Prevention of Future Deaths reports · 2015

Dorothy Delaney

Regulation 28 report to prevent future deaths, reference 2015-0402, written 23 Sep 2015. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report23 Sep 2015
Reference2015-0402
DeceasedDorothy Delaney
CoronerRachael Griffin
Coroner areaManchester (West)
CategoryCommunity health care and emergency services related deaths
Sourcejudiciary.uk record · original PDF
Responses publishednone published

The report

Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.

MEVISI VED
08 NOV 2015

ALEXANDER HOUSE HEALTH CENTRE

Dr M Ahmad Platt Bridge Health Centre
MBBS DFFP FRCS Rivington Avenue
Platt Bridge
Dr M Khan Wigan
MBBS WN2 S5NG
Dr S Patel Tel: 01942 482330
MBBS Fax: 01942 482347

Our Ref: SP /NM 470 411 5909
Your Ref: RCG/NMO/D. Delaney
DATE :15 July 2015

Ms Rachael C Griffin
Assistant Coroner

H M Coroners Court
Paderborn House
Howell Croft North
Bolton

BLI 1QY

Dear Ms Griffin

RE: Mrs Dorothy Delaney DOB 20 Jul 1928 (Deceased)
Warwick Drive, Hindley, Wigan, WN2 4DT

Thank you for your letter dated 23 September 2015 providing the inquest report on Mrs Dorothy Delaney,
and at the same time making us aware of your concerns regarding the combined treatment of
anticoagulant like Warfarin with an antiplatelet agent like Aspirin or Clopidogrel. This letter was
addressed to my senior Partner — but unfortunately he is on long term sick leave on medical
grounds and I did not feel it was appropriate to delay replying about the concerns over the patient’s
treatment. Herewith I am providing the details of the steps which were taken following the receipt of your
report, and I assure you that a copy of this report will be given to| hen he returns from his
illness, and a copy to the Practice Manager for her attention as well.

As you mentioned in your inquest report you were concerned with the combined prescribing of antiplatelet
with anticoagulant agents and this concern was raised because the Stroke Consultant from Salford
Hospital pointed out that it is not standard practice to prescribe this. I was not aware of any particular
guidelines or protocol on the matter. Hence at the time of the inquest I provided my contact details to the
Consultant from Salford Hospital to forward to me any kind of correspondence, guidelines or protocol he
might have which I could look into. To date I have not received any correspondence back from the
consultant.

Instead of just waiting for the Stroke Consultant from Salford Hospital to return the request to take further
action, I decided to approach Salford Hospital myself as well. I have spoken to the Haematology
Consultant at Salford explaining the situation and raising my concerns regarding the prescribing of

combined anticoagulant and antiplatelet agents. She was of the same opinion as the Stroke Consultant,
that it would not be appropriate to prescribe both antiplatelet and anticoagulant agents at the same time.
However, at the same time she also pointed out that there a certain group of patients who need to have
both treatments and that is usually recommended by the cardiologists, or following a stroke by a
Consultant Physician. When I asked for any particular protocol from Salford, or national guidelines she
was not able to provide me with any evidence, and she was not aware of any protocol regarding this.
According to her it was standard practice, and the doctor usually follows the advice, but she had not come
across any particular guidance on this.

Furthermore I have approached the local Haematology consultant at Wigan Hospital, as well as the
Clinical Director of Medicine Management for Wigan CCG, explaining the same concerns of combined
prescribing of the agents and requesting them to provide me with further guidance which I would be able
to use to help my patients and avoid any medication errors. I enclose copies of these letters

So far I have not had any feedback from the Clinical Director of Medicine Management following my
query. At the same time the local Haematology Consultant from Wigan Hospital has kindly provided me
with his feedback regarding how to deal with patients in prescribing antiplatelet and anticoagulant agents
together. His feedback was really very helpful.

