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It is acknowledged that aseptic compounding is one of, if not the, highest risk activities undertaken in pharmacy. Within the field of aseptic compounding, parenteral nutrition (PN) solutions are amongst the most complex and high risk products that are handled, due to their complexity, the number of ingredients, complex stability issues and the potential for the support of microbiological growth. The high risk nature of PN solutions has unfortunately been highlighted by a number of tragic incidents associated with compounding errors and microbiological contamination in recent years that have at times resulted in patient harm and even death. These incidents have occurred in the UK and abroad, and within the UK have been seen in both NHS facilities and commercial specials manufacturers. It is clear that wherever the compounding takes place, there is a risk of these errors and contamination incidents occurring and so robust systems need to be in place to ensure the risks are adequately controlled. This is equally relevant whether the PN is made in house or when the decision is made by a Trust to outsource PN to an external third party provider whether NHS or commercial. The purpose of this document is to give guidance to those outsourcing PN compounding on the risks in the outsourcing and supply process and to enable them identify where local risk control strategies will need to be developed and implemented to manage these risks. However, many of the risks highlighted will also apply to in house compounding and so those NHS units making PN for their own patients may also find this document a useful source of reference. Exploring the drivers for outsourcing and whether this is in fact the best option for supply of PN solutions is outside of the scope of this document; however these should be considered before an outsourcing decision is made.

In 2014 an investigation was commenced into the death of Yousef Al-Kharboush (born 23 May 2014, died 1 June 2014, aged 8 days), Oscar Barker (born 27 May 2014, died 29 June 2014, aged 1 Month) and Aviva Otte (born 10 October 2013, died 2 January 2014, aged 2 months). The investigation concluded at the end of the inquest on 23 October 2023.  Aviva’s death (January 2014) was in hospital where she had received TPN provided and compounded by the NHS establishment under a section 10 exemption. That TPN had, on balance, been contaminated by Bacillus cereus (subsequently identified as type BC.38). The Trust undertook a root cause analysis together with involving the UKHSA and its own infection and microbiological teams, but no definitive source for the outbreak was found. In June 2014 Oscar Barker and Yousef Al-Kharboush received TPN, compounded by a commercial provider, which it turned out was also contaminated by Bacillus cereus (subsequently typed as Bc.44). The compounder having positive finger dab testing for the Bacillus within its laboratory/environmental testing. This outbreak also affected other babies in other Trusts. Bacillus cereus is resistant (because it is spore forming) to the spray and wipe cleaning methods used (with alcohol) and sporocides are required to decontaminate the outside of, for example, ampoules containing one of the constituents. This was the information and a conclusion that the Trust had reached in early 2014 and therefore prior to the outbreak in May/June 2014. It had not passed on those findings either within other section 10 units compounding TPN or the wider market. Subsequently, the MHRA brought in further advice for the use of sporocides in 2015. Matters of concern There is no requirement for a section 10 exempt entity to report any of its findings to the MHRA or indeed to other Trusts or the industry in general if an adverse event occurs. The current reporting structures (for a section 10 entity) involve reporting to NHSE and the CQC but the threshold or necessity for such reporting appears unclear and, in essence, up to the Trust. There may be times when section 10 entities reach conclusions which would assist the wider industry and help to assist both other Trusts and commercial organisations in assessing their own risks and improving the provision of highly specific medication to a group of vulnerable patients. The same may also be true of commercial organisations but they have the power of the MHRA controlling and effecting recalls and actions and the wider dissemination of information. Response from NHS England

Parenteral nutrition (PN) is recognised as a complex high-risk therapy. Its practice is highly variable and frequently suboptimal in paediatric patients. Optimising care requires evidence, consensus-based guidelines, audits of practice, and standardised strategies. Several paediatric scientific organisations, expert panels, and authorities have recently recommended that standardised PN should generally be used over individualised PN in the majority of paediatric patients including very low birth weight premature infants. In addition, PN admixtures produced and validated by a suitably qualified institution are recommended over locally produced PN. Licensed multi chamber bags are standardised PN bags that comply with Good Manufacturing Practice and high-quality standards for the finished product in the frame of their full manufacturing license. The purpose of this article, published in Clinical Nutrition, is to review the practical aspects of PN and the evidence for using such multi-chamber bags in paediatric patients. It highlights the safety characteristics and the limitations of the different PN practices and provides some guidance for ensuring safe and efficient therapy in paediatric patients.

