Mary Fenton

From the Rt Hon the Earl Howe P.C.
AGS Parliamentary Under Secretary of State for Quality (Lords)

Depart 447/201

Richmond House

79 Whi
Mr J Pollard roe neae
Senior Coroner SW1A 2NS
Coroner’s Court Tel: 020 7210 4850
1 Mount Tabor Street
Stockport
SK1 3AG 04 DEC 2014

eo Me. Fala 5

Thank you for your letter of 13 October following the inquest into the death
of Mary Fenton. In your report you state that Mary Fenton died from
Coronary Artery Atheroma and Acute Cerebral Infarction.

I was sorry to read of Ms Fenton’s death and wish to extend my sincere
sympathies to her family.

On the 26th April 2014 Ms Fenton was admitted into Tameside Hospital in
need of an urgent heart pacemaker.

You state that various delays occurred and that opportunities were missed
to treat Ms Fenton. You express concerns about the lack of specialist staff
and facilities at Tameside Hospital and point out failures in Ms Fenton’s

care and assessment.

I note that many of your concerns are directed to the Tameside Hospital
NHS Foundation Trust and I would expect the Trust to respond

appropriately.
You raise the following concerns for our attention:-

. This patient was being kept alive by the use of Isoprenaline. It
transpires that there were severe shortages of this drug in the hospital but
also nationally. I was told that this drug is produced as an unlicensed drug
by NHS Pharmaceutical Productions. If so why do they not ensure

sufficient supply?
. The National pharmaceutical supply chain was described in evidence

by a Chief Pharmacist as being “very fragile”,

I would like to respond initially by making a general point about the scale
of pharmaceutical supply and dispensing in England, and set out the
following facts of interest.

Currently there are over 15,000 licensed medicines products comprising
different dosage forms (such as capsules, tablets, injections and other
formulations). Over 2 million prescription items are dispensed in England
every day of which the vast majority are not subject to supply problems. At
the end of March 2013, there were nearly 11,500 community pharmacies in
England and in that same year, over 1 billion NHS prescription items were

dispensed.

Medicines shortages are not new, nor are they confined to the UK. There
are a number of reasons why such shortages do arise but the two main
reasons are commonly referred to as ‘upstream’ and ‘downstream’:-

° upstream issues arise due to manufacturing difficulties, regulatory
problems and problems with the supply of raw materials. The nature of
these issues means that some supply problems with medicines are

inevitable and unavoidable; and,
. downstream issues arise due to changes in the distribution of

medicines,

Supply issues are complex and most have to be dealt with on a case by case
basis but in recognising the main problems it is possible to take action to
mitigate them. Our Government is currently working with other countries
in Europe and with North America to resolve some of these supply issues.

With regard to your concerns about the supply of Isoprenaline, I can
confirm that Isoprenaline injection is not licensed for use in the UK. It is
available from NHS Pharmaceutical Manufacturing Units (PMUs) as an
unlicensed “special”, and as an unlicensed import from abroad,

The Department of Health is aware that there have been problems with the
availability of isoprenaline and that earlier this year the NHS PMUs
experienced problems obtaining the active pharmaceutical ingredient. The
Department of Health therefore asked the NHS UK Medicines Information
service (UKMI) to produce a “Shortage Memo” which summarises the |
situation and advises on alternative sources of supply. This was sent out to
hospitals and uploaded to the UKMI website, at the following address, on

24 April 2014:-

a

Department
of Health

http://www.medicinesresources.nhs.uk/en/Communities/NHS/SPS-E-and-
SE-England/Medicines-Information/Discontinuation-Supply-Shortage-
Memos/Shortage-of-isoprenaline-injection/

For ease of reference I have also attached it as Ahhex A for your
information.

I hope that this response is helpful and I am grateful to you for bringing the
circumstances of Ms Fenton’s death to my attention.

