GPhC inspections: is your team ready?

The outcome of a pharmacy inspection will be ‘standards met’ or ‘standards not met’.

To achieve the ‘standards met’ category, a pharmacy must achieve an acceptable grade across five areas known as  ‘principle levels’. If the pharmacy misses just one of the standards expected at this level they will be issued with a ‘standards not met’ rating. Within each of these principle levels the pharmacy will be categorised as: standards not all met, standards met, good practice and excellent practice.

The five principles have not changed as part of the new inspection regime and cover areas including governance, staff empowerment, the pharmacy environment, safeguards for the wellbeing of patients, and quality of equipment.

GPhC inspectors will observe interactions with patients and will question and pose scenarios to your staff. Please make sure:

• All pharmacy staff are appropriately trained – 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. Consider the following:
  • Using PSNC / NPA resources
  • Reviewing SOPs regularly
  • Role plays with staff questioning them as the inspector might
  • Giving internal information on inspections relating to the pharmacy chain/ individual pharmacy
  • Meeting with all staff in advance to discuss the inspection process
  • Carrying-out your own internal inspection / self-audit
• All staff know where to find everything they need to do their job effectively. Consider:
  • complaints logs
  • cleaning matrix and details about waste collection services
  • equipment service docs
  • fire assessment audits
  • health and safety audits, risk assessments and COSHH documentation, as appropriate
  • safety incident reports and near miss logs
  • guidance on child protection and vulnerable adults
  • IG toolkit certificates
  • locum packs
  • training files
  • whistleblowing policy
  • Staff participate in ongoing training, not just their initial training. This will help you to achieve a higher rating in the inspection
  • Your locum pack contains all relevant pharmacy information to keep locum well informed for an inspection.]

When the inspector first arrives in the pharmacy, the responsible pharmacist should find out about the inspector’s plan for the visit.

It would be unusual for the GPhC inspector not to:

• give an outline of the inspection and how it will be conducted
• want to hear staff talk about the services you offer
• want to know about the whole staff team – those present on the day and those not present on the day

Everyone should be prepared to talk to the inspector:

• sell what you do — promote your pharmacy and your colleagues and communicate to the inspector what the pharmacy does
• be open and give as much information as possible
• volunteer information if the inspector does not ask, because once the inspectors have “left the building”, the ability to provide further information is limited.

The inspection is designed to be a fair and balanced reflection of your service on the day that it was inspected:

• It can be unfortunate if you happen to have several members of staff call in sick on the same day. But, this can be an opportunity to showcase how your business planning, induction and training programmes kick into life and that staff sickness does not disrupt your business.
• An inability to access information that is stored centrally at head office should be prompted by offers to visit head office, or to call someone at head office so that they can talk an inspector through a process. If information is not available upon request, or is not immediately visible, this needs to be addressed head on whilst the inspector is still in the building, as rectifying this after the event can be difficult.

At the end of the inspection the inspector will go through their findings with the responsible pharmacist.

The responsible pharmacist:

• should make additional comments, as necessary to aid clarity and they must tell the inspector if they disagree with anything.
• will be asked to sign that they have received the inspection feedback. See also section on Inspection reports (and what to do if you disagree)

Pharmacies which do not meet 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 .]

The GPhC will publish summary reports (and any associated improvement action plans), rather than the full inspector’s report, on a bespoke website from summer 2019.

Pharmacy owners will be expected to display inspection outcomes in their pharmacies.

Checking and challenging inspection reports

The ability to challenge the report, is no substitute for ensuring that on the day(s) of inspection, that you give the inspectors access to everything they need to see and know.

On the day of inspection

At the end of the inspection your inspector will go over the findings with you for information and this is your chance to make sure it is factually accurate.

For you this ‘factual accuracy’ check is about

• correcting inaccuracies or giving clarity to aid understanding
• the tone and inferences that can be drawn from conclusions, what will be written and the way it will be written
• gaining understanding and confirmation of what information about you will be published by the GPhC, making sure it is accurate and, if you disagree, noting your disagreement.

Please contact us immediately (T: 01372 417726) if the inspector has any issues relating to locally commissioned services .

Don’t forget: Our local essential guides to services and service evaluation tools, may be useful references in general preparedness for inspections: Surrey Essential Guide to Services- July 2019,  East Sussex Essential Guide to Services- July 2019 and West Sussex Essential Guide to Services- July 2019 and Brighton & Hove Essential Guide to Services- July 2019

If you are still not happy you can request a formal review of the overall outcome of an inspection where they consider that the evidence does not support the outcome. Read more about Formal Reviews below. 

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 always complying with GPhC standards.

A Controlled Drug self-assessment form for England and Scotland is available to help pharmacy owners/superintendent pharmacists ensure that the required procedures are in place for the safe management of CDs.

It has been produced by the GPhC to help you audit your processes around CDs.  See: https://www.pharmacyregulation.org/content/cd-self-assessment-form-april-2013

Your LPCs recommend you complete this before any inspection and that it is available for the GPhC inspector at their visit.

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

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

A new enforcement policy for registered pharmacies sets out the approach and principles to be used.

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

The person requesting the review must complete and return a formal request (see form) within five working days of receipt of the final report.

Here is the GPhCs guide to the review process