Complaint one - staff did not give Mr R adequate face to face information about the risks of olanzapine before prescribing it and he started taking it
14. Mr R says the Trust did not tell him about the risks of weight gain, raised blood sugar levels, or raised blood lipid levels before prescribing olanzapine.
15. In response to Mr R’s complaint, the Trust said the psychiatrist recalled discussing side effects with Mr R, but the medical records did not clearly say what had been discussed. The Trust acknowledged the possibility the psychiatrist may not have discussed the risks of weight gain, raised blood sugar levels, and raised lipid levels.
16. When considering what should have happened, we looked at GMC consent guidelines. These say doctors should give patients clear and accurate information about the risks of any proposed treatment, and these should be presented in a way the patient understands. The guidelines say this should include discussing information about potentially serious adverse outcomes and less serious but common side effects.
17. To consider what risks the Trust should have informed Mr R about, we referred to the BNF’s information about olanzapine. This says weight gain is a common side effect, and diabetes is an uncommon risk. It does not include raised blood lipid levels on its list of side effects or risks for olanzapine, or antipsychotic medication in general.
18. That means before prescribing olanzapine, the Trust should have informed Mr R of the risks of weight gain and diabetes, as these are either common or significant side effects. As blood lipids were not listed in the relevant part of the BNF, they are not something we would have expected to be mentioned to Mr R.
19. To consider how the Trust should have informed Mr R about the risks, we looked at GMC good practice guidelines and GMC consent guidelines. GMC good practice guidelines say doctors should record the information given to a patient. GMC consent guidelines say the approach should be proportionate. It gives an example situation of someone being examined by a GP and says, in that situation, verbal consent is not needed. There would then be a spectrum of levels of consent, all the way through to needing a specific signed form.
20. Now we know what should have happened, we have looked to see what did happen. We have Mr R’s account of events which is that weight gain and diabetes/blood sugar were not discussed. We have the psychiatrist, in the Trust’s complaints investigation, saying they did discuss the side effects. The medical records are silent on this point, although they contain evidence the psychiatrist offered Mr R a telephone appointment to monitor side effects. And we have the Trust’s information leaflet, which Mr R accepts he was given on 29 November 2016. This says many people taking olanzapine will gain weight. The leaflet also says ‘a few’ people taking olanzapine will get diabetes.
21. Mr R says it was not appropriate to expect him to learn about the side effects by reading the information leaflet, as he was in a severe depressive episode. We have two conflicting accounts of events about whether he was provided with the information face-to-face, and these are hard to resolve. But we do know Mr R was given the leaflet. And we also know that Mr R went on to investigate the side effects before starting to take (effectively consenting to) the medication.
22. We understand Mr R was going through a tough time when these appointments took place and would have preferred more of a discussion about the medication. We consider that the information he was provided with, and the way it was provided, was in line with the guidance set out above and was sufficient for him to be able to make an informed decision before taking the medication. We therefore do not uphold this part of the complaint.
Complaint two - staff did not explain Mr R’s weight and blood should be monitored regularly to check for side effects of olanzapine.
23. GMC prescribing guidelines say doctors should explain to patients about any relevant arrangements for monitoring, follow up and review, including blood tests.
24. The BNF and the Oxford medication guidelines both set out clear requirements for regular monitoring of weight, blood glucose and blood lipids whilst patients are taking olanzapine.
25. We have seen no evidence staff told Mr R about the need for regular monitoring of his weight and blood while taking olanzapine. The patient information leaflet the Trust gave to Mr R does not mention the need for regular monitoring. The clinical records show us the psychiatrist asked Mr R if he was experiencing side effects during his treatment, but there is no evidence he was specifically told about the need for monitoring. This was not in line with the guidelines, and we find this was a failing.
26. The impact of this failing interacts with other failings we have identified. Therefore, we will consider this separately, in paragraphs 78 to 83.
Complaint three - Staff did not weigh Mr R as often as recommended in national and local guidelines.
