Blake Lapthorn were pleased to welcome Duncan Rudkin, Chief Executive and Registrar of the General Pharmaceutical Council as their speaker on 29 January 2013.

1. Regulating people and
systems: a case study
Duncan Rudkin
Chief Executive and Registrar
General Pharmaceutical Council

2. Who we are
• Operational since 27 September 2010
• Independent GB regulator for
– pharmacists,
– pharmacy technicians and
– pharmacies
• Role to protect, promote and maintain the health, safety and
wellbeing of patients and people who use pharmacy services

3. Who we are
• We register competent professionals to practise pharmacy
and we regulate retail pharmacy services through the
registration of pharmacies
• Our role as a professional and ‘system’ regulator is unique in
health professional regulation

4. GPhC regulation

5. What we do #1
Professional regulation ‘System’ regulation
• Register competent • Register pharmacies
professionals; check skills • Inspect pharmacies to check
and knowledge up to date mandatory standards are
• Set and monitor being met
professional standards • In future, inspect against
• Take action when our new standards for
standards are not met, i.e. registered pharmacies, with
Fitness to Practise new enforcement powers

6. What we do #2
Professional regulation ‘System’ regulation
• Set education and training • In future, use our
standards, accredit courses enforcement powers to
and approve qualifications issue improvement notices,
• Set and run the final impose conditions and in
assessment for pharmacists the most serious cases,
which they must pass to be close pharmacies
eligible to register

7. Professionalism
• Prescriptive rules let us all off the hook
• Professionalism, not rules and regulations, provides most
effective protection for patients and public
• We are committed to regulating in a way which supports
pharmacy professionals to embrace and demonstrate
professionalism in their work
• And working with pharmacy to encourage compliance with
our standards; enforcement a last resort
• Positive focus on professionalism and accountability

8. Five key principles
1. The governance arrangements safeguard the health, safety and wellbeing of patients and the
public
2. Staff are empowered and competent to safeguard the health, safety and wellbeing of
patients and the public
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
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
5. The equipment and facilities used in the provision of pharmacy services safeguard the health,
safety and wellbeing of patients and the public

9. Issues
• Corporate accountability vs. individual professional
accountability
• The pharmacy superintendent
• Blame vs. accountability
• What the sub‐text says about attitudes to fitness to
practise
• Implications for our approach to FtP
• Risks for regulators

10. For more information about our new standards, go to:
http://www.pharmacyregulation.org/standards/standa
rds‐registered‐pharmacies
www.pharmacyregulation.org/

11. Thank you