On 22nd of July 2019 I wrote to The Scottish Government about concerns I had regarding the supply of medicines post Brexit. This was due to many different posts I was seeing on social media and in particular a poster which had appeared in the windows of some pharmacies in Scotland and which had been shared on social media. [Fiona Grahame]
Here is the reply in full which I have just received:
Thank you for your email of 22 July 2019 to Scottish Ministers regarding the current position on supply of medicines following the UK’s exit from the EU.
In particular, you have highlighted readers concerns about the recent press and social media coverage indicating that supplies of medicines cannot be guaranteed. We are aware that a pharmacy journal recently issued a poster to all community pharmacies on medicines shortages. The poster is not endorsed by the Scottish Government or by Community Pharmacy Scotland (CPS), the body which represents community pharmacy owners in Scotland. CPS issued a note to community pharmacy owners in June asking them to consider the impact on patients in displaying the poster, however it should be noted that community pharmacists are independent contractors and it is for them to decide what materials to display in their premises.
Medicines shortages and disruption are not unusual across NHS Scotland and our community pharmacy network have procedures in place to respond to them. There are over 100 million prescriptions dispensed each year in Scotland, and shortages in availability may occur for a number of reasons. Shortages can arise for various reasons such as difficulties with manufacturing or with supply of raw materials. The production of medicines and devices is complex and highly regulated, and materials and processes must meet rigorous safety and quality standards. There are however well established processes currently in place to ensure continuity of care for patients in the event of a medicine supply or shortage.
When supply issues relating to individual drugs or devices arise, that information is shared by NHS Scotland with the relevant networks within the service to help prescribers and dispensers meet patients’ on-going medical needs. The NHS Scotland Prescribing Advisers’ Network provides support to prescribers on the use of alternative products.
The Scottish Government have been working with the UK Government’s Department for Health and Social Care to allow community pharmacists to substitute prescription medicine with an alternative in the event of a serious shortage.
The legislation which governs the control of medicines is reserved to the UK Government and are set out in the Human Medicines Regulations 2012. These Regulations set out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance. Amendments to the Human Medicines Regulations were required to ensure that a pharmacists supplying a medicine substation in the event of a serious shortage, could do so legally. Following amendments made to the Human Medicines Regulations, the Scottish Government are now in the process of amending the NHS (Pharmaceutical Services) (Scotland) Regulations 2009 to comply with the changes made to the Human Medicines Regulations and these will be in place before the proposed EU exit date.
Turning to the general issue of access to medicines following a no deal exit from the EU, the UK Government has overall responsibility for EU exit contingency planning and for entry and any customs control at the UK Border.
The UK Government continues to fail to rule out a no deal exit from the EU. By necessity, therefore, the Scottish Government has been working with the UK Government to make sure that patients get the medicines and other medical supplies they need, as far as is possible, if the UK leaves the EU without a deal.
Since August 2018, the Department of Health and Social Care (DHSC) has been leading on UK-wide contingency plans to secure supplies of medicines, medical devices and clinical consumables in the event of a ‘no deal’ exit from the EU. The DHSC have asked pharmaceutical companies to increase their stockpiles of medicines which may be impacted by delays at the UK Border, with the aim of ensuring that the UK has an additional six weeks supply on top of normal stocks. Alongside the stockpiling arrangements, the DHSC are looking at alternative transportation arrangements such as additional ferry capacity and the potential to airfreight medicines that may require specific cold chain transportation.
The DHSC further wrote to companies involved in the supply of medicines and medical devices on 26 June 2019 to give an update on the UK Government’s position and offer guidance to help ensure that patients are able to get the medicines and other medical supplies they need, as far as is possible, in the event that the UK leaves the EU without a deal.
The Scottish Government’s Chief Medical Officer and Chief Pharmaceutical Officer wrote to health professionals across Scotland on 28 March 2019 to offer advice on preparations being made to enable the NHS to respond to and manage potential medicine shortages, as well as outlining the support that will be given to prescribers and pharmacists. A further update letter was issued to NHS Scotland and others on 27 June 2019.
In addition, an NHS Scotland Medicines Shortages Response Group, chaired by the Scottish Government’s Chief Pharmaceutical Officer and consisting of a range of health professionals has been established to ensure that UK wide plans to manage shortages that may arise in the context of a no deal exit from the EU are implemented effectively in Scotland, taking account of health and social care needs here.
Despite the continuing uncertainty around the timing and nature of the UK’s exit from the EU, the Scottish Government continues to engage fully with the UK Government and other devolved administrations to do everything we can to ensure that as far as is possible, patients will continue to have access to the medicines and other medical supplies they need. We will also continue to work closely with NHS Scotland to ensure that all our preparations are focussed on the needs of patients in Scotland.
I hope that this information is helpful in setting out the current position for your readers.
Medicines Policy Team