Day 2 – Council Induction• Visit to pharmacy for lay members (Optional) • Recap• Committee structure• Fitness to practise• The Pharmacy Forum• The Council• Strategy and Business plans 2012 – 2014• Summary and close

Governance Structure 2012

Regulatory Council

Resources Audit and RiskRegulatory Compliance

Public Forum Professional Forum

EducationStandards

and GuidanceRegistration Fitness to Practice

Fitness to Practise

Complaints management

Complaints and Concerns

Managing Complaints or Concerns

1. A portal for the public and healthcare professionals

2. We promote the receipt and processing of a complaint

3. Partnerships with DHSSPS and HSCB

4. Operate in a fair blame culture

5. Promote opportunities for learning

6. Aim to promote local resolution where possible

1. Medicines Act 1968 [plus Regulations]

2. Misuse of Drugs Act 1971 [plus Regulations]

3. Poisons Act 1972

4. Pharmacy (Northern Ireland) Order 1976 [plus Regulations]

5. Health and Personal Social Services (Northern Ireland) Order 1972

6. The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008

7. Veterinary Medicines Regulations

Legal context

DHSSPS

HSCBPharmaceutical Society PSNI

Pharmacy Network GroupPNGLocal

Intelligence Network [LIN]

HSC TRUSTSG5

The Pharmacy Network Group PNG

HSCB •Help to qualify harm and potential for harm using medics•Review SAI reports•Add data from BSO in relation to alleged fraud etc

DHSSPS•Access to wholesale and police•Powers to interview under PACE guidance•Powers of inspection SOPs RP records etc

PSNI•Measures professional performance vs Code of Ethics and Standards •Investigates health and conduct issues•FTP hearings

Medicines Errors

CRITERIA FOR HANDLING DISPENSING ERRORS

This sets out the agreed criteria regarding the handling of dispensing errors. Where there is any need to clarify the lead organisation, the information should then be referred to the PNG for discussion/decision.

CriteriaCases should be referred to the Department for discussion if one or more of the following criteria are true:

•There is suspicion of ill-health or substance abuse by the pharmacist•There is suspicion that the individual significantly departed from agreed safe protocols or standards operating procedures and in doing so took an unacceptable risk•There is suspicion of other misconduct that would form the basis of a complaint•There is suspicion that there are repeated/multiple dispensing errors by a single pharmacist or within the same pharmacy premises which are of a level that gives cause for concern

CRITERIA FOR HANDLING DISPENSING ERRORSThis sets out the agreed criteria regarding the handling of dispensing errors. Where there is any need to clarify the lead organisation, the information should then be referred to the PNG for discussion/decision.

CriteriaCases should be referred to the Department for discussion if one or more of the following criteria are true:

•There is suspicion of recklessness or intent•The dispensing error led to death or moderate or severe harm, or had the potential to do so (without, for example, the intervention of another person)•There was suspicion that there was an attempt to conceal the facts or that the pharmacist failed to co-operate with the investigation•There is evidence that the drugs were particularly potent/required very careful handling and additional checks to be in place, or that the dosage dispensed was substantially greater than that prescribed or substantially beyond the usual treatment range

All other cases should be investigated by the Board

• Pharmacy (Northern Ireland) Order 1976

Complaints and Concerns Current status

• Erasure single sanction• No other sanctions available

Complaints and Concerns - current status

Fitness to practiseinvestigations

Three stages

Statutory Committeeregulatory

Scrutiny Committeeadvisory

Registraradvisory

Complaints and Concerns - current status

Complaints and Concerns - current status

Complaint / Concern path

1. HSCB2. DHSSPS3. PPS4. PSNI

Complaints and concerns

Future status October 2012

Fitness to practiseInvestigations

Three stages

Statutory committee

Scrutiny committee

Registrar

Complaints and Concerns and the new Regulations

Registrar with reference to published criteria

Receives, complaints, concerns, reports

1. Manages case and closes or2. Refers case to Scrutiny Committee or3. Refers case to directly to the Statutory Committee i.e. high

risk• Interim orders• Registrant appeal to Statutory Committee [CPD]• Can suspend a registrant in regard to CPD until an appeal

is held by the Statutory Committee

Complaints and Concerns and the new Regulations

The Scrutiny Committee•Meetings in private no attendance rights •Paper based inquiry•Will be a committee in legislation post 01-10-2012 •Required to produce an annual report to Council•8 persons

•lay chair and deputy chair•2 lay •4 pharmacists

Powers to•Give advice•Give warnings•Give undertakings•Refer to Statutory Committee

Complaints and Concerns and the new Regulations

The Statutory Committee•Hearings in public unless health related •Registrant has attendance rights

Extended membership•12 persons•Lay chair and 2 lay vice chairs •Three lay and six pharmacists

Powers to•Give warnings•Suspend•Place conditions on practise •Interim order•Erase from register [strike off] minimum 5 years

Legislative changes new Regulations

Registrant•Make declarations on FTP matters within 7 days•Use statutory form to withdraw from the register•Use specific criteria to be restored after FTP

Regulator is required to•Publish FTP findings against name on the register•Use legal and/or clinical assessors where necessary

Legislative changes new Regulations

Registrar•Issues half year FTP reports which include

•Statistics•Adherence to KPIs•Learning points

Other Legislative changes captured in new Regulations

Continuing Professional DevelopmentRegulator must consult and publish a framework

The elements•Who does CPD•How it is submitted•Sampling and qualitative assessment•Processing sub standard and non submission•Reassessment(s)•Notice of removal•Suspension •Appeals•Restoration

Other Legislative changes captured in new Regulations

CPDRegulator framework

•Consultation to run over 12 weeks summer 2012•Published before end of 2012•Becomes statutory 1st June 2013

Other Issues

•Regulator framework.•Dual registrants, PSI, GPhC•Costs

Your questions?

