1. GPhC update
2019

2. What we will cover today
Regulating registered pharmacies
Consultation on draft guidance for pharmacist prescribers

3. Regulating registered pharmacies

4. Key principles
To be flexible, agile and responsive to the information we hold, intelligence we receive and issues we identify within pharmacy
Inspections should reflect as closely as possible how patients and the public experience pharmacy services day to day
The overall outcome of an inspection is clear and understandable
All standards for registered pharmacies need to be met every day
The outcome of an inspection is open, transparent and accessible to members of the public
Insights from inspection activities are accessible to everyone in the pharmacy sector
Our Council agreed the key principles that underpin our new approach at their meeting in December 2018:
To be flexible, agile and responsive to the information we hold, intelligence we receive and issues we identify within pharmacy. This primarily relates to the different suite of inspection types. So rather than having an approach of ‘one size fits all’, we will have different types of inspections that should allow us to use our resources more flexibly and responsively depending on the nature of the information received.
Inspections should reflect as closely as possible how patients and the public experience pharmacy services day to day.
The overall outcome of an inspection is clear and understandable to members of the public and enables pharmacy owners to be held to account against the standards.
All standards for registered pharmacies need to be met every day.
That the outcome of an inspection is open, transparent and accessible to members of the public (including where improvement action or regulatory enforcement action is required as a result). During the consultation we held focus groups with members of the public – they told us that people feel assured by knowing an improvement action plan is in place, and that this would not deter them from using that pharmacy.
That insights from inspection activities are accessible to everyone in the pharmacy sector

5. Key changes 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’
Changes to the types of inspections – the new model will include three types of inspection: routine inspections, intelligence-led inspections and themed inspections. I will cover these in more detail on the following slides.
Moving to unannounced inspections 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.
We would expect that the responsible pharmacist, whether a locum or not, should be able to answer the inspector’s questions. We involve the whole pharmacy team in the inspection, and so other members of the team would be able to answer questions too. The superintendent pharmacist will have the opportunity to comment on the draft report before it is published.
If our inspectors think that continuing an inspection may mean that patient safety may be put at risk, they will leave and come back at another time, as they do now.
Changing inspection outcomes –there will 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’). The ‘principle level’ refers to the five principles in our Standards for Registered Pharmacies.*
Requiring all standards to be met to receive an overall ‘standards met’ outcome – if any standard is found not to be met, this will result in a ‘standards not all met’ outcome overall.
Publishing 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. Pharmacy owners will also be expected to display inspection outcomes in their pharmacies.
Sharing examples of notable practice – examples of notable practice identified through inspections will be published in a ‘knowledge hub’ on the new website. This will help encourage continuous learning and improvement in pharmacy. Notable practice covers excellent, good and ‘poor’ practice. We are including all three because you can learn from them all - when things have gone well and also when they have not. We are working with an Operational Reference Group made up of external stakeholders from the sector across the three countries to develop this work, which will include criteria for selection as ‘notable practice’.  
* The five principles are:
Principle 1: The governance arrangements safeguard the health, safety and wellbeing of patients and the public.
Principle 2: Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public.
Principle 3: The environment and condition of the premises from which pharmacy services are provided, and any associated premises, safeguard the health, safety and wellbeing of patients and the public.
Principle 4: The way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public.
Principle 5: The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public.

6. The new types of inspections
Themed inspection
Routine inspection
Intelligence-led 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.

7. 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
Every pharmacy to continue to be inspected
We expect that a pharmacy would have a routine inspection every 4-5 years, as has been the case under the current inspection model which started in November But a pharmacy could have an intelligence-led inspection or be part of a thematic inspection before a 4-5 year period has passed since their last inspection
Moving to a more flexible programme, informed by indicators of risk when identifying which pharmacies should be inspected first
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.
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

8. Intelligence-led inspections
We will undertake rapid response inspections, initiated following intelligence identified from:
Concerns raised about a pharmacy or people working in a pharmacy
Other organisations
Media stories
Intelligence from inspectors
Will result in a written inspection report
To be unannounced as a general rule
Could be undertaken jointly with other regulators / bodies (such as CQC, MHRA, commissioners)
We will undertake rapid response inspections, initiated following intelligence identified from:
Concerns raised about a pharmacy or people working in a pharmacy
Other organisations - We have Memoranda of Understanding in place with a wide range of organisations which sets out how we will share information with each other, and we work to continually improve how information is shared with other organisations and are in the process of putting in place formal information sharing agreements with some of these.
Media stories
Intelligence from inspectors
We are working to ensure that we have robust processes in place to ‘weigh’ the veracity of the intelligence received, which will ensure that intelligence led inspections are undertaken in the right cases.
Will result in a written inspection report
To be unannounced as a general rule
Could be undertaken jointly with other regulators / bodies (such as CQC, MHRA, commissioners)
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.
We are currently working through whether a full inspection is completed each time, or whether one specific to certain standards is undertaken, or whether we retain flexibility so we respond proportionately in each case to the context of the information received. We will be developing some rules and principles around this.   

9. 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
We have not yet agreed the programme of themed inspections. But some examples of the potential topics for themed inspections include risk management in supplying medicines online or services provided to a care home
We are working on the operational details of themed inspections such as criteria for how we decide on ‘themes’.
We currently think there could be up to 3 themed inspections each year.     

10. Changes to inspection outcomes
The overall outcome for an inspection would be either ‘standards met’ or ‘standards not all met’. This provides clear and simple assurance for the public.

11. Changes to inspection outcomes
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
We have established an operational reference group to enable us to hear practical insights from owners and those directly involved in delivering services on how our new approach will be implemented and any operational considerations that need to be taken into account.