Tameside Hospital NHS)

NHS Foundation Trust

Chief Executive Office
Silver Springs

Tameside General Hospital
Ashton-Under-Lyne

OL6 9RW

Our Ref: f |

Date: 5 December 2014 ff

Mr Pollard ieee =]

Senior Coroner
Coroner’s Court

1 Mount Tabor Street
Stockport

SK1 3AG

Dear Mr Pollard
Mary Fenton (deceased)

| write further to your letter dated 14 October 2014 enclosing a Regulation 28 Report issued
at the conclusion of the inquest concerning the death of Mary Fenton, which took place on the
8 October 2014. | am very sorry that you found cause to issue this report and | hope to be
able to address your concerns to your satisfaction in this letter.

| understand that during the Inquest a number of matters of concern were revealed. | have
addressed each of your concerns as set out in Section 5 of your Regulation 28 Report in turn
below. Please note that | have dealt with the concerns numbered 1, 6, 7 and 8 together as
they all relate to the provision of pacing at the Trust and also concerns 4 and 5 together as

they relate to the assessment of mental Capacity and consent.
Dealing with the concerns raised in your Regulation 28 Report:

1. Although Tameside Hospital holds itself out as performing pacemaker
insertions, both temporary and permanent, no Cardiology Consultant is on call
after 5:00 pm or at weekends. There is therefore no one available to the junior
staff having the requisite levels of skill and expertise to advise.

6. Despite this being a major District General Hospital providing cardiology cover
for a large proportion of the population of Greater Manchester, there is no-one
with the skill or qualification to fit “temporary/permanent” Pacing wires.

7. There were inexcusable and potentially catastrophic delays in inserting the
pacing wires.

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Everyone

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8. It was demonstrated by the evidence that if there should be a situation where
the placing of the pacing wires causes unforeseen problems (e.g. by causing
bleeding within the pericardium leading to cardiac tamponade) there is a lack of
adequate facilities to address that situation.

Following the Inquest in to Mrs Fenton’s death a review was undertaken by the Trust into the
provision of pacing procedures out of hours. The Lead of the Cardiology Department was
charged with organising an on call rota for pacing wires. The rota became operational on the
10 November 2014 and provides for a Consultant Cardiologist on-call to cover all emergency
temporary pacing and pathway. The service is available 24 hours per day, every day of the
year. The on-call rota for temporary pacing wires is shared with the hospital switchboard and
CCU. The rota provides for out of hours cover by the following Consultant Cardiologists —

a This is currently being provided with nursing
support via the Night Nurse Practitioner and Level 2 / CCU nursing staff on shift.

There is also now a cardiac pacing room in theatre 4 and all equipment therein is operational.
Relocation took place in September 2014 and this facility provides an in-hours and out of
hours provision for all cardiac procedures, revisions and repairs and all Cardiologists are
capable of carrying out emergency cardiac ultrasound to deal with very rare complications.
Also, the old pacing room that the Trust was making use of is no longer required for pacing
and the Trust is currently considering whether this could be used to expand the CCU area.

As a result of the review a Temporary Pacing Wire Pathway has also been created, a copy of
which is attached.

2. After 5:00 pm there is no facility for an echocardiogram to be performed at the
hospital.

Currently, the provision of echocardiogram services is undertaken as a day case service
between the hours of 9.00am and 5.00pm and this existing service is provided by the
specialist CRI technicians. Due to the existing capacity and demand for the service, the
existing provision can only currently provide an in hours service. Echocardiograms are and
have been undertaken by qualified Consultants and Staff Grade Doctors as and when
required. Going forward, the recent external cardiology service review and your concerns
following the inquest into the death of Mrs Fenton have formed the basis for a service review
specifically around the provision of CRI services. As part of this review, the procurement of a
portable echocardiogram machine and out of hour provision is being explored as part of the

wider service developments.

3. This patient was being kept alive by the use of isoprenaline. It transpires that
there were severe shortages of this drug in the hospital but also nationally. |
was told that this drug is produced as an unlicensed drug by NHS
Pharmaceutical Productions. If so why do they not ensure sufficient supply?

