Instructions on how to take Rivaroxaban
22. Mr H says he was taking Rivaroxaban incorrectly as he was taking it without food. Mr H says he was taking it incorrectly for five days due to the Trust’s incorrect instructions. He believes his DVT got worse because of this, and he developed a blood clot which travelled to his lung.
23. The British National Formulary (BNF) is the main drug reference source in the UK. In relation to treating DVT and pulmonary embolism (PE), it states Rivaroxaban should be taken with food. A PE is caused by a blood clot blocking a blood vessel in the lungs, which can cause sudden difficulty breathing, chest pain which is worse breathing in, and coughing up blood.
24. The Drug Safety Update from the Regulatory Agency (Rivaroxaban) highlighted a small number of patients experienced clots when taking Rivaroxaban on an empty stomach.
25. Our physician adviser said studies had demonstrated that absorption of higher dose tablets especially 20 mg, was optimal when taken with a high fat and calorie meal. They further explained the advice to healthcare professionals in general (and not limited to just pharmacists) is to remind patients to take Rivaroxaban (15 mg or 20 mg) tablets with food.
26. From the records the discharge prescription does not indicate whether Rivaroxaban should be taken with food or not. On the discharge letter under ‘medication on discharge’, it states for precise instructions on how or when to take the medication to refer to the pharmacy label on each drug.
27. Mr H has told us he was told by the Trust he could take the medication with or without food. The Trust has not been able to speak to the doctor who prescribed the medication. It has apologised the wrong instructions were given to Mr H.
28. On the balance of probabilities, we think it is likely Mr H was told he could take the medication with or without food. This is because there is nothing to indicate Mr H was told he should take the medication only with food.
29. We find the Trust failed to act in line with the Drug Safety Update by not telling Mr H how to take his Rivaroxaban medication. This is due to the importance of Mr H taking Rivaroxaban with food. We think the doctors should have discussed this with Mr H and documented it in the medical notes.
30. We will consider the impact of this failing in the impact section below.
Time taken to undertake scans and provide treatment
31. Mr H says the Trust delayed carrying out scans of his lung. He says this meant there was a delay for Rivaroxaban to be started, or in changing to Apixaban.
32. The GMC’s Good Medical Practice says doctors must provide a good standard of care. When they assess, diagnose or treat patients, doctors must adequately assess the patient’s condition, taking account of their history and symptoms, and where necessary, examine the patient. Doctors must also promptly provide or arrange suitable advice, investigations or treatment were necessary.
33. When the Trust assessed Mr H for possible DVT, his heart rate was elevated at 118 beats per minute. Our physician adviser said Mr H’s heart rate was higher than normal, as it should be below or around 90 beats per minute.
34. In the records it stated there was ‘no obvious source of infection noted’ that would have potentially explained this. Our physician adviser said a DVT would not ordinarily cause a raised heart rate. However, a PE would.
35. In line with the GMC’s Good Medical Practice, we think the Trust should have taken into account Mr H’s high heart rate. It should have considered whether Mr H had a PE. From the records, there is no evidence to suggest the Trust asked Mr H questions to help rule out a PE.
36. Our physician adviser said there was no comment in relation to any shortness of breath or chest pain, which are important aspects to document. Although Mr H’s heart and chest examination were normal, this is not necessarily relevant, as they are usually normal in a PE.
37. In line with the GMC’s Good Medical Practice, we think the Trust should have documented whether Mr H was experiencing shortness of breath and chest pain.
38. The Trust should have considered Mr H’s high heart rate and considered whether he had shortness of breath or chest pain, in line with the GMC’s Good Medical Practice. If it had done so, we think the Trust should have suspected Mr H had a PE.
39. NICE (VTD) states when investigating for a PE, a clinician must ‘offer patients in whom PE is suspected and with a likely two-level PE Wells score either:
• an immediate computed tomography pulmonary angiogram (CTPA) or • immediate interim parenteral anticoagulation therapy followed by CTPA, if CTPA cannot be carried out immediately.’
40. In the context of a significantly elevated heart rate, our physician adviser said Mr H should have been kept in hospital for a CTPA to rule out a PE. They also said shortness of breath and chest pain are core features of a PE and if either one of these was present, it should have prompted the Trust to carry out a CTPA.
41. The Trust did arrange for Mr H to have a scan for a DVT the day after. During that time the Trust provided treatment which our physician adviser said was standard practice and treatment. This is the treatment even if a DVT and/or a PE is confirmed.
42. Our physician adviser said there was no undue delay in relation to the scans on Mr H’s lung and the treatment provided.
