William Northcott

NHS Devon  
Aperture House 
Pynes Hill 
Rydon Lane 
Exeter 
EX2 5AZ 
01392 205 205 

NHS Devon Response to Regulation 28 Report to Prevent Future Deaths 
To: HM Coroner Mr Spinney 
In the matter of: William Northcott 
Coroner’s Case Reference:
Date of Regulation 28 Report: 27th January 2025 
Date of NHS Devon Response: 30th April 2025 

Dear Mr Spinney, 

NHS Devon acknowledges receipt of the Regulation 28 Report to Prevent Future Deaths 
following the inquest into the tragic death of William Northcott, case reference 744577. We 
extend our sincere condolences to William’s family and loved ones. This letter sets out 
NHS Devon’s response to the matters of concern you have identified. 

Matters of Concern and Responses 

Concern 1: 
Approximately 40% of patients prescribed Clozapine under the care of Devon Partnership 
NHS Trust receive their monthly phlebotomy service via GP surgeries, often delivered by 
staff who may not be specifically trained in recognising Clozapine-related side effects. This 
may result in reduced opportunities to reinforce awareness of red flags and when to seek 
medical help. The Coroner notes this may also reflect a broader national concern. 

Response: 
In the 2025/26 financial year, NHS Devon will be cascading additional funding to Devon 
Partnership NHS Trust to support the implementation of more Clozapine clinics. This will 
increase capacity and allow more patients to receive their care from specially trained 
professionals. The clinics provide vital opportunities to reinforce education around 
Clozapine side effects and risks, including red flags and when to seek urgent medical 
attention. We believe this will reduce variability in patient care and improve overall safety 
for individuals receiving Clozapine. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Concern 2: 
William was found post-mortem to have significant cardiac abnormalities, including left 
ventricular hypertrophy, which had not been identified in life. While the risk of myocarditis 
is highlighted in policy, cardiomyopathies such as LVH receive less focus. ECGs may not 
be sufficient to detect these, and echocardiograms are not currently required at initiation or 
during treatment with Clozapine. The Coroner raised concern that similar risks may be 
present nationally. 

Response: 
NHS Devon is aware that clinical leads from Devon Partnership NHS Trust are in active 
discussions with the Royal College of Psychiatrists to consider new and emerging national 
evidence, including the findings set out in The Williams Protocol. NHS Devon will ensure 
that the outcomes of these discussions, and any changes to national policy, are shared 
and implemented within local systems. 

As a commissioner, NHS Devon is guided by national clinical standards and protocols. 
Should there be an update in national guidance concerning cardiac monitoring of 
Clozapine patients, NHS Devon will support Devon Partnership NHS Trust to implement 
those changes to improve patient safety. 

Concern 3: 
Patients with treatment-resistant schizophrenia typically receive support from multiple 
teams and agencies. During the inquest, it became apparent that communication between 
professionals was, at times, suboptimal. The Coroner seeks assurance that Devon 
Partnership NHS Trust is working to improve internal and cross-agency communication. 

Response: 
As this concern is directed specifically to Devon Partnership NHS Trust, NHS Devon has 
not provided a direct response. However, we remain fully committed to integrated working 
across systems and continue to collaborate with Devon Partnership NHS Trust and wider 
partners to promote high-quality, coordinated care for people with complex mental health 
needs. 

In summary, NHS Devon takes seriously its responsibility to commission safe and effective 
services. We are committed to working in close partnership with Devon Partnership NHS 
Trust and other agencies to address the issues you have raised and to ensure learning 
and improvements are made that will help prevent future deaths. 

Yours sincerely,  

Primary Care Medical Director, NHS Devon  

2

CONFIDENTIAL

Ms Louise Wiltshire
Assistant Coroner
County Hall
Topsham Road
Exeter
EX24QD

Sent via e-mail 

Dear Ms Wiltshire

Trust Headquarters
Wonford House
Dryden Road
Exeter
EX2 9AF

Tel: 01392 208683

Date: 3rd April 2025

Re. Mr William Antony Northcott – Regulation 28 report.

