MEDICINES USE AND SAFETY WEBINAR Welcome to the MUS Webinar on The - - PowerPoint PPT Presentation

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MEDICINES USE AND SAFETY WEBINAR Welcome to the MUS Webinar on The - - PowerPoint PPT Presentation

Sep 17, 2022 129 likes •360 views

MEDICINES USE AND SAFETY WEBINAR Welcome to the MUS Webinar on The Falsified Medicines Directive presented by Denise Farmer, Health and Justice Pharmacy Adviser to NHS England The webinar itself will start at 1pm. Shortly before 1pm

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www.sps.nhs.uk

MEDICINES USE AND SAFETY WEBINAR

  • Welcome to the MUS Webinar on The Falsified Medicines Directive

presented by Denise Farmer, Health and Justice Pharmacy Adviser to NHS England

  • 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 141 024 134
  • 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 will answer questions at the end of the presentation

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www.sps.nhs.uk

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Upcoming MUS Events

Webinars: WEDNESDAY 14th November – Patient Group Directions – Tracy Rogers interviews Jo Jenkins THURSDAY 13th December – Update on use of anticholinergic burden – Delia Bishara FACE TO FACE EVENTS 27th November – Older People Pharmacy Network (OPNet) annual meeting – Polypharmacy and the WHO medicines safety challenge: Moving from guidance to practice in the care of older people Medicines Use and Safety Update Sept 2018 - link

Contact LNWH-tr.MUS-SpecialistPharmacyServices@nhs.net to join networks and receive mailings

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www.england.nhs.uk

The Falsified medicines Directive

Implementation in H&J

Denise Farmer October 10th 2018

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www.england.nhs.uk

Falsified Medicines Directive

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  • EU legislation with UK implementation February 2019
  • Aims to prevent introduction of counterfeit medicines

into the medicines supply chain

  • Process tracks manufactured product end to end

(from factory to patient or healthcare delivery site)

  • Affects all sectors of healthcare in “healthcare

institutions” and pharmacies

  • Some exemptions permitted (Article 23) which

includes prisons (interpreted as all residential custodial environments)

  • HJ represented at national implementation board
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www.england.nhs.uk

The Falsified Medicines Directive

  • FMD applies to ALL prescription only medicines &;
  • Organisations supplying these medicines,

(Manufacturers & Pharmacy Wholesalers).

  • Healthcare Institutions/pharmacies supplying medicines

to patients (Community Pharmacies, Hospital Pharmacies and Dispensing Doctors).

  • Exclusions (ref. Article 23) include dentists, opticians,

paramedics, prisons, hospices and nursing homes. FMD requires Prescription Only Medicines (POMs) to be verified / decommissioned in the supply chain + a couple of P medicines

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www.england.nhs.uk

The Delegated Regulation (EU) 2016/161 - Published on 9 February 2016 – implementation,

EU wide from 9th February 2019 Anti-tamper device (ATD) Unique identifier (UI)

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www.england.nhs.uk

How does it work?

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www.england.nhs.uk 8

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www.england.nhs.uk

Key Points for Community/dispensing Pharmacy

  • (Community) pharmacies are expected to decommission
  • n supply to the patient.
  • Ideally barcode scan at point of dispensing would

generate a decommission message that is ‘held’ until the medicines are collected by the patient: Then scan bag of medicines handed over.

  • Wholesale items (bulk stock) can be decommissioned
  • n supply for Article 23 recipients – otherwise must be

decommissioned on receipt at other healthcare

  • rganisation
  • Can be scanned back into repository within 10 days
  • Guidance will be provided about what to do if a medicine is

scanned and an error message comes up

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www.england.nhs.uk

Implementation in H&J

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  • Article 23 exemption allows wholesaler to

decommission bulk stock delivered to H&J healthcare providers (term “prison” interpreted as all custodial residential settings)

  • On-site pharmacies in H&J are acting as community

pharmacies: Will need to decommission medicines

  • nce bagged up and sent to the wing (or handed to

the patient if collecting from the pharmacy)

  • External pharmacies supplying named patient

medicines to prisons will decommission the medicines as they are bagged up ready for delivery to HJ site

  • Rationale: Equivalence and accounts for community

pharmacy model

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www.england.nhs.uk

Scenario 1: On-site pharmacy

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Wholesaler delivery to HJ pharmacy - Not decommissioned HJ Pharmacy dispenses medicine & decommissions it as it is supplied to wings (or patient) Wholesaler delivery

  • f bulk stock to

healthcare provider: Decommissioned by wholesaler Healthcare provider receives decommissioned dispensed medicines and stock e.g. Methadone, vaccines etc. Pharmacy with WDL Detainee collects from pharmacy

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www.england.nhs.uk

Scenario 2: Off-site pharmacy e.g.

