Prevention of Future Deaths reports · 2022
Regulation 28 report to prevent future deaths, reference 2022-0125, written 25 Apr 2022. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 25 Apr 2022 |
|---|---|
| Reference | 2022-0125 |
| Deceased | Edward Capovila |
| Coroner | Kirsty Gomersal |
| Coroner area | County of Cumbria |
| Category | Alcohol, drug and medication related deaths · Product related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
KALLY CHEEMA SENIOR CORONER County of Cumbria Fairfield Station Rd Cockermouth, CA13 9PT Email hmcoroner@cumbria.gov.uk REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY 1 CORONER I am Miss Kirsty Gomersal Area Coroner for County of Cumbria 2 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: https://www.legislation.gov.uk/ukpga/2009/25/contents http://www.legislation.gov.uk/uksi/2013/1629/contents 3 INVESTIGATION and INQUEST On 3 November 2020, Dr Nicholas Shaw (Assistant Coroner) commenced an investigation into the death of Edward Jorge CAPOVILA who was known as Eddy. Eddy’s inquest was opened on 15 March 2021 and concluded on 22 April 2022 following a two-day hearing before me. The medical cause of Eddy’s death was: 1a Multi-drug toxicity II Hepatic steatosis The determination was: Mr Edward Jorge Capovila (who was known as Eddy) died on 30 October 2020 at in Barrow-in-Furness as the result of the combined toxic effect of prescribed medication. In administering that medication, Eddy did not intend to harm himself or take his own life. Eddy was prescribed nitrazepam, pregabalin and fentanyl (as transdermal patches). Nitrazepam metabolite was present in post-mortem blood but it could not be determined if levels were therapeutic or excessive. Pregabalin was found at 3.6 mg/l which is consistent with therapeutic use. Fentanyl was present at 6.3 μg/l. These medications are central nervous system depressants which have an additive effect when used together. No fentanyl patches were found on Eddy's body. On balance, Eddy has administered fentanyl by heating and inhaling it. The conclusion of the inquest was: Death by misadventure. 4 CIRCUMSTANCES OF THE DEATH I found that, on the balance of probabilities, Eddy had administered himself fentanyl by heating and inhaling it. It could not be determined how many patches Eddy had used as none were located on his body or in the house. Eddy had chronic pain which required strong painkilling medication i.e. fentanyl. He had also been known to use drugs and had demonstrated drug seeking behaviour. The inquest heard that the amount of fentanyl in a transdermal patch needs to be higher than that taken transdermally. For instance, the patches prescribed to Eddy required 2.7mg fentanyl to release 37.5 μg/hr hour over 72 hours. However, each patch contains 6.3mg fentanyl to maintain the concentration gradient. Even a “used” fentanyl patch therefore contains significant amounts of fentanyl that could be misused. Evidence was heard about the steps taken following Eddy’s death. Part of the wider learning was to increase awareness (at local Trust level) of how fentanyl can be abused / misused other than by the application of excess fentanyl patches. The inquest heard that there is relatively little information available about the other ways in which fentanyl can be abused. It is known that heating a fentanyl patch can increase the rate at which fentanyl is dispensed; hence the warnings not to wear patches in a hot bath, for example. Applying a direct heat source onto a patch can release fentanyl so that it can be abused – such as by inhalation (as in Eddy’s case). I was told of other means by which released fentanyl can be abused. Given the amounts of fentanyl that remain even in a used patch, a potentially lethal dose of fentanyl can be released for misuse. 5 CORONER’S CONCERNS 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: As indicated above, I was told that there is relatively little information available about the more unusual ways in which fentanyl can be misused or abused. Given the potential for fentanyl to be misused, as evidenced in Eddy’s inquest, I have concern that further deaths may occur in future if action is not taken. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe the MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY has 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 20 June 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. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons: Eddy’s parents. Eddy’s sister. Lancashire and Cumbria NHS Foundation Trust. University Hospitals of Morecambe Bay NHS Foundation Trust. I have also sent a copy to Bridgegate Medical Centre, Eddy’s GP, for information. 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. 9 25 April 2022 Miss Kirsty J Gomersal HM Area Coroner County of Cumbria
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.
Miss Kirsty Gomersal Area Coroner for the County of Cumbria By email: Reference: CSC 97973 20th June 2022 10 South Colonnade Canary Wharf London E14 4PU United Kingdom Dear Miss Gomersal, Report to Prevent Future deaths - Edward Jorge Capovila I am writing in response to the Regulation 28 Report concerning the tragic death of Mr Edward Capovila from overdose, likely from the inhalation of from prescribed patches. It may be helpful to first outline the role of the MHRA, which is to monitor the safety of all medicines to ensure that up-to-date information on the benefits and risks of a medicine is available for healthcare professionals and patients. The authorised 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. The MHRA became aware that if a patch is exposed to heat, it will increase the speed at which the fentanyl is absorbed into the body and therefore the patient is likely to be exposed to a higher initial dose than prescribed. In December 2014, the MHRA issued a drug safety bulletin1 warning healthcare professionals and patients of the risk of overdose and death with exposure of the increased heat including the instruction that the patch should not be cut. patch to In 2019 the MHRA undertook a review of the benefits and risks for all treatment of non-cancer pain and risks associated with dependence and addiction and sought the Expert Working Group of the Commission on Human Medicines, the MHRA’s advice of an advisory body. The Expert Working Group considered the benefit-risk profile of -containing medicines and made recommendations for regulatory action to better support appropriate use of prescription patients and healthcare professionals of the risks of dependence, addiction, tolerance, withdrawal reactions, and risks of neonatal abstinence syndrome during pregnancy. , with educational initiatives to increase the awareness of both medicines in the including Following this review, in April 2019, warnings were added to the packaging of all that the medicine contains an opioid and the risk of addiction. This information was relayed to the public through several media outlets including the Guardian2 and BBC news3. In 2020, additional to highlight 1 warnings about the risk of addiction were included in the Summary of Product Characteristics for healthcare professionals and in the patient information leaflets. Further to this action, an article was published in the MHRA’s drug safety bulletin, Drug Safety Update (DSU) on 23 September 20204 highlighting the risk of addiction with could be fatal. An additional patient leaflet that is linked to the DSU article was recently updated in August 2021 following user-testing to ensure that patients understood the messages. containing medicines and the potential for overdose which We are aware that fentanyl is available illicitly in several different forms. The MHRA works closely with other regulators and has highlighted this case to the Advisory Council on the Misuse of Drugs (ACMD). The ACMD undertook a review in 2020 on the misuse of analogues. The ACMD found that poison centre telephone enquiries of the misuse of is uncommon and prescribing had decreased between 2016 and 20185. patches and patches We note that Mr Capovila was also prescribed warning is included within the product information for of a high risk of respiratory depression and an increased risk of opioid-related death when taken concomitantly with an ). A concomitantly with any central nervous system (CNS) depressant or sedative, like . . A similar warning is included within the product information for opioids when used The product information for all of concomitant administration of clearly stated with the risk of coma or death. This action is being taken to ensure that all relevant product information is consistent. licences is currently being updated to ensure that the warning as further examples of CNS depressants is We continue to monitor the benefits and risks of opioid containing medicines and will take further prompt regulatory action when required. Yours sincerely, Chief Executive Medicines and Healthcare products Regulatory Agency E
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