the pharmacy law and ethics association current debates in ... annual seminar 2016 (… · the...

The Pharmacy Law and Ethics Association

Wednesday 4th May 2016 10.00 ‐ 3.45 #PLEA2016

Kindly hosted by Charles Russell Speechlys LLP

"Current debates in the pharmacy profession"

The Pharmacy Law and Ethics Association

Priya WarnerHead of Standards and Fitness to Practise Policy

General Pharmaceutical Council 

Standards for pharmacy professionals

Standards for pharmacy professionals

Priya WarnerHead of standards and fitness to practise policy

#ProfStandards

Pharmacy and the role of pharmacy professionals are changing . . .

• Increased expectations

• How healthcare is delivered 

• New and changing roles for pharmacy professionals

What we know

• The public will always have a right to expect safe and effective care 

• Attitudes and behaviours contribute most to patient safety and the quality of care

• Pharmacy professionals must uphold public trust and confidence

Pharmacy may be changing, but some things won’t change:

How we got here:• What does it mean to be a 

pharmacy professional in the 21stcentury?

• What do patients and the public expect from pharmacy professionals today?

• A national conversation on patient‐centred professionalism

What we learned:

• Patient‐centred and professionalismare the same

• There is consensus around the attitudes and behaviours that lead to safe and effective care:

Communication Teamwork Professional judgement Knowledge Leadership

The standards are:• A statement of what people 

expect from pharmacy professionals

• What pharmacy professionals have told us they expect of themselves and their colleagues

• Recognition that every person must be treated as an individual 

How does this affect you?

• Standards apply to pharmacists and pharmacy technicians – whether they see patients  or not 

• For students, standards will replace the student code of conduct.   

• Standards need to be met at all mes  ̶  not just during work or study hours

Standards for pharmacy professionals

Each standard is explainedPharmacy professionals must provide                         person‐centred care

Every person who receives care is an individual with their ownvalues, needs and concerns. Person‐centred care is deliveredwhen pharmacy professionals understand what is important tothe individual and then adapt the care to meet their needs –making the care of the person their first priority.

People receive safe and effective care when pharmacy professionals:

• involve, support and enable every person when making decisions about their health, care andwellbeing

• give the person all relevant information in a way they can understand, so they can make informeddecisions and choices

• respect and safeguard the person’s dignity• recognise and value diversity, and respect cultural differences–making sure that every person is treated

fairly whatever their values and beliefs• recognise their own values and beliefs but do not impose them on other people

What now:

• The GPhC is now consulting on the standards for pharmacy professionals

• Do these standards lead to effective care and improved patient outcomes?

• Please respond by June 27

Who:• GPhC is now engaging with a wider audience of patients and the public, pharmacy professionals, pharmacy students and trainees, professional groups, and other stakeholders

• We need feedback from those directly impacted and those with an interest in the development of the standards  

Next Steps

• Analysis

• Report

• Council to approve standards

• Communications/awareness‐building

• Implementation

How to get involvedHave your say on standards

Read more and take the survey at: www.pharmacyregulation.org  

@TheGPhC /#ProfStandards

facebook.com/TheGPhC

linkedin.com/company/general‐pharmaceutical‐council

Thank you

The Pharmacy Law and Ethics Association

Prof Rob DarracottChief Executive Pharmacy Voice and Rebalancing Medicines Legislation 

and Pharmacy Regulation Programme Board Member

Supervision ‐ the next step of rebalancing

Supervision – the next steps in rebalancing

Rob Darracott, Chief Executive, Pharmacy Voice  Member, Rebalancing Board 

Agenda

• Overall Programme update• Next Steps for Patient Safety• Governance Framework• Supervision: the key questions• Next steps• Q&A

19

Rebalancing Board

20

• Commenced work 2013• Led by DH on behalf of the four UK Governments and MHRA

• Covers Medicines Act, Human Medicines Regulations and professional regulation by GPhC established through primary legislation and S60 Orders

• Overall aim:  to strike a (more) appropriate  balance between the law and professional regulation

• Representation: professions, professionals, regulators, owners and operators, public, supported by officials, including legal advisers; independent chair Ken Jarrold

Workstreams update

21

• “Decriminalisation”• GPhC standards, and powers related to inspections 

• Responsibilities, standards etc for owners, superintendents and responsible pharmacists

• Supervision • Hub and Spoke

Latest position

22

• “Decriminalisation” – awaiting Parliamentary clearance x 2

• GPhC standards, and powers related to inspections – ready for commencement

• Responsibilities, standards etc for owners, superintendents and responsible pharmacists –drafting of S60 Order prior to public consultation

• Supervision – under discussion underway• Hub and Spoke – legislation to create level playing field under consultation 

Next steps for patient safety

23

• National leadership of pre‐implementation phase– Response to Stafford (Hard Truths), other safety concerns 

– Culture shift pro‐reporting (effective use of NRLS; role of MSOs); Right Care and professionalism 

• Profession‐led, but different in four jurisdictions• In England, PV has role for community pharmacy through MSO Group and workplan

• IT development necessary

Governance Framework

24

Transaction Level

Organisation Level III

Organisation Level II

Organisation Level I

Pharmacy Owners

Superintendent Pharmacist

Responsible Pharmacist

???

Supervision: key considerations

25

• Understanding the organisational governance context as precursor to framing transactional governance questions

• What’s a technician?– what are they trained to do (and not trained to do)– how might their skills and competencies be utilised in different scenarios– what work currently performed by pharmacists might registered pharmacy 

technicians do and take responsibility for• What assurances will RPs need about the competencies, skills, education 

and training of individual pharmacy technicians in order to assess what a team might work differently.  How might that assurance be provided?  

