There is now a draft basis on which the UK is due to leave the European Union (EU) in March 2019 – but in the event of a ‘no deal’ exit, officials want the health and care system to be prepared.
Enter the EU Exit Operational Readiness Guidance – a 34-page document from the Department of Health and Social Care (DHSC) summarising the contingency plans.
It details the actions all health and care organisations should be taking in preparation for the UK’s departure, covering seven key areas of activity in the two sectors. These include workforce, data sharing, research and clinical trials and supply of medicines and vaccines.
We picked out three of the most relevant pointers that community pharmacists need to know:
1. The “free movement” of medicines
The Government has a contingency plan to ensure medicines and vaccines continue to be available in a no deal scenario. It covers medicines used by patients, service users and all types of providers in the four UK nations, as well as the UK Crown Dependencies.
Pharmaceutical companies that supply the UK with prescription-only and pharmacy medicines from or via the EU or EEA have been contacted by the DHSC. They were asked to ensure they have a minimum of six weeks’ additional supply in the UK by March 2019, as well as making arrangements to air freight any medicines with a short shelf life.
Manufacturers are being supported to take part in the contingency planning and government funding has been provided to find extra storage space for medicines. A selection of wholesalers and pre-wholesalers of pharmaceutical warehouse space have also been given funding to secure the additional capacity needed for stockpiled medicines.
This six-week stockpiling activity is a “critical part” of the plan, the guidance says, but the government is also making sure there is enough roll-on, roll-off freight capacity (space for goods vehicles to travel by ferry) to keep medicines moving freely into the UK. All medicines, including general sales list medicines, will be prioritised on these routes.
The document says the contingency plans for medicines supply are being kept under review, and the DHSC will publish more guidance as and when necessary, it says.
2. Don’t stockpile
While manufacturers and wholesalers are part of the national plan to store extra medicines, community pharmacies, hospitals, care homes, GPs are being told not to stockpile beyond their “business as usual” stock levels. Clinicians should not write longer NHS prescriptions and the public should also be discouraged from storing up medicines.
The guidance says chief and responsible pharmacists must ensure their organisations do not stockpile medicines unnecessarily – incidences of over-ordering will be investigated.
3. The serious shortage protocol
A serious shortage protocol is being put in place by the DHSC, which will involve changes being made to medicines legislation to allow for more flexibility around the primary care dispensing of medicines. The guidance says there will be ‘robust safeguards’ to ensure this is used safely, including the provision of “authoritative clinical advice”.
Arrangements are also being made by the DHSC, NHS England and NHS Improvement to monitor stock levels at a local and regional level, but current shortage issues and queries on medicine supply should continue to be reported through the existing channels.
Commenting on the guidance, Ash Soni, president of the Royal Pharmaceutical Society (RPS), said: “We welcome the Government’s confirmation that health and social care providers should not stockpile medicines and the Secretary of State’s reassurance that the Government is working with industry to ensure continued supply of medicines.
“Short-term shortages of medicines due to supply chain issues or increased demand are not uncommon and pharmacists frequently help manage these in their everyday practice, ensuring patients are able to receive appropriate treatment.”
He added that the RPS has been in discussions with the DHSC on proposals to amend the Human Medicines Regulation 2012 to enable pharmacists to dispense an alternative medicine in case of shortages, and will continue to engage with relevant stakeholders on how the contingency plans will work in practice.