Continuity of supply frequently asked questions
Information for patients on getting medicines if there is a no deal EU exit can be found on the NHS website.
- What is being done to make sure medicines and medical products continue to be available?
- What should clinicians and NHS organisations be doing?
- Are there plans to stockpile medicines in the UK ahead of 31 October 2019 as there were ahead of 29 March 2019?
- Should patients keep ordering repeat prescriptions and taking medicines as normal?
- Should GPs provide larger or longer prescriptions?
- What about medicines with short shelf-lives?
- If there are problems with the government contingency plans or there are shortages for any other reason, will patients still be able to get suitable prescription medicines and medical products?
- Will information about specific medicines and medical products be made available?
- What are Serious Shortage Protocols?
- Will any routine NHS operations be affected
- What about ‘over the counter’ medicines?
- Will patients still get their medicine if they are on a clinical trial?
- What about the supply of blood and blood products?
- What about vaccines?
- What about unlicensed medicines and specials?
What is being done to make sure medicines and medical products continue to be available?
The Department of Health and Social Care (DHSC) has been working closely with the NHS, trade associations, wholesalers, pharmaceutical companies, suppliers of medical devices and many others, to help to ensure medicines and medical products continue to be available if there is a ‘no deal’ EU Exit.
The government has put in place contingency measures to help ensure medicines continue to be available. This includes:
- Improving trader readiness for new border arrangements.
- Building up buffer stocks of prescription-only and pharmacy medicines. These stocks will continue to be replenished as used.
- Procuring extra warehouse space for stockpiled medicines.
- Securing additional ferry capacity for all medicines, not just those included in the stockpiling. This will be done in two ways:
- buying extra space on ferries – the Department for Transport, acting on behalf of government, has started a procurement exercise for a framework to provide suppliers, including those who supply medicines and medical products, with the opportunity to use freight capacity on routes away from the ports where delays are more likely to occur
- procuring an ‘Express Freight Service’ – access to freight services that are able to deliver small consignments on a 24-hour basis and a two-to-four-day pallet delivery service
- Changing or clarifying regulatory requirements. The government is also making sure that medicines, devices and clinical trials licensed or tested in the EU can continue to be used in the UK by amending regulations to suppliers to ensure that medicines, devices and clinical trials licensed or tested in the EU can continue to be recognised in the UK in the event of a ‘no deal’ EU Exit.
- Strengthening the processes and resources used to deal with medicines shortages.
This approach is similar to the measures that were put in place before 29 March 2019 and remains essential to help ensure the continuity of medicines and medical supplies in the event of the UK exiting the EU without a deal.
Local stockpiling and prescribing over and above usual quantities ahead of 31 October is unnecessary and could cause shortages in other areas. It is also important that patients keep taking their medicines and order their repeat prescriptions as normal.
What should clinicians and NHS organisations be doing?
- Prescribe and dispense as normal: Doctors and pharmacists are encouraged to reassure patients that they do not need to order extra medication and in fact this could contribute to or cause supply problems. Prescriptions covering longer durations than normally prescribed should be avoided. Prescription durations will be monitored and investigated where necessary.
- Provide patients with information: NHS England will continue to provide updates to Senior Responsible Officers (SROs) and through the usual commissioning routes. Clinicians and NHS organisations are encouraged to prioritise keeping patients and health professionals informed about plans for continuity of supply.
- Do not stockpile medicines and medical products: It is not helpful or appropriate for anyone to stockpile medicines – organisations who stockpile risk pressure on availability of medicines. Hospital stock levels will be monitored and incidences involving over-ordering of medicines will be investigated.
Report any shortages through usual routes: Any shortages should be reported through usual routes and to support this, a national Medicines Shortage
- Response Group (MSRG) has been established to provide clear governance, communication and decision-making to improve the management of medicine shortages.
- Ensure your organisation is familiar with the latest information on supply disruption: This includes making sure your organisation is able to share the information in supply disruption emails, Central Alerting System (CAS)alerts and other communications to the system with clinicians. Medicines shortages will be managed at a national level in line with usual practice.
Information has been published on NHS.uk for patients.
Are there plans to stockpile medicines in the UK ahead of 31 October 2019 as there were ahead of 29 March 2019?
Yes, plans are in place to support medicine suppliers to build buffer stocks of prescription-only and pharmacy medicines in case there are difficulties in shipping medicines using current transport routes. This is part of the measures outlined above.