43. We have found the Trust did not act in line with the GMC’s Good Medical Practice, as it did not adequately assess Mr H’s condition. Had it done so, we think it should have suspected Mr H had a PE. However, we do not think there was an impact to this, as the Trust arranged for the scans and treatment it would have done had a PE been suspected.
44. We acknowledge how worrying it must have been for Mr H to feel the Trust had delayed undertaking scans and providing treatment. As the Trust did not delay undertaking scans or providing treatment, we find no failings here.
Prescription of Rivaroxaban and Apixaban
45. Mr H feels he should have been given Enoxaparin when he was first visited the Trust, rather than being given first Rivaroxaban and then Apixaban. He says this failing meant his symptoms of redness, swelling and pain in his leg and foot got worse, which prevented him from walking. Once he was given Enoxaparin, he says his symptoms quickly improved and he was discharged from the Trust the following day.
46. The NICE VTD guidance says where a DVT or PE is suspected, interim therapeutic anticoagulation should be started. It says apixaban or rivaroxaban should be offered. If neither are suitable, then a low molecular weight heparin should be offered. Enoxaparin is a type of low molecular weight heparin.
47. We can see the Trust acted in line with this. It first prescribed Rivaroxaban, before prescribing Apixaban. When Mr H did not respond to these medications, it also prescribed Enoxaparin.
48. We acknowledge how worrying it would have been for Mr H not to respond to the initial medications. We also understand how frustrating it would have been for Mr H to have responded when a third medication was tried. We do not find any failings in the Trust prescribing Rivaroxaban or Apixaban.
Mobilising
49. Mr H says the lack of support given by the Trust affected his mobility, which caused a blood clot to travel to his lung.
50. The NMC Code says nurses must respect, support and document a person’s right to accept or refuse care and treatment. They must also respect the skills, expertise and contributions of their colleagues, referring matters to colleagues when appropriate.
51. The NMC Proficiency Standard says nurses must use evidence-based, best practice approaches for meeting needs for care and support with mobility and safety. They must accurately assessing the person’s capacity for independence and self-care and initiating appropriate interventions.
52. Mr H was seen by SDEC (same day emergency care) when he first went to the Trust. The records show Mr H was referred by his GP due to the increased pain despite pain relief. Mr H was advised by the SDEC at the end of November and beginning of December 2021 that he was at an increased risk of blood clots and was given information on how he could reduce his risk.
53. Our nurse adviser said one of the main risk factors for DVT and PE is immobility.
54. The records show Mr H was reviewed by the vascular team the day after he first attended. The pain in his right thigh was worsening and affecting his mobility. He was also having difficulty weight bearing.
55. Our nurse adviser said the cause of Mr H’s reduced mobility was therefore pain. To support Mr H with his mobility, his pain would need to be effectively managed. Only when Mr H’s pain was controlled could he mobilise.
56. Our nursing adviser said nurses would be expected to administer prescribed analgesia and refer to physiotherapy. They would also have to respect Mr H’s choice in deciding if he wanted to mobilise, in line with the NMC Code outlined above.
57. The records show that staff were aware that Mr H’s mobility was reduced due to pain. He was referred to the pain management team. He was assessed by physiotherapy at the beginning of December 2021. The records also show the Trust administered analgesia such as codeine, morphine and paracetamol to help manage Mr H’s pain.
58. This shows the Trust acted in line with the NMC Code outlined above. The nurses escalated Mr H’s care to medical staff so the cause of his decreased mobility, his pain, could be treated. It also adhered to the NMC Proficiency Standard by initiating appropriate interventions.
59. We can see Mr H’s mobility was reduced secondary to pain. He was seen by medical staff, and analgesia was prescribed. He was mobilising around the ward early in December 2021 for consecutive days, which shows the pain was reduced.
60. We acknowledge this was a difficult time for Mr H, and he was understandably frustrated at not being able to mobilise as normal. As the Trust has acted in line with the relevant guidance as mentioned above, we find no failings.
Communication
61. Mr H says the failure to communicate with him and his family around imaging caused him to experience stress and anxiety. This is because he did not know if his blood clot was improving or not.
62. The GMC guidance under ‘sharing information with patients’ is applicable to this issue. This states ‘the exchange of information between medical professionals and patients is central to good decision making’. The guidance says doctors must give patients the information they want or need in a way they can understand. This includes information about their condition, diagnosis and prognosis, and the options for treating and managing their condition.
