The New GPhC Inspection Model

1. The New GPhC Inspection Model Leyla Hannbeck, Head of Pharmacy Services, NPA

2. The new inspection model “A show me, tell me story” The standards are designed to protect the health, safety and wellbeing of patients and the public Governance arrangements Empowered and competent staff Managing pharmacy premises Delivering pharmacy services Equipment and facilities Based on FIVE principles and the underpinning GPhC standards

3. Principle 1: Governance arrangements This is all about managing the potential risks that processes and services may pose to patients/public • 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 NPA standard operating procedure NHS Complaints Record Book

4. Principle 2: Empowered and competent staff This is all about the competency of staff, the skill mix and the way that training is managed within the pharmacy • 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 This is to certify that:

5. Principle 3: Managing pharmacy premises This is all about having well-maintained pharmacy premises that are hygienic, well-designed and secure • 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

6. Principle 4: Delivering pharmacy services This is all about the promotion and accessibility of pharmacy services to the public, and ensuring safe delivery of these • 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

7. Principle 5: Equipment and facilities This is all about ensuring that equipment and facilities used in the pharmacy are safe and for for purpose • Clean, well-maintained equipment is available • Equipment is fit for purpose and to the appropriate safety • Standard • IT equipment protects confidentiality

8. “A show me, tell me story” by the NPA

9. Summary of NPA resources: • The following resources are available in this series, with further documents planned in due course: • “GPhC inspections “A show me, tell me story”: introduction” • “GPhC inspections “A show me, tell me story”: Guidance — Principle 1” • “GPhC inspections “A show me, tell me story”: Guidance — Principle 2” • “GPhC inspections “A show me, tell me story”: Guidance — Principle 3” • “GPhC inspections “A show me, tell me story”: Guidance — Principle 4” • “GPhC inspections “A show me, tell me story”: Guidance — Principle 5” • “GPhC inspections: “A show me, tell me story”: Self-assessment grading” • “GPhC Inspections: FAQs (Dec 2013)” • “GPhC inspections: NHS public health campaign pharmacy log” • “GPhC inspections: Pharmacy cleaning matrix” • “GPhC inspections: Pharmacy date-checking matrix” • “GPhC inspections: Pharmacy drug/devicealert log” • “GPhC inspections: Pharmacy maintenance issues log” • “GPhC inspections: Recommended resources” • “GPhC inspections: Pharmacy self care log” • “GPhC inspections: Pharmacy signposting record log” • “GPhC inspections: Pharmacy team training record” (for individual members of the pharmacy team) • “GPhC inspections: Sale of medicines protocol guidance” • Other NPA resources: • Standard operating procedures: • o Controlled Drugs • o Responsible pharmacist • o National Patient Safety Agency (for example, supplying insulin, supply of lithium therapy) • o Medicines Use Review

10. How do inspectors grade pharmacies? Poor Excellent!! Our aim = NPA members Satisfactory Regulation is used to drive continuous improvement Good

11. What can I expect during an inspection? • Approximately 2h in duration • All pharmacy team involved • Observations made on hand-held electronic device • Responsible pharmacist (RP) may view the observations • Comments may be added by the RP, before signing to confirm agreement with the report • Report sent to the pharmacy owner/superintendent pharmacist • shortly after the inspection The focus is now on patient safety and inspectors will be looking for evidence of this

12. What evidence am I expected to provide? • Layout of pharmacy including work flow and availability of consultation area • Competence and skill mix of pharmacy team (training) • Insurance arrangements • Professional looking, well maintained, hygienic premises with clearly defined professional area • Security arrangements • Facilities for all patient groups, including those with disabilities • Equipment and facilities are available to provide pharmacy services

13. What if my pharmacy receives a poor* judgement? *This includes those pharmacies that have been graded as satisfactory but some standards have not been met • Moderate or high risk to patient safety: • Rectify within TEN working days • Action plan issued • Superintendent pharmacist to respond within two days • Must state any remedial action to be carried out, when and who will be responsible for doing so • No significant risk (ie satisfactory but some standards not met) • Rectify within TWENTY working days

14. Remember! • The focus of the inspections is patient safety • Inspectors are not looking to penalise minor issues • It does not matter what methods are used to achieve standards • The more prepared you are, the less time the inspection will take • The NPA Pharmacy Services toolkit is available to help you ensure that you are continually meeting GPhC standards GPhC inspections: “A show me, tell me” story” Introduction Principles 1, 2, 3, 4, 5 Self assessment grading tool Tools Sale of medicines protocol Summary of resources FAQs

15. Making a satisfactory pharmacy good/excellent GPhC inspections: “A show me, tell me” story” • Procedures and processes regularly reviewed • Pharmacy Services consistently and actively promoted • Regular review of patient needs • Risk assessments carried out • Comprehensive record keeping • Innovation • Clear, positive health outcomes for patients SOPs Records Evidence Services • Processes and procedures in place

16. Scenario 1 Dispensing error: Tegretol Prolonged Release tablets 200mg supplied instead of Voltarol Retard tablets. The patient took the tablets for two days before the error was detected and the patient’s doctor has contacted the pharmacy to notify the pharmacist of the error. The dispensing technician takes the call — what action would they take? HC11 NHS Help with health costs • Which member of the pharmacy team were involved? • How are incidents dealt with? • What processes are in place to notify the patient? • Are incident reporting procedures in place? • What possible factors were implicated in the incident? • Is indemnity insurance cover in place?