Day 2

• Break - Return by 1135

Council Induction Session

Pharmacy Forum(Leading Promoting Supporting)

Response to Trust Assurance and Safety (Feb 07)

Separation of regulation and professional leadership

Helm Report – perform both functions in a single organisation using a scheme of delegation

The Pharmacy Forum operates as an arms-length body

Why do we exist?

To advance Chemistry and Pharmacy

To promote pharmaceutical education and the application of pharmaceutical knowledge

To maintain the honour and safeguard and promote the interests of the members of the Society in their exercise of the profession of pharmacy

Scheme of Delegation

Scheme of Delegation

To provide relief for distressed persons as defined in the 1976 Pharmacy Order

To apply funds under the Society’s control towards scholarships for the furtherance of education and research in pharmacy, as authorised in writing and in advance by the Council.

Core functions

Primary duty to provide advice to the Council on:

Regulatory matters affecting the profession, particularly in relation to public safety

Providing professional leadership, allied to regulation Advising the regulatory arm of developments and possible

developments in the practice of pharmacy Being consulted on regulations and encouraging pharmacists to

work to develop the profession for the public benefit.

Political influencing and public affairs

Providing advice for council in the development of professional standards

Supporting the profession in the implementation of professional standards.

Supporting the professional development of pharmacists

Services to members and functions

One Year On

The Pharmacy Forum (PF) has been operating in shadow form since April 2011

Scheme of delegation now in place transferring professional leadership functions from Council to the PF

Transition work / committee to scope out the requirements

Re-branding exercise underway to ensure the PF is identified and positioned separately from the Regulator.

Dedicated Resource

Professional Forum Manager (3 days) – Julie Greenfield

Professional Forum Co-ordinator (4 days) – ChrisanneEnglish

• PASS (1 day) – sign posting and facilitation• Professional Forum Administrator – facilitation,

support PFB in delivery of objectives, assist in delivery and development of services to members, projects, admin support.

Structure of the Board

Professional Forum Board

(max 14 members)

Elected Members(8)

3 Allocated PlacesGHP, UCA, PCC

Option to Co-Opt(for specific skills or

knowledge)

Who are the Board

ElectedAnne McAlister (Chair) John Hamill (Vice-Chair)John Clark Johanne Barry Martin Kerr Raymond AndersonKate McClelland

RepresentativesTim Corrie (CPNI)Peter Wright (UCA)Niamh McGarry (GHP)

Co-optedColin AdairNaomi RobinsonFrances-Anne Archibald

Professional Forum Board

Policy and Practice

Marketing and

Communications

Pharmacist Advice

and Support(PASS)

ResourceEducation

and Training

Operating Structure

Awarding Fellowships ( inc dinner)

AGM

PGEU / CPA

Development of Professional Leadership Role

Engagement of the grass roots membership with their body

Other Activity

Joint research RPS and PFB (Jun 11)Survey of over 2K pharmacists and technicians in across UK. Open space event NI (Nov 11)

Final report 8 recommendations and conclusions focusing on• A just culture for pharmacists• Development of a quality framework• Informing the forthcoming consultation on Supervision

Responsible Pharmacist Regulations

Survey of Community Pharmacists

* launch at Stormont 3rd July

•Concerns about patient services and health and well being of pharmacist were brought to PFB attention

•Survey of 1400 community pharmacists

Looking at• Current working environment • Ability to deliver and improve

services for patients• Expectations for the future of

pharmacy

Mandatory CPD

Priority in the coming year – Facilitation and what that looks like going forward

is the responsibility of PF– Progressed work to transition and now developing

to be fit for future– Respond to the regulators consultations on behalf

of the profession

Advocacy

Advocating on behalf of the profession:Draft programme for Government A Review of Health and Social care NI (Compton

Review)DHSSPS Policy framework for long term conditionsDOE consultation on single use carrier bags.Consolidation of Medicines Act repeal s10(7)Law Commission – regulation of HC professionals

Questions

The Council

• Recap of responsibilities• Interface with staff, committees and

stakeholders• Policy

QUESTIONS?

LUNCH – return by 1320

Where are we now, what is planned and expected

• Strategic Plan 2010 to 2013• Business Plan Narrative 2012 / 2013• Law Commission• CHRE Cost efficiency and Effectiveness

To Do• Honorary Treasurer**• Going forward number of Council meetings and preferred timings• Transition arrangements• Composition, quorum and appointment of committee members – scheme of delegation for

Committees and CEO?• Council appraisals – future procedure**• Strategic plan, business plan narrative and risk register re-visit• Student FTP**• Code of Conduct 8 – removal*• Horizon scanning – workforce planning, issues and implications**• Departmental interface• Essential projects – paper on rationale*• Meeting P, VP and CEO ahead of August meeting*• August further induction meeting• Law Commission response to be circulated*Key - * Before August meeting - ** After August meeting, remainder at August meeting

Review against objectives

Some objectives for the induction• To understand the environment that we operate in• To understand the collective and individual

responsibilities of Council• An introduction to current organisational

arrangements• To review current and future plans

Council Induction 2012

• Close