Monthly planner

 

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

 

FMD goes live on February 9

The official date for implementing the Falsified Medicines Directive

(9 Feb) is looming and while it’s unlikely that everybody will be

ready the NPA advises that members should be taking the right

steps than to make rash steps in order to meet the deadline. This

would include signing up to long term PMR contracts without

first checking exit clauses, or changing workflows before staff are

properly trained in the new process. However, it is important for

every pharmacy to show that they are making progress.

It is understood there will be significant quantities of medicines in

the supply chain that do not carry the new safety features, after

February 9, but it can still be wholesaled and dispensed.

Pharmacies are expected to have clear standard operating

procedures in place to empower individuals to make judgement

calls they could later justify, rather than disrupt supply to patients.

General Pharmaceutical Council inspectors will not focus unduly

on any single issue and will assess the pharmacy in the round

considering the health, safety and wellbeing of patients and the

public.

To support members the NPA has launched updated standard

operating procedures (SOPs). There are also member-only rates for

a standalone FMD solution with business partners FMD-IT.

Go to www.npa.co.uk/fmd for more information. UK WIDE

 

Antiviral medicines can be prescribed on NHS

prescriptions for treatment of influenza during the

2018/19 season

The Department of Health & Social Care (DHSC) has issued a Central

Medical Officer (CMO) alert, “Influenza Season 2017/18: Use of

Antiviral Medicines”, stating that antiviral medicines can now

be prescribed by GPs and other primary care prescribers on NHS

prescriptions. This recommendation has been made in response

to surveillance data showing an increase in influenza cases and is

in-line with National Institute for Health and Care Excellence (NICE)

guidance for the treatment and prophylaxis of influenza. The “Public

Health England guidance on use of antiviral agents for the treatment

and prophylaxis of seasonal influenza” can be referred to for further

information regarding patient eligibility for receiving oseltamivir

(Tamiflu®) or zanamivir (Relenza®) on the NHS. This includes patients

in clinical at-risk groups or those at risk of complications or severe

illness from untreated influenza.

 

Advice for pharmacists and pharmacy teams

• Read the CMO alert for details on prescribing antiviral medicines

for specific age groups and those unable to swallow capsules.

• Ensure antiviral prescriptions are dispensed promptly to avoid

delaying treatment.

• Ensure FP10 prescriptions are endorsed with ‘SLS’ from the

prescriber in order for it to be passed for payment – antiviral

prescriptions need to be in accordance with Schedule 2 (the

Selected List Scheme (SLS)) to the National Health Service

(General Medical Services Contracts) (Prescription of drugs etc)

Regulations 2004).

• Only order antiviral medicines as needed to fulfil prescriptions – do

not over order.

• Ensure appropriate infection control measures are in place – refer

to the NPA standards operating procedures (SOPs) for infection

control and hand hygiene.

For further information on this or any other query, please contact

the NPA Pharmacy Services team on 01727 891 800 or email

pharmacyservices@npa.co.uk.

 

 

NHS England published its long term plan last month in order to unlock £20bn of additional promised funding from the government. There were few references to community pharmacy but there was a lot about community based services, medicines, workforce, urgent care and prevention, which are all areas inherently in our sector’s sphere of interest.

The document stated an aspiration to “make greater use of community pharmacists’ skills and opportunities to engage patients,” and “exploring further efficiencies [in community pharmacy], through reform of reimbursement and wider supply arrangements.”

NPA chief executive Mark Lyonette said that people access NHS care in community pharmacies more frequently than they do any other part of the health service so it was right that the plan states an aim to make more use of community pharmacies to engage with patients.

“The plan clearly signals that the NHS wants pharmacists to support the prevention agenda and urgent care, and provide part of the workforce solution in primary care.

“The guarantee of proportionately greater investment in community based care is common sense, because care closer to home is both more convenient for patients and more cost effective than sending people to hospital.

