We are currently acting for a group of clients that have all been adversely affected by the disruption in supply of their parenteral nutrition (TPN/HPN/PN) bags manufactured by Calea.
Total Parenteral Nutrition (TPN) is the administering of vital nutrients via the bloodstream through a central venous catheter (CVC).
TPN will be a patient’s only source of nutrition as the nature of their condition means they cannot absorb nutrients from food in the usual way. TPN can be administered at home or in hospital.
Parenteral Nutrition (PN) is also administered into the bloodstream through a CVC. However, this is administered as a supplement to a patient taking food normally.
The specific types of CVC devices that medical professionals may use to administer TPN are a PICC line (peripherally inserted central catheter) or a Hickman line. The device used will depend on the how long the TPN is required. Through this, a patient can be provided with a balance of nutrients quickly by bypassing the gastrointestinal tract to prevent malnutrition and sustain a life when a person is unable to eat or absorb nutrients.
The basic ingredients of TPN are fluids, sugars, electrolytes, lipids, amino acids, minerals, and vitamins. The TPN solutions will vary depending on an individual patients’ other medical conditions and the patient’s age.
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Calea is a specialised homecare company that aims to work with healthcare professionals to provide care and treatment packages that meet their tailored requirements and patients’ needs. Specifically, Calea formulates and supplies Total Parenteral Nutrition (TPN) to patients who cannot absorb nutrients on their own. Calea, based in Runcorn, is one of only a handful of firms that supply TPN in the UK.
Following a routine inspection on 24-26 June 2019 by the Medicine and Healthcare Regulatory Agency (MHRA), it was found that Calea’s Runcorn site failed to meet the requirements of guidance for manufacturing sites published by MHRA in 2015. This inspection resulted in the MHRA having “serious concerns” about Calea’s procedures and found a “significant risk to product safety” .
Due to the critical and major deficiencies identified by the MHRA in Calea’s manufacturing processes, Calea was forced to change their manufacturing processes resulting in an immediate and significant reduction in supply of TPN. The reduction in supply led to very limited availability of TPN, with many patients having their prescription TPN bags substituted for multi-chamber bags (MCB), also known as ‘off the shelf’ bags which are not tailored towards the needs of individual patients.
On the 13 August 2019, the NHS has declared this situation as an emergency incident “at the highest level” along with setting up a National Action Group run by the UK Government’s Department of Health and Social Care. Dr Aidan Fowler, the National Patient Safety Director, outlined a strategy to work with other TPN suppliers, monitor patients affected by the reduction in supply, ensure an adequate supply of MCBs and access stock from abroad.
Alongside these efforts, an incident management team was also created to allocate the limited supplies of prescription TPN to each Trust for future allocation to patients assessed to be at highest risk. Nonetheless, these measures have still left patients who are in desperate need of prescription TPN without the treatment they need.
Given Calea is “one of only a handful of firms” supplying TPN, this disruption has had significant impact on their current patients and has already started having a knock-on effect on patients awaiting treatment . A report by the BBC has stated that more than 500 patients have had their regular supplies halted and it is still unclear exactly how many people the shortage has affected. Initially, Calea was determined to resolve their supply issues within four weeks. However, the disruption has far surpassed this timescale and has still not been resolved.
We couldn’t have had a better solicitor. So knowledgeable and efficient, yet the most kind, caring and understanding friend all rolled into one, at a time when few people could really understand what my injury had done to me.
— Client
As a result in the disruption of supply from Calea of prescription TPN bags, many patients were required to substitute their prescription TPN for multichambered bags (MCB), also known as ‘off the shelf’ bags. However, these do not provide adequate nourishment and hydration to the individual patient.
This sudden increase in the demand for MCBs led to a shortage of MCBs nationally causing further difficulties for patients who rely on this treatment to supply life-sustaining nourishment. Patients were left worrying if they will end up being admitted to hospital with malnutrition after having to wait for days without nutrition.
Calea initially considered that four weeks would be sufficient to restore the supply issues. However, the period of disruption has extended far beyond this and has led to many patients who rely on TPN to suffer from a wide variety of symptoms which have included:
Calea is one of the country’s largest manufacturers of TPN bags. Hugh James is acting on behalf of a number of patients that have been adversely affected by the disruption in supply of TPN bags from Calea. If you or a member of your family has been adversely affected by a disruption in supply of their TPN supply, then please get in touch with our specialist lawyers at Hugh James by clicking on the “Start Your Claim” button at the top of this page.
Hugh James is authorised and regulated by the Solicitors Regulation Authority (SRA Number:303202) and is authorised and regulated by the Financial Conduct Authority (FCA Number: 231167)
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