Thomas Jackson
PFD Report
Partially Responded
Ref: 2018-0352
Alcohol, drug and medication related deaths
Hospital Death (Clinical Procedures and medical management) related deaths
Mental Health related deaths
1 of 2 responded · Over 2 years old
Response Status
Responses
1 of 2
56-Day Deadline
7 Jun 2019
Over 2 years old — no identified published response
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Coroner's Concerns
71) During the hearing it was noted that on a number of occasions record keeping was poor. This can make continuity of care difficult and it can lead to matters being missed . wonder if the Trust can take any action t0 improve this_ (2) It is apparent that patients do benefit from regular 'ward rounds' or 'multi-disciplinary team meetings' (there are variety of titles) and, apart the record of these meetings being poor at times, there is a concern about the conduct of these meetings_ In particular there appears to be on occasions inadequate consideration of the history in preparation for the meeting, failure of attendance of all appropriate personnel at such meetings and concern about the patient being able properly to participate (3) It is clear that Clozapine is a beneficial drug for many patients and that a large number of patients in the care of the Trust do receive this drug: However it appears that many staff are not aware of the significance of this medication particularly when considering potential side-effects and warning signs of deterioration (4) would not wish for patients or their families to be overloaded with paperwork but wonder if there could be a simple leaflet available to patients and family members covering standard information about treatment generally but including matters such as the dangers of patients smoking whilst they are receiving Clozapine_ (5) wonder if there needs to be a review of any lone-working policy or procedure with particular reference as to when to enter patients rooms (6) It is well known that it is important for lessons to be learnt following serious incidents. The SIR procedure is a significant part of this. understand there have been some changes since the time of Tom's death but the SIR carried out in this matter contained a number of significant inaccuracies which can affect the validity of the process_ Additionally although the records for patients who are in hospital for a long period of time can become voluminous there has also been some difficulty in disclosure of significant documents during the Inquest process_
Responses
Response received
View full response
Dear Mr Haigh,
Thank you for your correspondence of 13 November to Matt Hancock about the death of Mr Thomas Jackson. I am replying as Minister with portfolio responsibility for medicines and I am grateful for the additional time in which to do so.
Firstly, I would like to say how sorry I was to read of the circumstances of Mr Jackson’s death. I appreciate his loss, at such a young age, must be extremely distressing for his family and loved ones and I offer my sincerest condolences.
It is essential that we look to make improvements where we can to ensure the safety of healthcare and prevent future deaths and I am grateful to you for bringing these matters to my attention.
My officials have made enquiries with a number of bodies on the matter of concern in your report that there should be routine therapeutic blood monitoring (testing of blood plasma levels) in patients who are prescribed clozapine.
I am advised that there is no national guidance that requires NHS trusts to undertake routine (six monthly or annual) monitoring of clozapine plasma levels. There is NICE guidance, ‘Psychosis and schizophrenia in adults: prevention and management’ (CG178)1, which supports the routine monitoring of the physical health of people prescribed antipsychotic medication (including clozapine).
1 https://www.nice.org.uk/guidance/cg178
I am informed that clinical guideline CG178 is to undergo a surveillance review to check whether it needs to be updated and given the concerns you raise, the issue of monitoring blood plasma levels in people taking clozapine (or other antipsychotics) has been logged for the consideration of the guideline surveillance team undertaking the review process.
As you may be aware, the Medicines and Healthcare products Regulatory Agency (MHRA), is responsible for the safety of medicines and medical devices. The MHRA seeks independent advice from the Commission on Human Medicines (CHM) which advises on whether the overall balance of benefits and risks of medicines is favourable at the time of licensing and remains so thereafter.
One of the ways in which the MHRA monitors the safety of licensed medications is through the Yellow Card scheme which receives information from both healthcare professionals and patients on side effects suspected to be associated with medicines. The concerns you have raised have been added to the MHRA’s adverse drug reaction database under Yellow Card reference number ADR 24386668-001.
Detailed guidance on the monitoring requirements for clozapine is provided in the authorised product information which consists of the Summary of Product Characteristics (SmPC) for prescribers and the Patient Information Leaflet which is supplied with each pack of medicine. The SmPC and PIL for clozapine can be found at mhra.gov.uk/spc-pil.
Currently, patient monitoring requirements for clozapine include the measurement of clinical parameters such as regular full blood counts; blood pressure; electrocardiograms; hepatic enzymes; blood sugar; lipids and weight. Therapeutic drug monitoring of blood plasma levels is not currently required under the terms of the clozapine marketing authorisation.
Individual NHS trusts might monitor clozapine drug levels based on clinical signs and symptoms to check compliance with treatment or as part of investigations into suspected toxicity but they are not required to routinely monitor therapeutic drug levels.
