
*
Document what happened in your medication
error log and describe all steps taken to remedy the
error
*
Review procedures in light of your own internal
investigation/self-reflection.
Preventing mistakes
*
Ensure SOPs for the supply of medicines are in
place and regularly used, evaluated and reviewed
*
Ensure that one person is not the sole dispenser and
checker of the supply of medicines
*
Ensure that medicines with similar sounding names
or with similar company livery are not placed next
to each other
*
Separate different strengths of medicines from one
another by placing another medicine between the
two different strengths.
Medication error logs
When a medication error does occur it is seen as
good practice to record the error in a medication
error log. Pharmacists should maintain such a log
as part of practising good clinical governance and
its use should form part of the S OP for dispensing.
In March 2007 the council of the RPSGB agreed the
criteria for which single dispensing errors are likely
to amount to misconduct and would warrant referral
to the Investigating Committee (Box 8.1). The criteria for referral include both the lack of systems to
record errors in the pharmacy and the failure to
make an error log if the pharmacist was aware that
one had occurred. The RPSGB inspectorate may, as
part of the routine visits to a pharmacy, ask to see
evidence that a system is in place to deal with dispensing errors, including the maintenance and use of
medication error logs. Inspectors will not normally
ask to view the actual logs unless investigating a
specific complaint relating to a dispensing error,
and may then request to see that specific medication
error log. The RPSGB has also stated that it may be
Box 8.1
Criteria for consideration of single dispensing
errors
Single dispensing errors are not likely to be referred to
the Investigating Committee unless one or more of
the following statements is true:
*
There is potential for, or evidence that, the
dispensing error caused moderate or severe harm
or death (the definitions of these are from the
National Patient Safety Agency (NPSA) definitions
for grading patient safety incidents – see Box 8.2)
*
There is evidence that the dispensing error was a
deliberate attempt to cause harm to patients or the
public
*
There is evidence of ill health or substance abuse
by the pharmacist
*
There is evidence that the individual departed from
agreed safe protocols or SOPs and in doing so
took an unacceptable risk
*
There are no systems to record errors in the
pharmacy (this should result in the superintendent/
pharmacy owner being referred)
*
There has been a failure to make an error log (if
aware of the error)
*
There are no systems to learn from errors in the
pharmacy (this should result in the superintendent/
pharmacy owner being referred)
*
No attempt has been made to learn from the
specific error
*
The society’s inspector has previously given
advice that would have prevented the error if it had
been implemented
*
There has been an attempt to cover up the alleged
dispensing error
*
There has been a failure to cooperate with an
investigation carried out by the society’s inspector
or other investigatory body
*
There is evidence of other misconduct that would
form the basis of a complaint
*
Failure to apologize/provide an explanation to the
patient/representative (if aware of the error)
*
There is relevant history within the past 3 years
85
SECTION TWO Governance and good professional pharmaceutical practice
particularly helpful if the error log describes any
review of systems carried out at the pharmacy in
light of the incident. If there are concerns regarding
a pharmacist’s fitness to practise then i t may be
that the entire medication error log may be examined, particularly if there was a concern for public
safety.
NPSA definitions for grading patient safety incidents are shown in Box 8.2. See also Examples 8.1
and 8.2.
Box 8.2
NPSA definitions for grading patient safety
incidents
*
No harm
Incident prevented – any patient safety incident
that had the potential to cause harm but was
prevented, and no harm was caused to patients
receiving NHS-funded care. Incident not
prevented – any patient safety incident that
occurred but no harm was caused to patients
receiving NHS-funded care
*
Low harm
Any patient safety incident that required extra
observation or minor treatment and caused
minimal harm to one or more patients receiving
NHS-funded care. (Minor treatment is defined as
first aid, additional therapy or additional
medication. It does not include any extra stay in
hospital or any extra time as an outpatient, or
continued treatment over and above the treatment
already planned; nor does it include a return to
surgery or readmission)
*
Moderate harm
Any patient safety incident that resulted in a
moderate increase in treatment and that caused
significant but not permanent harm to one or more
patients receiving NHS-funded care. (Moderate
increase in treatment is defined as a return to
surgery, an unplanned readmission, a prolonged
episode of care, extra time in hospital or as an
outpatient, cancelling of treatment or transfer to
another area such as intensive care as a result of
the incident)
*
Severe harm
Any patient safety incident that appears to have
resulted in permanent harm to one or more
patients receiving NHS-funded care. (Permanent
harm directly related to the incident and not related
to the natural course of the patient’s illness or
underlying condition is defined as permanent
lessening of bodily functions, sensory, motor,
physiological or intellectual, including removal of
the wrong limb or organ, or brain damage)
*
Death
Any patient safety incident that directly resulted in
