Coventry LPC

BREXIT

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Government Brexit Guidance

Operational Readiness

Cover Letter (December 2018)

PSNC Brexit Guidance

PSNC Brexit Briefing

PSNC Drug Shortages Briefing

Patient Leaflet

Shortages Reporting Form

Serious Shortages Protocol

Draft legislation on SSP

PSNC’s response to consultation

Consultation Outcome

DHSC Brexit Update

25 February 2019 Update

The UK is due to leave the European Union on Friday 29th March 2019 and the Government is preparing contingency plans to ensure the continued supply of healthcare services and medicines in the event of a no-deal Brexit.

Draft legislation on Serious Shortage Protocols (SSPs) has been laid before Parliament and should come into force in early February 2019. The protocols, for use in the event of a serious shortage of a medicine, may give community pharmacies the ability to dispense less, give a different strength or pharmaceutical form or provide an alternative product.

Source: PSNC

March 2019 update: SSP came into effect on 9th February 2019, however, there are currently legal proceedings against the amendment. You can read more about it HERE.

We’ll bring you the latest updates on this issue as soon as new information becomes available.


Frequently Asked Questions and Additional Support


  • Should the pharmacy stockpile medicines in preparation for Brexit?
  • What can the pharmacy do to prepare for Brexit?
  • How will Brexit affect the Falsified Medicines Directive?
  • How will Brexit affect GDPR?
  • Is Brexit having an impact on medicine shortages?
  • Is there a resource that could help me explain about drugs shortages to my customers?
  • How do I report supply issues to PSNC?
  • What’s PSNC’s position on the proposed Serious Shortages Protocol?
Should the pharmacy stockpile medicines in preparation for Brexit?

Dr Keith Ridge, NHS England’s Chief Pharmaceutical Officer, wrote to community pharmacies in January 2019 to update them on the Government’s contingency preparations. Dr Ridge’s letter reiterates that it is ‘not helpful or appropriate for anyone to be stockpiling medicines locally’. Also, due to the risk of placing additional pressure on the availability of medicines for patients in other areas of the country, Dr Ridge writes that ‘any incidences involving the over-ordering of medicines will be investigated and followed up with the relevant Chief or Responsible Pharmacist directly’.

Source: PSNC

What can the pharmacy do to prepare for Brexit?

The government has issued the following guidance for the healthcare system in England to prepare for all eventualities of Brexit:

https://www.gov.uk/government/publications/brexit-operational-readiness-guidance-for-the-health-and-social-care-system-in-england

source: PSNC

How will Brexit affect the Falsified Medicines Directive?

The FMD came into effect from 9th February 2019, but the full implementation of FMD may depend on the UK’s future relationship with the EU.

Continued access to the EU FMD hub will depend on the future relationship between the UK and the EU. Access is likely to continue during the transition period, and if the UK government realises its aim of a close alignment on medicines policy within the Brexit agreement, it will continue after 2020 too.

How will Brexit affect GDPR?

The General Data Protection Regulation (GDPR) and the UK Data Protection Act 2018 came into force on 25th May 2018. Originating from the EU, this legislation represented an overhaul of data protection legislation.

PSNC position: At present, the GDPR will continue to apply to the UK. It may be that any EU law which takes effect as a result of the UK’s EU membership, such as the GDPR, no longer applies post-Brexit, but that depends on the terms of the negotiated agreement to leave the EU. The position is likely to become clearer as the UK approaches closer to formally leaving the EU.

Is Brexit having an impact on medicine shortages?

Medicines shortages can be caused by a whole range of factors, including manufacturing and distribution problems within the supply chain.  Uncertainty around Brexit and contingency planning is an additional factor currently exacerbating the already existing issues.

Is there a resource that could help me explain about drugs shortages to my customers?

PSNC has produced a Patient Leaflet that community pharmacy contractors may find useful to give to patients in the event of medicines supply problems.

There are also some FAQs on the NHSE site:
https://www.england.nhs.uk/eu-exit/medicines/medicines-faq/

How do I report supply issues to PSNC?

You can report any supply issues by using the Online Reporting Form.

What’s PSNC’s position on the proposed Serious Shortages Protocol?

PSNC supports the proposals, subject to their comments on the draft legislation.

https://psnc.org.uk/wp-content/uploads/2018/12/PSNC-response-to-the-consultation-on-urgent-changes-to-the-HMRs-2012.pdf


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