Annex 1
ADVICE TO THE DEPARTMENT OF HEALTH AND THE
PHARMACY REGULATION AND LEADERSHIP OVERSIGHT GROUP ON ASPECTS
OF THE ESTABLISHMENT OF THE GENERAL PHARMACEUTICAL COUNCIL NOVEMBER
2008
1. INTRODUCTION
1.1 Pharmacy practice will undergo significant
change over the next decade. The new regulator of the pharmacy
profession will need to meet that challenge. Pharmacists and pharmacy
technicians are a mobile workforce, operating in a wide range
of settings, often working within commercial imperatives while
ensuring that patients receive the best possible service. The
future development of pharmacy outlined by recent policy initiatives
presents the profession with exciting challenges and changes as
it moves increasingly towards the delivery of clinical services.
1.2 The establishment of the General Pharmaceutical
Council presents an opportunity to create a truly patient-focused
regulatory body, whose activities are directed by assessment of
risk to patient safety of rapidly developing pharmacy practice,
which anticipates change and reacts quickly to it. The GPhC has
the potential to become an exemplar of modern professional regulation:
effective in protecting patients, agile in identifying and responding
to change, and balanced in its approach to risk and regulation.
2. EXECUTIVE SUMMARY
OF RECOMMENDATIONS
2.1 The Council for Healthcare Regulatory Excellence's
key observations are:
— Change in pharmacy will be rapid, in
terms of role development of pharmacists and pharmacy technicians,
and technological advancement in pharmacy products.
— Pharmacists and pharmacy technicians will
be interacting with patients and the public in new and different
ways.
— With the changes in their roles, pharmacists
and pharmacy technicians will need to develop new ways of working
with colleagues.
— Change will introduce new areas of risk
to patient safety.
— Pharmacists and pharmacy technicians
will need clear advice and guidance on standards in these new
areas.
— Pharmacists and pharmacy technicians
will need to acquire what may be new skills and knowledge, for
example in behaviour change in the public health role.
— Pharmacy will in future be practised
in a wider range of settings, for example in patient's homes or
GP/veterinary surgeries.
— Individual pharmacists increasingly work
across different settings, in different sectors, potentially resulting
in a complex risk profile at an individual level.
— Changes in an increasingly globalised
society will affect both the practice of pharmacy and present
challenges to its regulation and the protection of public safety—for
example, the availability of pharmaceutical products on the internet.
— Changes in IT, for example electronic
prescribing and online pharmacy, will affect practice, and will
need to be reflected in GPhC's standards.
— Pharmacists will continue to play an
important role in industry, clinical departments and regulatory
matters.
2.2 Our main recommendations are that:
— It is essential to ensure that the closely
integrated regulation of pharmacy professionals, premises and
products continues. This is a great strength in ensuring patient
safety.
— Across all of its functions, GPhC will
need to allocate its resources according to assessment of risk
to patient safety, taking a light touch where risk to patient
safety is low and focusing on areas where risk is highest.
— The GPhC will need to establish a horizon-scanning
function capable of anticipating the changes in pharmacy practice
which will occur over the next decade.
— GPhC itself will need to be able to adapt
quickly to reflect change in its standards, structures and processes.
— The GPhC's standard-setting function
will need to be flexible, with new areas of practice being anticipated
and standards developed and promulgated quickly.
— In the establishment of the GPhC consideration
should be given to the examples of best practice which have arisen
from the CHRE 2008 performance review.
— In the transfer of responsibility to
GPhC, areas of good and developing practice in the current regulation
of the pharmacy professions, identified by CHRE's performance
review, should not be lost.
— In the preparation of legislation for
the new GPhC appropriate statutory powers should be included to
make continuing professional development (CPD) mandatory.
— The governance arrangements of the GPhC
should follow the principles set out in the report Enhancing
Confidence in Healthcare Professional Regulators.[86]
— The GPhC is set up in such a way that
at a logistical level it is a straightforward matter to register
Northern Ireland's pharmacists and pharmacy technicians, should
Northern Ireland's Health Minister decide in future that this
is his wish.
2.3 These recommendations are based on the Better
Regulation Executive's five key principles of better regulation:[87]
— Proportionate: regulators should only
intervene when necessary. Remedies should be appropriate to the
risk posed, and costs identified and minimised.
— Accountable: regulators must be able
to justify decisions, and be subject to public scrutiny.
— Consistent: government rules and standards
must be joined up and implemented fairly.
— Transparent: regulators should be open,
and keep regulations simple and user-friendly.
— Targeted: regulation should be focused
on the problem, and minimise side effects.
In addition CHRE proposes a sixth principle:
— Agile: regulators must be consistently
in a state of readiness to respond to changes and developments
in healthcare professional practice and circumstances.
2.4 These recommendations are also based
on the following good governance principles:[88]
— The council should uphold the purpose
of the organisation as established by parliament, determine its
values and keep both its purpose and values in mind at all times,
with mechanisms in place for annual review.
— The council should be forward- and outward-looking,
focussing on the future, assessing the environment, engaging with
the outside world, and setting strategy.
— The council should determine the desired
outcomes and outputs of the organisation in support of its purpose
and values.
— For each of the desired outcomes the
council should decide the level of detail to which it wishes to
set the organisation's policy—any greater level of detail
of policy formulation should then be a matter for the determination
of the chief executive and staff.
— The means by which the outcomes and outputs
of the organisation are achieved should be a matter for the chief
executive and staff; the council should not distract itself with
operational matters.
— The chief executive should be accountable
to the council for the achievement of the organisation's outcomes
and outputs.
— In assessing the extent to which the
outcomes have been achieved, the council must have a framework
of pre-determined criteria against which performance is reported
both internally and externally.
— The council should engage with its key
interest groups including patients, the public, registrants, employers,
educators and the devolved administrations, and be confident that
it understands their views and priorities.
— The membership of the council should
have the capacity and skill to understand the priorities of each
of these key constituents.
