GPh C New style pharmacy inspections and Revalidation

GPh. C: New style pharmacy inspections and Revalidation update Claire Bryce-Smith: GPh. C Leyla Hannbeck: NPA @Leyla. Hannbeck

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

Key changes at a glance 1. 2. 3. 4. 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 5. Publishing inspection reports 6. Sharing examples of notable practice in a ‘knowledge hub’

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 • GPh. C keen to visit 300 pharmacies every month! • GPh. C will actively look at NHS. UK for patient reviews

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 – – Standards not all met Standards met Good practice Excellent practice

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

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

GPh. C 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 GPh. C are accountable to the public and our enforcement actions can be judged against the principles and approach set out in this policy

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

Principles and Standards Principle 1 üStandard operating procedures (SOPs) üStaff have clear roles üComplaints procedure is in place üAppropriate records are kept üPatient confidentiality is protected üSafeguarding Children and vulnerable adults Principle 2 üSufficient staff with appropriate skill mix üTraining is appropriately supervised üIncentives and/or targets should not affect üProfessional judgement üCulture of openness, honesty and learning Principle 4 üClearly displayed pharmacy services üServices benefit the local community üPromotion of healthy lifestyles üStock is sourced, stored, supplied and disposed of appropriately üRecalls and alerts are actioned Principle 3 üWell-maintained, clean and safe pharmacy premises üWell-designed and compliant with the Health Act and protects patient’s privacy üClean and hygienic üSecure - ensuring protection of both stock and patient information Principle 5 üClean, well-maintained equipment is available üEquipment is fit for purpose and to the appropriate safety üStandard üIT equipment protects confidentiality Independent Pharmacies Rising to the Challenge

Staff involvement • The GPh. C 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

Registered pharmacy premises standards help and resources: GPh. C “Inspection decision making framework” “Prototype inspection model: examples of evidence” “Guidance to ensure a safe and effective pharmacy team” “Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet” • “Guidance for registered pharmacies preparing unlicensed medicines” • “Responding to complaints and concerns” • •

Registered pharmacy professional standards help and resources: GPh. C • In practice: – – – “Guidance on religion, personal values and beliefs” “Guidance on consent” “Guidance on maintaining clear sexual boundaries” “Guidance on confidentiality” “Guidance on raising concerns” • “Joint statement from the Chief Executives of statutory regulators of health and care professionals” • “Demonstrating professionalism online” • “Female genital mutilation: mandatory duty for pharmacy professionals to report”

Registered pharmacy premises standards help and resources: NPA • NPA website: https: //www. npa. co. uk/services-andsupport/practical-support/gphc-inspection/ – GPh. C booklet: “Show me, Tell me” – Tips in preparing for an inspections – Sales of medicines protocol • Pharmacy Services team: – Telephone: 01727 891 800 – Email: pharmacyservices@npa. co. uk

Additional support from the NPA • • • (list not exhaustive) Essential SOPs – also includes those with FMD steps Pharmacy services resources, such as: – Community pharmacy operations pack – Accessible Information Standards suite of resources – Flu vaccination suite of resources – NMS Toolkit – Service user consent policy Business and HR resources, including: – Staff handbooks, agreements, contracts – Confidentiality agreement – Locum pack – VAT – Whistleblowing suite of resources • • Patient safety resources: – Safeguarding vulnerable adults and children suite of resources – Travel: malaria and Zika – Look-alike and sound-alike items (LASA) – Eye products, inhaler, insulin identification checkers – Valproate checklist – Modern slavery act – Radicalisation Sale and supply of medicines resources: – Cannabis oil – COPD Toolkit – Drug driving – Poisons suite of resources

Revalidation 2019

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

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

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 200 -400 words, however there is no minimum nor maximum word limit

Peer discussion • Key steps: 1. Choose a suitable peer 2. Share information to guide the discussion 3. 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 agreement 1. Speak with your chosen peer 2. Seek their agreement to be your peer 3. They also need to agree for their name to be included in your peer discussion record 4. If your record is selected for review, the GPh. C will contact them to confirm that the peer discussion did take place – no other information will be asked about the discussion itself

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 GPh. C standards

Top tips for completing a peer discussion ü Include a description of why this peer was chosen ü Explain how the peer discussion has helped you reflect on your practice ü Describe changes made to your practice as a result ü Provide examples of how the changes implemented have positively impacted and benefited your service users ü Be between 200 - 400 words (but there is no minimum or maximum)

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 GPh. C standards

GPh. C 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

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 you have reflected on the GPh. C standards and applied them in practice • Suggestion – discuss what to include in the reflective account as part of your peer discussion

Top tips for completing a reflective account ü Describe the setting of your practice and your main roles ü Include a description of the typical users of your service(s) ü Explain how you have met the GPh. C standard(s) for pharmacy professionals ü Include examples ü Include any feedback or evidence

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 GPh. C 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

Revalidation recap • Check your revalidation timeline: https: //www. pharmacyregulation. org/your-revalidationtimeline • 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 GPh. C as soon as possible via my. GPh. C. org

Next webinar 26 March Cover aspects of pharmacy contract and reimbursement Category M Category C Margin survey Price concessions