Prevention of Future Deaths reports · 2015
Regulation 28 report to prevent future deaths, reference 2015-0402, written 23 Sep 2015. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 23 Sep 2015 |
|---|---|
| Reference | 2015-0402 |
| Deceased | Dorothy Delaney |
| Coroner | Rachael Griffin |
| Coroner area | Manchester (West) |
| Category | Community health care and emergency services related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | none published |
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MEVISI VED 08 NOV 2015 ALEXANDER HOUSE HEALTH CENTRE Dr M Ahmad Platt Bridge Health Centre MBBS DFFP FRCS Rivington Avenue Platt Bridge Dr M Khan Wigan MBBS WN2 S5NG Dr S Patel Tel: 01942 482330 MBBS Fax: 01942 482347 Our Ref: SP /NM 470 411 5909 Your Ref: RCG/NMO/D. Delaney DATE :15 July 2015 Ms Rachael C Griffin Assistant Coroner H M Coroners Court Paderborn House Howell Croft North Bolton BLI 1QY Dear Ms Griffin RE: Mrs Dorothy Delaney DOB 20 Jul 1928 (Deceased) Warwick Drive, Hindley, Wigan, WN2 4DT Thank you for your letter dated 23 September 2015 providing the inquest report on Mrs Dorothy Delaney, and at the same time making us aware of your concerns regarding the combined treatment of anticoagulant like Warfarin with an antiplatelet agent like Aspirin or Clopidogrel. This letter was addressed to my senior Partner — but unfortunately he is on long term sick leave on medical grounds and I did not feel it was appropriate to delay replying about the concerns over the patient’s treatment. Herewith I am providing the details of the steps which were taken following the receipt of your report, and I assure you that a copy of this report will be given to| hen he returns from his illness, and a copy to the Practice Manager for her attention as well. As you mentioned in your inquest report you were concerned with the combined prescribing of antiplatelet with anticoagulant agents and this concern was raised because the Stroke Consultant from Salford Hospital pointed out that it is not standard practice to prescribe this. I was not aware of any particular guidelines or protocol on the matter. Hence at the time of the inquest I provided my contact details to the Consultant from Salford Hospital to forward to me any kind of correspondence, guidelines or protocol he might have which I could look into. To date I have not received any correspondence back from the consultant. Instead of just waiting for the Stroke Consultant from Salford Hospital to return the request to take further action, I decided to approach Salford Hospital myself as well. I have spoken to the Haematology Consultant at Salford explaining the situation and raising my concerns regarding the prescribing of combined anticoagulant and antiplatelet agents. She was of the same opinion as the Stroke Consultant, that it would not be appropriate to prescribe both antiplatelet and anticoagulant agents at the same time. However, at the same time she also pointed out that there a certain group of patients who need to have both treatments and that is usually recommended by the cardiologists, or following a stroke by a Consultant Physician. When I asked for any particular protocol from Salford, or national guidelines she was not able to provide me with any evidence, and she was not aware of any protocol regarding this. According to her it was standard practice, and the doctor usually follows the advice, but she had not come across any particular guidance on this. Furthermore I have approached the local Haematology consultant at Wigan Hospital, as well as the Clinical Director of Medicine Management for Wigan CCG, explaining the same concerns of combined prescribing of the agents and requesting them to provide me with further guidance which I would be able to use to help my patients and avoid any medication errors. I enclose copies of these letters So far I have not had any feedback from the Clinical Director of Medicine Management following my query. At the same time the local Haematology Consultant from Wigan Hospital has kindly provided me with his feedback regarding how to deal with patients in prescribing antiplatelet and anticoagulant agents together. His feedback was really very helpful. According to him a patient on antiplatelet agent and full dose anticoagulation medication is at a very high risk from bleeding and for most patients this is an unnecessary risk, His recommendation was to screen all patients who may be on antiplatelet and anticoagulant therapy to find out if there is any documented reason why they need to be on both. At the same time if you read paragraph three of the report antiplatelet agents are still given to patient who have had a previous stroke, as well as cardiac patients with a stent procedure while they are taking anticoagulants. If you look at the second to last paragraph of the response it said that the responsibility for discontinuing therapy would primarily be with the consultant or the GP. But he did not say it is wholly the total responsibility of the specialist from secondary care to decide whether the patient should be on both agents. This is the opinion of the Haematology Consultant from our local Wigan area. This statement makes me believe that it is not up to the expert to decide combined treatment in every patient who is on both agents. The local Haematology Department is expecting the GP to make that decision as well. J also tried to find NICE guidelines or advice on prescribing anticoagulant with antiplatelet agents. So Sar I have been unable to locate any particular guidelines on this issue. You have kindly pointed out to me the technological appraisal document published in March 2015, advising on this topic, but the technological appraisal guidance means that this is an area which NICE has to look into to provide help with uniform guidance, as there will be variable practice in different parts of the country. The technologic appraisal guidance is not fully implemented NICE guidelines, but they are in the process of being implemented. Herewith I am enclosing technological appraisal guidance issued in March 15, which does suggest to have discussion with patient regarding combined treatment but not giving any advise like combined treatment can’t be given and we need to have expert advise before having combined treatment, In summary, most heath care professionals I have approached for advice on this issue have advised that it is safer to have a single agent, either anticoagulant or antiplatelet, instead of having combined treatment with both agents, but there is no agreed guidance or protocol in place to follow. Although I was not able to find any protocol or guidance on this issue, as I have feedback from our local Haematology Department, I decided to produce a protocol for