The General Pharmaceutical Council (GPhC) has approved new outcome-focused standards for registered pharmacies that will come into effect after a 12-month transition period. The standards aim to strengthen pharmacy regulation by holding owners and superintendents accountable for meeting five principles focused on patient safety. The principles cover governance, staff competency, premises safety, service delivery, and equipment use. A consultation on new Rules to enforce the standards will occur before they become fully enforceable in October 2013.

1. New standards for
registered pharmacies –
Sept 2012
Hugh Simpson
Director of Policy and
Communications
19 September 2012

2. 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

3. GPhC regulatory framework

4. 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

5. 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

6. 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)

7. 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

8. 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

9. 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

10. 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

11. Inspections: A more mature relationship
• Relationship management approach
1. Adding value
2. Strategic
3. Improvement
• Formal structured meetings
– 2 way information flow

12. 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

13. 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

14. For more information
• you can find the paper our Council considered on the
new standards at:
http://www.pharmacyregulation.org/sites/default/fil
es/Council%20September%202012%20Standards
%20for%20Registered%20Pharmacies.pdf
• and the paper about our transition plans at:
http://www.pharmacyregulation.org/sites/default/fil
es/Council%20September%202012%20Managing
%20the%20transition%20-%20working%20towards
%20standards%20for%20registered
%20pharmacies.pdf