27. The BNF and Oxford medication guidelines say patients taking olanzapine should have their weight measured at baseline, followed by regular weights taken in the first three months, then every three months for the first year.
28. Firstly, looking at the first three months, we have seen evidence Mr R’s weight was taken at baseline on 30 November 2016 by his GP. During the first three months, Mr R had only one appointment with his psychiatrist, at which there is no record of him being weighed.
29. The records show the Trust offered to weigh Mr R in June 2017, this was around after six to seven months of treatment, but he ‘was not keen’ and thought his weight was stable. The Trust recorded Mr R’s weight in August 2017 when it had increased.
30. In September 2017, Mr R’s weight has been recorded in his care notes (this may have been self-reported), after around nine to ten months of treatment. In November 2017, Mr R’s GP told the Trust Mr R’s weight had increased further.
31. In summary, the evidence is that Mr R was weighed at baseline, which was in line with the guidance. He was then not weighed at all during the first three months, when the guidance says he should be weighed regularly. Then at six months, when the guidance says he should be weighed, he did not want to be weighed but his weight was discussed with him, and he felt there had been no change. Given his reluctance to be weighed, and the subsequent discussion, we are satisfied the Trust’s actions broadly met the relevant guidance. Then at around nine months, and again at around 12 months, his weight was taken, which was in line with the guidance.
32. We find the Trust failed to weigh Mr R in line with relevant guidelines during the first three months. The impact of this interacts with other failings we have identified, so we will consider this separately in paragraphs 78 to 83.
Complaint four - when staff weighed Mr R in August 2017, they did not compare this to his baseline weight or explain that his weight gain could be a side effect of olanzapine.
33. In the section above we have said how often Mr R should have been weighed, and that there is no evidence he was weighed regularly during the first three months. The BNF and Oxford medication guidelines do not specifically say later weights should be compared to the baseline weight, but it is clear from the wording of the guidelines that weight should be monitored, and that would not be possible without comparing a weight with a previous one.
34. So, what did happen? In August 2017 the psychiatrist documented Mr R’s weight and said this was a gain of around 10kg. When actually he had gained around 23kg since he started the medication.
35. Despite this discrepancy, the key point is that Mr R had gained weight and, by comparing it to a previous figure, the Trust identified that. That was in line with the BNF and Oxford medication guidelines.
36. We next considered Mr R’s concern that he was not told his weight gain could be a side effect of the medication.
37. GMC prescribing guidelines say doctors must have suitable arrangements for medication reviews which take account of the patient’s needs and any risks arising from medications. GMC good practice guidelines say doctors must give patients the information they want or need to know in a way they can understand.
38. The clinical records say in August 2017, Mr R noted his weight had increased since being on his current medication and queried whether he should change to something else. The records also say the psychiatrist would keep his medication under review given the extent of his weight gain.
39. We can see from this that Mr R understood there was a potential link, and that the psychiatrist accepted that. In line with the guidance set out above, Mr R was aware of the risk of weight gain.
40. We find no failings in either of these aspects of the complaint.
Complaint five - staff did not communicate with Mr R or his GP when he was not having blood tests as often as the Trust requested.
41. In order to look at this, we have first looked to see when Mr R was having blood tests and what was happening around the communication of them.
42. We have said, under our consideration of complaint two, that the BNF and Oxford medication guidelines both set out a requirement for regular monitoring of weight, blood glucose and blood lipids while patients are taking olanzapine. The monitoring of blood glucose and blood lipids is done by blood tests. The BNF says blood lipids should be measured at baseline, monitored every three months for the first year and then yearly. Fasting blood glucose should be measured at baseline, after one months’ treatment and then every four to six months.