— Information received and considered by
the council should support one of three goals—to allow informed
decision making, to fulfil control and monitoring processes or
to enable the council to co-operate with CHRE and to be accountable
to parliament.
— The council must govern itself effectively,
with clear role descriptions for itself, its chair, and its members,
with agreed methods of working and self-discipline to ensure that
time is used efficiently.
— The council must ensure that issues of
equality and diversity are considered as part of all its work.
2.5 The recommendations are also based on CHRE
performance standards:[89]
2.5.1 Standards and guidance
— The regulator publishes standards of
competence and conduct which are appropriate, comprehensive, prioritise
patient interests and reflect up-to-date professional practice.
— The regulator makes its standards available
and accessible proactively to registrants and potential registrants
in the UK,[90]
and informs them of their current or future responsibility to
meet these standards.
— The regulator informs the public of the
standards that professionals should meet and the action that they
can take if these standards are not met.
— The regulator requires registrants to
maintain standards through a process of CPD or equivalent systems,
and is working towards a system of revalidation.
2.5.2 Registration
— The regulator has efficient, fair and
transparent processes for entry to the register and periodic renewal
of registration.
— Registers are accessible to the public
and include appropriate information about registrants.
— The regulator takes appropriate action
to prevent non-registrants practising under a protected title.
2.5.3 Fitness to practise
— The regulator has a process through which
patients, the public and others can raise concerns about registrants
and understand how their concerns will be dealt with.
— The regulator keeps all relevant parties
informed of progress on cases at all appropriate stages.
— Fitness to practise cases are dealt with
in a timely manner at all stages.
— There are quality processes for the appointment,
assessment and training of fitness to practise panel members.
Panel members also have clear guidance on how to assess cases.
— Decisions made at the initial stages
of the fitness to practise process (pre-fitness to practise panel
stage) are quality assured.
— Fitness to practise panels make appropriate,
well reasoned decisions on cases.
2.5.4 Education
— The regulator ensures that its standards
for the education and training to be met by students are appropriate,
comprehensive, prioritise patient safety and interests and reflect
up-to-date professional practice.
— The regulator ensures that its standards
for the delivery of education and training are appropriate, comprehensive,
prioritise patient interests and reflect up-to-date professional
practice.
— The regulator has a transparent and proportionate
system of quality assurance for education and training providers.
2.5.5 Governance and external relations
— The regulator is a transparent and accountable
organisation and significant policy decisions are demonstrably
based on the public interest.
— The regulator establishes and works within
efficient and effective organisational processes.
— The regulator fosters a culture of continuous
improvement within the organisation.
— The regulator co-operates with stakeholders
and other organisations.
3. BACKGROUND
3.1 On 6 May 2008 CHRE was commissioned by the
Department of Health to provide advice on the following aspects
of the establishment of the General Pharmaceutical Council:
— Existing good practice in relation to
the regulation of the pharmacy professions.
— Likely changes to pharmacy practice over
the next five to ten years which could have implications for the
way that the pharmacy professions are regulated.
— The core functions of a regulatory body
(drawing on the White Paper Trust Assurance and Safety—the
Regulation of Health Professionals in the 21st Century and the
preceding reviews of regulation).
— What constitutes good governance arrangements,
in terms of the functions and procedures of a Board and internal
governance processes.
— Operational implications arising from
the various settings for pharmacy practice (eg community, hospital,
industry etc), the need to operate in the context of devolved
government in the United Kingdom, European Community law and the
general movement of people across international boundaries.
3.2 In preparing to provide advice on these
aspects of the establishment of the new body, we have both looked
at the key documents setting out the future of pharmacy practice
across the UK, and have held face-to-face discussions with a wide
range of people and organisations. This has included the Royal
Pharmaceutical Society of Great Britain, the Pharmaceutical Society
of Northern Ireland, other regulatory bodies, the devolved administrations,
and organisations representing pharmacists working in specific
sectors. In a few cases, where meeting has not been possible,
written submissions have been received.
3.3 We are extremely grateful to those with
whom we have discussed aspects of this advice and other contributors
for the time that they have taken to share their thoughts with
us. We are particularly grateful to the RPSGB and the PSNI for
their proactive co-operation with us, and for the lengths to which
they have gone to ensure that we have the information that we
need and to set up meetings. We have enjoyed wide-ranging discussions
on the future of pharmacy, and ask our contributors to recognise
that unfortunately it has not been possible to reflect on all
of the matters that we have discussed when writing our advice
on the specific questions put by our commission, or to reflect
all points of detail.
3.4 Throughout this advice in discussing the
future of pharmacy we have taken a UK-wide perspective, unless
otherwise stated at any point, while appreciating that in the
first instance at least GPhC will be a body which covers England,
Scotland and Wales. We discuss the regulation of pharmacy in Northern
Ireland in more detail at 9.3.8-9.3.12.
4. EXISTING GOOD
PRACTICE IN
RELATION TO
THE REGULATION
OF THE
PHARMACY PROFESSIONS
4.1 In this section we draw on our performance
review of the RPSGB and PSNI in 2008, summarising the particular
points which were noted as good practice and commenting on wider
issues and areas for further work going forward into the establishment
of GPhC. As the existing regulatory departments of RPSGB will
form the basis of the new GPhC in the first instance, we have
considered the performance review of RPSGB in more depth than
that of PSNI.
Existing good practice at RPSGB and related issues
4.2 Our 2008 performance review confirmed that
the RPSGB carried out its regulatory functions successfully during
a period of change and challenge, not least of which being the
preparations for the establishment of the GPhC. It will be important
to ensure that successful performance of functions and current
developmental work across the organisation is not lost in the
transfer to GPhC.
