Prevention of Future Deaths reports · 2022
Regulation 28 report to prevent future deaths, reference 2022-0071, written 7 Mar 2022. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 7 Mar 2022 |
|---|---|
| Reference | 2022-0071 |
| Deceased | Jane Allison |
| Coroner | Crispin Oliver |
| Coroner area | County Durham and Darlington |
| Category | Community health care · Alcohol, drug and medication related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 4 |
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Regulation 28: REPORT TO PREVENT FUTURE DEATHS NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: And University Medical Group Chief Executive, Royal Pharmaceutical Society Chief Executive, National Institute For Heath Care Excellence Iam Crispin OLIVER, Assistant Coroner for the coroner area of County Durham and 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 02 December 2021 I commenced an investigation into the death of Jane Elizabeth ALLISON aged 84. The investigation concluded at the end of the inquest on 01 March 2022. The conclusion of the inquest was that: Died at University of North Durham on 20th November 2021. She had been admitted to the hospital on 11th November. She had been started on the nitrofurantoin for a UTI on 28th October. This is a conventional medication. She had a total course of 10 days. There were telephone consultations with her GP on Sth and 10th November. She suffered side effects of the medication but respiratory problems were not reported or noted. On 11th November she was discovered to be suffering from catastrophic pulmonary damage. CIRCUMSTANCES OF THE DEATH Jane passed away in hospital after being admitted on 11th November 2021 with severe During the course of the investigation my inquiries 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 are as follows: (brief summary of matters of concern) The Cause of Death was 1)3) Acute Pulmona Hi-fi ha ee ar ag cl patie i a was 2 narrative one, that she “died from the effects of prescribed medication”. The following, I acknowledge: that Nitrofurantoin is a well established medication with a long history of proven efficacy; deaths associated arising from side effects are very rare; the drug BNF content published by NICE does include in the listed side effects pulmonary and respiratory issues; likewise the BNF content does say that that in relation to monitoring of therapy ..monitor for pulmonary symptoms, especially i g function)”. All this said, Jane was aged 28 — After Inquest Document Template Updated 30/07/2021 84. She was he was fit and active for her age, but this has the effect of heightening my concerns, as that fact that she had no relevant co-morbidities. Also the course of treatment of the drug in this instance was not long, being 10 days in total, after which she died as a consequence of catastrophic pulmonary failure. Her GP, while reporting that Jane never informed her of any breathing difficulties when she consulted with her, also said that she had simply been following BNF content advice on this medication. In effect, my concern is that the BNF content had not advised to be alert to the danger of sudden pulmonary deterioration in an elderly patient, and certainly not one who was fit and active, and not in the context of the duration of a prescribing, dispensing and administration period of only 10 days. Effectively, the BNF content did not cover the eventuality of this case in that it was deficient in providing advice as to monitoring and being alert for pulmonary failure. For the avoidance of doubt, I am including the GP medical centre as a recipient of my concerns as clinicians there may concur with them, albeit the extent of their reaction to this death has been limited to peer group review and advice limited to within that medical practice. ACTION SHOULD BE TAKEN In my opinion 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, namely by May 02, 2022. 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. Other action i: ed. "s ‘COPIES and PUBLICATION I have sent 2 copy of my report to the Chief Coroner and to the following Interested Persons T have also sent it to 0} EE ciaypath and university Medical Group who may find it useful or of interest. Tam also under a duty to send a copy of your response to the Chief Coroner and all interested persons who in my opinion should receive it. I may also send a copy of your response to any person who I believe may find it useful or of interest. 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.
4 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.
MM/JS/54992) 2 April am wri On furtk action p een ane “eee Hd Elvet Durham Dill 3IX me Gh 0191 1894 019 022 nfidential Madam Mirs Jane Allison DOR g7. 024 ting in response to your Regulation 28 Report ler discussion with practice partners and colleagues we have come up with the following lan An email has been sent to all prescribing clinicians alerting them to the rare but significant and potential life threatening side effects of nitrofurantoin causing acute breathlessness and the need to advise patients to promptly report such symptoms, We will discuss this further in our next Significant Event Analysis Meeting We are also looking into our information technalogy to help us give written information to te patients about the side effects of this medication One of our partners has agreed to write to the Local Medicine Management Team highlighting this life threatening side effect and expecting possible changes to the local guidelines 'f you do need any further information please don’t hesitate to contact us. Many th anks Yours sincerely Dr
Mr. Crispin Oliver Assistant Coroner for County Durham and Darlington H.M. Coroners Office P.O. Box 282 Bishop Auckland Co. Durham DL14 4FY MHRA 10 South Colonnade Canary Wharf London E14 4PU www.gov.uk/mhra 18 July 2022 Dear Mr Oliver, Regulation 28 Report concerning Jane Elizabeth Allison (nitrofurantoin) Thank you for your email dated 14th April 2022, in which you asked the Medicines and Healthcare products Regulatory Agency (MHRA) to provide a response to the Regulation 28 Report to Prevent Future Deaths following the inquest into the sad death of Ms Jane Elizabeth Allison. Your report identified a number of matters of concern, including the following points relating to information available for healthcare professionals about the potential pulmonary side effects of nitrofurantoin: 1. The patient died of acute pulmonary damage following the administration of nitrofurantoin for a urinary tract infection (course of treatment 10 days), however the BNF does not advise healthcare professionals to be alert to the danger of sudden pulmonary deterioration in elderly patients. 