Modernising pharmacy regulation: from prototype to full implementation
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Update paper: February 2015
Modernising
pharmacy regulation:
from prototype to full
implementation
Update paper
In 2012 we set out a new vision for the regulation Over the previous twelve to eighteen months we
of pharmacies. In our consultation on new have completely overhauled our inspection model.
standards for pharmacies, Modernising Pharmacy We implemented a new prototype inspection
Regulation1, we made clear our ambition for system which makes assessment against a single
pharmacy regulation to move beyond a focus on set of standards. This assessment is supported by
legal compliance, check lists and standard operating a clear decision-making framework developed in
procedures. partnership with the profession. It is focussed not
just on safety, but on quality improvement. We
Our aim was to develop new standards which all are pleased that this model has received such high
pharmacies registered with the GPhC would have levels of support from stakeholders, particularly
to meet. These standards would put patients through the feedback we capture from the
first, describing the things that pharmacies need pharmacies we inspect.
to deliver – or ‘outcomes’ – rather than publish
a long list of prescribed rules from the regulator. However, in part due to the need for further
The feedback we have received about these new legislative change2, our inspection model remains
standards has been very positive. in a prototype phase. This has enabled us to learn
and refine our new inspection model and to provide
Alongside the new standards we identified a need feedback to pharmacies on a confidential basis.
to reform the outdated inspection model. The Although we have a range of legal powers to protect
feedback we received through our engagement patients, we do not yet have full enforcement
and consultation was that the previous inspection powers or the power to publish inspection reports.
model lacked transparency, was inconsistent, It is our intention to do so, when we have the
narrow in focus towards issues such as controlled necessary legal powers, and only after a public
drugs monitoring, and too focussed on monitoring consultation exercise on our regulatory model
compliance with checklists and standard operating including the process of publication.
procedures.
1 http://pharmacyregulation.org/get-involved/consultations/our-previous-consultations
2 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/403387/consultation_doc.pdf
Modernising pharmacy regulation:
from prototype to full implementation 1Update paper: February 2015
We are a regulator that listens and uses evidence This publication is intended to set out clearly the
to inform our policy development and the way we following key points:
carry out our regulatory activities. We’re willing • our approach to regulation; how it is designed and
to learn, adapt and – where necessary – change what we hope to achieve
our approach. In October 2014 we held a large
stakeholder event in London and have hosted • key elements of our approach which we believe
further events in Scotland and Wales where we are working well and those we need to build on
were able to have an open discussion with the • the areas of our model where we need to carry
profession, with representative bodies and with out further engagement with all stakeholders,
patients. At those meetings we made clear our particularly patients and the profession before we
intention to reflect and, in due course, to consult on can implement fully our new model
key elements of our regulatory model. • the parts of the model where we know changes
need to be made if we are to deliver what we
set out to achieve; a model which helps protect
patients and encourages improvement and quality
in pharmacy
• the way in which we will carry out engagement
and formal consultation; and the associated
timetable
Modernising pharmacy regulation:
from prototype to full implementation 2Update paper: February 2015 Summary points • Based on feedback received, we believe • Where research and evidence exists from our standards are working well and remain pharmacy, or other sectors, we have attempted appropriate. However, our planned consultation to draw upon it in the development of our will provide a further opportunity to test if any regulatory policy. However, it is right that we test changes need to be made, particularly to take and challenge ourselves to see whether we are into account changes to the range of pharmacy meeting, or are likely to meet our dual objectives services and the way in which they are delivered. of promoting patient safety and encouraging • Running our inspection model in prototype improvements in pharmacy. We are therefore phase has allowed us to introduce a new and commissioning independent evaluation research improved model of pharmacy inspection, but also to test how we are doing against these objectives. continue to modify and enhance the process as This research will be published in the summer and we learn more. We will continue to engage with before we consult on final proposals. pharmacy stakeholders as we seek to bring further • We will be reviewing our inspection cycle and the improvements to our approach so that it works opportunities to carry out inspections focussed well for patients, but also for pharmacy staff and on specific services, or thematic inspections. Our pharmacy owners as we seek to maintain safety approach is likely to change over time based on and encourage improvement. a range of factors including the information