Medicines and medical devices
- Key messages
- Local authorities’ role
- Escalation process
- Resource implications
- Useful links
24 July 2020
This guidance is to support you and your clients with the supply of medicines and other items important for managing people’s health. It is mainly focused on people living in residential and nursing homes, but also gives advice for people providing medicines support for adults (aged 18 and over) who are receiving social care in the community. It aims to ensure that people who receive social care are supported to take and look after their medicines effectively and safely, whether in a care home or in their own home.
The guide covers:
- prescribed medicines
- over-the-counter medicines (those you can buy without a prescription)
- medical devices
- nutritional products
The CPA assumes no responsibility or liability for any errors or omissions in the publication of this communication. The information contained in this update is provided on an “as is” basis with no guarantees of completeness, accuracy, usefulness or timeliness.
The production of medicines and medical devices is a complex, highly-regulated global business. Problems with supplies do arise for a wide range of reasons, such as manufacturing issues, access to ingredients and batch failures. And if there is a sudden increase in prescribing particular medicines, or demand for particular products, whether in the UK or in other countries, companies may not have sufficient reserves to meet immediate demand.
So, supply problems with medicines and medical devices will always occur. There are national and local arrangements in place across the Department of Health and Social Care (DHSC), the NHS and prescribers to help lessen the risk of these affecting patients – including patients who also use social care services.
This guidance only covers situations where a particular product is in short supply generally. It does not relate to local supplies issues, for example because the pharmacy can’t get stock due to inclement weather.
In the case of any shortage, social care providers are advised to:
- not stockpile any medicines, medical devices or clinical consumables. Stockpiling could cause shortages in other areas and put people who use services at risk
- allow a little extra time for orders to be delivered
- ensure your contingency plan covers continuity of supply, and that it’s reviewed, updated and shared regularly with your local authority and clinical commissioning group commissioning teams as appropriate
- share with clients and carers the latest NHS information for the public.
Coronavirus pandemic 2020 §
The coronavirus pandemic of 2020 is active across the world. As a novel virus it is causing major disruption to everyday life, and to care and health services in particular. This paper does not cover detailed guidance on the impact on supplies during the pandemic, but the issues identified may act as a useful tool for providers to consider. Please see the following resources for detailed advice on coronavirus:
Several organisations are involved in managing the supply of medicines, medical devices and clinical consumables. We’ve included a short summary of what Government departments and national bodies do to help ensure continuity of supply and manage any concerns. Further details are available in the DHSC and NHS Guide to managing medicines supply and shortages.
The DHSC works closely with the NHS and those involved in manufacturing, supplying and transporting medicines and medical products to help prevent shortages and to ensure that the risks to patients are minimised when supply issues do arise. DHSC has well established processes and uses a host of tools to help mitigate and manage any supply issues. This includes working with the Medicines and Healthcare Products Regulatory Agency (MHRA) to expedite regulatory procedures, working with manufacturers to manage remaining supplies and expedite the delivery of further stock, exploring the import of unlicensed medicines from abroad and commissioning clinical advice on alternative options from specialist clinicians. As a result, not all medicine supply issues will result in a shortage.
The Government has also introduced legislation to enable medicine supplies to be managed in the case of any shortages. A Serious Shortage Protocol (SSP) is an additional tool to manage and mitigate medicine and medical devices shortages. An SSP would only be used in the case of a serious shortage if in the opinion of Ministers, it would help manage the supply situation and if clinicians advising Ministers think it is appropriate.
When an SSP is issued, this means community pharmacists can substitute a patient’s prescribed medicine with a specified alternative, without the need to refer to the prescribing clinician and only when clinically appropriate to do so. An SSP may cover the supply of one or more of the following:
- an alternative quantity
- an alternative pharmaceutical form
- a different strength
- a generic equivalent
- a therapeutic alternative
of the medicine that is prescribed. In the case of devices, it may simply be a different product.
SSPs are not suitable for all medicines and patients, such as those with complex medication regimes or those who need a particular brand of medicine for clinical reasons. In these cases, any decisions on the patients’ treatment regime should be referred back to their prescriber. For more information, please refer The NHS Business Services Authority (NHS BSA) has published information on Serious Shortage Protocols.
Government and NHS England§
The Department of Health and Social Care, working with NHS England, communicates with clinical commissioning groups, GPs, hospitals, pharmacies and other care providers about everyday issues affecting supplies. It also shares information with patient and specialist clinical groups and various networks where supply issues could affect certain patients. Other important messages are also shared quickly when needed, for safety or public health reasons.
DHSC has well established processes to manage and mitigate the small number of supply problems that may arise at any one time. In the event of specific medicines or medical product shortage, they ensure pharmacies and prescribers are alerted quickly with details of how to support people who might be affected.
If you provide residential or nursing care, you’ll already know what medicines and medical devices the people you care for require. This is part of their assessment of need and will be logged in their care plan. So, you’ll already have a record of the supplies you need for your service.
