Karl Willis

RECEIVED - 8 NOV.2078 NHS)

YEARS

England = ars

Professor Stephen Powis
Nationa! Medical Director
; Skipton House
Ms Lydia Brown 80 London Road
H.M Assistant Coroner for Exeter and SE1 6LH
Greater Devon
Room 226 County Hall i
Topsham Road
Exeter
Devon :
EX2 4QD 10" October 2018

Dear Ms Brown

Re: Regulation 28. Report to Prevent Future Deaths — Karl James Willis,
date of death 06/12/2017

Thank you for your Regulation 28 Report (Report) dated 24 August 2018
concerning the death of Karl Willis on 06/12/2017. Firstly, | would like to express
my deep condolences to Karl's family.

Your Report concludes Karl Willis’ death was a result of aspiration pneumonitis
secondary to amitriptyline and morphine toxicity.

Following the ‘inquest you raised concerns to NHS England regarding the (i) toxic
effects of amitriptyline when taken in excessive amounts or in conjunction with
other medications. (ii) Permitting a vulnerable patient to ‘self-certify’ information
on a questionnaire to enable them to obtain access to such medication without
checks being made on the accuracy of the patient’s answers, and (iii) permitting
the option for patients to refuse information to be passed to their GP.

It may be helpful if | first explain that NHS England is formally known as the NHS
Commissioning Board (Board) in legislation (Section 9 Health & Social Care Act
2012 amending Sections 1G & 1H of the NHS Act 2006).

The Board’s functions and duties are set out in that legislation and include a duty
in respect of commissioning arrangements for NHS services. These include
commissioning primary care services (including general practice and pharmacy),
managing the NHS performer's lists and maintaining the pharmaceutical list.

We have responsibility for ensuring that GPs work within the terms of their
contract and pharmacies adhere to their Terms of Service which are outlined in
the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations
2013). The Board can take action such as issuing breach notices and requiring
action or withholding payments in certain circumstances.

High quality care for all, now and for future generations

! recognise your concerns around the availability of some prescription only
medication through the internet, however, when this arises outside the NHS (on a
private basis in England or abroad), thé Board has limited powers to influence.

In relation to your specific points, amitriptyline is medication which has well
known side effects including sedation and in overdose, it can have cardio-toxic
effects. As an antidepressant, it is less commonly used because of these side
effects, but its use is still widespread in clinical practice as a medication that in
comparatively low.doses is effective in managing pain and anxiety symptoms. It
is a licensed medication that by law requires a medical prescription before it can
be obtained. It is not a licensed as a controlled drug under the misuse of drugs
legislation. . ,

In the case of Karl, the prescription was obtained on a private basis through the
internet. The ‘consultation’ was in the form of an online questionnaire which
would have informed the prescribing clinician about relevant past medical history,
but as you have indicated, it is dependent on how accurately a patient submits
their response. The use of a questionnaire for patients to ‘self-certify’ their
medical history carries risks that.the treating doctor would not be aware of the full
extent of a patient’s past medical history. It is why there is much work being done
in the NHS to connect NHS services to the patient's summary care record so
clinicians can access a summary of.the patient’s main conditions.

To be eligible to provide NHS care, all GPs working in England have to be
included on the NHS England ‘Performer list’. The Performer List regulations give
the Board responsibility for assuring the quality of GPs providing NHS services in

England, The Board has no powers to take action against a clinician who only ,

practices privately, although such doctors do need to maintain their registration
with the General Medical Council (GMC). . :

In choosing to access private health care, a patient is stepping outside the NHS,
as a result, the Board has no jurisdiction over private consultations and none of
the Board’s powers relating to community pharmacy, prescriptions or regulation
would apply. ’ :

It remains a patient's right to choose to seek private treatment even where this
would be detrimental to their health. There is a wider question on whether an
online prescriber should be able to prescribe all/certain medications but this is
not in the Board’s control. :

You finally highlight the concern that Karl was given an option to refuse to have
the details of his consultation with the private on-line provider to be shared with
his own GP. We have checked the website for the provider which has been
involved in this case and note that it is recommended that information is shared
with a patient’s own GP. As you will appreciate, whilst most often in a patient's
best interest for information to be shared, the bar at which it is appropriate for
confidentiality to be breached is set high and in the tragic circumstance of Karl
Willis, there would have been no legal justification. to have breached his
confidentiality and informed his GP or anyone else involved in his care.

High quality care for all, now and for future generations

Thank you for bringing this important patient safety issues to my attention and we
hope our response has addressed your concerns. Please do not hesitate to
contact me should you need any further information.

Yours sincerely,

; Professor Stephen Powis
National Medical Director
NHS England

High quality care for all, now and for future generations