12. Publication
We plan to begin publishing inspection reports, as well as improvement action plans where appropriate, in the first quarter of 2019/2020
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

13. Consultation on draft guidance for pharmacist prescribers
We are consulting on draft guidance for pharmacist prescribers which sets out the key areas pharmacist prescribers should consider when prescribing to ensure safe and effective care. This consultation is open until 21 June 2019.

14. Context
Government strategies that recognise value of pharmacist prescribers
Increasing numbers of pharmacist prescribers
Pharmacist prescribers working in new roles and settings
Since 2016 the number of independent prescribers on our register has gone up by over 4,000 which is more than double.
While national pharmacy strategies vary across the countries in Great Britain, there is a consistent recognition that employing pharmacist prescribers across healthcare settings makes the best use of pharmacists’ prescribing knowledge and skills, and complements the skills of other members of the healthcare team.
The public’s expectations about health services are continuing to change.

15. How the draft guidance was developed
Research carried out over the past three years
Information received through a prescribers’ survey (2016)
Information from fitness to practice cases
Previous discussion papers, including on making sure patients and the public obtain medicines and other pharmacy services safely online (2018)
Consultation on education and training standards for pharmacist prescribers (2018)
See slide

16. Key areas covered in guidance
taking responsibility for prescribing safely
keeping up to date and prescribing within your level of competence
working in partnership with other healthcare professionals and people seeking care
prescribing in certain circumstances
prescribing non-surgical cosmetic medicinal products
remote prescribing
safeguards for the remote prescribing of certain categories of medicines
raising concerns
Plus information for pharmacy owners and employers of pharmacist prescribers
The guidance sets out the key areas that relate to the provision of safe and effective prescribing. Pharmacist prescribers should consider these areas when prescribing, to ensure safe and effective care. These are:
See slide
Section 9 in the guidance deals with information for pharmacy owners and employers of pharmacist prescribers.

17. The guidance includes some key questions that pharmacist prescribers should ask themselves when thinking about how they can ensure and demonstrate that they have provided person-centred care.

18. Prescribing safely
Draft guidance sets out what pharmacists prescribers should do to make sure they are prescribing safely
We are seeking views on circumstances where a pharmacist prescriber has to decide if they can prescribe safely- for example, without access to a person’s medical records
Having all the relevant medical information about a person and their medicines is vital to ensure safe prescribing. This may be obtained by communicating with the person’s regular prescriber or by having access to the person’s medical records.
We are seeking views on circumstances where a pharmacist prescriber has to decide if they can prescribe safely. For example, when you do not have access to a person’s medical records or the person does not have a regular prescriber (such as a GP)

19. Prescribing and supplying
Draft guidance proposes initial prescribing should usually be kept separate from supply of medicines prescribed
But describes certain circumstances where it may be necessary, such as when a person needs the medicines urgently
We are seeking views on whether there are other circumstances when pharmacist prescribers should be able to prescribe and supply
The draft guidance proposes that pharmacist prescribers should usually keep the initial prescribing separate from the supply of medicines prescribed to protect the person’s safety.
The draft guidance describes certain circumstances where it may be necessary to prescribe and supply - for example, when a person needs the medicines urgently
And certain circumstances when a pharmacist prescriber may prescribe and supply on a regular basis – for example, when administering travel vaccines.
We are seeking views on whether there are other circumstances where a pharmacist prescriber should be able to prescribe and supply

20. Safeguards for remote prescribing of certain categories of medicines
Draft guidance outlines certain categories of medicines which are not suitable to be prescribed remotely unless further safeguards have been put in place
Safeguards include checking identity and seeking consent to contact regular prescriber
We are seeking views on any additional safeguards
Certain medicines are not suitable to be prescribed remotely unless further safeguards have been put in place to make sure they are clinically appropriate.
We have proposed safeguards including having a robust process for checking identity and asking for consent to contact the person’s regular prescriber.
They are seeking views on additional safeguards for remote prescribing of certain categories of medicines.
For information, the categories of medicines include:
Antimicrobials (antibiotics)
Medicines liable to abuse, overuse or misuse, or where there is a risk of addiction and ongoing monitoring is important such as opiates
Medicines that require ongoing monitoring or management, such as those used to treat diabetes, asthma, epilepsy and mental health conditions.
Non–surgical cosmetic medicinal products
For information, the safeguards set out in the guidance are:
If a pharmacist prescriber decides to prescribe remotely or work with an online prescribing service, the above categories of medicines should be prescribed only if the prescriber:
• has robust processes in place to check identities, to make sure the medicines prescribed go to the right person
• has asked the person for the contact details of their regular prescriber, such as their GP, and for their consent to contact them about the prescription
• will proactively share all relevant information about the prescription with other health professionals involved in the care of the person (for example their GP)
• has systems in place so that the pharmacy team can clearly document the prescriber’s decision to issue a prescription, if the person does not have a regular prescriber such as a GP or when there is no consent to share information
is working within national prescribing guidelines for the UK and good practice guidance

21. Take part in the consultation: www. pharmacyregulation
Take part in the consultation: guidance-pharmacist-prescribers
Closes
21 June 2019
The consultation will be open until 21 June and you are encouraged to respond to the consultation via the GPhC website.
The feedback received through the consultation will be considered by the GPhC Council in Autumn 2019

22. Find out more Visit the GPhC website – www.pharmacyregulation.org
Join the discussion on social media
on Twitter #PrescribingGuidance - Facebook.com/TheGPhC
Find out more about the GPhC on their website and on social media.