1. GPhC: New style pharmacy inspections and Revalidation update
Leyla Hannbeck FRPharmS, MBA, MA
Director of Pharmacy at NPA
Reference for information : GPhC consultation document

2. Agenda GPhC new style inspections
Explain why these changes are taking place
The format of the new GPhC inspections
What to do to prepare
Support available for preparing
Revalidation
Requirements explained

3. 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’

4. New types of inspections
Three types:
Routine
Intelligence-led (potentially with another stakeholder)
Themed
Aim to be flexible, agile and responsive
General rule: most inspections to be unannounced to reflect as closely as possible how patients and public experience pharmacy services on an day to day basis
GPhC keen to visit 300 pharmacies every month!
GPhC will actively look at NHS.UK for patient reviews
Allow for agility and quicker response to information held by the GPhC on pharmacies, intelligence received and issues identified in pharmacies
The GPhC have indicated that they are likely to notify pharmacies in advance when considering “Themed” Inspections

5. New inspection outcomes
New inspection overall outcome:
Be clear and understandable to members of the public
Enable pharmacy owners to be held to account against the standards
Moving to a binary outcome of an inspection for a pharmacy overall – 2 possible outcomes
Standards met
Standards not all met
Supporting findings at each principle level – 4 possible findings
Good practice
Excellent practice
3.8 Under our proposed new approach, a pharmacy must meet all the standards for registered pharmacies to get an overall outcome of ‘standards met’. If a pharmacy has not met a standard, this would result in a ‘standards not all met’ rating overall. This is because the standards have been in place for five years. Patients expect that if a pharmacy receives a ‘standards met’ outcome they have met all the standards.
3.9 As is the case now, inspectors will use their judgement based on the evidence they collect at the pharmacy to decide whether a standard has been met or not. They use the inspection decision-making framework to help them do that. When considering whether a standard has been met, the inspector will consider the impact and scale of the area for improvement. The greater the impact on patient safety, the more likely it is that the standard will not be met. Relatively minor non-compliance is unlikely to result in a standard not being met, as is the case now.

6. Inspection reports
Inspection outcomes are to be open, transparent and accessible to members of the public
Including any improvement actions or regulatory enforcement action
Therefore, inspection reports will publish improvement action plans and details of any enforcement action to be undertaken
Insights from inspection activities will be accessible to everyone in the pharmacy sector
Examples of notable practice will be published in the knowledge hub for all to access

7. Process for publishing reports
A new website will be set up with inspection reports and improvement action plans, as relevant
GPhC will publish examples of ‘notable practice’ in relation to meeting GPhC standards
Published on new GPhC ‘Knowledge Hub’
Notable practice identified through inspections
Encourage learning and improvement to ensure patients/public received effective and safe care

8. GPhC: Individual pharmacy webpage
GPhC will host an individual webpage for each pharmacy premises
These will be available for the public to search and will be linked to the GPhC online register
GPhC to determine the length of time inspections reports are visible on the website
Webpage to show multiple inspection reports, not just the most recent inspection
The next slide shows a mock-up of how a pharmacy premises page would be displayed on the GPhC website

10. GPhC enforcement principles
The following principles guide decision-making:
Proportionality responding appropriately and taking the right action to secure compliance
Consistency be consistent in applying our enforcement options by, as far as possible, dealing with similar cases in a similar manner
Transparency open and transparent about our approach to enforcement
Targeting concentrate on the activities which create the most serious risk, either because the nature of the activity is inherently high-risk or because of a lack of appropriate controls Accountability GPhC are accountable to the public and our enforcement actions can be judged against the principles and approach set out in this policy
Proportionality:
Proportionality is about responding appropriately and taking the right action to secure compliance. This will generally involve taking account of the degree of the risk. -
We take enforcement action when people are at risk of harm or registered pharmacies are repeatedly or seriously failing to meet our standards
Where appropriate, if the pharmacy owner is able to improve the service on their own and the risks to people who use services are not immediate, we will generally work with them to meet our standards rather than taking enforcement action.
Consistency
We aim to be consistent in applying our enforcement options by, as far as possible, dealing with similar cases in a similar manner
the facts in one case are rarely replicated exactly in another case: even though we aim to achieve broad consistency, we will take different decisions in cases where the facts are not the same
we train and support our inspectors and others involved in the decision-making processes to promote consistency
Transparency
We are open and transparent about our approach to enforcement
We also publish information about the enforcement action we have taken, when this is appropriate and allowed by law
Targeting
We concentrate on the activities which create the most serious risk, either because the nature of the activity is inherently high-risk or because of a lack of appropriate controls
Accountability
GPhC are accountable to the public and our enforcement actions can be judged against the principles and approach set out in this policy
Pharmacy owners need to know what to expect when our inspectors visit and how to raise any complaints they may have.

