www.sps.nhs.uk

MEDICINES USE AND SAFETY WEBINAR

7 FEBRUARY 2019

• Welcome to the MUS Webinar – on FMD in Community Health

Services (CHS) organisations

• The webinar itself will start at 1pm. Shortly before 1pm the SPS webinar host

will be doing sound checks so bear with us if you hear this more than once!

• To join the audio call 0203 478 5289 Access code: 147 708 848.

• The webinar will be recorded and both recording and slide set will be

available on the SPS website – under Networks (you need to be logged onto

the SPS site to access the recording)

• If you want to make a comment or ask a question – please use the “chat”

function (you need to choose to direct your question to “All Participants” from

the drop down box)

• The presenters and Subject Matter Experts (SMEs) will answer questions at

the end of the presentation

9 January 2019 1

www.sps.nhs.uk 2

Upcoming MUS Events

WEBINARS:

13 February Update on RMOCs with Justine Scanlon

13 March Safety of Injectable Medicines with Virginia Aguado

and Sue Keeling

10 April End of Life Care with Sara Bernstein

FACE TO FACE EVENTS

14 March MUSN Meeting - Tackling medicines safety

challenges in transfer of care and adherence

14 May Community Health Services Pharmacists (CHS)

Contact LNWH-tr.MUS-SpecialistPharmacyServices@nhs.net

to join networks and receive mailings

www.sps.nhs.uk 3

Today’s Webinar

Presentations

Overview

Richard Bateman - Regional Pharmacy Procurement Specialist

What’s happening in our organisation

Arti Punn - Birmingham Community Healthcare NHS Foundation Trust

Tessa Seward - Dorset Healthcare University NHS Foundation Trust

Question Time

Subject Matter Experts

Pascal Loiseau & Martha Waters - NHS Digital

Brian Long - SecurMed UK

www.sps.nhs.uk www.sps.nhs.uk

The first stop

for professional

medicines advice

Falsified Medicines Directive – Challenges for implementation in CHS

Richard Bateman Regional Pharmacy Procurement Pharmacist –

South East Coast

www.sps.nhs.uk

FMD Implementation

• SecurMed – UK Medicines Verification System (national repository)

• Link to EU central system

• Verification and decommissioning

• Need to decommission on supply

• “as close as possible to issue to patient”

• In house Pharmacy – dispensed items, stock items, 3rd party supply (WDL)

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FMD Implementation

• Systems available - functionality

• Integration and data

• System selection and SecurMed registration

• 3rd party / no centralised pharmacy – options?

• Dispensed items – by supplier?

• NB – returns – 10 day limit

• Stock items – supplier cannot do

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Options?

• Central delivery – decommission – supply

• Decommission at each point of use (who, training IT, pack compliance, error messages)

• Staff visit / based at supplier to decommission?

• Regulatory – MHRA, GPhC, CQC?

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Options

• Need for a pragmatic approach – what is achievable now with reasonable resource implications

• Patient safety underpins the reasons for FMD

• Risk Register

• Review options going forward – systems development

• Monitor regulatory approach and outcomes

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Falsified Medicines

Directive NHS Birmingham Community Healthcare Trust (BCHC)

Arti Punn

BCHC at a glance

A Final Consultation on

implementing ‘safety features’

under FMD states… Article 23 provides flexibility in the supply chain about where verification and decommissioning must take place. It allows Member States to choose whether it is best to require wholesalers to verify and decommission a medicinal product before supplying to certain Article 23 providers, thereby exempting those which fall under that category from the obligation to do so.

Article 23 providers who can be exempted as:

persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy;

veterinarians and retailers of veterinary medicinal products;

dental practitioners;

optometrists and opticians;

paramedics and emergency medical practitioners;

armed forces, police and other governmental institutions maintaining stocks of

medicinal products for the purposes of civil protection and disaster control;

universities and other higher education establishments using medicinal

products for the purposes of research and education, with the exceptions of healthcare institutions;

prisons;

schools;

hospices; and

nursing homes.

