Supply issue to people on home parenteral nutrition from Calea

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Information on the supply issue to people on home parenteral nutrition from Calea

Calea is working to safely increase production of home parenteral nutrition at the company’s manufacturing site in Runcorn. This involves close oversight from NHS England and Improvement, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health and Social Care (DHSC).

Calea has devised a detailed programme for implementing changes in the production process which has been reviewed by the MHRA. This includes key milestones and inspections where progress will be closely monitored. Calea has indicated that implementation of the agreed changes will allow for a phased increase in production.

We will update patients as more information becomes available. The clinical support group will continue to allocate the available compounded slots to patients according to clinical need. The questions and answers below explain more about this process.

New questions have been added marked with asterisks**. If you have any further questions please send these to our customer contact centre or via the patient group PINNT on comms@pinnt.com

Background

An inspection at the end of June 2019 by the Medicines and Healthcare Products Regulatory Authority (MHRA) at the Calea site identified a need for Calea to permanently change some aspects of the manufacturing process to ensure product safety for patients supplied with total parenteral nutrition bags.

Whilst no evidence was found of defective product on the market, the changes have led to supply problems which risks increased hospital admissions for patients as supplies run short. The replacement product, multi-chamber bags (MCBs), are being supplied where clinically appropriate to people who cannot have their usual compounded parenteral nutrition.

When the situation initially arose, an NHS action group was established to determine the effect this would have on those receiving parenteral nutrition. In order to deal with the issue as quickly as possible the NHS set up an incident management team to replace the action group. The NHS incident management team continue to work with Calea, MHRA and other key health sector partners.

Frequently asked questions

**You said that this will go on ‘well into 2020’ – can you provide an update on when this situation will be resolved?

Unfortunately at this time, we’re unable to give a more specific timescale for when this situation will be resolved. Calea has devised a detailed programme for implementing changes in the production process which has been reviewed by the MHRA. This includes key milestones and inspections where progress will be closely monitored. Calea has indicated that implementation of the agreed changes will allow for a phased increase in production.

As more compounded slots become available these will continue to be allocated to the patients with the greatest clinical need by the clinical support group. All applications to the clinical support group are made by a clinician on behalf of their patient.

**What reassurances can you give that those working to resolve this situation understand the personal burden on patients and carers?

We understand that this has been a difficult time for patients, carers and their families. We appreciate that some patients are continuing to require extra infusions which is having an impact on their general well-being and that some patients may be experiencing issues with part or missed deliveries.

Please note, if you have experienced issues with your deliveries you will be contacted by your homecare co-ordinator who can provide further details.

We hope you feel reassured that all the organisations involved are working hard to make sure your care is of the high standard you expect.

**Are there any plans to increase compounding capacity in England through the Home Parenteral Nutrition framework?

A procurement process is underway to identify suppliers to provide Home Parenteral Nutrition for NHS patients in England, once the current contract expires on 31 March 2020.

*updated - Progress at Calea seems to be slow, how long will this situation go on for?

The NHS, the Department of Health and Social Care (DHSC), the Medicines and Healthcare products Regulatory Agency (MHRA) and Calea, are working hard to ensure that patient safety remains a priority. Whilst we all want to see a return to the production levels seen prior to June 2019, it is imperative that the safety of all patients is not compromised. The situation, as outlined above, is expected to continue for several more months and well into 2020.

*updated - How many patients are affected by this?

Prior to June 2019 Calea provided over 1,300 patients with home parenteral nutrition across the UK and Ireland. Approximately 460 patients were initially affected in England by the reduction in capacity at Calea. As production levels have gradually increased, the number of patients affected in England is now approximately 385. This number may fluctuate as the number of patients requiring home parenteral nutrition changes.

The NHS is working closely with Calea, DHSC and PINNT – the support and advocacy group for people on home artificial nutrition (parenteral nutrition), other parenteral nutrition suppliers, as well as local nutrition teams. This is to ensure that patient care plans are reviewed on an on-going basis and amended if required. We continue to share information with PINNT and Trusts to provide regular updates on this issue.

*updated - How do we know if the service from Calea is safe?

Throughout this process, the NHS, the Department of Health and Social Care and the Medicines Healthcare and products Regulatory Agency have put in place the measures necessary to ensure that the company’s processes comply with regulatory requirements and that the service patients receive, improves.

