New GPhC inspection regime Gareth Jones MRPharmS NPA Public Affairs - - PowerPoint PPT Presentation

New GPhC inspection regime

Gareth Jones MRPharmS NPA Public Affairs Manager

GPhC regulation

Professional regulation

• Regulating pharmacy professionals

through standards for conduct, ethics and performance

• Taking action where the fitness to practise
• f a registered pharmacy professional may

be impaired

• If the standards are not met,

registration of that pharmacy professional at stake

• Individual professional accountability

‘System’ regulation

• Regulating pharmacies through standards

for registered pharmacies

• Requiring owners and superintendents to

secure compliance with those standards

• If the standards are not met,

registration of the pharmacy is at stake

• Organisational accountability (through
• wner/superintendent)

GPhC philosophy

• Using regulation to promote a culture of patient-

centred professionalism in pharmacy

• GPhC “committed to regulating in a way which supports

pharmacists and pharmacy technicians to embrace and demonstrate professionalism in their work”

• Professionalism, not rules and regulations, provides

most effective protection for patients

• Prescriptive rules let us all off the hook

Standards for registered pharmacies

• A focus on outcomes, not

prescriptive rules

• Leaves it to pharmacists to decide

how to deliver safe and effective practice

• New accountability structure:

pharmacy owners and superintendents are accountable for meeting the new standards

New GPhC inspection regime

• Launched 4th Nov 2013
• Based on new GPhC standards
• Pharmacies need to demonstrate

compliance with 5 sets of standards

• Inspection label (grade) will be issued
• Publication of report
• Statutory improvement notices

Registration of nre pharmacy premises Registration of new premises Risk assessment Pre-inspection preparation On-site pharmacy inspection Report writing Quality assurance Publication

Inspection Cycle

Strategic Relationship Management

GPhC standards

Principles

• 1. Governance arrangements
• 2. Empowered and competent

staff

• 3. Premises environment and

condition

• 4. Delivering pharmacy services
• 5. Equipment and facilities

Principle 1: Governance arrangements

This is all about managing the potential risks that processes and services may pose to patients/public

Standard operating procedures (SOPs)  Staff have clear roles  Complaints procedure  Appropriate records  Safeguarding Children and vulnerable adults

NPA standard

• perating

procedure

NHS Complaints Record Book

Governance arrangements

Satisfactory Good Procedures are in place that are appropriate to the risks for all pharmacy services provided Proactive and regular review of adverse incidents to identify trends, review procedures, train staff Storage and management of medicines is appropriate to the risks Risk of potential failure or disruption to services planned for There are complaints and feedback mechanisms Systematic monitoring and review mechanisms are in place Patient identifiable information is not shared Passwords are used and changed frequently Staff aware of and apply safeguarding policies There is a clear culture of safeguarding

Governance arrangements

• Have I got arrangements in place to

regularly review systems and processes?

• How have I made sure that staff are clear

about what they can and cannot do?

• Do I keep records of near misses?
• Are patients asked for feedback?
• How can I demonstrate that staff act on

concerns/complaints from patients?

Principle 2: Empowered and competent staff

This is all about the competency of staff, the skill mix and the way that training is managed within the pharmacy

 Sufficient staff with appropriate skill mix

 Training is appropriately supervised  Culture of openness, honesty and learning

This is to certify that:

Empowered and competent staff

Satisfactory Good Staffing levels and roles are appropriate Staff numbers and skill mix and continually and systematically reviewed in line with workload All staff are appropriately supervised Staff are actively encouraged to reflect

• n their performance

All staff accept responsibility for their mistakes Regular reporting and review of errors The pharmacy has a whistle-blowing policy in place There is a culture in the pharmacy that means that staff are confident to raise concerns

• Can I demonstrate that there are enough

suitably qualified/trained pharmacy staff?

• Do staff have 1-2-1 appraisals or team

meetings?

• Do staff know what to do should they have

concerns about the poor professional practice of others?

Empowered and competent staff

Principle 3: Managing pharmacy premises

This is all about having well-maintained pharmacy premises that are hygienic, well-designed and secure

 Well-maintained and safe pharmacy

premises  Compliant with the Health Act  Clean and hygienic

Pharmacy premises

Satisfactory Good The pharmacy premises are clean, tidy and well organised Patient and public feedback informs the design and layout of the public area

• f the pharmacy

Patients are able to have confidential conversations with pharmacy staff Confidential discussions take place in an area/room which is suitably screened Security measures prevent unauthorised access and safeguard staff, patients and the public Security measures are regularly reviewed in light of local incidents

Pharmacy premises

• Can I demonstrate that the size, design

and layout of the pharmacy supports safe practice?