“We are encouraged that NHS England will require measurable goals to be set for narrowing health inequalities, as a condition for receiving Long Term Plan funding for new schemes. One of the acid tests the

NPA has set for the plan was that the poorest patients and communities must benefit from the new investment.”

Another NPA test was that the NHS should use technology to achieve efficiencies but without losing the human touch in health care, characterised by advice, support and treatment delivered face to face. The plan duly recognises that “inperson” services will always be there to do what computers can’t and provide personal

contact for those who want or need it. Overall, the NHS long term plan makes a common-sense case for greater investment in community based care, without going into detail on the ‘what and how’. A large

part of its purpose is to provide a framework for local planning over the next five years and beyond.

Mark said: “The NHS is planning for the next decade but many pharmacies are managing only month-by-month, because of overwhelming pressures on their funding and rising medicines costs.

A new, multi-year, funding settlement for community pharmacies in England is needed, to give pharmacy owners the confidence to invest in services that will meet the priorities described in the Plan.

He added: The NPA looks forward to being involved in the ongoing conversations about how community pharmacy can make its full contribution to meeting the challenges outlined in the plan.”

 

BUSINESS PRACTICE

Being careful about data protection.

It’s not uncommon to see at least one message every day from a company or website highlighting their data

protection policies.

Since the General Data Protection Regulation (GDPR) came into force on May 25, 2018, to provide greater regulation and enforcement relating to data protection there’s been a much greater emphasis to take care of peoples’ information.

In December however, one of the biggest independent pharmacy chains in the country, had to apologise after inadvertently leaking sensitive employee information.

The details of more than 24,000 staff and locum workers were accidentally included in an email that included names, addresses, phone and payroll numbers and email addresses.

The company did however stress that no patient information formed part of the data, but the incident gave the whole sector a wake-up call.

 

Consequences of breaching GDPR

The Information Commissioner’s Office (ICO) is the UK’s independent authority set up to enforce the GDPR and they have the power to ensure that both individuals and organisations comply with data protection laws.

One of the ICO’s primary functions is to uphold data protection rights in the best interests of the public. Under the GDPR, the ICO will have greater regulatory powers.

In previous years, the ICO has brought media attention to organisations that have breached data protection regulations.

Naming and shaming through the media is one way the ICO display their regulatory powers. The administrative fines imposed on an organisation if they fail to comply with the GDPR requirements will be dependent on the circumstances.

The ICO’s decision of whether to impose a fine, and the amount, will be assessed on a case-by-case basis. Fines can apply to both data controllers as well as data processors.

The ICO has outlined a fine system as summarised below:

• Fines of up to 4% of an

organisation’s annual global turnover or

€20 million (whichever is greater) can

be imposed for ‘serious’ infringements –

including noncompliance of orders from

the ICO and failure to follow the basic

principles of the GDPR.

• Fines of up to 2% of an

organisation’s annual global turnover or

€10 million (whichever is greater) can be

imposed for ‘less serious’ infringements

– including failure to notify a data breach

and failure to follow data controller or

processor obligations.

 

Changes to Data Breaches

Data breaches are one of the areas of the GDPR which the ICO can investigate and enforce. Changes to data breaches are discussed next. Changes to data breaches Data breaches will be strictly regulated under the GDPR – there will be a duty on all organisations to report certain types of data breaches to the ICO, as well as to the affected individual(s), in certain circumstances.

The GDPR outlines that a ‘data breach’ covers ‘any information relating to an www.npa.co.uk ICP February 2019 45 identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person’.

Failure to notify a data breach under the GDPR can result in substantial fines and potentially result in legal repercussions for organisations. You need to be aware that a data breach is not just about the loss/theft of personal data.

Some examples of data breaches in pharmacy include:

• Sending medicines with patient details to

an incorrect recipient.

• Altering patient information without

consent.

• Unauthorised access to patient

information from a PMR system.

 

Clear robust organisational policies and procedures should be in place within the pharmacy. You need to be aware of the process for reporting a breach – each personal data breach must be assessed on a case-by-case basis by the organisation.