Community pharmacy or other prison pharmacy

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Wholesaler delivery to pharmacy - Not decommissioned External Pharmacy dispenses medicine and decommissions it then delivers to H&J site Wholesaler delivery

  • f bulk stock to HJ

healthcare provider: Decommissioned by wholesaler Healthcare provider receives decommissioned named patient medicines from pharmacy and decommissioned stock e.g. Methadone, vaccines etc. Pharmacy with WDL

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www.england.nhs.uk

Putting it simply…….

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  • The dispensing pharmacy (on or off site)

decommissions named patient medicines that are dispensed against prescriptions they receive from H&J

  • Wholesalers decommission bulk stock before it is

delivered to the healthcare provider in H&J (but not to the pharmacy if it is on-site).

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www.england.nhs.uk

This agreement means…….

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  • No need to develop TPP HJIS to scan medicines to

decommission them 

  • No need for H&J provider staff to scan medicines as

they receive them OR as they supply them to the patient = Zero impact on medicines queues. 

  • Only impact for H&J commissioned services is on-site

pharmacies (x42- all in prisons) .

  • SARCs and Police custody settings exempt as not

healthcare institutions 

  • Provides equivalence for people in H&J to people in

primary care 

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www.england.nhs.uk

Decommissioning in HJ pharmacies

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  • 42 on-site pharmacies in H&J in England: Not all

registered pharmacies

  • Pharmacy dispensing system providers should be

developing software to enable FMD scanning and comms with the UK repository

  • Blue tooth scanners and hard-wired scanners will be OK in

H&J but not wireless/WiFi

  • FMD comms under development and NHS Digital working

to support IT infrastructure

  • NHS England H&J will liaise with commissioners and

providers where on-site pharmacies are to support implementation

  • Non-registered HJ pharmacies that are same legal entity

as healthcare provider could use hospital model for FMD

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www.england.nhs.uk

What are next steps: Strategic

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  • Clarify/confirm:
  • Pharmacy PMR system providers for H&J are on track for

developing software

  • Partnership and support from NHS Digital
  • Scanner choices and fitness for H&J- link with HMPPS
  • On-site pharmacy leads identified for H&J to link with
  • Costs of IT infrastructure and training and who pays?
  • Comms needed for
  • Commissioners and HJ senior leads in NHS E
  • external pharmacy providers
  • Other stakeholders
  • Outcomes from the consultation on FMD to inform plans
  • Close working with Wholesalers
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www.england.nhs.uk

Priority actions for on-site H&J pharmacies

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  • Clarify/confirm:
  • Your Pharmacy PMR system providers are on

track for developing software

  • Ask software providers about
  • compatible 2D barcode scanner choices
  • User training
  • FMD pharmacy lead to be named and advise NHS

E H&J which PMR system is being used

  • Start thinking about dispensing workflow and

whether this is impacted/needs to change due to need for scanning POM packs.

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www.england.nhs.uk

Further information

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  • Read the info about FMD- Useful links

 Main FMD site: Link  Sign up to the UK FMD newsletter: email FMD.safetyfeatures@mhra.gov.uk and ask to be added to their mailing list  Check out the PSNC FMD web-pages and resources: Link  Check out FMD FAQs (secondary care but it’s relevant and useful for H&J): Link  Fantastic community pharmacy FMD group web pages: https://fmdsource.co.uk/

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www.sps.nhs.uk 19

Questions?

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www.sps.nhs.uk

Poll Question Number 1 Overall I found the webinar content useful to me:

  • Agree strongly
  • Agree
  • Disagree
  • Disagree strongly

10/10/2018 20

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www.sps.nhs.uk

Poll Question Number 2 I would recommend this learning event to others:

  • Agree strongly
  • Agree
  • Disagree
  • Disagree strongly

10/10/2018 21

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www.sps.nhs.uk

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Upcoming MUS Events

Webinars: WEDNESDAY 14th November – Patient Group Directions – Tracy Rogers interviews Jo Jenkins THURSDAY 13th December – Update on use of anticholinergic burden – Delia Bishara FACE TO FACE EVENTS 27th November – Older People Pharmacy Network (OPNet) annual meeting – Polypharmacy and the WHO medicines safety challenge: Moving from guidance to practice in the care of older people Medicines Use and Safety Update Sept 2018 - link

Contact LNWH-tr.MUS-SpecialistPharmacyServices@nhs.net to join networks and receive mailings