Decision to stop Clozapine and treatment plan
14. Mr R says on 20 July, the Trust incorrectly stopped his Clozapine medication without providing him with an appropriate alternative treatment plan. He feels it did not correctly follow guidelines when making this decision. He says this caused his mental health to significantly decline and he suffered from Neuroleptic Malignant Syndrome. We are sorry to hear Mr R went through this experience, and we recognise how distressing it must have been for him.
15. We first considered whether the Trust made an appropriate decision to stop Mr R’s Clozapine after he got a RED blood test rating on 18 July 2023.
16. The Trust’s ‘Clozapine Prescribing and Monitoring Guidelines’ explain if a patient gets a ‘RED’ result on a cloazapine blood test, clinicians should ‘immediately cease treatment’ and ‘Clozapine supplies should be returned to team base or hospital’. It also says Trust staff should arrange ‘local blood sampling daily’ until the patient recovers.
17. The records show on 18 July, Mr R had a Full Blood Count (FBC) blood test. The test results showed he scored a ‘RED’ rating for Clozapine. This test result indicates Mr R’s Neutrophil Count (a white blood cell which is used as part of the immune system) was too low for Clozapine to be safely continued. The Trust further reviewed the test result at the next available appointments on 19 and 20 July where both outcomes were RED results. Based on the FBC blood test, it decided to immediately stop this medication.
18. We consider the decision to stop this medication was correct and in line with the Trust’s guidelines. Mr R had a RED rating on his blood test, so it was clinically appropriate to ‘immediately cease treatment’. We so no indications of failings for this part of the complaint.
19. We next explored whether the medical records indicated the Trust provided an appropriate treatment plan after it stopped Mr R’s Clozapine medication.
20. The records indicate Trust staff correctly repeated Mr R’s FBC blood test in line with its guidance. On 19 July, his blood test showed he still had a RED rating for Clozapine. The Trust did not restart his medication. A consultant psychiatrist and pharmacist decided to invite Mr R’s parents to discuss and review his treatment plan the following day.
21. We are satisfied it was not appropriate to restart Mr R’s medication on 19 July. It appears he had yet to recover from his RED result, so it was clinically appropriate not to give him Clozapine in line with the Trust’s guidelines.
22. The records show on 20 July, Trust staff and Mr R’s parents agreed to a treatment management plan for him. This included repeating his daily blood tests and not to restart his Clozapine medication until he had a ‘GREEN’ result on his FBC blood test. Trust staff also recommended prescribing an alternative anti-psychotic medication called Lurasidone until Mr R got a GREEN result on his FBC blood test. Finally, Trust staff recommended a short course of Diazepam, to help manage his anxiety and agitation and Procyclidine (a drug which helps treat chemical imbalances) to help with his withdrawal from Clozapine. On 21 July, Trust staff also put a plan in place with the community mental health team, to help support Mr R in the community whilst he was withdrawing from Clozapine.
23. NICE guidelines for ‘Medicines associated with dependence or withdrawal symptoms: safe prescribing and withdrawal management for adults’ (April 2022) explain in cases where medicine has to be stopped abruptly, clinicians should ‘schedule more frequent reviews’ to closely monitor their patient. They should also use ‘short term medicines to treat the physical symptoms of withdrawal’ and ensure the plan for withdrawal is ‘clearly recorded in the overall management plan’.
24. In this case, it appears Trust staff acted in line with NICE guidance. It made sure it ‘closely monitored’ Mr R, by arranging daily FBC blood tests to determine when it would be safe to reintroduce Clozapine. They also prescribed appropriate alternative medication, to try and minimise his withdrawal symptoms including anxiety and agitation. Finally, it clearly recorded the management plan in Mr R’s records, so Trust staff had a clear understanding of what steps they needed to take to support and monitor him whilst he was not taking Clozapine. Overall, we consider the treatment plan was appropriate, and we see no indications of failings for this part of the complaint.
25. The records show on 21 and 22 July 2023, Mr R got an AMBER result on his FBC blood test. Trust staff started his alternative, antipsychotic medication, Lurasidone immediately to treat his schizophrenia. Our adviser explained this was clinically appropriate and in line with NICE guidelines. Trust staff did not delay providing appropriate ‘short term medicines’ to help manage his symptoms.
26. On 24 July 2023, Mr R had a FBC blood test and got a ‘GREEN’ result for Clozapine. This means his Neutrophil count had returned to normal. In light of this test result, the Trust reviewed his management plan and considered what steps it then needed to take to safely reintroduce Clozapine. This was the correct action to take in line with GMC guidelines in taking care when reintroducing medication. We consider this was an appropriate action to take, as the Trust needed to make sure it prescribed Mr R medication safely in line with NICE guidelines to minimise the risks of potential adverse side effects.
27. In summary, we are very sorry to hear Mr R felt so poorly after his Clozapine medication was stopped. This clearly has been an incredibly stressful, upsetting and worrying time for him and his family. We hope to reassure Mr R Trust staff correctly followed its guidelines when it made this decision. It also appears they put in place an appropriate treatment plan, in line with NICE guidelines, to support and monitor him whilst it stopped this medication. We hope this provides him with some closure for this part of his complaint.