The ICO must be notified where the data breach is likely to risk the freedoms and rights of an individual – such breaches may cause a significant negative effect if not addressed. In certain data breaches, other relevant organisations may need to be notified, for example, the local NHS authority, the General Pharmaceutical Council/Pharmaceutical Society of Northern Ireland or the police.

Examples of data breaches which must be reported include:

• Damage to reputation.

• Discrimination.

• Financial loss.

• Loss of confidentiality.

 

For more information on how to become GDPR compliant go to www.npa.co.uk/general-dataprotection-regulation-gdpr/

 

 

Tapentadol: seizure and serotonin syndrome risk when taken with other medicines

The MHRA drug safety update on tapentadol, which may increase seizure risk and cause serotonin syndrome when coadministered with other medicines.

The Medicines & Healthcare products Regulatory Agency (MHRA) has published a drug safety update highlighting:

The potential risks of seizures when tapentadol (PALEXIA®) is

co-administered with medicines which lower seizure threshold,

for example, antidepressants (including selective serotonin

norepinephrine reuptake inhibitors (SNRIs), serotonin reuptake

inhibitors (SSRIs) and tricyclic antidepressants (TCAs)) and

antipsychotics. 

 

• Tapentadol (PALEXIA®), like all opioid medicines can induce

seizures, therefore, it should be prescribed cautiously in patients

with a history of epilepsy or seizure disorders.

Reports of serotonin syndrome when tapentadol is co-administered

with serotoninergic antidepressants (including SNRIs, SSRIs and

TCAs) and antipsychotics.

• Serotonin syndrome include, hypertonia, inducible/ocular clonus

with agitation or sweating, increase of body temperature above

38C, and tremor.

• Withdrawing serotoninergic medicines with supportive

symptomatic care usually allows a quick improvement in serotonin

syndrome – abrupt cessation can induce withdrawal symptoms.

The Summary of Product Characteristics (SPCs) and Patient

Information Leaflets (PILs) for tapentadol now include strengthened

warnings on seizure risk and the above interactions.

• Advice has also been included to avoid monoamine oxidase inhibitors

(MOIs) as there is a potential for hypertensive crisis to occur.

 

Reporting drug interactions

The MHRA is reminding healthcare professionals to report all

suspected adverse drug interactions (ADRs) to the Yellow Card

Scheme – this is via the Yellow Card website or Yellow Card App

available on iOS devicesand Android devices.

• The Yellow Card App has been updated with an easy login,

increased stability, new features, and questions on medicines in

pregnancy.

 

NPA advice for pharmacists

• Ensure any interactions flagged with tapentadol are queried with

the patient’s prescriber.

• Highlight serotonin syndrome symptoms to patients so they know

what to look out for and what steps to take.

• Make necessary notes on the patient’s medication record.

• Report suspected ADRs to the Yellow Card Scheme.

For further information on this or any other query, please

contact the NPA Pharmacy Services team on 01727 891 800 or

email pharmacyservices@npa.co.uk.

 

The MHRA has issued new information about the potential

risk of fatal and severe burns with paraffin-based and

paraffin-free emollients

The Medicines and Healthcare products Regulatory Authority

(MHRA) has released new information about the potential risk of

fatal and severe burns with paraffin-based (regardless of paraffin

concentration) and paraffin-free emollients due to an increasing

number of fire-associated incidents. The initial MHRA update,

published in 2016, provided guidance on supporting patients and

their carers when supplying paraffin-based emollients; however,

this has now been extended to paraffin-free emollients as well.

 

MHRA advice for pharmacists and pharmacy teams

when selling/supplying emollients

• There is a fire hazard with all paraffin-based

emollients, paraffin-free emollients and

other skin-based products that are

applied to large areas of the body

or repeatedly over several days

in large volumes, irrespective of

paraffin concentration.

• Emollients can be soaked into bedding

and clothing which has been in contact

with it, becoming a fire hazard due to buildup

of residue.

