Prevention of Future Deaths reports · 2019

Joanna Flynn

Regulation 28 report to prevent future deaths, reference 2019-0369, written 14 Nov 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report14 Nov 2019
Reference2019-0369
DeceasedJoanna Flynn
CoronerCaroline Beasley-Murray
Coroner areaEssex
CategoryCommunity health care · Alcohol, drug and medication related deaths
Sourcejudiciary.uk record · original PDF
Responses published3

The report

Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.

ANNEX A 

REGULATION 28:  REPORT TO PREVENT FUTURE DEATHS 

NOTE: This form is to be used after an inquest. 

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

THIS REPORT IS BEING SENT TO: 

Mid Essex CCG Trust 
NHS England 
Minister of Health 
Fern House Surgery 

1 

CORONER 

I am Caroline Beasley-Murray, Senior Coroner, for the Coroner area of Essex 

2 

CORONER’S LEGAL POWERS 

I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 
and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 

3 

INVESTIGATION and INQUEST 

On 26th May 2019 I commenced an investigation into the death of Joanna Clare Alice 
Flynn. The investigation concluded at the end of the inquest on 14th November 2019. 
The conclusion of the inquest was: - 

The deceased suffered from a number of long standing medical conditions. It is 
not possible to arrive at an ascertained medical cause of death nor a conclusion 
other than an Open conclusion. This is set against a background of long standing 
prescribed opiate addiction. 

4 

CIRCUMSTANCES OF THE DEATH 

The deceased, a 31 year old lady with a long-standing history of hoarding medication, 
had last been seen on the 23rd May 2019. On the 26th May 2019, the deceased was 
found slumped over the side of her bed. The pathologist provided 1a) Unascertained, as 
the cause of death. Only possible medical causes were oxycodone toxicity, positional 
asphyxia and pneumonia. 

5 

CORONER’S CONCERNS 

During the course of the inquest, the evidence revealed matters giving rise to concern. 
In my opinion there is a risk that future deaths will occur unless action is taken. In the 
circumstances, it is my statutory duty to report to you. 

1

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 The MATTERS OF CONCERN are as follows.  –  

The General Practitioner who gave evidence told the court that there was a lacuna in the 
healthcare provided for patients such as the deceased in terms of giving assistance for 
weaning off addictive prescription drugs such as opiates. It was clear that General 
Practitioner’s require highly specialised assistance in order to help such patients and 
agencies within the healthcare system to which to refer them. This was all lacking in this 
particular sad set of circumstances. The court was informed about a proposed pilot 
scheme – a substance misuse Locally Enhanced Service for people with dependence to 
prescribed opiates. There was no assurance that this had commenced or indeed yet 
been funded. I would like an assurance that this hopeful initiative has got off the ground 
and indeed I would like to have information about any other initiatives to endeavour to 
address this dreadful problem. I would also like to hear what strides have been taken to 
improve training and education for general practitioners and GP practices in this 
worrying area of care. 
ACTION SHOULD BE TAKEN 

6 

In my opinion action should be taken to prevent future deaths and I believe you and your 
organisation have the power to take such action.  

7 

YOUR RESPONSE 

You are under a duty to respond to this report within 56 days of the date of this report, 
namely by 31st January 2020. I, the Coroner, may extend the period. 

Your response must contain details of action taken or proposed to be taken, setting out 
the timetable for action. Otherwise you must explain why no action is proposed. 

8 

COPIES and PUBLICATION 

I have sent a copy of my report to the Chief Coroner and to the following Interested 
Persons- 
Solicitors for 
Ms Flynn’s family 

I am also under a duty to send the Chief Coroner a copy of your response.  

The Chief Coroner may publish either or both in a complete or redacted or summary 
form. He may send a copy of this report to any person who he believes may find it useful 
or of interest. You may make representations to me, the coroner, at the time of your 
response, about the release or the publication of your response by the Chief Coroner. 

9 

14th November 2019                                             Caroline Beasley-Murray 

2

Responses

3 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.