I write in my capacity as Chief Nursing Officer at Devon Partnership NHS Trust (the Trust) in
response to your regulation 28 report dated 27 January 2025.

Can I first of all pass on my condolences to Mr Northcott’s family and friend’s.

In your report you highlighted areas of concern to The Pembroke Medical Practice, Devon ICB,
Medicines &  Healthcare  Projects  Regulation  Authority  along  with  us  Devon Partnership  NHS
Trust (DPT). In respect to the concerns pertinent to DPT I respond as below:

(1)  The inquest heard evidence that there should be regular repetition of information
to patients suffering from treatment resistant schizophrenia about the risks and
red  flags  associated  with  the  side  effects  of  taking  Clozapine.  Since  William's
death Devon Partnership  NHS  Trust has set up Clozapine  clinics which provide
the  opportunity  for  staff  who  are  familiar  with  the  side  effects  associated  with
Clozapine to discuss these with patients attending for their monthly phlebotomy
appointments (required for the purpose of monitoring their white blood cell count).

At  these  appointments  healthcare  professionals  will  specifically  ask  patients
about  their  smoking  habit,  caffeine  intake,  bowel  movements,  hypersalivation,
sedation, nausea, incontinence, heartburn, infection, and medication changes, in
addition  to  open  questions  about  any  other  side  effects  a  patient  might  be
experiencing.    I  am  also  assured  that  Devon  Partnership  NHS  Trust  will  be
including additional questions to be discussed at this appointment surrounding
recent physical illnesses, palpitations, chest pain, breathlessness and dizziness.

 Currently  around  60%  of  the  cohort  of  patients  prescribed  Clozapine  who  are
under the care of Devon Partnership Trust have access to these clinics.  The other
40% will attend their GP surgery for their monthly Clozapine phlebotomy service.
The phlebotomy service provided at a GP practice is usually an appointment with
a non-qualified member of staff, who will not have been specifically trained in the
side effects of Clozapine. I am therefore concerned that the level of care provided
to patients attending Clozapine clinics on a monthly basis, is likely to be superior
from the care provided to those patients who attend their GP practice. In particular,
I  am  concerned  that  any  discussion  and  repetition  of  information  surrounding
regular flags and side effects associated with Clozapine, and advice about when
to  seek  medical  attention,  will  be  significantly  more  limited  for  those  patients
attending their GP practice than for those attending the monthly Clozapine clinics.
I am also concerned that this limitation is likely to extend further than the 40% of
patients in receipt of Clozapine  under the care  of Devon Partnership NHS Trust
and that this may be a national issue.

We recognised that there is variability in the quality and frequency of side effect screening and
monitoring processes undertaking for patients prescribed Clozapine.

There  are  around  230  patient  that  attend  the  DPT  lead  specialised  Clozapine  clinics  where
Physical monitoring and side effects screening occurs in accordance to the regularity of when
blood test is required. This varies between weekly, two weekly or every 4 weeks. However, the
40 % that accounts for 160 patients that attend GP surgeries where the side effect monitoring
and screening does not occur. For this group we will be implementing the following

As  a  Trust  we  have  developed  a  business  case  in  order  for  the  organisation  to  increase
resources and to bring all the patients receiving Clozapine onto dedicated  Specialist Clozapine
clinics  across  Devon  in Barnstaple,  Exeter  and  Torquay  (excluding  Plymouth  where  Livewell
provide mental health services) to receive the Gold Standard in Physical health monitoring and
side effects screening.

(2)  At post mortem examination  William was found to have a significantly enlarged
heart and  left  ventricular  hypertrophy.    This was  not  known to  those  caring  for
William in life. Clozapine is a cardiotoxic drug, and is often used in conjunction
with other drugs which may also have a cardiotoxic effect.

