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 www.sps.nhs.uk 1
Upcoming MUS Events Webinars : WEDNESDAY 14 th November – Patient Group Directions – Tracy Rogers interviews Jo Jenkins THURSDAY 13 th December – Update on use of anticholinergic burden – Delia Bishara FACE TO FACE EVENTS 27 th 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 www.sps.nhs.uk 2
The Falsified medicines Directive Implementation in H&J Denise Farmer October 10 th 2018 www.england.nhs.uk
Falsified Medicines Directive • 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 www.england.nhs.uk 4
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 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) www.england.nhs.uk
How does it work? www.england.nhs.uk
www.england.nhs.uk 8
Key Points for Community/dispensing Pharmacy • (Community) pharmacies are expected to decommission on 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 on supply for Article 23 recipients – otherwise must be decommissioned on receipt at other healthcare organisation • 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 www.england.nhs.uk
Implementation in H&J • 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 once 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 www.england.nhs.uk 10
Scenario 1: On-site pharmacy Wholesaler delivery to HJ Pharmacy HJ pharmacy - Not dispenses medicine Detainee collects decommissioned & decommissions it from pharmacy as it is supplied to wings (or patient) Pharmacy with WDL Wholesaler delivery Healthcare provider receives of bulk stock to decommissioned dispensed healthcare provider: medicines and stock e.g. Decommissioned Methadone, vaccines etc . by wholesaler www.england.nhs.uk 11
Scenario 2: Off-site pharmacy e.g. Community pharmacy or other prison pharmacy External Pharmacy Wholesaler delivery dispenses medicine and to pharmacy - Not decommissions it then decommissioned delivers to H&J site Pharmacy with WDL Wholesaler delivery Healthcare provider receives of bulk stock to HJ decommissioned named patient healthcare provider: medicines from pharmacy and Decommissioned decommissioned stock e.g. by wholesaler Methadone, vaccines etc . www.england.nhs.uk 12
Putting it simply……. • 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). www.england.nhs.uk 13
This agreement means……. • 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 www.england.nhs.uk 14
Decommissioning in HJ pharmacies • 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 www.england.nhs.uk 15
What are next steps: Strategic • 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 www.england.nhs.uk 16
Priority actions for on-site H&J pharmacies • 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. www.england.nhs.uk 17
Further information • 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/ www.england.nhs.uk 18
Questions? www.sps.nhs.uk 19
Poll Question Number 1 Overall I found the webinar content useful to me: • Agree strongly • Agree • Disagree • Disagree strongly www.sps.nhs.uk 10/10/2018 20
Poll Question Number 2 I would recommend this learning event to others: • Agree strongly • Agree • Disagree • Disagree strongly www.sps.nhs.uk 10/10/2018 21
Upcoming MUS Events Webinars : WEDNESDAY 14 th November – Patient Group Directions – Tracy Rogers interviews Jo Jenkins THURSDAY 13 th December – Update on use of anticholinergic burden – Delia Bishara FACE TO FACE EVENTS 27 th 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 www.sps.nhs.uk 22
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