Prevention of Future Deaths reports · 2019
Regulation 28 report to prevent future deaths, reference 2019-0387, written 18 Nov 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 18 Nov 2019 |
|---|---|
| Reference | 2019-0387 |
| Deceased | Deborah Headspeath |
| Coroner | Nigel Parsley |
| Coroner area | Suffolk |
| Category | Alcohol, drug and medication related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: Mr Matt Hancock Secretary of State Department of Health and Social Care 39 Victoria Street London SW1H OEU 1 CORONER | am Nigel Parsley, Senior Coroner, for the coroner area of Suffolk. 2 | CORONER’S LEGAL POWERS | 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 3 August 2017 | commenced an investigation into the death of Deborah Michelle HEADSPEATH The investigation concluded at the end of the inquest on 11** November 2019. The conclusion of the inquest was that the death was the result of:- Debbie Headspeath died of a medical condition (aspiration pneumonitis) caused by an inflammation of the pancreas (pancreatitis). The inflammation to Debbie’s pancreas was a direct result of the uncoordinated availability of codeine medication which she sourced from multiple prescription-only medication suppliers. The medical cause of death was confirmed as: 1a Aspiration pneumonitis 1b Acute on chronic pancreatitis 1c Chronic codeine use 4 | CIRCUMSTANCES OF THE DEATH Debbie Headspeath was a 41-year-old woman who died suddenly on the 28" July 2017 at her home address of 252 Woodbridge Road, Ipswich in Suffolk. Debbie’s death was the result of her suffering from a condition called pancreatitis (inflammation of the pancreas). This condition arose due to Debbie’s long-standing dependence on the medicinal drug codeine. Debbie’s dependence started in 2008 when she was first prescribed dihydrocodeine for back pain by her GP. Due to Debbie’s long-term dependence she had developed a tolerance to codeine and therefore needed to take much higher quantities than is normally prescribed. Initially Debbie purchased large quantities of over-the-counter medication which contained both codeine and larger quantities of either Ibuprofen or Paracetamol. Due to the known toxic effects of these drugs her GP prescribed her high doses of codeine so she could avoid taking toxic quantities of Ibuprofen or Paracetamol. The GP prescribed codeine proved insufficient in meeting Debbie’s dependent need, so she continued to supplement her prescription with additional over-the-counter medication containing codeine. At some point before late 2016, Debbie identified that she could obtain additional codeine tablets ‘on-line’ and obtained prescriptions of this drug from on-line suppliers. Due to there being no central record of these prescriptions, and the way Debbie herself identified how to manipulate the systems in place, she was able to obtain significant quantities of codeine. In just the last six months prior to Debbie’s death, investigations revealed she had received significant quantities of codeine from 16 different on-line suppliers in addition to that prescribed by her GP. Debbie’s access to significant quantities of codeine with no coordinated and therefore no effective medical supervision directly led to her death. 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 could occur unless action is taken. In the circumstances it is my statutory duty to report to you; the MATTERS OF CONCERN as follows. — During the inquest evidence was heard from the Care Quality Commission national advisor on clinical matters relating to the provision of on-line health care in the independent sector. Evidence was also heard from a number of general practitioners who provide prescriptions for prescription only medications on-line. This evidence identified the three main concerns listed below. 1. There is no single database that allows a prescribing clinician to identify what prescription only medication has already been prescribed to any particular patient. Because there is no central record, in order for the prescribing clinician to identify previous/current prescriptions, they need to personally contact every other prescribing clinician or clinicians. Before being able to do this they would need to obtain the patients express permission. The evidence heard clearly demonstrated that this system was totally ineffective in Debbie’s case, especially so in relation to the supplies of prescription only medication from on-line. It was identified that in relation to the prescription of opiate based drugs on-line that the NHS Business Authority already collates that data for NHS prescribers. However, this information is currently used for statistical purposes only and does not include any prescriptions from third party providers. 2. Evidence was heard from both the CQC and CQC registered on-line pharmacists of the changes that have been made to the way in which the prescription of opiate based medication (including codeine) is now conducted. CQC registered pharmacies should now not supply opiate based medications unless the patient provides permission for them to contact their registered GP. However, those suppliers who do not want to adhere to this requirement are simply changing their business model (primarily by only using prescribing doctors based overseas) and are relinquishing their CQC Regulated status. These prescribers are therefore still able to provide on- line prescription services (including opiate based medication) in the UK but now fall outside the CQC regulation regime. Clearly this is an area of concern as it will continue to allow patients to access uncoordinated quantities of prescription only medication from unregulated on-line suppliers. 3. New guidance from the General Pharmaceutical Council was issued in April 2019 and this includes specific advice regarding on-line prescriptions. This is clearly welcome, however some witnesses highlighted that the guidance is advisory and not mandatory. As such there was some uncertainty as to what sanctions would be available against any supplying pharmacist who chose not to adhere to the new guidance? ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you or your organisation have the power to take such action. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 13 January 2020 I, the Senior Coroner, may extend the period if | consider it reasonable to do so. 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. COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested Persons (see separate addendum for the complete list of Interested Persons). | am 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 Senior Coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. 18" November 2019 y af Nigel Parsley
1 response 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.
