GPhC Standards for Registered Pharmacies & Inspectorate

Question 1

What may the GPhC standards relate to

Answer 1

The standards may, in particular, relate to:
1. governance arrangements for registered pharmacies, including arrangements for managing and monitoring the safe and effective provision of pharmacy services at or from registered pharmacies;
2. working environment at, and condition, of registered pharmacies;
3. patient and public experience of pharmacy services provided;
4. condition of equipment and facilities used in the provision of pharmacy services;
5. working environment at, and condition of, associated premises;
6. training of staff of the retail pharmacy business;
7. arrangements for ensuring staff of the retail pharmacy business—
i. have the authority and ability to act to ensure, and
ii. are properly held accountable for,
the health, safety and well-being of patients to whom pharmacy services are provided, and of other persons at registered pharmacies

Question 2

What do GPhC standards for registered pharmacies apply to

Answer 2

Apply to all GPhC registered pharmacies

Purpose: is to create and maintain the right environment, both organisational and physical, for the safe and effective practice of pharmacy

Question 3

Definte pharmacy services

Answer 3

pharmacy-related services provided at or from a registered pharmacy including the management of medicines, provision of advice and referral, clinical services such as vaccination services, and services provided to care homes

Question 4

Define pharmacy staff

Answer 4

includes agency and contract workers, as well as employees and other people who are involved in the provision of pharmacy services by a registered pharmacy

Question 5

Who are responsible for meeting standards (added in 2018)

Answer 5

Pharmacy owners are responsible for ensuring the safe and effective provision of pharmacy services at or from a registered pharmacy. They are accountable for making sure that the standards for registered pharmacies are met.

If owned by a ‘body corporate’, the directors must assure themselves that the standards for registered pharmacies are being met.

All registered professionals working in a registered pharmacy should also be familiar with these standards; and pharmacists and pharmacy technicians must understand that they have a professional responsibility to raise concerns if they believe the standards are not being met.

Question 6

What are governace arrangements (principle 1) and what do they include

Answer 6

Governance arrangements safeguard the health, safety and wellbeing of patients and the public

‘Governance arrangements’ includes:

having clear definitions of roles & accountabilities of people involved in providing & managing pharmacy services

arrangements for managing risks

the way registered pharmacy is managed and operated (safeguarding, indemnity insurance, feedback framework)

Question 7

What is principle 2 of the standards

Answer 7

Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public

The staff you employ and the people you work with are key to the safe and effective practice of pharmacy.

Staff members, and anyone involved in providing pharmacy services, must be competent and empowered to safeguard the health, safety and wellbeing of patients and the public in all that they do.

Question 8

What is principle 3 of the standards

Answer 8

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

Pharmacy premises need to be:
suitable for the services being provided and
protect and maintain patients’/ public health, safety and wellbeing

Question 9

What is principle 4 of the standards

Answer 9

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

‘Pharmacy services’ covers all pharmacy-related services provided by a registered pharmacy, including
Management of medicines
Incl. arrangements for obtaining, keeping, handling, using and supplying medicinal products and medical devices, as well as security and waste management
Management of advice and referral
Wide range of clinical services pharmacies provide

Question 10

What is principle 5 of the standards

Answer 10

The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public
Availability of safe and suitable equipment and facilities

Question 11

What does the guidance to ensure a safe and effective pharmacy team detail

Answer 11

Responsibilities and accountability of

Pharmacy owners
Pharmacy professionals
Pharmacists
Pharmacy technicians

Unregistered staff
- Dispensers, medicines counter assistants, delivery drivers, pharmacy managers
(some have leadership and management roles)

Guidance set out under 5 principles (standards above)

Question 12

What are traditional pharmacy services

Answer 12

‘Traditional’ pharmacy service
all parts of the pharmacy service, including the sale and supply of medicines, takes place in the same registered pharmacy

Question 13

What are distance pharmacy services

Answer 13

‘Distance’ pharmacy service
when any of activities below carried out at different registered pharmacies or places.
also applies in all cases when the member of staff (or third party) providing any part of the pharmacy service - and the patient/ person who uses the pharmacy service, are not both in the same registered pharmacy together.
Includes online