The Trust currently keeps a supply of 200 ampoules of Isoprenaline supplies in stock. This
would last a patient approximately 17 calendar days if prescribed in the same dosage as that
provided to Mrs Fenton. The Trust has replenished its stocks following the end of the national
alert on the Isoprenaline shortage due to manufacturing difficulties in August/September
2014. Actions have also been taken to ensure that within Critical Care there is safe storage

and adequate medication and that staff regularly check this. The Principal Pharmacist and
Critical Care Pharmacist undertake regular audits.

Where there is a shortage and we are unable to maintain supplies due to the national
shortage every effort is made, both by the pharmacy team and the local network, to ensure
that stocks are maintained. The Trust is aware that medicine shortages are occurring more
frequently in the UK and globally for a variety of reasons. At any one day there can be 20-30
different products for which there are concerns about continuity of supply. Some of these
have simple solutions but increasingly a large number have the potential to cause risks to
patients. The guiding principle must be that appropriate medicines should be available for all
patients. However, the role of our Chief Pharmacist is to ensure that no action is taken within
the Trust which can exacerbate a medicines shortage within the greater NHS. The Trusts
average stockholding for all products in our inventory is approximately three to four working
weeks and stocks are typically replenished when minimum order stock levels are reached. As
a Trust we are expected to work collaboratively across regions to avoid duplication of work on
risk assessments, by sharing stock, seeking procurement alternatives and production of
clinical advice, and our Chief Pharmacist reassures me that this was certainly done with

lsoprenaline.

There are well developed systems in place to communicate shortages of drugs in a timely
manner. Typically the information on a medicines shortage is derived from the pharmaceutical
industry or from the Department of Health / NHS England or the Commercial Medicines Unit.
They provide as much supporting information as possible to allow the Trust to take
appropriate action in order to mitigate any possible effects on patient safety. This is very
much a national and global issue which affects every hospital pharmacy in the UK and it is an
issue on which an increasing amount of time is being spent in trying to resolve. All
stakeholders in the pharmaceutical supply chain are aware of the current issues and the Trust
understands that the NHS is exploring better ways to manage and communicate those
situations. At present, the Trust is aware that a nationally available website is being
developed for medicines shortages information which should contain up to date information
on shortages, their duration and recommending actions that are available. However, if it is
considered that the Trust should escalate local concerns nationally then |, supported by our
Chief Pharmacist, will direct our concerns to the appropriate individuals at the Department of

Health.

Also, the Trust does have a protocol in place which is followed when any shortage arises.
This involves conducting a risk assessment to evaluate the potential effect of the shortage
and the assessment takes account of the estimated duration of the shortage; usage figures;
the availability of suitable alternative products; and the potential risk to Patients. As you will
appreciate, not all shortages will need further action but where the risk assessment supports
further work on a long term critical shortage, the Trust's Pharmacy Department makes an
estimate of the stock in hand within the entire organisation and of the time period this will
cover. Where limited stock might lead to a restriction being placed on the use of a medicine,
then this restriction will be discussed and agreed with the most relevant and appropriate
Senior Doctor within the Trust. Thereafter, this will be communicated immediately to relevant
hospital staff, to ensure patient safety and prevent medication errors. Please be assured that
this protocol along with the other processes discussed above will be reiterated to the Trust's

Pharmacy Department.

Please be assured that the Trust finds any shortage of drugs unacceptable and we are doing
everything within our power to ensure such shortages do not impact upon the care our
patients receive. The Trust does have a strong contingency plan in place and in the case of
Mrs Fenton this was evidenced by the incident itself whereby the Trust utilised local networks
to ensure continuity of supply. Following the inquest into the death of Mrs Fenton, the Trust
has reviewed all incidents relating to the Pharmacy Department and we cannot identify a case
where the Trust has not been able to supply either a medicine experiencing a shortage or a
clinically appropriate and suitable agreed alternative for a patient. The Trust does realise that
there might not always be a straightforward alternative but | would like to bring to your
attention a recent example where there has been a national shortage of Acetylcysteine
Injection which is used in every hospital centre for the management of a paracetamol
overdose and is the standard treatment. This shortage has gone on for several weeks but has
been managed effectively by hospitals sharing intelligence on stockholding and transferring
stock between organisations if urgently required. Such a potentially significant shortage has
not been perceived as an issue locally and the Trust has maintained their stocks.