63. Our physician adviser said standard anticoagulants help to stop further clots forming and allow the body’s natural processes to work to break down the blood clots that are already there. The process in which this happens takes weeks to months, not hours or days. As such, they explained there is usually no merit in scanning patients again in the short term, but this often needs to be explained carefully and clearly.
64. In Mr H’s case, further scans were needed as his symptoms were worsening. Our physician adviser said this was likely due to Rivaroxaban not being taken with food.
65. The records do not include much detail about what information the Trust gave to Mr H and his family. Although this does not mean information was not provided, it cannot be shown by the records that it was.
66. We cannot see evidence to suggest the Trust communicated to Mr H or his family, and Mr H has told us the Trust did not communicate with him clearly. We find the Trust has failed to act in line with the GMC guidance outlined above.
67. We will consider affect this had on Mr H in the impact section below.
Complaint Handling
68. Mr H says there was a long delay before the Trust provided a response to his complaint.
69. The Complaints Regulations outlines an organisation must respond to a complaint within six months of receiving a complaint. If this is not possible, the Complaints Regulations say the organisation should notify the complainant of the reason why and send a response as soon as reasonably practical.
70. Under Principle 2 of our Principles of Good Administration, it states that ‘Public bodies should behave helpfully, dealing with people promptly, within reasonable timescales and within any published time limits. They should tell people if things take longer than the public body has stated, or than people can reasonably expect them to take’.
71. Mr H first raised his complaint to the Trust on 18 January 2022. The Trust did not respond to Mr H’s complaint until 28 December 2023. This is 23 months and 11 days later.
72. The Trust did not adhere to the ‘relevant period’ as outlined by Complaints Regulations. It deviated from the Principle of Good Administration by not responding to Mr H’s concerns in a timely manner. It also did not provide Mr H with updates as to when it would respond to his concerns.
73. We find failings in the time the Trust took to respond to Mr H’s concerns. We will consider the impact of the failings below.
Impact
74. In summary, we have found the Trust did not act in line with relevant guidance when it:
• did not give Mr H the correct instructions on how to take his Rivaroxaban medication • did not communicate with Mr H or his family around further imaging • took nearly two years to respond to Mr H’s complaint.
75. Mr H feels if the Trust provided him with the correct instructions on how to take his Rivaroxaban medication, his DVT would not have worsened. He thinks this would have prevented a blood clot developing which travelled to his lung.
76. In relation to the Trust’s lack of communication around his scans and delayed response to his complaint, he says this caused him stress and anxiety.
77. Given Mr H’s concerns, we have considered whether his outcome could have been different considering the failings we have identified.
78. The impact of Mr H not taking his Rivaroxaban medication with food is that his treatment may not have been effective as it should have been.
79. Our physician adviser said the reduced effectiveness of the Rivaroxaban may have allowed Mr H’s DVT to increase and potentially contribute to a PE. However, as we have set out above, it is possible Mr H’s PE may have potentially been present from the outset.
80. In Mr H’s original ultrasound scan it was stated the iliac vessels were free of clots. Iliac vessels consist of iliac arteries and veins, which are crucial for blood supply and drainage in the lower body.
81. In Mr H’s subsequent CT scan several days later, the scan showed the external iliac veins had clots in them, and these clots extended to the inferior vena cava (IVC) above those. The IVC is a large vein that carries the deoxygenated blood from the lower and middle part of the body into the right atrium of the heart.
82. Mr H’s PE was not massive, and thrombolysis (medical treatment to dissolve blood clots) was not indicated. If Mr H had been advised to take the Rivaroxaban with meals, then this should have been effective treatment for a PE even while he waited for his scans.
83. We note here that it appears Mr H has since been diagnosed with antiphospholipid syndrome (APS). This is condition where the immune system produces abnormal antibodies, which make the blood more likely to clot. It increases the risk of someone developing blood clots, such as DVTs. It may have impacted the effectiveness of the initial anticoagulant medication.
84. In summary, we cannot say by the Trust not advising Mr H to take medication with food caused the PE, as there is evidence to suggest it was already present. We can say the failing of the Trust not advising Mr H to take Rivaroxaban with food may have impacted the care he received, as he may have needed further scans and additional treatment. We appreciate how worrying it would have been for Mr H at this time, and the uncertainty it caused.
85. We acknowledge the Trust not communicating effectively with Mr H or his family in relation to scans would have increased his anxiety and stress about his condition at an already difficult time.
86. Given the Trust took over 23 months to respond to Mr H’s complaint, we acknowledge Mr H experienced stress and anxiety over the uncertainty on the outcome to his complaint. We accept how distressing this would have been for Mr H.
87. We will make recommendations in the section below to address this.