Question 14

Give some examples of distance pharmacy services

Answer 14

pharmacy service where prescriptions are not handed in by people using pharmacy services but are collected by pharmacy staff, or received by post or electronically

delivery service from the registered pharmacy to people in their own home, a care home or a nursing home

collection and delivery service

‘click and collect’ service

mail-order service from a registered pharmacy

internet pharmacy service, including one linked to an online prescribing service, whether or not the prescribing service is owned and operated by you or by a third party business

a ‘hub and spoke’ pharmacy service – where medicines are prepared, assembled, dispensed and labelled for individuals against prescriptions at a central ‘hub’ registered pharmacy

Question 15

Why do we need inspections relating to standards

Answer 15

2 processes:
Proactive:
Assess all
Registrants=> Revalidation
Premises => Inspection

Reactive:
Concern identified => Investigation

Question 16

What are the roles of the GPhC inspectorate

Answer 16

GPhC appointed: Inspectorate – inspectors
Inspector functions are to:

Enforce standards

Secure compliance by registrants and by persons carrying on a retail pharmacy business at a registered pharmacy with the Medicines Act 1968

Secure compliance by registered pharmacists and persons carrying on a retail pharmacy business with the provisions of Poisons Act 1972 & Poisons Rules

Enforce:-
Article 38: Offences relating to Register*
Any other provisions and of rules under Order

Assist Council in investigation of fitness to practise matters

Question 17

What does article 38 relate to

Answer 17

False representation & use of title
(e.g. pharmacist – ‘protected title’)

Practising without being on GPhC register

Proceedings for offence under this article may begin within 6 months of sufficient evidence available

Question 18

How is the GPhC inspectorate made up in the UK

Answer 18

41 inspectors across Great Britain

Four regional groups:
Scotland and North of England, Wales and West of England, South of England, East of England
Each managed by Regional Manager

Each inspector

Responsible for registered pharmacy premises in ~ 5-7 Primary Care Organisations

Inspects 500-600 registered pharmacy premises

On average, complete 200+ visits per year

Question 19

What are the two main roles of the inspectorate (and their other roles)

Answer 19

Inspection visits:

• Inspect registered pharmacy premises
• To monitor & secure compliance with relevant legal requirements and professional standards

Investigations:

• Investigate complaints and allegations involving registered pharmacists or registered pharmacy technicians

In addition
Inspectors provide advice on compliance issues and
liaise with other regulatory & enforcement agencies, and local Primary Care Organisations

Question 20

What is the inspectorates power of entry

Answer 20

GPhC Inspector has power to enter any registered pharmacy premises at any reasonable hour in order conduct an inspection

Inspector must provide evidence of their identity and that they are authorised GPhC inspector

Inspectors are not obliged to notify premises that they want to carry out inspection

Question 21

What powers do inspectors hold

Answer 21

An inspector may, upon entering any premises —

Inspect premises and any plant, machinery or equipment

Search premises

Inspect and remove any substance, article or product

Carry out examinations and tests, and make enquiries
- Incl. fitness to practise of a registrant who is or has been employed on the premises

Require documents or records (whether or not at premises) to be produced (incl. electronic) => Inspector can:

• Take copies
• Take possession & retain for as long as considers necessary
• Require access and check operation of any computer or other electronic device

NB. It is an offence to obstruct inspector in above => fine

CD reg is always checked

Question 22

What are improvement notices and when are they used

Answer 22

If, during an inspection visit, an inspector finds that the pharmacy is not compliant with legal requirements or regulatory standards

Inspector may serve “improvement notice”

• Pharmacist and superintendent (or owner)
• How they can secure compliance

Improvement notice will:

• State grounds for believing there is a failure of compliance
• Specify measures that must be taken to rectify failure
• Require that those measures taken within specified period (not < 28 days)
• State: Right of appeal & period to bring appeal

Question 23

What happens if a pharmacy does not comply with improvement notices

Answer 23

Is an offence => fine

Inspector must give notice in writing to Registrar

Following receipt, Registrar can:-

• Remove registered pharmacy from Register
• Suspend registration, pending compliance with such requirements or conditions as Registrar considers necessary

