14. Mr Q’s complaint centres on the care and treatment he received from the Trust for his anxiety. He specifically complains the Trust did not explore a variety of treatment options to treat his anxiety, including his suggestion to trial Pregabalin (a prescription medication used to treat generalised anxiety disorder) to treat his anxiety disorder.
15. Mr Q was referred to the Trust’s mental health services by his GP in March 2024 and was assessed by a mental health practitioner from the triage service on 10 March. The records show that by that appointment, Mr Q had been trialled on several different psychotropic medications (drugs that affect a person’s mental state) to treat his anxiety and at the time of the triage appointment, he was being treated with the tricyclic antidepressant Nortriptyline (known as TCA, this is a class of second-line medication for depression and anxiety) which he explained was ineffective.
16. The records show during the triage appointment in March 2024, Mr Q had asked for a trial of Pregabalin, and the mental health practitioner recommended that his GP liaise with the link- in consultant psychiatrist for medication advice. Mr Q was subsequently discharged back to the care of his GP.
17. On 10 April 2024 Mr Q was further assessed by a link-in consultant psychiatrist from the mental health triage service. The outcome was that the potential risks of prescribing Mr Q’s preferred medication, Pregabalin, outweighed the potential benefits.
18. The service advised that Mr Q’s GP should seek advice from a Cardiologist to enquire about the safety of increasing his dose of Nortriptyline given his cardiac status (having high blood pressure) and left ventricular hypertrophy (thickening of the wall of the heart’s main pumping chamber) as it seemed that Mr Q’s currently prescribed dose of Nortriptyline (25 mg once daily) was not high enough to constitute an effective treatment dose.
19. The GMC guidance explains in providing clinical care, clinicians should adequately assess a patient’s condition and take account of their medical history including, ‘symptoms, relevant psychological, spiritual, social, economic, and cultural factors, the patient’s views, needs and values’. It also says clinicians must make good use of the resources available.
20. Mr Q was already being treated with Nortriptyline 25 mg once daily for four weeks for his anxiety disorder at the time he was referred to the mental health triage service.
21. The BNF Nortriptyline guidance provides key information on the selection, prescribing, dispensing and administration of medicines. It advises that Nortriptyline should be initiated at a low dose, then increased if necessary to 75- 100 mg once daily; maximum 150 mg per day. Our adviser said based on the BNF guidance, the expected dose to treat anxiety disorder would be at least 75 mg daily and up to 150 mg daily.
22. The BNF Nortriptyline guidance also states that Nortriptyline should be used with caution in individuals with cardiovascular disease, which would include Mr Q with his known high blood pressure and left ventricular hypertrophy.
23. As Mr Q was only prescribed 25 mg once daily at the time of his referral in March and his consultation in April 2024, the link-in consultant identified that in line with the BNF Nortriptyline guidance, he needed a higher dose in order for the treatment to be effective. But, in line with the BNF Nortriptyline guidance they recommended that Mr Q’s GP seek advice from a cardiologist before altering his dosage.
24. Taking into consideration the cautionary guidance and Mr Q’s health circumstances, our adviser said the Trust was correct and justified in recommending that Mr Q’s GP seek cardiology advice before increasing his dosage of Nortriptyline. Our adviser said the Trust’s actions were representative of good and safe clinical practice.
25. Mr Q made it clear at both of his appointments in March and April that he had read about Pregabalin and was keen to try it.
26. The GMC guidance paragraph 24 says:
‘All patients have the right to be involved in decisions about their treatment and care, and be supported to make informed decisions if they are able to. You must start from the presumption that all adult patients have capacity to make decisions about their treatment and care.’
27. As such, to act in line with this, the Trust should consider patients’ preferences where it relates to their care and treatment options.
28. Our adviser said Mr Q’s request to be considered for a trial of Pregabalin was a viable treatment option because according to the NICE guidance clinicians should consider prescribing Pregabalin if a person cannot tolerate SSRIs or SNRIs (selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors respectively, are both first line antidepressants for depression and anxiety). The clinical notes demonstrate that Mr Q had previously experienced adverse effects with SSRIs and SNRIs.
29. The NICE guidance or BAP guidelines do not provide any recommendations or information about whether Pregabalin is, or might be appropriate, to use in patients with anxiety disorder who have co-existing cardiac problems, as in Mr Q’s case.
30. The BNF Pregabalin guidance states that Pregabalin should be used with caution for patients with conditions that may precipitate severe congestive cardiac failure. The records show that Mr Q has high blood pressure and left ventricular hypertrophy of a moderate severity and thus is at risk of developing congestive cardiac failure.
31. Having considered the guidance available on the safe prescription of Pregabalin together with Mr Q’s health circumstances, our adviser said it was correct for the Trust to request that Mr Q’s GP seek a specialist opinion from a Cardiologist about safe prescribing of any medication to treat Mr Q’s anxiety disorder; this would include the possibility of Pregabalin being prescribed for Mr Q.
