14. Our analysis of Ms C’s care and treatment refers to the following medications (with explanations taken from the NHS website);
Zopiclone is ‘a type of sleeping pill that can be taken for short-term treatment of severe insomnia… You'll usually be prescribed zopiclone for just 2 to 4 weeks. This is because your body gets used to this medicine quickly, and after this time it's unlikely to have the same effect. Your body can also become dependent on it.’
Sertraline is ‘a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It's often used to treat depression, and also sometimes panic attacks, obsessive compulsive disorder (OCD) and post-traumatic stress disorder (PTSD)… It helps many people recover from depression, and has fewer unwanted side effects than older antidepressants.’
Olanzapine ‘helps to manage symptoms of mental health conditions such as… schizophrenia, bipolar disorder. It belongs to a group of medicines called antipsychotics.’
Diazepam ‘belongs to a group of medicines called benzodiazepines. It's used to treat anxiety…’ 15. Following her GP’s referral, Ms C was assessed urgently at home on 12 March 2020 by Dr F, Specialty Doctor in Psychiatry with the Trust’s Community Mental Health Recovery Service (CMHRS) for North East Hampshire.
16. Dr F concluded Ms C had GAD. He recommended she start taking sertraline on an initial once-daily dose of 25mg for a week, before increasing to 50mg once daily. The process of slowly adjusting the dose of a medication to find the right balance is called titration.
17. Dr F advised Ms C that after starting sertraline, her anxiety levels might increase for the first few days. (The BNF lists anxiety as a ‘common or very common’ side-effect.) Therefore, he prescribed her a short course of diazepam at 2mg three times daily to address this. He recommended she continue with her current use of zopiclone at 7.5mg at night to help with sleep. Dr F arranged to review Ms C again in the outpatient clinic in two to three weeks’ time. He recommended exploring psychological therapy once her mental state was more settled.
18. We found Dr F’s management plan was safe and appropriate and of a good standard. NICE CG113 says that if a person with GAD chooses drug treatment, the doctor should consider offering sertraline first. Dr F’s decision to start Ms C on sertraline was in line with this guidance. The titration regime was in accordance with BNF guidance for initiating sertraline.
19. Our adviser would have expected Ms C to be offered an information leaflet for sertraline, in keeping with Good Medical Practice which says ‘you must give patients the information they want or need to know in a way they can understand’ but there is no indication this was done. But overall, Dr F’s management plan was at this time was safe. He put appropriate safety netting in place. Safety netting refers to advice given to patient about what to do in unexpected or worsening circumstances. This included advice on what Ms C could do if she felt her mental health was in a state of crisis.
20. Dr F reviewed Ms C again 30 March. It now had to be by telephone as it was a week after the government had announced a ‘stay at home’ order in response to COVID-19. Dr F recommended Ms C increase her dose of sertraline from 50 to 100mg once daily. We found this was appropriate because she was still experiencing anxiety and reported that she was tolerating the medicine without any issues. The BNF says the maximum daily dose is 200mg per day. Dr F advised her she could continue her regular diazepam prescription but that, by this stage, the dose had been increased from 2mg three times daily to 5mg twice daily. It is not clear why the dose of regular diazepam was increased. However, Ms C said she was continuing to experience anxiety, which would justify continuing it. The BNF says the maximum daily dose is 30mg, so the new total daily dose of 10mg was safe practice.
21. Dr F also recommended Ms C could continue her zopiclone 7.5mg at night to help her sleep. Dr F reiterated she should consider psychological therapy part of her treatment plan once her mental state has improved. He recommended her medication be prescribed once a week and arranged to review her again in two to three weeks’ time. He gave her safety netting advice, explaining what she could do if she reached crisis point.
22. The continuation of both the regular diazepam and regular zopiclone was not against NICE recommendations in terms of use of both benzodiazepines (such as diazepam) and of hypnotics (such as zopiclone). However, the BNF’s advice on ‘hypnotics and anxiolytics’ says zopiclone is ‘not licensed for long-term use’ and that benzodiazepines are ‘indicated for the short-term relief of severe anxiety; long-term use should be avoided’.
23. NICE CG113 says; ‘Do not offer a benzodiazepine for the treatment of GAD in primary or secondary care except as a short-term measure during crises. Follow the advice in the BNF on the use of a benzodiazepine in this context.’
24. The BNF describes short-term relief as ‘two to four weeks only’. At this time, Dr F had been prescribing regular diazepam and zopiclone for less than three weeks (12 to 30 March), although the GP had prescribed zopiclone before the referral and had said Ms C had been trying to get it elsewhere.
25. On 15 April, Dr F reviewed Ms C by phone. He recommended she stay on her current dose of sertraline of 100mg once daily due to her reporting diarrhoea for one week prior to her outpatient review. Diarrhoea is listed in the BNF as a ‘common or very common’ side effect of sertraline, and it was reasonable to think it better not to increase the sertraline in these circumstances. Ms C was still prescribed regular diazepam (5mg twice daily) and regular zopiclone (7.5mg at night). It was now more than four weeks since her initial review with Dr F (and the GP said she had prescribed zopiclone for Ms C before that). We found the continuation of diazepam and zopiclone as regular prescriptions was not in line with either the BNF guidance on hypnotics and anxiolytics, or with the NICE Clinical Guidelines for GAD.