43. There is evidence in Mr R’s care notes that a full set of bloods were taken in November 2016 by his GP, before olanzapine was prescribed. It appears that there was no result for triglycerides. We can see in January 2017 the psychiatrist discussed blood tests with Mr R. He confirmed he had some bloods taken in December 2016 but was not sure of the results. The psychiatrist spoke to Mr R’s GP on 1 February 2017, who confirmed he had a full set of blood tests taken in December 2016 and the results of these were normal. We acknowledge a test for triglycerides (type of fatty substance in the blood) appears to have been missed at baseline, but we do not consider this error falls so far below the standard that it amounts to a failing. This is because the rest of the blood tests were taken at baseline and a full set of bloods were taken one month after olanzapine was prescribed, which is in line with Oxford medication guidelines.
44. On 3 March 2017, the psychiatrist wrote to Mr R’s GP and asked them to do a full set of blood tests, including glucose and lipids. This was approximately a three to four month interval from when Mr R had been prescribed the medication, and fits with the Oxford medication guidelines.
45. The results of the tests were abnormal. The psychiatrist discussed the results with Mr R on 17 March 2017 and advised him to return to his GP for repeat tests. It seems he did not do this.
46. We can see the Trust asked Mr R’s GP to take further blood tests, including glucose and lipids, in early July 2017. It also asked that they be repeated regularly. This was approximately seven to eight months after he had been prescribed the medication, and approximately six to seven months after he had started taking it. That is broadly in line with the Oxford medication guidelines.
47. There is no evidence the psychiatrist had these results at the next review on 9 August 2017 but, following the appointment, they asked Mr R’s GP to do blood tests, including glucose and lipids, and to repeat these regularly. At the start of September, Mr R told his care co-ordinator he did not have the bloods done as requested by his psychiatrist but agreed to go to his GP for this. The psychiatrist repeated the request for blood tests in a letter to Mr R's GP, dated 18 September 2017. It seems those blood tests were done, as Mr R was diagnosed with high cholesterol in September. That is around ten to eleven months after he was first prescribed the medication, and around nine to ten months after he started taking it. That is broadly in line with the Oxford medication guidelines.
48. The records show that in November 2017 the GP checked Mr R’s blood glucose and lipid level again. That was around a year after he had first been prescribed the medication, and is in line with the Oxford medication guidelines.
49. Overall, we think the Trust fulfilled its responsibilities, under the guidelines, to request blood tests at the relevant times and it did communicate with his GP. When the March 2017 tests came back as abnormal, Mr R was advised to have them repeated. He did not do that, but that does not mean there is a failing on the part of the Trust. At his next appointment, the Trust again asked his GP that he have the blood tests. There is also evidence the psychiatrist asked Mr R’s GP to repeat the relevant blood tests regularly. Taking all that into account, we do not uphold this part of the complaint.
Complaint six - staff did not inform Mr R his blood test results were abnormal because of side effects of olanzapine and did not explain these abnormalities may continue to increase.
50. GMC prescribing guidelines say doctors must have suitable arrangements for medication reviews which take account of the patient’s needs and any risks arising from medications. It also says medication reviews are particularly important when medicines have potentially serious or common side-effects, or where clinical guidelines recommend blood tests or other regular monitoring.
51. GMC good practice guidelines says doctors must give patients the information they want or need to know in a way they can understand.
52. Maudsley prescribing guidelines say olanzapine can increase triglyceride levels by 40%. It says levels may continue to rise for up to a year. It also says up to two thirds of patients taking olanzapine will have raised triglyceride levels. They also say olanzapine has been strongly linked to impaired glucose tolerance and diabetes and appears to directly induce insulin resistance.
53. In line with these guidelines, the psychiatrist should have informed Mr R his raised blood sugar and lipids could be a result of olanzapine, and that the levels may continue to increase while he was taking the drug.
54. The Trust informed Mr R about his abnormal blood glucose and lipid levels on 17 March 2017. The notes say the psychiatrist advised Mr R to discuss these with his GP. There is no evidence the psychiatrist explained the blood results could be due to olanzapine, or that the abnormal results may continue to increase. We asked our adviser whether it would be necessary to share the link between the medication and the abnormal test results. They said it would.
