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A practice in the Wigan area

P-003261 · Statement · Decision date: 18 December 2024
Complaint (AI summary)
Mrs B complained her mother's blood cancer symptoms were not investigated promptly, antibiotics were inappropriately prescribed, and a contraindicated medication was given, causing harm.
Outcome (AI summary)
Indications of service failure were found regarding the prescription of contraindicated mirabegron for Mrs C. No other service failures were identified in symptom management or antibiotic provision.

Full decision details

The Complaint

7. Mrs B complains about the care provided to her late mother, Mrs C, by the Practice between October 2022 and May 2023. She complains that:

• Despite Mrs C reporting symptoms of blood cancer throughout this period, she was not referred for further investigations until February 2023.

• Mrs C was prescribed antibiotics for her symptoms on three occasions despite there being no apparent clinical need (21 October 2022, 24 October 2022 and, 23 December 2022) • On 7 February 2023, the GP refused to examine two lumps in Mrs William’s groin, instead referring her for an ultrasound scan • On 7 February 2023, Mrs C was prescribed mirabegron despite this being contraindicated for her,

8. Mrs B tells us Mrs C suffered from extremely unpleasant and painful headaches as a result of taking the mirabegron. Mrs B believes the delays in sending Mrs C for further investigations led to her mother’s death, as they meant her disease had progressed further before treatment could be given. She tells us the loss of her mother has been devastating for both her and her father and it has changed their lives completely.

9. As an outcome to the complaint, Mrs B is seeking an acknowledgement of what went wrong in Mrs C’s care.

Background

10. Between October and December 2022, Mrs C was in contact with her GP due to symptoms of an increased need to urinate in the night, aching on her left side in her stomach and abdomen, and hot sweats. She was prescribed antibiotics on 3 occasions, 21 October, 24 October, and 23 December.

11. On 4 February 2023, Mrs C noted lumps in her left groin area which were getting bigger, and she felt her urinary symptoms had not resolved despite taking antibiotics. She contacted the Practice on 7 February 2023 to make an appointment.

12. Mrs C was seen on 7 February 2023 and the GP prescribed 50mg of mirabegron and referred Mrs C for a pelvic ultrasound. Upon receipt of the scan results, the GP made a fast-track referral to the gynaecology clinic on 16 March 2023. Mrs C was seen in the gynaecology clinic on 23 March 2023 and was referred for a pelvic MRI scan.

13. On 4 May 2023, Mrs C was seen in the gynaecology clinic and was diagnosed with high grade non-Hodgkin’s lymphoma. Mrs C was seen in the haematology clinic on 9 May 2023. This clinic letter reported that Mrs C had undergone a CT scan of her chest, abdomen, and pelvis. The results had shown nodal masses in her left side. It is also noted she had developed a lump on the left side of her neck, which was getting bigger.

14. Mrs C was treated with steroids and chemotherapy and Mrs B tells us they had been told that from a scan undertaken after the two sessions of chemotherapy, the two tumours had shrunk by 80%. Mrs B tells us that after two sessions of chemotherapy, Mrs C contracted sepsis, clostridium difficile (C diff – an infection) and double pneumonia. This sadly led to her death on 3 August 2023.

Findings

Management of symptoms between October 2022 and February 2023, and prescription of antibiotics

18. Mrs B complains that despite her mother reporting symptoms of blood cancer throughout this period, including frequent infections, abdominal pain, lumps and swelling, she was not referred for further investigations until February 2023. She is alarmed that Mrs C was instead prescribed antibiotics for her symptoms on three occasions, despite there being no clinical need. We appreciate this is concerning for Mrs B, given how her mother later became seriously unwell.

19. In response to the complaint the Practice has explained that Mrs C was treated based on her symptoms. It was noted she had initially improved on nitrofurantoin, but her symptoms returned. Her urine dip was negative, and it was felt this was influenced by the fact she had been treated with antibiotics. It says the course was changed to an alternative antibiotic due to the ongoing symptoms reported by Mrs C.

20. The Practice provided an explanation from the treating GP that because Mrs C had urinary symptoms lasting six months, despite repeated negative urine cultures, it was likely an alternative diagnosis was causing these symptoms. The GP requested an ultrasound scan to further clarify this, and this led to the diagnosis.

21. We have reviewed Mrs C’s medical records with our clinical adviser. On 21 October 2022 Mrs C contacted her GP, she explained that she felt she had been experiencing symptoms of a urinary tract infection (UTI) for a couple of weeks. She said she had been needing to get up five to six times in the night and had an ache in the left side of her stomach, as well as hot sweats.

22. The Practice asked Mrs C to bring a urine sample and complete a short form advising of her symptoms. The GP had been unable to contact Mrs C by phone, and as the weekend was impending, they prescribed a three-day course of nitrofurantoin to treat potential infection. The plan was to review Mrs C after the weekend if her symptoms had not settled.

23. On 24 October 2022 Mrs C reported that she was initially better on nitrofurantoin but the frequency of needing to urinate more often during the day and night returned. The GP prescribed a seven-day course of trimethoprim and advised of symptoms which would indicate a review was needed.