32. In addition, our adviser said, given the lack of clinical guidelines about safe use of Pregabalin in individuals with anxiety disorder and co-existing cardiac problems, it was sensible from a patient-care and patient-safety perspective for a specialist opinion from a Cardiologist to be obtained.
33. This is also in line with the GMC guidance which says clinicians should work with colleagues in ways that best serve the interests of patients and recognise and work within the limits of their competence, including providing a good standard of practice and care.
34. Our adviser said had the Trust recommended that Mr Q be initiated on Pregabalin without any cardiology advice, this could potentially have caused Mr Q to develop heart failure or impacted negatively on his cardiac status, and resulted in deterioration of his physical health which could have been fatal for Mr Q.
35. We can see that the Trust formally responded to Mr Q’s request for Pregabalin on 1 May 2024 and in addition to recommending that advice should be sought from a cardiologist, it explained that it would not recommend prescribing Pregabalin as it did not feel that the benefit would outweigh the risks. The Trust did not provide any further details on the actual benefits of the medication or the risks. It did not explain why it concluded that the benefits are unlikely to outweigh the risks.
36. The GMC guidance says ‘you must treat patients with kindness, courtesy and respect. This doesn’t mean agreeing to every request or withholding relevant information that may be upsetting or unwelcome. It means being willing to explain your reasons for the options you offer (and the options you don’t) and any recommendations you make.’
37. Our adviser explained that the Trust should have explained to Mr Q and his GP why the potential risks of initiating Pregabalin to treat Mr Q’s anxiety disorder outweighed the potential benefits of initiating it.
38. The Trust did not do this. This is not in line with the GMC guidance, and we consider this to be an indication of a failing.
39. Having seen an indication of a failing, we next looked at whether this had a negative impact on Mr Q, and, if so, whether the Trust has put things right.
40. Mr Q says the Trust’s decision not to explore more treatment options for his anxiety, and particularly his preferred medication, worsened his symptoms. As we have not concluded that the Trust should have prescribed Pregabalin or any other medication without first seeking cardiology advice, we cannot link the lack of an explanation provided to Mr Q to the clinical impact he has described to us. Furthermore, it is clear from the records that alternative treatment options had been explored (discussed in more detail below) with Mr Q but were deemed unsuitable because of his health circumstances.
41. Although we cannot make a link between the lack of an explanation offered to Mr Q regarding why he was not offered his preferred treatment option, Pregabalin, during his appointment in March and April 2024, and his worsening anxiety, we recognise it would have been frustrating, confusing, and upsetting not receiving a robust rationale for denying him his preferred treatment option.
42. Based on Our Principles, where there have been failings leading to an injustice, the Trust should try to offer a remedy that returns the complainant to the position they would have been in, if the failings had not happened. An appropriate range of remedies include an apology, explanation and acknowledgement of responsibility.
43. We approached the Trust to explain what we had seen in our investigation and it has agreed to apologise to Mr Q for the frustration and distress caused by the lack of clarity about why Pregabalin was not being recommended. We consider this to be a proportionate remedy, and in line with Our Principles, because Mr Q was aware at the time that further specialist advice was required before a final decision could be made about whether it would be safe for him to be prescribed Pregabalin.
44. We have considered the Trust’s exploration of other treatment options in addition to Nortriptyline (which Mr Q had already been taking prior to his engagement with the Trust) and Pregabalin.
45. The records show that Mr Q had previously been treated with Escitalopram (treatment used for major depression) and he reported that this caused his tics to worsen. Escitalopram is an SSRI antidepressant which Mr Q stated worsened his Attention Deficit Hyperactivity Disorder (ADHD). We note that he declined the option of trying Trazodone (treatment for major depressive disorder) due to him developing the side effect of priapism (prolonged erection of the penis). His blood pressure had become high as a result of Venlafaxine (antidepressant used to treat major depressive disorder) and so this was also not a viable treatment option.
46. At the triage appointment in March 2024, Mr Q was given the option of Quetiapine, (medication his GP had also previously suggested) but he declined this option due to his concerns about the cardiac risk of this medication.
47. We can see from the records that at the time of his assessment in March 2024, Mr Q was also accessing psychological therapy which he reported to have been beneficial. He was encouraged to continue therapy and was told to ask the ADHD service he was under whether they could support him with any resources designed to teach patients about mental health conditions and coping strategies or advice around the impact of his ADHD on his anxiety symptoms.
48. Having carefully considered the records and the advice received, it is our view that in line with the GMC guidance, the Trust did consider a wide range of treatment options for Mr Q’s anxiety disorder, including revisiting previously considered options and discussed Mr Q’s preferred option.
49. Given Mr Q’s health condition and response to previous treatment options, it was reasonable and in line with the GMC guidance to seek specialist advice from a cardiologist before exploring and recommending further treatment options.
50. We are sorry to learn of Mr Q’s complaint about the Trust and the impact this has had. Our primary investigation decision is not made without recognition of the impact this has had. We hope we have explained the thorough consideration we have given to our decision and clearly outlined the reasons for them.