PFD report

Gavin Peter Pedleham · Prevention of Future Deaths report

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Issued 30 Dec 2022•Surrey

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
2

Raised in this report

Recipients
3

Named on the report

Responses found
3

Of 3 recipients

Stated actions
7

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised2

  1. Lack of requirements for safe community storage of Oramorph and prevention of access by others
    Part of recurring concern: Unreliable Oramorph storage and handling controls
  2. Lack of regulations governing Oramorph use in community settings
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.3

  1. Action

    Provide national guidance on safely storing controlled drugs, including discussing storage options, access, and incident risks.

    Stated by National Institute for Health and Care ExcellenceStated completedThe respondent said that this action was complete when they made their response on 9 January 2023.
  2. Action

    Work with Marketing Authorisation holders to update Oramorph product information on secure storage and not leaving diluted medicine unattended.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 9 January 2023.
  3. Action

    Continue reviewing drugs controls for evidence indicating a need for additional controls.

    Stated by Home OfficeStated in progressThe respondent said that this action was in progress when they made their response on 9 January 2023.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.4

  1. Position

    Existing national guidance is sufficient to address the safe use of controlled drugs in community settings.

    Stated by National Institute for Health and Care ExcellenceExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of requirements for safe community storage of Oramorph and prevention of access by others

Wider context from the report

“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. ”

Is this part of a recurring concern?

Yes — Unreliable Oramorph storage and handling controls.

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Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of regulations governing Oramorph use in community settings

Wider context from the report

“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. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Provide national guidance on safely storing controlled drugs, including discussing storage options, access, and incident risks.

Verbatim wording from the response

“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.”

Source location

Response from National Institute for Health and Care Excellence
Page 1 · response
Published 9 January 2023

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Work with Marketing Authorisation holders to update Oramorph product information on secure storage and not leaving diluted medicine unattended.

Verbatim wording from the response

“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.”

Source location

Response from MHRA
Page 2 · response
Published 9 January 2023

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Continue reviewing drugs controls for evidence indicating a need for additional controls.

Verbatim wording from the response

“However, drugs controls are kept under review, and should further evidence emerge indicating the need for additional controls I will consider whether it is appropriate to seek advice from the ACMD.”

Source location

Response from Home Office
Page 1 · response
Published 9 January 2023

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Existing national guidance is sufficient to address the safe use of controlled drugs in community settings.

Verbatim wording from the response

“We therefore believe that there is sufficient national guidance on the use of controlled drugs in a community setting.”

Source location

Response from National Institute for Health and Care Excellence
Page 2 · response
Published 9 January 2023

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Existing Oramorph warnings and guidance were clear; the unintended recipient would not have seen the product information.

Verbatim wording from the response

“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.”

Source location

Response from MHRA
Page 1 · response
Published 9 January 2023

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Additional patient controls are not pursued because extending healthcare safeguards could criminalise patients and obstruct timely access to pain relief.

Verbatim wording from the response

“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, I have no plans at present to consider additional controls on oral morphine.”

Source location

Response from Home Office
Page 1 · response
Published 9 January 2023

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Existing advice, patient information and controlled-drug safeguards are considered sufficient to reduce risks from oral morphine.

Verbatim wording from the response

“I 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.”

Source location

Response from Home Office
Page 1 · response
Published 9 January 2023

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Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.4

  1. 1

    Provide and disseminate information that controlled drugs must be used only by the person prescribed them.

    Stated by National Institute for Health and Care ExcellenceStated completedThe respondent said that this action was complete when they made their response on 9 January 2023.
  2. 2

    Investigate the potential for accidental exposure and accidental overdose involving Oramorph oral solution.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 9 January 2023.
  3. 3

    Review the benefits and risks of opioid medicines for non-cancer pain, including dependence and addiction risks, with expert working-group advice.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 9 January 2023.
  4. 4

    Continuously monitor accidental deaths involving opioid-containing medicines.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 9 January 2023.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Provide and disseminate information that controlled drugs must be used only by the person prescribed them.

Verbatim wording from the response

“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).”

Source location

Response from National Institute for Health and Care Excellence
Page 1 · response
Published 9 January 2023

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Investigate the potential for accidental exposure and accidental overdose involving Oramorph oral solution.

Verbatim wording from the response

“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.”

Source location

Response from MHRA
Page 1 · response
Published 9 January 2023

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Review the benefits and risks of opioid medicines for non-cancer pain, including dependence and addiction risks, with expert working-group advice.

Verbatim wording from the response

“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.”

Source location

Response from MHRA
Page 1 · response
Published 9 January 2023

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Continuously monitor accidental deaths involving opioid-containing medicines.

Verbatim wording from the response

“We continually monitor for accidental deaths of opioid containing medicines and will take further prompt regulatory action when necessary.”

Source location

Response from MHRA
Page 2 · response
Published 9 January 2023

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026