Brexit and Community Pharmacy

Brexit and Community Pharmacy

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.

PSNC is representing the interests of community pharmacies in important discussions on this topic as part of the Department of Health and Social Care (DHSC) EU Brexit Medicines working group. We are also working closely with the other national pharmacy organisations via our Community Pharmacy Brexit Forum. Our shared objective is to safeguard the continued supply of medicines to pharmacies and their patients when the UK exits the European Union and to minimise any disruption to supplies of medicines, pricing and the work of community pharmacies.

Guidance for community pharmacies

Like all parts of HM Government, DHSC is making contingency plans in case the UK exits the European Union with no deal and PSNC is encouraging community pharmacy contractors to follow the Government guidance issued on this topic.

Pharmacy teams will be aware that on 15th January 2019, MPs rejected the Prime Minister’s proposed Brexit deal meaning a no-deal Brexit scenario is still a possibility. PSNC is continuing to work with DHSC to safeguard the supply of medicines to pharmacies and their patients, whatever the outcome of the ongoing political debate about Brexit.

NHS England advice

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’.

Contractors should particularly note the Operational Readiness Guidance which sets out the actions that contractors should take to prepare for a no-deal exit from the EU.

Summarised guidance

PSNC has summarised the key actions for contractors in PSNC Briefing 005/19: Key actions for pharmacy contractors to prepare for a no-deal exit from the EU.

Serious Shortage Protocols

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.

It is envisaged that where serious shortages occur, each medicine would have its own SSP which will need to be developed carefully to ensure that it can be implemented in practice. PSNC will work closely with DHSC on this. The draft legislation now laid is intended to provide the legal basis for the introduction of these SSPs.

PSNC supports this legislation as part of the measures that will help to manage any serious shortages of medicines, such as those which may occur if the UK exits the EU without a ratified deal (a no-deal Brexit). Further information is available here.

Communications

PSNC has been receiving a high volume of media queries about medicines supply and Brexit and a range of resources are now available to support community pharmacy teams and LPCs in discussing these topics with patients, prescribers and others.

Further support for LPC members on handling media queries is available here (LPC Members Area login required).


Click on a heading below to reveal more information.

Government guidance

The latest guidance from the Government, as set out by Health Secretary Matt Hancock in a letter to frontline healthcare professionals in December 2018, is as follows:

  1. Community pharmacies (along with other healthcare providers) should not stockpile additional medicines beyond their business as usual stock levels;
  2. There is no need for clinicians to write longer NHS prescriptions;
  3. Local stockpiling is unnecessary and could cause shortages in other areas, which would put patient care at risk;
  4. Any incidences involving the over-ordering of medicines would be investigated and followed up with the relevant Chief or Responsible Pharmacist directly; and
  5. If asked, patients should be advised not to store additional medicines at home because the Government is working with industry to ensure a continued supply of medicines.

This builds on a previous letter sent by DHSC to frontline healthcare professionals in August 2018, where community pharmacies were told they “do not need to take any steps to stockpile additional medicines, beyond their business as usual stock levels” and said that pharmaceutical companies were being asked to hold an additional six weeks supply of medicines.

Discussions with DHSC

Since the summer, PSNC has been working closely with DHSC to help manage the potential risks to medicines supply from the UK’s exit from the EU, particularly in the event of a no-deal. As part of that ongoing dialogue, PSNC has been in discussion with DHSC officials about possible actions, in addition to the ongoing manufacturers’ stockpiling of six weeks’ supply of certain medicines, that may be required to help maintain the supply of medicines.

These so-called ‘secondary measures’ include suggestions such as:

  • Giving pharmacies the ability to exercise appropriate professional discretion to ensure the continuity of an alternative equivalent medicine to patients in accordance with patient need;
  • Measures to ensure community pharmacies have quick and clear reimbursement and stock availability information;
  • More responsive Drug Tariff pricing and reimbursement for contractors of any additional costs incurred; and
  • Appropriate regulatory and practical support, to ensure the continuity of medicine supplies to patients.

PSNC Chief Executive Simon Dukes wrote about Brexit in his blog for November 2018.

Meanwhile, DHSC has undertaken an exercise to identify any further actions that could support the continuity of medicines supply in a no-deal scenario. The actions range from trying to increase the manufacture or packaging of products in the UK to attempting to control distribution (wholesaling) and introducing dispensing flexibilities; and most of them do not need any change to legislation.

However, two steps that would require legislation change are:

  • The introduction of a national ‘serious shortage protocol’ to provide dispensers with more flexibility in case of serious shortages of POMs, to be introduced whether there is a Brexit deal or not; and
  • An amendment to the Human Medicines Regulation 2012 to allow regulation making powers, to safeguard the continuity of supply in case of a no-deal (this change is required as the current regulation making powers come from EU legislation).

DHSC is consulting with members of the Brexit Forum on these two matters, as well as on the wider proposed secondary measures. Draft legislation on Serious Shortage Protocols has been laid before Parliament and should come into force in early February 2019 (see above).

PSNC broadly supports the DHSC proposals. Where actual shortages of branded medicines occur, our preferred option would be to allow pharmacies to generically substitute certain medicines. However, the feasibility of enabling this within a short space of time means that, in the short term, it makes sense to relax the NHS Terms of Service obligation on pharmacists to allow them to refuse supply if necessary. This would allow pharmacies to avoid dispensing drugs at a significant loss and incurring costs that their business could not survive, as well as to manage the demand for medicines better and to prioritise stock for patients who need it most in a shortage situation.

