1. South Yorkshire & Bassetlaw LPC’s
Joint update event

2. Programme Overview 6.30pm Buffet and Networking
7-8pm GPhC Consultation on Proposals for Regulating Registered Pharmacies; GPhC Inspector Faiyaz Haque
8-9pm PSNC Vision for Community Pharmacy; Regional PSNC Representative Garry Myers
9pm Close

3. Consultation on developing our approach to regulating registered pharmacies
2018

4. A brief re-cap on our inspection journey
We first consulted on new standards for registered pharmacies and our new regulatory model in April 2012
Our standards for registered pharmacies were published in September 2012
We have been operating a new model of inspection since November 2013
Pharmacies ‘showing and telling’ us how they meet the standards; not a matter of simple checklists
Inspection covering the range of services and involving the whole pharmacy team
Evidence based judgements in a written report showing how pharmacies perform against the standards
We published an update paper in February 2015 to restate core principles and make clear our intention to listen and update our model on the basis of feedback and evidence
We published an independent evaluation in October 2015, which concluded that the new approach was working well overall
Apr 2012
Sept 2012
Feb 2015
Oct 2015
November 2013, introduction of new inspection model

5. To now - 2018 Almost completed a full cycle of inspections
Most pharmacies meet our standards
Evaluation indicates approach is working well
- Overall support, with areas for further consideration
We now want to further develop our regulatory approach
To take the next step to provide further assurance and drive improvement
Significant changes
We now have powers that enable us to publish our inspection reports
Since we introduced the new ‘show and tell’ approach to inspections, we have inspected around 13,000 registered pharmacies across Great Britain. We expect to have inspected every registered pharmacy in Great Britain by summer Of those inspected 85% were found to be meeting all the standards for registered pharmacies. Those that weren’t were required to develop an improvement action plan. Our own analysis suggests that improvement action plans are working well in practice – 99% of pharmacies which had to complete improvement action plans in 2016/17 made the improvements needed.
We have heard through the independent evaluation we commissioned, and other feedback we have received, that the changes we have made to how we regulate pharmacies are welcome and are working well in practice. But we have also heard that there are opportunities to develop our approach further and improve our ability to achieve our two aims of assurance and improvement
We now want to further develop our regulatory approach to provide further assurance to patients and the public and to drive improvement across pharmacy. We plan to make our approach more flexible, agile and responsive. We propose introducing new types of inspection and to use information and intelligence to target our resources more effectively to help us achieve this.
The most significant change proposed in this consultation is for us to begin publishing inspection reports. We now have powers that enable us to publish our inspection reports and more tools to enforce the standards, including improvement notices (NB from 24 May onwards this needs to say ‘we now have new powers’)
Publication is, in our view, marks a significant moment of change. It will allow us to provide much more assurance to patients and the public, and to those working across pharmacy and health, that pharmacies are meeting standards

6. Landscape Diverse nature of registered pharmacies Pace of change
Clinical role
New service models and greater use of technology
The registered pharmacies we regulate are diverse in nature. Registered pharmacies provide a wide range of services to patients and the public, and are located in many different environments – from busy shopping centres in large cities to small villages.
Pharmacies are increasingly playing a bigger role in supporting and maintaining the health and well-being of the people using their services, with many pharmacies now offering a range of new health services. And we know that technology, and the increased use of digital communications, will continue to influence the way services are provided in the future.
It is therefore vital that the way we regulate registered pharmacies does not stand still. Our approach to regulating pharmacies must be equally flexible and agile. And we must continue to refine and improve our approach to keep pace with developments in pharmacy. We believe that an outcome-focused approach, is still the only way to do this.