A patient shares her story of how catastrophic complications from a hysterectomy has changed her life forever. My health has always been a ‘challenge’ as they say. I had a stoma in 1988, when I was 28 years old, for bowel disease. They were never sure if it was Crohn's disease or ulcerative colitis, but I was more than happy to kiss my rotten colon goodbye. It restored my bowel health and I carried on working and living my life with my husband and child. Two years after the ileostomy, I had further abdominal problems and a MRI suggested ovarian cancer. I had an emergency laparotomy which revealed severe endometriosis which had obliterated my whole pelvis and infiltrated my internal organs. The gynaecologist closed me up and said nothing could be done as my pelvis was ‘frozen’ and I would have to be treated medically. The condition plagued me for the next 20 years; I developed cysts in the pelvis which were drained repeatedly. My health was at times poor but I still managed to work and live my life. In 2010, my gynaecologist retired and I was referred to a new team. They were based 80 miles from where I lived, which was a nuisance but I felt it was worth the journey to have the best. They were adamant I needed a hysterectomy – they were not happy with the recent imaging and felt one of the cysts looked suspect. I spent years putting this off as I was very fearful. I had been told it could be very easy to make things much worse. In 2012 my mum had a massive brain haemorrhage and I became her carer, but by 2014 they were still saying I needed the surgery to find out what the suspect mass actually was so, reluctantly, I agreed. January 2015 The hysterectomy went ahead at a private hospital. I was in BUPA, my mother was brain damaged and I was her carer, I needed this op out of the way so I could go back to caring for her. I awoke from the surgery to be told it had been very difficult – I felt totally wiped out. Two days after the operation, there was no improvement. I was encouraged to get up from the bed; I could barely move but I managed a few steps when I felt something running down my legs forming a green puddle on the floor. My bowel had perforated and the contents were flooding out of my vagina. My consultant was away and I was transferred late at night to the local NHS hospital. That was a nightmare in itself as they at first wouldn’t accept me. I lay there in A&E with warm liquid pumping out of me with every spasm of my bowel. I was convinced it was blood and I tried not to think of my loved ones whom I thought I’d never see again. My poor husband looked on helplessly; he spent a freezing night in the car as he wanted to be near me. I spent 3 months in hospital being fed through my central vein. I was told I may never eat or drink again and my whole life just fell apart. It was explained the suspect mass was in fact a twisted mess of bowel, adhesions and goodness knows what possibly caused by the repeated aspirations I’d had for the endometriosis. I was told because of the perforation I now had a fistula which is essentially a connection between my small bowel and my skin. Despite my numerous surgical experiences, I had never heard of such a thing but Dr Google soon educated me and it did not make good reading. I became seriously depressed, wanting my life to end. I was discharged in the spring of 2015 to a totally different world. I could by now eat small amounts but the holes appearing on my abdominal wall were evidence the fistula had not healed. I was too afraid to move as any activity meant I’d have ominous discharges from various orifices. I totally lost confidence in myself, the doctors and the world in general… I became a recluse. Life with a fistula was difficult. Apart from the constant dressings required to contain the output, I was in permanent pain and suffered frequent infections. Considering I had gone into hospital reasonably well and come out like this was almost too much to bear. I tried to access mental health support but I was put on a waiting list whilst my mental state got progressively worse. I was told I would have to wait for two years for the fistula to be repaired. It was a long wait, my daughter had a baby so that kept me going and I looked forward to being free of this demon within. I missed the old capable me so much. March 2017 The repair op took place this time in the NHS hospital, albeit as a private patient again. I couldn’t wait any longer and so once again made use of my medical insurance. Again I had serious complications. The days that followed the surgery were horrific, I truly wanted to die. My gut had stopped working, a condition called ileus. Bile was building up in the stomach so I had a nasogastric tube inserted; the thirst was causing me to have hallucinations. I tried to impress upon everyone how ill I