PSNC response to the Informal consultation on urgent changes to the Human Medicines Regulations 2012 to ensure the continuity of supply of medicines (including in a ‘no deal’ Brexit)

PSNC's Brexit Forum

PSNC has set up a Brexit forum involving the Chief Executives of the major representative bodies involved in community pharmacy and the medicines supply chain. Organisations represented on the forum are: National Pharmacy Association (NPA); Company Chemists’ Association (CCA); Association of Independent Multiple Pharmacies (AIM); Royal Pharmaceutical Society (RPS); Pharmacists’ Defence Association (PDA); Dispensing Doctors Association (DDA); Healthcare Distribution Association (HDA); and Proprietary Association of Great Britain (PAGB).

Whilst PSNC will continue to hold its own discussions to identify and raise relevant issues and concerns that Brexit may present, this forum provides a platform for all stakeholders to share thoughts and compile shared advice for community pharmacy teams. This will help to identify relevant issues and seek appropriate clarification as required, in the approach to the Brexit deadline.

Details of the Brexit Forum’s meetings:

September 2018 meeting report

November 2018 meeting report

The Forum is due to meet again in late January 2019.

Key issues

Medicine shortages and prices

As well as potentially impacting on patient safety and care, further medicines shortages could destabilise the already fragile medicines pricing and reimbursement systems operated by DHSC. If a large number of drugs remain unavailable at Drug Tariff prices, the current system for setting price concessions could be at risk in the immediate post-Brexit era. If medicine prices increase significantly post-Brexit, there could be a huge impact on individual pharmacies which dispense large volumes of any affected lines, particularly where the difference between purchase price and concessionary price is significant.

In the Public Accounts Committee’s (PAC) report of its investigation into price increases for generic medicines, MPs called on the Department of Health and Social Care (DHSC) to make plans to help address the impact of medicines price rises on the NHS by the end of the year. The inquiry report recommends that DHSC set out its plans for maintaining the supply of medicines both before and after Brexit, including the establishment of clear and timely information flows about generics price or supply issues.

PSNC position: We have asked the Government to consider the resilience of the supply chain and the work of community pharmacy teams battling to secure supply despite the current issues with medicine shortages. To help to mitigate against some of these risks, we would like to continue to work with DHSC to put in place:

  • measures to ensure that community pharmacies have quicker and clearer reimbursement and stock availability information;
  • greater responsiveness of the concession pricing system so that pharmacies can ensure the supply of prescription drugs to patients; and
  • reimbursement for pharmacies of any additional costs incurred to help them to cover their costs and continue to offer the full range of patient services.

PSNC Chief Executive Simon Dukes appeared on BBC Radio 5 Live’s ‘Wake Up to Money’ programme in December 2018 to discuss how preparations for a no-deal Brexit may be exacerbating ongoing medicine supply issues. This story has subsequently been picked up by various other media outlets.

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

Communicating with prescribers: PSNC has produced a Drug Shortages Briefing for GPs, CCGs and NHS prescribers.

Falsified Medicines Directive (FMD)

The FMD comes 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.

Commenting after a meeting of the UK Community Pharmacy FMD Working Group, Chairman and NPA Board member Raj Patel, said: “Given continued Brexit uncertainties, we recommend that whatever system pharmacies choose, they ensure that termination of the contract without penalties is possible, in the remote possibility there is no workable UK FMD repository.”

PSNC position: We have asked the Government to consider issues associated with FMD, including its importance, its cost and its implementation approximately one month before Brexit.

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.

Public affairs work

PSNC is engaging with politicians to ensure that they are aware of the impact that a no deal Brexit may have on community pharmacies. As well as meeting with MPs, we have been contacting and briefing others, written a public letter to the Health and Social Care Select Committee and responded to a Parliamentary consultation.

Dr Sarah Wollaston, MP for Totnes and Chair of the Health and Social Care Committee: Following a meeting with Dr Wollaston in November 2018, PSNC set out its position on Brexit and medicines supply in a letter. The letter highlights PSNC’s ongoing work with DHSC to minimise the impact of Brexit on the medicines supply chain, and also our work with other pharmacy organisations and stakeholders from across the medicines supply chain via the Brexit Forum. The letter describes a number of potential measures that could be in put in place to help minimise the impact of Brexit on medicines supply, pharmacies and patients.

The letter provides a useful summary of the sector’s concerns so may also be useful for pharmacy teams and LPCs to refer to when they are speaking to politicians or other stakeholders on this subject.

Read PSNC’s letter to Dr Sarah Wollaston

Parliament’s Health and Social Care Committee: We have also made a submission to the Committee’s inquiry on the effects that a no-deal Brexit might have on the health sector. The main points raised in PSNC’s submission to this inquiry included:

  • The potential impact a no-deal could have on the availability of medicines that are routinely used in patients’ care;
  • Ensuring additional costs to the community pharmacy sector are covered and reimbursement is quick and clear; and
  • Consideration of issues relating to FMD, including its implementation one month before Brexit.

Read the full PSNC response to the No-deal Brexit Inquiry

The All-Party Parliamentary Group on Access to Medicines and Medical Devices: We have written to this group about the need to maintain the supply of medicines after Brexit. We then met with the Chair of the group, and with other MPs, in December 2018.



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