7. Our strategic approach
Providing assurance that pharmacies are meeting standards and driving continuous improvement in the quality of services and care for the public
Moving to a flexible and agile approach, so we can respond effectively to the changing needs of patients and the public and to changes in pharmacy
Increasingly informed by information and intelligence, targeting our resources where they can have the greatest impact
Publishing reports to strengthen assurance for patients and to enable the sector to learn and continuously improve
See notes on slide

8. Key proposals at a glance
Changes to the types of inspections
Moving to unannounced inspections
Changing inspection outcomes
Requiring all standards to be met to receive an overall ‘standards met’ outcome
Publishing inspection reports
Sharing examples of notable practice in a ‘knowledge hub’
1 – Changes to the types of inspections – we are planning to move to a new model that includes three types of inspection: routine inspections, intelligence-led inspections and themed inspections. This will help us to make sure we are more agile and responsive to information we hold, intelligence we receive and issues we identify within pharmacy.
2 - Moving to unannounced inspections – we are proposing that inspections will be unannounced as a general rule in the future. This will make sure the outcomes of the inspection reflect whether the pharmacy is meeting the standards every day.
3 - Changing inspection outcomes – we are proposing to change our present model for inspection outcomes. There would be two possible outcomes for an inspection overall (‘standards met’ or ‘standards not all met’), and four possible findings at the principle level (‘standards not all met’, ‘standards met’, ‘good practice’ and ‘excellent practice’).
4 - Requiring all standards to be met to receive an overall ‘standards met’ outcome – if any standard was found not to be met, this would result in a ‘standards not all met’ outcome overall.
5 - Publishing inspection reports – we are planning to publish inspection reports, and improvement action plans when relevant, on a new website. This will be designed so that the information is easy to search and analyse.
6 - Sharing examples of notable practice – we will also publish examples of notable practice that we identify through inspections in a ‘knowledge hub’ on the new website. This will help encourage continuous learning and improvement in pharmacy.

9. Introducing the changes to the types of inspections
Routine inspection
Intelligence-led inspection
Themed inspection
We will use three types of inspection which we can use flexibly in different situations- routine inspections, intelligence-led inspections and themed inspections. This allows us to be more responsive when we need to be, and means we can look at specific issues in pharmacy and services in greater detail.

10. Routine inspections Every pharmacy to continue to be inspected
Moving to a more flexible programme, informed by indicators of risk when identifying which pharmacies should be inspected first
Inspections to be unannounced as a general rule
Any standard not met will result in pharmacy receiving ‘standards not all met’ outcome
An improvement action plan will be required if the pharmacy receives a ‘standards not all met’ outcome
See notes on slide
We will first inspect pharmacies previously rated as ‘poor’, followed by those rated as ‘satisfactory with an action plan’. Once we have inspected pharmacies which have had action plans, we will inspect the pharmacies rated as ‘satisfactory’ (without an action plan), followed by those rated as ‘good’ and then ‘excellent’. This will also allow us to evaluate whether previous improvements have been sustained.

11. Intelligence-led inspections
We will undertake rapid response inspections, initiated following intelligence identified from:
Other organisations
Concerns raised
Media stories
Intelligence from inspectors
Will result in a report with an overall ‘standards met’ or ‘standards not all met’ outcome
To be unannounced as a general rule
Could be undertaken jointly with other regulators / bodies (such as CQC, MHRA, commissioners)
See notes on slide
We know that our ability to carry out intelligence-led inspections will grow over time as we get better at using the information we receive from others. We will be able to see some of the patterns and trends that create problems for pharmacies, and this in turn will help us prioritise our future routine inspections.

12. Themed inspections
We will take forward a programme of themed inspections which will involve visiting a selection of pharmacies to focus on specific themes or issues
Enabling us to better understand underlying issues, their causes and effects
Composite reports will be published to inform the sector on the issues and risks that have been found
Findings will inform discussions on how to continually improve pharmacy services in these areas.
See notes on slide

13. Changes to inspection outcomes
Overall outcome for an inspection would be either ‘standards met’ or ‘standards not all met’ -providing clear and simple assurance for the public
Findings at principle level: ‘standards not all met’, ‘standards met’, ‘good practice’ or ‘excellent practice’
Designed to focus the pharmacy owner and the team on the content of the report, specific positive outcomes, areas for improvement or failed standards in the report
Enables us to identify notable practice, which we can share to help others to learn from and support continuous improvement
Notable practice is just the term which covers both excellent and good practice and where standards have not been met (i.e. poor practice, although we are not using that phrase). We are including all three because you can learn from them all - when things have gone well and also when they have not.

