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NPA Essential: June

Things to do and things to know in community pharmacy across the UK

 

Epanutin Infatabs 50mg out of stock until November 2019 – advice from Pfizer Epanutin Infatabs 50mg (containing phenytoin) will be out of stock until November 2019 due to a manufacturing delay. The manufacturer, Pfizer, has issued advice to healthcare professionals, including pharmacists, regarding the supply issue.

Epanutin Infatabs 50mg is licensed for the following indications:

• Control of partial seizures (focal including temporal lobe) and

tonic-clonic seizures (grand mal epilepsy) or a combination of

these.

• The prevention and treatment of seizures that occur during or

after neurosurgery and/or serious head injury.

• As a second-line treatment of trigeminal neuralgia in patients for

whom carbamazepine is ineffective or not tolerated.

 

Phenytoin is a Category 1 anti-epileptic drug - this means that when phenytoin is used for treatment of epilepsy, patients should be maintained on a specific brand/manufacturer’s product due to the risk that variability in therapeutic index, absorption and solubility between brands could lead to loss of seizure control.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has permitted Pfizer to import stock of Dilantin Infatabs 50mg from Canada. Dilantin Infatabs 50mg contain the same active ingredient (phenytoin) as Epanutin Infatabs 50mg. However no bioequivalence data is available, and there may therefore be clinically signifi cant differences between the two brands.

Patients switched to alternative presentations should be medically supervised and monitoring of serum phenytoin levels should take

place to establish a suitable dose. Pharmacists and their teams should be aware of the following key information from Pfizer:

• Dilantin Infatabs 50mg is an unlicensed product in the UK.

• Prescribers should take into account the MHRA guidance

“Supply unlicensed medicinal products (specials)” prior to issuing

a prescription for Dilantin Infatabs 50mg.

• Pfizer has provided a summary of differences between Dilantin

and Epanutin Infatabs and prescribing information for both

products are attached to its letter to healthcare professionals.

• When ordering Epanutin Infatabs 50mg using the standard PIP code with Alliance Healthcare, pharmacy teams will receive a

message to contact Pfizer Customer Contact Centre.

 

Last chance to book the NPA conference in Manchester

The conference, with the theme ‘Forwards in Partnership,’ is on June

20 at the Pendulum Hotel & Manchester Conference Centre. It is

a collaboration between the NPA and Pharmacy Magazine. Health

Secretary Matt Hancock is among the line-up of speakers. NPA members

are invited to attend the AGM in Manchester on the same day. Go to

the page on the NPA site or email events@npa.co.uk.

 

Yellow fever vaccine guidance: Stamaril – MHRA

guidance following fatal reactions after administration

The MHRA issued a drug safety update following two reports of fatal

adverse reactions after administration of the yellow fever (YF) vaccine

Stamaril.

• It is a live attenuated vaccine therefore it must not be

administered to a patient who may be immunosuppressed.

• It is contraindicated in the following patient groups:

- Individuals with a history of thymus dysfunction (this includes

myasthenia gravis and thymoma).

- Those who have had their thymus gland removed (thymectomy).

- Patients aged 60 years and over should only be given the YF

vaccine when there is an unavoidable and signifi cant risk of

contracting yellow fever infection.

• Healthcare professionals, including pharmacists, who administer

YF vaccine must:

- Understand the contraindications and special precautions prior to

administration –from the Summary of Product Characteristics for

Stamaril.

- Be familiar with the YF Vaccine Centre code of practice.

• Where there is any doubt over whether a patient is

immunosuppressed, vaccination with YF vaccine should be

postponed until specialist advice is obtained.

• Immunosuppression can be due to therapy, underlying illness or

pregnancy.

• Robust checklists and protocols should be in place for YF vaccine

administration to avoid the risk of incorrect administration that

may lead to severe/fatal side effects.

• A risk assessment should be conducted prior to vaccine

administration.

• Discuss the traveller’s medical history, details of the travel

itinerary, immune status and potential contraindications.

• A patient information leafl et should be given to the traveller.

• Suspected side effects during vaccination and any medication

error should be reported via the Yellow Card Scheme. Pharmacists

administering the YF vaccine against a patient group direction must

follow the terms of the PGD and contact the PGD provider where

appropriate.

