our approach to regulating registered pharmacies 2018 A brief - - PowerPoint PPT Presentation

Consultation on developing

• ur approach to regulating

registered pharmacies

2018

A brief re-cap on our inspection journey

November 2013, introduction of new inspection model

To now - 2018

• Almost completed a full cycle of inspections

– Most pharmacies meet our standards

• Evaluation indicates approach is working well
• Overall support, with areas for further consideration
• We now want to further develop our regulatory approach

– To take the next step to provide further assurance and drive improvement

• Significant changes

– We now have powers that enable us to publish our inspection reports

Landscape

• Diverse nature of registered pharmacies
• Pace of change
• Clinical role
• New service models and greater use of

technology

Our 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, so we can respond effectively

to the changing needs of patients and the public and to changes in pharmacy

• Increasingly informed by information and intelligence, targeting our

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

Key proposals at a glance

• 1. Changes to the types of inspections
• 2. Moving to unannounced inspections
• 3. Changing inspection outcomes
• 4. Requiring all standards to be met to receive an overall

‘standards met’ outcome

• 5. Publishing inspection reports
• 6. Sharing examples of notable practice in a ‘knowledge hub’

Introducing the changes to the types of inspections

Routine inspection Intelligence- led inspection Themed inspection

Routine inspections

• Every pharmacy to continue to be inspected
• Moving to a more flexible programme, informed by indicators of risk when

identifying which pharmacies should be inspected first

• Inspections to be unannounced as a general rule
• 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

• We will undertake rapid response inspections, initiated following

intelligence identified from:

– Other organisations – Concerns raised – Media stories – Intelligence from inspectors

• Will result in a report with an overall ‘standards met’ or ‘standards not all

met’ outcome

• To be unannounced as a general rule
• Could be undertaken jointly with other regulators / bodies (such as CQC,

MHRA, commissioners)

Themed inspections

• We will take forward a programme of themed inspections which will

involve visiting a selection of pharmacies to focus on specific themes or issues

• Enabling us 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.

Changes to inspection outcomes

• Overall outcome for an inspection would be either ‘standards met’
• r ‘standards not all met’
• providing clear and simple assurance for the public
• Findings at principle level: ‘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 us to identify notable practice, which we can share to help
• thers to learn from and support continuous improvement

Publication

• We plan to publish all inspection reports in the future, as well as

improvement action plans where appropriate

• We will also publish short examples of notable practice, to help drive

continuous learning and improvement

• New website will make it easy to search for and analyse inspection
• utcomes and the examples of notable practice

Future work

1. Reviewing our standards for registered pharmacies 2. Developing an enforcement policy 3. Seeking views on the information we collect about pharmacies 4. Seeking views on the information we publish and disclose in relation to registered pharmacies 5. Publishing a report of what we have learnt from our inspections 6. Considering whether other options for identifying which pharmacies to inspect- including sampling- would provide assurance

We want your views

• Will our proposals help to strengthen

assurance and to drive improvement?

• What do you think about each of our

proposals?

• What will be the impact of our proposals?

Closes 9 August 2018

Take part in the consultation: www.pharmacyregulation.org/ registered-pharmacies

Making sure patients and the public obtain medicines and other pharmacy services safely

• nline

Strengthening safeguards for patients

• Different organisations and agencies are responsible

for different elements of online healthcare services

• We are working closely with other regulators involved
• We are proposing to strengthen our guidance for

pharmacy owners

Proposals at a glance

• Transparency and patient choice - ensuring that patients have

enough information about the service to make an informed decision

• Making sure medicines are clinically appropriate for patients -

considering risks and benefits of allowing patients to choose a POM before a consultation with a prescriber has taken place

• Further safeguards for certain categories of medicines- making sure

appropriate further safeguards are in place

• Regulatory oversight - making it clear that pharmacy owners

working with prescribers or prescribing services outside the UK must successfully manage the additional risks that this may create

Tell us your views

• Do you think our proposals should be included in
• ur guidance?
• Do you have any comments on our proposals?
• What impact will the proposals have on patients,
• wners and the pharmacy team?

Closes 21 August 2018

Take part in the consultation: www.pharmacyregulation.org/online- pharmacy