An independent provider in the Cumberland area

6. Mr A complains about the care and treatment he received from the Practice between September 2023 and June 2024.

7. Mr A says the Practice:

• did not adequately review his pre-existing conditions before prescribing ramipril 549297152105

Page 1 of 9

• failed to respond to clear evidence of harm and abnormal test results • did not perform timely investigations into symptoms or make adjustments to treatment • ignored credible third-party clinical information • relied on an outdated, inaccurate diagnosis (IBS) to dismiss symptoms.

8. Mr A told us he thinks the Practice should have considered alternative treatment for hypertension due to his ANSD. He also said he thinks the Practice should have adjusted his medication sooner. He says as a result, he is still under specialist care for ongoing symptoms linked to his reaction to ramipril and has developed two chronic conditions which have caused significant, long-term restrictions in what he can eat.

9. He says he continues to experience fatigue, gastrointestinal problems, food-intolerance reactions, and issues with his autonomic system. These ongoing symptoms have led to emotional distress and anxiety, and his pre-existing health conditions have also worsened.

10. He also told us the situation has created financial pressure due to the cost of specialist foods, supplements, and private healthcare. His symptoms have also forced him to reduce his working hours, adding to the strain.

11. By bringing this complaint to us, Mr A is seeking: • acknowledgement from the Practice it showed a lack of timely and appropriate clinical response to repeated reports of harm and failed to integrate his existing medical history into ongoing care decisions • service improvements by the Practice to ensure that other patients receive timely, appropriate responses to post-prescription harm • financial remedy.

12. Following seven day blood pressure monitoring, Mr A was diagnosed by the Practice with hypertension (high blood pressure) in late September 2023 and prescribed ramipril to treat it.

13. Mr A has a preexisting condition of ANSD. Mr A describes this diagnosis as meaning his autonomic system is damaged and does not send signals to various parts of his body correctly. This can result in many physical symptoms and can be made worse by anxiety and stress.

No adequate review of pre-existing conditions and personal circumstances before prescribing ramipril Ignored credible third-party clinical information

17. 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. To do this, we look at policies and guidelines that outline what should happen. We have done this and have not found any indications that something has gone wrong.

18. Our adviser explained ANSD is a very complex condition and GPs do not come across it a lot. There is no single, unified NICE guideline that covers ANSD as a whole and how to treat it, so medical staff have to use guidelines related to the diagnosed conditions they are treating. The diagnosed condition is hypertension in this case.

19. The hypertension guidance recommends medications that may be used to treat hypertension. One option for the treatment of hypertension is ACE inhibitors (medication to lower blood pressure), including ramipril. The ramipril guidance does not list any cautions or contraindications with ANSD.

20. The hypertension guidance explains what to consider when treating hypertension. The guidance does not explicitly state a need to review existing medical conditions before treating hypertension, unless a condition is listed in cautions or contraindications.

21. The ramipril guidance recommends testing renal function and electrolytes before starting ramipril and monitoring during treatment but does not state how often they should be monitored.

22. The Practice tested Mr A’s renal function and electrolytes in July 2023, before prescribing ramipril, and these indicated renal function and electrolytes were within normal range.

23. The Practice prescribed ramipril in September and continued to monitor his renal function and electrolytes thereafter in September 2023, October 2023, December 2023, January 2024 and April 2024. This is in line with the ramipril guidance.

24. Mr A told us he believes his hypertension was caused by stressful personal circumstances in his life at the time. He said he thinks these should have been taken into account by the Practice when treating his hypertension. He also says the Practice should have taken into account information from other clinicians stating ramipril may have caused an allergic reaction.

25. We have seen in Mr A’s medical records Mr A discussed some of these personal circumstances with the Practice in late August 2023 during a pre-diabetes review and it was recorded by the Practice he said he was managing well.

26. Our adviser told us Mr A’s blood pressure results from the seven day blood pressure monitoring in September meant the Practice had to try to reduce his blood pressure. In line with the hypertension guidance, the Practice appropriately prescribed an ACE inhibitor to treat this.

