In light of today’s agreed by the Government to an extension of Article 50 of Brexit, PSNC has issued updated guidance to Community Pharmacy with regard to Medicines Supply Contingency Planning.
If the Government’s Withdrawal Agreement is approved by the House of Commons this week, the UK’s exit date from the EU will be confirmed as 22 May 2019. If the Withdrawal Agreement is not approved by the House of Commons, the legal default in UK and EU law is that the UK will leave the EU on 12 April 2019 without a deal.
The Department of Health and Social Care (DHSC) is continuing work on its no-deal planning and guidance to community pharmacy teams is focused on the seven key areas affecting Pharmacy:
- Supply of medicines and vaccines
- Supply of medical devices and clinical consumables
- Supply of non-clinical consumables, goods and services
- Reciprocal healthcare
- Research and clinical trials
- Data sharing, processing and access
PSNC has issued Pharmacy Contractors (owners, board directors and officers/senior managers of the business) with the following advice:
- Assess Brexit implications for their business and review business continuity plans. Take particular note of instructions indicating that all providers of NHS services, including NHS trusts and foundation trusts, primary care organisations and independent sector organisations which provide NHS services, ‘must consider and plan for the risks that may arise due to a ‘no-deal’ exit’.
- Mitigate one of the main risks for community pharmacy i.e. obtaining medicines and medical devices for supply to patients. Contractors should not stockpile additional medicines or medical devices beyond business as usual stocks. Current shortage issues should continue to be reported to PSNC and a concession price may be necessary. Other mitigations include the concession price mechanism (already in place) and a system for Serious Shortage Protocols (SSPs), which is being introduced. PSNC and other pharmacy representative groups are currently discussing the introduction of SSPs with DHSC.
- No clinician should write longer prescriptions for patients. The Department’s UK-wide contingency plan for the continued supply of medicines and vaccines from the moment we leave the EU is being developed with pharmaceutical companies and other government departments.
- Commercial preparation for EU Exit should be continued as part of usual resilience planning. Any risks and issues identified -including workforce planning- should be addressed through individual pharmacy risk assessments which should be managed locally. Where appropriate, these plans should be developed in conjunction with Local Health Resilience Partnerships. All health organisations should be engaged in their relevant Local Health Resilience Partnership, which should inform Local Resilience Forum(s) of local EU Exit plans for health and care.
- Contractor communication with Local Health Resilience Partnerships is likely to be through Local Pharmaceutical Committees. LPCs should ask their local NHS England teams about Local Health Resilience Partnerships, if they are not already involved with a partnership
- Undertake an assessment of risks associated with EU Exit covering, but not limited to:
- The seven key areas identified nationally and detailed above
- Potential increases in demand associated with wider impacts of a ‘no deal’ exit.
- Locally specific risks resulting from EU Exit.
- Staff should reassure patients that the Government has contingency plans for a no-deal exit from the EU and advise against stockpiling medicines at home.
- There is no need for health and adult social care providers to stockpile additional medical devices and clinical consumables beyond business as usual stock levels. Officials in the Department will continually monitor the situation and if the situation changes, will provide further guidance by the end of January 2019.
- Reassure members of the pharmacy team from other European countries that they have the same rights (including any current registration with the General Pharmaceutical Council) following the UK’s exit from the EU.
- Inform staff of the UK’s EU Settlement Scheme, which will remain open until 31st December 2020 in a ‘no deal’ scenario, as appropriate.
- Consider any potential impact on staff retainment and recruitment.
- Data and digital assets must be adequately protected by completion of the Data Security and Protection Toolkit assessment. This self-audit of compliance with the 10 Data Security Standards is mandatory completion by 31st March 2019 and will enable health and adult social care providers to more quickly identify and address any vulnerabilities.
- A key data protection issue is the transfer of personal data from the UK to the EU/EEA. In accordance with DHSC guidance, such transfers should not be affected in a ‘no deal’ scenario, because ‘it would continue to be lawful under domestic legislation for health and adult social care organisations to transfer personal data to the EU/EEA and adequate third countries in the same way we do currently’.
- The DHSC’s EU Exit Operational Readiness Guidance is the main source of information on Government plans to maintain the supply of medicines to patients in the event of a no-deal exit from the EU. These plans include:
- The ‘manufacturers’ six-week stockpile of Prescription Only Medicine and Pharmacy-only medicines imported into the UK, from or via the EU or European Economic Area (EEA);
- Arrangements for air freight where appropriate;
- Additional plans for alternative roll-on, roll-off freight ferry capacity (medicine supplies will be prioritised on these alternative routes);
- Other contingency plans including supply on a named patient basis of medicines licensed overseas (other than the EU);
- Developing plans for SSPs.
In addition, Professor Keith Willett, EU Exit Strategic Commander and Medical Director for Acute Care & Emergency Preparedness has issued the following advice:
“As you will no doubt be aware, the House of Commons last week voted against the UK leaving the European Union without a deal, and in favour of extending Article 50. Votes this week mean it is still possible that we can leave on 29 March with a deal, although time is very short.
However, the Department has made clear to us that unless and until a Withdrawal Agreement is ratified by the UK and the European Parliament, or until any extension is agreed by the EU, the legal default in UK and EU law remains that the UK will leave the EU on 29 March 2019 without a deal. We must therefore continue to plan for a no deal outcome on 29 March.
The Department of Health and Social Care will continue to implement its no deal plans in full, and we are writing in similar terms to all other organisations in the health and care system to ask they continue with their no deal plans.
The NHS is well practised in managing operational risk – it’s something we all do in daily practice. We will particularly benefit from the extensive planning undertaken to date. But we cannot be complacent and it’s essential that we now finalise our preparations in anticipation of a possible no deal.
Please therefore continue to check that you are as ready as you can be for the possibility of a no deal exit from the EU. This includes working with your system partners to ensure you are on track with your operational and commercial preparations, as set out in the Department’s Operational Guidance.
To achieve that readiness, we now ask that by next Monday (25 March) provider trusts will have brought together members of their senior executive team with their EU Exit SRO and EU Exit team, and directors or lead managers from key areas (such as pharmacy, estates, facilities and procurement) to scrutinise preparations to operate under the conditions of a no deal. Representatives from your Clinical Commissioning Groups and Local Resilience Forum should also attend where possible. We also recommend that you include non-executive directors to critique that preparation. CCGs should organise similar sessions.
Please ensure your incident management procedures are now in place and are scalable if multiple issues arise, including:
- A single point of contact for local and national partners
- Clinical reference points in the event of issues such as supply shortages
- A local communication plan is in place
- On-call directors understand what is required of them and the escalation routes for problems
- The DHSC has set up a National Operational Response Centre, with support from NHS England, NHS Improvement and Public Health England.
- NHS England and NHS Improvement plan to establish an Operational Support Structure for EU Exit, which will operate at national, regional and local levels.
- The EU Exit National Coordination Centre in Leeds is fully operational and regional coordination centres (listed below) are live and acting as the single point of contact for each area:
North East England.email@example.com
North West England.firstname.lastname@example.org
East of England England.email@example.com
South East England.firstname.lastname@example.org
South West England.email@example.com
EU Exit information published specifically for NHS organisations: NHS England
Information for the public and patients: nhs.uk
Information published by DHSC and other parts of Government can be viewed here.
Download DHSC EU Exit Operational Readiness Guidance