Laura Parsons

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D ep artm ent Parliamentary Under Secretary pee (or ination
of Health & 39 Victoria ae
Social Care SWIH OEU

Your Ref:

Mr James E Thompson
HM Assistant Coroner, County Durham & Darlington
HM Coroner's Office
PO BOX 282
Bishop Auckland DL.14 4FY
01 December 2020

Dear Mr Thompson

Thank you for your letter of 3 September to Matt Hancock about the death of Laura Eve
Parsons. | am replying as Minister with responsibility for data and technology and
medicines and | am grateful for the additional time in which to do so.

| would like to say how sorry | was to read of the circumstances of Laura Parsons’ death
and | offer my heartfelt condolences to her family and loved ones. | can appreciate how
deeply upsetting Laura’s death must be for her family and those who loved Laura and we
must do all we can to learn from the circumstances of her death to prevent such tragedies
from occurring again.

In preparing this response, my officials have taken advice from NHS England and NHS
Improvement (NHSEI); NHSx, the body responsible for developing best practice for NHS
technology, digital and data; the National Institute for Health and Care Excellence (NICE)
and the Care Quality Commission (CQC).

First, it may be helpful if | explain that prescribers are expected to take account of NICE
guidance when making treatment decisions with their patients. NICE National Guideline
46: Controlled drugs: safe use and management’, gives recommendations on the
prescribing of controlled drugs that include:

e Taking into account the benefits of controlled drug treatment and the risks of
prescribing, such as dependency or overdose;

e Documenting the regimen (dosing and frequency, quantity to supply) in the patient's
care record and including dosage instructions on the prescription (with the
maximum daily amount or frequency of doses) so this can be included on the label
when dispensed;

1 httos:/Avww.nice.org.uk/quidance/ng46

e Checking a person's clinical needs and if appropriate, adjusting the dose until a
good balance is achieved between benefits and harms; and,

¢ Discussing with the person the arrangements for reviewing and monitoring
treatment.

The guideline recommends that when prescribing a repeat prescription of a controlled drug
(such as morphine) for treating a long-term condition in primary care, the prescriber should
take into account the person's individual circumstances to determine the frequency of
review for further repeat prescriptions; and prescribe enough of a controlled drug to meet
the person's clinical needs for no more than 30 days (and if, under exceptional
circumstances, a larger quantity is prescribed, the reasons for this should be documented
in the person's care record).

NICE National Guideline 46 also gives recommendations on governance arrangements
and clear lines of accountability, as well as policies, processes and procedures in relation
to safe management of controlled drugs. In addition, there are governance processes that
should be followed in relation to patient safety incident reporting. For example, NICE
National Guideline 5: Medicines Optimisation? gives several recommendations on systems
for identifying, reporting and leaming from, medicines-related patient safety incidents.

| am advised by NHSx that electronic clinical systems have the facility to create alerts or
warnings linked to coded problems, conditions and diagnoses that launch when a patient
record is opened. In some GP systems, additional capability enables the use of system
protocols to create pop-ups that launch during the prescribing process. It is not clear if a
flag on the risk of overdose was added to Ms Parsons’ patient record. However, GP
clinical system best practice is that:

e GP practice staff should ensure all incidences of overdose are added to patient GP
Clinical system records using the appropriate code;

e GP practice staff should utilise GP clinical system functionality to create
wamings/alerts linked to coded entry;

e Repeat requests for Schedule 2 and 3 controlled drugs, such as morphine, should be
subject to a strict Standard Operating Procedure within the GP practice with clear
lines of accountability and responsibility for staff:

e GP practice staff should review all incoming hospital correspondence relating to
incidences of overdose against a patients’ list of repeat medications and remove the
medication(s) to prevent the patient from ordering further repeat prescriptions;

e GP practice staff should not add controlled drugs to repeat prescribing where clinical
risk of an overdose exists; and,

? https://www.nice.org.uk/quidance/na5

e GP practices should carry out an urgent structured medication review of all patients
who have taken an overdose.

All GP practices are expected to have mechanisms in place to review patient safety
incidents internally within their practice. In doing so, GP practices should ensure that they
meet the recommendations set out in NICE guidance as described above. The findings of
reviews into patient safety incidents will usually be shared with their local clinical
commissioning group (CCG) and reported to NHSEI for the purposes of national learning?.

| am informed by NHSE] that the GP practice where Ms Parsons was registered has
advised that it has reflected carefully on the circumstances of Ms Parsons’ death and the
findings of your investigation. This includes a review of its prescribing processes to
confirm they comply with NICE guidance, the General Medical Council’s Good Practice
Guidance on Prescribing and Managing Medicines and Devices‘, as well as the regional
Protocol on prescribing of controlled drugs. in addition to this, | understand that a report
on the learning from Ms Parsons’ death has been shared with the local clinical
commissioning group (CCG), from which there may be further cascade of learning to the
wider GP community.

! note that you copied your report to the CQC. As you may be aware, CQC is responsible
for making sure that health and social care providers, and other regulators, maintain a safe
environment for managing controlled drugs in England.

As part of its responsibilities under the Regulations5, CQC reports annually on its findings
through oversight activity and makes recommendations to help ensure the continuing
effectiveness of the arrangements for managing controlled drugs in England.

| am advised by the CQC that it is aware through its analysis of prescribing data,
attendance at controlled drug local intelligence networks (CDLINs), and its wider
inspection and regulatory work, that patients need to be regularly monitored before repeat
prescriptions are issued for controlled drugs across all Schedules.

In its Controlled Drugs Annual Update for 2019°, CQC made the following
recommendation to strengthen existing arrangements.

3 https://improvement.nhs.uk/resources/reporting-patient-safety-incidents-general-practice

4 https://Awww.gme-uk.org/ethical-quidance/ethical-quidance-for-doctors/prescribin
medicines-and-devices

5 Controlled Drugs (Supervision of Management and Use) Regulations 2013, amended on 1 April 2020 to the
Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations 2020.

6

httos://www.cac.org.uk/sites/defaultfiles/The_safer_management_of_controlled drugs Annual update 204
9.odf

The level of controlled drug prescribing continues to increase year on year.
Unnecessary prescribing for long-term treatment can result in an accumulation of
unwanted medicines in patients’ homes, which increases waste and the associated
risks of misuse. Furthermore, patients commonly do not fully understand the risk of
dependence on long-term treatment with many of the scheduled controlled drugs
and the importance of returning them to a community pharmacy once they no
longer need them. To address this:

o Prescribers should regularly review patients’ clinical needs before prescribing
and consider the quantity prescribed, particularly when issuing repeat
prescriptions; and,

o CQC encourage healthcare professionals to fully explain patients’ medicines
at the point of prescribing and supply. This should include giving guidance
and warnings of the potential for dependence and actions to take,
appropriate to patient need.

CQC will continue to recommend and support measures that strengthen the safe use of
controlled drugs in ail settings to help improve patient safety.

| hope this information is helpful. Thank you for bringing these concerns to my attention.

(Gorter -

LORD BETHELL

With my very best wishes,