1. Dr Ambrose McLoughlin- Registrar, Pharmaceutical Society of Ireland (PSI) Sunday November 13 th 2011

2. Effective Regulation = Patient Safety + Public Protection = Protection for all in society Safe Pilot Safe Crew Safe Aircraft Safe Air Space Safe Cargo Safe Ground Space 2 Source: U2 World Tour 2010

3. Agenda Why Regulate – Pharmacy is a Front Line Profession Fitness to Practise/ Disciplinary inquiries How to avoid risk of disciplinary process

4. Effective regulation - Benefits all Public protection and confidence critical Raised standards – Best Outcomes Potential for growth – Real Added Value

5. Why Regulate? Public protection Patient Safety/Best Outcomes Pharmacy – potential for irreversible harm Raise and maintain standards Expansion of the scope of Pharmacy Practice

6. Real World - target regulation Professor Campbell Gemmell CEO SEPA criminal chancer careless confused compliant champion Hit hard Recognise and reward enforce educate enable engage

7. How does the PSI regulate Register of pharmacists and pharmacies Education/CPD/Guidance to the Profession and Sector Inspections/Investigations/Enforcement Disciplinary inquiries and sanctions Action to improve the profession of pharmacy

8. Fitness to practise/ disciplinary inquiries Why hold inquiry Serious sanctions Conduct that can result in inquiry What happens at an inquiry - potential consequences for practitioner dictate procedures

9. Complaint in writing received against registered pharmacist/ registered retail pharmacy business S35/S36 Complaint referred to PPC for advice to Council on whether sufficient cause to warrant further action S38 PPC advises Council no further action required S39 PPC advises Council further action required S40 Council decides whether further action required S39(2) PPC refers matter to: (a)Mediation (b)Health Committee (c)Professional Conduct Committee S40 Further action required No further action required Interim suspension of registration s45

10. Committee of inquiry S41-47 Mediation S37 Complaint resolved Complaint cannot be resolved S40(2) Referral from PPC S40 Complaint substantiated Complaint not substantiated Council dismisses complaint S48(1)(a) Council imposes one or more of following sanctions: (a)admonishment/ censure (b)Attach conditions to registration (c)Suspension of registration (d)Cancellation of registration (e)Prohibition on application for restoration for prescribed period S48(1)(b) Terms do not correspond to s48 sanction Terms correspond to s48 sanction S37(6) High Court confirmation required where sanction other than admonishment/ censure imposed S50 Undertaking/ Consent S46

11. How to avoid disciplinary action Code of conduct Patient’s normative need Robust risk assessment Maintain Competencies/Apply Evidence-Based Best Practice Don’t bury problems/Seek advice from IPU

12. “Managers and leaders who fail generally do so not because of things they don’t know, but because of things they know perfectly well, that they just aren’t doing.” Bertrand Russell, 1927

13. The Past 1875 – 2005 A proud heritage An honourable profession 2005-2007 Leadership by IPU, PSI and others Pharmacy Act 2007 2007 Act Real Opportunity for All