was feeling, but I didn’t feel believed; they told me I was anxious and all my problems were normal post op things. My husband called as usual to visit, getting more worried as each day was passing. I had spiked a temperature of 39.6⁰C. I cried into his chest as I tried to sit up to relieve the horrific symptoms I was experiencing. Next minute I had no breath, I was suffocating. My husband called for help and, even at that point, I was told I was having a panic attack until the nurse saw my oxygen levels – they were 71% which was dangerously low. I was having a stage 1 respiratory arrest, and I was rushed to ICU and spent days fighting for my life. A three month hospital stay followed and this further catastrophe had resulted in a fistula worse than the one I went in with. I now had to wear three stoma bags, two of which leaked constantly. I felt a mutilated mess. Again, I left hospital a broken shell, with no support apart from my family who were also finding it hard to accept what had happened to me. Life now... It’s now 3 years since the failed repair and I have never recovered. It actually made things much worse. As well as the fistulae and three stoma bags, I now have bladder problems as part of my bladder was excised during the last op and gallbladder disease thanks to the parenteral nutrition. The inflammation in my body has led to autoimmune diseases, such as scleritis, which is an agonising and destructive eye condition. The whole awful experience has left me a broken, psychological wreck. I finally accessed mental health support at the end of 2019 and have been diagnosed with post traumatic stress disorder (PTSD), anxiety and depression. Life is difficult. In my mind there are so many unresolved issues which have plunged me into a deep pit of depression I can’t get out of. The therapy I now receive is ‘systemic’ so basically addresses how my husband and I are responding to the trauma, rather than the trauma itself. The initial trauma of my surgery going so wrong has now been followed by a second trauma of lack of support, feelings of worthlessness and the consequences of having a complex condition whilst living in rural west Wales where my local hospital can’t treat me. How I wish I’d said NO to that fateful hysterectomy! But we don’t do we. The surgeons are the experts, they lead and we follow, that’s how it works. Lamb to the slaughter springs to mind. That is probably unfair, my surgical luck was bound to run out one day, but I am angry at losing one of life’s most important gifts – good health. To make matters worse I’ve discovered that the suspect mass that they told me had to come out, had actually been identified 30 years previously. It was a harmless benign fibroma. That makes things harder to bear as I realise I probably never even needed the surgery. I didn’t complain or even ask many questions as I was too ill, traumatised and exhausted. My mother ended up in a home, my marriage is understandably struggling, my husband and I no longer work. I had nothing left to challenge anyone. My psychologist says I need answers to help me move on but I’m now told it’s too late. I have to go back to that hospital because I am now so complex my local hospitals won’t treat me. It’s a 3 hour round trip to a place that absolutely terrifies me. An enterocutaneous fistula is a very rare complication of surgery. But as I told my Consultant, it’s only rare until it happens to you. Then statistics become irrelevant. They seem to overlook the fact that there is a person behind that tiny statistic, who has to somehow learn to live again with all the fallout of that disastrous surgical experience.

Total parenteral nutrition (TPN, also known as PN) is a method of providing nutrition directly into the bloodstream to those unable to absorb nutrients from the food they eat. TPN is used in all age groups, but in babies its use is often as part of a temporary planned programme of nutrition to supplement milk feeds in those too immature to suckle or too sick to receive milk feeds as a result of intestinal conditions. TPN consists of both aqueous and lipid components, which are infused separately into the baby via specific administration sets and infusion pumps. The rate at which TPN is administered to a baby is crucial: if infused too fast there is a risk of fluid overload, potentially leading to coagulopathy, liver damage and impaired pulmonary function as a result of fat overload syndrome. In a recent three and a half year period 10 incidents were identified where infusion of the aqueous and/or lipid component of TPN at the incorrect rate resulted in severe harm to babies through pulmonary collapse, intraventricular haemorrhage or organ damage, and where intensive intervention and treatment were needed. Most of these incidents involved too rapid a rate of infusion.