Response from Mid Essex CCG (PDF)
KD

livewell

NY NHS

Clinical Commissioning Group

Wren House
Hedgerows Business Park
Colchester Road

RECEIVED Chelmsford

Essex, CM2 5PF

08 JAN 2020 Tel: 01245 398750
Fax: 01245 449056

www.midessexccg.nhs.uk
Tweet us: @MidEssexCCG

Private & Confidential

Mrs Caroline Beasley-Murray
HM Senior Coroner

HM Coroner’s Office

County Hall

Seax House

Victoria Road South
Chelmsford CM1 1QH

Date: 6 January 2020
Dear Mrs Beasley-Murray
Re: Regulation 28 Report to Prevent Future Deaths

Further to my letter of 25 November 2019 in respect of the Prevention of Future Death Report
touching upon the death of Ms Joanna Clare Alice Flynn, | am writing as requested to provide
additional information about the progress of the mid Essex substance misuse Local Enhanced
Service and other initiatives to address the issue of people with dependence upon prescribed
Opiates. Firstly, however, | would like to convey on behalf of Mid Essex CCG our sincere
condolences to the family of Ms Flynn for their loss.

Background Information

| thought it might be helpful to begin by providing some wider background context in view of
the fact that over use of opioids is a nationally recognised issue.

Opioids are frequently prescribed to manage chronic pain; however, the clinical evidence
shows limited effectiveness and patient safety concerns due to the risks associated with their
long-term use such as fractures and falls, endocrine abnormalities, immunomodulation, opioid
induced hyperalgesia and dependence.

GPs face difficulties in reducing the use of prescribed opioids for chronic pain, both in

differentiating between adequate analgesia from patients who may be dependent on these
medicines and then in engaging patients to reduce and discontinue appropriately and safely,

Accountable Officer: Caroline Rassell » Chair: Dr. Anna Davey AWARD‘

“ . > Q 35
) Mid Essex

livewell Clinical Commissioning Group

due to limited training and experience in substance misuse and the time required to assess
and address the emotional influences that may be contributing to a patient’s chronic pain.

In September 2019 Public Health England (PHE) published a prescribed medicines review
reporting for the first time on the extent of dependence and withdrawal problems associated
with commonly prescribed medicines in England.

The report's findings confirmed that one in 4 adults in England were prescribed
benzodiazepines, z-drugs, gabapentinoids, opioids for chronic non-cancer pain, or
antidepressants in 2017/18 and that, whilst prescriptions for opioid pain medicines are
decreasing after rising for many years, longer-term prescribing is still widespread. The report
concluded that patients who want to stop using a medicine must be able to access
appropriate medical advice and treatment and that as inappropriate limiting of medicines may
be harmful, there should be increased public and clinical awareness of other interventions,
such as cognitive behavioural therapy.

The PHE report provides data for each CCG. In 2017/18 Mid Essex CCG showed a lower
than expected number of patients on long term opioids and was ranked 140 out of 195 CCGs.
Due to differences in the way that local data is captured, it is not possible to replicate the PHE
report figures exactly. However in September 2019 for the number of items of opioids per
1000 patients the CCG was ranked 125 out of 191 CCGs (where 1 is lowest).

Actions now being undertaken to implement the recommendations from the PHE report
include:

e Using prescribing data to identify local need in relation to dependence on, or
withdrawal from, prescribed medicines. We have undertaken further analysis at
practice level of certain metrics in relation to controlled drug prescribing and are using
these to monitor progress in de-prescribing.

e Working closely with our local substance misuse service provider, mental health trust
and local pain consultants to develop a Management of Prescribed Opioid
Dependence Local Enhanced Service, more details of which are provided below.

e Building on previously developed resources to support safe management and
withdrawal of opioids and making these publicly available on the CCG website,
including patient information leaflets on the safe use of opioids.

e Providing a range of learning resources to help clinicians develop their knowledge of,
and competence to identify, assess and respond to, dependence or withdrawal
associated with some medicines and the support needs of people experiencing
problems with withdrawal or dependence.

