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New standards for registered pharmacies – Sept 2012
Hugh SimpsonDirector of Policy and Communications19 September 2012
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A bit of history• Design of Pharmacy Order strengthens regulation of
pharmacy, not just of pharmacy professionals
• Step change rather than revolution
• Why now? two years and rules
• Introduction of any significant change is well managed
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GPhC regulatory framework
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New standards for registered pharmacies
• Agreed Thursday 13 September by our governing council• Once in a generation change in pharmacy regulation• Move from prescriptive rules to outcome focused standards –
offering the best protection for patients and the public • Not only new standards, but new regulatory model:
– Owners and superintendents are accountable for meeting the new standards – share the same set of responsibilities
– Clear set of enforcement powers – no longer ‘one club’ ftp
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Where does accountability sit• Aim = move away from focus on ‘who is to blame’
• New standards are aiming for clear accountability within a flexible framework
• Owners and superintendents share that overall accountability for meeting the new standards, while enabling the professionals who work for them to take responsibility
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Professionalism is key• Professionalism, not rules and regulations, provides most
effective protection for patients and public• GPhC committed to regulate in a way which supports
pharmacy professionals to embrace and demonstrate professionalism in their work
• Responsibility on owners and superintendents, and the pharmacy professionals who work for them, to sort out how to deliver the outcomes we seek
• Subject to GPhC inspection and, if required, enforcement (improvement notices, conditions on registration of the pharmacy etc)
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Five key principles under the standards• Principle 1: The governance arrangements safeguard the
health, safety and wellbeing of patients and the public
• 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
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Five key principles under the standards
• 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
• Principle 5: The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public
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Transition process• This is not happening tomorrow!• 12 month transition process• Familiarisation: you will receive copies of the new standards
in the next few weeks (replacing the interim premises standards currently in place)
• Compliance guidance: we are developing three sets on guidance – on self selection, s10 manufacturing and internet pharmacy
• Inspection decision framework: in development• Engagement: we want your help
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Inspection decision framework• Operational framework• Comprises example outcome focussed compliance indicators• Support inspectors to make consistent judgements on
‘how well a pharmacy meets our standards’• Provides assurance • Supports, recognises and enables good and innovative
practice• Promotes transparency in decision making• Enables us to proactively manage currency of practice• Detailed compliance guidance in key areas:
– Internet pharmacies, section 10 and self selection
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Inspections: A more mature relationship• Relationship management approach
1. Adding value2. Strategic3. Improvement
• Formal structured meetings– 2 way information flow
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So our approach
• External sounding boards– England – Scotland; and– Wales
• Public and patient reference engagement group
• Extensive testing throughout• Engagement and awareness
raising plan in development• Maximise as much involvement in
its development internally
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Key message on timings
• New standards need to be put into Rules, which are approved and laid before Parliament. (Only then are they fully enforceable through improvement notices and conditions on registration)
• We need to consult on those Rules before they are approved
• Don’t expect the Rules to be approved before October 2013
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For more information• you can find the paper our Council considered on the
new standards at: http://www.pharmacyregulation.org/sites/default/files/Council%20September%202012%20Standards%20for%20Registered%20Pharmacies.pdf
• and the paper about our transition plans at:http://www.pharmacyregulation.org/sites/default/files/Council%20September%202012%20Managing%20the%20transition%20-%20working%20towards%20standards%20for%20registered%20pharmacies.pdf