55. By not having a discussion with Mr R about the reasons for his abnormal blood test results, the psychiatrist was not acting in line with the guidance set out above. We consider this was a failing.
56. The impact of this failing interacts with other failings we have identified. Therefore, we will consider this separately later in this report.
Complaint seven - staff did not take any action following Mr R’s weight increase, and when his blood test results were abnormal.
57. In considering what should have happened, we referred to GMC and Maudsley prescribing guidelines.
58. GMC prescribing guidelines says doctors must have suitable arrangements for medication reviews which take account of the patient’s needs and any risks arising from medications. They also say medication reviews are particularly important when medicines have potentially serious or common side effects, or where clinical guidelines recommend blood test or other regular monitoring.
59. Maudsley prescribing guidelines say if patients experience changes to their weight, blood lipids and blood glucose while taking an antipsychotic drug, clinicians should offer lifestyle advice, and consider changing the medication and/or dietary or drug interventions. It also says the clinician should refer the patient to their GP.
60. The Trust became aware of Mr R’s raised blood sugar and lipid levels in March 2017. The notes of the consultation on 17 March 2017 say they discussed the results with Mr R and advised him to discuss these with his GP.
61. The notes say Mr R needed to repeat the fasting glucose test because he drank a cup of tea with milk before the test. The notes suggested the possibility of lipid-lowering medication as Mr R had had high lipids in the past and lifestyle changes did not help.
62. These notes show the psychiatrist discussed lifestyle changes and drug interventions with Mr R following the raised blood sugar and lipid levels. We can see the Trust also wrote to Mr R’s GP following the appointment. These actions are in line with Maudsley prescribing guidelines.
63. We have seen no evidence the Trust considered stopping the prescription of olanzapine, following Mr R’s abnormal blood test results, in March 2017. However, we would not necessarily expect that to be recorded. We have thought about whether this was considered, and we asked our adviser to help us with this.
64. We can see Mr R’s depression was severe and difficult to treat with other medications. That meant it was appropriate to first try and see if Mr R’s blood glucose and lipids could be controlled with other methods such as lifestyle changes and medication, before considering in more depth whether to stop prescribing olanzapine.
65. The Trust gave Mr R further lifestyle advice on 9 August 2017 when the psychiatrist noted he had gained weight. The notes of this appointment say the psychiatrist advised Mr R to try and continue more activities in his daily routine, such as walking and exercise. This lifestyle advice was in line with the Maudsley prescribing guidelines.
66. We can see the Trust considered changing Mr R’s medication at this time but decided not to. It is important to recognise this appointment was Mr R’s second contact with a new psychiatrist. The psychiatrist documented this made it difficult to establish his treatment response. The psychiatrist said they would review Mr R’s medication after he had a psychotherapy assessment later in the month.
67. We think this was in line with GMC prescribing guidelines. The psychiatrist recognised olanzapine seemed to be having little benefit and may be causing unwanted weight gain. However, it was appropriate not to decide to stop olanzapine at this time as the psychiatrist had not known Mr R long enough to properly assess the benefits and risks of the medication.
68. Before Mr R’s next psychiatry appointment, he met his care coordinator. The care coordinator documented Mr R said he had gained 20kg and had started to eat less. The notes also say Mr R had been helping his parents in the house and garden.
69. When the psychiatrist reviewed Mr R on 18 September 2017, they noted he was in a brighter mood. They also noted he had started his hobbies again, and had agreed to further psychotherapy, and a referral to a therapeutic gardening service.
70. The improvement in Mr R’s condition and his engagement with new services indicated a potential benefit from the olanzapine, which the Trust had not seen previously. Mr R also appeared to be engaging with lifestyle changes to potentially limit weight gain.
71. Given this, our adviser said it was in line with GMC prescribing guidelines to continue prescribing olanzapine in September 2017. This is because despite Mr R’s weight gain, there was some evidence his severe, difficult to treat depression was improving.