Initially we held daily tele-conferences with Calea. As production is gradually increasing, we now have calls twice a week. We will continue to be in regular contact with Calea to discuss issues as they arise and until we are satisfied that the service is of a high standard.

*updated - Why does my multi-chamber or fluid bag keep changing?

Due to the unexpected nature of this incident, the initial stock levels of some multi-chamber bags (MCBs) and magnesium containing fluids within the UK was lower than required.

The NHS has been working with Calea, manufacturers, homecare companies the MHRA and DHSC to make sure that we have enough stocks to maintain supply.

You may have noticed that some bags were labelled in a language other than English, although the name of the bag will be clear to you. These bags have been imported from European countries where stock was available. We would like to assure you the contents are the same as the product that is made for the UK.

We continue to monitor the availability of all MCBs from all homecare companies, to avoid further disruption for patients, receiving nutrition via this method.

Given how fragile the supply chain of parenteral nutrition is, what is being done to secure the longer-term supply of parenteral nutrition?

We recognise we need to avoid a repeat of Calea’s problems, so work is underway to examine longer-term solutions for the supply of parenteral nutrition to NHS patients.

The production of medicines and medical products including Home Parenteral Nutrition (HPN) is complex and highly regulated. Materials and processes must meet rigorous safety and quality standards. In such a complicated supply chain which draws on ingredients produced across the world, problems can arise for various reasons including manufacturing issues, access to raw ingredients, batch failures and regulatory intervention. In England there are only a few manufacturers of parenteral nutrition and when one supplier experiences a problem with production such as the issue with Calea, it creates further pressure on the whole supply chain. Addressing the long-term supply issue with HPN for NHS patients is complex we are working with the Department of Health and Social Care (DHSC), NHS trusts, clinical experts and suppliers to explore a number of options. These include a review of the pathway of care and a review of pharmacy aseptic services in England, which the DHSC commissioned NHS England and NHS Improvement to undertake. The aim of the review is to develop recommendations to deliver a high quality, safe and resilient service able to meet both current need and cope with the increase in demand for aseptic production of chemotherapy, parenteral nutrition and other medicines.

Why has Calea’s ability to make parenteral nutrition changed?

Following the MHRA inspection, Calea was required to make permanent changes to their compounding process. Calea have not yet been able to achieve previous levels or production whilst implementing necessary changes. However, there have been some improvements in this process and this has meant Calea is now able to gradually increase the amount of parenteral nutrition made. The company’s processes will continue to be monitored to ensure compliance with all the required quality and safety standards.

What fluids and replacement parenteral nutrition are those unable to have their compounded parenteral nutrition receiving?

The NHS has been in regular contact, through local trusts or nutrition teams, with all patients who have been affected by this. Where this is clinically appropriate, some patients have been receiving a different type of parenteral nutrition than usual, multi-chambers bags or fluids, for example, with vitamins and trace elements provided separately. You can be reassured that you will receive support and the best level of care when using a different feed than you are used to.

What is the impact of receiving a different type of parenteral nutrition?

It depends on your circumstances. Some patients will have received a parenteral nutrition known as a multi-chamber bag (MCB) and, whilst providing most of the nutrition and minerals you need, it is not tailored to your individual requirements, meaning that you may need to administer an additional infusion of vitamins and trace elements. For some patients, their clinical needs mean that MCBs cannot be used. In these circumstances, patients will remain on individually tailored compounded bags. If you have any concerns about your treatment then please speak to your clinical team.

What does additional infusions mean?

Compounded parenteral nutrition includes vitamins and trace elements whereas multi-chamber bags (MCBs) do not. Those receiving MCBs are likely to need vitamins and trace elements which are given separately. Your nutrition team will look at your individual circumstances as it may be possible for you to have oral vitamins and minerals in this interim period. If you require intravenous vitamins and trace elements, these will be administered either by your nursing team or by you after training has been received and you are capable of managing this procedure.

If you have any concerns or questions about the vitamins and trace elements that you are taking either orally or through an intravenous (IV) drip please contact your nutritional team.

My parenteral nutrition is set up by a homecare nurse. Will this change?

If you are having home nursing support for your parenteral nutrition, this will continue. If required, you will have the infusions of vitamins and trace elements prepared and administered during your usual nursing visits. These nurses have undertaken additional training to make sure extra infusions are given safely.

I do not have homecare nurses, I do my own procedures. What should I do?

