Look out for changes to pharmacy inspections coming soon

21 March 2019

We are making changes to how we inspect and regulate registered pharmacies in 2019/20, as we explained in the last edition of Regulate. You will begin to see some of these changes from next month, when we expect to begin carrying out unannounced inspections as a general rule.

Pharmacies that are inspected next month can also expect to be some of the first pharmacies to have the reports from their inspections published on a new pharmacy inspections website, when the website launches in Summer 2019.

Before any inspection report is published, the pharmacy owner or superintendent pharmacist will be given an opportunity to review the report and check its factual accuracy. They will also be able to ask for a review of the overall outcome of an inspection where they consider that the evidence does not support the outcome.

Outcomes from inspections

The outcome a pharmacy will receive from an inspection is also changing. There will now be 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 of the standards will need to complete an improvement action plan, as they do now. The improvement action plan would also be published alongside the report on the new inspections website.

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

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

This will help the pharmacy owner and the team to understand the positive areas of practice from the inspection, as well as areas for improvement. Having these four findings at principle level also enables us to identify notable practice- the good and excellent practice our inspectors are seeing during inspections, as well as poor practice.

The new pharmacy inspections website will include a ‘knowledge hub’ which will feature these examples of notable practice, which people working across the pharmacy sector can use to learn from.  This will help to support continuous improvement across pharmacy for patients and the public. The new inspections website is currently being developed and is due to launch in Summer 2019.

Types of inspections

Another key change is that we will use three types of inspection: routine inspections, intelligence-led inspections and themed inspections. This will enable us to use our resources in a more flexible way so that we can be more agile and responsive to information we hold, intelligence we receive and issues we identify within pharmacy.

Every pharmacy will continue to have a routine inspection, but we plan to factor in risk indicators to determine which pharmacies should have routine inspections first under the updated approach. This means that pharmacies previously rated as poor, and those that received a rating of satisfactory with an action plan, will be inspected first. We will be able to see some of the patterns and trends that create problems for pharmacies, and this in turn will help us prioritise our future routine inspections.

We also plan to build on our current approach to carrying out intelligence-led inspections, using information we receive from other people or organisations, including regulators, healthcare professionals and the public, as well as from journalists and the media. We also know that our ability to carry out intelligence-led inspections will grow over time as we get better at using the information we receive from others.

We also plan to introduce themed inspections, with the first themed inspection due to take place in the second half of 2019. These will involve visiting a selection of pharmacies to focus on specific themes or issues in more depth, and then producing a report identifying learning and good practice that can be shared across pharmacy.

New enforcement policy for registered pharmacies

Our overall approach is to support and encourage pharmacy owners to meet the standards for registered pharmacies. We aim to use the minimum regulatory action required to ensure that pharmacy owners are meeting our standards.

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

We will use our 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 our standards are met, or in situations when there is a serious risk to patient safety.

We have now published a new enforcement policy for registered pharmacies which sets out the approach and principles we will follow when using our enforcement options and supports consistent decision-making.

Further resources 

Over the last few months we have been explaining the changes we are making and what they mean for pharmacy owners at a range of events across Great Britain. We also recently held a webinar where Julian Graville, our Head of Inspections, explained the changes we are making to inspections and answered questions from people joining the webinar.  You can watch the webinar on YouTube here.

We are currently developing further resources which will provide more detailed information about how the updated approach to inspections will work in practice. These resources will be published in the ‘Inspections’ section of our website from next month so look out for them then.

These resources will cover key areas including:

  • when we will use the three different types of inspection 
  • the operational principles we will use to triage incoming information, intelligence and concerns to help us make decisions as to when to have an intelligence-led inspection 
  • the process for how a report will be drafted, quality-assured, reviewed and published, including the process if a pharmacy owner or superintendent wanted to challenge the overall outcome of an inspection
  • what happens next if a pharmacy receives a ‘standards not all met’ outcome, and the timescales for completing an improvement action plan and re-inspection.