According to him a patient on antiplatelet agent and full dose anticoagulation medication is at a very high
risk from bleeding and for most patients this is an unnecessary risk, His recommendation was to screen
all patients who may be on antiplatelet and anticoagulant therapy to find out if there is any documented
reason why they need to be on both. At the same time if you read paragraph three of the report
antiplatelet agents are still given to patient who have had a previous stroke, as well as cardiac patients
with a stent procedure while they are taking anticoagulants. If you look at the second to last paragraph of
the response it said that the responsibility for discontinuing therapy would primarily be with the
consultant or the GP. But he did not say it is wholly the total responsibility of the specialist from
secondary care to decide whether the patient should be on both agents. This is the opinion of the
Haematology Consultant from our local Wigan area. This statement makes me believe that it is not up to
the expert to decide combined treatment in every patient who is on both agents. The local Haematology
Department is expecting the GP to make that decision as well.

J also tried to find NICE guidelines or advice on prescribing anticoagulant with antiplatelet agents. So
Sar I have been unable to locate any particular guidelines on this issue. You have kindly pointed out to me
the technological appraisal document published in March 2015, advising on this topic, but the
technological appraisal guidance means that this is an area which NICE has to look into to provide help
with uniform guidance, as there will be variable practice in different parts of the country. The technologic
appraisal guidance is not fully implemented NICE guidelines, but they are in the process of being
implemented. Herewith I am enclosing technological appraisal guidance issued in March 15, which does
suggest to have discussion with patient regarding combined treatment but not giving any advise like
combined treatment can’t be given and we need to have expert advise before having combined treatment,

In summary, most heath care professionals I have approached for advice on this issue have advised that it
is safer to have a single agent, either anticoagulant or antiplatelet, instead of having combined treatment
with both agents, but there is no agreed guidance or protocol in place to follow.

Although I was not able to find any protocol or guidance on this issue, as I have feedback from our local
Haematology Department, I decided to produce a protocol for our practice for future prescribing of
anticoagulant with antiplatelet agents. Furthermore I have reviewed all the patients who are on combined
treatment. I have looked at their medical records and checked the suitability of the patient to be on both
groups of medication. In any patient, if I was not sure , I have liaised with secondary care to clarify the
matter .,

I felt on reviewing their records, most of the patients could be managed by a singly anticoagulant agent
instead of combined treatment, as per our local Haematology guidance. Accordingly I made the

necessary changes to prescriptions after having a discussion with each individual patient.

Herewith I am including the audit report on the work I have done.

T hope this level of work will help to satisfy the concerns following the inquest, and the questions you have
raised regarding my medical practice on the prescribing of combined antiplatelet and anticoagulant
agents. If you are not satisfied with the outcome pleases feel free to contact me again and I will look into
the matter further.

Kind regards

Yours sincerely

MBBS

HEE Practice Manager, Alexander House Health Centre.

Enc
Also filed under 2015-0402: Delaney-2015-0402.pdf
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)

NOTE: This form is to be used after an inquest.

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:

1. | Senior Partner at Alexander House Health Centre, Platt Bridge
Health Centre, Rivington Avenue, Platt Bridge, Wigan

CORONER

I am Rachael Clare Griffin, Assistant Coroner, for the Coroner Area of
Manchester West

CORONER’S LEGAL POWERS

I make this report under paragraph 7, Schedule 5, of the Coroners and Justice
Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations
2013.

INVESTIGATION and INQUEST

On the 18" June 2015 I commenced an investigation into the death of Dorothy
Delaney, born on the 20" July 1928.

The investigation concluded at the end of the inquest on the 18" September
2015.

The Medical Cause of Death was:
1a Spontaneous Intracerebral Haemorrhage

1b Amyloid Angiopathy
2 Anti Coagulation, Atrial Fibrillation

The conclusion of the inquest was that Dorothy Delaney died as a consequence
of naturally occurring disease exacerbated by a recognised complication of
anticoagulation therapy, in circumstances where antiplatelet medication was
prescribed and administered.

CIRCUMSTANCES OF THE DEATH

At around 10.20 hours on the 11" June 2015 Mrs Dorothy Delaney, who had
been prescribed Rivoroxaban, an anticoagulant, following her diagnosis of atrial
fibrillation in March 2015, and who was prescribed Clopidogrel, an antiplatelet
medication due to previous transient ischaemic attacks, was found in a
collapsed condition at her home address at Ash Tree House Care Home,
Warwick Drive, Hindley in Wigan. She was transferred to the Salford Royal
Hospital, Salford where she was diagnosed as having suffered a large
intracerebral haemorrhage. Her condition deteriorated and she died later that
day at 13.10 hours.

