GPhC Inspections


Is Your Team GPhC Inspection Ready?

There will now be three types of inspections:

  • intelligence-led
  • routine
  • themed

As a general rule, inspections are to be unannounced, each pharmacy is expected to be visited every 3-5-year cycle and more frequent if there is local intelligence. It is  important that the whole pharmacy team  are aware of the standards and can provide evidence to support they are meeting them.

Inspection reports will be published from Quarter 1 2019/20 with examples of notable practice being shared in a ‘knowledge hub’ on the new website

The standards you must meet are all detailed on the GPhC website:

https://www.pharmacyregulation.org/sites/default/files/Inspection%20Decision%20Making%20Framework%20Nov%202013.pdf

https://www.pharmacyregulation.org/sites/default/files/document/standards_for_registered_pharmacies_june_2018_0.pdf

To assist pharmacy owners/superintendent pharmacists in ensuring that the required procedures are in place for the safe management of CDs, the GPhC produced a Controlled Drug self-assessment form for England and Scotland.  Although the GPhC don’t use this anymore it will help to ensure you audit your processes around CDs.  The audit is available here under CD self-assessment:

https://www.pharmacyregulation.org/content/cd-self-assessment-form-april-2013

We recommend this is completed prior to the inspection and be available for the GPhC inspector.

All pharmacy premises and staff should be suitably prepared to host a General Pharmaceutical Council (GPhC) inspection at all times.

The GPhC will be holding pharmacy owners and superintendent pharmacists accountable for the outcomes of the inspection, so owners and superintendent pharmacists should ensure all their pharmacy teams are suitably prepared.

The GPhC inspection guidance is available here

https://www.pharmacyregulation.org/inspecting-registered-pharmacies

https://www.pharmacyregulation.org/standards

For DSPs and those providing services at distance: https://www.pharmacyregulation.org/sites/default/files/document/guidance_for_registered_pharmacies_providing_pharmacy_services_at_a_distance_including_on_the_internet_april_2019.pdf

The new GPhC inspection model places an emphasis on patient safety. After initially reviewing the standards and collecting evidence for inspection, pharmacy staff should continually renew evidence, and receive training.

Suitable procedures should be in place to meet standards when locum pharmacists are present, during staff absences or during times of pharmacy maintenance. This may mean reviewing procedures on a day-to-day basis, as necessary, to ensure the pharmacy is complying with GPhC standards. 


How to prepare staff for a General Pharmaceutical Council inspection

General

  • GPhC inspectors will be observing interactions with patients and questioning and posing scenarios to staff. All pharmacy staff should be appropriately trained, and it may be beneficial to talk them through the inspection process and prepare them for questioning by the inspector, so they do not feel put ‘on the spot’ during an inspection.
  • Staff should participate in ongoing training, not just their initial training, in order for a pharmacy to achieve a higher rating in the inspection.
  • The locum pack can be used to help ensure locums have all relevant pharmacy information to keep them well informed for an inspection.

How to prepare staff for an inspection

  • Use the PSNC / NPA resources
  • Review SOPs regularly
  • Role play with staff questioning them as the inspector might
  • Internal information on inspections relating to the pharmacy chain/ individual pharmacy
  • Meeting with all staff in advance to discuss the inspection process
  • Carry out your own internal inspection / self-audit

How to host an inspector

  • Staff should be prepared to talk to the inspector on the day. Services should be thought about in advance in order to accommodate the needs of the inspector, for example, time needed for the inspector to speak to pharmacists.
  • The GPhC inspector will give an outline of what the inspection is and how it will be conducted, before going onto the services provided and the staff present or not present. This would be good knowledge for the staff to have
  • Staff should be polite and courteous to the inspector and should be open when answering questions. When the inspector first arrives in the pharmacy, the responsible pharmacist (RP) should try and ascertain the plan of the inspector for the inspection.