More recently (12th December 2 the Controlled Drugs Accountable
Officer for the East of England region of NHS England, sent out a letter to prescribers and
dispensers in response to regulation 28 notices being issued to two other CCGs - one relating
to stopping the prescribing of oxycodone and amitriptyline concurrently and the other relating
to overuse of prescribed and purchased (over the counter) codeine products. The letter asks
GPs to identify patients for an early medication review. scocunnane 8
HSJ

Accountable Officer: Caroline Rassell » Chair: Dr. Anna Davey AWARDS RE

WINNER

Mid Essex
livewell Clinical Commissioning Group

In response to this letter, we have used Eclipse Live to identify 174 patients in mid Essex on
oxycodone and amitriptyline and have sent an alert message to each patient’s registered GP
encouraging an early medication review. We have also added onto Scriptswitch® (a
prescribing support system which runs on GP practices’ clinical systems) a reminder to GPs
to ask about over the counter codeine or codeine-containing products when they are
considering prescribing any codeine.

Mid Essex Substance Misuse Local Enhanced Service

The ‘pilot’ scheme referred to iii at the inquest is a local service that the
CCG has been seeking to introduce to support patients with a dependency upon prescribed
medicines. Whilst the commissioning of substance misuse services is one of the public
health responsibilities of Local Authorities, the Essex Specialist Treatment and Recovery
Service (STaRS) commissioned by Essex County Council only provides advice and support
to help GPs manage patients dependent on prescribed opioids. STaRS will only see people
for adjunctive problematic use of prescribed and/or over-the-counter medications, if their
primary problematic substances are alcohol or illicit drugs. This is in contrast to similar
substance misuse services commissioned by local authorities elsewhere - for example in
Cambridgeshire & Peterborough or Suffolk - who will accept referrals for patients dependent
upon prescribed medication without associated alcohol or illicit drug misuse.

To address this gap in services, Mid Essex CCG agreed in November 2018 to fund a service
to support GPs and patients dealing with this issue. Initially the CCG was hoping to work with
Essex County Council to extend the existing STaRS service to include patients dependent
upon prescribed opioids. Unfortunately after an extended dialogue with the Council and also
directly with Essex Partnership University Trust (the provider of STaRS) it became apparent
that this would not be possible and so the CCG has been working with local GPs and
pharmacists to develop an alternative service model.

The new Management of Prescribed Opioid Dependence Local Enhanced Service
commissioned by the CCG will provide patients who are identified as having problematic
prescribed opioid use and their GPs with access to multi-professional expert support at a
multi-disciplinary team meeting (MDT). The MDT will engage the patient in the need for
change and then develop an opioid weaning care plan for the GP and patient to implement.

In Mid-Essex we have approximately 180 patients who are prescribed the equivalent of 120
mg or more per day (high risk) and approximately 570 patients who are prescribed a
Schedule 2 Controlled Drug like morphine along with pregablin (medium to lower risk). These
patients will be the initial focus of the service.

The service will also provide GPs and other primary care practice staff who prescribe opioids
for people with chronic pain with education and support, enabling them to implement the MDT
agreed care plan and support patients during their opioid wean.

The opportunity to provide this service as a Local Enhanced Service has been offered to GP
practices within Mid Essex CCG and, as you will see from the table overleaf, the aim is for the

service to be fully operational by 1 April 2020.

. VALUE IN HEALTHCARE
Accountable Officer: Caroline Rassell +« Chair: Dr. Anna Davey AWARDS

WINNER

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livewell Clinical Commissioning Group

Implementation Stage

Receipt of completed applications 31 December 2019
Evaluation of applications 10 January 2020

Successful applicant(s) notified 17 January 2020
Initial mobilisation of service February 2020 onwards
Service fully operational 1 April 2020

Other initiatives to address the issue of people with dependence upon prescribed opiates

Other initiatives introduced by the CGG to support patients and healthcare professionals
address the issues of dependence upon prescribed opiates include:

1) Inclusion of opioid reduction within the Medicines Optimisation Local Enhanced
Scheme

Mid Essex CCG has in place a Medicines Optimisation Local Enhanced Scheme (MOLES)
which provides funding to practices to resource a programme of medicines optimisation and
then rewards high quality, cost-effective prescribing. Medicines optimisation is about
ensuring the right patients get the right choice of medicine, at the right time. It is a person-
centred approach that improves safety, adherence to treatment and reduces waste.
Medicines optimisation promotes the use of high-quality, evidence-based medicines and
better systems for managing patients with a focus on outcomes. MOLES links to the CCG’s
Medicines Optimisation Five Year Strategy, which itself supported the aims of the NHS Long
Term Plan and provide a formal arrangement for working with member practices.