CORONER’S CONCERNS

During the course of the inquest the evidence revealed matters giving rise to
concern. In my opinion there is a risk that future deaths will occur unless action
is taken. In the circumstances it is my statutory duty to report to you.

The MATTERS OF CONCERN are as follows:

1. During the inquest evidence was heard that:

vi.

Dorothy Delaney became a patient at Alexander House Health
Centre, Platt Bridge Health Centre, Rivington Avenue, Platt
Bridge, Wigan in August 2013. At that time she was prescribed
Clopidogrel, an antiplatelet medication, by her previous general
practitioner, due to her history of transient ischaemic attack. This
prescription continued to be given by her general practitioner at
Alexander House Health Centre up until her death on the 11"
June 2015.

In March 2015 Mrs Delaney was diagnosed with atrial fibrillation
and as a result was prescribed Rivoroxaban, an anticoagulant, by
her general practitioner at Alexander House Health Centre, which
she continued to take up until her death.

The Consultant Neuropathologist gave evidence during the
inquest that Mrs Delaney had died as a consequence of a
spontaneous intracerebral haemorrhage which had been caused
by amyloid angiopathy, which is naturally occurring disease of
the vessels within the brain that can cause the vessels to rupture,
resulting in haemorrhage. Evidence was given that when a
person who suffers from amyloid angiopathy — takes
anticoagulation medication there is an enhanced risk of a
haemorrhage occurring. The fact that Mrs Delaney was taking
Rivoroxaban was determined to be a contributory factor in her
death. Evidence was also given that there is an increased risk of
bleeding when a person takes both antiplatelet and anticoagulant
medication together.

The policy adopted at Salford Royal Hospital, Salford is that if a
person who is prescribed antiplatelet medication requires
anticoagulation therapy, they would discontinue one of the
medications, in order to reduce the risk of a haemorrhage, unless
there is a specific reason why both should be prescribed at the
same time.

Guidance provided by the National Institute for Health and Care
for oral anticoagulation was referred to during the inquest and
this guidance states that if a person is prescribed Rivoroxaban
there is an increased risk of bleeding if anti platelet medication,
such as Clopidogrel, it is taken at the same time. The Guidance
states that the use of both medications should be avoided,
except on specialist advice.

Following Mrs Delaney’s diagnosis of atrial fibrillation and the
subsequent prescription of Rivoroxaban, no specialist advice was
sought regarding the appropriateness of continuing to prescribe

both Clopidogrel and Rivoroxaban together. Evidence was given
at the inquest that advice is not sought on an individual basis for
patients at Alexander House Health Centre who are prescribed
both Clopidogrel and Rivoroxaban as they rely on advice
previously sought in respect of other patients in similar
circumstances.

2. I therefore have concerns that there are patients under the care of
Alexander House Health Centre who are being prescribed both
anticoagulation therapy and antiplatelet medication at the same time,
which increases the risk of a haemorrhage occurring, in circumstances
where specialist advice has not been sought, taking into account the
individual patient’s previous medical history and circumstances.

3. I therefore request review the treatment of all patients in his
practice who are being treated with Clopidogrel, or any other antiplatelet
medication at the same time as Rivoroxaban, or any other
anticoagulation medication, having regard to the NICE guidelines in

relation to oral anticoagulation.

ACTION SHOULD BE TAKEN

In my opinion urgent action should be taken to prevent future deaths and I
believe you and/or your organisation have the power to take such action.

YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this
report, 18" November 2015. I, the coroner, may extend the period.

Your response must contain details of action taken or proposed to be taken,
setting out the timetable for action. Otherwise you must explain why no action
is proposed.

COPIES and PUBLICATION

I have sent a copy of my report to the Chief Coroner and to the following
Interested Persons:

oii” Dorothy Delaney’s son on behalf of the family
(2) Wigan Borough Clinical Commissioning Group, Wigan Life Centre, College
Avenue, Wigan, WN1i 1NJ

I am also under a duty to send the Chief Coroner a copy of your response.

The Chief Coroner may publish either or both in a complete or redacted or
summary form. He may send a copy of this report to any person who he
believes may find it useful or of interest. You may make representations to me,
the coroner, at the time of your response, about the release or the publication
of your response by the Chief Coroner.

23" September 2015 Rachael C Griffin

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