Prevention of Future Deaths reports · 2014
Regulation 28 report to prevent future deaths, reference 2014-0211, written 9 May 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 9 May 2014 |
|---|---|
| Reference | 2014-0211 |
| Deceased | Akua Anokye-Boateng |
| Coroner | Andrew Harris |
| Coroner area | London Inner (South) |
| 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 THIS REPORT IS BEING SENT TO: (1) Dr lan Hudson, Chief Executive Medicines and Healthcare Products Regulatory Agency (MHRA), 151 Buckingham Palace Road, London SW1W 9SZ : CORONER | am Dr Andrew Harris, Senior Coroner, London Inner South | 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. INQUEST On 23rd January 2013, | opened an inquest into the death of: Miss Akua Anokye-Boateng, aged 7 years, died 16th January 2013, Case Ref: 00154-13. It was concluded on 26th March 2014. The court found that the medical cause of death was: 1a Acute Peritonitis and Shock 1b Perforated Duodenum 1¢ Non steroidal anti-inflammatory (NSAID) ingestion and Helicobacter associated chronic ulceration of duodenum in sickle cell disease CIRCUMSTANCES OF THE DEATH The following narrative was recorded: Akua had weil managed and well controlled sickle cell disease. She suffered a 3 day ifiness, consulting her GP but collapsing suddenly, unresponsive to prompt resuscitation and dying at 19.16 at KCH on 16.01.13. She had ingested a non steroidal anti- inflammatory drug in May 2012 and suffered a GI upset in August. Her death was unrelated to sickle disease and was caused by unexpected duodenal perforation, although chronic and multi-factorial. 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 MATTER OF CONCERN is as follows. — Expert evidence was heard from an experienced academic pathologist that one dose of NSAID was sufficient to damage the G! mucosa in children, which, coupled with a presumed Helicobacter infection, led in this case to the perforation. The consultant paediatrician with responsibility for haemoglobinopathies was unaware of the risk of a single dose in the past and gave evidence that Ibuprofen was an important drug in the management of sickle cell patients, having less side effects than opiates. He reported that it is not current practice to routinely give gastro-intestinal protection when NSAIDs are used briefly in children with sickle disease. Thus it is unclear what is best practice or whether the scientific evidence suggests that guidance is needed for clinicians about further precautions or prevention such as Proton pump inhibitors being routinely used alongside NSAIDs in children, to minimize the risk of similar deaths. 6 | ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe that the general practitioner and medical director have the power to take such action. [7 | YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by Friday 4h July 2014. |, 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. If you require any further informati i the case, please contact the 8 | COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the followi cd Persons: a: °( nt it il consultant haematologist and le ant pathologist, who may find it useful or of interest. | 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. [SIGNED BY COR@GNE
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.
Medicines and Healthcare Products Regulatory Agency Se0 Dr Andrew Harris 151 Buckingham Paiace Road Senior Coroner for Inner London South District London SW1W 9SZ Inner London South Coroner’s Court United Kingdom 1 Tennis Street Southwark mhra.gov.uk London SE11YD Your ref: 154/2013 18 July 2014 Re: Miss Akua Anokye-Boateng (Regulation 28 Report to Prevent Future Deaths) Dear Dr Harris Thank you for your letter dated 9" May 2014 and bringing to my attention the circumstances of the death of Miss Akua Anokye-Boateng (Regulation 28 Report to Prevent Future Deaths). On reading your Prevent Future Deaths (PFD) report | identified two distinct points for MHRA to address. These are: a) the apparent lack of awareness amongst healthcare professionals that there is the potential for serious gastrointestinal toxicity to occur with short-term use of NSAIDs; and b) whether gastrointestinal protective agents should be routinely used alongside NSAIDs in children. The MHRA has sought the advice of its Pharmacovigilance Expert Advisory Group of the Commission on Human Medicines regarding any necessary actions to address these concerns. | set out below the actions. a) Healthcare professional awareness of the potential for serious gastrointestinal toxicity to occur with short-term use of NSAIDs. Following a number of national and Europe-wide reviews of the gastrointestinal safety of NSAIDs, a set of key elements was agreed for inclusion in