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Sheffield Teaching Hospitals NHS Foundation Trust

P-003262 · Statement · Decision date: 3 January 2025 · View Sheffield Teaching Hospitals NHS Foundation Trust scorecard
Drugs / medication Drugs / medication Medication Contamination/Misadministration
Complaint (AI summary)
Ms S complained Sheffield Teaching Hospitals NHS Foundation Trust inappropriately prescribed Ramipril and gave too much oxygen to her mother, believing these actions contributed to her death.
Outcome (AI summary)
Complaint closed. Doctors acted in line with relevant guidance when prescribing Ramipril and administering oxygen; no indication of failings was found.

Full decision details

The Complaint

5. Ms S complains that her mother, Mrs A was prescribed Ramipril, a medication for managing high blood pressure, in April 2023 when it was not required. She believes that Ramipril caused her next hospital admission on 11 June 2023. Ms S complains that during this admission her mother was given too much oxygen

6. She believes that both the Ramipril and the ‘high’ levels of oxygen contributed to her mother’s death on 11 Jun 2023.

7. If we identify failings, Ms S wants the Trust to acknowledge the failings in her mother’s care, an apology and for the Trust to implement service improvements to ensure other patients do not have the same experience as her mother.

Background

8. Mrs A was a 66-year-old lady who had a very uncommon heart condition called Ebstein’s anomaly. Ebstein’s anomaly is a congenital heart defect where the valve that separates the top and bottom right heart chambers does not form correctly. This valve is called the tricuspid valve. As a result, the valve does not close as it should causing blood to move back from the lower to the upper heart chamber.

9. On 3 June, Mrs A started taking Ramipril. On the morning of 10 June, Mrs A complained of headache and nausea. She attended the Emergency Department (ED) on 11 June reporting she vomited after taking her morning Ramipril medication and had reduced oral intake.

10. Mrs A’s oxygen saturations were abnormally low, so she was started on oxygen therapy, but she sadly died later that day.

Findings

14. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any indications that something has gone wrong.

Prescription of Ramipril 15. Ms S complains that her mother, Mrs A was prescribed Ramipril in April 2023 when it was not required.

16. The Trust say Ramipril is a very commonly used medication, known as ACE inhibitors, to support patients with left ventricular dysfunction and its prescription was in an attempt to improve Mrs A’s left ventricular impairment and to the reduce her blood pressure.

17. On the morning of 11 June, Mrs A was sick after taking her medication. The Trust say that it is unlikely caused by the Ramipril because she had been taking it for a week and any reaction would have happened sooner.

18. Our cardiology adviser agrees with the Trust’s explanation in paragraph REF _Ref186709657 \r \h \* MERGEFORMAT 16 for why ACE inhibitors such as Ramipril are prescribed and says that [ACE inhibitors] are shown to improve symptoms and prognosis of the patient.

19. The GMC Good medical practice provides instruction on how doctors should assess, diagnose and treat a patient.

20. Paragraph 15 says that doctors must

‘a. adequately assess the patient’s conditions, taking account of their history (including the symptoms and physiological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient

b. promptly provide or arrange suitable advice, investigations or treatment where necessary’

21. The consultation notes and subsequent letter to the GP show that the consultant had a full discussion with Mrs A, detailed the tests and examinations completed, and reviewed the results, before their recommendation to start Ramipril.

22. NG106 gives instruction for how to introduce ACE inhibitors to a patient and gives detail on the monitoring required.

23. Section 1.4.3 says:

‘Start ACE inhibitor therapy at a low dose and titrate upwards at short intervals (for example every 2 weeks) until target or maximum tolerated dose is reached.’

24. Section 1.4.4. says:

‘Measure serum sodium and potassium, and assess renal function, before and 1 to 2 weeks after starting an ACE inhibitor, and after each dose increment.’

25. Mrs A was seen at the Trust as an outpatient on 17 April 2023. Following the appointment and examinations completed, the consultant wrote to the GP recommending that Mrs A be prescribed Ramipril and ‘started on a low dose of 2.5mg which is then increased in stages to a full dose of 10mg over time, if the medication is tolerated’.

26. The ESC Clinical Practice guidelines recommend that ACE inhibitors such as Ramipril should start within 24-48 hours of recommendation or as soon as possible.