2. The BNF is deficient in providing advice as to monitoring and being alert for acute pulmonary damage. If the patient or her GP had been aware of this possible side effect, they might have been able to intervene earlier to avoid her death. 3. The information sent out with nitrofurantoin should be reviewed. The MHRA is the executive agency of the Department of Health and Social Care (DHSC) with responsibility for the regulation of medicinal products in the UK. The MHRA ensures that medicines are efficacious and acceptably safe, and that any possible side effects which have been recognised to occur with use of a medicine are appropriately described in the authorised product information. This comprises the Summary of Product Characteristics (SmPC, intended for healthcare professionals), labelling, and Patient Information Leaflet (PIL, provided to patients in each medicine pack). As you have noted, the product information for nitrofurantoin does list pulmonary and respiratory issues as possible side effects. We have conducted a review of the available evidence concerning nitrofurantoin and pulmonary adverse drug reactions and sought expert advice from the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines on the strength of the evidence and whether the nitrofurantoin product information should be further amended. As you will be aware, nitrofurantoin has been widely used in the UK since the 1950s for the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures. Aside from Ms Allison’s case, as of 10th May 2022, we have received a small number of other fatal Yellow Card reports of nitrofurantoin and respiratory failure, with other durations of use. Some of these cases offer possible alternative explanations for the events, either due to the patient’s previous medical history or concomitant medications that are themselves associated with respiratory reactions. The PEAG agreed that pulmonary adverse reactions in patients taking nitrofurantoin are generally well known and that the frequency of these events appears low. Furthermore, there are no significant new data on the risk considering the cumulative exposure to this drug in the UK which is likely to be in the order of millions of people. It was agreed that awareness amongst healthcare professionals and patients should be improved so they are alert for any new breathing symptoms when taking nitrofurantoin. Action being taken by the MHRA In summary, we have considered the available evidence on nitrofurantoin and acute pulmonary reactions and, based on expert advice from the PEAG, will request that Marketing Authorisation Holders (MAHs) strengthen the wording in the UK Summary of Product Information (SmPC) and Patient Information Leaflet (PIL). We are aware that the BNF, which is not the responsibility of the MHRA, has recently updated the nitrofurantoin monograph. These updates, adding additional information on acute pulmonary reactions, are in line with the current UK SmPC and PIL. The MHRA will communicate any SmPC and PIL updates, to the BNF, so that they can further revise their monograph as needed. Companies marketing nitrofurantoin will be requested to emphasise to healthcare professionals and patients/carers in the nitrofurantoin product information the need to be vigilant for respiratory symptoms including during use to treat acute urinary tract infections, and to ensure that these warnings are sufficiently prominent. The PEAG also agreed that it would be appropriate to communicate to UK healthcare professionals to inform them of these updates and remind them of the potential for pulmonary and chronic adverse drug reactions in association with nitrofurantoin, and that any such symptoms should be investigated and reported promptly. The PEAG considered that an article in the MHRA’s monthly ‘Drug Safety Update’ bulletin may be an appropriate method to communicate these messages, and we will be taking this forward. We will continue to keep the issue of nitrofurantoin and acute pulmonary reactions under close review, and we will let you know when the product information updates are complete and the Drug Safety Update Bulletin has been issued. Yours sincerely Chief Executive Medicines and Healthcare products Regulatory Agency
2nd Floor 2 Redmond Place London E20 1JQ United Kingdom 22 March 2022 Mr Crispin Oliver Assistant Coroner for County Durham and Darlington H.M. Coroners Office P.O. Box 282 Bishop Auckland Co. Durham DL14 4FY Dear Mr Oliver, I write in response to your correspondence, sent to NICE on 7 March 2022, regarding the very sad death of Jane Allison. I would like to offer my sincere condolences to Jane’s family. We have reflected on the circumstances surrounding Ms Allison’s death, and the concerns raised in your report regarding the British National Formulary (BNF) entry for nitrofurantoin. The BNF is a joint publication of BMJ Group and Pharmaceutical Press, the publishing division of the Royal Pharmaceutical Society. While we make the BNF available on the NICE website, responsibility for the content remains with the publishers and therefore NICE cannot comment on the concerns you have raised. I am aware that your report has also been sent to the chief executive of the Royal Pharmaceutical Society who will be better placed to respond to your concerns. You may also wish to contact the Medicines and Healthcare products Regulator Authority (MHRA) with respect to the summary of product characteristics for nitrofurantoin. Yours sincerely, Dr Chief executive
BNF Publications bnf.org ________________________________________________________________________________ Mr Crispin Oliver H.M. Coroners Office PO Box 282 Bishop Auckland Co Durham DL14 4FY 23rd March 2022 Dear Mr Oliver, We write in response to your Regulation 28 report dated 7th March 2021 which was forwarded to us as the Publisher of the British National Formulary. We are sorry to hear the sad circumstances surrounding this case. We have reviewed the BNF content for nitrofurantoin in response to your report and can confirm that we will add additional information regarding acute pulmonary reactions to the nitrofurantoin monograph in the BNF. To increase awareness of this side-effect, we will highlight it specifically in an additional section of the side-effects information. We will also add information on the importance of counselling patients on the possible symptoms of acute pulmonary reactions and the necessity of promptly reporting such symptoms. This will mean that the risk of acute pulmonary reactions will be highlighted in the nitrofurantoin monograph in future. We trust that this addresses this important issue. Yours sincerely, Associate Content Director (BNF Publications) ________________________________________________________________________________ Royal Pharmaceutical Society 66-68 East Smithfield, London E1W 1AW
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