Source · Prevention of Future Deaths

Gavin Pedleham

Ref: 2023-0005Deceased Date: 30 Dec 2022 Coroner: Caroline Topping Area: Surrey 3 responses identified · 3 indexed addressees View PDF

AI-generated concerns summaryThe coroner notes a lack of regulations governing the storage and handling of Oramorph in community settings, unlike in institutional settings, and no requirement for recipients to keep it safe from others.

Date 30 Dec 2022

56-day deadline 24 Feb 2023 stated in the report

Responses identified 3 of 3

Alcohol, drug and medication related deaths

Coroner's concerns

AI summary

The coroner notes a lack of regulations governing the storage and handling of Oramorph in community settings, unlike in institutional settings, and no requirement for recipients to keep it safe from others.

View full coroner's concerns

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.

Responses

3 respondents

Home Office

Central Government

Letter dated 13 Feb 2023 PDF

AI-classified response stance Noted

AI-generated response summary

• The Home Office sought views from the Department for Health and Social Care regarding the report. • The Home Office stated it had no plans at present to consider additional controls on oral morphine. • The Home Office indicated that it would consider seeking advice from the Advisory Council on Misuse of Drugs should further evidence emerge regarding the need for additional controls.

View full response

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 Pedleham, which was forwarded to the Home Ofice 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 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 Advisory Council on Misuse of Drugs (ACMD): Liquid morphine in this form is placed in Schedule 5 to 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:

National Institute for Health and Care Excellence

Regulator / Inspectorate

Letter dated 17 Feb 2023 PDF

AI-classified response stance Noted

AI-generated response summary

• The National Institute for Health and Care Excellence (NICE) has published guideline NG46 on controlled drugs, which covers safe use and management in all settings, including people's homes. • Guideline NG46 recommends health professionals provide advice and information to people prescribed controlled drugs regarding safe storage and use. • NICE's public information explains the advice in NG46 and advises against sharing prescribed medicines.

View full response

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).

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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.

Medicines and Healthcare Products Regulatory Agency

Regulator / Inspectorate

Letter dated 27 Feb 2023 PDF

AI-classified response stance Action Planned

AI-generated response summary

• The MHRA stated it would work with Marketing Authorisation holders to update the product information for Oramorph. • The updated product information will highlight the need to keep the medicine in a secure place. • The updated product information will highlight the need not to leave any diluted Oramorph unattended.

View full response

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.

Report sections

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 poured out and 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. The conclusion was that Gavin met his death by accident.

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Shared signals

Report details

Reference: 2023-0005Deceased
Date of report: 30 December 2022
Coroner: Caroline Topping
Coroner area: Surrey

Responses identified

Responses identified 3 of 3

All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 24 Feb 2023 (stated in the report).

Sent to

Home Office

Medicines and Healthcare Products Regulatory Agency

National Institute for Health Care Excellence

Source links

Judiciary.uk page → Report PDF →

Data: judiciary.uk.

Contains public sector information licensed under the Open Government Licence v3.0.