we • We accept that our current ratings model needs hold, the development of new – potentially higher to change and that, as a minimum, we need to risk services in pharmacy – and feedback from find an alternative to the ‘satisfactory’ rating. our stakeholders. We will set out proposals in our We intend to carry out an urgent review of our planned consultation document. ratings model and the descriptors given to ensure • If government legislation is put before parliament that any final framework helps us to achieve before the end of 2015 we expect to begin our our objectives of a system which encourages formal consultation within weeks to enable us to improvement and provides reassurance for the finalise proposals and move to full implementation public. in 2016, subject to the outcomes of that GPhC • Subject to the passing of legislation, the GPhC consultation. will publish inspection reports in future. These reports would, as a minimum, be published on our website. We need further input from all our stakeholders, including patients and users of pharmacy services, as well as those in pharmacy to help us develop the process of publication which is open, transparent, fair and accessible. We will only publish after we have held our consultation in advance of full implementation. Modernising pharmacy regulation: from prototype to full implementation 3
Update paper: February 2015
Our approach to
regulation
When we first published our vision for regulation of Our role is very different to that of the professional
pharmacies in 2012 we said our primary goal was leadership bodies. Our role requires us to review key
public protection and that we had a responsibility elements within our work including:
not to stand in the way of developments in practice • the knowledge and skills that are required of
which have the potential to bring significant benefits pharmacists and pharmacy technicians of the
to patients and the public. future and how our standards for the initial
education and training of pharmacists and
Our strategic plan 2015-18 took this concept pharmacy technicians will need to change to
further. We believe that pharmacy regulation has address these
a significant role to play in quality improvement – • the need to focus on patients on who are cared
of which safety is a critical element – in pharmacy for by pharmacy professionals and receive advice,
practice and ultimately health and wellbeing in services and care from registered pharmacies; and
England, Scotland and Wales. how to promote professionalism and the delivery
of compassionate and person-centred care
This strategy reflects the ambition within the
pharmacy profession to play a much greater role • how we can use our privileged position, as both
in healthcare and in public health, as well as a regulator of individual professionals and of
statements from governments in England, Scotland pharmacy services provided from registered
and Wales which all highlight the role that pharmacy pharmacies, to share data, knowledge,
must play if we are to meet the public health information and insight into how pharmacy is
challenges. This requires leadership from pharmacy changing so that positive developments and
but also from us, as the pharmacy regulator. innovation can be shared, and risks identified
and mitigated
It also requires us to review and update our
regulatory model, both for the regulation of
individual pharmacists and pharmacy technicians,
but also the regulation of pharmacies.
Modernising pharmacy regulation:
from prototype to full implementation 4Update paper: February 2015
Our regulatory
model for pharmacy
– what would
success look like?
Success, to some degree, involves a rejection of • Is the regulatory model flexible enough to adapt to
previous models of standards and inspection. We changes in the pharmacy landscape across Great
have explicitly rejected a model where the regulator Britain?
focuses on prescriptive rules; which encourage • Does our regulatory model support and
a ‘minimum standards’ approach; and where encourage professionalism and ensure meaningful
assessment is about tick-box or compliance against accountability for the maintenance of standards
standard operating procedures. If we were to focus and the provision of safe and effective services
on very basic safety and minimum standards or from pharmacies?
rules, this would involve a very different approach
to standards setting which would focus on strict
criteria and inspection with a simple ‘pass/fail’ test. And most importantly…
Our aim is to focus, where possible and appropriate, Do the changes to the regulation of pharmacies
on the things that matter to pharmacy professionals we have introduced to date, and the further
and patients alike. That is safe and effective changes proposed, contribute, or are they likely
outcomes for patients. The success of our standards to contribute, to improvements in the quality of
and the inspection model designed around those pharmacy and outcomes for patients and users of
standards should be judged on some simple pharmacy services?
questions:
It is important that when assessing the impact of
• Can patients be assured that pharmacies are safe? our regulation of pharmacies, we are evaluating
• Does our registration process ensure that all ourselves against these questions and being held
those pharmacies that should be registered, are to account by patients, pharmacy professionals and
registered? pharmacy owners. We discuss this further in the
• Do our standards for registered pharmacies section on evaluation.
encourage pharmacies to think about patient
outcomes, not ticking boxes?