age From Nadine Dorries MP Parliamentary Under Secretary of State for Patient Safety, Department Suicide Prevention and Mental Health of Health & 39 Victoria Street ° Lond Social Care SWIH OEU 020 7210 4850 Our Ref: PFD-1197115 Mr Nigel Parsley HM Senior Coroner, Suffolk HM Coroner's Office Beacon House 53-65 Whitehouse Road Ipswich IP1 5PB Zt February 2020 Nev W\v Yous\ay), Thank you for your letter of 18 November 2019 to Matt Hancock about the death of Deborah Michelle Headspeath. | am replying as Minister with responsibility for patient safety and | am grateful for the additional time in which to do so. Firstly, | would like to say how very saddened | was to read the circumstances of Ms Headspeath’s death. | can only imagine how devastating her death must be to those who loved and knew her. Please share my heartfelt condolences with her family and loved ones. While the great majority of medicines prescribed online are done so appropriately and safely, we know there have been cases where a patient has been able to access particular types of medicine, or medicines on a scale that they would not likely be prescribed by their GP and that this has led to serious harm and, very sadly, death. It is deeply concerning that patients are being put at risk in this way and we must do ail we can to prevent future tragedies. The Department is working closely with the Care Quality Commission (CQC) and relevant professional regulators to look at how they can better regulate online prescribers and close the loopholes in legislation that allow a small number of online organisations to operate without the necessary oversight. A UK-wide regulatory forum was established in 2017, chaired by the CQC, to consider the issues around online prescribing and to agree co-ordinated action to address regulatory gaps. The following measures have been taken by members of the forum: e In November 2019, a range of healthcare regulators and organisations, co-authored and agreed principies of good practice in remote consultations and prescribing that are expected of UK regulated healthcare professionals when prescribing medication online’. The principles set out clear responsibilities and expectations for all prescribing healthcare professionals (doctors, nurses, pharmacists, dentists and opticians) and are underpinned by existing standards and guidance from both professional and system regulators. The principles make clear that prescribers of medication are expected to understand how to identify vulnerable patients and take appropriate steps to protect them; carry out checks to ensure medication is safe; and take responsibility for raising concerns when adequate patient safeguards are notin place. Serious or persistent failure to act in accordance with standards of practice within their professions may put at risk a healthcare practitioner's fitness to practice; « Publication in November 2019 by the General Pharmaceutical Council (GPhC) of revised Guidance for Pharmacist Prescribers?, to ensure that they provide safe and effective care when prescribing. This includes further examples of prescribing in different settings and strengthens the guidance in relation to online prescribing of high-risk medicines, such as opioids. The guidance sets out when prescribers should consider if extra safeguards are needed, for example, when prescribing antibiotics online or medicines likely to be abused or misused, such as opioids. Where there is concer that a GPhC registrant is not meeting the required professional standards they may face enforcement action, including removal from the register; and, * Guidance from the General Medical Council (GMC) is available to doctors on remote consultations and prescribing?, as well as advice on good practice*. The GMC is currently seeking the views of its members on remote consultations and prescribing to decide if changes are necessary to its guidance. The call for evidence closes on 18 February 2020. The CQC has inspected all registered online providers and published the findings®. All online providers in England, registered with the CQC, now receive a quality rating following inspection. There is a range of enforcement action that the CQC can take if it identifies that providers are not meeting regulations. | am aware that the CQC, GPhC and the GMC have each taken enforcement action against online prescribers and providers of prescription medicines online, where insufficient safeguards have been put in place or followed, and where checks have not been made to ascertain that the medicines supplied, such as opioids and other high-risk ? hitps:/Awww.pharmacyrequlation.ora/news/qphc-launches-new-quidance-pharmacist-prescribers 3 httos:/Awww.gme-uk. oO . . ; . devices/remote-prescribing-via-telephone-video-link-or-online * httos:/Awww.gmc-uk.ora/ethical-quidance/ethical-hub/remote-consultations medicines, are clinically appropriate. As a result, there are recent examples of providers stopping the prescribing of high-risk medicines or ceasing to operate altogether. In relation to your concern that online providers are changing their business model to circumvent regulatory scrutiny, the Department is working with the CQC and other regulators to understand what the options might be to address this. Where a provider is outside the scope of CQC regulation, oversight might fall to other regulators, namely the GPhC and the Medicines and Healthcare products Regulatory Agency (MHRA), and | am assured that all three regulators are working collaboratively to share information where there are concerns about a provider. | am advised that, at present, there is no single database that prescribers can use to ascertain whether medication is clinically appropriate for a patient, or whether a patient has access to medicines from another source. However, healthcare providers are legally obliged (under section 251(b) of the Health and Social Care Act 20125) to share