11. What will stay the same?
At the heart of an inspection, the GPhC will still want to see:
Pharmacists are upholding the GPhC’s standards for pharmacy professionals
Pharmacies meet the GPhC’s five principles for registered pharmacy premises

12. Principles and Standards
Standard operating procedures (SOPs)
Staff have clear roles
Complaints procedure is in place
Appropriate records are kept
Patient confidentiality is protected
Safeguarding Children and vulnerable adults
Principle 2
Sufficient staff with appropriate skill mix
Training is appropriately supervised
Incentives and/or targets should not affect
Professional judgement
Culture of openness, honesty and learning
Principle 3
Well-maintained, clean and safe pharmacy premises
Well-designed and compliant with the Health Act and protects patient’s privacy
Clean and hygienic
Secure - ensuring protection of both stock and patient information
Principle 4
Clearly displayed pharmacy services
Services benefit the local community
Promotion of healthy lifestyles
Stock is sourced, stored, supplied and disposed of appropriately
Recalls and alerts are actioned
Principle 5
Clean, well-maintained equipment is available
Equipment is fit for purpose and to the appropriate safety
Standard
IT equipment protects confidentiality

13. Staff involvement The GPhC will ask questions of all members of staff
Staff should demonstrate knowledge of processes in line with the pharmacies SOPs
Locums employed at the pharmacy will be expected to understand all relevant processes
The inspection will examine the day-to-day function in the same way patients experiencing it

14. FAQs
What will be the main focus of the new style inspection? The main focus of the new style of inspections will primarily be to provide assurance to the public that pharmacies are providing safe and effective service, inline with GPhC standards.
Will the inspection reports be GDPR compliant? The GPhC has given assurances that the content of inspection reports will be screened to prevent the disclosure of any patient-sensitive information or details that would compromise the safety or security of a pharmacy premises.
If an action plan has been set for a pharmacy, will the inspection report be updated when the pharmacy completes the plan? Where standards are not met and an action plan is issued, the GPhC will always re-inspect the premises to confirm satisfactory completion, usually within 6 months. The findings of this inspection will also be published, and members of the public will be able to see both reports.
Will all inspections be unannounced? Most inspections will be unannounced to reflect as closely as possible how patients and public experience pharmacy services on an day to day basis. However, the GPhC may be given advanced notice of ‘themed’ inspections in some circumstances.

15. FAQs
When there is a change of ownership, within what time period you would expect an inspection? Changes made to a pharmacy business, such as nomination of a new superintendent, a change of ownership or a change of premises can influence the timing of a GPhC inspection however timelines are not definite and teams should be aware that unannounced inspections can occur at anytime, regardless of such changes.
If standards are not met but put right then is published report updated or does it show not met for 3-4 years? Where standards are not met and an action plan is issued, the GPhC will always re-inspect the premises to confirm satisfactory completion, usually within 6 months. The findings of this inspection will also be published.
How will the Falsified Medicines Directive (FMD) be inspected during the inspection? The GPhC will include FMD compliance within the inspection process, sharing information with MHRA as appropriate. Pharmacies are expected to be compliant with FMD from 9 Feb 2019, and even in the event of a ‘No-deal Brexit’ the MHRA “will evaluate the options for a future UK falsified medicines regulatory framework, taking into account the investment already made by stakeholders.”