the death of one or more patients receiving NHSfunded care. (The death must be related to the
incident rather than to the natural course of the
patient’s illness or underlying condition)
KEY POINTS
*
Clinical governance was introduced to improve the
quality of care to patients
*
The four main components are: lines of
responsibility, programme of quality improvement,
risk management policies and remedying poor
performance
*
Standards are set by national service frameworks
*
Errors or near misses should be recorded, reflected
upon and shared with others
*
Quality of care should be subject to clinical audit
*
The 2005 contract for community pharmacists
included clinical governance as a requirement
*
During practice, pharmacists are subject to both
criminal and administrative law
*
Currently the RPSGB has three committees with
responsibility in these areas – Investigating
Committee, Health Committee and Disciplinary
Committee
*
A new General Pharmaceutical Council will take on
the RPSGB role of governance
*
Mistakes will happen – how they are dealt with and
learned from is most important
*
When an error is made, the welfare of the patient is
paramount
*
A medication error log should be used to record all
lapses – and this should be part of a SOP
86
Clinical governance – an overview CHAPTER 8
Example 8.1
You are a community pharmacist manager and you are
asked to deal with a complaint from Mrs A.B. who claims
she was supplied with the wrong medication for her mother
yesterday. You establish that she was supplied with 28
amiodarone 100 mg tablets instead of 28 atenolol 100 mg
tablets. What action should you take?
It is important to first of all establish whether or not the
patient has taken any of the incorrect medication. If so, then
you are best placed to use your knowledge of medicines to
determine the risk to the patient. If there is any risk to the
health of the patient then you must advise the patient to
seek urgent medical attention. It may be necessary to
telephone the A&E department in advance of the patient
arriving to provide as many details as you can. It would also
be good practice to telephone the patient’s GP to inform
them of the risk to the patient.
Mrs A.B. informs you that her mother did take one of the
amiodarone tablets this morning.
You should advise her not to take any more and ask her to
seek medical attention. You should then phone the
patient’s GP to discuss the incident. The Code of Ethics for
Pharmacists and Pharmacy Technicians requires you to
‘make the care of patients your first concern’. Once you
have taken all reasonable steps to assure the patient’s
health and safety have been considered then it is important
to document the incident in the medication error log while it
is fresh in your mind. If you are working for a company then
you should inform the superintendent pharmacist and if
appropriate you could also seek advice from the RPSGB
inspectorate.
How should you reflect on this incident and prevent it or
similar errors from reoccurring?
Pharmacists and other healthcare professionals are only
human and accordingly dispensing and prescribing errors
do happen. What is important is to learn from them and take
action to prevent this or other similar errors from occurring.
Good clinical governance involves auditing and reflecting
on our own professional practice and when something
goes wrong taking action to improve systems and minimize
risk.
Example 8.2
You receive a letter from the PCT indicating that there is a
member of the public purporting to be a medical
practitioner who is contacting pharmacies in the area
with a view to obtaining illegal supplies of prescription
only medicines (POMs) and controlled drugs. What
action should you take now and what should you do if
you find that you have supplied him with a medicine
illegally?
Practising good clinical governance is not just about
preventing mistakes from recurring, it is about auditing
our policies and SOPs to ensure they protect the public
and are robust enough to allow for all eventualities,
including preventing medicines getting on to the black
market.
In this case you should ensure that your SOP requires
that all personal requests for prescription only medicines
and controlled drugs by persons purporting to be
medical practitioners, whether in person or by telephone,
are dealt with personally by the responsible pharmacist and
all early warning letters such as these are made available to
all pharmacists practising from your pharmacy. It is
essential that all unknown doctors are authenticated and if
necessary confirmation verified by a phone call to the
medical practice and if necessary the General Medical
Council.
While reviewing your procedures with the pharmacy
assistants, a member of staff indicates that a doctor visited
the pharmacy last Saturday requesting the purchase of a
number of medicines. She informs you that the relief
pharmacist dealt with the requests. You check the POM
register but find no record of the sale of POM medicines to
a GP last Saturday. What should you do now?
You must act on this information and assure yourself that
POMs were not supplied illegally from the pharmacy.
Although you were not the responsible pharmacist last
Saturday you would be as culpable as the pharmacist who
was if you later found out that the public was put at risk and
you did nothing about it.
You should contact the pharmacist in charge on that day to
ascertain the facts. If POMs or controlled drugs (CDs) were
sold to a member of the public who was purporting to be a
doctor then you must inform the police, the PCT, the
superintendent pharmacist and the RPSGB inspector. You
should make a full record of the events that occurred and
ask the relief pharmacist to do likewise.
87
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