Prevention of Future Deaths reports · 2014

Kerry Jacobs

Regulation 28 report to prevent future deaths, reference 2014-0133, written 21 Mar 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report21 Mar 2014
Reference2014-0133
DeceasedKerry Jacobs
CoronerBridget Dolan
Coroner areaWest Sussex
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedSurrey and Sussex Healthcare NHS Trust
Sourcejudiciary.uk record · original PDF
Responses published1

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.

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

Mr M Wilson, The Chief Executive, Surrey and Sussex NHS Trust, Trust Headquarters, East Surrey
Hospital, Redhill, Surrey RH1 5RH

CORONER

| am Bridget Dolan, Assistant Coroner, for the Coroner area of West Sussex

CORONER’S LEGAL POWERS

| 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 19 March 2014 | concluded the inquest into the death of MRS KERRY JACOBS born 11June 1969
(aged 44 yrs), who died on 8 July 2013. | determined that Mrs Jacobs had died as a result of (1a) a
pulmonary embolism arising from (1b) a deep vein thrombosis in the right calf and that her death was
from a natural cause.

CIRCUMSTANCES OF THE DEATH

1. Mrs Jacobs suffered with progressive hearing loss and tests suggested that she probably had an
auto-immune disorder putting her at risk of becoming deaf. Her treating Consultant ENT surgeon
sought advice from a Consultant Otologist and a Consultant Oncologist, and it was determined
that ‘high dose’ steroids (prednisolone) should be prescribed to her for a four week period,
tapering off thereafter. The advice, as recorded in a typed note, was for a starting dose of
1mg/kg od.

2. The ENT consultant stated in evidence at the inquest that, in accordance with BNF guidelines, he
considered that the maximum appropriate prednisolone dose was 60mg od.

3. However it was an ENT speciality doctor, rather than the ENT Consultant who next saw Mrs
Jacobs in outpatients. He stated that he had discussed Mrs Jacobs’ case with the consultant
before the appointment. The specialty doctor prescribed 95mg prednisolone od. for four weeks,
to then be reduced to 75 mg od._ This dosage was based on his understanding that Mrs Jacobs’
weight was 95kg. He stated that he had previously prescribed up to 60mg prednisolone and had
never prescribed steroids at as high a dosage as 95mg od, however he knew of high dose
steroids being given for a different disorder (myasthenia gravis) and he understood that he was
following the consultants’ recommendation. The speciality doctor did not recognise at the
material time that he was prescribing outside BNF guidelines.

4. The ENT consultant stated in evidence that although a doctor can prescribe outside BNF
guidelines if this is clinically indicated, he would not have prescribed steroids for Mrs Jacobs at
this high level. However the ENT consultant was not copied into the relevant clinic letter and
remained unaware that a dose of 95mg od. had been prescribed to his patient.

5. On 29 May 2013 Mrs Jacobs presented the prednisolone prescription at a pharmacy. The
dispensing pharmacist_noted the high dosage and declined to dispense the medication. The

5981872.1

11.

12)

13.

pharmacist contacted the hospital to query the prescription. On 4 June 2013 the pharmacist was
informed by a hospital secretary that the prescription dose was as intended. Therefore the
prednisolone was then dispensed to Mrs Jacobs and taken as per the prescription.

The prescribing doctor had no recollection of being asked to confirm the prescription (although he
stated usual procedure would be for the secretary to raise it with him). There was nothing within
Mrs Jacobs’ hospital records to indicate that a pharmacist had queried this prescription of
steroids. | was informed that there is no policy or procedure within the Trust which requires
such an inquiry by a pharmacist to be recorded.

The ENT consultant was unaware of the query by the pharmacist. He stated that if he had seen
the clinic letter, or had the pharmacist contacted him, he would have reduced the prescribed
dosage to 60mg.

On 30 June 2013 Mrs Jacobs developed pain in her right calf after a 2 hour car journey. She
attended her GP the next day (1 July 2013) and was appropriately referred directly to Crawley
Hospital for investigations for suspected deep vein thrombosis (DVT). Her right calf had a 2cm
greater circumference than her left and her d-dimer level was above the normal range. An
ultrasound examination was appropriately advised, however that examination did not reveal any
thrombus. Mrs Jacobs understood the outcome of the tests was that she did not have DVT and
she reported to her husband that an explanation offered to her for her continuing leg pain was
that she may have suffered a muscle tear.

In the early hours of 8 July 2013 Mrs Jacobs suffered a fatal pulmonary embolism.

. On post mortem examination a large thrombus was identified in Mrs Jacobs’ right calf. A

consultant physician advised, and | accepted, that it was probable that a clot had been present in
the right calf on 1 July 2013. However the unanimous clinical evidence was that, in accordance
with the standard procedure, only the proximal (upper) leg is examined on ultrasound sound and
hence one would not expect that procedure to have identified a thrombus present in the lower
leg.

Thrombo-embolism is one of the many potential side effects of steroids. The inquiry therefore
considered whether the prescription of steroids had contributed to the death. The unanimous
medical evidence was that thrombo-embolism is an extremely rare complication of steroids and
that it was unlikely that the administration of 95mg prednisolone had caused or contributed to the
DVT.

The Trust had conducted a Serious Untoward Incident (SUI) investigation following Mrs Jacobs’
death and recommendations had been made regarding (i) improvements in the DVT pathway and
protocols and (ii) changes to the information provided to patients and their GPs on discharge from
the DVT assessment ward. These recommendations have already been acted upon and
changes have been put place.

