The New GPhC Inspection Model
Leyla Hannbeck,
Head of Pharmacy Services,
NPA
The new inspection model
“A show me, tell me story”
The standards are designed to protect the health, safety and wellbeing of
patients and the public
Based on FIVE principles and
the underpinning GPhC
standards
1. Governance
arrangements
2. Empowered and
competent staff
3. Managing pharmacy
premises
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)
NPA standard
operating
procedure
 Staff have clear roles
 Complaints procedure is in place
 Appropriate records are kept
NHS Complaints
Record Book
 Patient confidentiality is protected
 Safeguarding Children and vulnerable
adults
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
This is to
certify that:
 Sufficient staff with appropriate skill mix
 Training is appropriately supervised
 Incentives and/or targets should not affect
 professional judgement
 Culture of openness, honesty and learning
Principle 3: Managing pharmacy premises
This is all about having well-maintained pharmacy premises
that are hygienic, well-designed and secure
 Well-maintained, clean and safe pharmacy
premises
 Well-designed and compliant with the Health Act
and protects patient’s privacy
 Clean and hygienic
 Secure - ensuring protection of both stock and
patient information
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
 Services benefit the local community
 Promotion of healthy lifestyles
 Stock is sourced, stored, supplied and
disposed of appropriately
 Recalls and alerts are actioned
Principle 5: Equipment and facilities
This is all about ensuring that equipment and facilities used
in the pharmacy are safe and for for purpose
 Clean, well-maintained equipment
is available
 Equipment is fit for purpose and to
the appropriate safety
Standard
 IT equipment protects
confidentiality
“A show me, tell me story” by the NPA
Evidence
How am
I doing?
Principles
Signposting
In practice
scenarios
Summary of NPA resources:
The following resources are available in this series, with further documents planned in due course:
“GPhC inspections “A show me, tell me story”: introduction”
“GPhC inspections “A show me, tell me story”: Guidance — Principle 1”
“GPhC inspections “A show me, tell me story”: Guidance — Principle 2”
“GPhC inspections “A show me, tell me story”: Guidance — Principle 3”
“GPhC inspections “A show me, tell me story”: Guidance — Principle 4”
“GPhC inspections “A show me, tell me story”: Guidance — Principle 5”
“GPhC inspections: “A show me, tell me story”: Self-assessment grading”
“GPhC Inspections: FAQs (Dec 2013)”
“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” (for individual members of the pharmacy team)
“GPhC inspections: Sale of medicines protocol guidance”
Other NPA resources:
Standard operating procedures:
o Controlled Drugs
o Responsible pharmacist
o National Patient Safety Agency (for example, supplying insulin, supply of lithium therapy)
o Medicines Use Review
How do inspectors grade pharmacies?
Poor
Our aim =
NPA
members
Excellent!!
Satisfactory
Regulation is used to drive
continuous improvement
Good
What can I expect during an inspection?
 Approximately 2h in duration
 All pharmacy team involved
 Observations made on hand-held
electronic device
 Responsible pharmacist (RP) may view
the observations
The focus is now on patient
safety and inspectors will
be looking for evidence of
this
 Comments may be added by the RP,
before signing to confirm agreement with
the report
 Report sent to the pharmacy
owner/superintendent pharmacist
shortly after the inspection
What evidence am I expected to provide?
 Layout of pharmacy including work flow and availability of
consultation area
 Competence and skill mix of pharmacy team (training)
 Insurance arrangements
 Professional looking, well maintained, hygienic premises with
clearly defined professional area
 Security arrangements
 Facilities for all patient groups, including those with disabilities
 Equipment and facilities are available to provide pharmacy
services
What if my pharmacy receives a poor* judgement?
*This includes those pharmacies that have been graded as satisfactory but
some standards have not been met
 Action plan issued
 Superintendent
pharmacist to respond
within two days
 Must state any
remedial action to be
carried out, when and
who will be responsible
for doing so
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
Remember!
 The focus of the inspections is patient
safety
GPhC inspections: “A
show me, tell me” story”
Introduction
Principles 1, 2, 3, 4, 5
Self assessment grading tool
Tools
Sale of medicines protocol
Summary of resources
FAQs
 Inspectors are not looking to penalise
minor issues
 It does not matter what methods are
used to achieve standards
 The more prepared you are, the less
time the inspection will take
 The NPA Pharmacy Services toolkit is
available to help you ensure that you are
continually meeting GPhC standards
Making a satisfactory pharmacy good/excellent
GPhC inspections: “A
show me, tell me” story”
Procedures and processes regularly
reviewed
SOPs
Records
Evidence
Services
 Pharmacy Services consistently and
actively promoted
 Regular review of patient needs
 Processes and
procedures in place
 Risk assessments carried out
 Comprehensive record keeping
 Innovation
 Clear, positive health outcomes for
patients
Scenario 1
Dispensing error: Tegretol Prolonged Release tablets 200mg
supplied instead of Voltarol Retard tablets.