 

Contact the NPA pharmacy services team on 01727 891 800

or email pharmacyservices@npa.co.uk

 

 

The NPA has given new evidence to government

about the financial pressures on independent pharmacies

A survey of nearly 250 NPA members

carried out in January shows that cash

flow is having a “critically negative

effect” on their ability to operate and

sustain a successful pharmacy business.

Nine in 10 said the current financial

situation is making it more difficult for

pharmacies to maintain a safe service

to patients. Many reported a drop in

staff morale.

The NPA presented the evidence to the

Department of Health and Social Care last

month. Chief executive Mark Lyonette said

this is to “help inform decisions about future

investment in the sector, and make the

case for improvements to the concessionary

pricing system.”

The results provide a troubling insight into

the harsh realities on the pharmacy frontline

right now. NPA members tell us they are

Representing you

really struggling with fi nances and above

all the rising cost of medicines. Our survey

confi rms that morale is suffering. This has

to change so that pharmacies can step up,

energised to meet the challenges laid out in

the NHS long-term plan.

The survey reveals:

• 54% of independent pharmacies are

“very worried about the survival” of

their business.

• 89% said that their total monthly

wholesaler bills have exceeded their NHS

payments for at least one of the last

six months.

• 64% of owners said that they had needed

to put a cash injection into the business to

maintain working capital.

• 31% said they had asked their wholesaler

for an extension to credit terms, in the last

12 months.

• 69% say that cash fl ow is currently having

a “critically negative effect” on their ability

to operate & sustain a successful pharmacy

business.

• 86% said that they had been adversely

affected, mentally or physically, by funding

cuts and escalating costs.

• 79% reported that the morale of their

pharmacy team was lower than a year ago.

The NPA recognises the limitations of this

survey – in particular the self-selecting nature

of the data pool. Nevertheless, it clearly

shows a high degree of distress for many

independents at this time.

We want Ministers and offi cials to have a

clear, unspun, picture of the situation. Just

when the NHS wants to make greater use of

community pharmacists’ skills, according to

the NHS Long term Plan, the current financial

situation is a powerful disincentive to

pharmacy owners to invest in NHS services.

 

PATIENT SAFETY

NPA Director of Pharmacy, Leyla

Hannbeck, is the Medication Safety

Offi cer (MSO) for all independent

community pharmacies in England with

fewer than 50 branches. Here are some

of the key findings from the January to

April report.

There was a 29% increase in patient

safety incidents reported in the first quarter

of 2019 compared to Quarter 4 of 2018.

The submission rate of reports almost

doubled in February compared to January

and March. The quality payments scheme

may have contributed to this as a higher

number of lookalike/sound-alike incidents

were reported in February.

Five per cent of incidents were due to

prescribing errors (up from 3% during

Q4 2018), most of which involved issues

such as:

• Incorrect nystatin dosages.

• Increasing patients’ current dose half

way through their treatment and this

change not being communicated to

pharmacies.

• Prescribing certain medicines knowing

that patients were allergic to the active

ingredients/excipients.

• Not following prescription requests made

by the pharmacy and/or patient directly.

 

The two most common error categories

reported continued to be dispensing a

wrong drug/medicine (33%) and dispensing

the wrong strength (21%). Wrong strength

incidents included a patient receiving

600mg gabapentin capsules instead of

100mg. The patient took the wrong

strength for fi ve days resulting in extreme

drowsiness. They were taken to hospital for

a full medical assessment.

Other wrong strength incidents

concerned 10, 20 and 30mg citalopram

tablets. The majority of the errors were

due to similar packaging leading to the

pharmacy segregating its stock as part of its

sharing and learning.

The majority of wrong formulation

incidents involved inhaler preparations being

dispensed incorrectly in place of dry powder,

breath actuated and/or nasal spray, and

vice-versa.

 

Example of wrong dose prescribing

An incident occurred where a patient received

a double dose of methylphenidate prolonged

release tablets due to wrong dosage

instructions on the dispensing label. The

prescription originally for Delmosart prolonged

release tablets 18mg and 36mg at a dosage

instruction of once daily was instead written

as ‘Take ONE tablet TWICE a day.’ This led the

patient to experience hallucinations due to

the long acting properties of Delmosart and

the patient was taken to hospital for further

medical assessment.