• Can I demonstrate that there is a quiet

area where patients can have confidential conversations?

Principle 4: Delivering pharmacy services

This is all about the promotion and accessibility of pharmacy services to the public, and ensuring safe delivery of these

 Clearly displayed pharmacy services

 Promotion of healthy lifestyles  Stock is sourced, stored, supplied and disposed of appropriately

Delivery of services

Satisfactory Good Pharmacy services available are clearly displayed Pharmacy team can articulate to patients benefits of services offered Adequate stock management procedures are in place Patients are actively counselled to promote the return of unwanted/unused medicines There is an audit trail to identify staff involved in dispensing a medicine Patients receiving high-risk medicines are proactively counselled Patients are signposted to other providers when pharmacy can not meet their needs The pharmacy proactively follows up patients who have received a medicine which is not fit for purpose

Delivery of services

• Do I signpost to other service providers
• Do I tailor services to the local population?
• How can I demonstrate that patients are

given the right advice about how to take their medicines?

• Do I have an audit trail for deliveries?
• Can I demonstrate that I have robust stock

management arrangements?

Principle 5: Equipment and facilities

This is all about ensuring that equipment and facilities used in the pharmacy are safe and for for purpose

 Well-maintained equipment is available  Equipment is fit for purpose and to the appropriate safety standard  IT equipment protects confidentiality

Equipment and facilities

Satisfactory Good Appropriate equipment and facilities readily available (eg, internet access) Proactive review of equipment and facilities to improve patient care (eg, able to produce large print labels) All equipment is fit for purpose and validated Equipment regularly monitored to identify deficiencies and corrective action taken Equipment is stored securely, safely and appropriately The pharmacy shares any concerns about equipment deficiencies with

• ther pharmacies/organisations

Equipment and facilities are clean and hygienic

Equipment and facilities

• Do I have all the equipment I need to

provide the services I offer?

• How can I demonstrate that the equipment

is clean, working and properly calibrated?

• How can I demonstrate that the pharmacy

has up-to-date reference sources?

• Are PMR passwords protected?

Early trends – standards not met

• Management of medicines & medical devices

(4.3)

• Risk management identification & management

(1.1)

• Records management (1.6)
• Risk reviewed & monitored (1.2)
• Pharmacy services managed & delivered safely

(4.2)

• Premises safe, clean & properly maintained (3.1)

Inspection label (grade)

• Pharmacies will be graded - in line with

wider regulatory practice

• Result of inspection no longer “met” or “not

met”

• Allows a more realistic judgement
• Use regulation to drive continuous

improvement

An excellent pharmacy

• Will meet all the standards consistently

well but also demonstrate innovation in the delivery of pharmacy services with clear positive health outcomes for its patients

• It is envisaged that there will be very few

pharmacies where the outcome of the inspection is excellent, especially in the early days of the new inspection model.

A good pharmacy

• Will need to be consistently good across

the standards and demonstrate some positive outcomes for patients

• A good pharmacy is likely to conduct

continuous and systematic reviews of its staff, their skills, operating procedures, records, risks and patient needs

A satisfactory pharmacy

• Meet the vast majority of individual

standards

• Any standards not met will only have a low

risk of harm to patients/public safety

• It is highly likely that most pharmacies

will fall within this category

A poor pharmacy

• Has not met the satisfactory standard
• verall. It is likely to have a range of

concerns and/or standards not met

• There may be systemic weaknesses or a

collection of aggregated concerns

• Will always have to fill in an action plan

with clear and timed commitments to improve.

PV Results

1 2 96 92 3 6

CCA & AIMp CCA & AIMp

1st May - 31st July 2014 Poor Satisfactory Good 1st Jan - 28th March 2014

Public Perception

Poor Satisfactory Good Excellent

Mid point / average / pass Below standard Above standard

HM Inspectorate of Prisons

OFSTED inspections

PV Results – no advice

• 1

2 31 52 65 40 3 6

CCA & AIMp CCA & AIMp

Poor Satisfactory (with action plan or suggestions) Satisfactory (NO action plan or suggestions) Good 92% Satisfactory 96% Satisfactory

1st Jan - 28th March 2014 1st May - 31st July 2014

What if my pharmacy receives a poor* judgement?

