Medication:
16.Mr I says the Trust failed to review his father’s regular medications and administer his pantoprazole medication following his admission to hospital on 30 July 2021.
17.The Trust acknowledge there is no evidence staff checked Mr A’s regular medications at time of his admission onto the ward or following the ophthalmology team review. The Trust also acknowledge the ophthalmology team had an opportunity to review Mr A’s regular medications again on 1 August, but they took no further action.
18.The Trust explain Mr A had an extended stay in A&E and this may have contributed to confusion around which team was responsible for his care on admission and the prescription of the regular medication. It says Mr A was admitted under the maxilla-facial team before being transferred to the ophthalmology service, which also may have contributed to confusion around clinical roles and responsibilities.
19.Mr A had been taking pantoprazole (a type of PPI) since he had a suspected upper GI bleed during his previous hospital admission in April 2020. PPI’s are used in the management of a variety of acid-related disorders and they all act in a similar way by preventing active parietal cell acid secretion. The parietal cell is found in the stomach lining.
20.NICE quality standard on medicines optimisation says, ‘service providers (such as secondary care and mental health providers) should ensure that systems are in place for people who are inpatients in an acute setting, to have a reconciled list of their medicines within 24 hours of admission’.
21.We can see from the records Mr A attended A&E on 30 July and his presenting complaint was a right eye infection spreading across his face. The A&E doctor listed Mr A’s regular medications (including pantoprazole) in the notes.
22.Doctors diagnosed Mr A with acute chronic dacryocystitis (inflammation and infection of the tear sac and duct) and decided to admit him to a ward for further observation and treatment. The notes say it was not possible to admit Mr A to the ophthalmology ward as there were no beds, so he was admitted to another ward as an outlier. On review of the records, we cannot see any mention of Mr A’s regular medications when he arrived on the ward or any notes to suggest this was reviewed.
23.Following a conversation between an ophthalmology consultant and a maxillo-facial clinician on 1 August, the notes say ‘ophthalmic registrar to prescribe regular medications’ but there is no evidence this was done. Later the same day, a nurse recorded ‘medication list found in property’ but again there is no evidence this was followed up with any further action.
24.A pharmacist completed a medicines reconciliation on 2 August but there is no indication in the notes they identified Mr A’s regular medications including pantoprazole and/or flagged this to the clinicians or ward staff.
25.The notes show clinicians prescribed Mr A’s regular medications on 3 August at 10:56am and they were given at 10:37pm that evening. This means there were three days where Mr A did not receive his pantoprazole medication following his admission to hospital, and there was a further almost 12-hour delay between when the pantoprazole was prescribed and when it was given.
26.We can see the Trust has acknowledged in its investigation reports there were multiple missed opportunities to identify and prescribe Mr A’s regular medications both in A&E and on the ward. It did not act in line with the NICE quality standard by carrying out medication reconciliation within 24 hours of his admission to hospital and we consider this is a failing.
Impact
27.Mr A believes the missed pantoprazole doses caused his father’s upper GI bleed and this led to his father’s very sad death.
28. In its second investigation report, the Trust says whilst the exact cause of the upper GI bleed cannot be known, it is considered possible but unlikely that the omission of four doses of pantoprazole had a material effect. It says it is known that patients who are generally unwell have a significantly increased risk of developing an upper GI bleed. It says it considers the omission of the doses of pantoprazole over a four-day period would have had little effect. During the local resolution meeting on 25 November 2022, the Trust said it was more likely Mr A’s death from the GI bleed was due to systemic infection and a stress response linked to the local eye infection.
29.On the Death Certificate, Mr A’s cause of death was:
1a. spontaneous upper GI bleed
2. Acute on chronic Dacryocystitis Frailty of old age
30.Mr A was 92 years old, and he was clinically frail. Before his admission to hospital, he was in a care home, dependant for personal care and he was a high falls risk. There is also mention in the notes that he had some cognitive impairment. Our geriatrician adviser says these factors combined with his advanced age would put Mr A with a score of seven on the rockwood clinical frailty scale, which would indicate severe frailty.
31.Journal article ‘association of frailty with all-cause mortality and bleeding among elderly patients’ concluded that frailty and advanced age are associated with an increased risk of bleeding in older patients.
32.Prior to his hospital admission, Mr A was quite stable and there was no indication he was at high risk of dying in the next six months. However, when the clinical frailty score is high (i.e. a score of 7-9) even when illness acuity was low, the risk of the person dying within 30 days is still significantly high. This means even a mild illness can make clinically frail, older people very unwell and put them at risk of dying.