• Does our regulatory model – including publication
of inspection reports and ratings – promote
confidence in pharmacy and encourage
improvement?
Modernising pharmacy regulation:
from prototype to full implementation 5Update paper: February 2015
Based on feedback received, we believe
our standards are working well and
remain appropriate. However, our planned
The standards consultation will provide a further opportunity
to test if any changes need to be made,
for registered particularly to take into account changes to
the range of pharmacy services and the way in
pharmacies which they are delivered.
Our standards for registered pharmacies were The feedback we received from our consultation and
developed in 2012 following a period of extensive the subsequent feedback we have received from GPhC
engagement over eighteen months. The standards events and from events of others we have attended has
are set out under five ‘principles’: been very positive. Stakeholders within pharmacy have
• Principle 1: The governance arrangements generally welcomed the move away from prescriptive
safeguard the health, safety and wellbeing of rules and the focus on operating procedures. But we
patients and the public. are also aware the move to standards which describe
• Principle 2: Staff are empowered and competent what we wish to be achieved and outcomes for patients
to safeguard the health, safety and wellbeing of has been a challenge for some. For example, some
patients and the public. stakeholders remain concerned about the absence of
regulatory ‘rules’ about the display of pharmacy (‘P’)
• Principle 3: The environment and condition of medicines over and above the legal requirement for
the premises from which pharmacy services are pharmacist supervision.
provided, and any associated premises, safeguard
the health, safety and wellbeing of patients and The standards were designed to apply equally to
the public. different and emerging models of pharmacies. When
• Principle 4: The way in which pharmacy services, we consult about what needs updating, we will wish to
including the management of medicines and medical consider the extent to which they remain appropriate
devices, are delivered safeguards the health, safety given the increasing range of services provided by
and wellbeing of patients and the public. pharmacies and the staff working within or from
• Principle 5: The equipment and facilities used in the them. We have also received specific feedback about
provision of pharmacy services safeguard the health, particular standards which could be improved or
safety and wellbeing of patients and the public. consolidated.
These standards relate to the provision of pharmacy Many responsible pharmacists and superintendents
services at, or from, registered pharmacies. We make have fed back that they felt the inspection process
clear that responsibility for meeting the standards lies supported both individual and team learning and
with the pharmacy owner. If the registered pharmacy is understanding of the premises standards. It is our
owned by a ‘body corporate’ then the superintendent intention to use the feedback we have received to date
pharmacist also carries responsibility. through events and inspections carried out to inform
the development of updated standards for registered
pharmacies which we will consult on in due course.
Modernising pharmacy regulation:
from prototype to full implementation 6Update paper: February 2015
How we inspect –
assessment against
standards, reaching
a judgement and
providing a report
Our standards apply to all registered pharmacies in At the heart of this new approach are inspections
Great Britain. We have developed our approach to where pharmacies are ‘showing and telling’ us
inspection to be consistent across England, Scotland how they meet the standards; not simply showing
and Wales. documents or standard operating procedures. These
more detailed inspections ensure that the inspection
Our professional inspectors have a number of can cover the full range of services provided and involve
tools to ensure they are recording evidence in a the whole pharmacy team.
consistent way. We have processes to assure the
quality of those inspections and the evidence With this new model we have carried out over 3000
collected. This means that any pharmacy which is inspections since the launch of the prototype in
inspected should receive consistent approaches to November 2013. We are collecting information for
assessment regardless of which inspector is present. the first time on performance and on the standards
Most importantly patients can be confident that commonly met. We can differentiate by country and
they will be kept safe and expect the same level type of pharmacy, allowing us to begin to build a
of care whichever pharmacy they visit in England, picture of pharmacy standards. We will be able to use
Wales or Scotland. this information to encourage improvement across
the sector. We are also using action plans to work
Our two key aims for inspection are: with pharmacies so that they can deliver important
1. to provide assurance for patients and the public improvements.