4.3 We found that standards form the basis of the
RPSGB's statutory functions, prioritise patient safety, are comprehensive
and the Code of Ethics is well laid out. There is an effective
communications strategy with key groups. The registration process
is well-managed with applications handled in a timely manner;
the register is accessible and reasonably easy to understand and
search. There is an effective process to deal with cases of unregistered
individuals claiming to be pharmacists. Work is in hand to introduce
improved IT-based case management in fitness to practise which
we consider is essential for the effective operation of fitness
to practise processes. Cases are handled relatively quickly by
the RPSGB and further improvements are anticipated.
4.4 The Inspectorate is effective in detecting
fitness to practise concerns and investigating them; a future
issue to address will be to establish the relationship between
the Inspectorate, the fitness to practise department and the National
Clinical Assessment Service, as NCAS expands its remit to include
pharmacists.
4.5 In the oversight of pharmacy practice the
RPSGB collaborates effectively with the Medicines and Healthcare
Products Regulatory Agency, the Healthcare Commission and the
police. A future issue for resolution will be to manage the relationship
and the interface with the Care Quality Commission (once established)
to agree protocols on registration of premises, for example, when
a pharmacy registered with GPhC expands its activities into areas
that are registerable with the CQC.[91]
It is essential to ensure that the closely integrated regulation
of professionals, premises and products continues. This is a great
strength in ensuring patient safety.
4.6 Areas needing further work include raising
the profile of the register, in particular with the public, introducing
IT-based fitness to practise case management as noted, and setting
service standards across fitness to practise. The membership of
the Council of the RPSGB does not reflect a sufficiently broad
range of interests in view of the wide range of stakeholders in
pharmacy regulation, due to existing legislative restraints. This
must be addressed by the GPhC in establishing its Council. We
discuss board governance in more detail below (paragraphs 7.1-7.3).
Finally, the RPSGB does not currently have the statutory power
to make CPD mandatory, and it will be essential that the GPhC
has the right statutory powers in this area.
Existing good practice at PSNI and related issues
4.7 In our performance review of PSNI we found
that it fulfils most of its functions satisfactorily within the
constraints of existing outmoded legislation. Noting the good
work that is already underway across the range of functions to
improve its performance, and the obvious desire and commitment
of its leadership to develop its practice, we strongly recommend
that a new legal framework for the regulation of pharmacy in Northern
Ireland is put in place as soon as possible.
4.8 A particular area of good practice which
we commend to GPhC (and other regulatory bodies) is the appointment
of pre- and post-registration facilitators by PSNI. These professionals
play a useful role in improving communication and promoting standards
with students, registrants and employers.
4.9 We discuss pharmacy regulation in Northern
Ireland further at paragraphs 9.3.8-9.3.12.
5. LIKELY CHANGES
TO PHARMACY
PRACTICE OVER
THE NEXT
FIVE TO
TEN YEARS
WHICH COULD
HAVE IMPLICATIONS
FOR THE
WAY THAT
THE PHARMACY
PROFESSIONS ARE
REGULATED
Summary of the likely changes to pharmacy practice
5.1 Pharmacy practice will undergo significant
change over the next decade. In the community, there will be an
expanded public health role, with emphasis shifting from the dispensing
of medicines to the provision of clinical services. Pharmacies
will provide a wider range of services supporting healthy living,
including helping patients to manage long-term conditions and
supporting self-care. In hospital practice, there will be an enhanced
clinical role, taking a higher profile in the work of multidisciplinary
teams and leading in areas such as medicines reconciliation on
admission. Hospital and community pharmacy will work together
in health community clinical pharmacy teams. From industry, we
heard in particular about innovations in proteomics, and their
potential for the development of new more individualised medicines.
From veterinary pharmacy we heard about the likely increase in
the dispensing of medicines for companion animals by community
pharmacies. Increasing automation and technological advancements
have freed up pharmacy technicians to be able to make a fuller
contribution to services. Pharmacy products and their administration
are also changing and developing rapidly, including the increasing
range of pharmacy medicines.
5.2 Another area of rapid development will be
in the use of IT. Increasingly, prescriptions will be transferred
electronically. As pharmacists develop their clinical role, protocols
will need to be developed to enable them to access and contribute
to the NHS Care Records Service, both the detailed locally-held
information and the Summary Care Records held nationally.
5.3 We asked many of those with whom we have
discussed this advice if there were significant differences in
the development of pharmacy in the different countries of the
UK. We heard that there were some differences in emphasis, with
specific initiatives occurring in only a single country, or innovations
that were more advanced in some locations than others. To some
extent this is explained by the different distribution of the
workforce in the different countries across the settings in which
pharmacy is practised. However, in general it is clear that that
the general principles and direction of travel apply across all
four countries of the UK.
Key considerations for GPhC arising from change
in pharmacy practice
5.4 The key considerations for GPhC are as follows:
— Change will be rapid, in terms of role
development of pharmacists and pharmacy technicians, and technological
advancement in pharmacy products.
— Pharmacists and pharmacy technicians
will be interacting with patients and the public in new and different
ways.
— With the changes in their roles pharmacists
and pharmacy technicians will need to develop new ways of working
with colleagues.
— Change will introduce new areas of risk
to patient safety, for example, in the area of the maintenance
of proper boundaries in hands-on diagnostic procedures, and in
the risks inherent in the prescribing, dispensing and use of more
individualised pharmaceutical products which may require highly
skilled administration.
— Pharmacists will need clear advice and
guidance on standards in these new areas. For example, community
pharmacists expanding their role into dispensing veterinary pharmaceutical
products will need to understand the boundaries between this area
of work and those tasks which must only be carried out by a registered
veterinary surgeon, as well as the other considerations specific
to dispensing for animals.[92]
— Pharmacists and pharmacy technicians
will need to acquire what may be new skills and knowledge, for
example in behaviour change in the public health role.
— Pharmacy will in future be practised
in a wider range of settings, for example in patient's homes or
GP/veterinary surgeries.
— Individual pharmacists increasingly work
across different settings, in different sectors, potentially resulting
in a complex risk profile at an individual level.