• Washing clothes/fabric at high temperatures may help to reduce

build-up of emollient residue but not completely remove it.

• Patients must not smoke or go near naked flames if they are using

paraffin-based or paraffin-free emollients due to the associated

risk of clothing/fabric igniting rapidly when in contact with open/

naked flames.

• All emollient products will include a visual warning on the outer

packaging to indicate the risk of fire hazard.

• To report any fire-associated incidents with emollients or other

skin-based products to the Yellow Card Scheme.

 

The National Patient Safety Alert (NPSA) published a suite

of resources in 2007 on “Fire hazard with paraffin-based skin

products” which included information for healthcare staff, a

poster and patient leaflet. In addition, the “Medicines Safety

Matters Community Pharmacy Vol 2 Issue 2” in Northern Ireland

and the Yellow Card Centre Scotland sets out guidance for

pharmacy contractors when supplying paraffin-based emollients to

patients.

The NPA standard operating procedure on “Supplying paraffinbased

skin products,” is available to support pharmacy teams –

this will be updated in 2019 to reflect these changes.

For further information on this or any other query, please

contact the NPA Pharmacy Services team on 01727 891 800 or

email pharmacyservices@npa.co.uk.

 

The government has announced it

will introduce a statutory Code of

Practice on sexual harassment

The aim is to make clear

the action employers need

to take to comply with their

legal obligations

 

What is behind the government’s decision?

All the high-profile and public cases and the prevalence of the #MeToo movement have shown the scale and magnitude of sexual harassment in our workforces.

The Women & Equalities Committee published a report in July 2018, which called upon the government to establish a mandatory duty on employers to protect employees from sexual harassment in the workplace. They believed that a breach of this duty should be enforceable by the Equality and Human Rights Commission

(EHRC) with substantial financial penalties. The Committee also suggested that there should be a statutory code of practice on sexual harassment which should lay down what employers are required to do in order to fulfil this duty.

 

How has the government reacted?

The government has decided to work with the EHRC and introduce a Code of Practice. However, they have stopped short of creating a duty on employers to protect workers from victimization or harassment and they have also not decided to bring in tougher sanctions on those employers with poor practices.

As part of their 12 point plan, the government will consult on non-disclosure agreements and third party harassment. The government has announced it will introduce a statutory Code of Practice on sexual harassment.

They will also consult on whether additional protection is needed for volunteers and interns and whether to extend the time limit for submitting claims to Employment Tribunals. The government will also consider the evidence base for a legal duty imposed on employers to stop employees from being harassed. The government has also agreed to gather data on the pervasiveness of workplace sexual harassment.

 

Ellis Whittam’s top tips for employers:

• Develop and promote a working

environment where employees are

encouraged to report any cases of sexual

harassment.

• Have all the right HR policies and

procedures in place. Seek legal advice

when drafting your codes of conduct,

grievance procedure, bullying and

harassment procedure and all other

appropriate HR policies.

• Train your managers so they understand

how all internal policies and procedures

work.

• Take allegations of sexual harassment

seriously and act when issues arise.

 

If you would like to discuss this further,

call the NPA Employment Law Advisory

Service Team on 0330 123 0558 or email

employmentadvice@npa.co.uk.

 

 

NPA Malaria prophylaxis information updated

An updated version of the NPA Malaria prophylaxis information leaflet, which expires 30 June 2019, has been

produced by the NPA Pharmacy Services team. The leaflet is available to download from the Travel health section of the NPA website.

The NPA Travel Health website is currently being updated; to provide travellers with information and recommendations on malaria prophylaxis. Further information on malaria prophylaxis can also be found in the PHE document, “HYPERLINK “www.gov.uk/government/publications/malaria-prevention-guidelines-fortravellers-from-the-uk” Malaria prevention guidelines for travellers from the UK: 2017."