However the SUI investigation had not identified the overprescribing of steroids, nor were the SUI
report authors aware that a pharmacist had queried the dosage and that this had been confirmed
without reference back to the consultant in charge of the patient’s care.

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) There was nothing within Mrs Jacobs’ hospital records indicating any awareness that she had

been prescribed steroid dose which was out with usual ENT practice and the BNF guidelines.
Nor was the actual prescription issued confirmed with or reported to patient's consultant. The
evidence was that there is no policy or procedure within the Trust which requires a doctor who
prescribes a medication outside usual practice and/or BNF guidelines to note within the patient's
clinical record that they have made the deliberate decision to do so and to record their grounds
for so deciding.

1 5981872.1

(2) There was no discussion between the pharmacist and either the prescribing doctor or the
patient’s consultant regarding the dosage when the query was raised by the pharmacist. | was
informed by the consultant physician who conducted the SUI that, where a pharmacist queries
the intended prescription of a drug, it is good practice for the clinician and pharmacist to discuss
the matter and consider together the risks and benefits of the prescription. He stated that it
“would clearly be of value” to have a protocol requiring such a discussion to take place, where
practicable. The Trust has no such protocol.

| consider that, although | did not find that Mrs Jacobs’ death would have been prevented by correction of
her prescription, there is a risk that future deaths may occur in similar circumstances and action should
be taken to reduce the risk that the prescription of an unintentionally high dose of a drug is not identified
and corrected.

ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and | believe you 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, namely by 16 May
2014. |, 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

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

1. | a of the deceased.

lam 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.

DATE: 21/03/14 SIGNED: Bridget Dolan, Assistant Coroner, West Sussex
Ary & eo

2 5981872.1

Responses

1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.

Response from Surrey Sussex Healthcare NHS Trust (PDF)
Acting Chief Executive
a:

Fax:
Email

Bridget Dolan
Assistant Coroner

Surrey and Sussex NHS

Healthcare NHS Trust

Headquarters

East Surrey Hospital
Canada Avenue
Redhill

RH1 5RH

Tel: 01737 768511
www.sash.nhs.uk

H M Coroner for West Sussex
Orchard Street

Chichester

West Sussex

PO19 1DD

By recorded delivery

4 June 2014
Dear Ms Dolan

Thank you for your letter dated 25 March 2014, and the enclosed Regulation 28 Report
to Prevent Future Deaths, following the Inquest into the death of Kerry Jacobs.

The Trust has taken the Regulation 28 Report very seriously and is keen to implement
the changes that will prevent a similar event from happening again. | note from your
Report the two areas of concern arising from the Inquest, and submit the Trust’s formal
response to these issues as follows:

1. There is no policy or procedure within the Trust which requires a doctor who
prescribes medication outside usual practice and / or BNF guidelines to note
within the patient's clinical record that they have made the deliberate decision to
do so and to record their grounds for so deciding.

Response: It is correct that there is no formal Trust policy in place, bose
 Chict Medical Officer, has issued a directive to the Chiefs of Service in the
Divisions (see attached email dated 4 June 2014) that all staff should record and
specify the rationale for the decision to prescribe a medication dosage that is outside
guidance within BNF, or usual practice. In addition, when a query is raised by a
pharmacist regarding a patient’s prescription, an entry must be made within the
patient's medical records, noting the discussion and outcome. This directive will be
disseminated to the clinical staff within each Division, at Multi Disciplinary Team (MDT)
meetings each week, and departmental meetings; and will be added to the Trust’s
Audit Programme for 2014/2015.

It is the Trust’s expectation, and it is set down in the health professionals’ Codes of
Conduct, that when prescribing medication to a patient the decision is based upon the
patient's clinical diagnosis, symptoms, with reference to the BNF guidance, and based
upon the clinicians’ expertise, and knowledge of the patient.

Putting people first >< An Associated University Hospital of
Delivering excellent, accessible healthcare e Brighton and Sussex Medical School

2. There is no policy or procedure within the Trust that requires a discussion
between the prescribing doctor and the dispensing pharmacist, if and when
there is a query regarding a prescription of a drug

Response: It is correct there is no formal Trust policy in place, however [ii
Chief Pharmacist, has re-iterated the medication screening procedure to the Trust's
Pharmacy Technicians and Pharmacists. | attach a copy of his email communication
dated 7 May 2014 in which he specifically has instructed the Pharmacy Department
that “the prescribing clinician and the screening and dispensing pharmacist must have
an inter-professional direct discussion about the prescription (not via secretaries), and if
the prescribing clinician is not available, then the pharmacy technician or pharmacist
must speak to another prescriber/ clinician who is able to make a decision.”

Be ::; informed me that he has shared the above together with contact
information for the Trust's Lead Pharmacists with the CCG Lead Pharmacists and GP
practices, in an email communication and the “GP newsletter’ so they may inform
community pharmacists of the Trust’s procedure. Please see the attached email
correspondences dated 27 and 29 May 2014.

The Trust is conscious that the prescription of steroids did not cause or contribute to
the death in this case, but | hope you are satisfied with the actions that have been
taken and that the risk of future deaths occurring in similar circumstances is reduced.

Yours sincerely

Paul Simpson
Acting Chief Executive

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