(Right of appeal)

Question 24

What does a routine inspection involve

Answer 24

Routine inspections

• increasingly more flexible and effective
• based on indicators of risk

previously rated as poor, or rating of satisfactory with action plan

other indicators such as:

• change of ownership
• significant changes to governance structures (e.g. superintendent pharmacist)
• where range of services is large & complex, and/or has changed significantly

Question 25

What does an intelligence led inspection involve

Answer 25

• using information received from other people or organisations, e.g.
• regulators, healthcare professionals, public, journalists and the media
• GPhC can deal more rapidly with risks or concerns raised

Question 26

What happens during an inspection

Answer 26

Inspectors looking for evidence to show that the standards for registered pharmacies are met

Speak to pharmacy team as a whole
- rather than just owner, superintendent or Responsible Pharmacist

Not looking for standard set of documents or practices

Owner and superintendent, in collaboration with pharmacy team
- must provide evidence of how they meet the standards

Question 27

What are the 2 potential outcomes of inspections

Answer 27

Two potential outcomes

• ‘standards met’ outcome
  All of the standards need to be met
• ‘standards not all met’
  any pharmacy not meeting all of the standards
  needs to complete an improvement action plan
  Improvement action plan will be published alongside report

Question 28

What are the four possible findings for each of the five principles

Answer 28

‘excellent practice’*
‘good practice’
‘standards met’
‘standards not all met’

To help pharmacy owner and team to understand positive areas of practice and areas for improvement

Enables GPhC to identify notable practice

‘knowledge hub’
features these examples of notable practice, as a learning resource
support continuous improvement across pharmacy for patients and the public

Question 29

What consitiutes excellent practice

Answer 29

• already be performing well against the standards
• provide services designed and delivered with patients at their core
• be improving outcomes for individual patients; making a significant difference to them
• be optimising patients’ use of medicines to ensure they take the right medicines at the right time and to reduce wastage of medicines
• be looking outside the walls of the pharmacy to understand the health needs of your local community and deliver pharmacy service to meet those needs
• be working in partnership with other healthcare providers and community groups to improve outcomes for individual patients and groups of patients
• be continually learning and researching good practice to identify ways of improving patient safety
• be a model for other pharmacies to learn from

=> To achieve ‘excellent practice’, a pharmacy will need to not only meet all the standards under a particular principle consistently well, but also demonstrate innovation in the delivery of pharmacy services with clear positive health outcomes for its patients.

Question 30

When are improvement action plans required

Answer 30

All pharmacies which have not met one or more of the standards during an inspection will be required to complete and implement an improvement action plan.

Pharmacy needs to tell GPhC within 5 days what action(s) they intend to take to meet the standards and improve practice

Improvement action plans are filled in by owner and superintendent pharmacist

• Inspector indicates whether improvement action must be completed within 10, 20 or 60 working days
• Pharmacy owner and superintendent identify who will be responsible for completing actions

Improvement action plans are published on the pharmacy inspections website alongside the inspection report.

Question 31

What type of enforcement action is avaiable (when a pharmacy doesnt adhere to its action plan)

Answer 31

Number of different enforcement options available to secure compliance with GPhC standards

• Improvement action plans
• Statutory enforcement powers
  >improvement notices
  >conditions

GPhC will use its statutory enforcement powers in situations when

• pharmacy owner does not comply
• when there is a serious risk to patient safety

Question 32

When do GPhC improvement notices get issued

Answer 32

When GPhC inspectors identify that the pharmacy was not meeting some of the standards for registered pharmacies they are published publicly

• document serious system-wide failures in the governance and management of risk at the pharmacy, and a lack of safeguarding, which presents a risk to patient safety.
  inspectors
• considered the volume and type of medicines supplied, the age range and potential vulnerability of the patients, and the additional risks of working with prescribers based in the EEA and working outside UK regulatory oversight.

The improvement notice required the pharmacy to put a number of measures in place to rectify the failures and meet the standards, including

• developing and putting in place a comprehensive risk assessment for the services they provide
• updating their safeguarding policy and procedures.