24. We can see Mrs C was presenting with common symptoms of a urine infection, as outlined in the NICE Clinical Knowledge Summary (CKS) for UTI in women. The NICE CKS recommends the use of nitrofurantoin and trimethoprim as first-line antibiotic treatments for suspected UTI.

25. The GMC’s Good Medical Practice says when doctors assess, diagnose, or treat patients, they must adequately assess the patient’s conditions, taking account of their history, and promptly provide or arrange suitable advice, investigations or treatment (15 a and b). It also says that doctors must provide effective treatments which serve the patient’s needs (16a).

26. Based on this guidance, we consider the management of Mrs C’s symptoms up to this point was appropriate.

27. On 31 October 2022 Mrs C contacted the Practice to say that trimethoprim had eased the problem, but it had not gone. Mrs C spoke with the GP and said she was generally not feeling great. The GP noted she had not been experiencing any fevers, nausea, or back pain. The plan was to obtain a urine sample and review again once the results were back, or to review sooner if the symptoms worsened. The urine culture was reported as normal on 2 November 2022.

28. As Mrs C’s symptoms were suggestive of a urine infection and the antibiotics seemed to be helping (although not fully resolving her symptoms), our adviser explained it was suitable to send a urine sample to the lab for further testing as a next step. She had no clear red flag symptoms which would suggest any additional investigations were required and did not report any worsening symptoms. We consider the management up to this point was in line with the GMC’s Good Medical Practice guidance.

29. On 22 December 2022, Mrs C contacted the Practice as she was still experiencing the same urinary symptoms. She had gone to the pharmacy on 21 December and was advised there was a medication she could take in the evening, but it could only be given through prescription. A telephone consultation was arranged.

30. The GP spoke with Mrs C on 23 December 2022. Mrs C reported a history of ongoing UTI-like symptoms, she had increased need to urinate up to five-six times a night and lower abdomen pain. The GP prescribed a longer course of nitrofurantoin, and the plan was to review Mrs C if she did not experience any improvement, noting that she may need a specialist review.

31. Our adviser explained that at this point, it may have been better to repeat a urine test to send to the laboratory first, rather than prescribing another antibiotic straight away, to ensure the most effective antibiotic treatment was provided. Despite this, our adviser confirmed the symptoms reported were not in keeping with something more sinister. This means there were no indications a referral for a scan was needed at this time.

32. We can see that during the next appointment on 7 February when Mrs C reported there had been no improvement, the GP sent Mrs C for further investigations, in line with the GMC’s Good Medical Practice points 15 a and b (outlined above).

33. Our adviser has commented that overall, Mrs C was presenting with more urinary symptoms, and these were more in keeping with alternative diagnoses rather than a diagnosis of lymphoma. It was not clear that Mrs C’s urinary symptoms were directly linked with a diagnosis of lymphoma, and therefore not something a GP would necessarily think of with the symptoms she presented with.

34. For the reasons we have explained, we have not identified any indications that something went wrong in the care Mrs C received from her GP between October 2022 and February 2023. Despite this, we understand this was a worrying and distressing time for Mrs C and her family, and we do not wish to underestimate the impact of her experience with the decision we have made.

Examination on 7 February 2023

35. Mrs B tells us Mrs C attended an appointment on 7 February 2023 due to concerns about lumps in her groin. Mrs C recalls the doctor advising her he would not look at the lumps.

36. In response to the complaint, the Practice explained that having reviewed the medical records and spoken to the GP, there was no mention of any lumps during the appointment, or within the request for an appointment.

37. The GMC’s Good Medical Practice guidance says when doctors assess, diagnose, or treat patients, they must adequately assess the patient’s conditions and where necessary, examine the patient (15a).

38. Our review of the records shows Mrs C requested an appointment as she felt the antibiotics previously prescribed were not working. She had been unwell over the weekend with frequent nocturia and had pain down her left side. There is no mention within the notes from the appointment of a request to examine lumps in the groin.

39. We acknowledge there are two differing views on what happened. We do not doubt Mrs C’s recollection of events, and we appreciate how concerning this must have been for Mrs C at the time of her appointment, and for Mrs B upon learning of what happened.

40. We have considered whether we would be able to give an independent view on what should have happened and what did happen. In this situation, there are two differing views on what has happened, and we do not have further independent evidence which would help us to reach a robust conclusion.

41. We do not have the evidence to say there are indications a service failure took place, and it is unlikely that further investigation into this issue would be beneficial or proportionate. Therefore, we have decided not to take further action on this part of the complaint.

42. In making our decision, we do not wish to diminish what Mrs B told us about Mrs C’s experience. We appreciate this response may not offer the closure Mrs B seeks, and we are sorry for any further distress this may cause. We hope that our view on Mrs C’s overall care, which is outlined in the above section, provides some reassurance to her family that she was sent for investigations at the appropriate time.

Prescription of Mirabegron

43. Mrs B complains that Mrs C had been prescribed mirabegron to trial, but this caused her extremely unpleasant and painful headaches. They later found out this medication was unsuitable for those with high blood pressure and tachycardia. Both of which Mrs C had and was receiving prescribed medication for.