• Are decisions around sale or supply different to those around assembly? • Does the classification of medicines make a difference?• What decisions might be made about whether a non‐registered member 

of the pharmacy team can perform a certain task?  Who might make those decisions ‐ just the RP, or a registered pharmacy technician? 

• How might hub and spoke considerations affect any/all of these issues? 

The Pharmacy Law and Ethics Association

Bill RialPLEA Chair

Lunch and AGM

The Pharmacy Law and Ethics Association

David ReissnerPartner, Charles Russell Speechlys LLP

The Falsified Medicines Directive and other hot 

legal topics

charlesrussellspeechlys.com

David Reissner, Senior Healthcare Partner

Falsified Medicines Directive and other hot legal topicsPLEA 2016

• In force 9 February 2019• End-to-end verification system• Obligatory safety features

08 May 2016 29

Falsified Medicines Directive

• Anti-tampering device

• Unique identifier – barcode

08 May 2016 30

Safety Features

Repositories

• OTC medicines originating outside UK

• Verification at the time of supply only

• How does this fit in with hub and spoke dispensing?

08 May 2016 31

Issues

• No re-supply

• What if the patient is not at home?

• What if the wrong item has been selected?

• Decommissioning can be reversed within 10 days – if no supply made

08 May 2016 32

Decommissioning

• Verify when first opened

• Decommission when first opened

08 May 2016 33

Split packs

• Supply permitted

• Record the identifier

• Verify and decommission when technical problem solved

08 May 2016 34

Technical problems

• EU Tobacco Directive

• The Tobacco & Related Products Regulations

• In force 20 May 2016

08 May 2016 35

E-cigarettes

• Maximum nicotine 20mg per ml

• Restrictions on additives

• Child resistant packaging

• Information leaflets

• Possible adverse effects

• Addictiveness and toxicity

08 May 2016 36

Requirements

First licensed e-cigarette

08 May 2016 37

“e-cigarettes possibly cause risks to human health and…could — above all in the case of adolescents and young adults — develop into a gateway to nicotine addiction and, ultimately, traditional tobacco consumption.”

08 May 2016 38

What does the European Court Say?

“While vaping may not be 100% safe, most of the chemicals causing smoking-related disease are absent and the chemicals present pose limited danger...The current best estimate is that e-cigarette use is around 95% less harmful to health than smoking.”

08 May 2016 39

What does Public Health England Say?

• The law today

• Consultation ends 17 May 2016

Hub and spoke

• Data protection• Labelling• Supervision• FMD• Civil liability for errors• Criminal liability for errors

08 May 2016 41

Hub and spoke issues

• Pharmacists must access SCR if in the best

interests of patient

• When providing services

• Clinical judgement

• The effect on liability for claims

08 May 2016 42

Summary care records

• No need to check every time a repeat is dispensed

• Check for allergies if penicillin prescribed

• Check when patients are new• Check if there are queries or concerns

08 May 2016 43

RPS guidance – when to check SCR

• Improvement notices

• Criminal offence

08 May 2016 44

Then – up to 11 April 2016Premises regulation

• Working arrangements

• Working environments

• Governance arrangements

• No checklist approach

08 May 2016 45

Now (from 12 April 2016) – GPhC must set standards -

New Premises Regulations

• Warehouses

• Premises where data is stored

08 May 2016 46

All premises

• Interim suspension

• Disqualification

• Publication of inspection reports

08 May 2016 47

Fitness to practiseGPhC powers

•What is important to the individual•Listen and give all relevant information

•Get consent to provide care•Make and use records

08 May 2016 48

“Person-centred” care and working in partnership

GPhC – new standards – consultation until 27 June 2016

• Communicate – make sure the person has understood

• Use professional judgement in partnership• Declare any personal interest and put the

person’s needs first• Behave professionally at all times• Show empathy and compassion

08 May 2016 49

Communication, professional judgement and behaviour

GPhC standards

•Privacy and confidentiality•Blow the whistle where there are concerns or things go wrong

•Take responsibility•Assess risks

08 May 2016 50

Confidentiality, whistleblowing and leadershipGPhC standards

charlesrussellspeechlys.com

Charles Russell Speechlys LLP is a limited liability partnership registered in England and Wales, registered number OC311850, and is authorised and regulated by the Solicitors Regulation Authority. Charles Russell Speechlys LLP is also licensed by the Qatar Financial Centre Authority in respect of its branch office in Doha. Any reference to a partner in relation to Charles Russell Speechlys LLP is to a member of Charles Russell Speechlys LLP or an employee with equivalent standing and qualifications. A list of members and of non-members who are described as partners, is available for inspection at the registered office, 5 Fleet Place, London. EC4M 7RD.

David ReissnerSenior Healthcare PartnerT: 44+ (0)20 7203 5065E: david.reissner@crsblaw.com

The Pharmacy Law and Ethics Association

Bill RialPLEA Chair

Summing up

The Pharmacy Law and Ethics Association

Tuesday 6 September 2016Aston University

Student Fitness to Practise:What does the next 5 years hold?

Confirmed speakersDamian Day, Head of Education, GPhC

Prof Tim David, Pan‐faculty FtP lead University of ManchesterJohn Murphy/ Mark Pitt, Pharmacist Defence Association