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

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

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.

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

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 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 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 patients who may be dependent on these medicines and then in engaging patients to reduce and discontinue appropriately and safely, AennenO HSJ VALUE WN HEALTHCARE Accountable Officer: Caroline Rassell Chair: Dr. Anna AWARDS WINNER the from Davey

NHS] 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 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 is lowest). Actions now being undertaken to implement the recommendations from the PHE report include: 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: Working closely with our local substance misuse service provider; mental health trust and local consultants to develop a Management of Prescribed Opioid Dependence Local Enhanced Service, more details of which are provided below: 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. 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 201 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: SAe HSJ VALUE IN HEALTHCARE Accountable Officer: Caroline Rassell Chair: Dr: Anna Davey AWARDS WINNER pain

NHS] 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 are considering prescribing any codeine_ Mid Essex Substance Misuse_Local Enhanced Service The 'pilot' scheme referred to byL 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 andlor 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 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 s0 the CCG has been working with Iocal 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 approximately 180 patients who are prescribed the equivalent of 120 mg or more per (high risk) and approximately 570 patients who are prescribed a Schedule 2 Controlled 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 April 2020. HSJ VALUE WN HEALTHCARE Accountable Officer: Caroline Rassell Chair: Dr: Anna Davey AWARDS WINNER they drug have day Drug

NHS] Mid Essex livewell Clinical Commissioning Group Implementation Stage Deadline 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 April 2020 Qther 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 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 12Omg 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 prescribing support system which runs on GP practices' clinical systems in Mid Essex CCG. This system is set up to: Highlight to prescribers the risk of harm to the patient each time prescribe high dose opioid medication; Provide the contact details for a substance misuse consultant who can provide advice to support patient management; Provide a link to the opioid resource pack developed by Mid Essex CCG to support patients and prescribers https Ilmidessexccg nhs uklmedicines-optimisationlopioid_ resource-pack-for-practices: HSJ VALUE IN HEALTHCARE Accountable Officer: Caroline Rassell Chair: Dr: Anna Davey AWARDS WINNER get they '

NHS Mid Essex livewell 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 dont think that 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 IIw_prescqipp infol - 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 Ilmidessexccgnhs uklmedicines- optimisation/clinical-pathways-and-medication-quidelineslchapter-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: Psychological support, for example cognitive behavioural therapy https Ilme silvercloudhealth com/signup or https:IIW northessexiapt nhs uklmid- essex: Mid Essex Live Well Link Well: a 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 HSJ VALUE IN HEALTHCARE Accountable Officer: Caroline Rassell Chair: Dr. Anna AWARDS WINNER they free Davey

NHS] Mid Essex livewell Clinical Commissioning Group social issues https Ilmidessexccg nhs ukllivewellllive-well-link-well Patients can also self- refer for support https IIconnectwellessex org ukl#tmodal:
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 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.