27. Taking everything into account we consider it was appropriate, and in line with the hypertension guidance for the Practice to prescribe Mr A ramipril. We can see the Practice appropriately tested Mr A’s kidney function before prescribing this and continued to monitor this thereafter in line with the ramipril guidance.

28. We have seen the Practice were aware of Mr A’s personal circumstances before prescribing ramipril and there is no guidance to suggest that the Practice should have considered alternative treatment for hypertension due to his ANSD.

29. We have not seen any evidence in the records that the Practice had information from third-party clinical advisers stating Mr A could not be treated with ramipril for hypertension. We have also not seen any evidence that the Practice had third party information that stated ramipril had caused destabilisation of Mr A’s ANSD. We have seen evidence that when Mr A raised concerns based on third party information, the Practice engaged with Mr A and considered making a referral as per his request.

30. Mr A wrote a letter to the Practice in May 2024. In this letter Mr A told the Practice he had sought advice from a Nutritionist who gave him information on Mast Cell Activation Syndrome (MCAS). MCAS, or Mastocytosis, is a rare disorder in which too many mast cells build up in the skin or other tissues. Mast cells are immune cells made in the bone marrow. In mastocytosis, the excess mast cells can trigger exaggerated allergic‑type reactions because they release these chemicals more easily and in larger amounts.

31. The Practice tried to contact Mr A about this letter at the end of May and left a voice message. In June 2024, the Practice called Mr A to discuss his complaint and invite him to a meeting at the Practice. Mr A declined to attend and requested the Practice refer him for a PoTs assessment (postural tachycardia syndrome, an abnormality of the functioning of the autonomic nervous system) to assess the possibility ramipril had caused MCAS.

32. In July, the Practice held an MDT and asked Mr A to come in for a review to see if the referral would be appropriate. This is line with GMC guidance that says doctors should use clinical judgment to refer a patient to another suitably qualified practitioner when this serves their needs.

33. Mr A changed GP surgeries in August 2024 and his new Practice began handling his care and treatment from that point.

34. We have not seen evidence the Practice ignored third party information when treating Mr A for hypertension in relation to ANSD or when responding to his reported symptoms. Therefore, we cannot see indications of failings for this aspect of the complaint.

Repeated failure to respond to clear evidence of harm and abnormal test results

35. The GMC guidance says that when providing clinical care doctors must promptly provide (or arrange) suitable advice, investigation or treatment where necessary. It also says doctors should work effectively with colleagues in the interests of patients.

36. During the period Mr A was taking ramipril, he visited the ED and contacted Out of Hours services (OOH) several times. Mr A told us he believes the Practice should have acted and reviewed his medication when receiving this information from the relevant departments.

37. In late September 2023 Mr A presented to the ED with chest pain which he told staff had been part of his ANSD for 20 years and had been increasing. ED discharge notes state Mr A’s examination was normal and that all tests of the heart returned normal results. He was discharged and advised to follow up with his GP regarding chronic neck pain. The Practice followed up with Mr A four days later and discussed a referral to neurology with him.

38. In early February 2024 Mr A presented to ED with upper abdomen discomfort, feeling clammy and breathless. Tests showed no abnormalities and the diagnosis was suspected anxiety disorder. No recommendation to follow up with his GP was made.

39. In early April 2024 Mr A contacted OOH services for gastric symptoms, sore/swollen throat and enlarged tonsils. The diagnosis was tonsilitis. It was noted that bloating was being looked at by his GP and Mr A was waiting for bloods. Mr A was advised to contact his GP surgery if he required a follow up.

40. In late April 2024, Mr A contacted OOH services stating his throat felt swollen every time he ate, he was freezing cold, had reduced urination and stools. An examination showed no fever and no swelling of his tongue, throat or lips. Several possible diagnoses were noted: bowel problems, malabsorption syndrome, or allergic reaction.

41. During this consultation Mr A stated he thought his symptoms were related to ramipril and he had stopped taking it three weeks prior. Mr A was directed to his GP for a faecal immunochemical test (a screening tool to test for colorectal cancer and other significant gastrointestinal conditions, FIT test) and referral to gastroenterology. The Practice had already done both in early April.

42. Our adviser said when someone attends the ED or OOH services a discharge summary is sent to their GP. The discharge summary includes what symptoms the person presented with, the suspected diagnosis and any recommended treatment, tests or prescribed medications.