Work and environment factors continue

to be the main contributing factor, mainly

involving time pressures, distractions

and increased staff turnover. The latter

is resulting in an inappropriate skill mix

and more staff undergoing training which

ultimately leads to the pharmacist selfchecking

more prescriptions.

Although the error rate reduced by 1%

for ‘moderate harm’ compared to Quarter

4 of 2018, all the incidents involved giving

the wrong drug to patients who were

then hospitalised. One patient received

pravastatin tablets, instead of paroxetine

tablets, and took it for three weeks before

being hospitalised due to feeling ‘sick’ for

not taking the paroxetine tablets. A second

patient received amisulpride tablets 200mg

instead of amiodarone tablets 200mg,

and took it for four weeks resulting in

hospitalisation due to frequent arrhythmias.

 

Community pharmacy diary and

step-by-step guidance to completing

end of month submissions – dates you

need to remember

In a busy pharmacy environment it is easy to forget relevant

deadlines and dates. In addition, it is easy to forget the fi ner

details of endorsing prescriptions. The NPA ‘pharmacy diary’

resource will allow contractors to keep on top of important

dates and support them with completing their end of month

submission.

The community pharmacy diary will help you:

• Keep track of key deadlines and events.

• Remember to carry out important day-to-day and monthly tasks,

for example fi lling out the responsible pharmacist log and fridge

temperatures.

• Add reminders for your own key dates.

How to use the community pharmacy diary

• Each page represents one month of the year – from April 2019 to

March 2020.

• The two columns on the left show the day and day of month.

• The third column shows the key deadline or event.

• The last column shows ongoing daily and monthly tasks.

• For each day of the month there is space to add in your own key

dates – for example locally commissioned service claim deadline.

• The community pharmacy diary will continue to be updated as

and when new dates are published.

Three appendices have also been included within the

diary to help ensure you receive correct payment from

your end of month prescription submission:

• Appendix 1 – Checklist to ensure correct payment including top

tips for submission.

• Appendix 2 – Sorting your submission bundle.

• Appendix 3 – Completing the FP34C.

To access this resource go to

www.npa.co.uk/news-and-events/news-item/

community-pharmacy-diary

For further information, advice and support, please contact

the NPA Pharmacy Services team on 01727 891800 or email

pharmacyservices@npa.co.uk

NPA patient safety Incident Reporting Platform (IRP)

— user information

The NPA IRP, updated and launched end of October 2018, has

proven to be user-friendly. The completed form can be sent via email

helping to reduce administrative time as it can be kept for pharmacy

record keeping requirements.

Key points for using the IRP

• Patient identifi able information must not be included when

completing the report — this is especially important since the

implementation of the General Data Protection Regulation (GDPR)

on 25 May 2018.

• An option has been created for selecting ‘Look-alike sound-alike

(LASA) errors’ when a ‘wrong drug’ has been dispensed — be

aware if the ‘wrong strength’ or ‘wrong formulation’ has been

selected, it is not considered a LASA error.

• It is important that a detailed description of the patient safety

incident in the ‘describe what happened’ fi eld is provided (think

about the sequence of events and how the error was concluded)

— simply writing a brief description, for example, ‘wrong strength

given’ is not enough as it does not provide suffi cient information

for us to conduct a full and complete data analysis which is a key

part of the NPA’s role as the MSO for all community pharmacies in

England with fewer than 50 branches.

• Although the Quality Payments Scheme has ended, please

continue to use the MSO quarterly reports to demonstrate

evidence of sharing and learning.

 

Incentivising staff the

smart (and legal) way

Done right, employee incentives can

play a significant role in attracting

and retaining talented employees and

keeping them focused and engaged. As

well as making employees feel valued,

they can promote particular behaviours

or levels of performance that are

necessary for the organisation’s success.

However, incentives can also be

problematic; it can be easy to unwittingly

emphasise the wrong behaviours and there

are also legal pitfalls to avoid.