 

Royal Mail delivery service

The NPA has a partnership with the Royal Mail for a dropoff

service for end of month prescriptions. This replaces the

previous collection service and will require you to understand

the new process and sign up using an online form on the NPA

website.

Registration for this service cannot be taken over the phone

and is only available for members. Pharmacies must register by

the 22nd of the month to access the service at the beginning of

the following month. Registrations past this date will not go live

until the month following your next return. Go to www.npa.co.uk/prescriptiondropoffservice.

 

NEWS IN BRIEF

Expressions of interest for ORIEL 2020-2021 are now open

Pharmacies are invited for their expressions of interest for

ORIEL 2020-2021.

Health Education England is inviting pharmacies to be part of the

year 3 centralised pharmacy pre-registration recruitment for student

intake 2020.

The medical system ORIEL is used as a template, where applicants

will be able to apply, book interview slots and be sent offers/

relevant communications via one system. Please note that this is not

a mandatory process. You may register to recruit via the national

scheme for the 2019 for pre-registration pharmacists commencing

training in summer 2020.

In order to register you are required to:

• Confirm your participation by reading and agreeing to the

“Confirmation of Participation” terms and agreeing to comply

with Health Education England’s Quality Framework.

• Provide us with relevant programme information to enable us to

advertise your places on Oriel.

 

Please complete the Programme Information Form and

Confirmation of Participation by going to www.lasepharmacy.hee.

nhs.uk/national-recruitment/employer-registration-and-programmeinformation/.

More detail about how the Scheme works is available in the

Employer Guidance Handbook also found by going to the website

above. It contains a step-by-step guide to completing your employer

programme submission, a recruitment timeline, regional contact

support details and a frequently asked question section.

If you decide to recruit via the National Scheme, we strongly

advise you to read the Employer Guidance Handbook before

you begin completing the online form with your programme

information. The deadline to register and submit your information is

close of play 1st March 2019.

More advice can be found the NPA website - www.npa.co.uk/training/pre-registration-pharmacist-training-programme.

 

 

Your FMD questions answered

A selection of questions taken from the

UK FMD Working Group for Community

Pharmacy website. For more FMD related

guidance go to fmdsource.co.uk and

www.npa.co.uk/fmd. Follow the NPA: @NPA1921

 

 

Will I have to link scans/UIs to patient records on my

PMR system? 

There is not a specific requirement within the Delegated

Regulation to record or link unique identifiers to

particular patients. No patient-specific information will be

captured or stored within the repositories system, including

the UK hub.

 

How long will it take to authenticate a medicine? 

The maximum response time of an individual

repository, such as the UK hub, is 300 milliseconds. If

the system has to check repositories in other Member States,

each stage will take a maximum of 300 milliseconds.

 

Who owns the data held in the system? 

Manufacturers, wholesalers and pharmacists only have

ownership of, and access to, the data they generate

when they interact with the UK hub. This means that

pharmacists own the data that they create and no one else

can access or use it, except the MHRA and DHSC for auditing

and investigation purposes.

 

Who has access to the data? 

The MHRA or DHSC can request access to specific data

from the UK hub for supervisory purposes or when

investigating potential incidents of falsification.

 

Can I still sell data to IMS? 

Pharmacy contractors will be able to sell dispensing

data generated by their PMR systems in the normal

way, but it is likely that commercial restrictions will be placed

on the use of individual pack data derived from the FMD

system, in line with the data ownership rules outlined above.

 

Will manufacturers and wholesalers be able to see

data on products I have dispensed? 

No. The Delegated Regulation is clear that all parties

that are connected to the repositories system, including

manufacturers, wholesalers and pharmacies, have sole

responsibility, ownership and access to any data that they

generate. This data is not shared with any other parties, other

than DHSC/MHRA, where necessary.

The only exception is the status (“active”/“inactive”) of

products’ UIs, which is available to any party that has a

relevant pack in their possession.

