David Wade

NHS
England

Professor Sir Bruce Keogh
National Medical Director
Skipton House

80 London Road

Michael J H Singleton SE1 6LH
H M Senior Coroner

Coroner's office

Blackbum Central Library

Town Hall Street

Blackburn
BB2 1AG dist October 2016

Your ref: MJHS/JKE/C44820/2016

Dear Mr Singleton,

Re: David Wade (Decea — Regulation 28 Report to Prevent Future
Deaths

Thank you for your letter of 8” September 2016, together with your regulation 28
report, setting out the sad circumstances surrounding the death of Mr Wade. |
was very sorry to read of the circumstances around his death, and would like to
express my deep condolences to his family

In your report you outline your primary concern as:

“Patients who are provided with anti-coagulant therapy are at an increased risk
of the development of haemorrhagic strokes. There appears to be no system in
place to provide patients with literature setting out the symptoms of a bleed on
the brain and the steps patients should take in response”

In light of your concerns | would wish to bring to your attention the standard
anticoagulant booklet (more commonly known as the “yellow book” — which is
warfarin specific) given to patients as recommended by the former National
Patient Safety Agency. A link to its content is below:

http:/Awww.nrls.npsa.nhs.uk/resources/?Entryid45=61777

As you will see the yellow book does set out a list of symptoms which if any occur
then urgent medical advice should be sought. This advice is also available to
patients on NHS Choices. The National Institute for Health and Clinical
Excellence also supports the use of the yellow book as their clinical knowledge
summary on warfarin makes reference to patients being given the yellow book.

| can confirm that the ‘Yellow’ Oral Anticoagulant Therapy (OAT) book is still in

High quality care for all, now and for future generations

print and widely available in the NHS. Shown in the table on page 2 of this letter,
is the latest available data (2015) on distribution of the booklet across the NHS.

in addition to distributing the booklet, | note the second part of your concern
regarding steps to be taken by the patient should they experience symptoms of a
bleed. Whilst this is an important issue it is, fortunately, an uncommon one. In
terms of absolute risk, the rate of spontaneous intracerebral haemorrhage
{ICH) among 70-year-old subjects not on anticoagulants averages 0.15% per
year, In those anticoagulated with warfarin to an “INR” (please see below) of 2.0
to 3.0 (the usual range), the risk of ICH is increased to 0.3 to 0.8% per year.

International Normalised Ratio (INR) is the measure of the degree to which
anticoagulation the ain is to double the time coagulation takes when measured
by the INR. The risk of bleeding is probably slightly lower with the newer oral
Novel Oral Anticoagulants ("NOAC's).
his is a record book used to record the patients use
of warfarin.
It contains critical information concerning the patient,
is or her warfarin use and the associated INR.
OAT Book 264,700 It is the patients tracking record.
older is taking warfarin.
his is to communicate the fact of warfarin use tol
he patient-held information supporting the need for|
onitoring INR with Warfarin.
OAT Patient — Info It provides general high-level information on warfarin
Book sé but is not exhaustive in this regard.
his is a pack containing the OAT Book, the OAT!
ard, the OAT Patient information Book
OAT Pack 184,750 fand the OAT Sheet.
When people do experience a bieed into their brain, whilst on anticoagulants,
then the effect is usually obvious and profound, As a consequence patients
this would appear to have happened in Mr Wade's case). NHS England agrees
that all patients starting on anticoagulants (both warfarin and DOACs) should be

clotting is inhibited by the drug and for most clinical conditions requiring
anticoagulants which are known as Direct Oral Anticoagulants (“DOAC’s) or
ol patient-held credit-sized card indicating that the
OAT Card 104,700 pthers, potentially in an emergency situation
is is an A4 sheet that can be used in a printer
suitably aligned for use) to record warfarin dose and
OAT Sheet INR against time.
typically nearly always arrive promptly in hospital (from your regulation 28 report
given all the relevant information, including that outlined above.

Anticoagulant clinics are where the majority of patients start their anticoagulants
and usually have protocols for information provision. Currently most patients
being started on DOACs have their initial few months of treatment initiated by
hospital clinicians who would also be expected to provide the relevant advice.

High quality care for all, now and for future generations

Overall, there is, of course, a balance to be struck. It is important that patients.
are not deterred from taking a treatment where the balance of benefit over risk is
usually strongly in favour of benefit so information should be provided in a
considered way focussing on those benefits and not just the risks. Indeed the
biggest issue in terms of population health is the failure to anti-coagulate people
with atrial fibrillation. It is estimated that about 5000 people have unnecessary
strokes each year in the UK because of fears about anticoagulation by patients
and clinicians.

Thank you for bringing this matter to my attention and | hope this addresses your
concerns.

Yours sincerely,

Pu |

Professor Sir Bruce Keogh KBE, MD, DSc, FRCS, FRCP
National Medical Director
NHS England

High quality care for all, now and for future generations