that our standards are being met and that the full
range of pharmacy services are safe We seek formal feedback from responsible pharmacists
2. to encourage and support improvement in the after inspections. We are pleased that particularly
quality of pharmacy services to patients and positive feedback has been received about the
the public accuracy of inspection reports, the understanding of
the standards as a result of the inspection as well as
the positive influence the inspection had on identifying
ways to improve the quality of services provided to
patients and the public.
Modernising pharmacy regulation:
from prototype to full implementation 7Update paper: February 2015
Importantly, feedback from owners and superintendent At the end of the inspection the inspector will
pharmacists also highlights the use of inspection as go through their findings with the responsible
an improvement tool and our reports are seen to be pharmacist, who will be asked to sign the report
properly evidenced. to confirm their agreement of the findings. The
responsible pharmacist has an opportunity to
There have been some concerns raised which we make any additional comments. This is important
are addressing. We have acted on the concern raised to show that the evidence recorded on the report
that there is not enough time for superintendents is an accurate reflection of what the inspector saw
and owners to comment on the inspection report. or was shown on the day. The inspector will then
So we have increased the time to five days3. There is provide feedback to the responsible pharmacist
still a concern that inspections are taking longer than summarising the main things that are working well
necessary. We are continually reviewing our practice and the main areas for improvement.
to make our inspections more streamlined, recognising
however that our prime focus remains on patient Following an inspection, the inspector has a short
safety and ensuring the pharmacy gets the best value time to go through the report and to finalise their
from our visit. We have also received some feedback judgements. The inspector will also record if there
that there is a preference for inspections to be held at is not enough evidence to show that a pharmacy
a notified date and time, rather than the current has met a specific standard, or if there are particular
model whereby we send advance notice that we will concerns. This process is supported by key GPhC
be inspecting in the forthcoming weeks. We do not documents: the inspection decision-making
think it is right to give timed notice of inspections framework and the evidence bank of examples4.
by appointment.
We continue to update and review these documents
Our inspectors record evidence gathered during to ensure that the process is fair, transparent and
an inspection electronically using a report meets our overarching objectives of assuring the
template. This will contain relevant information public that pharmacies are safe and encouraging
and context, such as whether the pharmacy is a pharmacies to make improvements.
busy high street pharmacy, a rural pharmacy or
supermarket pharmacy, and also what services Running our inspection model in
the pharmacy is providing, whether dispensing prototype phase has allowed us to
only or enhanced services such as flu vaccinations. introduce a new and improved model of
Having some information about context will help us pharmacy inspection, but also continue
to understand the evidence collected and enable to modify and enhance the process as we
judgements to be quality assured, and is essential to learn more. We will continue to engage with
understanding how well risks are managed. pharmacy stakeholders as we seek to bring
further improvements to our approach so
that it works well for patients, but also for
pharmacy staff and pharmacy owners as
we seek to maintain safety and encourage
improvement.
3 Two days if a pharmacy is ‘poor’.
4 http://www.pharmacyregulation.org/pharmacystandardsguide/useful-documents
Modernising pharmacy regulation:
from prototype to full implementation 8Update paper: February 2015
We accept that our current ratings model
needs to change and that, as a minimum, we
need to find an alternative to the ‘satisfactory’
rating. We intend to carry out an urgent review
of our ratings model and the descriptors given
to ensure that any final framework helps us
How we inspect – to achieve our objectives of a system which
encourages improvement and provides
Inspection labels reassurance for the public.