14. Publication
We plan to publish all inspection reports in the future, as well as improvement action plans where appropriate
We will also publish short examples of notable practice, to help drive continuous learning and improvement
New website will make it easy to search for and analyse inspection outcomes and the examples of notable practice
See notes on slide

15. Future work 1. Reviewing our standards for registered pharmacies
Developing an enforcement policy
Seeking views on the information we collect about pharmacies
Seeking views on the information we publish and disclose in relation to registered pharmacies
Publishing a report of what we have learnt from our inspections
Considering whether other options for identifying which pharmacies to inspect- including sampling- would provide assurance
While the main focus of this consultation is on inspections and the publication of inspection reports, we are committed to making other improvements to the way we regulate registered pharmacies. We will, in the future, be:
1. Reviewing our standards for registered pharmacies to ensure they continue to prioritise patient care and the provision of safe and effective care
2. Developing an enforcement policy to inform the way in which we use our enforcement powers.
3. Seeking views on the information we collect about registered pharmacies, at the point of registration, at renewal and on-going basis
4. Seeking views on a new appendix to our publication and disclosure policy which will cover the information we publish and disclose in relation to registered pharmacies. This will include the length of time that reports remain on our website.
5. Publishing a report of what we have learnt from our inspections, including sharing examples of notable practice
6. Considering whether we should continue to inspect all pharmacies on a rolling basis, or whether other options, such as sampling a cohort of pharmacies, would provide assurance to patients and the public that our standards for registered pharmacies are being met.

16. We want your views
Will our proposals help to strengthen assurance and to drive improvement?
What do you think about each of our proposals?
What will be the impact of our proposals?
We are consulting until 9 August and would urge you to respond to our consultation via our website.
I am keen to hear your initial thoughts about our proposals now, particularly the answers to these questions on the slide, and to answer any questions you may have about the proposals too.
(Note to speaker:
If time allows you may want to go through each question in turn, going back to slide 6 which lists the proposals so you can seek views on each one of the proposals.)

17. Take part in the consultation: www. pharmacyregulation
Take part in the consultation: registered-pharmacies
Please respond to the online consultation by 9 August
Closes
9 August 2018

18. Making sure patients and the public obtain medicines and other pharmacy services safely online
We regulate all registered pharmacies in Great Britain, including pharmacies that provide services to patients and the public on the internet. We inspect registered pharmacies and check they are meeting the standards for registered pharmacies.
Advances in technology and the development of new services have brought opportunities to deliver pharmacy and healthcare services in new ways. We want to continue to support and encourage responsible innovation as long as people using pharmacy services receive safe, effective person-centred care.
But the delivery of services online carries particular risk which need to be successfully managed. We are aware of situations where patients have been put at risk because of the inappropriate sale and supply of medicines over the internet, through concerns raised with us and through our work with other regulators.

19. Strengthening safeguards for patients
Different organisations and agencies are responsible for different elements of online healthcare services
We are working closely with other regulators involved
We are proposing to strengthen our guidance for pharmacy owners
Regulating healthcare services on the internet is complex, with different organisations and agencies responsible for different parts of the service.
We are also working closely with other regulators in Great Britain involved in regulating online prescribing services to make sure patients are protected at each stage.
We want to play our part in strengthening the safeguards in place for patients and the public through the guidance we set for pharmacy owners and through our inspections of online pharmacy services.
I’ll now take you through our proposed changes, which come under four headings.

20. Proposals at a glance
Transparency and patient choice - ensuring that patients have enough information about the service to make an informed decision
Making sure medicines are clinically appropriate for patients - considering risks and benefits of allowing patients to choose a POM before a consultation with a prescriber has taken place
Further safeguards for certain categories of medicines- making sure appropriate further safeguards are in place
Regulatory oversight - making it clear that pharmacy owners working with prescribers or prescribing services outside the UK must successfully manage the additional risks that this may create
1. Transparency and patient choice
Ensuring that patients have enough information about the service and who is providing it to make an informed decision
2. Making sure medicines are clinically appropriate for patients
Considering the risks and benefits of allowing patients to choose a prescription only medicines before a consultation with a prescriber
3. Further safeguards for certain categories of prescription only medicines
Making sure the appropriate safeguards are in place for antimicrobials (antibiotics), opiates/sedative, medicines for chronic conditions (including asthma and diabetes) and non-surgical cosmetic medicinal products (such as Botox)
4. Regulatory oversight
Making it clear that if a pharmacy owner decides to work with prescribers or prescribing services operating lawfully outside the UK, then they must successfully manage the additional risks that this may create.