The  risk  of myocarditis  is  reasonably  well explained  in  Devon  Partnership  NHS
Trust's  policy  documentation,  but  there  is  less  of  a  focus  on  cardiomyopathies
which  would  include  left  ventricular  hypertrophy.  I  understand  that  the  Trust's
guidance is based on national guidance.  Annual ECGs are required for patients
prescribed Clozapine and questions about cardiac function will now be asked at
monthly Clozapine clinics. However, I understand that ECGs are not a diagnostic
tool used to assist in the diagnosis of cardiomyopathies such as left ventricular
hypertrophy  and  that  left  ventricular  hypertrophy  can  be  asymptomatic.  I  also
understand 
identify  such
cardiomyopathies, but that this is not currently required on initiation of Clozapine
or routinely at any other time whilst a patient is taking Clozapine.

that  an  echocardiogram  may  be  able 

to 

Page 2 of 5

 I  am  concerned  that  these  cardiomyopathies  could  therefore  go  undetected  in
patients prescribed Clozapine and leave them at unknown increased risk of fatal
cardiac  arrhythmias,  as  occurred  in  William's  case.  Given  that  the  Trust's
guidance is  based  on  national  guidance  I am concerned  this  may  be a  national
issue.

Following your concerns we have reviewed the evidence based regarding Clozapine physical
health monitoring and will be continuing seeking expert opinions as regarding the screening for
cardiomyopathy in unsuspected patients to decrease the risk of harm.

Myocarditis has a number of clinically well-defined features that makes it slightly easier to be
identified  in  earlier  stages of  prescribing.  It  is more  likely  to occur  within  the  first 8  weeks  of
commencing Clozapine treatment, the frequency is in a 3% of patients. It is a highly suspected
condition in patients that present with fever above 38 degrees, chest pain, a heart rate above
120 bpm and respiratory rate of 20/ min. At blood test a raised troponin and C - reactive protein
(CRP) above 100 mg would support findings. The florid presentation is identifiable by trained
health professionals triggering an alert to activate a sudden cessation of Clozapine and seeking
medical review and treatment

However the screening for cardiomyopathy for unsuspected patients is significantly difficult.
The current evidence based does not support the use of echocardiography as a pre-monitoring
requisite given the excessive cost that this will bring. The incidence of cardiomyopathy in people
taking Clozapine has been cited as 0.02% of patients in the USA and 0.1% in Australia. This is
1 in 1000 to 1 5000 patients taking Clozapine.

In  the Australian study where the designed a protocol that included Echocardiography it was
found that Echocardiography are not viable as a screening tool for cardiomyopathy [Murch S,
Tran  N,  Liew  D,  Petrakis  M,  Prior  D,  Castle  D.  Echocardiographic  monitoring  for  Clozapine
cardiac toxicity:  Lessons  from  real-world experience. Australasia  Psychiatry  2013;21(3):258–
61. Search PubMed].

The  prevalence  of  cardiac  dysfunction  in  patients  commencing  Clozapine  is  high.  Routine
echocardiography is not useful in the detection of Clozapine-associated myocarditis. Although
cardiomyopathy  may  be  identified,  it  is  rare  and  associated  with  significant  treatment  costs.
Recommendations for routine echocardiographic monitoring should be re-examined

It is recommended for the clinician to be alert of any sign or symptoms of congestive heart failure
so  that  the  appropriate  referral  for  expert  opinion  is  sought.  The  key  symptoms  are;  new
complaint  of  tiredness  without  obvious  medication  changes,  leg  swelling  or  ankle  oedema,
palpitation and or shortness of breath.

Further  Developments:  We  are  in  communication  with  the  Royal  College  of  Psychiatrists
(RCPsych)  seeking  information  regarding The  William’s  Protocol.  We understand  in  a  blog
posted at the RCPsych that the William Protocol is a suite of measures worked between 

 (sister of William) and the Royal College of Psychiatrists. It is stated in the article
that  these  measures  will  ensure  far  stricter monitoring of  Clozapine,  education  for  clinicians,
families and carers on red flag side effects, better physical care and alongside address the unfair
prejudice faced by people with severe mental illness.

In order to get a deeper understanding on what is proposed by the William Protocol we as an
organisation will be meeting with 
 the Royal College of Psychiatrists Presidential
lead for Physical Health to gather further details.

