Prevention of Future Deaths reports · 2018
Regulation 28 report to prevent future deaths, reference 2018-0272, written 8 Aug 2018. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 8 Aug 2018 |
|---|---|
| Reference | 2018-0272 |
| Deceased | Ian Wolstenholme |
| Coroner | Lisa Hashmi |
| Coroner area | Manchester North |
| Category | Alcohol, drug and medication related deaths · Community health care and emergency services 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: 1. Department of Health, London 2. Medicines and Healthcare Regulatory Agency, London CORONER tam Ms L J Hashmi, Area Coroner for the Coroner area of Manchester North. CORONER’S LEGAL POWERS | make this report under paragraph 7, Schedule 5, of the Coroner's and Justice Act 2009 and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. INVESTIGATION and INQUEST | On the 21*' December 20171 commenced an investigation into the death of lan Paul Wolstenholme, concluding by way of inquest on the 6" August 2018. CIRCUMSTANCES OF DEATH Against a backdrop of pre-existing co-morbidities (including Diabetes Mellitus and associated neuropathy), chronic alcoholism and a history of heroin addiction (under long-term treatment), the deceased was found in a collapsed state at his home address on the 17" December 2017. Emergency services were summoned. Paramedics confirmed the fact of the deceased's death later the same day. The deceased had a complex medical history and was prescribed a significant number of medications (polypharmacy), all of which were clinically indicated and prescribed with caution. At the time of his death the deceased remained under review by secondary care Diabetologists and the substance misuse service. His GP’s involvement in the management and review of his medication was therefore minimal. Whilst clinicians were of the overall view that the deceased was compliant with his medication regime, the evidence suggested that he tended to hoard some medication yet take others as prescribed. The police investigation identified large amount of medication at the deceased's home address, including 112 unused bottles of Methadone. Whilst the deceased was on balance, afforded some degree of tolerance, his variable compliance had a material bearing upon this. Furthermore the presence of liver cirrhosis identified at post mortem examination, more likely than not, impacted upon his ability to metabolise medication resulting in a degree of accumulation. The combination of the drugs identified by way of toxicological analysis brought about a respiratory depressant effect, resulting in the deceased’s death. There was no evidence to suggest that the deceased deliberately took any of his medication to excess, with the intent to harm himself. The medical cause of death was: 1a) Combined drug toxicity (Codeine, Morphine, Pregabalin, Methadone) te) 2) Liver cirrhosis, Diabetes Mellitus My Conclusion was: ‘Drug related death to which natural, pre-existing co-morbidities more than minimally contributed’. 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. The MATTERS OF CONCERN are as follows:- 1. During the course of the evidence, it became apparent that there is no guidance — national or otherwise - available to Clinicians such as GPs, Hospital doctors etc. on the how best to approach the prescribing of highly addictive and potentially very harmful drugs alongside one another. In this case, the deceased had been legitimately prescribed three different types of neuropathic analgesia (including Pregabalin), alongside other opiate based medications. Whilst such drugs are almost always prescribed for very good clinical reason/s, this type of polypharmacy gives rise to the potential risk of serious harm/death. | believe that guidance would help to prevent future deaths from combined drug toxicity. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe each of you respectively 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 3" October 2018. 1, 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. COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested Persons namely:- The deceased's family Bury/Rochdale Oldham CCGs NHS England Public Health England Royal Pharmaceutical Society Royal College of Physicians Royal College of General Practitioners MIDAS (Drugs & Alcohol) (sent to all the above for information purposes only) lam 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 from. 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. 8" August 2018 Signed: Fra eae SN <r”
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.
