Recurring concern

Unreliable Oramorph storage and handling controls

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First reported 28 Dec 2018•Latest report 30 Dec 2022

Definition

What this concern includes

Includes failures in controls specifically governing Oramorph storage, handling and access prevention across institutional and community settings, including strength-based classification, secure storage, restrictions on access by others and related operational requirements.

Not included

Excludes medication prescribing, dosing, administration, monitoring or clinical-assessment failures where Oramorph storage, handling or access control is not the unsafe condition.
Excludes generic medication-security concerns not specifically involving Oramorph storage or handling.
Excludes general opioid or controlled-drug regulation where Oramorph storage, handling or access is not materially identified.
Excludes medication-supply, dispensing or treatment-continuity failures unrelated to Oramorph storage and handling.

Reports: 2
Individual concerns: 2
Date range: 2018–2022
Stated actions: 3

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Reports about this concern sent to each recipient.

Department of Health and Social Care1

Home Office1

Medicines and Healthcare products Regulatory Agency1

National Institute for Health and Care Excellence1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

30 Dec2022
Surrey
Concerns raised1
1. Lack of requirements for safe community storage of Oramorph and prevention of access by others
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response 2
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 completed
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 planned
Respondent positions 3
1. Position
  Existing Oramorph warnings and guidance were clear; the unintended recipient would not have seen the product information.
  Stated by Medicines and Healthcare products Regulatory AgencyDisputes the concern
1. Position
  Existing advice, patient information and controlled-drug safeguards are considered sufficient to reduce risks from oral morphine.
  Stated by Home OfficeExisting arrangements considered sufficient
2. Position
  Additional patient controls are not pursued because extending healthcare safeguards could criminalise patients and obstruct timely access to pain relief.
  Stated by Home OfficeUnable to act
AI-generated summary

Gavin Peter Pedleham · Prevention of Future Deaths report

This summary was generated using AI from the published report. Please read the original report for the complete account.

Report summary

Gavin Peter Pedleham inadvertently drank a dose of Oramorph left in a glass at a family Christmas party after consuming a significant quantity of alcohol. He was found dead the following morning, and the inquest recorded morphine and ethanol toxicity, concluding that his death was accidental. The substantive concern was that community use of Oramorph is not subject to similar safe-storage requirements as its use in institutional settings, allowing access by others.

Read the report on judiciary.uk
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
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. ”
Source location
Gavin Peter Pedleham · Prevention of Future Deaths report
Page 2 · concerns
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
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
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
Open published response
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
Open published response
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
Open published response
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
Open published response
28 Dec2018
Manchester South
Concerns raised1
1. Failure to maintain consistent classification-based storage and handling arrangements for Oramorph
This report raised 8 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response 1
1. Action
  Implement the Controlled Drugs Regulations establishing tighter controls and mandatory governance arrangements for prescribing, records, custody, monitoring and accountable officers.
  Stated by Department of Health and Social CareStated completed
Respondent positions 1
1. Position
  Registered providers and managers are responsible for ensuring the proper and safe management of medicines in care homes.
  Stated by Department of Health and Social CareRedirects responsibility
AI-generated summary

Joan Wright · Prevention of Future Deaths report

This summary was generated using AI from the published report. Please read the original report for the complete account.

Report summary

Joan Wright, who had poor mobility and was unable to communicate verbally, died at Belmont Residential Home on 16 September 2017; the post-mortem found extensive coronary artery atheroma. The report raised concerns about the incorrect administration and handling of Oramorph, medication management at a care home rated inadequate, and failures to recognise and address safeguarding risks after the medication incident.

Read the report on judiciary.uk
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Failure to maintain consistent classification-based storage and handling arrangements for Oramorph
Wider context from the report
“1. The inquest heard that Oramorph had different classifications depending on the strength prescribed. This impacts the storage/handling arrangements. The inquest heard that opioids can have a significant impact at whatever strength they are prescribed if given in excess; ”
Source location
Joan Wright · Prevention of Future Deaths report
Page 2 · concerns
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
Implement the Controlled Drugs Regulations establishing tighter controls and mandatory governance arrangements for prescribing, records, custody, monitoring and accountable officers.

Verbatim wording from the response
“You mention the Shipman Inquiry in your report. In response to the Shipman Inquiry's Fourth Report¹, there have been significant changes in the governance arrangements for the use and management of controlled drugs.”

Source location
2018-0408-Response-by-Department-of-Health
Page 1 · response
Published 28 December 2018
Open published response
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
Registered providers and managers are responsible for ensuring the proper and safe management of medicines in care homes.

Verbatim wording from the response
“It is the registered provider and the registered manager’s responsibility to ensure the proper and safe management of medicines and guidance is available to support them to achieve this. The National Institute for Health and Care Excellence (NICE) has produced a national guideline on the ‘Safe use and management of controlled drugs’ (NG46)⁶, published in 2016, and a social care guideline (SC1), published in 2014, provides guidance on ‘Managing medicines in care homes’⁷. Furthermore, the CQC has clear guidance on its website on ‘Storing controlled drugs in care homes’⁸.”

Source location
2018-0408-Response-by-Department-of-Health
Page 4 · response
Published 28 December 2018
Open published response

Data last updated 7 September 2026

What this concern includes

Not included

Reports over time

Concerns raised1

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

Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.2

Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.3

Concerns raised1

Failure to maintain consistent classification-based storage and handling arrangements for Oramorph

Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1

Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1

Actions described in response 2

Respondent positions 3

Actions described in response 1

Respondent positions 1