the Summary of Product Characteristics (SPC) for all non- selective NSAIDs available as prescription only medicines (POM). These key elements include contraindications to use and extensive warnings in relation to the gastrointestinal side effects. MHRA also formulated a set of key elements for inclusion in the SPC for ibuprofen-containing products available in the UK without prescription as Pharmacy (P) or General Sales List (GSL) medicines. | attach a copy of the key elements for POM non-selective NSAIDs and also for P and GSL ibuprofen. These were implemented for all relevant products (including products authorised for use in children) in the UK in 2008. ; 2 CPRD 4: NIBSC Medicines and Healthcare . Products Regulatory Agency eee The SPCs for POM, P and GSL NSAIDs including ibuprofen state the following in section 4.4 (Special warnings and precautions for use): ‘GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.’ The MHRA and its independent experts consider that this statement in the SPC is sufficient to alert readers to the possibility of serious gastrointestinal side effects occurring early in NSAID treatment. However, we acknowledge that healthcare professionals do not always read the SPC before prescribing, particularly when prescribing commonly used medicines, and your report highlights that there are some healthcare professionals who are unaware of this fact. Therefore we propose to inform and remind healthcare professionals about this through an article in the September 2014 issue of our monthly bulletin ‘Drug Safety Update’. b) Should gastroprotective agents be routinely given alongside NSAIDs in children? The SPCs for all POM non-selective NSAIDs include a recommendation to use gastro-protective agents (proton pump inhibitors or misoprostol) when prescribing NSAIDs to those at high risk of gastrointestinal side-effects, as follows: ‘The risk of G! bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and 4.5).’ . This recommendation is also included in the SPCs for POM non-selective NSAIDs authorised for use in children. For non-prescription use of ibuprofen in adults and children, a recommendation for the concurrent use of PPIs is not included in the SPC. For those NSAIDs available over-the-counter, the authorised doses are lower than prescription-only products, and the indications only cover short term self-limiting conditions which do not require diagnosis & supervision by a medical practitioner. Patients (or parents of patients) at high risk of gastrointestinal side effects who purchase ibuprofen as an over-the-counter product are advised in the package leaflet to discuss taking these products with their doctor so that they can be properly advised about the need for gastro-protective medicines to be taken at the same time. After careful consideration of the details of the case presented in your PFD report, the MHRA and its independent experts do not consider that this case changes the overall benefit-risk balance of ibuprofen in children or warrants a change to the current warnings about the need for gastro-protective agents for prescription only medicines. However, for all NSAIDs we will be strengthening the information for patients/parents provided in the package leaflet on the risk and recognition of gastrointestinal side effects and the action they should take. In summary, in response to your report under Regulation 28 to Prevent Future Deaths, concerning the death of Miss Akua Anokye-Boateng, MHRA will take the following action to help minimise risk from the gastrointestinal side-effects of NSAIDs: #8 CPRD ig NIBSC edicines and Healthcare Products Regulatory Agency Proposed action Purpose of proposed action Timeline for action Drug Safety Update (DSU) article (www. mhra.gov.uk/drugsafet yupdate) To remind healthcare professionals of information already included in the SPCs for NSAIDs, that: « the GI side-effects of NSAIDs can be serious and life-threatening. Fatalities have been reported. e serious Gl side-effects can occur with short-term use of NSAIDs e serious Gl side-effects can occur in people who may be considered to be at low risk, including in children Publication in the September 2014 issue of DSU Strengthen the Patient Information for all NSAIDs with regards to GI risk. e To strengthen the NSAID product information provided to patients/parents on the risk. e To aid patient/parent recognition of gastrointestinal side-effects and provide information on the action they should take if symptoms arise Review and implement changes within 12 months. | hope that this response addresses your concerns Yours sincerely Dr lan Hudson Chief Executive, MHRA Telephone: +44 wee 3080 6100 Email: #8 CPRD “## NIBSC
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