44. We are sorry to hear of this experience. We acknowledge Mrs C was in a lot of pain with severe headaches. We can also understand why Mrs B has questions about the medication the Practice prescribed.

45. In response to the complaint, the Practice has apologised that Mrs C suffered from headaches and says her blood pressure was much lower than what is mentioned in the BNF. Therefore, it considered it appropriate to prescribe this medication.

46. The GMC’s Good Medical Practice says when assessing, diagnosing, or treating patients, doctors must adequately assess the patient’s conditions, taking account of their history (15a). They must only prescribe medication where they have adequate knowledge of the patient’s health and are satisfied that the medication will serve the patient’s needs, and they must check that any treatment provided is compatible with any other treatments the patient is receiving (16a and f).

47. The GMC’s Good Medical Practice also says doctors must also ensure clinical records include relevant clinical findings and decisions made and actions agreed (21a and b).

48. We understand that mirabegron is usually prescribed for a patient with increased urinary frequency. The BNF explains that the main contraindication is uncontrolled hypertension. This is measured as more than systolic 180 mmHg (the top number in a blood pressure reading) or more than diastolic 120mmHg (the bottom number in a blood pressure reading). The BNF explains it should be prescribed with caution in patients with stage 2 hypertension. The BNF also states that blood pressure should be monitored before starting treatment, and regularly during treatment, especially in patients with pre-existing hypertension.

49. We can see from the records that Mrs C was seen by a cardiologist on 5 January 2023. Her blood pressure was noted to be 191/94. Our adviser confirmed this puts Mrs C above of the threshold to start mirabegron.

50. Mrs C was prescribed mirabegron approximately one month later, on 7 February. We appreciate the Practice’s response to the complaint states that Mrs C’s blood pressure was lower than it was during the cardiology appointment, but we cannot see within the records that her blood pressure was checked or recorded. Therefore, based on the evidence available to us, there are indications that mirabegron was contraindicated in Mrs C’s care.

51. We consider that if Mrs C’s blood pressure had been taken and was lower than the threshold outlined in the BNF, there is still no evidence recorded in the medical records to support the prescription being suitable for her.

52. For this reason, we consider there are indications of service failure relating to this part of the complaint.

53. Mrs B has told us that Mrs C suffered from extremely unpleasant and painful headaches. The BNF details headaches as a common or very common side effect of this medication. Whilst the Practice has apologised that Mrs C suffered from headaches, it has not acknowledged that the medication was contraindicated, or, the alternative, that there was poor record keeping.

54. We discussed this with the Practice and highlighted our concerns about the prescription of mirabegron. The Practice reviewed the information we provided, and has agreed to write to Mrs B to acknowledge the indications of poor service we have identified, as well as providing an apology for this, and the impact it had on Mrs C. The Practice has committed to doing this by 31 January 2025.

55. We are satisfied that agreeing to take these steps to put things right is in line with the NHS Complaint Standards with regards to giving a fair and accountable response and providing a sincere apology. For this reason, we will not be taking any further action on this part of the complaint.

56. We recognise this does not change the experience Mrs C had. We hope it is reassuring for Mrs B that these circumstances will be reflected upon in the care provided by the GP going forward.

Our Decision

1. We have carefully considered Mrs B’s complaint about the Practice. We were sorry to learn how Mrs B, and her late mother, Mrs C, have been affected by the concerns raised. Understandably this has been a cause of great concern for Mrs B and her family, and we recognise Mrs B is seeking answers about Mrs C’s care, as well as an acknowledgement of what went wrong.

2. We have reviewed the information provided by Mrs B and the Practice, as well as considering the guidance and standards relevant to the case. We also sought advice from a General Practitioner (GP) who is familiar with the issues raised in this case.

3. After doing so, we have not identified any indications of service failure in relation to the management of Mrs C’s symptoms between October 2022 and February 2023, nor in the provision of antibiotics in the same period.

4. With regards to the appointment of 7 February 2023, we recognise there are differing accounts of what happened. We do not have independent evidence to say there has been a service failure, and it is unlikely this conclusion would be reached with further investigation. For this reason, we have decided not to take further action on this part of the complaint.

5. We have identified indications of service failure in relation to the prescription of mirabegron, as it was contraindicated (a condition/circumstance which indicates the medication should not be used) based on Mrs C’s high blood pressure. As a result of taking the medication, Mrs C suffered from painful headaches. We have raised these concerns with the Practice, and it has agreed to send Mrs B a letter acknowledging and apologising for this aspect of the care provided. Once it has done this, we consider the Practice will have taken proportionate action to remedy this part of the complaint.

6. We will explain the reasons for our decision in this statement. Complaints give us valuable insight into the organisations we investigate, so we would like to thank Mrs B for sharing her experiences with us. It is important to acknowledge where we have not identified any indications something went wrong in relation to the concerns Mrs B raised, it does not detract from Mrs C’s experience, nor the impact it had on her and her family.

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