There are a number of things to keep in

mind to ensure an incentive scheme has the

desired effect.

 

Be fair

One sure-fire way to invite problems is to

apply incentives in a way that puts certain

people at a disadvantage. While you may

wish to set certain eligibility requirements,

it’s important that any conditions placed

on entitlement to rewards are not

discriminatory.

For example, if you’re incentivising

attendance, you need to ensure you don’t

discriminate against employees who are

absent due to pregnancy or genuine

health reasons. This will help to avoid

claims for possible discrimination at a time

when you’re trying to incentivise staff and

create a positive and motivating working

environment.

 

Be realistic

You should be realistic about what is viable

for your pharmacy. Staff perks don’t have

to break the bank. Recognition incentives,

such as simply thanking employees, a

personal note of praise or announcing an

accomplishment at a company meeting can

go a long way.

 

Think about the bigger picture

Ad-hoc incentives may only keep employees

motivated for so long. You should also

consider career progression opportunities

and be clear about the path to get there. For

many employees, this can count for a lot.

Ask yourself:

• Have you given employees the tools,

resources and opportunities to progress?

• Do employees understand their career

pathways?

• Are you investing in training and

development?

Not only can these measures improve

retention but working towards a clear

goal can be an effective way of enhancing

productivity.

 

Avoid creating implied terms

Allowing incentives to become expected

can mean that these intended perks actually

become implied terms – terms that aren’t set

out in a written contract but are understood

to exist through custom and practice.

For example, if you have paid employees

an annual bonus for many years, this may,

over time, have become a contractual term.

This can be difficult to establish and will be

up to an Employment Tribunal to decide;

however, it’s defi nitely something to be

mindful of.

For advice on setting up a fair and

motivating incentive scheme, contact

the NPA Employment Advisory

Service on 0330 123 0558 or email

employmentadvice@npa.co.uk

 

Safer community pharmacies in Northern

Ireland for staff and patients

The Northern Ireland Health and Social Care Board (HSCB)

announced a funding allocation of £1,500 per pharmacy in

January 2019 to facilitate a number of measures to help protect

pharmacists, pharmacy staff, and the public and pharmacy

premises from attacks. As part of this funding HSCB has asked

for procedures to be in place in the pharmacy covering a range

of areas to reduce the risks of aggressive, dangerous and

violent incidents in community pharmacy. Below are some key

resources to assist you in putting these measures in places to

enhance the security of your pharmacy staff and premises.

Written policies and procedures must be in place covering the

following areas:

 

Staff training

Ensure all staff are fully trained in understanding the security policies

and procedures in place. Training should be reviewed annually.

Training of the pharmacy team should cover areas such as:

• Types of security risk.

• How to operate security equipment – for example CCTV.

• Procedures for addressing a security breach in the pharmacy

and where to report crimes/attacks.

• Emergency call out procedure.

• Managing situations to prevent crimes taking place – for

example dealing with suspicious customers.

Ensure all members of your pharmacy team(s) are security-aware,

for example, understanding the need to refrain from discussing

security-sensitive matters such as closing-up procedures or who

is carrying shop/controlled drug (CD) cabinet keys in front of

customers/patients.

 

NPA resources:

• Training can be recorded in the “Staff training Log” from the NPA

“Supporting Members in Northern Ireland” pack.

• Training modules from the NPA CPD Hub on Body Language and

Communication Skills may also support staff knowledge.

 

Security assessment and security equipment

Complete the HSCB self-assessment (appendix 2) annually and in the

event of a security breach. Copies of the assessment should be kept in

the pharmacy and provided to HSCB when requested.

 

Review security

Ensure that basic security measures are in place and being

implemented. This includes ensuring doors are locked as appropriate,

premises and CD keys are kept secured, controlled stationery,

such as pharmacy vouchers, are stored securely, alarms are set

as required, key codes are not shared, ensure there is adequate

lighting at staff entrances and there are pass codes on doors. Ensure

security processes are reviewed regularly, especially in the event of

any incidents. Familiarise yourself with PSNI Safe Shop scheme for

preventing crime.

