Joan Wright

From the Baroness Blackwood

Department Parliamentary Under Secretary of State (Lords)
of Health

Department of Health
39 Victoria Street
London

SWIH 0EU

Tel: 020 7210 4850

Your Ref: 8223/CH
Our Ref: PFD-1161533
2 | FEB 2019
Ms Alison Mutch OBE
HM Senior Coroner, Manchester South
HM Coroner's Court
1 Mount Tabor Street
Stockport
SKI 3AG

eae Ms Malek

Thank you for your correspondence of 28 December to Matt Hancock about the
death of Mrs Joan Wright. I am replying as Minister with portfolio
responsibility for medicines.

Firstly, I would like to say how sorry I was to read of the circumstances of Mrs
Wright’s death. If you have the opportunity to do so, please pass my
condolences to her family.

I have noted carefully the matters of concern in your report relating to the
management of controlled drugs.

You mention the Shipman Inquiry in your report. In response to the Shipman
Inquiry's Fourth Report', there have been significant changes in the governance
arrangements for the use and management of controlled drugs.

The Home Office put in place tighter controls through Regulations covering
prescribing, record keeping and safe custody of controlled drugs, and the then

* http://www.nicpld.org/nes/assets/4thShipmanreport.pdf

Department of Health, implemented The Controlled Drugs (Supervision of
Management and Use) Regulations 2006 (the 2006 Controlled Drugs
Regulations) (as amended)”. These Regulations mandated health care
organisations to put in place standard operating procedures on the prescribing,
supply and administration of controlled drugs and the clinical monitoring of
patients.

The 2006 Controlled Drugs Regulations also require the appointment of a
Controlled Drug Accountable Officer (CDAO). This Officer has statutory
responsibility for the safe management and use of controlled drugs within their
organisation. These Officers are required to work with healthcare providers,
regulators and enforcement authorities, including Controlled Drug Liaison
Officers (CDLOs), through local intelligence networks (CD LINS) to share any
concerms about the use and management of controlled drugs.

The 2006 Controlled Drug Regulations were replaced by the current version of
the Regulations in April 2013°. This replacement was largely due to the
approval of the Health and Social Care Act 2012 by Parliament, which Jed to
the removal of primary care trusts (PCTs) and therefore required the
responsibilities and powers of PCT CDAOs to be transferred to the then-new
NHS Commissioning Board (now NHS England). Under the 2013 Regulations,
clinical commissioning groups are not ‘designated bodies’ but are named as
‘responsible bodies’. The responsibilities of ‘responsible bodies’ are set out in
the Regulations.

NHS England Area Teams are responsible for the appointment of a lead
Controlled Drugs Accountable Officer to ensure that systems are in place for the
safe and effective management and use of controlled drugs and that these
systems are working effectively in their region.

A statutory post-implementation review of the revised 2013 Regulations will be
undertaken and published before 31 March 2020. I hope this information is
helpful and provides assurance that the Regulations will be reviewed to ensure
their continued effectiveness,

More generally, the NHS has taken important steps towards improving the
safety of medication.

? http://www. legislation.gov.uk/uksi/2006/3 148/contents/made

3 https://www.legislation.gov.uk/uksi/2013/373/contents/made

Department
of Health

The chief pharmacist role, following the report Pharmacy in England (2008)',
was identified as the organisational lead for medicines safety, and a Patient
Safety Alert in 2014 required all organisations to identify the role of Medicines
Safety Officer to coordinate local medicines safety processes and work
collaboratively nationally.

NHS Improvement and the Medicines and Healthcare Products Regulatory
Agency (MHRA) jointly support a network of Medication Safety Officers and
Medical Device Safety Officers.

In addition, as part of the Government's response to the World Health
Organisation's patient safety challenge on medicines safety, we are developing a
programme of work led by NHS Improvement to improve medicines safety.
Work is underway to accelerate the roll-out of electronic prescribing to
controlled drugs and medicines administration, and to deploy more clinical
pharmacists in primary care and care homes. We have also introduced
monitoring of the highest risk prescribing practice linked to hospital admissions.

Furthermore, in response to the Gosport Inquiry*, NHS England has initiated the
following actions:

e A review of the governance and leadership of the Controlled Drug
Accountable Officer role in NHS England;

e A review of the operation of the lead Controlled Drug Accountable
Officers in NHS England, including the effectiveness of Local
Intelligence Networks; and

e An assurance process to assess how 'designated bodies’ (which include
NHS trusts and foundation trusts) are reflecting on the learning from the

* htups://www.gov.uk/government/publications/pharmacy-in-england-building-on-strengths-delivering-the-

future
5

https://www.gosportpanel.independent.gov.uk/media/documents/070618_CCS207_CCS03183220761_ Gosport
Inquiry Whole Document.pdf

Gosport Panel report and reviewing arrangements in their organisation in
the light of it.

More broadly, system governance is provided by the Care Quality Commission
(CQC), which ensures that health and adult social care providers maintain a safe
environment for the management of controlled drugs in England. The CQC
reports its findings through individual local inspection reports and by means of
published annual updates to Government.

It is clearly of great concern that the maladministration of a controlled drug to
Mrs Wright occurred at a time when the care home was being monitored by the
local authority.

It is the registered provider and the registered manager’s responsibility to ensure
the proper and safe management of medicines and guidance is available to
support them to achieve this. The National Institute for Health and Care
Excellence (NICE) has produced a national guideline on the ‘Safe use and
management of controlled drugs (NG46)°, published in 2016, and a social care
guideline (SC1), published in 2014, provides guidance on ‘Managing medicines
in care homes”. Furthermore, the CQC has clear guidance on its website on

‘Storing controlled drugs in care homes’®,

I note your comment about the definition of ‘regular’. I am advised that
guidance with regard to checking stocks is given within the NICE guidance
NG46. This makes clear that providers should develop a controlled drugs
policy and standard operating procedures for storing, transporting, destroying
and disposing controlled drugs. Detailed guidance is provided on process and
procedures for storage, stock checks and audits, including on the frequency of
stock checks.

While no system can ever completely prevent the mismanagement or misuse of
controlled drugs, we believe the measures that have been put in place mean that
the inappropriate use of opioids and other controlled drugs can be detected more
quickly and minimised, so that protracted poor practice is less likely to continue
unchecked.

© https://www.nice.org.uk/guidance/ng46
T https://www.nice.org.uk/guidance/sc]

Ree

Department
of Health

Your report raises concerns about the actions of Greater Manchester Police in
responding to the potential safeguarding risks following the incident report of
maladministration of Oramorph to Mrs Wright, and questions if learning from
this incident has been shared at a national level.

The Health Act 2006 placed a greater emphasis on Controlled Drugs Liaison
Officers being involved in not only the investigation of offences concerning
controlled drugs in the health service, but also intelligence and partnership
working; particularly through CD-LINs.

As CDLOs are employees of the police force, I would suggest taking up this
point with the Home Secretary, the Right Honourable Sajid Javid.

Ni

NICOLA BLACKWOOD