One of the requirements of MOLES 2018/19 and 2019/20 is for practices to reduce the overall
quantity of opioids prescribed in line with national guidance. For 2019/20, the expectation is
that practices do not increase the number of opioid items/1000 patients or the number of
patients on 120mg or more morphine equivalent from their baseline April 2019 data and that
practices are working towards a reduction in both of these metrics.

2) Inclusion of pop-up information message on Scriptswitch®

Scriptswitch® is a prescribing support system which runs on GP practices’ clinical systems in
Mid Essex CCG. This system is set up to:

e Highlight to prescribers the risk of harm to the patient each time they prescribe a high
dose opioid medication;

e Provide the contact details for a substance misuse consultant who can provide advice
to support patient management;

e Provide a link to the opioid resource pack developed by Mid Essex CCG to support
patients and prescribers https://midessexccg.nhs.uk/medicines-optimisation/opioid-
resource-pack-for-practices.

Accountable Officer: Caroline Rassell » Chair: Dr. Anna Davey AWARDS

WINNER

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Clinical Commissioning Group

3) Open letter to patients encouraging self-reduction of low dose opioids

An open letter, which is displayed on the CCG’s website and on some GP practice websites,
has been developed to encourage self-reduction of low dose opioids, which some practices
have used to send to individual patients.

An example of such a letter from one GP website states:

Advice for patients - Weaning opioids

We are contacting patients who have been taking painkillers for a long period of time,
particularly a type of painkiller called an opioid; like co-codamol, co-dydramol, codeine,
dihydrocodeine, and tramadol.

Recent medical evidence questions the benefit of opioids (which are in the morphine
family) for long-term pain. Strange as it might sound — we don’t think that they are very
good at killing pain at all when taken for more than a few months.

Please see the links below for more information and advice.
Weaning opioids - Information for patients

4) Signposting to webinars and e-learning

The CCG has access through its subscription with PrescQIPP (https:/Awww.prescaipp.info/ - a
not-for-profit organisation that supports quality, optimised prescribing for patients) to webinars
and e-learning resources, details of which have been distributed and promoted to all
prescribers. The CCG aims to include mandatory completion of the ‘Reducing opioid
prescribing in chronic pain’ e-learning module within its 2020/21 MOLES scheme, however it
is accessible now and GP practice staff are already being encouraged to complete it as soon
as possible.

5) Revised Pain Guidance

The CCG has engaged with the pain consultants at Mid Essex Hospitals NHS Trust to revise
our Pain Guidance, now published on our website. https://midessexccg.nhs.uk/medicines-
optimisation/clinical-pathways-and-medication-quidelines/chapter-4-central-nervous-system-
2. The joint guidance now has a clear strategy for de-prescribing and social prescribing when
appropriate and highlights access to alternative non-pharmacological therapies such as:

e Psychological support, for example cognitive behavioural therapy -

https://me.silvercloudhealth.com/signup or https://www.northessexiapt.nhs.uk/mid-
essex.

e Mid Essex Live Well Link Well: a free and confidential social prescribing service that
provides practical or emotional support of a non-medical nature, including opportunities
to take part in community events and groups that have been shown to improve quality
of life for people with long-term pain as well as support with money worries or other

Accountable Officer: Caroline Rassell + Chair: Dr. Anna Davey AWARDS

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livewell Clinical Commissioning Group

social issues - https://midessexccg.nhs.uk/livewell/live-well-link-well. Patients can also
self- refer for support - https://connectwellessex.org.uk/#modal.

6) Engagement with GPs

The safety of patients who are being prescribed long term opioids has been regularly
discussed at the CCG’s Medicines Optimisation Committee, which is attended by GP
prescribing leads from across the CCG. This committee considers new guidance to seek GP
support prior to final agreement at the Mid Essex Area Prescribing Committee.