 

CCTV

Consider using CCTV to enhance staff safety in consultation rooms

whilst maintaining patient confi dentiality; for example, by ensuring

sound recording is not used and the camera is positioned in a way

that protects patient confi dentiality so that lip-reading cannot take

place. If CCTV is used in the consultation room, a notice must be

clearly displayed indicating that CCTV is in use. Patient consent

obtained for use of the CCTV should be documented. Ensure that the

system is operational, and procedures are in place to ensure images

captured are clear and stored securely in case a crime takes place.

 

Alarm system

Ensure an appropriate alarm system is fi tted. Some alarm systems

differentiate between the normal sounds made in your pharmacy and

those associated with a forced entry. When activated either by forced

entry when closed, or panic button when trading, the alarm can be

useful for calling for help and facilitating a response from the police.

- Ensure that the alarm is tested regularly and is fully functional.

- Ensure that the working alarm system in place covers all areas of the

pharmacy, particularly where medicines and confi dential patient

information is kept. Any keypad/alarm codes should be changed

regularly.

- Where you have an external monitoring contract in place for your

alarm system, ensure that it is current, and all staff are aware of the

relevant contact details and actions to take in the event of a crime

taking place.

 

Lone working procedure

There may be circumstances where it is not possible for staff to avoid

working on their own.

• Ellis Whittam has provided some guidance on working alone.

• Consider a chaperone when patients use the consultation area

 

Incident Reporting and Review

Incidents can be recorded on a template record form provided by Ellis

Whittam. If there is a security incident at your premises, members of

the pharmacy team should:

• Contact the police (and ambulance service in case of injuries).

• Try not to touch anything, or only touch minimally, to preserve

forensic evidence without contaminating it. Any spilt blood must

not be touched as there may be a risk of biological contamination

and it can damage valuable DNA evidence.

• Document full details of the event including the time, notifi ed

persons and what was observed, etc.

• Notify appropriate persons both within and outside the

organisation. This may include managers, area managers,

superintendent pharmacist, pharmacy owner, local Controlled

Drugs Accountable Offi cer (CDAO), Police CD Liaison Offi cer

(CDLO), and the local HSCB team, Pharmaceutical Society NI as

appropriate.

• Contact Victim Support Northern Ireland, an independent charity

which helps people affected by crime.

• Liaise with Pharmacist Advice and Support Services (PASS) who help

pharmacists and their families to manage stress.

 

Contact the NPA pharmacy services team on 01727 891 800 or

email pharmacyservices@npa.co.uk

 

How often should pharmacies expect to be visited? 

Pharmacies are currently inspected about once

every three years. As part of the inspection process,

pharmacies that are considered to have greater patient safety

concerns will be inspected more frequently.

 

How does this differ from contract monitoring visits by

the local Area Teams (England)? 

Contract monitoring visits are carried out by local

Area Teams (ATs) to ensure that pharmacies are

providing Essential and Advanced Services to the required

standards and are complying with their contractual NHS

requirements. Only those pharmacies that appear in NHS

England’s pharmaceutical lists are required to undergo

contract monitoring visits. Community Pharmacy Assurance

Framework (CPAF) resources are available on the NPA

website, which can be used to help prepare for a contract

monitoring visit. All registered pharmacy premises are subject

to GPhC inspections, irrespective of whether or not they have

an NHS contract. There is some overlap between the two

types of visits. Clinical Governance, an essential service that

is monitored by ATs, includes a risk management programme

while new GPhC inspections focus heavily on patient safety

and how the pharmacy is ensuring that risks to patients are

minimised.

 

Do the same principles, with their underpinning

standards, apply to all registered pharmacy

premises?

Yes. The five principles, with their underpinning

standards, apply to all registered pharmacy premises in

England, Scotland and Wales regardless of whether they are

a traditional pharmacy (with 40 core contractual hours), a 100

hour pharmacy or a distance-selling pharmacy. Compliance

with all of the standards across the five key principles must

be demonstrated.

 

I have all of my standard operating procedures in

place. Is there anything I can do to ensure that an

improvement action plan is not required?