The UK hub will maintain an audit trail of when and where

product information was uploaded and accessed, and

where and when UIs are decommissioned. This data cannot

be shared with other parties, other than with the express

written permission of the data owner. The only exception is

when there is an investigation into an incident of potential

falsification.

 

I have a Wholesale Dealer’s Authorisation. What does

this mean for me? 

Not only will you have to abide by the regulations

for pharmacies, but you will need to abide by the

regulations for wholesalers as well. This will involve

numerous different steps and we recommend that you read

the Delegated Regulation [2016/161] to ensure that you will

be familiar with the rules you will have to work to.

 

Do I need to verify medicines received from the

wholesaler/manufacturer? 

There is no requirement to do this, but you can if you

wish.

 

Will my wholesaler decommission for me or can I

decommission stock when I receive the stock from

the wholesaler?

No. Decommissioning within pharmacies has to occur

“at the time of supplying it to the public”. This means

that decommissioning needs to occur in the process as close

to the patient as possible. Decommissioning when stock

is received would not fulfil this criterion. In addition once

decommissioned, stock can only be re-commissioned within

10 days. This would mean that anything decommissioned

more than 10 days ago could not be returned to the

wholesaler.

Wholesalers can decommission products for a range of

healthcare professionals, public service bodies and other

organisations that use or supply medicines as an occasional

part of their work, but community and hospital pharmacies

are specifically excluded from this.

 

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

 

 

 

The NPA has produced two new

resources to support members in

Northern Ireland and Scotland

Both resources cover the similar themes

but the guidance within them is unique

to the operating environment and

challenges faced in each two nations.

The themes are:

• meeting contractual arrangements

• maximising service income and growing

your business

• you and your team.

 

NPA Supporting Members in Northern Ireland considers how the wider health service in Northern Ireland, including community pharmacy, remains in a period of uncertainty with following the collapse of the NI government. However, the introduction of the Transforming Your Care agenda in 2013 heralded proposals to radically change how health and social care services will be delivered to meet the changing needs of the population.

Community pharmacy has a significant role to play in this transformation as recognised by the then Health Minister Michelle O’Neill, in 2017. when she endorsed the development of a new framework to fully realise the potential of pharmacy services to support better health outcomes from medicines and prevent illness.

The NPA is aware of the serious pressures that our members in Northern Ireland are currently operating under, and we know that in the absence of significant funding members will need to continue to operate their businesses ever more efficiently.

However, with the experience of our colleagues elsewhere in the UK, we need to also consider the eventual changes to how services are delivered that will undoubtedly bring more challenges. Balancing the need to operate efficiently and to support your teams through these changing times the NPA is delighted to provide NPA members in Northern Ireland with this Supporting Members in Northern Ireland resource. It is our intention that this becomes a working toolkit and will be added and updated as the need arises.

Supporting Excellence for Scottish NPA Members looks at how the Strategy for Pharmaceutical Care - Achieving Excellence, published in August 2017, aims to transform all areas of pharmacy to increase capacity and offer person-centred care with improved integrated pharmacy services.

The 2018 General Medical Services Contract has as a priority to establish a sustainable NHS pharmacotherapy service, which includes pharmacist and pharmacy technician support to the patients of every GP practice. Community pharmacy services for minor ailments, public health, serial dispensing and medication review, monitoring, titration, and feedback are all included in the new GP contract as part of an integrated pharmacotherapy service.

Quality Improvement techniques are now a key focus for community pharmacy in Scotland and will exert a greater influence on funding agreements moving forward. Significant changes to our previous ways of working in community pharmacy will undoubtedly bring challenges, however, the value of medicine expertise that pharmacists have, and the advantages of having that expertise, near and convenient to patients in community pharmacies, is being recognised by the NHS.

The development and integration of Scottish community pharmacy services will enable our pharmacy teams to fulfil their potential in providing safe, efficient and patient centred NHS care.

Both titles are the basis of a working toolkit and will be added to and updated as the need arises. Hard copies will be distributed on member visits and through events. USB sticks with electronic copies, including additional templates, will also be available.