Our answers to commonBrexit questions
- I am an EEA-qualified pharmacist, what does Brexit mean for me if I want to work/continue working in the UK?
- How do I deal with a prescription issued in an EEA member state or Switzerland?
- Am I still legally required to comply with FMD requirements post Brexit?
- What is a Serious Shortage Protocol?
- Will the Serious Shortage Protocol apply to any medicine that is in shortage or difficult to obtain post Brexit?
- Who should I speak to if I feel the Serious Shortage Protocol should apply to a particular medicine in short supply?
- What is being done to ensure continuity of supply?
- What is the advice for the NHS and the public?
- Where can we go for the most up to date information on pharmacy post-Brexit?
I am an EEA-qualified pharmacist, what does Brexit mean for me if I want to work/continue working in the UK?
Pharmacists with professional qualifications from EU and Swiss institutions will continue to be recognised by the General Pharmaceutical Council, meaning those who are currently registered can continue to practise in the UK as they do now.
Employment contracts will not need to be changedand staff won’t have to reapply for their current positions.
The deal does not include provision for mutual recognition of qualifications for UK pharmacists seeking to work in the EU.
More information is available from the General Pharmaceutical Council.
If you’re an EU citizen, the government encourages you and your family to apply to the EU Settlement Scheme to continue living in the UK.Find out more about the EU Settlement Scheme.
How do I deal with a prescription issued in an EEA member state or Switzerland?
The Government has issuedguidancefor pharmacists. A prescription issued in anEEAmember state or Switzerland can be dispensed in the UK if the prescriber is from a profession recognised by this guidance that is legally entitled to issue a prescription of that kind in the country in which the prescription is issued.
We also havea pharmacy guide ondealing with EEA prescriptions.
Am I still legally required to comply with FMD requirements post Brexit?
The Falsified Medicines Directive (FMD) aims to create a system that ensures medicines supplied in the UK are safe. This will include new security features on individual packs and a new electronic scanning authentication process.
Without anegotiated agreement on FMD, the legal obligation to comply with FMD ceased on 31 December 2020. The UK willno longer have access to the EU central data hub, and stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK. Packs containing the FMD safety features would still be accepted in the UK, provided that they are in line with other UK packaging requirements.
The MHRA has stated it would evaluate the options around a future national falsified medicines framework, which would inform the detail of any short or longer-term modifications. Further information is available on theFMD Source website.
What is a Serious Shortage Protocol?
Medicines shortages can have a huge impact on patients and healthcare professionals involved in their care.
A Serious Shortage Protocol is intended to speed up patient access to appropriate treatment and reduce pressure on the prescriber, most likely GPs, in the event of the prescribed medicine being in serious shortage.
Currently, if a pharmacy cannot obtain a medicine that is on a prescription, it will either send the patient back to the prescriber or contact the prescriber to discuss an alternative and get the prescription changed.
Legislation has been passed that would enable Ministers to issue protocols that would enable community pharmacies to dispense against a protocol instead of a prescription without going back to the prescriber first.
Each protocol would clearly set out what action can be taken by the pharmacist, under what circ*mstances, for which patients and during which period. In cases where a substitution might not be appropriate, or where the patient does not consent to a change, patients would be referred back to the prescriber.
The NHS Business Authority publishes details of any SSPs currently issued, along withOperational Guidance and a detailed Q&A.
PSNC have published a briefing for community pharmacy contractors.
There is also a feature in the Pharmaceutical Journal:Everything you need to know about serious shortage protocols.
You can also read explanatory notes aboutThe Human Medicines (Amendment) Regulations 2019andThe National Health Service (Amendments Relating to Serious Shortage Protocols) Regulations 2019.
Will the Serious Shortage Protocol apply to any medicine that is in shortage or difficult to obtain post Brexit?
Serious Shortage Protocols would only be issued for specific medicines in the event of a serious shortage, developed on a case-by-case basis with input from senior clinicians.
Who should I speak to if I feel the Serious Shortage Protocol should apply to a particular medicine in short supply?
A Serious Shortage Protocol would only be introduced in case of a serious shortage and is only one of the tools that can be used to manage shortages. The Government has well-established processes for managing shortages in collaboration with manufacturers and suppliers, clinicians, the NHS and the Medicines and Healthcare Products Regulatory Agency.
Any medicines supply issues (regardless of whether or not they are considered to be related to EU Exit) should continue to be reported through your usual process:
Community pharmacists should continue to report supply issuesvia the PSNC.
Pharmacists in secondary care should continue to report supply issues via your Pharmacy Department to the specialist Regional Procurement Leads.
What is being done to ensure continuity of supply?
The Department of Health and Social Care (DHSC) has been working closely with the NHS, pharmaceutical companies, suppliers of medical devices, and supply chains to make sure medicines and medical products continue to be available in the event of a no deal EU exit.
Since 2018, DHSC has been working with all pharmaceutical companies that supply prescription-only medicines and pharmacy medicines to the UK that come from, or through, the EU or European Economic Area (EEA). DHSC has been asking companies to ensure they have extra stocks available in the UK.
Where these medicines have a short shelf life, DHSC has asked companies to ensure that they can fly these medicines in from the EU in the event of supplydisruption. The Government hasprocuredan ‘Express Freight Service’ – access to freight services that are able to deliver small consignments on a 24-hour basis and a two-to-four-day pallet delivery service.The NHS Supply Chain organisation is holding extra stocks of medical products.
To ensure that there will be enough space available for extra stocks of medicines and medical products, the Government has secured extra warehouse space including refrigerated and controlled drug storage that companies can use to store products.
The Government has also put in place extra shipping for suppliers to use on a variety of routes to ease pressure on the short straits crossings to Dover and Folkestone. This includes capacity on ferries to Poole, Portsmouth, Plymouth, Immingham and Felixstowe. The Government has agreed that medicines and medical products will be prioritised on these alternative routes.
What is the advice for the NHS andthe public?
The Government has said that it is not necessary for local providers, whether in hospitals or primary care, to stockpile medicines or for clinicians to write longer prescriptions for patients. Unnecessary stockpiling puts more pressure on the supply chain and can risk additional pressure on the availability of medicines in other parts of the country. Prescribers and pharmacists should explain to patients that they should continue to order their prescriptions as normal.
Where can we go for the most up to date information on pharmacy post-Brexit?
Aletter fromProfessor Keith Willett, NHSSenior Responsible Officer forEU Exit,covers the outcome of the UK negotiations with the EU.(30 December 2020)
A letter from Chief Pharmaceutical Officer Keith Ridge outlines measure onmedicines supply continuity. (10 December 2020)
We have published a joint statement, along with other pharmacy organisations, on the potential impact of Brexit on medicines supply.
ThePSNC websitehas information andguidance for community pharmacy contractors.
The MHRA has a range ofguidance and publications about the end of the transition period.