4. There was a failure of the medical staff to assess and/or document the mental
capacity of the patient

5. There was a failure of the medical staff to obtain “consent” to treatment or to
document why such consent was unavailable and why they were “self-

consenting”.

The Trust has employed a specialist nurse in safeguarding adults, MCA and DOLS to support
medical and nursing staff and to ensure that a thorough and correct assessment relating to
mental capacity is completed and that any decisions made are made in the best interests of
the patient. During 2013/14 the Trust has seen a significant increase in activity (146%) and
profile of adult safeguarding. Therefore, an assertive training programme has been put in
place and we have seen over 828 staff trained to date. The Trust’s solicitor, Weightmans
have also been utilised in providing training and they have provided an extensive training
course throughout the year titled “The Legal Principles of the Mental Health Act; Mental

Capacity Act and Deprivation of Liberty’.

The Trust's Policy for Consent to Examination or Treatment deals with the obtaining of
consent for treatment, in situations where the patient has capacity and in situations where it is
deemed the patient lacks capacity. | can only apologise for the actions of the particular
individuals concerned in the care of Mrs Fenton in that the Trust's Policy does not appear to
have been followed in these circumstances. | have described the actions that are being taken

in respect of the individuals concerned further below.

40. There was very poor communication between staff and other staff, and between
staff and the family of the deceased and the patient herself (e.g. in relation to
DNAR notice, consent forms etc.).

The Trust is striving to improve communication between clinicians, patients and family
members. The Trust has created a bedside booklet, available for patients and relatives —
“Patient Safety — Keeping you safe during your stay in hospital’. This empowers patients and

their families to ask questions.

In May 2014 the DNACPR policy was reviewed in line with R (on the application of David
Tracey) v Cambridge University Hospitals NHS Foundation Trust to involve discussion with
patients/their families. A DVD was created and is available on the Trust’s intranet. The
review of the policy was promoted through screensavers, to inform staff of the new policy.

A patient leaflet was created in August 2014 by the Lead Resuscitation Officer. This
document, entitled “Decisions about cardiopulmonary resuscitation” provides information as
to what CPR is, in what circumstances it is relevant to an individual patient and how decisions
are made.

The current Trust policy dealing with decisions relating to DNACPR, which was updated in
November 2014, stresses the importance of clear, accurate and honest communication with
the patient and (unless the patient has requested confidentiality) those close to the patient,
including provision of information and checking their understanding of what has been
explained.

As to the actions of the particular staff involved in the care of Mrs Fenton, and with particular
reference to the assessment and documentation of mental Capacity, consent and
communication, we have reminded the clinicians of the relevant policies and advised them
that we will be rolling out refresher training. All Cardiology staff have also been informed by
the Lead Consultant Cardiologist that no usage of Isoprenaline should be permitted in the
CCU / Ward 31 without the consent of a Consultant Cardiologist / the on-call Cardiologist for

pacing out of hours.
You also requested that the Trust issue a warning to all medical staff as to their duties to

report matters to Her Majesty’s Coroner and the circumstances in which this duty arises. |
have attached a copy of the warning that has been issued to all medical staff as a result of

your request.

! do hope that | have addressed your concerns and that | have reassured you that the steps
taken by the Trust will prevent the recurrence of a similar set of circumstances as those in the
case of Mrs Fenton.

Should you have any further questions arising from the contents of this letter please do not

hesitate to contact me. | am again sorry that your investigation into this death caused you
such significant concern to issue a Regulation 28 Report but | hope that you are now

reassured.

Yours sincerel

Karen James
Chief Executive