Hints and tips for the day

  • Sell what you do — promote yourself and your team
  • Be open and give as much information as possible
  • Make sure you show them everything — the inspector may not ask
  • Promote yourself and your team — effectively communicate to the inspector what the pharmacy does
  • Ensure all staff know where all information is, including things such as patient group direction documents/SLAs , safety incident reports and near miss logs, guidance on child protection and vulnerable adults, Complaints logs, Training files, locum packs, cleaning matrix, Health and safety audits, Fire assessment audits, equipment service docs, IG toolkit certificate, CAS alert process, whistleblowing policy

Standards are grouped under five principles. The principles are the backbone of the regulatory approach and are all equally important.


The principles:

 Principle 1:

The governance arrangements safeguard the health, safety and wellbeing of patients and the public.

  • Standard operating procedures (SOPs)
  • Staff have clear roles
  • Complaints procedure is in place – Staff can explain complaints procedure
  • Appropriate records are kept- CD register, Private prescriptions, emergency supplies, Extemp prescriptions, specials, RP logs, CAS alert actioning
  • Patient confidentiality is protected- consent forms
  • Safeguarding Children and vulnerable adults- staff trained and know where local contact details are held, Flow charts
  • Incident Reporting and near miss reporting – review and analysis evidence
  • Patient safety reports
  • Indemnity Insurance details to hand
  • IG Toolkit completed and certificates to hand, confidentiality agreements – staff understand GDPR

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.

  • Well‐maintained, clean and safe pharmacy premises- cleaning matrix
  • Well‐designed and compliant with the Health Act and protects patient’s privacy
  • Clean and hygienic- infection control materials
  • Secure ‐ ensuring protection of both stock and patient information
  • Health and safety audits, Fire assessment audits, equipment service docs

 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.

  • Clearly displayed pharmacy services- Posters, practice leaflets to hand
  • Services benefit the local community- adjustments available when needed e.g. hearing loops, staff can describe all enhanced and advanced services
  • Promotion of healthy lifestyles- leaflets and staff aware of signposting information and recording, evidence of public health campaign participation
  • Stock is sourced, stored, supplied and disposed of appropriately- date checking matrix
  • Recalls and alerts are actioned- CAS alert process
  • Targeting of high-risk meds and promotion of healthy lifestyles in diabetes/CVD etc. and recording of interventions
  • Evidence of compliance with FMD
  • Disposal of medicines – hazardous waste bins, protocols for accepting waste, equipment e.g. gloves, aprons, spillage kits

Principle 5:

The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public.

  • Clean, well‐maintained equipment is available- evidence of maintenance /calibration and PAT testing
  • Equipment is fit for purpose and to the appropriate safety Standard – up to date reference sources
  • IT equipment protects confidentiality- passwords

Inspection reports

The evidence collected by the inspectors will be used to assess whether a pharmacy has met all of the standards.

The  Inspection Decision-Making Framework is used when assessing if a pharmacy has met all of the standards. The Decision-Making Framework is a guide to help support inspectors to make consistent decisions.

At the end of the inspection the inspector will go through their findings with the Responsible Pharmacist, who will be asked to confirm they have received feedback from the inspection. The Responsible Pharmacist has an opportunity to make any additional comments. This is important to show that the evidence recorded on the report is an accurate reflection of what the inspector saw and was shown on the day.

Pharmacies which have not met one or more of the standards will also be asked to complete an improvement action plan setting out what action they are planning to take to improve against those standards.

Outcomes from inspections

The outcome a pharmacy will receive from an inspection has changed as part of the updated approach. There are now two potential outcomes; standards met or standards not all met.

All of the standards will need to be met for a pharmacy to receive a ‘standards met’ outcome, and any pharmacy not meeting all the standards will need to complete an improvement action plan, as before. The improvement action plan will be published alongside the report on the new inspection’s website.

The pharmacy will also receive one of four possible findings for each of the five principles within the standards for registered pharmacies.