27. Mrs A started taking Ramipril on 3 June 2023 at 2.5mg. Ms S says that the delay in her mother starting the Ramipril is because she was undergoing tests to see if the medication was suitable. We have not seen any evidence of tests being requested after the consultant recommended Mrs A to start taking Ramipril. It is likely the delay from 17 April to 3 June is because of the time it took for the consultation letter to reach the GP and then for the GP to action the prescription request and arrange for any tests for monitoring purposes.

28. We do not know if any review was arranged by the GP, but it is unlikely any review was completed as Mrs A became unwell before the recommended review period. We cannot comment on the actions of the GP as they are not subject to the complaint made by Ms S.

29. After full consideration of the evidence and the comments from our cardiology adviser, we have not seen any indication that the recommendation to prescribe Ramipril was not in line with the GMC Good Medical Practice guidance or NG106. The consultant fully assessed Mrs A before making the decision to start additional treatment and it was recommended, she started on a low dose and was instructed for the dose to increase over time if tolerated.

30. We understand why Ms S believes that the Ramipril caused her mother to become unwell. We hope that we have been able to provide some reassurance that the medication was not prescribed unnecessarily.

Oxygen saturations

31. Due to Mrs A’s condition, her normal oxygen saturation range was between 70-80%. This information is recorded in her notes from previous admissions and her outpatient reviews.

32. When Mrs A was admitted to the ED, her oxygen saturation was recorded as 50-60% and she was experiencing hypoxia (deficiency in the amount of oxygen reaching the tissues of the body). Our cardiology adviser confirms that Mrs A’s oxygen saturations were dangerously low.

33. They say that when a patient is experiencing an acute stage of significant hypoxia, as Mrs A was when she was admitted, oxygen therapy is recommended to bring the patient back to target level. Section 2 of the BTS Guideline explains that a patient’s oxygen flow rates should be adjusted to keep the oxygen saturation in the target range. Oxygen should be prescribed to achieve a target saturation of 94-98% for most acutely ill patients, for patients with chronic obstructive pulmonary disease (COPD) 88-92%, or a patient specific target range.

34. This means that for staff for to act within the BTS Guideline, oxygen would be given to achieve Mrs A’s baseline target of 70-80% oxygen saturation as this is her specific target range.

35. The Trust started Mrs A on oxygen therapy with a plan to maintain oxygen saturations within her normal range of 70-80% and alter the flow if the target is exceeded as indicated in the BTS Guideline.

36. The records show that Mrs A’s oxygen saturation was maintained within the target level except for one instance at 2.17pm, when her saturation levels were recorded at 93%.

37. Although the reading of 93% is above Mrs A’s target saturation range, staff altered her flow of oxygen to bring her saturations down within her target range. Our cardiology adviser says that although Mrs A’s oxygen saturation was higher than target at 2.17pm, her blood gases show she did not retain carbon dioxide, which is a side effect of maintaining oxygen saturations above a patient’s target. This means it is unlikely that the oxygen flow causing the singular high saturation level at 2.17pm contributed to her experiencing a stroke, which caused her death.

38. It is understandable that Ms S has been worried given how unwell her mother was when she attended the Trust and that Mrs A believed she was being given too much oxygen, knowing that she only needed low amounts of oxygen.

39. After carefully considering all the available evidence, and the comments from our adviser, we have not seen any indication that staff did not act line with the BTS Guideline.

40. We are deeply sorry to hear about how upset Ms S has been and how she has been affected. We extend our condolences to her. We understand how much this complaint means to her and thank her for sharing the details. We hope this statement clearly explains the reasons why we will not be considering the complaint further and we regret any further distress this decision may cause.

Our Decision

1. We have carefully considered Ms S’ complaint about the Trust.

2. We have seen that the doctors acted in line with relevant guidance and standards when prescribing Ramipril to her mother.

3. We have also seen no indication the Trust gave her mother too much oxygen on 11 June 2023. We found their actions to be in line with relevant guidelines and standards.

4. We are very sorry to hear how upset Ms S has been and how she has been affected. We understand how much this complaint means to her and thank her for sharing the details. We hope this statement clearly explains the reasons why we will not be considering the complaint further.

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