A session on Opioids and Safe Prescribing is also planned at the CCG’s Time to Learn event
in March. These are quarterly events organised by the CCG for all surgeries in mid Essex,
with paid clinical cover to allow GPs to attend in normal working hours, where practices can
take part in collective learning and share best practice.

| hope that the above information is helpful and provides the reassurance that you are
seeking, however please do not hesitate to contact me if you have any further queries or
remaining concerns.

Yours sincerely,
Chair

Fon veALrHcans eAbeRs 9
VALUE IN HEALTHCARE
Accountable Officer: Caroline Rassell « Chair: Dr. Anna Davey AWARDS

WINNER
Response from NHS England and NHS Improvement (PDF)
Mrs Caroline Beasley-Murray 
HM Senior Coroner 
County Hall 
Seax House 
Victoria Road South 
Chelmsford 
CM1 1QH          

                                    Professor Stephen Powis 
                                    National Medical Director 
                                                    Skipton House 
                                                 80 London Road 
                                                              SE1 6LH 

                                              24 December 2019 

Dear Mrs Beasley-Murray, 

Re: Regulation 28 Report to Prevent Future Deaths – Ms Joanna Clare Alice 
Flynn  

Thank you for your Regulation 28 Report dated 14th November 2019 concerning 
the death of Ms Joanna Clare Alice Flynn. Firstly, I would like to express my deep 
condolences to Ms Flynn’s family.  

Following the inquest you raised concerns in your Regulation 28 Report to NHS 
England: 

The General Practitioner who gave evidence told the court that there was a lacuna 
in the healthcare provided for patients such as the deceased in terms of giving 
assistance for weaning off  addictive presecription drugs such as opiates.  It was 
clear that General Practitioner’s require highly specialised assistance in order to 
help such patients and agencies within the healthcare system to which they refer 
them.  This was all lacking in this particular sad set of circumstances.  The court 
was informed about a proposed pilot scheme – a sunstance misuse Locally 
Enhanced Service for people with dependencies to prescribed opiates.  There was 
no assurance that this had commenced or indeed yet been funded.  I would like an 
assurance that this hopeful initiative has got off the ground and indeed I would like 
to have information about any other initaitives to endeavour to address this dreadful 
problem.  I would also like to hear what strides have been taken to improve training 
and education for general practitioners and GP practices in this worring area of 
care.  

NHS England/Improvement are aware of this important issue and the need for work 
at a national level, to provide guidance and support across the NHS. 

A review group has been established in response to the recent Public Health 
England review of dependence on, and withdrawal from, prescribed medicines. The 
group has senior NHSE/I input including Keith Ridge (Chief Pharmaceutical Officer) 
 and Nikki Kanani (Medical Director for Primary Care) as well as other system 
stakeholders.  It will include opiate prescribing.  I do not have details of the case 
other than as outlined in your Regulation 28 report but hopefully the following 

NHS England and NHS Improvement 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                         
 comments are relevant to the context and cover appropriate issues for 
consideration by the review group. 

JF was known to have a number of longstanding medical conditions and a history 
of hoarding. Patients addicted to prescribed medicines often have associated 
physical, psychological or socioeconomic needs and can be significantly complex 
for primary care to support.  As highlighted by the GP in your report, the availability 
of resources to support primary care vary across the country. The needs of patients 
with addiction to prescribed medications often differ from those with other chemical 
addictions and are likely to need multidisciplinary input including a specialised pain 
service with embedded psychological practitioners.  Many of these patients will 
require input beyond ‘conventional’ general practice, usually via a CCG 
commissioned service that could take the form of a Locally Commissioned Service 
(in effect an enhanced GP service) or through a contract with an alternative 
provider, usually across a CCG footprint. 

In addition to considering service provision, NHSE is aware of the need to facilitate 
primary care clinicians offering best practice to include appropriate prescribing of all 
medicines of addiction and misuse such as benzodiazepines, 
pregabalin/gabapentin as well as opiates.  Implicit in this is a need for robust 
processes of monitoring prescriptions issued given the risks of hoarding or misuse. 

It is important to acknowledge the current pressures on primary care.  NHSE 
continues to support primary care with additional funding, staff and organisational 
development to ensure time and resources are available to care for these 
vulnerable patients who are potentially high risk and will often need input from the 
most experienced staff. 