— Changes in an increasingly globalised
society will affect both the practice of pharmacy and present
challenges to its regulation and the protection of public safety—for
example, the availability of pharmaceutical products on the internet.
— Changes in IT, for example electronic
prescribing and online pharmacy, will affect practice, and will
need to be reflected in GPhC's standards.
— Pharmacists will continue to play an
important role in industry, clinical departments and regulatory
matters.
Implications for the new regulatory body—risk-based
regulation
5.5 Having identified the characteristics and
changes listed in 5.4, we considered the implications for the
new regulatory body. In order to regulate in the diverse, complex
and fast-moving area of pharmacy practice it will be necessary
for the GPhC to allocate its resources and order its priorities
on the basis of risk-assessment in accordance with the Hampton
principles[93]
and the principles set out by the Better Regulation Executive,
as referenced by the Foster review,[94]
namely that statutory regulation should be:
— Proportionate: regulators should only
intervene when necessary. Remedies should be appropriate to the
risk posed, and costs identified and minimised.
— Accountable: regulators must be able
to justify decisions, and be subject to public scrutiny.
— Consistent: government rules and standards
must be joined up and implemented fairly.
— Transparent: regulators should be open,
and keep regulations simple and user-friendly.
— Targeted: regulation should be focused
on the problem, and minimise side effects.
5.6 In addition, we propose a sixth principle—agile.
The regulatory body must be able to anticipate change, including
in the environment in which its registrants work, and react quickly.
This should be reflected in its structure, standards, policies
and processes.
5.7 The RPSGB is thorough and detailed in the
application of its processes. Given the rapid pace of change that
is anticipated in the development of pharmacy practice, the GPhC
will need to develop its approach to risk management and proportionality
so that it can focus most closely on those areas where risk to
patient safety is assessed to be highest. This approach will give
GPhC the flexibility to adapt quickly as pharmacy practice develops
in future. The organisation will wish to refer to the outcome
of the work currently being commissioned by the Department of
Health on risk assessment in the context of the implementation
of Trust, Assurance and Safety, specifically for the working
groups on non-medical revalidation and extending professional
regulation.
5.8 We heard about the work currently being
undertaken to develop and define advanced practice, both within
RPSGB and other initiatives such as that being led by the Joint
Programmes Board (London, East and South East England).[95]
This is an area of rapid development, where pharmacists are working
in the areas of greatest uncertainty and have the highest levels
of responsibility for managing that uncertainty, for example in
combining drugs in unprecedented ways for critically ill patients.
As such, it is a good example of an area where GPhC should focus
its attention, where there are demonstrable issues of public protection.
GPhC should support those working in high risk areas by defining
standards and advising on the circumstances and parameters within
which risks can reasonably be taken. Following the report A
High Quality Workforce: NHS Next Stage Review,[96]
CHRE will be undertaking work on advanced practice in close liaison
with the regulatory bodies, and drawing on existing work from
across the UK.
Implications for the new regulatory body—horizon
scanning and stakeholder network management
5.9 The next question that we considered was
how the new regulatory body would stay abreast of, and ahead of,
the rapid advance in practice that is anticipated over the next
five to 10 years.
5.10 Our advice is that from the outset GPhC
will need to establish the capacity for continuous horizon scanning.
This will ensure that it stays ahead of practice and anticipates
changes and developments before they occur, enabling it to reflect
these back into its standard-setting and other functions of the
organisation. In doing so, it will need to manage proactively
a network of stakeholders, including the professional body, patients
and the public, consumer groups, employers in all sectors, organisations
representing pharmacists and pharmacy technicians working in particular
sectors, higher education institutions, trades unions, the Medicines
and Healthcare Products Regulatory Agency, and the devolved administrations
(see section 9).
5.11 Several times during our interviews the
issue arose of whether it would be cost effective for the regulatory
body to perform its own horizon scanning given that the professional
body would also be performing a similar function, and whether
the professional body might in some way be commissioned to perform
horizon scanning on behalf of the regulatory body. Although there
could be some sharing of intelligence in this area, and the professional
body will be an important source of advice and input, the organisations
must perform their own horizon scanning, reflecting their distinct
roles—the professional body will be creating and shaping
the future of pharmacy practice, while the regulatory body will
be anticipating change and reflecting it in the standards that
it upholds for its registrants.
Implications for the new regulatory body—standard
setting
5.12 We are aware that the standards documentation
of the RPSGB was revised last year and published in August,[97]
and that a wide range of stakeholders was involved in the redrafting.
We are also aware that, in order to remain up to date for as long
as possible without the need for review, the standards were worded
in such a way as to be statements of principle and therefore to
some extent future-proof. The standards are comprehensive, prioritise
patient safety, and are well laid out.
5.13 However, given the likely pace of change
over the next 10 years, a standards-setting function based on
a document reviewed at intervals and published in paper form will
not be the best way to ensure that standards stay up-to-date with
practice and cover all eventualities.
5.14 We advise that the GPhC moves towards a
more flexible and dynamic standards-setting process, in which
standards can be reviewed and changed quickly. The organisation
will need to establish protocols for deciding when changes to
practice as they occur require changes to standards, and how stakeholders
will be consulted on proposed changes. It will also need to find
ways to communicate changes to registrants, building on the RPSGB's
current effective communications strategy, for example through
supplementary and issue-specific guidance. As changes to the standards
may occur more frequently in future, an archiving and version
control process will be required to ensure that it will always
be possible to know what version applied at any given time, not
least to inform fitness to practise processes.
5.15 In the remaining paragraphs in this section
we reflect in general terms on the implications of a more flexible,
rapidly developing standards-setting function for the other functions
of the new regulatory body.
