Prevention of Future Deaths reports · 2017
Regulation 28 report to prevent future deaths, reference 2017-0195, written 16 Jun 2017. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 16 Jun 2017 |
|---|---|
| Reference | 2017-0195 |
| Deceased | Aaron McCaffrey |
| Coroner | Rachel Galloway |
| Coroner area | Manchester South |
| Category | Product related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | none published |
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 REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: Medicines and Healthcare Products Regulatory Agency (MHRA) CORONER lam Rachel Galloway, assistant coroner, for the coroner area of South Manchester 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 INVESTIGATION and INQUEST On the 20" January 2017 an investigation was commenced into the death of Aaron John Peter McCafirey. An inquest was opened on the 20" January 2017 and concluded on the 31° May 2017. The medical cause of death was: 1a Hypoxic brain injury b Multiple cardiac arrests c Loperamide overdose The Coroner's Conclusion was: “drug-related” death. CIRCUMSTANCES OF THE DEATH Mr McCaffrey had a history of taking large quantities of loperamide medication. This is a medication that is available “over-the-counter” and is often referred to under the brand name “Imodium”. Mr McCaffrey had a history of addiction to opiate medications, which dated back a number of years. This included addiction to medications such as co- codamol. However, he later developed an addiction to loperamide medication and — the years prior to his death — he was known to regularly take in the region of 150 tablets per day. Mr McCaffrey’s ex-partner explained in evidence that this was the amount that Mr McCaffrey would admit to taking but she suspected that he took more than this on occasion, It was clear that the history of addiction was part of the reason for the relationship breakdown, although EEE remained in close contact with Mr McCaffrey, as they had young children together. Loperamide medication contains a low level of opiate. Mr McCaffrey was known to suffer from anxiety, although he kept any mental health concerns mainly to himself. He ‘ole tht he took large amounts of loperamide medication because it made him feel better. On the 13" January 2017 Mr McCaffrey took in the region of 250 loperamide tablets. He collapsed in the toilets at the Tesco Store in Droylsdon, Manchester and was taken by ambulance to Tameside General Hospital, His condition deteriorated in hospital (despite medical treatment) and he died on the 19" January 2017. The Conclusion was recorded as: “drug-related death”. Mr McCaffrey did not intent to end his own life. His death was an unintended consequence of consuming the large amount of loperamide medication. CORONER'S CONCERNS Ouring 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. — Mr McCaffrey's ex-partner gave evidence that Mr McCaffrey would regularly purchase large quantities of loperamide medication. Following the incident on the 13" January 2017, she counted 250 tablets that had been taken (the empty packets were in the back- pack in his possession). The receipts were also present within the bag. She advised that he had purchased large amounts of this medication from a budget store as well as smaller quantities from a supermarket and a chemist. It was clear that Mr McCaffrey would frequently buy large amounts of this medication from a single store. The concern is that there is no apparent limit on the amount of loperamide medication that can be purchased from a single store. This makes the medication easier to purchase in large quantities. [ am concerned that action should be taken to limit the amount of loperamide medication that can be purchased from a single store, due to the fact that it is apparently being used (on occasion) to fuel addiction and due to the risk of overdose and death. ACTION SHOULD BE TAKEN in my opinion action should be taken to prevent future deaths and | believe you 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 11"° August 2017. |, 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 si ort to the Chief Coroner and to the following Interested Persons: (ex-partner) and [EE (mother of Mr McCaffrey) 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. 16.06.2017
a Medicines & Healthcare products RA Regulating Medicines and Medical Devices. Regulatory Agency H.M.Coroner Manchester South Coroner’s Court . 1 Mount Tabor Street H Cc STOCKPORT. SK1 3AG. MHRA 151 Buckingham Palace Road London SW1W 9SZ United Kingdom 15 August 2017 www.gov.uk/mbra Dear Ms Galloway Regulation 28 Report concerning Aaron John Peter McCaffrey Thank you for your letter of 16 June 2017 in which you asked the MHRA to provide a response to the Regulation 28 Report to Prevent Future Deaths following the inquest into the death of Mr Aaron John Peter McCaffrey. Your report identified one matter of concern which falls within the remit of the MHRA. The concern is that there is no apparent limit on the amount of loperamide medication that can be purchased from a single store. The MHRA as a regulatory agency has a responsibility to ensure that medicines are efficacious and acceptably safe, that guidance on the use of a medicine is appropriately described in the authorised product information (Summary of Product Characteristics for healthcare professionals, labelling and patient information leaflet), and that the legal classification of a medicine is appropriate to the level of professional supervision required for safe access. Loperamide is available as a General Sale List (GSL) medicine and as a Pharmacy medicine under the supervision of a pharmacist. There are no restrictions on the numbers of packs which can be purchased. Pack sizes of up to 12 tablets/capsules are available GSL and larger packs are available in pharmacies. One of the criteria for Prescription Only classification is that a medicine is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health. We do not consider that there is sufficient evidence that this criterion applies to loperamide. We have checked the report of the Advisory Council on Misuse of Drugs on Diversion and Illicit Supply of Medicines (DISM) from December 2016 and this has no mention of loperamide. The DISM report is available following this link: https://www.qov.uk/government/uploads/system/uploads/attachment_data/file/580296/Meds_report- final report 15 December LU 2 .pdf Medicines & Healthcare products Regulatory Agency RA Regulating Medicines and Medical Bevices. In particular, we have reflected on whether restricting the amount which can be purchased would have deterred a determined individual from obtaining such large quantities as in Mr McCaffrey's case. On the evidence available to date, we consider that the benefit of access in retail outlets for those patients who use this medicine responsibly, outweighs the harms which may come to the very small number of individuals who deliberately misuse these medicines. Turing to the medical cause of death, we note that this was hypoxic brain injury, multiple cardiac arrests and loperamide overdose. As part of an EU-wide review the cardiac toxicity of loperamide was assessed in March 2017. The EU Pharmaceutical Risk Assessment Committee (PRAC) considered that there was the potential for loperamide in doses significantly in excess of the maximum therapeutic dose to cause cardiac problems. As a result of that review the product information is being updated for all loperamide-containing products to advise patients not to exceed the labelled dosing instructions along with warning statements about the risk of cardiac effects in overdose. As part of the PRAC update to include the cardiac warnings we are writing to the marketing authorisation holders who have not updated their Summary of Product characteristics (SmPCs) and Patient Information Leaflets (PILs). We will also publish an article in the MHRA’s Drug Safety Update Bulletin to alert healthcare professionals to the risks. We will keep this issue under review and will consider whether any further regulatory action is needed in the light of any new evidence. Yours sincerely, Director VRMM (Vigilance and Risk Management of Medicines) Division T_ 0203 080 6400
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