information about a patient where it will facilitate that patient's care and is in their best interests (there are certain circumstances where this does not apply, for example, if the patient objects to their data being shared). Health professionals must meet the standards set by their professional regulatory body. This includes accurate record keeping and where possible, the sharing of patient information with other health professionals to facilitate patient care. Regulators can take action when expected practice is not met. A number of local initiatives to share patient care records are in place, though it is acknowledged that it will be some time before there is national coverage. Led by NHS England and NHS Improvement, five Local Health and Care Record Exemplars (LHCRE’s’), covering 23.5 million people, are putting in place complete electronic patient records with joined-up IT systems to enable better coordinated and safer care. LHCRE's will enable data to be accessed by doctors, nurses and other health professionals as patients move between different parts of the NHS and social care system. LHCRE’s will improve the monitoring and analysis of population health and inform the commissioning and delivery of services. Public awareness of the risks that can be associated with obtaining medicines online is another key aspect to responding to this patient safety issue. The MHRA has led a number of public awareness campaigns, including a targeted and sustained campaign, #Fakemeds®, which has run online and through social media for maximum coverage. In addition, the GMC ts working with the GPhC and others to develop information for patients on how to stay safe when accessing medication and treatment online. To assist patients to purchase medicines safely online, there is a European wide Distance Selling Logo to help the public identify websites that can legally sell medicines. § http://www legislation.gov.uk/uksi/2015/1470/pdfs/uksiem 20151470 en.odf 7 https://www.england.nhs.uk/publication/local-health-and-care-record-exemplars/ 8 https://fakemeds.campaign.gov.uk/ Under the provisions of the European Falsified Medicines Directive®, all Member States of the European Union (EU) are required to introduce national arrangements to register suppliers of medicines at a distance. For the UK this means that anyone based in the UK, wising to sell medicines online in the UK (or any European Economic Area country), must be registered with the MHRA and display a Distance Selling Logo on pages of the website offering medicines for sale, with a link to the MHRA's website. The MHRA is responsible for managing the UK list of online retailers that have registered to sell medicines to the public remotely. The MHRA routinely monitors medicines being offered for sale on the internet and has taken enforcement action to remove illegally trading websites and to seize products. Overall, this is a complex issue. However, | can provide assurance that the Department is working with healthcare regulatory partners to identify what more can be done to protect the public and improve the safety of the provision of medicines online. Turning to the wider issues raised in your report, you explain that Ms Headspeath had a long-standing dependence on the opioid, codeine. We are very concerned about the recent increase in people addicted to opioid medicines and, in 2017, the Government asked Public Health England (PHE) 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 2019'° and made the following recommendations: e 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; e Enhancing clinical guidance and the likelihood it will be followed; e Improving information for patients and carers on prescribed medicines and other treatments, and increasing informed choice and shared decision making between clinicians and patients; e Improving the support available from the healthcare system for patients experiencing dependence on, or withdrawal from prescribed medicines; and, e Further research on the prevention and treatment of dependence on, and withdrawal from prescribed medicines. 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. ° https://ec.europa.eu/health/human-use/falsified_medicines_en In addition, we asked the National Institute for Health and Care Excellence (NICE) to develop guidance on the safe prescribing of drugs associated with dependence (such as opioids) and the careful management of withdrawing from these drugs"'. NICE is also developing guidance on Chronic pain: assessment and management’. The MHRA is currently undertaking a review of opioid medicines and the risk of addiction and dependence. Following initial recommendations of an Expert Working Group, endorsed by the Commission on Human Medicines, in April 2019, we announced that all opioid medications will carry prominent addiction warnings on their labels. Furthermore, the MHRA is working with stakeholders to better support appropriate use of prescription opioids and provide better guidance and consistent information for healthcare professionals. In addition, a leaflet for patients is expected to be available in the coming months, either directly from pharmacists or online. The MHRA continues to review other regulatory options to respond to concern about overuse or misuse of opioids and it has added the concerns within your report to its Yellow Card Scheme database", to help inform this review. | hope that this response is helpful. Thank you for bringing these concerns to my attention. SPA Nadu NADINE DORRIES 11 https://www.nice.org.uk/guidance/indevelopment/gid-ng10143. 1 https://www.nice.org.uk/auidance/indevelopment/gid-ng10069 13 The Yellow Card Scheme is the UK system for collecting and monitoring information on suspected adverse drug reactions. Its aim is to provide an early waming that the safety of a product may require further investigation.
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