The stockpiling element of the government’s medicines contingency measures is for medicines and medical products that would require a prescription or that patients would usually get under supervision from a pharmacist, and that are either made in the EU/EEA or contain ingredients or components made in the EU/EEA.
DHSC has been working closely with medicines suppliers. DHSC originally wrote to suppliers in August 2018 in order to give them time to increase production. DHSC received assurances from companies that they had an additional six-week stockpile of the vast majority of in-scope medicines. This has been followed up with a letter from DHSC’s Chief Commercial Officer, Steve Oldfield, to suppliers on 26 June 2019 about the Government’s approach to delivering continuity of supply of medicines and medical products in the event of a ‘no deal’ EU exit on 31 October 2019. DHSC has recently contacted all those suppliers individually again, seeking further reassurances on their plans.
Should patients keep ordering repeat prescriptions and taking medicines as normal?
Yes. There is no need for patients to change the way they order prescriptions or take their medicines. Patients should always follow the advice of doctors, pharmacists or other prescribers who prescribe and dispense their medicines and medical products. The NHS does experience temporary shortages of some medicines, and has tried-and-tested ways of making sure patients receive their medicines and medical products, even under difficult circumstances. If patients order extra prescriptions, or stockpile, it will put pressure on stocks, meaning that some patients may not get the medicines or medical products they need.
Should GPs provide larger or longer prescriptions?
No. GPs will continue to prescribe medicines and medical products as normal. Patients asking for longer than normal duration prescriptions is not helpful or appropriate because oversupply to some patients could mean others don’t get what they need. Prescription durations will be monitored and investigated where necessary.
What about medicines with short shelf-lives?
For medicines that cannot be stockpiled because they have short shelf-lives, such as medical radioisotopes, DHSC has asked suppliers to arrange alternative routes using air freight, which some suppliers do already. DHSC is continuing to work with suppliers of short shelf-life medicines, including medical radioisotopes, to ensure that robust contingency arrangements continue to be in place ahead of a possible ‘no deal’ EU exit on 31 October 2019.
If there are problems with the government contingency plans or there are shortages for any other reason, will patients still be able to get suitable prescription medicines and medical products?
Yes. The NHS has tried-and-tested ways of mitigating the impact of temporary medicines shortages. In addition to these, a new clinically chaired Medicines Shortage Response Group (MSRG), which the DHSC Medicines Supply Team and Commercial Medicines Unit report to, has been created to support the management of medicines shortages.
The MSRG will receive regular reports from the pharmaceutical industry about issues that could interrupt the supply of medicines. It will work with stakeholders to explore options to mitigate and manage any issues. This might include working with the Medicines and Healthcare products Regulatory Agency (MHRA) to expedite regulatory procedures, working with manufacturers to manage remaining supplies, expediting the delivery of further stock and commissioning clinical advice on alternative options from specialist clinicians.
This means that if a medicine is temporarily unavailable, patients may be supplied with the most suitable alternative by a pharmacist. This will be under very strict parameters, for a limited time and approved by very senior medical staff. This might be a reduced quantity of the patient’s medicine, a different brand of the same medicine or perhaps a different strength of their usual medicine to make up the dosage.
On rare occasions, it may mean a different medicine to do the same thing, or if the patient’s device is unavailable, a different device. Pharmacists will be provided with clear national clinical guidance in each case should this become necessary. Clinicians will make the decision in discussion with patients, who will be provided with all the necessary information on any decision in order to ensure the patient’s informed consent. This will ensure that patients continue to receive the treatment they need.
Will information about specific medicines and medical products be made available?
The NHS and DHSC will be monitoring the medicines and medical products supply chain very carefully, using well-established mechanisms to deal with supply issues when they arise.
Through everyday business, unrelated to EU Exit, DHSC circulates regular updates about supply issues affecting any medicines used by the NHS, including to clinical commissioning groups (CCGs), GPs, pharmacies, hospitals and other care providers. DHSC also liaises with specialist clinical groups, patient groups and other relevant networks to share information about supply issues that may affect specific patient groups.
There are existing systems in place to share messages quickly to the NHS and others for patient safety alerts, important public health messages and other safety critical information and guidance. If a specific medicine shortage emerges prescribers and pharmacies will be quickly alerted and advised of the appropriate management plan for patients who may be affected.
What are Serious Shortage Protocols?