Regulators often publish ratings or labels. The reasons We also acknowledge that further work is required
for this vary and depend on the sector and the style to review the descriptors across all four scales as
of the ratings – numbers, words or a combination of well as reviewing the ‘poor, satisfactory, good and
the two. The Care Quality Commission5, for example, excellent’ labels.
has set out its desire for performance to help people
choose their care provider and also to encourage and The ratings are only indicative at this stage and
drive improvement. Research6 points to a range of intended for the use of the individual pharmacy and
reasons why publishing inspection ratings can for the GPhC to build up a picture of performance of
be beneficial. the sector as a whole. We will continue to provide
feedback to pharmacies across the current rating
The GPhC is committed to openness and scale while we carry out a detailed review. The
transparency and by publishing ratings we can review will involve assessment of the wider research
be open with the public about what we find in available, discussion with pharmacy stakeholders,
pharmacies. We also believe that by identifying with patients and the public and with commissioners
those pharmacies providing particularly high of pharmacy services. We will only publish ratings
quality services, the publishing of ratings could when we come out of the prototype phase, after
help to drive improvement of others through a full consultation and once we have been able to
sharing good practice. Publishing ratings can also develop robust alternative labels.
act as a reassurance to the public about the quality
of pharmacy. We have committed to avoiding a It is also important to add that while we could carry
regulatory model which focusses on achievement of out an assessment of the impact of a particular
minimum standards; if we had them a more binary, rating provided to pharmacies, it will only be possible
‘met/not met’ scale may have been appropriate. to fully evaluate the impact of any ratings model
after implementation and publication. Detailed
Involvement of the profession and patients has engagement will therefore be required with both
underpinned the current inspection labels. But we pharmacy stakeholders and patients to ensure we
recognise that for a ratings system to work effectively have carried out testing of any revised ratings system
it must have credibility with both the public and the before it goes ‘live’ and we publish ratings.
pharmacy sector. The feedback we have received
through inspections and from our engagement events
is that the current prototype ratings system needs to
change and there has been particular criticism of the
‘satisfactory’ label which should be avoided in any
final ratings model. We agree.
5 http://www.cqc.org.uk/public/about-us/our-performance-and-plans/our-strategy-and-business-plan
6 http://www.nuffieldtrust.org.uk/publications/rating-providers-quality
Modernising pharmacy regulation:
from prototype to full implementation 9Update paper: February 2015
Publication of
inspection reports
The GPhC has from the outset stated our intention We do not yet have explicit powers in law to publish
to publishing inspection reports. One of the core reports of inspections. The government has indicated
principles of good regulation is that we should be open its support for this policy. Legislative proposals which
and transparent; to keep inspection findings secret are currently subject to public consultation would
would, in our view, be inconsistent with that principle. provide this legal power7.
We will carry out further testing to consider the impact
this might have in relation to decisions of patients and Subject to the passing of legislation, the
the public, as well as the behaviour of pharmacies. GPhC will publish inspection reports in
future. These reports would, as a minimum,
This will be difficult to evaluate until we publish but our be published on our website. We need further
position is as follows: input from all our stakeholders, including
1. We believe transparency can be a powerful driver in patients and users of pharmacy services, as
relation to quality improvements well as those in pharmacy to help us develop
2. Evidence from other sectors suggests that being able the process of publication which is open,
to see how your peers are performing can act as a transparent, fair and accessible. We will only
positive stimulus to improve publish after we have held our consultation in
advance of full implementation.
3. Localised innovation can be positive but
improvements at scale can only be delivered when
good practice is shared widely and the localised
improvements become commonplace across
pharmacy
7 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/403387/consultation_doc.pdf
Modernising pharmacy regulation:
from prototype to full implementation 10Update paper: February 2015
Evaluating our
approach to
the regulation
of registered
pharmacies
We recognise that the new approach to regulation of
pharmacies has required significant changes in the way Where research and evidence exists
we carry out our work and from those we regulate. from pharmacy, or other sectors, we have
We have set some ambitious goals and are committed attempted to draw upon it in the development
to independently evaluating whether we are meeting of our regulatory policy. However, it is right
those ambitions. To this end we are in the process of that we test and challenge ourselves to see
tendering for independent evaluation research. whether we are meeting, or are likely to meet
our dual objectives of promoting patient safety
This will enable us to assess the extent to which our and encouraging improvements in pharmacy.
approach is consistent with our wider objectives and We are therefore commissioning independent
goals and to consider any lessons to be learnt from evaluation research to test how we are doing
progress to date. This will inform further changes which against these objectives. This research will be
may be required, on top of those outlined in this paper. published in the summer and before we consult
on final proposals.
