Consultation on developing approach to regulating registered pharmacies Speaking notes for presentation We have provided these notes for organisations to use when using the consultation on developing approach to regulating registered pharmacies presentation in the resources for organisations toolkit. Slide 2 A brief re-cap on the inspection journey The GPhC first consulted on new standards for registered pharmacies and their new regulatory model in April 2012. And published new standards for registered pharmacies were published in September 2012. They have been operating a new model of inspection since November 2013. In this model pharmacies show and tell how they meet the standards rather than having to tick checklists. Inspections cover the range of services offered, and involve the whole pharmacy team. Evidence based judgements in a written report show how pharmacies perform against the standards. The GPhC published an update paper in February 2015 to restate the core principles and to make clear their intention to listen and update their model on the basis of feedback and evidence. An independent evaluation was published in October 2015, which concluded that the new approach was working well overall. Slide 3 To now - 2018 Around 13,000 registered pharmacies across Great Britain have been inspected using the show and tell approach. By summer 2018, the GPhC expect to have inspected every registered pharmacy in Great Britain. Of those inspected 85% were found to be meeting all the standards for registered pharmacies. Those that weren t were required to develop an improvement action plan. Analysis suggests that improvement action plans are working well in practice 99% of pharmacies which had to complete improvement action plans in 2016/17 made the improvements needed. An independent evaluation, and other feedback has shown that the changes made to how GPhC regulate pharmacies are welcome and are working well in practice. But they also heard that there are opportunities to develop the approach further and improve their ability to achieve the two aims of assurance and improvement.
The GPhC now want to further develop their regulatory approach to provide further assurance to patients and the public and to drive improvement across pharmacy. They plan to make their approach more flexible, agile and responsive. They propose introducing new types of inspections and to using information and intelligence to target resources more effectively to help them achieve this. The most significant change proposed in this consultation is for the GPhC to begin publishing inspection reports. From 24 May 2018, the GPhC will have powers that enable them to publish inspection reports and more tools to enforce the standards, including improvement notices. Publication marks a significant moment of change. It will provide more assurance to patients and the public, and to those working across pharmacy and health, that pharmacies are meeting standards. Slide 4 The GPhC strategic approach Providing assurance that pharmacies are meeting standards and driving continuous improvement in the quality of services and care for the public. Moving to a flexible and agile approach, responding effectively to the changing needs of patients and the public and to changes in pharmacy. Increasingly informed by information and intelligence, targeting resources where they can have the greatest impact. Publishing reports to strengthen assurance for patients and to enable the sector to learn and continuously improve. Slide 5 Key proposals at a glance Changes to the types of inspections moving to a new model that includes three types of inspection: routine inspections, intelligence-led inspections and themed inspections. This will help GPhC to make sure they are more agile and responsive to information they hold, intelligence they receive and issues they identify within pharmacy. Moving to unannounced inspections, as a general rule in the future. This will make sure the outcomes of the inspection reflect whether the pharmacy is meeting the standards every day. Changing inspection outcomes There would be two possible outcomes for an inspection overall ( standards met or standards not all met ), and four possible findings at the principle level ( standards not all met, standards met, good practice and excellent practice ).
Requiring all standards to be met to receive an overall standards met outcome if any standard was found not to be met, this would result in a standards not all met outcome overall. Publishing inspection reports, and improvement action plans when relevant, on a new website. This will be designed so that the information is easy to search and analyse. Sharing examples of notable practice by publishing these in a knowledge hub on the new website to help encourage continuous learning and improvement in pharmacy. Slide 6 - Introducing new types of inspections The GPhC is proposing that there will be three types of inspections - routine inspections, themed inspections, intelligence-led inspections. These can be used flexibly in different situations. This allows the GPhC to be more responsive when they need to be, and means they can look at specific issues in pharmacy and services in greater detail. Routine inspections Every pharmacy will continue to be inspected and inspections will be unannounced as a general rule. Moving to a more flexible programme, informed by indicators of risk when identifying which pharmacies should be inspected first. So a pharmacy previously rated as poor would be inspected first, followed by those rated as satisfactory with an action plan. Once all pharmacies which have had action plans have been inspected, the GPhC would inspect the pharmacies rated as satisfactory (without an action plan), followed by those rated as good and then excellent. This will also allow the GPhC to evaluate whether previous improvements have been sustained. Any standard not met will result in pharmacy receiving standards not all met outcome. An improvement action plan will be required if the pharmacy receives a standards not all met outcome. Intelligence-led inspections Rapid response inspections, initiated following intelligence identified from other organisations, concerns raised, media stories, intelligence from inspectors. These will be unannounced as a general rule. And will result in a report with an overall, standards met or standards not all met
outcome. They could be undertaken jointly with other regulators / bodies (such as CQC, MHRA, commissioners). Themed inspections A programme of themed inspections which will involve visiting a selection of pharmacies to focus on specific themes or issues. This will enable the GPhC to better understand underlying issues, their causes and effects. Composite reports will be published to inform the sector on the issues and risks that have been found. Findings will inform discussions on how to continually improve pharmacy services in these areas. Slide 7 Changes to inspection outcomes Overall outcome for an inspection would be either standards met or standards not all met This provides clear and simple assurance for the public. Findings at principle level would: standards not all met, standards met, good practice or excellent practice. Designed to focus the pharmacy owner and the team on the content of the report, specific positive outcomes, areas for improvement or failed standards in the report. Enables the GPhC to identify notable practice, which they can share to help others learn from and to support continuous improvement. Slide 8 Publication The GPhC plans to publish all inspection reports in the future, as well as improvement action plans where appropriate. They also plan to publish short examples of notable practice, to help drive continuous learning and improvement. A new website will make it easy to search for and analyse inspection outcomes and the examples of notable practice.
Slide 9 Future work While the main focus of this consultation is on inspections and the publication of inspection reports, the GPhC are committed to making other improvements to the way they regulate registered pharmacies. They will, in the future, be: 1 - Reviewing standards for registered pharmacies to ensure they continue to prioritise patient care and the provision of safe and effective care. 2 - Developing an enforcement policy to inform the way in which they use enforcement powers. 3 - Seeking views on the information they collect about registered pharmacies, at the point of registration, at renewal and on-going basis. 4 - Seeking views on a new appendix to their publication and disclosure policy which will cover the information they publish and disclose in relation to registered pharmacies. This will include the length of time that reports remain on the new website. 5 -Publishing a report of what has been learnt from inspections, including sharing examples of notable practice. 6 - Considering whether they should continue to inspect all pharmacies on a rolling basis, or whether other options, such as sampling a cohort of pharmacies, would provide assurance to patients and the public that the standards for registered pharmacies are being met. Slide 10 Take part in the consultation The consultation will be open until 9 August and you are urged to respond to the consultation via the GPhC website. Slide 11 Find out more See slide