43. We have not seen any evidence that Mr A’s attendances in the ED or with OOH were linked with ramipril until his visit in late April when Mr A told staff he thought his symptoms were related to ramipril and that he had stopped taking it. There is nothing in the discharge summaries from ED or OOH that recommend stopping ramipril or for the GP to contact Mr A directly about this.

44. We have seen evidence that each time the ED or OOHs recommended an action for the Practice, it did this without delay. This is in line with the GMC guidance.

45. In relation to abnormal test results, the hypertension guidance recommends monitoring kidney function (creatinine and estimated glomerular filtration rate (eGFR)) and potassium levels while somebody is taking ramipril. The guidance explains what abnormal test results

are: “if an adult's eGFR change is 25% or more, or the change in serum creatinine is 30% or more” or “if the person's serum creatinine level increases by more than 50%”.

46. Our adviser said Mr A’s test results do not meet these criteria and his results were within normal range and stable, as such no action was required. Therefore, we cannot see any indication the Practice failed to respond to abnormal test results.

47. We have not seen any evidence that the Practice failed to respond to evidence of harm or abnormal test results during this period. We have not seen any indications of failings for this aspect of the complaint.

No timely investigation or treatment adjustment due to reported side-effects Relied on outdated, inaccurate diagnosis (IBS) to dismiss symptoms

48. In early September 2023, Mr A’s seven day average blood pressure readings were too high, and the Practice diagnosed him with hypertension and contacted him to tell him. The Practice prescribed ramipril starting at 2.5mg a day.

49. Mr A told the Practice he was not happy to start ramipril due to having bad reactions to new medications in the past. He said he would prefer to increase his propranolol medication instead. The Practice advised Mr A propranolol is not normally prescribed for hypertension and it can cause a drop in pulse. Mr A spoke to the Practice again two days later and agreed to try ramipril.

50. The hypertension guidance does not recommend prescribing propranolol instead of ramipril due to ANSD. Propranolol is a beta blocker and is not recommended in step 1 or step 2 treatment in the hypertension guidance. Our adviser confirmed propranolol is usually only considered when other medicines have been tried or in addition to other medications. This is also confirmed in the NHS beta blocker guidance.

51. Between early October 2023 and late January 2023, Mr A attended the Practice four times for routine monitoring of his hypertension. It is noted in his records that his blood pressure was coming down but not to target. Ramipril was increased in increments during this time until it reached the maximum dose of 10mg a day.

52. During this time, the Practice noted in Mr A’s records he was tolerating ramipril with no side effects. We cannot see evidence Mr A raised an issue or mentioned side effects relating to ramipril to the Practice before this point.

53. In late January 2024 Mr A told a member of the Social Prescribing Service (an NHS service that helps people improve their wellbeing) ramipril was making him feel tired and weak. He said he wanted to chat to the GP about having a medication review. At the

beginning of February 2024, the Practice sent a message to Mr A to make an appointment for a medication review with the doctor.

54. Mr A wrote a detailed letter to the Practice, dated 2 February 2024, about his medical history in relation to ANSD. In it, he said he had struggled to get correct support for various medical diagnosis including ANSD. He wrote he would like a medication review and felt increasing propranolol should be considered for the treatment of hypertension in his case. He states in this letter he believes ramipril is causing weakness in his legs, extreme tiredness, and indigestion and bloating issues.

55. At the beginning of March 2024, Mr A had a medication review with the Practice. It was noted in his records that Mr A said he felt ramipril was making him tired and itchy. The Practice agreed to reduce ramipril to 7.5mg and increase propranolol to see if that would improve his blood pressure.

56. In early April 2024, Mr A had another appointment to review his hypertension. It is noted he told the GP he had reduced ramipril to 5mg due to abdominal discomfort and that he felt it was improving now. A FIT test was requested to address the abdominal discomfort. A week later, Mr A told the Practice he had stopped taking ramipril due to gastrointestinal side effects.