You can help prepare for any possible local supply issues by taking the following actions:
- ensure your contingency plan covers continuity of supply, and that it’s reviewed, updated and shared regularly with staff and partners who need access to it. This element of your contingency plan should reflect the plans developed by your local prescribers (GPs and consultants), pharmacies and local authority or other NHS partners. Ensure you’ve included all relevant contact details in your plan, so they’re readily to hand if needed urgently.
- consider accessing supplies from other suppliers, including other pharmacists, in situations where the shortage is localised to only one supplier.
- ensure all members of staff understand the process for ensuring continuity of supply and reporting any concerns they might have.
- do not stockpile any medicines, medical devices or clinical consumables. Stockpiling could cause shortages in other areas and put people who use services at risk.
- keep the people who use your services, their families and carers up-to-date with the latest relevant NHS information on their medicines
- keep up-to-date with any announcements about continuity of supply in your area (see escalation process).
- be prepared for pharmacists to issue different medications from those normally prescribed, should supplies become short nationally. You may need to adjust clients’ medication plans and explain the changes to them. This is likely to take up additional staff time, so you should consider whether there are other tasks that could be postponed or temporarily reduced in scale, or whether you could increase your staffing capacity for a short period.
If you support people in the community to take their medication, you’ll find NICE guidance here.
Should a supply shortage arise, you can also tell people you support that:
- They should not ask for prescriptions to cover more time than normal as this might mean others can’t get what they need.
- there’s no need for them to change the way they order prescriptions or take their medicines. In particular, they should not reduce the frequency with which they take their medicines to make it last longer, as this can be dangerous.
- they should always follow the advice of their doctors, pharmacists or other professionals who prescribe and dispense their medicines and medical products. They may temporarily be switched to a different medicine or medical device, should their usual one become in short supply. They should follow the advice they’re given at the time.
- if they do start to run short of medicine, they should alert their GP and their care provider.
Case study: The Polesworth Group§
The Polesworth Group operates seven care homes, a respite day service and a domiciliary care service for more than 100 people with learning disabilities in North Warwickshire. Warwickshire County Council commissions 97 per cent of the group’s work, with clients ranging from 19 to 78. Most clients need support in managing medicines, but some using the day service manage their own.
As part of its business continuity planning process, the company works closely with the local authority and its preferred pharmacy. It also engages in provider forums and contract portals, and managers have read national guidance to understand the key issues that might affect the supply of medicines. It carries out regular reviews of all client medicines to determine supply arrangements and make sure sufficient stock is available.
Local authorities’ role§
Local authorities have a duty to ensure the wellbeing of people who are in the care system – including the people you support.
You should expect your local authority to check that, as part of your contingency planning arrangements, you’ve taken all reasonable steps to ensure you have plans to manage any concerns about continuity of supply of medicines.
If you can’t resolve service issues because of medicines supplies then you should approach your local authority commissioning team. They will advise on how to escalate the issue further if required.
Your contingency plan should outline your escalation process, which identifies who you’d contact if you couldn’t resolve any issues relating to the supply of medicines or medical devices.
In most cases, it’s likely any imminent shortage would become known to your local pharmacist or GP first, as this would be flagged in the supply chain and they’d alert you to this and agree with you the most appropriate steps to reduce any impact.
Should these steps fail to resolve the issue, or you experience a shortage you hadn’t already been told about, you should talk with your local pharmacist or GP to see if the issue could be resolved. In most instances they’d provide an alternative medicine if it was suitable for the patient to change brand. If there was a need to prescribe an alternative medicine they’d also be able to provide a new prescription through the local surgery. Their contact information should be visible on any prescription items or doset boxes clients have.
If you couldn’t resolve issues to do with any supplies, you should contact your local authority commissioning team. In the event that there was a significant risk to your ability to maintain services, they might then advise on further action. The local authority might look to support you by working collaboratively with other local providers to share supplies.
If the issue might affect your ability to deliver your service, you should also alert your local Care Quality Commission contact.
Access updated information on escalation processes – including the DHSC letter issued to care providers on 21 December 2020. This sets out steps that care providers can take in the event of, for example, disruption to supplies or travel.
You’ll need staff to develop and regularly review and update your business continuity plan, including the section on managing concerns about supplies of medicines and medical devices. You should also take into account that any temporary changes in medication or medical devices needed to respond to shortages could mean you have to update clients’ medication plans, possibly at short notice.
Guide to managing medicines supply and shortages – DHSC and NHS England
Serious Shortage Protocol (SSP) – NHS Business Services Authority
Business continuity guidance and template – Care Provider Alliance
There are many people and organisations who may be able to help.
- A local care association or one of the national associations which make up the Care Provider Alliance could offer peer support, resources and advice.
- Other local services, or networks such as the Skills for Care Registered Manager Forums, which can provide peer support for first line leaders.
- Local authority and health care commissioners – who may have concerns, but who don’t want to see a service close unless it is unavoidable.
The following organisations may be able to provide you with additional guidance and support.