Implications for the new regulatory body—quality
assurance of education
5.16 The standards-setting function will need
to inform the quality assurance of the education function to ensure
that pharmacists and pharmacy technicians with the right skills,
knowledge and professional attitudes to meet contemporary standards
are emerging from pharmacy courses. We note as a result of the
recently published A High Quality Workforce: NHS Next Stage
Review CHRE is to be commissioned to conduct research to identify
and promote best practice in the quality assurance of education.[98]
Implications for the new regulatory body—fitness
to practise
5.17 A mechanism will be required to ensure
that the standards setting function and the fitness to practise
function inform each other. As standards change, this will inform
the way that referrals are handled at an early stage, the indicative
sanctions guidance available to panels when a case proceeds to
a hearing and the training of panellists. Likewise, learning from
fitness to practise cases will need to feed back into the standards
setting function. If in future standards are to evolve more quickly
than has previously been the case, version control will be required
so that throughout the consideration of a case it is judged against
the standards applicable at the relevant time.
5.18 It will be essential to ensure that GPhC
has a full range of sanctions available to it in fitness to practise
cases. CHRE is currently working on harmonisation of the sanctions
available across the healthcare professions. Another issue for
the GPhC to consider in establishing its fitness to practise function
concerns the chairing of panels in fitness to practise hearings.
From its consideration of over 4,000 decisions by fitness to practise
panels CHRE concludes that panels with legally qualified chairs
do not produce higher quality decisions or better-written adjudications
than panels with chairs who are not legally qualified.
Implications for the new regulatory body—continuing
professional development
5.19 High-quality continuing professional development
will be essential for a profession going through rapid change
and development, to ensure that the existing workforce in pharmacy
is able to keep pace with the new skills and knowledge they will
need to acquire. This adds further weight to the urgency for CPD
to be made mandatory under the GPhC, which we discuss elsewhere
in this advice (paragraphs 4.6 and 8.5).
Implications for the new regulatory body—revalidation
5.20 Revalidation decisions will be based on
whether a registrant meets the contemporary standards, based on
submitted evidence. It will need to be clear to registrants which
is the contemporary set of standards against which this decision
will be made in order to ensure that they provide relevant evidence
and information.
5.21 The GPhC will need to develop sophisticated
methods of risk profiling its registrants as the basis for revalidation,
given the increasing appearance of combined roles across sectors
in pharmacy, the increasing differentiation of roles within sectors
and the mobility of the pharmacy workforce. The organisation will
need to determine the amount and nature of information that it
will be reasonable to demand of registrants towards the revalidation
decision, given the range of roles that they may have at any one
time. To do so will require dedicated efforts to map trends in
the pharmacy workforce, building on the work that RPSGB already
undertakes in this area.
Implications for the new regulatory body—patient
and public involvement
5.22 The rapid pace of change will present GPhC
with a considerable challenge in patient and public involvement,
both in finding ways to communicate to the public the standards
that they can expect from pharmacists and pharmacy technicians,
and in involving patients and the public in its work. There are
various successful models of patient and public involvement, such
as the approach by the General Medical Council, which we would
encourage GPhC to consider, building on the strong programme of
work already being developed by RPSGB and on its existing links
with public and patient representative organisations. Key characteristics
of successful models are that they engage with a wide range of
people, use a variety of methods and that those involved are able
to see that their involvement makes a difference.
6. THE CORE
FUNCTIONS OF
A REGULATORY
BODY
6.1 CHRE reviews the performance of the health
professional regulators against five key standards and a set of
minimum requirements under each standard. The standards were developed
during 2007 in collaboration with nine health regulators, and
focus on the outcomes for regulation and the protection of patients
and the public.[99]
They were piloted in the 2008 performance reviews. It should be
noted that the standards will be reviewed in the light of this
pilot process and in advance of the 2009 performance review round.
For reference they are quoted below in paragraphs 6.2-6.6. At
6.7 we quote the functions as defined by the White Paper Trust
Assurance and Safety.
6.2 Standards and guidance
— The regulator publishes standards of
competence and conduct which are appropriate, comprehensive, prioritise
patient interests and reflect up-to-date professional practice.
— The regulator makes its standards available
and accessible proactively to registrants and potential registrants
in the UK, and informs them of their current or future responsibility
to meet these standards.
— The regulator informs the public of the
standards that professionals should meet and the action that they
can take if these standards are not met.
— The regulator requires registrants to
maintain standards through a process of CPD or equivalent systems,
and is working towards a system of revalidation.
6.3 Registration
— The regulator has efficient, fair and
transparent processes for entry to the register and periodic renewal
of registration.
— Registers are accessible to the public
and include appropriate information about registrants.
— The regulator takes appropriate action
to prevent non-registrants practising under a protected title.
6.4 Fitness to practise
— The regulator has a process through which
patients, the public and others can raise concerns about registrants
and understand how their concerns will be dealt with.
— The regulator keeps all relevant parties
informed of progress on cases at all appropriate stages.
— Fitness to practise cases are dealt with
in a timely manner at all stages.
— There are quality processes for the appointment,
assessment and training of fitness to practise panel members.
Panel members also have clear guidance on how to assess cases.
— Decisions made at the initial stages
of the fitness to practise process (pre-fitness to practise panel
stage) are quality assured.
— Fitness to practise panels make appropriate,
well-reasoned decisions on cases.
6.5 Education
— The regulator ensures that its standards
for the education and training to be met by students are appropriate,
comprehensive, prioritise patient safety and interests and reflect
up-to-date professional practice.
— The regulator ensures that its standards
for the delivery of education and training are appropriate, comprehensive,
prioritise patient interests and reflect up-to-date professional
practice.
— The regulator has a transparent and proportionate
system of quality assurance for education and training providers.
6.6 Governance and external relations
— The regulator is a transparent and accountable
organisation and significant policy decisions are demonstrably
based on the public interest.
— The regulator establishes and works within
efficient and effective organisational processes.
— The regulator fosters a culture of continuous
improvement within the organisation.
— The regulator co-operates with stakeholders
and other organisations.