y) be From the Lord O'Shaughnessy Parliamentary Under Secretary of State for Health (Lords) Department of Health Our reference: PFD 1144474 39 Victoria Street, Ms L J Hashmi Pare HM Area Coroner, Manchester North Coroner’s Service, Tel: 020 7210 4850 Phoenix Centre L/Cpl Stephen Shaw MC Way (formerly Church Street) Heywood, OL10 1LR 02 OCT 2018 Dear Ms Hashmi Thank you for your letter of 8 August to the Department of Health and Social Care about the death of Mr Ian Paul Wolstenholme. I am responding as Minister with portfolio responsibility for medicines and I am grateful for the additional time in which to do so. I was extremely saddened to read of the circumstances surrounding Mr Wolstenholme’s death. If you have the opportunity, please convey my sympathies to his family. I have noted carefully the matters of concern identified in your report. My officials have made enquiries with the Medicines and Healthcare products Regulatory Agency (MHRA), to which you also issued your report. Please accept this response on behalf of the MHRA. The MHRA monitors the safety of medicines and endeavours to ensure that up-to- date information on the benefits and risks of a medicine is available for healthcare professionals and patients. The Summary of Product Characteristics (SmPC) for a medicine provides information for healthcare professionals about the medicine, including warnings and precautions of use in higher risk situations. The same information is provided to patients in a patient information leaflet, which is written in language that can be understood by the lay person and accompanies each medicine. Codeine is a weak opioid which is available in pharmacies under the supervision of a pharmacist or by prescription. Morphine is a prescription only medicine indicated for the treatment of severe pain. Pregabalin is indicated for neuropathic pain, epilepsy and generalised anxiety disorder, whilst methadone is indicated for the treatment of opioid addiction. Each of these drugs carry a risk of dependence, addiction and tolerance. The SmPC for each medicine (codeine, pregabalin and methadone), contain warnings concerning interactions with other medicines and advises healthcare professionals and patients that concomitant use of central nervous system depressants, can increase the risk of side effects. The SmPC and leaflet provides guidance for healthcare professionals and patients on dose control and advises that cessation of treatment should be undertaken gradually over a period of time. The MHRA endeavours to ensure that the patient information leaflet and labelling have clear and understandable information for patients and carers with clear direction to seek medical advice in the event of adverse reactions suggestive of tolerance, sedation or respiratory depression. You will be interested to note that the MHRA is currently undertaking a review of the product information for all opioid medicines and will be seeking the advice of an Expert Working Group of the Commission on Human Medicines. The Expert Working Group will consider the benefit risk of opioid-containing medicines and make recommendations for regulatory action to better support appropriate use of prescription opioids, including educational initiatives to ensure awareness of risks for both patients and healthcare professionals. In addition, the information in your report relating to the medicines involved in Mr Wolstenholme’s death has been added to the MHRA’s Yellow Card database that collates suspected adverse drug reactions to help monitor medicine safety (reference ADR 24340935). My officials also sought the advice of the National Institute for Health and Care Excellence (NICE) on the matters of concern in your report. NICE advises that it has issued a guideline on ‘Mutltimorbidity: clinical assessment and management "' (NG56), and a guideline on ‘Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes’? (NGS). NICE has also published a key therapeutic topic on ‘Multimorbidity and polypharmacy” (KTT18). The guideline on multimorbidity (NG56) includes the following recommendations: 1.3.2 Consider using a validated tool such as eF'l, PEONY or QAdmissions, if available in primary care electronic health records, to identify adults with multimorbidity who are at risk of adverse events such as unplanned hospital admission or admission to care homes. 1.3.5 Consider an approach to care that takes account of multimorbidity for adults of any age who: ' https://www.nice,org.uk/guidance/ng56/chapter/Recommendations * https://www,nice,org.uk/guidance/ng5 3 https://www.nice.org.uk/advice/ktt18 Department of Health ° are prescribed 10 to 14 regular medicines e are prescribed fewer than 10 regular medicines but are at particular risk of adverse events Establish treatment burden by talking to people about how treatments for their health problems affect their day-to-day life, including the number and type of medicines a person is taking and how often, and any harms from medicines. I am advised that NICE agrees that there is currently no guidance, national or otherwise, available to clinicians specifically on how best to approach the prescribing of highly addictive and potentially harmful drugs alongside one another, However, I can confirm that NICE has been commissioned to produce guidance on safe prescribing and withdrawal management of prescribed drugs associated with dependence and withdrawal. This work is due to start in early 2019. I hope this information is helpful. Thank you for bringing your concerns to our attention. JAMES O’SHAUGHNESSY
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