Prevention of Future Deaths reports · 2022
Regulation 28 report to prevent future deaths, reference 2023-0005, written 30 Dec 2022. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 30 Dec 2022 |
|---|---|
| Reference | 2023-0005 |
| Deceased | Gavin Pedleham |
| Coroner | Caroline Topping |
| Coroner area | Surrey |
| Category | Alcohol, drug and medication related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
IN THE SURREY CORONER’S COURT IN THE MATTER OF: GAVIN PETER PEDLEHAM __________________________________________________________ The Inquest Touching the Death of Gavin Peter Pedleham A Regulation 28 Report – Action to Prevent Future Deaths __________________________________________________________ THIS REPORT IS BEING SENT TO: • • • , Chief Executive of the National Institute for Health Care Excellence CBE Chief Executive of the Medicines and Healthcare Products Regulatory Agency The Right Honourable Suella Braverman KC MP Secretary of State for the Home Office • CORONER 1 Caroline Topping HM Assistant Coroner, for the County of Surrey 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. 3 INVESTIGATION and INQUEST The inquest was opened on the 12th May 2022 and resumed and concluded before a Coroner on the 9th December 2022. The cause of death was Morphine and Ethanol Toxicity The Coroner found that Gavin Peter Pedleham inadvertently drank a dose of oramorph at a family Christmas event which, in combination with the alcohol he had consumed, led to his death at home at 45, Hurst Green Road, Oxted on the 26th December 2021. The Conclusion was that he met his death by Accident. 4. CIRCUMSTANCES OF THE DEATH Gavin was present at a family Christmas party on the 25th December 2021. One of the guests present at the party suffered from chronic back pain for which he was prescribed, inter alia, oramorph, on a PRN basis. This was prescribed in accordance with national guidelines at 300ml dispensed on a monthly basis. The oramorph was taken to the party for the guest to use for pain relief. It was placed in the kitchen and drunk from a glass. A dose inadvertently left in the glass. Gavin, who had consumed a significant quantity of alcohol, drank it by mistake. The following morning, he was found dead on the sofa. poured out and The conclusion was that Gavin met his death by accident. 5 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 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. – The evidence showed that: 1. Oramorph is a controlled drug the storage, handling and administration of which in institutional settings is highly regulated. However, there are no similar regulations which govern its use in a community setting. There is no requirement for the recipient of the drug in the community to keep it in a safe place and ensure that it cannot be accessed by others. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe your organisation 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 24th February 2023. 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 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 Signed: Caroline Topping Dated this 30th December 2022.
3 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.
Rt Hon Chris Philp MP Minister of State for Crime, Policing and Fire 2 Marsham Street London SW1P 4DF www.gov.uk/home-office Home Office Caroline Topping, HM Coroner for Surrey HM Coroner’s Court Station Approach Woking Surrey GU22 7AP 13 February 2023 Dear Ms Topping, INQUEST INTO THE DEATH OF GAVIN PETER PENDLEMAN: REGULATION 28 REPORT Thank you for your report of 30 December 2022, following the inquest into the tragic death of Gavin Peter Pedieham, which was forwarded to the Home Office on 6 January. Mr Pedleham inadvertently consumed liquid morphine (under the brand name “oramorph”) prescribed to another after having consumed alcohol, and the report suggests that action should be taken to place regulatory duties on the storage, handling and use of oral morphine once prescribed. | am replying as the Minister of State for Crime, Policing and Fire with responsibility for regulations under the Misuse of Drugs Act 1971, including the Misuse of Drugs Regulations 2001 (“the 2001 Regulations”). In considering the report, the Home Office has sought views from the Department for Health and Social Care, which has responsibility for medicines policy. | consider that appropriate measures to reduce the risk of accidents like this from happening are already in place. Prescribers and dispensing pharmacists are obligated to provide advice to patients or carers on what the medicines are and how they should be taken, including any risks and information on drug interactions. This advice is also a statutory requirement in the patient information leaflet provided with licensed medicines, which for oramorph includes that alcohol should be avoided whilst taking this medicine. As the report mentions, the 2001 Regulations make controlled drugs available in healthcare, and impose administrative obligations and requirements to mitigate risks of harm, misuse and diversion of controlled drugs. Before making decisions on the appropriate safeguards under the 2001 Regulations, Ministers take expert advice from the Advisory Council on the Misuse of Drugs (ACMD). Liquid morphine in this form is placed in Schedule 5 to the 2001 Regulations. Extending the legal requirements applicable in healthcare, for example, those requiring safe custody, to patients would risk criminalising patients lawfully prescribed a controlled drug, and potentially put in place barriers to legitimate and timely access to pain relief. Therefore, | have no plans at present to consider additional controls on oral morphine. However, drugs controls are kept under review, and should further evidence emerge indicating the need for additional controls | will consider whether it is appropriate to seek advice from the ACMD. Yours sincerely, Rt Hon Chris Philp MP