Consistency with Trust Assurance and Safety
6.7 The definition of the functions of a regulatory
body as set out above in our view is consistent with that set
out in the White Paper Trust, Assurance and Safety, namely:
setting and promoting standards for admission to the register
and for remaining on the register; keeping a register of those
who meet the standards and checking that registrants continue
to meet the standards; administering procedures for dealing with
cases where a registrant's right to remain on the register has
been called into question; and ensuring high standards of education
for the health professionals that they regulate.[100]
Examples of best practice arising from CHRE's
2008 performance review
6.8 We have recently published our reports on the
performance reviews of the healthcare professional regulatory
bodies, including a general report on the state of healthcare
professional regulation.[101]
We commend the examples of best practice that are identified.
7. WHAT CONSTITUTES
GOOD GOVERNANCE
ARRANGEMENTS IN
TERMS OF
THE FUNCTIONS
AND PROCEDURES
OF A
BOARD AND
INTERNAL GOVERNANCE
ARRANGEMENTS
General observations—policy governance model
7.1 CHRE supports the findings of the report
of the working group (chaired by Niall Dickson) Implementing
the White Paper Trust Assurance and Safety: Enhancing Confidence
in Healthcare Professional Regulators. As a contribution to
the discussions of the working group CHRE compiled a list of principles
that should underpin the work of a board, which the working group
refined into principles specifically applicable to the council
of a healthcare professional regulator. The principles are quoted
in 7.3 below.
7.2 We advise that the governance arrangements of
the GPhC reflect the findings of that report, and the "policy
governance" model developed by John Carver.[102]
7.3 Principles that should underpin the work of a
council of a healthcare professional regulator:[103]
— The council should uphold the purpose
of the organisation as established by parliament, determine its
values and keep both its purpose and values in mind at all times,
with mechanisms in place for annual review.
— The council should be forward- and outward-looking,
focusing on the future, assessing the environment, engaging with
the outside world, and setting strategy.
— The council should determine the desired
outcomes and outputs of the organisation in support of its purpose
and values.
— For each of the desired outcomes the
council should decide the level of detail to which it wishes to
set the organisation's policy—any greater level of detail
of policy formulation should then be a matter for the determination
of the chief executive and staff.
— The means by which the outcomes and outputs
of the organisation are achieved should be a matter for the chief
executive and staff; the council should not distract itself with
operational matters.
— The chief executive should be accountable
to the council for the achievement of the organisation's outcomes
and outputs.
— In assessing the extent to which the
outcomes have been achieved, the council must have a framework
of pre-determined criteria against which performance is reported
both internally and externally.
— The council should engage with its key
interest groups including patients, the public, registrants, employers,
educators and the devolved administrations, and be confident that
it understands their views and priorities.
— The membership of the council should
have the capacity and skill to understand the priorities of each
of these key constituents.
— Information received and considered by
the council should support one of three goals; to allow informed
decision making, to fulfil control and monitoring processes or
to enable the council to co-operate with CHRE and to be accountable
to parliament.
— The council must govern itself effectively,
with clear role descriptions for itself, its chair and its members,
with agreed methods of working and self-discipline to ensure that
time is used efficiently.
— The council must ensure that issues of
equality ands diversity are considered as part of all its work.
Implications of CHRE's special report to the Minister
of State for Health Services on the Nursing and Midwifery Council
7.4 CHRE's special report to the Minister of
State for Health Services on the Nursing and Midwifery Council[104]
highlighted the importance of good governance arrangements to
a healthcare professional regulator. Our recommendations to the
NMC reflect this.
7.5 We commend the recommendations to the NMC in
some respects as general pointers for good governance, and in
particular, that "there should be no representative members
on the new council and no reserved places for interest groups.
All members, whether registrant or public should be appointed
against defined competencies and be subject to appraisal. The
President should be appointed not elected".[105]
We also highlight to GPhC the recommendations for an effective
statement of organisational values and a code of conduct for council
members.
Office of the Health Professions Adjudicator
7.6 A strategic decision will need to be made
at an early stage about the point at which the Office of the Health
Professions Adjudicator will hear cases against pharmacists and
pharmacy technicians. GPhC should anticipate the likely transfer
of the adjudication to OHPA at whatever stage by ensuring best
practice in the separation of adjudication from other fitness
to practise functions. The capacity of OHPA may be affected by
our recent recommendation that the Department of Health and the
Nursing and Midwifery Council consider early transfer to OHPA.
8. OPERATIONAL IMPLICATIONS
ARISING FROM
THE VARIOUS
SETTING FOR
PHARMACY PRACTICE
8.1 Our commission asked us to consider the
operational implications arising from the various settings for
pharmacy practice. We have focused our advice in four particular
areas.
Revalidation
8.2 A key component of revalidation will be
evidence and information about performance which arises from the
registrant's workplace. This places two specific responsibilities
on a regulatory body. First, it will need to understand the workplaces
in which any given registrant practises pharmacy, in order to
be able to determine what is a reasonable evidence base to require
from the registrant in support of their revalidation application.
In pharmacy this will be a significant challenge, given the high
percentage of locums in the workforce and the increasing trend
towards pharmacists moving between sectors not just as a sequence
of jobs but as part of a portfolio of different posts held at
any one time. Within this mobile workforce, the GPhC will need
to find ways to manage the particular risk around failing professionals
who move jobs quickly.
8.3 Secondly, the regulatory body will also
need to keep up to date with different employers' processes for
producing the kinds of evidence and information which will be
germane to revalidation decisions. The regulatory body will also
need to set out evidence requirements for those who work outside
a corporate structure which is routinely producing information—for
example, owners of individual high-street pharmacies.
Receiving fitness to practise referrals
8.4 Concerns about registrants working within
corporate structures with developed human resources capacity,
for example in the commercial sector or where NHS clinical governance
arrangements apply, will often be dealt with by their employers,
and will frequently not be brought to the attention of the GPhC.