At  present  the  national  guidelines  available  to  us  do  not  recommend  the  routine  use  of
echocardiography as a screening tool in patients to be treated or receiving Clozapine treatment.

Page 3 of 5

 (3)  It  is  clear  that  patients  suffering  with  treatment  resistant  schizophrenia  are
complex, and as such there are often a number of different agencies involved in
an  individual's  care.   In  addition,  there  are  often  multiple  members of  the  same
team involved in an individual's care. During the inquest it became clear that, at
times, communication of important issues was not as clear as it should have been.
I note that Devon Partnership NHS Trust has significant training available for its
staff and other agencies it engages with in relation to patients who are prescribed
Clozapine.  However,  it  would  be  of  great assistance  to  understand  what  Devon
Partnership  NHS  Trust  is  doing  to  ensure  that  optimum  communication  of  key
information  is  achieved  within  the  community  mental  health  team,  and  when
dealing with its other agencies involved in a patient's care.

Delivering  mental  health  care  for  individual  suffering  Severe  Mental  Illness  requires  a
multidisciplinary  and  multiagency  approach,  ensuring  effective  information  sharing  can  be
challenging at times.

There are a number of steps that Devon Partnership NHS Trust has adopted to ensure effective
information sharing between those involved in the care of the patients.

DPT has adopted a new Electronic Patient Records (EPR) named SystmOne. This EPR is used
by a significant number of others GPs surgeries (60%) in the county and when patients consent
to information sharing it allows both primary and secondary mental health services to see the
information entered. Meaning that the GP will have immediate access to the entry made by a
Consultant  Psychiatrist  following  a  consultation  and  vice-versa.  This  is  of  tremendous
importance  as  one  can  access  physical  health  related  and  medication  information.  This  of
course requires the patient to consent information sharing and as already stated it is not used
by all the GP practices. Of course EPR sharing does not constitute a communication device

Secondary Mental Health services communicate with primary care by sending clinic letters or e-
mails. This tends to occur following consultations, assessments, reviews or any other clinically
relevant interaction with patients.

As we developed and designed Systmone to meet the specific needs of the service we identified
a number areas for improvements that can communication effective. Including

  A single individualised Care Plan across all DPT services which supports ensuring that
the plan provides all the information pertaining to the patient promptly and in one place.
  Care  Plans  to  be  coproduced  by  patients  together  with  the  clinician  and  shared  with

family members and carers

  Other agencies such as  the voluntary service will be having access to Systmone and
consequently have access to the information relevant to patients taking Clozapine and
their care plans
Information regarding physical health and findings that requires action will require active
communication escalation between clinicians with clear actions.

 

Page 4 of 5

 .I trust the above responds clearly to your questions,

Yours Sincerely

PP 

, Deputy Director Nursing

Chief Nursing Officer

Page 5 of 5

10 South Colonnade 
Canary Wharf 
London 
E14 4PU 
United Kingdom 
gov.uk/mhra 

Ms Louise Wiltshire 
Assistant Coroner for County of Devon, Plymouth and Torbay 
By Email: 

Reference: 

19 March 2025 

Dear Ms Wiltshire, 

Regulation 28 Report into the death of William Antony Northcott 

Thank you for your Regulation 28 Report relating to the death of William Antony Northcott. I 
would like to offer my sincere condolences to Mr Northcott’s family on their tragic loss. 

I understand from your report that Mr Northcott’s death resulted from sudden cardiac 
arrhythmia caused by the combined effect of mixed drug toxicity with a background of an 
enlarged heart and left ventricular hypertrophy. Mr Northcott’s medication included clozapine 
and fluoxetine which were prescribed and maintained at therapeutic levels. Postmortem 
toxicological analysis also revealed amphetamine levels consistent with recreational use.  

Clozapine, fluoxetine and amphetamine are all recognised to be cardiotoxic drugs and carry 
risk of causing sudden cardiac arrhythmia. Your report identified the following matters of 
concern relating to clozapine and fluoxetine.  