10 South Colonnade Canary Wharf London E14 4PU United Kingdom gov.uk/mhra Ms Caroline Topping HM Coroner for the County of Surrey 27 February 2023 Dear Ms Topping, Report to Prevent Future deaths - Gavin Peter Pedleham Thank you for your report dated 30 December 2022 which was received on 10 January 2023. I would like to offer my sincere condolences to Mr Pedleham’s family on their tragic loss. The MHRA monitors 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 Summary of Product Characteristics (SmPC) for a medicine provides information for healthcare professionals (HCPs) 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. However, this tragic event did not occur to a patient but to an unintended recipient, therefore, will not have seen the product information. In 2019 we undertook a review of the benefits and risks for all opioid medicines in the treatment of non-cancer pain and risks associated with dependence and addiction and sought the advice of an Opioid Expert Working Group of the Commission on Human Medicines, the MHRA’s advisory body. The Expert Working Group considered the positive benefit-risk profile of opioid-containing medicines and made recommendations for regulatory action to better support appropriate use of prescription opioids including morphine oral solutions like Oramorph. An investigation into the potential for accidental exposure and accidental overdose has been undertaken. Oramorph oral solution contains morphine in strengths of either 10mg/ml or 20mg/ml. The patient information leaflet and labels include clear guidance on the correct use of Oramorph. The leaflet states: This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. The leaflet highlights that the oral solution should not be taken with alcohol. If it is diluted in a soft drink, then it should be consumed immediately. This was a tragic accident which was not circumvented by the warnings and guidance clearly present in the product information. However, it is evident that the glass containing Oramorph was left unattended. Therefore, we will work with the Marketing Authorisation holders to update the product information to highlight the need to keep the medicine in a secure place and not leave any diluted Oramorph unattended. We continually monitor for accidental deaths of opioid containing medicines and will take further prompt regulatory action when necessary. Should you have any further questions, I should be pleased to assist. Yours sincerely, Chief Executive Medicines and Healthcare products Regulatory Agency
2nd Floor
2 Redman Place
London
E20 1JQ
United Kingdom
17 February 2023
Caroline Topping
HM Assistant Coroner
HM Coroner’s Court
Station Approach
Woking
Surrey
GU22 7AP
Dear Ms Topping,
I write in response to your regulation 28 report of 30 December 2022 regarding the
very sad death of Mr Gavin Peter Pedleham. I would like to express my sincere
condolences to Mr Pedleham’s family.
Having reviewed your report, and the circumstances surrounding Mr Pedleham’s
death, we believe our guideline on controlled drugs: safe use and management
[NG46] is directly relevant to this case. The scope of this guideline covers all
settings, including people's own homes, where publicly funded health and social care
is delivered. It was developed in line with UK controlled drugs legislation and
regulations.
In the guideline we recommend that health professionals should provide advice and
information to people who are prescribed controlled drugs about how to store
controlled drugs safely. This includes discussing storage options, taking into account
the person's preference for a lockable or non-lockable storage box; whether the
controlled drugs will be accessible to people who should and should not have access
to them; whether the storage method could increase the risk of controlled
drug-related incidents, including patient safety incidents (recommendation 1.8.2).
Furthermore, we recommend documenting and giving information to the person
taking the controlled drug or the carer administering it, including: that it is to be used
only by the person it is prescribed for (recommendation 1.5.9).
Our information for the public explains the advice set out in NG46 and advises that
‘You must not let anyone else take your medicine. Your healthcare professional
should explain this clearly.’
We therefore believe that there is sufficient national guidance on the use of
controlled drugs in a community setting.
Please do let me know if you require any further information.
Yours sincerely,
Chief executive
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