57. In late April 2024, Mr A had an appointment at the Practice and reported uncomfortable gastrointestinal symptoms and swollen throat which he thought was caused by ramipril. The Practice examined Mr A and confirmed abdominal bloating and suggested he may have IBS. Options were discussed with Mr A for investigation and treatment of symptoms, and he said he would like a referral to gastroenterology which the Practice made the same day.

58. The GMC guidance says doctors should listen to a patient’s wishes and encourage an open dialogue about their health. It also says to use clinical judgment to assess the likely effectiveness of the treatment options, to promptly provide (or arrange) suitable advice, investigation or treatment where necessary, and to refer a patient to another suitably qualified practitioner when this serves their needs.

59. We can see when Mr A was first prescribed ramipril he raised concerns about trying a new medication due to bad reactions to medications in the past. We can see the Practice spoke to him about this and explained the reasons for prescribing ramipril. This is in line with the GMC guidance as the Practice listened to Mr A’s wishes and used clinical judgment to assess the likely effectiveness of the treatment options.

60. The next time Mr A raised an issue about the medication with the Practice was in late January 2024 and early February 2024 when he asked for a medication review which took

place at the beginning of March 2024. At this review, the Practice agreed to reduce the dose of ramipril and increase the dose of propranolol.

61. Our adviser said that some of the side effects Mr A presented with to ED, OOH and eventually the Practice are similar to symptoms he had had before taking ramipril such as gastrointestinal issues and feeling faint. Mr A acknowledges he has had these symptoms before in the letter he sent to the Practice in early February 2024. Due to this, our adviser said it would be difficult for the Practice to say if the symptoms were related to ramipril or a continuation of existing conditions.

62. Our adviser also said the Practice made many referrals when Mr A raised various symptoms with the Practice, some related to ramipril and some related to ANSD.

63. During the period Mr A was taking ramipril, the Practice referred him to the neurological and persistent physical symptoms service in October 2023, the neurological rehabilitation service in October 2023, the SPS in November 2023, cardiology in January 2024, for nerve conduction studies and an electromyography (EMG) in March 2024, and to gastroenterology in April 2024.

64. Although the referrals were not all related to events following ramipril, we consider that in line with the GMC guidance, this shows that the Practice did refer Mr A for timely investigations, treatment, or to another practitioner when he reported side-effects.

65. Our adviser said IBS is primarily a diagnosis of exclusion, meaning doctors rule out other conditions first because there is no single test that can confirm IBS. Despite the negative FIT test, the Practice referred Mr A to gastroenterology in late April 2024 for further tests, to rule out all possible causes.

66. We can see the Practice suggested Mr A’s symptoms might be linked to IBS. We have not seen evidence it dismissed his symptoms due to this, and as above, we consider the Practice appropriately listened and responded to the symptoms Mr A reported. As such we can see no indications of failings for this aspect of the complaint.

67. We realise this is unlikely to be the outcome Mr A was looking for when he approached us. We hope we have explained the thorough consideration we have given to our decision and clearly outlined the reasons for it. We would like to thank Mr A for bringing his concerns to our attention.

1. We have carefully considered Mr A’s complaint about a GP surgery in the Cumbria area (the Practice). We have seen no indication that anything went seriously wrong.

2. Between September 2023 and April 2024, the Practice prescribed Mr A ramipril to treat hypertension. Mr A told us he felt the Practice did not take his existing medical condition of Autonomic Nervous System Disorder (ANSD) and personal circumstances at the time into account when deciding to prescribe ramipril. He also told us the Practice failed to respond to clear evidence of harm from ramipril and dismissed his symptoms as IBS.

3. We can see this was a difficult time for Mr A and that he had several visits to the Emergency Department (ED) during this time. We can also see communication between Mr A and the Practice broke down which we understand added to Mr A’s frustration and anxiety.

4. We would like to reassure Mr A we have not seen indications the Practice missed an opportunity to treat his symptoms sooner. Additionally, it appears the Practice made appropriate decisions about his treatment plan.

5. The evidence we have seen indicates the prescription of ramipril was in line with relevant guidelines. We have also seen evidence the Practice adjusted Mr A’s medication once he raised concerns about his symptoms. We explain this in more detail below. We hope our explanation below goes some way to provide Mr A some closure for his concerns.