The four possible findings are:

  • excellent practice
  • good practice
  • standards met
  • standards not all met

Improvement action plans

  • All pharmacies which have not met one or more of the standards during an inspection will be required to complete and implement an improvement action plan.
  • The pharmacy would be expected to tell the GPhC within 5 days of the action they intend to take to meet the standards and improve practice in the pharmacy. They will consider some flexibility in this timescale if there are exceptional reasons why this deadline cannot be met.
  • They require improvement action plans to be filled in by the owner and superintendent pharmacist and returned to them. The inspector will already have identified whether the improvement action in relation to each standard, must be completed within 10, 20 or 60 working days.
  • The pharmacy owner and superintendent will identify when the actions will be completed within these timescales and who will be responsible for this.
  • Pharmacy owners and superintendent pharmacists will be expected to action their improvements as soon as possible, especially where a risk to patient safety has been identified.
  • Improvement action plans will be published on the new inspections’ publication website alongside the inspection report.

Next steps

When the actions set out in the improvement action plan have been completed, the owner or superintendent pharmacist must notify the GPhC.

Once the inspector is satisfied that evidence has been provided that indicates completion of the improvement action plan, a new inspection will be scheduled six months from the date when the inspection report was sent to the owner. However, the Inspector is quite flexible when they return to the pharmacy and it may be sooner than 6 months if there is a serious concern about patient safety. The visit at 6 months will be a full inspection visit with a new report.

At the 6-month inspection, the inspector will visit the pharmacy again to assess whether the pharmacy is meeting the standards and that the improvements are being sustained. If that is the case, then they will issue an updated report with the new overall outcome showing that the pharmacy has met all of the standards. This report will be published on the inspection publication website, once it has been through the usual pre-publication process.

Publication of inspection reports

The GPhC will publish reports from pharmacy inspections that take place from April 2019 onwards. Reports will be published on a new pharmacy inspection publication website which will launch in Summer 2019.

Before an inspection report is published, it goes through a quality assurance process. The pharmacy owner or superintendent pharmacist will be given an opportunity to review the report and check its factual accuracy before the report is finalised.

Inspection reports will then usually be published on the new pharmacy inspection publication website within six weeks of the inspection taking place.

Review of overall outcome of the inspection process

Pharmacy owners and superintendent pharmacists can ask for a formal review of the overall outcome of an inspection where they consider that the evidence does not support the outcome.

The owner or superintendent must complete this form requesting a review -and send by email to inspectionreviews@pharmacyregulation.org within 5 working days of receipt of the final report.

The GPhC has produced a guide to the review process:

https://www.pharmacyregulation.org/sites/default/files/document/guide-to-process-for-review-of-overall-outcome-of-an-inspection-april-2019_0.pdf

 Enforcement action

The GPhC’s overall approach is to support and encourage pharmacy owners to meet the standards for registered pharmacies.

They have a number of different enforcement options available to secure compliance with standards. These range from improvement action plans to statutory enforcement powers including improvement notices and conditions on registered pharmacy premises.

They will use their statutory enforcement powers in situations when a pharmacy owner does not complete an improvement action plan and carry out the necessary changes to make sure the standards are met, or in situations when there is a serious risk to patient safety.

To support consistent decision-making, they have published a new enforcement policy for registered pharmacies which sets out our approach and principles we will follow when using our enforcement options, to support consistent decision-making. https://www.pharmacyregulation.org/sites/default/files/document/registered_pharmacies_enforcement_policy.pdf

Hints and tips for responding

  • On holiday — let the GPhC know; NPA Members report having been able to delay their response
  • Ensure areas of patient safety are dealt with promptly through action plans – Set Reminders and make someone accountable.
  • Set deadlines to ensure action plans are met

Contact your Inspector for advice

Contact details can be downloaded here:

https://www.pharmacyregulation.org/sites/default/files/document/inspection-team-contact-information-february-2019.pdf


Further resources

https://www.pharmacyregulation.org/helpful-resources

With thanks to Sefton LPC for sharing the information contained in this briefing.