26. Dr F reviewed Ms C by telephone on 4 May and recommended she increase her dose of sertraline from 100 to 150mg once daily to try to achieve better control of her ongoing anxiety symptoms. Ms C was still prescribed regular diazepam (5mg twice daily) and regular zopiclone (7.5mg at night). This was now more than seven weeks since her initial review with Dr F.
27. Ms C admitted to Dr F she had been taking double her prescribed dose of 7.5mg of zopiclone at night due to disturbed sleep. Dr F warned her of the potential for dependence on zopiclone and encouraged her to ‘use it sensibly’. We saw no evidence in the records that Dr F recommended or suggested reducing the dose of zopiclone to try to get Ms C off it. There was now clear evidence that Ms C was abusing the zopiclone and taking more that the BNF advisory maximum dose of 7.5mg at night.
28. Dr F told Ms C he was ‘not keen to give extra diazepam’. We saw no indication that he recommended or suggested she should reduce her dose of diazepam and the record does not provide any information about a safe diazepam reduction regime. Ms C had now been taking it regularly for almost two months and we found evidence she had developed a dependence on it as a result.
29. On 8 May, Ms C presented at her local accident and emergency department (A&E) after she had cut her wrists. The mental health liaison team assessed her. She agreed to be referred to the Trust’s Crisis Resolution and Home Treatment Team (CRHTT), with a view to considering admission to hospital if things deteriorated in the community. The CRHTT carried out what we found to be a comprehensive risk assessment. Our adviser said the management plan agreed from this assessment was safe and appropriate and representative of good clinical care.
30. On 14 May, Ms C presented at A&E again after taking a mixed tablet overdose, involving diazepam, zopiclone and Bisoprolol (a medicine used to treat high blood pressure). She denied this was an attempt to end her life but rather felt she had been experiencing a panic attack and wanted to slow her heart rate. Staff noted her previous presentation a week earlier. The mental health liaison team decided to discharge Ms C to her home address and to remain under the care of the CRHTT. Having reviewed the assessment documentation, our adviser said this course of action was safe and appropriate and representative of good clinical care.
31. On 2 June, the CRHTT wrote to Ms C’s GP to say that Ms C had now finished her episode of care with them. It said her care had been transferred to her local community mental health team, who would allocate a care co-ordinator. The letter states that, as well as being supported with appropriate mental health medication, Ms C had also been able to access ‘talking therapy’ (such therapies can include counselling, cognitive behavioural therapy, guided self-help). She had made good improvement under the care of the CRHTT and was no longer considered to be in crisis. At the time of discharge from the care of the CRHTT, Ms C was prescribed sertraline 150mg once daily, diazepam 4mg twice daily, and zopiclone 7.5mg when required. A crisis and contingency plan was completed at the time of her discharge from the CRHTT.
32. We found this communication of a progress update from the CRHTT to Ms C’s GP was in line with Good Medical Practice, which requires doctors to ‘contribute to the safe transfer of patients between healthcare providers and between health and social care providers. This means you must… share all relevant information with colleagues involved in your patients’ care within and outside the team…’ 33. On 3 June, Ms C presented at A&E having cut both arms with a knife. She told the mental health liaison team practitioner that she had not intended to end her life and had no suicide plans. She had no intent on acting on any suicidal thoughts and showed evidence of future thinking and planning. It was not felt Ms C required admission to a psychiatric ward or another referral to the CRHTT for input in the community. The practitioner noted that Ms C was waiting for an outpatient appointment with Dr F. She was discharged from A&E to her home address.
34. On 16 June, Ms C attended A&E again after taking an intentional overdose of Paracetamol, caffeine and Codeine Phosphate (an opiate painkiller) due to worsening anxiety, along with an act of self-harm to her wrist. She said her actions were a cry for help and that she regretted them. Following an assessment by one of the mental health liaison team practitioners, she was discharged home. It was noted she had an outpatient appointment with Dr F the following day. The mental health liaison team practitioner notified Dr F and Ms C’s Care Co-ordinator of her presentation to A&E and subsequent mental health assessment.
35. We found this communication of Ms C’s admission to A&E and subsequent assessment by the mental health liaison team was representative of good and safe clinical practice and in keeping with the Good Medical Practice’s requirement on the safe transfer of patients between healthcare providers.