our practice for future prescribing of anticoagulant with antiplatelet agents. Furthermore I have reviewed all the patients who are on combined treatment. I have looked at their medical records and checked the suitability of the patient to be on both groups of medication. In any patient, if I was not sure , I have liaised with secondary care to clarify the matter ., I felt on reviewing their records, most of the patients could be managed by a singly anticoagulant agent instead of combined treatment, as per our local Haematology guidance. Accordingly I made the necessary changes to prescriptions after having a discussion with each individual patient. Herewith I am including the audit report on the work I have done. T hope this level of work will help to satisfy the concerns following the inquest, and the questions you have raised regarding my medical practice on the prescribing of combined antiplatelet and anticoagulant agents. If you are not satisfied with the outcome pleases feel free to contact me again and I will look into the matter further. Kind regards Yours sincerely MBBS HEE Practice Manager, Alexander House Health Centre. Enc
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. | Senior Partner at Alexander House Health Centre, Platt Bridge Health Centre, Rivington Avenue, Platt Bridge, Wigan CORONER I am Rachael Clare Griffin, Assistant Coroner, for the Coroner Area of Manchester West 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. INVESTIGATION and INQUEST On the 18" June 2015 I commenced an investigation into the death of Dorothy Delaney, born on the 20" July 1928. The investigation concluded at the end of the inquest on the 18" September 2015. The Medical Cause of Death was: 1a Spontaneous Intracerebral Haemorrhage 1b Amyloid Angiopathy 2 Anti Coagulation, Atrial Fibrillation The conclusion of the inquest was that Dorothy Delaney died as a consequence of naturally occurring disease exacerbated by a recognised complication of anticoagulation therapy, in circumstances where antiplatelet medication was prescribed and administered. CIRCUMSTANCES OF THE DEATH At around 10.20 hours on the 11" June 2015 Mrs Dorothy Delaney, who had been prescribed Rivoroxaban, an anticoagulant, following her diagnosis of atrial fibrillation in March 2015, and who was prescribed Clopidogrel, an antiplatelet medication due to previous transient ischaemic attacks, was found in a collapsed condition at her home address at Ash Tree House Care Home, Warwick Drive, Hindley in Wigan. She was transferred to the Salford Royal Hospital, Salford where she was diagnosed as having suffered a large intracerebral haemorrhage. Her condition deteriorated and she died later that day at 13.10 hours. 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 inquest evidence was heard that: vi. Dorothy Delaney became a patient at Alexander House Health Centre, Platt Bridge Health Centre, Rivington Avenue, Platt Bridge, Wigan in August 2013. At that time she was prescribed Clopidogrel, an antiplatelet medication, by her previous general practitioner, due to her history of transient ischaemic attack. This prescription continued to be given by her general practitioner at Alexander House Health Centre up until her death on the 11" June 2015. In March 2015 Mrs Delaney was diagnosed with atrial fibrillation and as a result was prescribed Rivoroxaban, an anticoagulant, by her general practitioner at Alexander House Health Centre, which she continued to take up until her death. The Consultant Neuropathologist gave evidence during the inquest that Mrs Delaney had died as a consequence of a spontaneous intracerebral haemorrhage which had been caused by amyloid angiopathy, which is naturally occurring disease of the vessels within the brain that can cause the vessels to rupture, resulting in haemorrhage. Evidence was given that when a person who suffers from amyloid angiopathy — takes anticoagulation medication there is an enhanced risk of a haemorrhage occurring. The fact that Mrs Delaney was taking Rivoroxaban was determined to be a contributory factor in her death. Evidence was also given that there is an increased risk of bleeding when a person takes both antiplatelet and anticoagulant medication together. The policy adopted at Salford Royal Hospital, Salford is that if a person who is prescribed antiplatelet medication requires anticoagulation therapy, they would discontinue one of the medications, in order to reduce the risk of a haemorrhage, unless there is a specific reason why both should be prescribed at the same time. Guidance provided by the National Institute for Health and Care for oral anticoagulation was referred to during the inquest and this guidance states that if a person is prescribed Rivoroxaban there is an increased risk of bleeding if anti platelet medication, such as Clopidogrel, it is taken at the same time. The Guidance states that the use of both medications should be avoided, except on specialist advice. Following Mrs Delaney’s diagnosis of atrial fibrillation and the subsequent prescription of Rivoroxaban, no specialist advice was sought regarding the appropriateness of continuing to prescribe both Clopidogrel and Rivoroxaban together. Evidence was given at the inquest that advice is not sought on an individual basis for patients at Alexander House Health Centre who are prescribed both Clopidogrel and Rivoroxaban as they rely on advice previously sought in respect of other patients in similar circumstances. 2. I therefore have concerns that there are patients under the care of Alexander House Health Centre who are being prescribed both anticoagulation therapy and antiplatelet medication at the same time, which increases the risk of a haemorrhage occurring, in circumstances where specialist advice has not been sought, taking into account the individual patient’s previous medical history and circumstances. 3. I therefore request review the treatment of all patients in his practice who are being treated with Clopidogrel, or any other antiplatelet medication at the same time as Rivoroxaban, or any other anticoagulation medication, having regard to the NICE guidelines in relation to oral anticoagulation. ACTION SHOULD BE TAKEN In my opinion urgent action should be taken to prevent future deaths and I believe you and/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, 18" November 2015. 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. COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons: oii” Dorothy Delaney’s son on behalf of the family (2) Wigan Borough Clinical Commissioning Group, Wigan Life Centre, College Avenue, Wigan, WN1i 1NJ 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. 23" September 2015 Rachael C Griffin
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