This is desirable; ensuring that concerns are identified and dealt
with quickly at a local level where appropriate should be an objective
of the new regulator. However, where there is no corporate structure,
referrals will often be made directly to the regulatory body.
The GPhC will need to be able to manage referrals at all levels,
with appropriate training and protocols for staff on how to handle
reported concerns at all levels of seriousness.
Continuing professional development
8.5 Pharmacists are increasingly moving between
jobs at any one time as part of a portfolio of posts in different
sectors. This raises significant challenges for the GPhC in developing
a system of continuing professional development which will be
able to address development needs arising from those different
sectors. It will also be a significant challenge to ensure that
CPD is effective in supporting the upskilling of the existing
pharmacy workforce. The system developed will need to feed into
GPhC's processes for making decisions on whether or not to revalidate
registrants. We are aware of, and commend, the work currently
being undertaken by RPSGB on developing CPD systems, and advise
that in the preparation of legislation for the new GPhC appropriate
statutory powers are included to make CPD mandatory.
Standards-setting function
8.6 As has previously been discussed, the GPhC
will need to stay abreast, and indeed ahead, of practice development
across all of the different settings for pharmacy practice as
part of its standards-setting function, and will need to understand
the characteristics of the different environments in which pharmacists
and pharmacy technicians work through its network and stakeholder
management.
9. THE NEED
TO OPERATE
IN THE
CONTEXT OF
DEVOLVED GOVERNMENT
IN THE
UK
General observations
9.1 It will be important for the new regulatory
body to maintain close contact with the devolved administrations,
to participate in discussions about the future direction of pharmacy
in the different countries and to reflect this back into GPhC's
standard-setting and other functions. For example, as part of
its horizon scanning the GPhC will want to understand the effects
on practice of the different contractual arrangements for pharmacy
services. This process could be led by country-based offices,
subject to the decisions taken about the functions to be conducted
at country level as described in the section below.
Delegation of functions to country level
9.2 A major focus of discussion in the preparation
of this advice has been the question of what country presence
the GPhC should have, distinct from its headquarters functions.
9.3 A number of suggestions were made for country-level
functions, the most frequently occurring of which were:
Receiving fitness to practise referrals
9.3.1 It was suggested by many interviewees
that a country-level facility for receiving fitness to practise
referrals would be desirable, not least on the grounds that members
of the public might be likely to be most comfortable reporting
concerns to an office based in their own country. We are not however
aware of any evidence to support this proposition. GPhC might
wish to commission market research to establish the views of the
public and other complainants on this point.
Providing advice to registrants
9.3.2 No interviewees were of the opinion that
separate standards of conduct and performance were needed for
the different countries. However, many felt that it would be useful
if GPhC could offer a service to registrants to assist them in
understanding how the GPhC's standards applied to the particular
circumstances in their own country. This could well arise in `learning
points' to be fed back to GPhC's central standards-setting function.
Holding fitness to practise hearings
9.3.3 Several interviewees suggested that fitness
to practise hearings should be held in the country in which the
concerns arose, rather than requiring registrants who were the
subject of hearings to travel to distant venues. It was also noted
by some, however, that from a registrant's perspective it might
be preferable to have a hearing held at a distance from home.
If GPhC wished to pursue this policy, it would need to commission
further research and advice on the Scottish law implications.
Country-level relationship management and stakeholder
engagement
9.3.4 Many interviewees commented that there
was a country-level role for working with the devolved administrations
and other country-based stakeholders.
Patient and public involvement work
9.3.5 Several interviewees felt that public
and patient involvement work conducted at country level, feeding
into the central standards-setting and other functions, would
result in patients and the public having greater confidence in
the regulatory body, its standards and their application. It was
noted that many patient groups are locally based and it would
be sensible for there to be a country-based presence to which
they could relate.
9.3.6 Less frequently occurring suggestions
included assessing CPD portfolios and making revalidation decisions,
pre-registration examination and assessment and support for health
problems.
9.3.7 We advise that the costs and benefits
to the organisation of conducting these functions at a country
level are assessed and used as the basis for deciding what GPhC's
country presence will be. There is the possibility of different
regulators sharing premises, functions and costs to achieve economy
at country level.
Northern Ireland
9.4 We have heard the arguments surrounding
the issue of whether or not Northern Ireland's pharmacists and
pharmacy technicians should be registered by a UK-wide GPhC.
9.5 At the time of writing the position of Northern
Ireland's Health Minister is that a final decision will be deferred
until the GPhC has been established and its protocols for working
with the devolved administrations have been agreed.
9.6 It could be some considerable time before
a final decision is taken, and therefore we advise that In the
context of the provision made in the Health Act, the GPhC is set
up in such a way that at a logistical level it is a straightforward
matter to register Northern Ireland's pharmacists and pharmacy
technicians should the Minister decide in future that this is
his wish.
9.7 We have also drawn attention in our
2008 performance review of PSNI to the need for early legislative
change in Northern Ireland to enable PSNI to fulfil its aspirations
to be a better regulator and to perform its functions better on
behalf of the people of Northern Ireland.
9.8 We have no doubt whatever of the commitment
of PSNI's leadership to protect the public in Northern Ireland.
However, we believe that it would be in the interests of public
protection in the longer term for a closer working relationship
between GPhC and PSNI to be developed, perhaps through working
towards shared standards and CPD, as an interim measure until
the way ahead for Northern Ireland is made clear. This could assist
in maintaining cost-effectiveness.
10. EUROPEAN COMMUNITY
LAW AND
FREEDOM OF
MOVEMENT ACROSS
INTERNATIONAL BOUNDARIES
10.1 The RPSGB collaborates with other regulatory
bodies is discussing and managing the issues arising from the
free movement of professionals and patients across borders. This
work should continue within GPhC, such that the new body stays
up to date with European Union developments and contributes to
best practice. The GPhC must comply with EU legislation particularly
in respect of mutual recognition of professional qualifications.