36. Dr F reviewed Ms C by phone on 17 June. He recommended she continue her sertraline 150mg once daily. Dr F noted Ms C’s GP was slowly weaning her off her regular diazepam by reducing the daily dose by 2mg every two weeks. (She was being prescribed diazepam 2mg three times daily at the time of this review with Dr F). Dr F advised Ms C of the potential for dependence on zopiclone and encouraged her to ‘use it sensibly’. The record does not show he recommended or suggested she be weaned off zopiclone, although there was ongoing evidence that she was abusing it in the community on more than one occasion. Dr F encouraged Ms C to self-refer for some cognitive behavioural therapy (CBT) and that she was happy to be referred to a ‘coping skills’ group. He recommended she continue to work with a care co-ordinator and that he would review her again in six weeks’ time. He recommended she remain on once weekly issuing of any prescribed medications. Weekly prescriptions (rather than for a longer period) are given if the doctor is concerned about possible overdose or misuse and thinks that restricting the quantity of medication that a patient holds at any time is safer for them 37. Dr F next reviewed Ms C over the phone on 27 July. She was still being prescribed sertraline 150mg once daily and her GP was continuing a diazepam reduction regime, reducing her daily dose by 1mg every three weeks. (Ms C was now prescribed 2mg twice daily at the time of this review with Dr F). She was still being prescribed zopiclone 7.5mg at night. Dr F had, by this stage, added in olanzapine 5mg at night, which Ms C said helped with her sleep, reduced her anxiety levels and improve her mood. Dr F advised Ms C of the potential for dependence on zopiclone and encouraged her to ‘use it sensibly’. He did not make any recommendation or suggest that she be weaned off it. Dr F noted that Ms C had not engaged in any self-harming or suicidal behaviours since June and that she was due to start the ‘coping skills’ group the following week. He recommended she remain on once weekly issuing of any prescribed medications and arranged to review her again in six weeks’ time.
38. Use of olanzapine in the treatment of GAD is not recommended in NICE CG113. The only statement it makes about the use of antipsychotic medications is ‘Do not offer an antipsychotic for the treatment of GAD in primary care’. There is no mention of use of antipsychotic medication for the treatment of GAD in secondary care (i.e. whilst under the care of community or inpatient mental health services).
39. The BAP guidelines state the following in relation to augmentation of an antidepressant as treatment for GAD: ‘The findings of small, randomised placebo-controlled augmentation studies suggest that augmentation of antidepressants with antipsychotic drugs (olanzapine, quetiapine, risperidone) may be beneficial… ’ 40. Therefore, Dr F’s decision to augment Ms C’s sertraline with olanzapine to treat her GAD had an evidence base and was clinically justifiable. The 5mg dose was the minimum recommended by the BNF.
41. On 20 August, Ms C presented at A&E after taking a mixed tablet overdose involving Paracetamol and Zolpidem (a sleeping pill). She was intoxicated with alcohol at the time of the overdose. She was assessed by the mental health liaison team, who then discharged her home and informed her community team.
42. We found this assessment and communication with the community team were representative of good and safe clinical practice and in line with Good Medical Practice.
43. Dr F assessed Ms C by phone on 8 September. At the time, she was prescribed sertraline 150mg once daily and olanzapine 10mg at night.
44. Ms C was still prescribed zopiclone 7.5mg, despite being started on olanzapine to help her sleep at night, which she said had helped improve her sleep. Dr F advised her of the potential for dependence on zopiclone and encouraged her to ‘use it sensibly.’ We saw no evidence he suggested she be weaned off zopiclone. Ms C was no longer being prescribed regular diazepam. We saw no evidence that concerns were raised at the time of this review about Ms C misusing or abusing any of her prescribed medications. Dr F recommended that Ms C remain on once weekly issuing of prescriptions and arranged to review her again in eight weeks’ time. It was felt that Ms C should continue to be managed by the community team with a care co-ordinator and Ms C was encouraged to continue to attend the weekly team virtual ‘coping skills’ group.
45. On 27 September, Ms C was admitted to A&E after taking an overdose of Solpadeine tablets (Paracetamol and Codeine Phosphate) while intoxicated with alcohol. She told the mental health liaison team practitioner who assessed her that she had taken them to ‘calm herself down’ and admitted she has ‘doubled her zopiclone dose for the past few days.’ Ms C was not felt to require admission to a psychiatric ward or referral to the CRHTT and she was discharged to her home address, with her community team made aware of her A&E attendance.
46. This communication of Ms C’s admission to A&E and subsequent assessment by the mental health liaison team was representative of good and safe clinical practice and in keeping with Good Medical Practice.
47. In an email to Dr F on 19 October, Ms C’s GP expressed her concerns about Ms C abusing both her prescribed zopiclone and her prescribed olanzapine. She said for the last two Mondays that they had spoken, Ms C had used a four-day prescription for zopiclone within two days. That day she had also used her olanzapine within two days. The GP asked Dr F to review Ms C to more optimally manage her ongoing high anxiety and agitation levels.
48. On the early evening of 21 October, Ms C phoned the Trust’s Single Point of Access. She told the call handler she was having suicidal thoughts and was not sure if she could keep herself safe that night. The call hander advised her they may have to call the emergency services at which point, Ms C hung up. After speaking to a senior clinician, the call handler phoned Ms C back and as she did not pick up, left a message. She also called an ambulance to attend to Ms C. Sadly, the next day, the GP called the Trust to inform them that Ms C had been found dead. The coroner later stated that her death had occurred at sometime between 7pm and 8pm.