Responding to concerns about treatment
28. Mr R says Trust staff ignored his and his family’s concerns about stopping his Clozapine medication. He feels they were ‘dismissive’ and were ‘reluctant to change his treatment plan’. This left him feeling like nobody would take responsibility for his care.
29. We recognise how important it would have been for Mr R and his family to feel supported and heard during this time. It is clear he suffered significant distress after his medication was stopped. We are sorry to hear this left him feeling ignored, especially when he was feeling so unwell and his mental health significantly deteriorated whilst in the community.
30. The GMC ‘Good Medical Practice’ guidelines explain clinicians have a duty to work closely with their patients and ‘those close to the patient. It says clinicians should be ‘sensitive and responsive in giving them information and support’.
31. It also states clinicians have a duty to ‘work collaboratively with colleagues’ and contribute to the ‘safe transfer of patients between healthcare providers and between health and social care providers’. This means clinicians should ‘share all relevant information with colleagues involved in your patients’ care within and outside the team, including when you ‘delegate care or refer patients to other health or social care providers’.
32. The records show on 27 July, Mr R’s family told Trust staff his mental health had significantly worsened in the community. This concern was escalated to the community mental health team. A Care Coordinator visited Mr R the same day and assessed him under the Mental Health Act. Having done so, they said he should be detained under Section 2 of the Mental Health Act and made an urgent request to admit him as an inpatient.
33. Sadly, no beds were available to admit Mr R to hospital on 27 July. The community mental health team offered a further home visit the next day. Mrs R (Mr R’s mother) declined this offer, as she felt a further home visit might make his mental state worse.
34. On 28 July, an out of area bed was found for Mr R and he was admitted for treatment. The community mental health team contacted the inpatient Consultant Psychiatrist and gave them Mr R’s clinical history on 2 August. He was then transferred back to the Trust’s mental health ward on 9 August 2023.
35. This evidence indicates Trust staff were ‘sensitive and responsive’ to Mr R’s needs. When his family informed them his mental health had significantly deteriorated, they promptly arranged staff to visit him the same day to assess him. Trust staff identified Mr R needed urgent inpatient treatment. They correctly put a request in the same day for him to be admitted to hospital and facilitated the ‘safe transfer’ of his treatment at an out of area hospital when no beds were available at the Trust. We can also see Trust staff correctly ‘shared relevant information’ about Mr R’s medication history with the out of area hospital. On this basis, we consider they acted in line with GMC guidelines and offered appropriate support when his mental health sadly deteriorated.
36. On arrival on the Trust’s mental health ward, Mr R was assessed as not having capacity to make decisions about his treatment. The records show Trust staff decided to put a new treatment plan in place for Mr R. He then underwent regular, weekly ward reviews where Trust staff considered his treatment plan and updated his parents on his progress and treatment.
37. This initial plan was to start his Clozapine medication again on a low dose. Trust staff administered him Clozapine in a liquid form called Denzapine. It started him on 12.5mg at night for two weeks and then gradually increasing his dose in a process called titration.
38. Whilst undergoing titration, Trust staff decided Mr R should remain on his existing oral antipsychotic medication and increase this from 10 to 15mg at night in the ‘early stages’ to help him with his sleep. They also prescribed a regular short-acting benzodiazepine, called Clonazepam, on a regular basis to manage his levels of anxiety/agitation whilst his Denzapine was slowly increased.
39. The records show Mr R’s parents met with a Consultant Psychiatrist on 29 November. They discussed the care plan and agreed to reduce his Clonazepam medication in line with his parent’s wishes. The records also show Mr R asked Trust staff to refer him to a rehabilitation service for more support. It agreed and he underwent an assessment for this service on 19 December.
40. The rehabilitation service said Mr R was not ‘medically optimised’ in terms of his medication for schizophrenia. This meant, they wanted Trust staff to do further work to stabilise his medications before accepting him in the rehabilitation service. The records show Trust staff then gradually increased his Clozapine medication from 600 to 650mg daily.
41. By 11 January 2024, Mr R had been referred to, and accepted, by a high dependency rehabilitation service provider to provide ongoing inpatient care and treatment of his schizophrenia.
42. It is very unfortunate Mr R was not well enough to be involved in discussions about his treatment whilst he was an inpatient on the Trust’s mental health ward. We can appreciate why this would have left him feeling unheard at what was already a very difficult and upsetting time for him.
43. The records show strong evidence Trust staff encouraged Mr R’s parents to be involved in decisions about his treatment throughout his stay. This included weekly ward reviews and regular meetings with the nursing team and Consultant Psychiatrist about his care. We consider these actions were in line with GMC guidelines. Trust staff correctly considered the concerns and opinions of Mr R’s parents who are ‘close to him’ when he assessed as not able to make decisions about his care. When Mr R made a request to be referred to the rehabilitation service, it appears Trust staff were ‘sensitive and responsive’ and agreed to his wishes.
44. Further, there is strong evidence Trust staff acted in line with GMC guidelines and ‘worked collaboratively’ when making decisions about his treatment plan. It appears a number of different medical specialists, including nursing, pharmacy and psychiatry ‘shared relevant information’ and were involved in the delivery of his care. For these reasons, we have seen no indications of failings for this part of the complaint.
45. We wish Mr R and his family the best in the future, and we hope this decision brings reassurance that the Trust did provide the correct care and treatment to Mr R. We thank Mr R and his parents for taking the time in bringing the complaint to our attention.