The patient took the tablets for two days before the error was
detected and the patient’s doctor has contacted the pharmacy
to notify the pharmacist of the error. The dispensing technician
takes the call — what action would they take?
 Which member of the pharmacy team were
involved?
 How are incidents dealt with?
 What processes are in place to notify the patient?
 Are incident reporting procedures in place?
 What possible factors were implicated in the
incident?
 Is indemnity insurance cover in place?
HC1
NHS
1Help
with
health
costs
Scenario 2
You overhear a conversation on the chemist
counter in which a member of the pharmacy
counter staff is selling chloramphenicol eye drops
0.5% for use in a dog.
You intervene in the sale and afterwards take the
member of staff to one side; how do you ensure
that this does not happen again?.
 What training has the member of staff
completed?
 How often is staff training planned and is this
recorded?
 Are one-to-one meetings planned in?
 Is there a Sale of Medicines Protocol in place
and do staff adhere to it?
Scenario 3
Your pharmacy is located within a GP practice and the
practice manager has informed you that the cleaning
contractor will be coming in prior to the surgery and pharmacy
opening to clean the premises.
A member of the pharmacy team will not be present. Are
additional security arrangements required?
 A risk assessment should be carried out due to the change in
circumstances
 Are additional security arrangements required, for example locked
shutters, use of CCTV, use of locked drawers
 Will there be a risk of a breach in information governance?
Scenario 4
One of your patients comes in with two new items
on their prescription. They will need counselling
about both medicines, however, English is not their
first language.
You struggle to relay the information regarding their
prescription, and no-one in the pharmacy speaks
their language.
 Availability of information from Local NHS Organisation, for
example, leaflets
 Does the patient have sufficient information to safely take their
medicine(s)?
 Consider reviewing the local population demographics
 Signposting
Scenario 5
Extemporaneous preparation of an urgently medicine:
you have the ingredients to prepare the medicine,
however, the weighing scales have been placed in the
stock room and some of the weights are missing. The
dispensing technician advises you that they haven’t been
used ‘for years’. Ordering via your specials wholesaler
will take too long.
Can you attempt to make the medicine?
 Is the pharmacist competent in preparing extemporaneous
preparations?
 Appropriate facilities and equipment should be in place to dispense
medicines
 Procedures in place for maintaining pharmacy equipment
 Signposting
Scenario 6
Computer technical issues: prescriptions requiring hand endorsement
and labels having to be written by hand.
The pharmacist decides to take the prescriptions home to complete and
check the endorsements as it has been too busy during pharmacy
opening hours to do so. The prescriptions are in a carrier bag and are
left overnight in the flat that the pharmacist shares with other flatmates,
before being returned to the pharmacy the following morning.
 Business continuity planning
 Data protection and confidentiality
 Information Governance SOPs in place and
adhered to
 Information Governance training for all staff
 Safe storage of prescriptions at all times
FAQs: general
Will I get a notification of the
intention of a GPhC inspectors
visit?
If there is a locum pharmacist
on duty, can the inspection be
deferred?
FAQs: action plans
I have received an action plan to
complete, I am not sure what to do?
Can the responsibility for the action
plan be delegated to a RP?
FAQs: action plans
What if the Superintendent Pharmacist is on
holiday and an action plan needs to be
produced?
I am not sure that ten days is sufficient time
to rectify the shortfalls, what can I do?
FAQs: judgements
The inspector has
asked me to sign the
report at the end of
the inspection, what
if I don’t agree with
the observations?
• No grading is made at this stage
• Signing is to denote that the inspectors observations
are accurate
• The RP may add comments
• The report will be sent to Superintendent shortly after
• Superintendent may correct factual accuracies once
received but not observations made by the inspector
• Superintendent will be asked to confirm their
agreement with the report
•The judgement cannot be challenged, however
FAQs
How often will my pharmacy be visited?
Are the visits similar to the contract monitoring
visits?
• There is some overlap
• GPhC inspections focus heavily on patient safety; risk assessment
forms part of Clinical Governance (an NHS Essential Service)
• Contract monitoring visits are carried out by Local Area Teams, and
only apply to those pharmacies in NHS England’s pharmaceutical
lists; GPhC inspections apply to all registered pharmacies
Any questions?
GPhC inspections:
Pharmacy log
Record keeping
 Legal records maintained
 Logs/matrices maintained as
supporting evidence
NPA standard operating
procedure
SOPs:
 In place for all the processes in
the pharmacy
 Up to date and regularly
reviewed
 Staff can demonstrate that
processes are followed in line with
SOPs
 Evidence of where incidents
have occurred and SOPs reviewed,
thus improving processes
Remember!
Use the NPA self-assessment grading tool to give your
pharmacy a grading and identify where you can improve
Pharmacy call to action:
•creating a ‘pharmacy first’ culture
•ensuring patients get the best from their medicines
•integrating community pharmacy into the patient pathway
•Increasing safety of dispensing
Put yourself in the shoes of inspectors and patients and see
your practice through their eyes
The end!
Thank you for listening and good luck!!