New standards for registered pharmacies – Sept 2012

Hugh SimpsonDirector of Policy and Communications19 September 2012

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

GPhC regulatory framework

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

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

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)

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

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

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

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

Inspections: A more mature relationship• Relationship management approach

1. Adding value2. Strategic3. Improvement

• Formal structured meetings– 2 way information flow

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

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

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