72. The psychiatrist planned to review Mr R during October 2017, but Mr R asked to delay the appointment until November 2017. When the psychiatrist reviewed Mr R in November 2017, his mood had deteriorated again.
73. The psychiatrist documented they discussed medication changes but wanted to wait for the outcome of some cardiac investigations before making any decisions. We find this was in line with GMC prescribing guidelines. To make an informed decision the psychiatrist needed the outcome of the cardiac investigations.
74. Mr R chose to stop taking olanzapine before his next appointment with the psychiatrist.
75. We can see Mr R’s weight did increase while he was taking olanzapine. We can also see the weight increase (and subsequent weight loss) has had a significant impact on him. We do not underestimate how difficult this was for Mr R and the effect it had on his day-to-day life. We have considered the relevant clinical guidelines and we find the Trust acted in line with them, following the abnormal blood tests in March 2017, and Mr R’s documented weight gain in August 2017. This is because the Trust gave advice in line with relevant guidelines, referred him to his GP, and made decisions in line with relevant guidelines to continue prescribing olanzapine. Therefore, we do not uphold this aspect of the complaint.
Impact of the failings we have identified
76. The failings we have identified are:
· not telling Mr R that his weight and bloods should be monitored while he was taking olanzapine · not weighing him as regularly as it should have during his first three months of him taking olanzapine · not making clear to him that his abnormal blood tests could potentially be a side effect of olanzapine.
77. We have looked at the impact on Mr R of those failings. We have considered the significant impact Mr R says he has experienced. Our role is to look at the impact of the failings we identify, so our consideration here is limited to looking at the impact of the three failings set out above. That does not mean we underestimate what a difficult time Mr R has had overall, only that we are only permitted to look at the impact of the failings we identify.
78. By looking first at the Trust’s failure to tell Mr R his weight and bloods should be monitored, we can see from Mr R’s medical records and complaints correspondence that he was aware olanzapine may cause weight gain and other side effects such as diabetes, before he started taking it. His weight and bloods were being monitored (albeit that his weight was not taken enough in the first three months) and we cannot see he would not have been aware of that, so we do not find that failing had any impact on him.
79. Next, looking at the Trust’s failure to weigh Mr R in line with guidance during the first three months. We find at six months Mr R would not be weighed, and he said his weight had not changed. Given that, we do not see the Trust attempting to weigh him more frequently during the first three months would have resulted in it recording a weight gain. This is because he may have refused to have been weighed but also, by his own admission, he had not gained any weight in the first six months. As such, we do not find the failing had any impact on him.
80. Finally, we have thought about the impact of the Trust failing to tell Mr R that his abnormal blood test results could be caused by olanzapine. Mr R was already aware of the side effects of olanzapine and, although the Trust should have made it clear to him following the abnormal test results, he was in possession of sufficient information (as set out in the paragraph above) to realise the medication could have been the cause of that. And it did not have any impact on his treatment, meaning we are satisfied the decision to continue with olanzapine following the abnormal blood tests was in line with the relevant guidance. We do not find the Trust’s failing had any impact on him.
81. Because we cannot see the failings had any impact on Mr R, we partly uphold these parts of the complaint.
Summary of our decision
82. There were some failings in the Trust’s actions. However, none of the failings had an impact on Mr R. That is not to say we think Mr R has not had a really difficult time – we can see he has - but we cannot link those difficulties to any failing on the part of the Trust. Our conclusion is, we partly uphold his complaint.
Action taken by the Trust in response to Mr R’s complaint
83. Although we cannot see the Trust’s failings had an impact on Mr R, we can see the Trust has taken steps to prevent similar failings happening again. We include this in this report for completeness, and to reiterate to Mr R that his complaint has resulted in improvements being made. This will try to prevent something similar happening again, which was one of the outcomes Mr R was looking for. The detail of the improvements has already been shared with Mr R, but they are focused on improved monitoring and improved communication.