In light of the concerns you have raised, the MHRA has undertaken further investigation of the utility of drug monitoring in supporting safe use of clozapine and in doing so, has sought advice from the Pharmacovigilance Expert Advisory Group, which advises the Commission on Human Medicines. I am advised that further analysis of the available data is underway and further expert advice is being sought. The MHRA is happy to keep you informed on the progress of its assessment and I have asked that they do so with you directly.
Finally, I am informed that the national Medicine Safety Programme (MSP) is also aware of the issues concerning clozapine toxicity. The MSP is due to announce its initial priority areas in April 2019, and is currently in discussions as to whether to prioritise clozapine toxicity as a core component of the programme’s initial work to improve the safety of medication use across England.
I hope this reply is helpful.
NICOLA BLACKWOOD
Thank you for your correspondence of 13 November to Matt Hancock about the death of Mr Thomas Jackson. I am replying as Minister with portfolio responsibility for medicines and I am grateful for the additional time in which to do so.
Firstly, I would like to say how sorry I was to read of the circumstances of Mr Jackson’s death. I appreciate his loss, at such a young age, must be extremely distressing for his family and loved ones and I offer my sincerest condolences.
It is essential that we look to make improvements where we can to ensure the safety of healthcare and prevent future deaths and I am grateful to you for bringing these matters to my attention.
My officials have made enquiries with a number of bodies on the matter of concern in your report that there should be routine therapeutic blood monitoring (testing of blood plasma levels) in patients who are prescribed clozapine.
I am advised that there is no national guidance that requires NHS trusts to undertake routine (six monthly or annual) monitoring of clozapine plasma levels. There is NICE guidance, ‘Psychosis and schizophrenia in adults: prevention and management’ (CG178)1, which supports the routine monitoring of the physical health of people prescribed antipsychotic medication (including clozapine).
1 https://www.nice.org.uk/guidance/cg178
I am informed that clinical guideline CG178 is to undergo a surveillance review to check whether it needs to be updated and given the concerns you raise, the issue of monitoring blood plasma levels in people taking clozapine (or other antipsychotics) has been logged for the consideration of the guideline surveillance team undertaking the review process.
As you may be aware, the Medicines and Healthcare products Regulatory Agency (MHRA), is responsible for the safety of medicines and medical devices. The MHRA seeks independent advice from the Commission on Human Medicines (CHM) which advises on whether the overall balance of benefits and risks of medicines is favourable at the time of licensing and remains so thereafter.
One of the ways in which the MHRA monitors the safety of licensed medications is through the Yellow Card scheme which receives information from both healthcare professionals and patients on side effects suspected to be associated with medicines. The concerns you have raised have been added to the MHRA’s adverse drug reaction database under Yellow Card reference number ADR 24386668-001.
Detailed guidance on the monitoring requirements for clozapine is provided in the authorised product information which consists of the Summary of Product Characteristics (SmPC) for prescribers and the Patient Information Leaflet which is supplied with each pack of medicine. The SmPC and PIL for clozapine can be found at mhra.gov.uk/spc-pil.
Currently, patient monitoring requirements for clozapine include the measurement of clinical parameters such as regular full blood counts; blood pressure; electrocardiograms; hepatic enzymes; blood sugar; lipids and weight. Therapeutic drug monitoring of blood plasma levels is not currently required under the terms of the clozapine marketing authorisation.
Individual NHS trusts might monitor clozapine drug levels based on clinical signs and symptoms to check compliance with treatment or as part of investigations into suspected toxicity but they are not required to routinely monitor therapeutic drug levels.
In light of the concerns you have raised, the MHRA has undertaken further investigation of the utility of drug monitoring in supporting safe use of clozapine and in doing so, has sought advice from the Pharmacovigilance Expert Advisory Group, which advises the Commission on Human Medicines. I am advised that further analysis of the available data is underway and further expert advice is being sought. The MHRA is happy to keep you informed on the progress of its assessment and I have asked that they do so with you directly.
Finally, I am informed that the national Medicine Safety Programme (MSP) is also aware of the issues concerning clozapine toxicity. The MSP is due to announce its initial priority areas in April 2019, and is currently in discussions as to whether to prioritise clozapine toxicity as a core component of the programme’s initial work to improve the safety of medication use across England.
I hope this reply is helpful.
NICOLA BLACKWOOD
Action Should Be Taken
In my opinion action should be taken to prevent future deaths and believe you and your organisation have the power to take such action_
Report Sections
Investigation and Inquest
On 6th September 2016, commenced an investigation into the death of Thomas Paul Arthur JACKSON, aged 24 years. The investigation concluded at the end of the inquest on 1st November 2018 The conclusion of the inquest was a detailed narrative one with the Cause of Death being: la) Clozapine Toxicity Ib) Pneumonia II) Treatment Resistant Schizophrenia.
Circumstances of the Death
Tom was subject to compulsory Mental Health Detention at a secure unit within St George's Hospital, Stafford. In the early hours of 25th August 2016 Tom was found in a poorly state in his room: He was certified dead at 02.25 hours.
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.