NHSE is committed to fully understanding contributing factors to this serious 
problem and ensuring that all appropriate expertise and resources are universally 
available to support these patients and reduce the likelihood of future associated 
morbidity and mortality. 

Yours sincerely, 

Professor Stephen Powis 
National Medical Director   
NHS England and NHS Improvement  

NHS England and NHS Improvement 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 NHS England and NHS Improvement
Response from The Department of Health and Social Care (PDF)
From Jo Churchill MP 
Parliamentary Under Secretary of State for Prevention, 
Public Health and Primary Care 

39 Victoria Street 
London 
SW1H 0EU 

020 7210 4850 

09/03/2020 

Our Reference: PFD-1196897 

Mrs Caroline Beasley-Murray 
HM Senior Coroner, Essex 
HM Coroner's Office 
County Hall 
Seax House 
Victoria Road South 
Chelmsford CM1 1QH 

Dear Caroline, 

Thank you for your letter of 15 November 2019 to the Department of Health and Social 
Care about the death of Ms Joanna Flynn.  I am replying as the Minister with responsibility 
for primary care and I am grateful for the additional time in which to do so.  

Firstly, I would like to say how very saddened I was to read the circumstances of Ms 
Flynn’s death and I extend my deepest sympathies to her family and loved ones.  I agree, 
we must do all we can to learn from these deeply regrettable incidents to prevent future 
deaths. 

In 2017, Public Health England (PHE) was commissioned to conduct an evidence review 
to identify the scale, distribution and causes of prescription drug dependence, and what 
might be done to address it.  PHE’s report of the review was published in September 
20191.   

The report acknowledged that work to tackle this issue has already started or is planned.  
For example, England’s Chief Pharmaceutical Officer, Dr Keith Ridge, was asked by the 
Secretary of State for Health and Social Care, Matt Hancock, to review overprescribing in 
the NHS, problematic use of multiple medications concurrently, and how to help patients 
come off repeat prescriptions they no longer need.    

In addition, the Department asked the National Institute for Health and Care Excellence 
(NICE) to develop guidance on the safe prescribing of drugs associated with dependence 

1 https://www.gov.uk/government/publications/prescribed-medicines-review-report 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
 
 (such as opioids) and the careful management of withdrawing from these drugs2.  NICE is 
also currently developing guidance on Chronic pain: assessment and management3.   
To prescribe safely, medical practitioners are expected to keep up to date with information 
sources, such as the British National Formulary (BNF), that includes information on 
controlled drugs and drug dependence4 and to take into account NICE guidelines.  The 
Care Quality Commission (CQC) looks for evidence of how providers of healthcare 
services are using NICE guidelines and quality standards when it conducts inspections.  

Recommendations made by the PHE review include:  

• 

Increasing the availability and use of data on the prescribing of medicines that can 
cause dependence or withdrawal to support greater transparency and 
accountability and help ensure practice is consistent and in line with guidance; 

•  Enhancing clinical guidance and the likelihood it will be followed;  

• 

Improving information for patients and carers on prescribed medicines and other 
treatments, and increasing informed choice and shared decision making between 
clinicians and patients;  

• 

Improving the support available from the healthcare system for patients 
experiencing dependence on, or withdrawal from, prescribed medicines; and, 

•  Further research on the prevention and treatment of dependence on, and 

withdrawal from, prescribed medicines.  

The Medicines and Healthcare products Regulatory Agency (MHRA) is currently 
undertaking a review of opioid medicines and the risk of addiction and dependence and 
has sought advice from an Expert Working Group of the Commission on Human Medicines 
(CHM).  In April and June 2019, the Expert Working Group made recommendations, which 
have been endorsed by the CHM, for regulatory action to better support appropriate use of 
prescription opioids and to increase awareness of risks for both healthcare professionals 
and patients.  