We intend to select our research partner in spring
2015 with the research report to be completed by the
summer of 2015. This research will inform our formal
consultation which we will launch once government
has published the outcomes of their current
consultation, Rebalancing Medicines Legislation and
Pharmacy Regulation.
Modernising pharmacy regulation:
from prototype to full implementation 11Update paper: February 2015
We will be reviewing our inspection
cycle and the opportunities to carry out
inspections focussed on specific services, or
thematic inspections. Our approach is likely
to change over time based on a range of
Assessing risk and factors including the information we hold, the
development of new – potentially higher risk
reviewing the cycle services in pharmacy – and feedback from our
stakeholders. We will set out proposals in our
of inspections planned consultation document.
As the pharmacy regulator, it is our responsibility to At the moment we aren’t yet able to capture all
reassure patients that all pharmacy professionals and the right information at the point of registration to
pharmacies registered with us have to meet both enable us to compile evidence and data to assess this
professional standards and pharmacy standards. We impact, but this will be a priority once the rebalancing
can also provide reassurance to patients that through legislation is in place and we can start to analyse data
the setting and monitoring of standards, they can and information and share this with the sector and
be confident in the quality of pharmacy services and the public. In future, we also wish to consider how we
the fitness to practise of the pharmacy professionals make better use of thematic inspections – looking at
providing them. particular types of pharmacy – as well as inspections
which may focus on a particular service.
We also know from academic research that against any
measurement of safety relative to other healthcare So what does this approach to risk mean for inspections
environments, pharmacies and the services that they and in particular the frequency of inspections? The
provide are safe. We know, for example that error rates GPhC inherited an inspection cycle where most
from dispensing are very low – and are lower than for pharmacies were inspected once every three years. Our
prescribing, administering or monitoring medication8. new model means that we are taking longer to inspect
pharmacies. We see this as a positive thing, bringing
So a visit to a pharmacy should be seen not in terms of real value to pharmacy, helping improvement and
risk but in terms of opportunity. An opportunity to get strengthening the assurance we can give to the public.
the right medication at the right time, to seek advice on But this also means that we need to review the cycle of
taking medicines and to consider wider opportunities inspections bearing in mind our desire to consider how
for health improvement. Governments in England, we take into account risk, the challenge on resources
Scotland and Wales have each set out visions for how – for both us and the sector – and the feedback we
pharmacy, particularly pharmacy in the community receive from pharmacy about how the process can
setting needs to develop. Although we see assessment contribute to improvements.
of risk to patients as an important element to our work,
increasing evidence from our inspections indicates that
our focus on improvement is where patients will gain
most benefit. We will increasingly be looking at levels of
risk in new and emerging service models and how our
inspection model can take these into account.
8 http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=61392
Modernising pharmacy regulation:
from prototype to full implementation 12Update paper: February 2015
Next steps
This document sets out a number of issues about • Rebalancing Medicines Legislation and Pharmacy
which we intend to carry out urgent engagement, Regulation consultation: Mid-Feb – Mid May 2015
including reviewing our draft ratings system. But • GPhC engagement on key issues set out in this
there are a range of other policy issues we will wish paper: March 2015 – November 2015
to discuss with stakeholders before we carry out
formal consultation which is critical before we
move to full implementation from the current
prototype phase.
If government legislation is put before
We are unable to commit to a specific timetable parliament before the end of 2015 we
for this consultation as it is linked to the expect to begin our formal consultation within
implementation of government legislation which weeks to enable us to finalise proposals and
is subject to a current consultation from the move to full implementation in 2016, subject to
Department of Health on behalf of UK and the outcomes of that GPhC consultation.
Scottish Ministers.
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from prototype to full implementation 13You can also read