1.  That the discussion and repetition of information surrounding red flags and side effects 
associated with clozapine, and advice about when to seek medical attention, will be 
significantly more limited for those patients attending their GP practice than for those 
attending the monthly clozapine clinics under the care of Devon Partnership Trust, and 
that this may be a national issue. 

2.  That clozapine-related cardiomyopathies could go undetected in patients under the care 

of Devon Partnership NHS Trust who are prescribed clozapine and leave them at 
unknown increased risk of fatal cardiac arrythmias, and that this may be a national issue. 

3.  That communication from healthcare professionals at Devon Partnership NHS Trust of 
important issues to patients suffering from treatment resistant schizophrenia was not as 
clear as it should have been. 

 
 
 
 
 
 
 
 
 
 
 
 
 The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency 
of the Department of Health and Social Care (DHSC) with responsibility for the regulation of 
medicinal products in the UK. The MHRA ensures that medicines are efficacious and 
acceptably safe, and that information to aid the safe use of a medicine, including possible 
side effects are appropriately described in the authorised product information.  

This information comprises the Summary of Product Characteristics (SmPC, intended for 
healthcare professionals), labelling, and Patient Information Leaflet (PIL, provided to patients 
in each medicine pack). The product information can support discussions between 
healthcare professionals and patients. The PIL is not intended to replace the discussion with 
prescribers about the benefits and risks of treatments. 

The current special warnings and precautions for use section of the SmPC for clozapine 
states within the sub-section relating to cardiovascular disorders: 

“Analysis of safety databases suggests that the use of clozapine is 
associated with an increased risk of myocarditis especially during, but not 
limited to, the first two months of treatment. Some cases of myocarditis have 
been fatal. Pericarditis/pericardial effusion and cardiomyopathy have also 
been reported in association with clozapine use; these reports also include 
fatalities.”  

“If myocarditis or cardiomyopathy is suspected, clozapine treatment should 
be promptly stopped and the patient immediately referred to a cardiologist.”  

Cardiac disorders are also described in the ‘undesirable effects’ section of the SmPC of 
clozapine, which lists arrhythmias, cardiac arrest and cardiomyopathy as possible adverse 
reactions to the treatment with clozapine. In addition, the contraindication section states that 
clozapine is contraindicated in patients with “severe renal or cardiac disorders (e.g. 
myocarditis)”. The section on interaction with other medicinal products states that “Some of 
the other serotonin reuptake inhibitors such as fluoxetine, paroxetine, and, to a lesser 
degree, sertraline, are CYP 2D6 inhibitors and, as a consequence, major pharmacokinetic 
interactions with clozapine are less likely.” Similar messages can be found in the current PIL 
for clozapine. 

We have considered the evidence provided and the circumstances leading to Mr Northcott’s 
death and acknowledge that most of your concerns relate to clinical discussions between a 
patient and their prescriber or via the clinical care delivered by the Trust. Unfortunately, the 
MHRA cannot directly address these points, as it is not within our remit to comment on the 
clinical care in specific cases.  

The MHRA continuously reviews the safety of medicines on the UK market and take 
appropriate regulatory action as required. Currently, the MHRA is reviewing the product 
information for clozapine. As part of this review, we will be giving careful consideration to the 
information which is provided to healthcare professionals, patients and their families and 
carers, and whether this can be improved to provide greater clarity. We intend to engage 
with relevant stakeholders during this process to ensure the regulatory documents meet the 
needs of patients and prescribers. It is anticipated that this review of clozapine will be 
completed this year. 

 
 
 
 
  
 
 
 
 
 Should you have any further questions, please do not hesitate to contact my office: 

Yours sincerely, 

Chief Executive 
Medicines and Healthcare products Regulatory Agency 
E:

Pembroke Medical Group response to the Report to Prevent Future Deaths related to the 
investigation into the death of William Northcott  

We have reviewed the findings of the inquest undertaken into the death of William Northcott, and 
considered the concerns raised in the Report to Prevent Future Deaths issued to us. 