21. Tell us your views
Do you think our proposals should be included in our guidance?
Do you have any comments on our proposals?
What impact will the proposals have on patients, owners and the pharmacy team?

22. Take part in the consultation: www. pharmacyregulation
Take part in the consultation:
The discussion period will run for eight weeks, until 21 August During this time, the GPhC are keen to hear from individuals and organisations with an interest in how medicines and pharmacy services are provided over the internet or at a distance, including patients and the public and those who own or work in these pharmacies.
We would like to hear what you think of our proposals, and whether they will provide additional safeguards to patients and the public. We are also keen to understand the impact of our proposals, both on patients and the public who may wish to use pharmacy services online and those who offer these services.
Closes
21 August 2018

23. PSNC’s service development proposals
Development of the CPCF

24. Letter to PSNC from Steve Brine
Keen to exploit the underutilised resource of pharmacy in tackling increased demand in primary care
Open to Department officials working with PSNC to develop alternative funding models that incentivise community pharmacy differently
Welcome proposals on how that might be achieved within current financial constraints
Changes to arrangements must be well developed with clear plans for embedding them into primary care pathways
Must be able to demonstrate the cost effectiveness of undertaking any new work in the community pharmacy sector, over and above undertaking it in other settings

25. Revising the Community Pharmacy Contractual Framework
Developing proposals for a revised CPCF that supports implementation of the Community Pharmacy Forward View
Needs to address DHSC/NHS England priorities
5YFV Next Steps, Meds Value Programme, etc.
Needs to address Murray Review challenges
The existing Medicine Use Reviews (MURs) element of the pharmacy contract should be redesigned to include on-going monitoring and regular follow-up with patients as an element of care pathways

26. Our proposals to DHSC and NHS England
PSNC’s ultimate proposal for the development of CPCF services, to support people with LTCs, is the commissioning of a Community Pharmacy Care Plan (CPCP) service
The full CPCP service may not be appropriate for all people with LTCs and a move to provision of such a service would need to be undertaken in a managed way, via a transitional framework

27. Our proposals to DHSC and NHS England
We have also developed proposals for a revised CPCF - the “Universal Community Pharmacy Care Framework”
elements of the framework would be applicable to all patients
it would provide a transitional framework to support the eventual introduction of a CPCP service
implementing this would also need to be phased over an agreed time period
It will also require a completely new funding structure…

28. How the two service proposals fit together
Rollout of CP Care Plan Service to selected cohort of patients
Introduction and transition to full provision of the Universal Community Pharmacy Care Framework
Ongoing provision of the Universal Community Pharmacy Care Framework
Current CPCF
Present time
Introduction of Universal Community Pharmacy Care Framework
Full provision of the Universal Community Pharmacy Care Framework PLUS
introduction of the CP Care Plan service

29. Universal Community Pharmacy Care Framework
Clinical safety
Providing a clinically safe dispensing service – the community pharmacist clinical check provided under our professional obligations [Dispensing service]
A review of medicines returned by patients for disposal, to identify issues which need to be addressed with the patient [Prompted by return of POM meds for disposal]

30. Universal Community Pharmacy Care Framework
Transfer of care
Medicines reconciliation post-discharge from hospital (where appropriate data is shared with the pharmacy) [Triggered by referral/information provision]
MUR or NMS-type support where required by the patient [Triggered by referral/information provision]
New medicines
Current New Medicine Service repurposed as an Essential Service (potentially review conditions, e.g. addition of depression, and need in all cases for the follow up (3rd) stage) [Triggered by the dispensing of a new medicine]

31. Universal Community Pharmacy Care Framework
Clinical effectiveness
Compliance with the community pharmacy Antibiotic Guardian Pledges [Triggered by self care support request/script]
Tackling polypharmacy and identifying potential gaps in prescribing using specific indicators, e.g. selected STOPP/START indicators [Triggered by script content]
Querying prescribing of medicines of low clinical value (on an identified list) and supporting CCGs’ work on promoting self-care and removing prescribing for minor illness [Triggered by script content]
Patient experience
Checking the suitability of the current prescribed dosage forms or devices for the individual (focus on use of medicines/devices) at least once a year [Triggered by first disp & on a planned basis]

32. Community Pharmacy Antibiotic Guardian Pledges:
Every time a customer presents with a self-limiting respiratory infection I will use the patient information leaflet to explain the potential duration of illness and how to treat their symptoms
When handing out a prescription that includes antibiotics, I will inform the patient of dose and duration and to take their antibiotics exactly as prescribed and to return any unused antibiotics to a pharmacy for safe disposal
When customers pick up an antibiotic prescription, I will encourage them to take the Antibiotic Guardian quiz online and to choose their own pledge to become Antibiotic Guardians
To help reduce demand for unnecessary antibiotics, I will display materials from the Keep Antibiotics Working campaign to raise awareness of AMR, e.g. via local stands, social media campaign or handing out information leaflet
To help reduce demand for unnecessary antibiotics, I will display other locally developed/other materials to raise awareness of AMR, e.g. via local stands, social media campaign or handing out information leaflet

33. Universal Community Pharmacy Care Framework
Patient activation and support
Discuss adherence with individuals in a specified cohort of patients at least once a year (understanding of, beliefs about and recognised need for their medicines) [Planned provision]
Measurement of Patient Activation Level via PAM for a specified cohort of patients at least once a year and sharing with GP (and supports future provision of the care plan service) [Planned provision]
Healthy living advice / public health interventions and Signposting / care navigation provided to all patients, as appropriate [Triggered, planned and opportunistic provision]
Cost & System Effectiveness
Ascertaining the patient’s need for a repeat medicine at each dispensing (as per the current eRD requirements) [Dispensing service]
Cost effectiveness of the medicine – querying the prescribing of specific medicines or groups of medicines, e.g. specials, in line with national or local guidance [Triggered by script content]

34. Illustrative CPCP service patient pathway
Patient identified, service explained, consent obtained and registration initiated
First consultation
Patient Activation Measure
Assess general health and wellbeing
Discuss patient’s health goals & beliefs
Reconcile and discuss patient’s regimen and assess adherence
Appropriate seasonal advice & education on condition
May be undertaken across one or two consultations, dependent on the complexity of the patient
Establish Patient Care Plan
Review adherence and use of devices
Utilise appropriate screening / assessment tools‡
Agree desired outcomes and actions to be taken
Identify appropriate public health interventions
Request initiation of eRD / Synchronise scripts
The elements of the agreed community pharmacy care plan form part of the patient’s personalised care and support plan, agreed with their general practice
Regular assessments*
Assess progress towards goals in care plan
Appropriate health & social care referrals / social prescribing
Appropriate seasonal advice & education on condition
Monitor adherence and device use
Monitor/support progress with public health interventions
If a patient is discharged from hospital, reassess goals, ensure medication regimen is documented correctly and eRD changes are made as appropriate, and ensure patient is supported to use their new regimen effectively
Six month review*
Patient Activation Measure
Review period of treatment of meds supplied
Monitor/support progress with public health interventions
Appropriate health & social care referrals / social prescribing
Assess progress and identify any new goals
New Medicine Service-type support provided when new medicine prescribed
Regular assessments*
Appropriate health & social care referrals / social prescribing
Appropriate seasonal advice & education on condition
Assess progress towards goals in care plan
Monitor adherence and device use
Monitor/support progress with public health interventions
Cycle of support continues
Twelve month review*
Patient Activation Measure
Assess progress and identify any new goals
Monitor adherence and device use
Monitor/support progress with public health interventions
Review period of treatment of meds supplied
eRD – the NHS electronic Repeat Dispensing service
* Consultations usually occur when the patient is due to collect their next set of eRD prescriptions; patient’s need for individual eRD items is checked before each supply. Domiciliary consultations would be necessary for some patients.
‡ e.g. STOPP/START, ACT, CAT, Frailty/Falls/Independent living assessment, Pain score

35. Further developments? Urgent care
NHS Urgent Medicine Supply Advanced Service
Community Pharmacy Referral Service (Digital Minor Illness Service)
Minor illness services using PGDs/POMs
A pharmacist workforce who are independent prescribers…