16. FAQs
How long will the reports be available for the public to view on the GPhC website, and will only the most recent inspection report be visible? The GPhC are finalising details of how long inspection reports will be available. It is likely that members of the public will be able to search any reports published within the last 3-5 years; this means that more than one report could be available. Also, where action plans have been issued, the public will see the initial ‘standards not met’ report and then the subsequent inspection once the plan has been actioned.
Will pharmacies be required to display copies of inspection reports within the pharmacy? The GPhC are considering ways that a pharmacy can display information about recent inspections. One proposal is the allocation of a poster or window sticker than could be provided by the GPhC for the pharmacy to display to let the public know how a pharmacy is performing with respect to GPhC standards.
If we had an inspection in 2017 , will the next inspection be in four years or earlier with the new unannounced inspection? A routine inspection could take place at anytime after 1 April 2019 regardless of the date of last inspection.

17. Revalidation 2019

18. Revalidation example: Registration expiry 31/12/19 Registration renewal 31/10/19
Last year, you submitted four CPD entries by 31/10/18
Now, you need to submit all six records
Four CPD cycles plus one reflective account and one peer discussion
When your renewal window opens on 1st September 2018, you can submit your 4 CPDs prior to paying the fees
Each registrant will be sent a personal timeline on exactly what they are required to complete in 2018 as part of their renewal

19. Revalidation example: Registration expiry 31/05/19 Registration renewal 31/03/19
This year, submit four CPD entries by 31/03/19
From next year (2020), you need to submit all six records
Four CPD cycles plus one reflective account and one peer discussion
When your renewal window opens on 1st September 2018, you can submit your 4 CPDs prior to paying the fees
Each registrant will be sent a personal timeline on exactly what they are required to complete in 2018 as part of their renewal

20. Peer discussion Key steps: Choose a suitable peer
Share information to guide the discussion
Conduct discussion and engage with it in a reflective manner
Format
Face to face
By phone
Web chat / video call
Any means of real-time communication that works for both parties
Peer discussion
Peer discussion is a learning and development activity that encourages you to engage with others in your reflection on learning and practice. Research shows that having another person’s view can help pharmacy professionals to reflect on their practice and can reduce the potential for professional isolation.
To be most effective, these discussions should be designed to aid your development, open and honest and with someone who you trust and respect. Peer discussions can take place in any format: face to face, over the phone, via web chat, via a video call or any other means of real-time communication that is effective for you.
For your peer discussion to be effective you need to consider the following things:
 deciding on an appropriate peer or peers
 sharing relevant information to guide the discussion
 having the discussion and responding to it in a reflective way

21. CPD records
Each year, pharmacists and pharmacy technicians must submit four CPD entries
At least two of which must be planned learning activities
Should be relevant and demonstrate the benefit on people using the services provided by the registrant
Each entry length suggested is between words, however there is no minimum nor maximum word limit
each year pharmacy professionals must submit four CPD entries, of which a minimum of two must be planned learning activities
CPD entries should relevant and demonstrate the benefit on people using the services the pharmacist/pharmacy technician provides
Additionally, the CPD entries should submit records that demonstrate benefits to people who have used the service, not the potential benefits to individuals using services in the future – the GPhC want to see records of actual outcomes as a result of pharmacy professionals putting their learning into practice
Each CPD entry is suggested to be between words, however there is no minimum nor maximum word limit and it is important to focus entries on meeting the review criteria

22. Peer agreement Speak with your chosen peer
Seek their agreement to be your peer
They also need to agree for their name to be included in your peer discussion record
If your record is selected for review, the GPhC will contact them to confirm that the peer discussion did take place – no other information will be asked about the discussion itself
You must make sure your peer has agreed to be named in the record of your discussion, and contacted about it. If you are selected for review, we will contact your peer to confirm the discussion has taken place. We will not ask your peer for any information about the discussion other than to confirm that it has happened.

23. What to discuss?
Share information before the discussion as this will make it more effective
Discussion ideas:
CPD activities
Reflective account
Critical incidents and/or other important events
Feedback received
Complaints and compliments
Performance reviews
GPhC standards
We know some peer discussions happen spontaneously rather than being pre-planned, and work well. However, these are generally less effective as a reflective exercise because preparation – including thinking about the discussion in advance – will make the discussion more effective.