Complications (1) Immunisations & Vaccine Service

3 separate base sites to receive the vaccine orders

On average the following numbers of vaccines per week: Flu 1000-3000 per base

Senior school programme either hpv or meningitis /Revaxis between 500-2500 per week per base

Issue

Large quantities received and to be kept within the cold chain supply – risk jeopardising this

Small working spaces

Inadequate resources to verify & decommission each vaccine

Have been told aggregate coding will not be utilised

BCHC Resolution

Contacted NHS digital who advised to contact the suppliers for clarification of responsibility

Encouraged that the “end users” were listed in the exemption list

Contacted Immform and Movianto to query above – initial response was ‘No’ as Imms&Vacc fall into BCHC – a healthcare institution

We are waiting for a final line from Immform

Contingency plan: FMD software and scanners to be purchased for each vaccine base. Work processes to be analysed regarding point of verification/decommission

(2) Dental Division

Dental clinics around the WM , includes Birmingham Dental Hospital

POMs and non-POMs ordered via Dental suppliers Henry Schien released a statement they would continue to decommission on behalf of dental clinics as per Article 23 exemption list

Issue

Large quantities of stock ordered to BDH from HS

BDH falls into the BCHC dental division, therefore under a listed healthcare institution

Ethically – HS would not be able to decommission on behalf of any of our clinics or BDH

SLA from other hospitals supplying emergency medicines have been pulled as one healthcare institution cannot verify & decommission for another, unless process are in place

BCHC Resolution

Contacted NHS digital who advised to contact the suppliers for clarification of responsibility

Encouraged that the “end users” were listed in the exemption list

Contacted HS to query above – response ‘No’ as Dental division fall into BCHC – a healthcare institution

Workplan: Pull all POMs for dental division in house for FMD compliance then transport out.

How this will affect BCHC

Resources and sources them

Stringently review of BCHC work processes

Review available funding

Review current contracts with other hospitals

Introduce medicine processes to health care staff not

routinely used to dealing with them

Review cold chain supply

Review and take over Dental POM orders

Advice to other trusts Ask the relevant questions

Not to assume responsibility is all yours as the government is

not aware of the intricate processes in hospitals regarding

medicine supply

Good luck!

Implementing FMD

Dorset HealthCare – A Community and Mental

Health Trust

Tessa Seward

Pharmacy Operations Manager

Dorset HealthCare

• Responsible for all mental health and many physical health services in Dorset including

community health services

• Provides healthcare at over 300 sites as well as peoples’ homes

• Inpatient units – Mental Health

Poole - St Ann’s Hospital - 8 wards

Poole - Alumhurst Road and Alderney – 6 units

West Dorset – 3 units

• 9 Community Hospitals throughout Dorset

Inpatient wards, Day surgery, MIUs, Outpatient clinics

• Medication Supply

All Bournemouth and Poole - St Ann’s Pharmacy

Rest of County – outsourced to Dorset County Hospital (WDA)

Challenges • Implementation of ePMA – risk waiting for integrated

solution or implement short term fix?

• How many sites should we register?

• Different processes for medication supply

Process Mapping – when and who to decommission ?

• St Ann’s

verify and decommission on receipt .

• DCH ???? - Separate legal entity

Named patient meds - responsibility lies with Supplier

Stock – responsibilty lies with receiving Trust

• Childhood Immunisation, (by our school nurses) – Does

article 23 apply?

Phased Approach

• Start at St Ann’s with simple short term solution

Bournemouth

and Poole (Units

served by St

Ann’s pharmacy)

Rest of Dorset

(Units served by

DCH pharmacy)

Named

Patient

Medications

One Stop,

Discharge

medications

Medications

Verified and

Decommissioned

upon receipt from

wholesaler

Medications

Verified and

Decommissioned

upon dispensing at

DCH

Stock

Medications

Medications

Verified and

Decommissioned

upon receipt from

wholesaler

Solution in

development with

DCH

Solutions –our responsibilities

• Supplied by St Ann’s – verify and decommission on receipt

• Supplied by DCH Decommission on receipt at each unit by nurses?

Preferred Option - Decommission by payrolled member of our staff on DCH site . Check with MHRA whether possible Need agreement from DCH Then register an end user location with SecurMed

- either Trust HQ or DCH.

• Childhood Immunisation If article 23 does not apply - Nurses decommission on school site

register school nurse bases as end user location with SecurMed

If article 23 does apply: DCH /wholesaler to decommission

Check with MHRA whether article 23 applies

Bournemouth

and Poole (Units

served by St

Ann’s pharmacy)

Rest of Dorset

(Units served by

DCH pharmacy)

Named

Patient

Medications

One Stop,

Discharge

medications

Medications

Verified and

Decommissioned

upon receipt from

wholesaler

Medications

Verified and

Decommissioned

upon dispensing at

DCH

Stock

Medications

Medications

Verified and

Decommissioned

upon receipt from

wholesaler

Solution in

development with

DCH

Solution – Software

• Interim : Falsified Medicines App – FOC for first year. 2 cordless barcode scanners Zebra DS 2278

• Thereafter ePMA integrated solution

SOPs

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Questions?