Standard operating procedures (SOPs) are best practice

procedures that all of the pharmacy team should follow,

if it applies to them in their job role. Pharmacy teams should

be able to explain to the GPhC inspector why the SOP is in

place and provide examples or scenarios of how they follow

these. Having SOPs in place is not suffi cient — pharmacy

teams are required to demonstrate that these documents

are referred to, consistently followed, and reviewed as

appropriate.

In addition, examples of action where procedures have been

inadequate should be available.

 

What will the new inspection process be checking

for? 

The inspection will continue to confi rm that all

legal requirements are in place relating to, for

example, medicines and CD legislation, health and safety,

employment law, data protection, responsible pharmacist

(RP) regulations and SOPs as well as regulatory standards,

for example, staff training is complied with. There is also an

emphasis on the analysis of risk, particularly with respect to

patient safety.

 

What kind of evidence will GPhC inspectors be

looking for? 

There is no standard set of documents inspectors

are looking for. GPhC inspectors may wish to see

documented evidence that all the standards are being

complied with. They may observe interactions of the

pharmacy team with patients, and pose scenarios to check

that the team work in line with procedures. The NPA

pharmacy services toolkit ‘GPhC inspections: A show me,

tell me story’ - can be used to assist in preparing evidence

for inspectors, and confi rming that all the necessary SOPs,

records and logs are in place.

 

Are there any examples available of what evidence

GPhC inspectors will be looking for? 

The NPA pharmacy services toolkit ‘GPhC inspections:

‘A show me, tell me story,’ provides examples of

evidence that inspectors may be looking for. Pharmacy

owners/superintendent pharmacists may wish to add

additional examples of evidence to those listed within the

resources depending on the services they offer. Inspectors

are not intending to penalise minor issues that do not pose

a signifi cant risk to patient safety but are looking to improve

pharmacy services and standards within pharmacies. Using

cleaning logs and training matrices, for example, are not

legal requirements but are instead examples of evidence of a

proactive approach to improving standards. GPhC inspectors

may also wish to see evidence from more than one source.

 

These FAQs were correct at the time of publishing. To read more visit www.npa.co.uk

 

NPA PGD Training

PGDs enable pharmacists to supply and

administer specified medicines to predefined groups of patients without a

prescription.

 

Benefits to your business from

offering PGDs:

• Increase your footfall and your revenue

streams

• Drive repeat demand for your services

• Expand the range of services you can

offer

• Additional skill set for the pharmacist

• Improve the visibility of your business in

the local community profi le

• Develop your potential market

 

PGDs are good for your patients

and customers:

• Community pharmacies are highly

accessible

• Assurance of being vaccinated by a

trained, accredited and trusted front-line

healthcare professional

• Convenient – no appointment necessary

• Out of hours access due to extended

opening hours

 

Types of vaccination

training available

Please note that, although the new

requirement for face-to-face vaccination

training is now every three years to provide

the NHS flu service (except Scotland), all

pharmacists must ensure their competency to

administer parenteral vaccinations is assessed

and maintained, especially if they also provide

other NHS and/or private vaccination services.

In the event of a patient safety incident,

as part of the incident investigation, the

pharmacist’s vaccination skills competency

may be reviewed. Therefore, it is strongly

recommended that each pharmacist completes

a vaccination skills assessment each year to

self-check their own competency to provide

vaccination services, both NHS and private. For

more information, refer to the article entitled:

‘Implications for professional indemnity

regarding changes to the NHS fl u service

for 2018/19’ in the news section of the NPA

website.

 

Professional indemnity insurance

with NPA

Comparing insurance options and what is

suitable for your pharmacy business is often

confusing.

NPA Insurance offers you a holistic and

long-term approach to the risks faced by

pharmacists. Even when you are retired

and have stopped paying your Professional

Indemnity insurance we will still cover you for

claims made while the error occurred during

the time you had the policy.

 

Dates and locations of the NPA’s

half-day face-to-face vaccination

training events:

23rd June Edinburgh

30th June Liverpool

7th July Newcastle

14th July Manchester and St. Albans

 

For further information call 01727 800 402 or

go to www.npa.co.uk/pgd

If you require cover contact the NPA’s

membership team on 01727 795914.

 

 

 

 

 

 

 

Recommended

NPA Essential: October

NPA Essential: September




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