If you are self-caring for your parenteral nutrition, patients and carers will receive additional training, either via group training sessions or individually. You will be contacted by your specialist team to arrange this training which may be in your own home or at a location close to you.

You will have the opportunity to discuss this with your own nutrition team, before and during, these essential infusions. You will be fully supported, and any concerns will be addressed for as long as these infusions are required.

Who is prioritising those people for compounded parenteral nutrition?

Initially trusts were asked to prioritise the patients who required compounding slots as they are aware of all your clinical details.

We have now formed a clinical support group to oversee this process of allocations of compounding slots across England and Wales. This group comprises of healthcare professionals who are fully aware of the importance of patients receiving compounded parenteral nutrition.

Each NHS trust submits a list of those patients most in need of being considered for one of the compounding slots. The clinical support group then uses this information to allocate slots based on a set number of clinical priorities that are known to be more difficult to manage on multi-chamber bags. The submissions to the group are anonymous and they base their decision only on the medical evidence received.

What is the process of managing parenteral nutrition allocations?

Processes are in place to ensure patients with the highest clinical need are allocated compounding slots and to ensure that this is undertaken fairly. This is supported by the clinical support group.

A protocol for this prioritisation process has been developed and issued to all trusts. This sets out the clinical priorities used to allocate new compounding slots to patients. It also details the process for trusts to follow when applying for a compounding slot for one of their patients.

A small number of compounding slots may become available if a hospital decides to remove a patient from compounding to a multi-chamber bag (MCB). The hospital can then decide to put another of their patients onto compounding.

While a number of hospitals have facilities capable of producing parenteral nutrition, many do not. The hospitals that are able to produce parenteral nutrition may be able to produce some extra compounded parenteral nutrition or manipulated MCBs (these are MCBs with vitamins and trace elements added) for Home Parenteral Nutrition (HPN) patients but have a very limited capacity to do this.

Those hospitals which cannot produce parenteral nutrition would order MCBs.

How many compounding slots are becoming available?

This varies, but please be assured that when slots are available they are assigned to those with the greatest clinical need.

Are the new compounding slots with Calea or new homecare providers?

Slots become available with Calea and other homecare providers. These compounding slots will be available to new Home Parenteral Nutrition (HPN) patients and those patients who are not managing on multi-chamber bags (MCBs). If you are a patient moving back from MCBs to compounded, you may get your HPN from a different provider than Calea. You will be informed about this in advance.

Due to the production issues at Calea described above, any patients being phased back into Calea compounding are being closely monitored to ensure the parenteral nutrition can be made and supplied to the patient on time and in full.

How long is this issue likely to last?

It is expected that the issue will last well into 2020 but we continue to work with all partners to try and return to normality as soon as it is safe to do so.

Why did this incident happen?

The parenteral nutrition market is very specialised and as a result has very few providers. Any disruption in the supply chain has a destabilising effect further down the line, which is what we have experienced with the reduction in supply from Calea. However, patient safety must always remain a priority which is why we are working with MHRA and Calea to resolve the on-site situation as well as searching the market across Europe to increase safe alternative products from elsewhere.

Who is representing the patients’ voice in this issue?

The NHS has engaged with the patient group, PINNT, as an expert body to represent the broad-ranging views of patients/parents/carers. PINNT has stated from the outset that they do not represent everyone affected by this situation. They have agreed to share all relevant updates on their website. Due to patient confidentiality there were no patient representatives on the initial action group (which is no longer operational) nor is there a representative on the clinical support group.

What other support is available?

We are working hard to make sure your care is maintained to the high standard you expect. NHS England and NHS Improvement continue to work closely with your nutrition support team to make sure you receive answers to any questions or concerns you may have.

If you would like to speak to someone, please contact your local nutrition support team in the first instance. Following the MHRA inspection, Calea was required to make permanent changes to their compounding process. Calea have not yet been able to achieve previous levels or production whilst implementing necessary changes. However, there have been some improvements in this process and this has meant Calea is now able to gradually increase the amount of parenteral nutrition made. The company’s processes will continue to be monitored to ensure compliance with all the required quality and safety standards.

What other support is available?

We are working hard to make sure your care is maintained to the high standard you expect. NHS England and NHS Improvement continue to work closely with your nutrition support team to make sure you receive answers to any questions or concerns you may have.

If you would like to speak to someone, please contact your local nutrition support team in the first instance.

You can also send queries via the NHS England and NHS Improvement customer contact centre.

or via PINNT on comms@pinnt.com

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