The answers are the opinions of the panel, but we

are aware that decisions are still pending that may

change things in the future

www.sps.nhs.uk

Question 1

There have been some questions about what constitutes a healthcare “institution”. This is important for school immunisation teams as to my mind they work for a healthcare institution, the fact that the medicines they administer in a school rather than a health centre is immaterial, and they too would be subject to FMD. Same applies to a community nurse immunising a housebound patient on behalf of a GP. I think some are seeking to define a healthcare institution as a healthcare building rather than an organisation which delivers health care services, which I don’t think is in keeping with the spirit of FMD regulations, any clarity on this point would be very welcome.

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Question 2

We are commissioned by 2 local CCGs and the Local Authority to provide Community Services to patients. We have the following services – are any of them exempt from FMD under Article 23?

· Imms & Vaccs Team,

· Sexual Health Service

· Community Nursing Teams

· Podiatric Day Surgery Unit

· MSK Service

· Dermatology Service

· TB Screening service

· Walk in Centre

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Question 3

Is there an agreed definition of a healthcare institution to assist with the interpretation of the Article 23 exemption?

We are a community interest company providing primary care services in the community including out of hours/urgent care and sexual health, some locations provide POM medication directly to patients which has been sourced from a 3rd party wholesaler.

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Article 23 UK Guidance a) persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy;

This is a catch all for organisations who may not be explicitly listed. Critically it is clear that they are neither a healthcare institution nor pharmacy.

b) veterinarians and retailers of veterinary medicinal products;

For all products leaving the human medicines supply chain.

c) dental practitioners; All dental practices.

d) optometrists and opticians; All optometrists and opticians.

e) paramedics and emergency medical practitioners;

NHS Employed Paramedics and emergency medical practitioners working for NHS ambulance trust/service receive their medicines supply via their employing organisation acting as a healthcare institution. This will be via a managed supply process through an ambulance station or remote holding facility acting as a collection and supply point direct to paramedics. The NHS Ambulance trust/service is a healthcare institution and will be required to verify and decommission its medicines as required under the FMD regulations. When individual paramedics or emergency medical practitioners are not providing services directly for an NHS ambulance trust/service their medicines supplier is able to decommission medicines for these practitioners.

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Article 23 UK Guidance

f) armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control;

All MOD sites.

g) universities and other higher education establishments using medicinal products for the purposes of research and education, with the exceptions of healthcare institutions;

All universities and other higher education establishments but limited to medicinal products for the purposes of research and education. As set out in the Delegated Regulation it does not apply to healthcare institutions i.e. a university hospital or GP surgery.

h) prisons;

All prisons and other custodial ‘secure environments’, for example - immigration removal centre, secure training centres and secure children’s homes. However, a pharmacy operating in a prison or other ‘secure environments’ would need to decommission themselves.

i) schools; Education establishments.

j) Hospices; and Institutions whose primary function is the provision of palliative care.

k) nursing homes

Nursing and care home providing residential care.

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Questions 4 - 7

4. If a pack contains 10 vaccines (e.g. Prevenar; Men B) will there be one barcode to decommission all 10 vaccines at the same time?

5. Will large outers of vaccines have one barcode to decommission the contents?

6. For mass vaccination campaigns (school immunisation team) can we decommission when vaccines leave base? Or is it best to decommission when they enter the service?

7. Can all items be decommissioned on receipt into the service?

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Question 8

What happens with over labelled stock received from pharmacy suppliers?

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Question Answer

If a manufacturer over-labels the original licensed

pack, can they decommission on behalf of a hospital or

pharmacy?

No. As outlined in the Government’s consultation

response, the UK position on Article 23 would require

wholesalers to decommission for persons authorised

or entitled to supply medicinal products to the public

who do not operate within a healthcare institution or

within a pharmacy. Hence the manufacturer that over

labels the original licensed pack will not be able to

decommission for the hospital / pharmacy giving the

contract.

From FMD Safety Features – Common

Questions and Answers 11/01/2019

www.sps.nhs.uk

Questions 9 - 11

9. Adrenaline kits received whole, with needles – how are they decommissioned – via Specials Manufacturer?

10. Is it only items classified as medicines, not medical devices e.g.PosiFlush?

11. What about P and GSL medicines?

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Questions

Any questions from the chat?

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Feedback

If you have any feedback please send it in the chat box

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Upcoming MUS Events

WEBINARS:

13 February Update on RMOCs with Justine Scanlon

13 March Safety of Injectable Medicines with Virginia Aguado

and Sue Keeling

10 April End of Life Care with Sara Bernstein

FACE TO FACE EVENTS

14 March MUSN Meeting - Tackling medicines safety

challenges in transfer of care and adherence

14 May Community Health Pharmacists (CHS)

Contact LNWH-tr.MUS-SpecialistPharmacyServices@nhs.net

to join networks and receive mailings