Jennifer Lacey

INHS

England

Professor Stephen Powis
National Medical Director

Dr Fiona Wilcox 6" Floor, Skipton House
HM Senior Coroner 80 London Road
Inner West London SE1 6LH

Westminster's Coroner’s Court
65 Horseferry Road

London 13! February 2019
SW1P 2ED

Dear Dr Wilcox,

Re: Regulation 28 Report to Prevent Future Deaths — Jennifer Anne Lacey, died
on 4th June 2018.

Thank you for your Regulation 28 Report concerning the death of Jennifer Anne Lacey
on 4" June 2018. Firstly, | would like to express my deep condolences to Ms Lacey’s
family.

The regulation 28 report dated 24 October 2018 concludes Ms Lacey’s death was a
result of cardiorespiratory failure triggered by consumption of tramadol and alcohol
and that a conclusion was reached that Ms Lacey took her own life.

Following the inquest, you raised the following concerns in your Regulation 28 Report
to NHS England:
1. The such potentially dangerous and addictive drugs are so freely available over
the internet.
2. That they can be prescribed without any contact with the patients’ regular
medical practitioner or access to the patients’ medical records.
3. The such prescriptions of such potentially dangerous and addictive drug may
be being filled in UK pharmacies without any further checks.

We are grateful you have brought this to our attention and we also share these
concerns. Firstly, it is important to set out that providers of controlled drugs based in
England must comply with legislation which is enforced by healthcare regulators such
as Care Quality Commission (CQC), the Medicines and Healthcare products
Regulatory Agency (MHRA) and the General Pharmaceutical Council (GPhC). In
addition, all healthcare professionals are subject to their respective codes of
professional conduct and these are enforced by, for example, the General Medical
Council (GMC) for doctors.

With regards to NHS England’s role, we have a clear responsibility in providing
systems oversight for the management and use of controlled drugs, including
tramadol. NHS England’s Controlled Drugs Accountable Officers (CDAOs)' undertake

1 https://www.england.nhs.uk/contact-us/privacy-notice/how-we-use-your-information/safety-and-quality/controlled-drugs-
accountable-officer-alerts-etc/

Health and high quality care for all, now and for future generations

this role within each geographical region across England. They provide assurance that
all healthcare organisations, including pharmacies, adopt a safe practice for
appropriate clinical use, prescribing, storage, destruction and monitoring of controlled
drugs. CDAOs facilitate the routes to share concerns, report incidents, and take
remedial action as well as highlighting good practice. This is shared with wider
partners such as Clinical Commissioning Groups and the Police through the Controlled
Drugs Local Intelligence Networks (CD LINs). Details of all CDAOs in England are
held on a national register, which is owned and published by the CQC:

www.cqc.org.uk/content/controlled-drugs-accountable-officers

However, we are aware of cases where coroners have highlighted an online
consultation with a doctor, issue of a prescription and supply of medicines, as having
contributed to a death. We recognise further work is needed to ensure patient safety
where consultations are given online. As a result, in April 2017, the National Quality
Board? - jointly chaired by NHS England and CQC - held a workshop focusing on
online providers of primary care services and online prescribing. The workshop
identified a number of challenges for the system including gaps in the current
regulatory framework to protect patients from harmful practice. Following the
workshop, the CQC established a UK-wide forum to review the regulatory landscape
for online prescribing. As well as CQC, the group includes Healthcare Inspectorate
Wales (HIW), Healthcare Improvement Scotland (HIS), The Regulation and Quality
Improvement Authority (RQIA) (Northern Ireland), Medicines and Healthcare products
Regulatory Agency (MHRA), the General Medical Council (GMC), General
Pharmaceutical Council (GPhC) and Nursing and Midwifery Council (NMC). This
group now meets regularly.

Linked to this, the CQC inspected every company in England that provided online
primary care services. Its findings were published in March 2018 in ‘The state of care
in independent online primary health services’ °. Providers were assessed against five
key areas: whether they were safe, caring, effective, responsive to people’s needs and
well-led. The CQC also reviewed the provider's registered location, its systems and
policies, examined how it delivered care, and analysed information it held against the
provider including, where available, feedback from people who have used or have
come into contact with the service. One of the questions CQC’s inspectors asked
included, how the service makes sure the identity of the patient is authenticated and
that their NHS GP is kept informed of any treatment. These issues are important for
NHS England and we will ensure that NHS online consultations provide a safe and
secure way for patients to discuss their health concerns with an appropriate clinician
connected to their own GP practice and place centred around their needs.
NHS England has adopted a robust system of quality assurance, safety and
security standards so that patients and clinicians can feel confident in using online
consultations.

These services will continue to be regulated by CQC and we understand that they are
progressing plans to help increase public understanding of the quality and safety of
online services in England by rating providers as ‘outstanding’, ‘good’, ‘requires
improvement’ or ‘inadequate’, as used on other healthcare services.

? The National Quality Board is a national cross organizational board comprising the clinical leaders of national arms-length
bodies across health care, social care and public health. It is jointly chaired by NHS England and Care Quality Commission.
* httos://www.cac.org.uk/publications/major-report/state-care-independent-online-primary-health-services

Health and high quality care for all, now and for future generations

With regard to this case, and based on the information provided within the Regulation
28, it appears that this death was not the result of services provided by NHS, but from
services outside of the NHS. It is unclear where this doctor or company were registered
and the site from which the deceased obtained the consultation, prescription and
medication. Nevertheless, the provision of remote consultations and the supply of
medicines through distance selling remains a concern. We are working with other
health regulators who have a greater role in responding to this challenge. Relevant UK
agencies, such as the CQC and MRHA, have worked collaboratively to review the
healthcare framework and, importantly, identify gaps to ensure patients are protected
from loopholes — notably, for example, where some companies have deliberately
configured themselves to avoid regulation by CQC - within and outside the UK system.

NHS England remains committed to improving the safety of controlled drugs and
online prescribing. We will continue to work across the system with key partners
nationally, regionally and locally to ensure patient safety. We would also suggest that
contact is made directly with the CQC and MRHA would will be better placed should
you wish to understand the work in this area further.

Thank you for bringing these important patient safety issues to my attention and please

do not hesitate to contact me should you need any further information.

Yours sincerely

i

os

Professor Stephen Powis
National Medical Director
NHS England

Health and high quality care for all, now and for future generations