A Serious Shortage Protocol (SSP) is an extra tool to manage and mitigate medication shortages. It may be used in the exceptional and rare situation that other measures have been exhausted or are likely to be ineffective. NHS Business Services Authority (NHS BSA)has published information on Pharmaceutical Services Negotiating Committee.
An SSP enables community pharmacists to supply a specified medicine in accordance with a protocol when the medicine prescribed is in short supply or unavailable, without the need to seek authorisation from the prescriber. This means patients would not need to go back to the prescriber or GP before receiving an alternative quantity, brand, formulation or medicine.
An SSP may cover the supply of one or more of the following:
- an alternative quantity
- an alternative pharmaceutical form
- a different strength up to the same dose
- a generic equivalent or different brand
- a therapeutic equivalent of the medicine that was prescribed.
Any protocol would be developed by senior, specialist doctors and pharmacists, with input from national experts and Royal Colleges and engagement with the relevant patient groups. Each protocol would clearly set out what action can be taken by the pharmacy, under what circumstances, for which patients and during which period.
SSPs will not be suitable for all medicines and patients. For example, protocols would not be suitable for patients with complex medication regimes, and protocols for generic or therapeutic equivalent medicines would not be suitable for patients who need to be prescribed medicines by brand for clinical reasons. In these cases, patients would be referred to the prescriber for any decision about their treatment.
Will any routine NHS operations be affected?
Planning for EU Exit has been developed in partnership between the government and the NHS, with the focus on making sure there is as little impact on the NHS as possible. This means that routine operations should not be affected. However, in exceptional circumstances, NHS organisations would be expected to prioritise care for patients in emergencies and minimise disruption.
What about ‘over the counter’ medicines?
General sales medicines, often referred to as ‘over the counter’ medicines, which can be sold in general retail outlets without the supervision of a pharmacist are not included in the stockpiling element of the government’s approach to medicines supply because there are multiple alternatives available if there is short-term supply disruption.
However, all over the counter medicines are part of the government’s approach outlined above. This includes DHSC’s work with suppliers to support their contingency plans, including the re-routing of supply chains away from the ports where delays are more likely to occur and improving suppliers’ readiness of their logistics and supply chains to meet the new customs and border requirements from 31 October 2019 in a ‘no deal’ EU exit.
Will patients still get their medicine if they are on a clinical trial?
The NHS and the government are working with organisations running clinical trials to ensure that research continues as normal in the coming months. They have encouraged these organisations to consider their supply chains for clinical trials, and to ensure appropriate supplies of trial drugs and medical products are in place.
Those responsible for recruiting patients into clinical trials should continue to do so unless they hear from a trial sponsor, from the organisation managing the trial or clinical investigation, or from formal communications.
Chief investigators, or the organisation managing the clinical trial/investigation, should liaise with trial sponsors to understand their arrangements for ensuring supply for clinical trials and investigations. Organisations should not stockpile locally and if approached to do so by a sponsor, should escalate via your organisation’s EU Exit Senior Responsible Officer (SRO).
What about the supply of blood and blood products?
There are some medicines that are derived from blood plasma such as immunoglobulin, albumin, and clotting factors. As these are licensed medicines, they are included in the medicine supply plans.
The UK is largely self-sufficient in blood and blood components and does not routinely export or import these products, except for relatively small quantities of plasma imported by NHS Blood and Transplant (NHSBT) for use in those born after 1996 as an agreed safety measure. In very special cases NHSBT does export or import very rare blood for urgent clinical need, usually in single unit quantities. DHSC is working closely with NHSBT, which is leading on the contingency planning for blood and blood components, to help ensure continuity of a safe blood supply.
What about vaccines?
Public Health England (PHE) manages significant stockpiles of vaccine for the national immunisation programme, as part of their business as usual planning. PHE is working closely with vaccine suppliers to ensure replenishment of these stockpiles continues if supply is disrupted, for example, agreeing increases in supplier’s own UK stockpiles.
DHSC is also working to help ensure there are sufficient stockpiles of vaccines for other NHS and non-NHS uses, such as for travel and occupational health purposes, within its medicines contingency measures.
What about unlicensed medicines and specials?
DHSC is working closely with the suppliers of unlicensed medicines and specials. Active ingredients and excipients used in the manufacture of unlicensed and special medicines are included in the government contingency plans.
Suppliers of unlicensed and special medicines with an EU/EEA touchpoint will be contacted by DHSC in order to help ensure they have in place appropriate mitigations to help ensure continuity of supply.