24. Top tips for completing a peer discussion
Include a description of why this peer was chosen
Explain how the peer discussion has helped you reflect on your practice
Describe changes made to your practice as a result
Provide examples of how the changes implemented have positively impacted and benefited your service users
Be between words (but there is no minimum or maximum)

25. Reflective account
Each year, pharmacists and pharmacy technicians must submit one record of a reflective account
A reflective account is an activity designed to encourage pharmacists and technicians to think about the way in which they work in relation to the GPhC standards
A reflective account is aimed to encourage individuals to think about how the work they do as a pharmacy professional relates to the GPhC standards for pharmacy professionals
A reflective account is intended to focus on how individuals meet the GPhC standards and therefore raise awareness and understanding of the standards, while reflecting on current practice and how this affects those using the services provided
The GPhC will inform pharmacy professionals well in advance of the required submission date, which standards should be the basis and focus of the reflective account – this will be communicated through channels such as the online portal, GPhC renewal correspondence, through Regulate

26. GPhC standards for reflection 2019
Reflect on one or more of the following:
Standard 3 - pharmacy professionals must communicate effectively
Standard 6 - pharmacy professionals must behave professionally 
Standard 9 - pharmacy professionals must demonstrate leadership

27. Writing the reflective account
Brief description to give context
What setting do you work in?
What is your main role?
What are you main responsibilities?
Who are your service users?
One or more examples to support your reflection, to show how you have reflected on the GPhC standards and applied them in practice
Suggestion – discuss what to include in the reflective account as part of your peer discussion
We want you to tell us briefly about your work (the setting of your practice, your main roles and responsibilities, the typical users of your service). Giving us this type of context is helpful if your record is selected for review, and also helps you to consider if the people using your services have changed.
We want you to give at least one (but ideally more) examples to support your account so that we can see how you have reflected on the standards and their application in practice. The standards for pharmacy professionals are all inter-related, so you will find that you can show how you met more than one of them using just one example. You can look at our example records to see how this can be done.
You may find it helpful to discuss what to include in your reflective account as part of your peer discussion.

28. Top tips for completing a reflective account
Describe the setting of your practice and your main roles
Include a description of the typical users of your service(s)
Explain how you have met the GPhC standard(s) for pharmacy professionals
Include examples
Include any feedback or evidence
Additionally It is advised that the reflective account record should be between words, however there is no minimum nor maximum word limit and it is important to focus entries on meeting the review criteria

29. If I miss the submission deadline or I cannot complete/submit all the records, will I be able to renew my registration?
When renewing registration, registrants must declare that you will comply with the revalidation framework
If unable to submit some/all records - inform GPhC in advance of renewal
Dependant on individual circumstances/reasons, may still be able to renew registration
Without good reasons, you will enter a remediation process
At the point of renewal, all registrants must declare that they will continue to comply with the revalidation framework
If you cannot submit some/all of the required records for good reason, you must inform the GPhC in advance of your renewal date – the GPhC will review you reasons and personal circumstances and you may still be able to renew your registration without submitting the records or an extension to submit may be permitted
Such reasons may include sick leave, maternity/paternity leave, military postings and breaks from practice – however gaps in records should not usually exceed 12 months
However, without good reason for failure to complete and submit the records, you will enter a process of remediation which includes intervention from the GPhC and a requirement for the records to be submitted
Following the period of remediation, if records have not been submitted then a process called administrative removal will be undertaken – if you are removed from the register following this process and an individual reapplies to the register, then all six records (4 CPDs, peer discussion and reflective account) must be submitted during the application

30. Revalidation recap
Check your revalidation timeline:
If your renewal deadline is 31 October 2019, you need to submit four CPD, one peer discussion and one reflective account for your expiry deadline of 31 December 2019.
If your renewal deadline is on 31/03/2019 you only need to submit four CPDs this year.
Exceptional circumstance?
Tell GPhC as soon as possible via myGPhC.org

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