We  share  the  concerns  of  the  Coroner  in  that  the  patients  attending  Clozapine  clinics  could 
receive a higher standard of care than those attending their GP practices.  For this reason, the 
Practice has withdrawn from the agreement with DPT to provide phlebotomy services (see letter 
dated 27/3/24).  As stated in our previous correspondence, we had concerns that the psychiatric 
oversight  provided  by  Devon  Partnership  NHS  Trust  for  this  cohort  of  patients  fell  below  the 
service standard we would consider safe.  We had concerns regarding the number of agencies 
involved  in  the  monitoring  and  prescribing  of  clozapine,  without  sufficient  responsibility  being 
taken by one team.  Clozapine clinics can give continuity of care for these patients and ensure 
that regular education and all appropriate checks are undertaken. 

We have noted the comments by the Coroner that an ECG is not as helpful a diagnostic tool as 
echocardiography  to  assist  in  the  diagnosis  of  cardiomyopathies.    We  agree  that  the  use  of 
echocardiography for monitoring of patients on clozapine could be explored, as this is used in 
some other countries.  Again, this is something that could not be undertaken in Primary Care as 
we do not have echocardiography. 

In  response  to  the  Coroner’s  concern  about  a  Health  Care  Assistant  who  may  have  less 
experience  and  knowledge  of  anti-psychotic  medication  seeing  patients  and  undertaking  the 
investigations  required  for  annual  monitoring,  the  Health  Care  Assistant  will  generally  use  a 
computer template to enter information, which can have prompts to ask relevant questions.   This 
could  be  considered  for  those  40%  of  practices  who  are  continuing  to  undertake  clozapine 
monitoring. 

We  use  a  template  when  undertaking  the  annual  physical  health  monitoring  required  for  all 
patients  on  our  Severe  Mental  Illness  register  as  mandated  by  the  Quality  &  Outcomes 
Framework (NICE CG178 and NICE CG185). 

Following the Health Care Assistant appointment, there is a follow-up In Person or telephone call 
with a GP  or trained clinician  who  reviews the results and undertakes  a  review of their Mental 
Health  care  plan.    The  Practice  has  ensured  that  all  GPs  and  clinicians  carrying  out  these 
appointments are made aware of the physical effects of clozapine/side effects to look out for. 

We  do  not  usually  share  results  of  the  health  checks  with  the  Mental  Health  teams,  unless 
information  is  specifically  requested.    We  agree  however  that  good  communication  is  very 
important.   

The  practice  would  be  happy  to  communicate  the  findings  and  results  of  the  annual  health 
checks with the Mental Health Services, providing that the patient has consented to this.  We had 
considered involvement of the ICB and LMC to facilitate a streamlined approach.  However, we 
have established that there is a Local Enhanced Service in place which we are currently reviewing 
and implementing a process to be able to share the outcomes and results from the annual review 
with Mental Health Services.   

 
 
 Clozapine  monitoring  has  already  been  raised  at  the  LMC,  which  resulted  in  many  practices 
withdrawing from the agreement to provide monitoring services.  I believe that this has led to the 
expansion of the clozapine clinics.  The LMC secretary was notified of the concerns raised at the 
inquest on 14th January 2025 and we can request that it is  raised again on the LMC agenda to 
encourage the further expansion of clozapine clinics. 

We have already highlighted the outcome of this case at our practice GP meeting on 12th February 
2025 and provided education for GPs to remind them of the side effects of clozapine, particularly 
constipation/  smoking  status  and  potential  cardiovascular  side  effects. (see attached 
information sheet). 

We  undertook  an  audit  of  all  our  clozapine  patients  in  January  2024  to  ensure  that  they  had 
received the annual monitoring checks required for patients on our Severe Mental Illness register 
as mandated by the Quality and Outcomes Framework (NICE CG178 and NICE CG185). We plan 
to undertake a further audit and add an alert to the medical record to highlight to clinicians that 
they are taking clozapine.  The timescale for this is for this to be completed by 1st April 2025. 

Dated: 

Signed: