The New GPhC Inspection Model

Leyla Hannbeck,Head of Pharmacy Services,

NPA

The new inspection model“A show me, tell me story”

1. Governance arrangements

2. Empowered and competent staff

3. Managing pharmacy premises

4. Delivering pharmacy services

5. Equipment and facilities

Based on FIVE principles and the underpinning GPhC

standards

The standards are designed to protect the health, safety and wellbeing of patients and the public

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 is in place

Appropriate records are kept

Patient confidentiality is protected

Safeguarding Children and vulnerable adults

NPA standard operating procedure

NHS ComplaintsRecord Book

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

Incentives and/or targets should not affect

professional judgement

Culture of openness, honesty and learning

This is to certify that:

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

Principles

Evidence

In practice scenario

s

Sign-posting

How am I

doing?

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?

Our aim = NPA

members

Poor

Satisfactory

Good

Excellent!!

Regulation is used to drive continuous improvement

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

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

The focus is now on patient safety and inspectors will be looking for evidence of this

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?

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

*This includes those pharmacies that have been graded as satisfactory but some standards have not been met

Remember!

The focus of the inspections is patient safety

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

IntroductionPrinciples 1, 2, 3, 4, 5Self assessment grading toolToolsSale of medicines protocolSummary of resources FAQs

GPhC inspections: “A show me, tell me” story”

Making a satisfactory pharmacy good/excellent

SOPsRecordsEvidenceServices

GPhC inspections: “A show me, tell me” story”

Processes and procedures in place

Procedures and processes regularly reviewed

Pharmacy Services consistently and actively promoted

Regular review of patient needs

Risk assessments carried out

Comprehensive record keeping

Innovation

Clear, positive health outcomes for patients

Scenario 1

Help with

health costs

HC11 NHS

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?

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

If there is a locum pharmacist on duty, can the inspection be

deferred?

Will I get a notification of the intention of a GPhC inspectors

visit?

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?

Record keeping Legal records maintained Logs/matrices maintained as

supporting evidence

GPhC inspections: Pharmacy log

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

NPA standard operating procedure

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

Thank you for listening and good luck!!

The end!