• Action plan

issued

• Superintendent

pharmacist to respond within two days Moderate or high risk to patient safety:

• Rectify within TEN

working days No significant risk (ie satisfactory but some standards not met)

• Rectify within

TWENTY working days

Publication of report

• Once the prototype period is completed,

pharmacy inspection reports will be published

OFSTED report

CQC report

Publication of report

• A powerful marketing tool?
• An albatross?
• Labelling a pharmacy based on

performance on one day?

• Something the public will use when

deciding which pharmacy to use?

• Driver of quality, consistency and

innovation?

Statutory notices

• The GPhC will have the powers to issue

statutory improvement notices to pharmacies

GPhC feedback

• Pharmacists value the instant

feedback

• Positive engagement with staff

team

• ‘Show and tell’ approach

welcomed

• Seen as a learning and

development opportunity for all pharmacy team

• Inspector on site for longer

GPhC feedback

• Quite a low level of

awareness of new premises standards in general

• Language of governance

and risk management is quite challenging

NPA learning

• Demonstrating that the pharmacy is

reviewing practice and constantly improving is key to being “good”

• “Good” in a couple of areas isn’t

necessarily enough for “good” overall

• Some problems with staffing levels
• Some staff were not au fait with

terminology

NPA learning

• The ability of staff to demonstrate that they

understand and follow standards will be crucial

• Inspection currently taking a long time
• Inconsistencies?
• Superintendent absent from the pharmacy
• n day of inspection shut out of process
• Difficult to get a “good” grading

Inspection length

• Inspection length is variable – upto 7

hours

• There should be greater consistency, and

ideally inspections should be completed within 3 hours

• Key standards could be identified and

inspections completed at principle level

Regular pharmacist absent

• A GPhC inspection will take place – even

in the absence of the regular pharmacist

• Whilst pharmacies must meet minimum

standards every day – there is a risk that the report does not give the public the full picture on a pharmacy

Interaction with pharmacy staff

• Staff can get stressed by inspections,

particularly those that last a long time. This could increase risk

• Pharmacy staff can become nervous

about speaking to an inspector

• Pharmacy staff not always familiar with the

terminology that the inspector uses

• A satisfactory label can undermine staff

morale

• This can be amplified if the feedback on

the day led staff to believe that they were would a “good”

Interaction with pharmacy staff

Follow-up

• 48 hours was not long enough to respond

to the inspection report – the increase to 5 days is welcome

• Some reports taking a long time to be sent

back to the pharmacy

“A show me, tell me story” by Your NPA

Principles Evidence In practice scenarios

Sign- posting How am I doing?

• GPhC inspections: introduction
• GPhC inspections: Guidance — Principle 1
• GPhC inspections: Guidance — Principle 2
• GPhC inspections: Guidance — Principle 3
• GPhC inspections: Guidance — Principle 4
• GPhC inspections: Guidance — Principle 5
• GPhC inspections: Self-assessment grading
• GPhC Inspections: FAQs

Summary of Your NPA resources

• GPhC inspections: NHS public health campaign pharmacy log
• GPhC inspections: Pharmacy cleaning matrix
• GPhC inspections: Pharmacy date-checking matrix
• GPhC inspections: Pharmacy drug/device alert log
• GPhC inspections: Pharmacy maintenance issues log
• GPhC inspections: Recommended resources
• GPhC inspections: Pharmacy self care log
• GPhC inspections: Pharmacy signposting record log
• GPhC inspections: Pharmacy team training record
• GPhC inspections: Sale of medicines protocol guidance

Summary of Your NPA resources

Other NPA resources

Standard operating procedures

• CDs, RP, Serial Prescription

Essential Resources

• MDS, Equality Act, EEA, other HPs

• Superintendent alerts
• Member news email subscription
• Factsheets ( inc electronic registration)
• Health and safety
• HR
• Log books
• Sales items

Your NPA Learning & Development Team

• Meeting all regulated

training requirements

• Quality assurance at the

centre of all we do

• Developing the pharmacy

team for the future

• Influencing pharmacy

workforce development

• Flexible learning options

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