The Summary of Product Characteristics (SmPC) of a medicine is intended to provide 
information for healthcare professionals.  Although the SmPC for oxycodone (you 
reference oxycodone toxicity in your report), currently contains warnings on the risks of 
dependence, addiction and tolerance, this information is being updated to highlight that 
patients and healthcare professionals should discuss a treatment regimen that includes 
planning for cessation of treatment.  The information will be consistent for all opioid 
medicines and similar information will also be provided in the patient information leaflet.  
The MHRA will communicate this information in a forthcoming publication of its drug safety 

2 https://www.nice.org.uk/guidance/indevelopment/gid-ng10141 

3 https://www.nice.org.uk/guidance/indevelopment/gid-ng10069 

4 https://bnf.nice.org.uk/guidance/controlled-drugs-and-drug-dependence.html 

 
 
 
 
 
 
 
 
 
 
                                                           
 
 
 
 bulletin, Drug Safety Update, which will also cover how to report cases of dependence to 
the MHRA Yellow Card Scheme5.   

In addition, the labels for all opioid medicines, including oxycodone, have been updated to 
inform the patient that their medicine ‘contains opioid’, and that it ‘can cause addiction’.  
Opioid medicines with these updated warnings are now starting to be delivered to 
pharmacies and received by patients. 

As part of the review of opioid medicines, the MHRA is also looking at the availability of 
medicines containing codeine for purchase in pharmacies. 

In the UK, strict legal requirements apply to the retail sale and supply of medicines for 
example, Prescription Only (POM) and Pharmacy (P) medicines may only be legally sold 
or supplied to the public through registered pharmacy premises, by or under the 
supervision of a pharmacist and POMs may only be sold or supplied in response to a 
prescription from an authorised healthcare professional (such as a doctor, dentist, or 
certain trained nurses and pharmacists).  Legal controls apply without distinction to 
medicines sold online and much is being done by healthcare regulators to protect the 
public and improve the safety of medicines online.  The Department is working closely with 
healthcare regulatory partners to support this work.  

The MHRA is working with stakeholders to better support appropriate use of prescription 
opioids and provide better guidance and consistent information for healthcare 
professionals.  This includes the development of an independent leaflet for patients, to be 
available either directly from pharmacists or online, and the MHRA expects this to be 
available in the coming months.   

This case has been added to the MHRA’s Yellow Card database (reference ADR 
24467546) and will contribute to the evidence base for taking regulatory action and 
engaging further with stakeholders as described above.  

In relation to the education and training of GPs on supporting patients dependent on 
prescribed medicines, it is for individual medical schools to sets their own undergraduate 
medical curriculum.  These have to meet the standards set by the General Medical Council 
(GMC), which monitors and checks to make sure that the standards are maintained.   

The curricula for postgraduate specialty training, which includes training for GPs, is set by 
individual royal colleges and faculties, and the GMC approves curricula and assessment 
systems for each training programme.  Training curricula for doctors emphasise the skills 
and approaches that a doctor must develop in order to ensure accurate and timely 
diagnoses and treatment plans for their patients.   

The Royal College of General Practitioners sets the curriculum for GPs.  The current 
version of the GP curriculum6 includes a topic guide that sets out the issues relating to 

5 The Yellow Card Scheme is the UK system for collecting and monitoring information on the safety of medicines.  
6 https://www.rcgp.org.uk/-/media/Files/GP-training-and-exams/Curriculum-2019/Curriculum-Topic-Guides-
300819.ashx?la=en 

 
 
 
 
 
 
 
 
 
 
                                                           
 
 improving the quality and safety of prescribing and states, “it is important to apply effective 
strategies for communicating about and reducing the risk of dependency or addition to 
medicines where this may occur (e.g. opioids, benzodiazepines, GABA drugs) as well as 
supporting and managing patients who have become dependent on medications, seeking 
specialist advice and intervention where appropriate”. 

Finally, the provision of specialised services to support people dependent on prescription 
medicines is a matter for local commissioners.  I am aware that the Mid-Essex Clinical 
Commissioning Group (CCG) has responded to your report explaining the services that 
are in place locally to support patients and GPs.  This includes the new Management of 
Prescribed Opioid Dependence Locally Enhanced Service (referenced in your report), that 
is anticipated to be in place from 1 April 2020.  I am advised that other measures are being 
taken locally to promote better prescribing and reduce the amount of opioids being 
prescribed.  

I hope this response is helpful.  Thank you for bringing these concerns to my attention.  

Kind regards, 

JO CHURCHILL

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