17. Scenario 2 You overhear a conversation on the chemist counter in which a member of the pharmacy counter staff is selling chloramphenicol eye drops 0.5% for use in a dog. You intervene in the sale and afterwards take the member of staff to one side; how do you ensure that this does not happen again?. • What training has the member of staff completed? • How often is staff training planned and is this recorded? • Are one-to-one meetings planned in? • Is there a Sale of Medicines Protocol in place and do staff adhere to it?

18. Scenario 3 Your pharmacy is located within a GP practice and the practice manager has informed you that the cleaning contractor will be coming in prior to the surgery and pharmacy opening to clean the premises. A member of the pharmacy team will not be present. Are additional security arrangements required? • A risk assessment should be carried out due to the change in circumstances • Are additional security arrangements required, for example locked shutters, use of CCTV, use of locked drawers • Will there be a risk of a breach in information governance?

19. Scenario 4 One of your patients comes in with two new items on their prescription. They will need counselling about both medicines, however, English is not their first language. You struggle to relay the information regarding their prescription, and no-one in the pharmacy speaks their language. • Availability of information from Local NHS Organisation, for example, leaflets • Does the patient have sufficient information to safely take their medicine(s)? • Consider reviewing the local population demographics • Signposting

20. Scenario 5 Extemporaneous preparation of an urgently medicine: you have the ingredients to prepare the medicine, however, the weighing scales have been placed in the stock room and some of the weights are missing. The dispensing technician advises you that they haven’t been used ‘for years’. Ordering via your specials wholesaler will take too long. Can you attempt to make the medicine? • Is the pharmacist competent in preparing extemporaneous preparations? • Appropriate facilities and equipment should be in place to dispense medicines • Procedures in place for maintaining pharmacy equipment • Signposting

21. Scenario 6 Computer technical issues: prescriptions requiring hand endorsement and labels having to be written by hand. The pharmacist decides to take the prescriptions home to complete and check the endorsements as it has been too busy during pharmacy opening hours to do so. The prescriptions are in a carrier bag and are left overnight in the flat that the pharmacist shares with other flatmates, before being returned to the pharmacy the following morning. • Business continuity planning • Data protection and confidentiality • Information Governance SOPs in place and adhered to • Information Governance training for all staff • Safe storage of prescriptions at all times

22. FAQs: general Will I get a notification of the intention of a GPhC inspectors visit? If there is a locum pharmacist on duty, can the inspection be deferred?

23. FAQs: action plans I have received an action plan to complete, I am not sure what to do? Can the responsibility for the action plan be delegated to a RP?

24. FAQs: action plans What if the Superintendent Pharmacist is on holiday and an action plan needs to be produced? I am not sure that ten days is sufficient time to rectify the shortfalls, what can I do?

25. FAQs: judgements • No grading is made at this stage • Signing is to denote that the inspectors observations are accurate • The RP may add comments • The report will be sent to Superintendent shortly after • Superintendent may correct factual accuracies once received but not observations made by the inspector • Superintendent will be asked to confirm their agreement with the report • The judgement cannot be challenged, however The inspector has asked me to sign the report at the end of the inspection, what if I don’t agree with the observations?

26. FAQs How often will my pharmacy be visited? Are the visits similar to the contract monitoring visits? • There is some overlap • GPhC inspections focus heavily on patient safety; risk assessment forms part of Clinical Governance (an NHS Essential Service) • Contract monitoring visits are carried out by Local Area Teams, and only apply to those pharmacies in NHS England’s pharmaceutical lists; GPhC inspections apply to all registered pharmacies

27. Any questions? GPhC inspections: Pharmacy log • Record keeping • Legal records maintained • Logs/matrices maintained as supporting evidence NPA standard operating procedure • SOPs: • In place for all the processes in the pharmacy • Up to date and regularly reviewed • Staff can demonstrate that processes are followed in line with SOPs • Evidence of where incidents have occurred and SOPs reviewed, thus improving processes

28. Remember! • Use the NPA self-assessment grading tool to give your pharmacy a grading and identify where you can improve • Pharmacy call to action: • creating a ‘pharmacy first’ culture • ensuring patients get the best from their medicines • integrating community pharmacy into the patient pathway • Increasing safety of dispensing • Put yourself in the shoes of inspectors and patients and see your practice through their eyes

29. The end! Thank you for listening and good luck!!