33.Mr A went three days without his pantoprazole medication, and it was given late in the evening on the fourth day (3 August). On the morning of 4 August at 6:58am, the notes say Mr A shouted he was in terrible pain and by 7:11pm, he had ‘coffee ground vomiting’ which is a sign of a developing a GI bleed. Clinicians started a pantoprazole infusion at 11pm that evening, but by this time Mr A had already deteriorated.
34.Causes of upper GI bleeding include gastric and duodenal ulcers. The duodenum is the first part of the small intestine that connects to the stomach. Our gastroenterology adviser says major life-threatening GI bleeding usually originates from an artery in the stomach or duodenal wall. PPI therapy alone is mostly inadequate to manage this severity of bleeding and usually requires endoscopy therapy. The acid suppression effects of pantoprazole last up to 24 hours and therefore the omission of PPI therapy for three days may have had an impact. On balance our gastroenterology adviser says the omission of PPI therapy alone would not have been the primary cause of a life-threatening arterial bleed from the stomach or duodenum.
35.Mr A was at high risk of developing a GI bleed as he was elderly, had an acute illness and had a previous GI bleed. PPI’s have a protective effect and reduce the risk of developing a bleed, but it does not reduce the risk to zero. There is some evidence in the literature that PPI therapy can potentially reduce the seriousness of a bleed. Our gastroenterology adviser says if Mr A had his PPI continuously, it would have lowered his risk of developing a GI bleed. It is not possible to quantify the level of risk had the PPI been given, as there is no data or literature about the risk of bleeding while on PPI’s.
36.We recognise the missed doses may have increased Mr A’s risk of having a GI bleed but it not possible for us to say what caused the bleed or whether on the balance of probabilities it contributed to his subsequent sad death, given his overall frailty and other co-morbidities.
37.We appreciate it was very upsetting for Mr I and the rest of the family to find out that their father did not receive his regular medications and to have questions and uncertainty about the cause of his sad death. We recognise this caused additional distress at an already very difficult time.
38.The Trust has apologised for what happened and acknowledged what went wrong. It has detailed a number of ‘lessons learned’ in its investigation report and set out how it will share with the relevant teams for wider learning. It set out an action plan on what it will do to prevent the same issues from happening again including:
•integrating a pharmacist into the A&E team to support medication reconciliation for patients whose transfer to a ward is delayed •creating a new role of patient safety facilitator •developing and trialling a new app to manage patients’ property more effectively.
Contradiction in reports:
39.Mr I says there was conflicting information contained in the Trust’s two investigation report. He said after saying the failing was a contributory factor in his father’s death, the Trust changed their mind and said it was unlikely. He says he feels the Trust were trying to avoid accountability for his father’s death.
40.The Trust issued its first investigation report on 12 November 2021. It concluded ‘the cause of the recurrence of the GI bleed was considered to be multifactorial; however, the patient had missed three doses of pantoprazole during transfer between A&E and a ward in July 2021, which was identified as a contributory factor to the resurgence of the GI bleed’.
41.In the second report dated 10 June 2022 the Trust say ‘whilst the exact cause of the upper GI bleed cannot be known, it is considered possible but unlikely that the omission of four doses of pantoprazole has had a material effect. It is known that patients who are generally unwell have a significantly increased risk of developing an upper GI bleed’.
42.NHS complaints standards say ‘an effective complaint handling system makes sure staff take a thorough, proportionate and balanced look into the issues raised in a complaint. It gives people fair and open answers to their questions based on the facts, and takes full accountability for mistakes identified….wherever possible, staff explain why things went wrong and identify suitable ways to put things right for people. Staff give meaningful and sincere apologies and explanations that openly reflect the impact on the people concerned’.
43.Throughout our investigation we have found it is difficult to say what (if any) impact the missed doses had on Mr A’s sad outcome. We therefore understand why there was some degree of uncertainty between the Trust’s two investigation reports over what the likely impact was.
44.We can see the Trust provided limited rationale about why it changed its view in the second report, and it would have been helpful if it provided further explanation about what information it considered to form this view. We can see some further explanation was provided by the Trust during meeting five months later.
45.Overall, we can see the Trust has investigated these issues fully and has been open and honest about what went wrong in line with the NHS complaint standards. We appreciate the discrepancies and lack of further explanation in the second report would have been frustrating and confusing for Mr I and the rest of the family. In its final response letter, the Trust has apologised for the inaccuracies identified in the Trust's first report. We consider enough to remedy this shortcoming in line with the complaint standards.