They must be consistently aware of changes and developments in
EU legislation which affect patients, professionals and the pharmaceutical
industry. RPSGB has played an active and valuable role both in
the development of EU directives and also with the cross member
state voluntary project Healthcare Professionals Crossing Borders.[106]
It is recommended that GPhC continues with this valuable work.
10.2 GPhC will need to keep abreast of pharmacy
practice internationally, in order to understand any risks to
patient safety that might result from pharmacy practice in other
countries differing from that in the UK.
DOCUMENTS CONSULTED
A High Quality Workforce: NHS Next Stage Review,
Department of Health (June 2007)
Boards that Make a Difference,
John Carver (Jossey-Bass 2006)
Code of Ethics for Pharmacists and Pharmacy Technicians,
Royal Pharmaceutical Society of Great Britain (August 2007)
Future of Pharmacy Registration, Regulation and
Representation in Northern Ireland, Pharmaceutical
Society of Northern Ireland (February 2008)
Implementing the White Paper Trust
Assurance and Safety: Enhancing Confidence in Healthcare Professional
Regulators, Department of Health (June 2008)
Healthcare Professionals Crossing Borders Agreement,
Alliance of Health Regulators on Europe, Scottish Executive, Department
of Health (October 2005)
Healthcare Professionals Crossing Borders Portugal
Agreement (October 2007)
Making it Better—A Strategy for Pharmacy
in the Community, DHSSPSNI (February 2004)
Pharmacist Work Patterns—Pharmacy Workforce
Census 2005: Main Findings, Royal Pharmaceutical
Society of Great Britain, University of Manchester (August 2006)
Pharmacy in England, Building on Strengths, Delivering
the Future HM Government, Department of
Health (April 2008)
Professional Leadership in Pharmacy—Exploring
the Case for a Royal College for the Pharmacy Profession,
King's Fund (April 2007)
Professional Standards and Guidance Documents,
Royal Pharmaceutical Society of Great Britain, August 2007
Reducing Administrative Burdens: Effective Inspection
and Enforcement, HM Treasury (March 2005)
Remedies for Success—A Strategy for Pharmacy
in Wales, Welsh Assembly Government (September
2002)
Report of the Independent Inquiry into a Professional
Body for Pharmacy, The Clarke Inquiry
(April 2008)
Report of the Working Party on Professional Regulation
and Leadership in Pharmacy, Department of Health (May 2007)
Special report to the Minister of State for Health
Services on the Nursing and Midwifery Council,
Council for Healthcare Regulatory Excellence (June 2008)
Standards of Good Regulation,
Council for Healthcare Regulatory Excellence (2007)
Statutory Code of Practice for Regulators,
Department for Business, Enterprise and Regulatory Reform (December
2007)
The Regulation of the Non-medical Healthcare Professions—a
Review by the Department of Health, Department
of Health (July 2006)
The Right Medicine—A Strategy for Pharmaceutical
Care in Scotland, Scottish Executive (2002)
Trust, Assurance and Safety—The Regulation
of Health Professionals in the 21st Century,
Secretary of State for Health (February 2007)
86 Department of Health (2008). Implementing the White
Paper Trust Assurance and Safety: Enhancing Confidence in Healthcare
Professional Regulators. Back
87
Better Regulation Executive www.berr.gov.uk/bre/index.html Back
88
Department of Health (2008). Implementing the White Paper Trust
Assurance and Safety: Enhancing Confidence in Healthcare Professional
Regulators, Table 1. Back
89
CHRE (2007). Standards of Good Regulation. Back
90
It is noted that at establishment GPhC will cover England, Scotland
and Wales. Pharmacy regulation in Northern Ireland is discussed
at paragraphs 3.4 and 9.3.8-9.3.12. Back
91
In England. We note the comment at paragraph 7.8 of Pharmacy in
England Building on Strengths-Delivering the Future that it will
not be an immediate requirement for pharmacies to be registered
with the CQC but that in future as their range of services expand
this may be necessary. Back
92
We note that this is not a new area in legal terms, however is
likely to become more prevalent in future. The boundary with the
veterinary surgeon is only one example of the various areas that
would need to be covered, including matters relating to dispensing,
storage, the "cascade", breaking of packs, labelling
and recording as specific to veterinary products. Back
93
Hampton, P (2005). Reducing Administrative Burdens: Effective
Inspection and Enforcement, Box E2, p 7. Back
94
Department of Health (2006). The Regulation of the Non-medical
Healthcare Professions: A Review by the Department of Health,
chapter 1 paragraph 12. Back
95
www.postgraduatepharmacy.org Back
96
Department of Health (2008) A High Quality Workforce: NHS Next
Stage Review. Back
97
RPSGB (2007). Code of Ethics for Pharmacists and Pharmacy Technicians
and Professional Standards and Guidance Documents. Back
98
Department of Health (2008). A High Quality Workforce: NHS Next
Stage Review, paragraph 138 p 41. Back
99
CHRE (2007). Standards of Good Regulation. Back
100
Department of Health (2007). Trust, Assurance and Safety-the Regulation
of Healthcare Professionals in the 21st Century, chapter 1, paragraph
1.2. Back
101
CHRE (August 2008) Performance review of health professions regulators
2007/08-Helping regulation to improve. Back
102
In preparing the principles, we drew in particular on the work
of John Carver, and his "policy governance" model as
described in Boards that Make a Difference, Third Edition, 2006.
We commend this model to the GPhC. It draws a clear distinction
between the strategic, monitoring, and oversight role of a board,
and the delivery of an organisation's executive functions. Back
103
Department of Health (2008). Implementing the White Paper Trust
Assurance and Safety: Enhancing Confidence in Healthcare Professional
Regulators, Table 1. Back
104
CHRE (2008). Special Report to the Minister of State for Health
Services on the Nursing and Midwifery Council. Back
105
As footnote 10, paragraph 5.2.1. Back
106
http://www.hpcb.eu/ Back
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