Chief officers update Brexit medicine supply guidance

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Thursday 28th March 2019

Dr Catherine Calderwood and Professor Rose Marie Parr, Scotland’s Chief Medical Officer (CMO) and Chief Pharmaceutical Officer (CPO), have written to health professionals on preparations to ‘enable the NHS to respond to and manage medicine shortages if the UK leaves the EU without a deal’.

A specialist Scottish Government taskforce has been set up to oversee the supplies of medicines, monitor potential shortages and issue guidance to doctors and pharmacists.

Support that will be given to prescribers and pharmacists is also included within the letter, which follows on from a note from the Chief Pharmaceutical Officer on possible medicine shortages sent in January of this year.

In the event of a no-deal Brexit the letter warns ‘shortages may occur’, ‘but the NHS will manage the situation and if necessary provide suitable alternatives or other treatment while supply is restored to normal levels’.

Not unique to Brexit, medicines shortages can occur for a number of reasons, whether that be because of batch failures or issues obtaining raw ingredients.

The CMO and CPO advise ‘the UK Administrations have well established procedures to deal with shortages, to ensure that the risks to the public are minimised’, but ‘additional steps have now been taken’ to prepare for the risk that a no deal departure could lead to more shortages than usual.

The Scottish Government has already been working with the UK Government to try to ensure patients and staff do not experience any interruptions in the availability of medicines, medical devices and clinical consumables, and pharmaceutical companies have been stockpiling medicines.

Across the UK, the health service has stockpiled other supplies including medical devices and clinical consumables, and arrangements are being made for items that cannot be stockpiled to be transported to the UK by air.

The UK Government has also stated that, if there are delays at the UK border, medical supplies will be given priority for entry.  

Stockpiling arrangements are kept under daily review by the UK Government, which recently asked pharmaceutical companies to increase stocks beyond an additional six-week supply where possible.

A specific list of the medicines where a six-week stockpile has not been gathered is kept under regular review. Plans are in place to try to manage each of these medicines, which include seeking alternative suppliers and using alternative products where possible.

It is hoped companies will report any potential problems they have in advance, to provide time to plan for an ‘appropriate response’.

A Medicines Shortage Response Group (MSRG) has been established by the UK Government to monitor and respond to any developments, while the Scottish Government has established an equivalent group, MSRG (SCO), clinically led by the CPO.

The letter advises of the MSRG (SCO)’s focus on ‘strengthening extant guidance for managing the shortages of medicines in primary and secondary care’, including improving existing surveillance, reporting, and communication systems. 

The group will work to ensure that in the event of any shortages the NHS in Scotland ‘is well placed to respond with a streamlined, robust, agile and responsive process ensuring that is effective and protective of public health’.

Prescribers are advised they do not need to do anything new and the public, hospitals, GPs and community pharmacists are reminded not to stockpile medicines.

The authors advise further information on the ‘strengthened processes for managing medicine shortages in primary and secondary care will follow shortly’. 

‘Due to the commercial in confidence nature of the stockpiling data’, the letter states, information will be provided on a case-by-case basis for any shortages and next steps, in order to ‘minimise any additional burden on GP practices and community pharmacies’.

GP practices are expected to continue reporting any shortages to their local health board, while community pharmacists continue to report shortages to Community Pharmacy Scotland (CPS). In secondary care, pharmacists are advised to follow their health board policy for managing shortages. 

Further guidance is to be published on additional steps being taken to manage medicines shortages in both primary and secondary care.

The letter refers to low impact shortages that in some circumstances can be dealt with by community pharmacists amending prescriptions, rather than a request having to be made to the patient’s GP practice.

‘Where national shortages arise’, the letter states, ‘the MSRG will produce recommendations for the NHS, drawing where necessary on advice from the Chief Medical Officers and their special advisors’.

Where serious shortages of medicines occur, time-limited serious shortage protocols are to be developed to enable pharmacists to amend prescriptions to dispense a different strength, formulation or an alternative medicine.

Additional information is to be published on how such protocols would operate in practice.

NHS National Services Scotland (NSS) and the Scottish Government state they have made contingency plans for continued supply of medical devices and clinical consumables.

Medical devices refer to anything used for diagnostic or therapeutic purposes, including instruments, software or appliances, and range in complexity from simple medical thermometers to life-sustaining pacemakers.

Clinical consumables also cover a vast array of items, such as blood pressure cuffs and ECG cables.

 ‘Arrangements have been made for Scotland’s participation in a UK-wide National Supply Disruption Response (NSDR) centre that, in turn, provides access to dedicated shipment channels’ that will ‘enable delivery of ambient, non-temperature controlled products into the UK from the EU,’ the letter notes.

A ‘phased stock build of goods’ has also been undertaken by NSS in its national distribution centre in Scotland.

Health boards, primary care providers and social care providers in Scotland are expected to continue to apply a business as usual approach to the procurement of goods if the UK leaves the EU without a deal, with contingency measures only to take effect ‘in the event of difficulty in obtaining a particular product’.

In such circumstances, health boards and other providers will be expected to use the triage centre being established by NSS as a first port of call for resolving supply issues, before any issue is escalated to the UK-wide NSDR.

Contact details for the centre are not yet available but will be provided ‘in due course’, the letter states.

The letter can be read in full here.