PFD report

Charlene Roberts · Prevention of Future Deaths report

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Issued 8 Dec 2023•Manchester North

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.

View original report
Concerns
4

Raised in this report

Recipients
4

Named on the report

Responses found
4

Of 4 recipients

Stated actions
14

Described in 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.

Report evidence summary

Concerns raised4

  1. Failure to enforce pharmacy questioning and pharmacist presence for over-the-counter cyclizine purchases
    Part of recurring concern: Inadequate safeguards for access to dangerous drugs
  2. Lack of professional understanding of using the Controlled Drugs local intelligence network for non-controlled drugs
  3. Absence of a commissioned pathway for GPs to refer compromised community patients requiring blood tests
    Part of recurring concern: Unreliable access to blood testing for patients with difficult venous access
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.5

  1. Action

    Raise the potential cyclizine addiction risk with mental health organisations and bodies responsible for mental health system oversight.

    Stated by Royal College of PsychiatristsStated plannedThe respondent said that this action was planned when they made their response on 12 December 2023.
  2. Action

    Communicate the potential cyclizine addiction risk to members through newsletters, faculty communications and other suitable channels.

    Stated by Royal College of PsychiatristsStated plannedThe respondent said that this action was planned when they made their response on 12 December 2023.
  3. Action

    Review cyclizine safety, including misuse evidence and this case, to determine whether current risk-minimisation measures remain sufficient.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 12 December 2023.

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

  1. Position

    The Controlled Drugs Local Intelligence Network cannot support sharing information about non-controlled drugs under the 2013 Regulations.

    Stated by NHS EnglandUnable to actThe respondent said that a constraint prevented them from taking the relevant action.

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

Failure to enforce pharmacy questioning and pharmacist presence for over-the-counter cyclizine purchases

Wider context from the report

“The court heard evidence that intravenous cyclizine is by prescription only but oral cyclizine can be purchased over the counter at a pharmacy. In order to purchase oral cyclizine in a pharmacy a pharmacist should seek information as to why it is required and should be present. Charlene’s family gave evidence that following Charlene’s death they had been able to obtain cyclizine in a pharmacy directly from a pharmacy assistant with no questions being asked of them. ”

Is this part of a recurring concern?

Yes — Inadequate safeguards for access to dangerous drugs.

Open source report

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 professional understanding of using the Controlled Drugs local intelligence network for non-controlled drugs

Wider context from the report

“Cyclizine is not a controlled drug. At one stage consideration was given to using the Controlled Drugs local intelligence network as convened by NHS England (Controlled Drugs (Supervision and Management of Use) Regulations 2013) to put an alert out to local pharmacies to warn them about Charlene’s purchasing of cyclizine. From the evidence there was a lack of clarity and understanding from professionals as to whether this local network could be used for drugs which are not controlled drugs. The fact that the legislation refers to controlled drugs may mean there is a lack of understanding about using this for system for non controlled drugs such as cyclizine. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

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

Absence of a commissioned pathway for GPs to refer compromised community patients requiring blood tests

Wider context from the report

“During the course of the evidence the court heard evidence from the GP who was responsible for obtaining weekly bloods to monitor her eating disorder. There is no commissioned pathway in Rochdale for GPs to refer patients who require bloods but who are compromised and therefore hard to obtain blood from. As a result patients are attending A&E departments for these to be taken. ”

Is this part of a recurring concern?

Yes — Unreliable access to blood testing for patients with difficult venous access.

Open source report

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

Failure to consider cyclizine addiction in eating disorder services

Wider context from the report

“The court was made aware of the research conducted in 2009 as published in the journal PNS, “Proceedings of the Nutrition Society”, “Cyclizine dependence in patients with complex nutritional requirements” Thursby-Pelham, De Silva, Stroud and Fine, 23 July 2009. This identified cyclizine dependence in four female patients who all had complex nutritional problems. Whilst it is acknowledged that this is one study and as stated cyclizine addiction is rare, it was not something which had been considered before Charlene’s addiction by the Eating Disorder Service. For the Manchester Eating Disorder Service there is now a greater awareness of cyclizine. This may be important nationally given its use as an anti-emetic. ”

Is this part of a recurring concern?

Yes — Unreliable clinical assessment and management of eating disorders.

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

Raise the potential cyclizine addiction risk with mental health organisations and bodies responsible for mental health system oversight.

Verbatim wording from the response

“We will also, where possible, raise it with mental health organisations themselves as well as those who have responsibility and oversight for the mental health system and who will have routes by which this information can be disseminated.”

Source location

Response from Royal College of Psychiatrists
Page 2 · response
Published 12 December 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

Communicate the potential cyclizine addiction risk to members through newsletters, faculty communications and other suitable channels.

Verbatim wording from the response

“Therefore, will be using mechanisms to communicate this potential risk to our members, such as through our College Newsletters, Faculty specific communications and any other opportunity where we can make this issue more widely known.”

Source location

Response from Royal College of Psychiatrists
Page 2 · response
Published 12 December 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 cyclizine safety, including misuse evidence and this case, to determine whether current risk-minimisation measures remain sufficient.

Verbatim wording from the response

“The MHRA keeps the safe and effective use of medicines, including cyclizine, under continual review. We will consider the case raised in this report as well as wider evidence regarding the misuse of cyclizine and determine whether the current risk minimisation measures are sufficient. If further action is required, we will communicate this to healthcare professionals and patients.”

Source location

Response from MHRA
Page 2 · response
Published 12 December 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

Complete a Greater Manchester review of phlebotomy provision to identify variation and support more consistent patient access.

Verbatim wording from the response

“In addition to the locality-specific actions as set out above, a GM level review of phlebotomy provision has been undertaken recently which has identified the variation in provision and sets out the intention to improve the consistency of offer to patients across Greater Manchester. This is also a priority deliverable of the Greater Manchester Primary Care Blueprint.”

Source location

Response from Greater Manchester NHS
Page 2 · response
Published 12 December 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

Reiterate the process for arranging supported blood testing to all GP practices through GP communications.

Verbatim wording from the response

“There are a very small group of people who may be more difficult to take blood than others due to clinical presentation. Rochdale GPs do have the ability to arrange, on a case-by-case basis, where a compromised patient needs to have bloods taken with support from ultrasound.”

Source location

Response from Greater Manchester NHS
Page 2 · response
Published 12 December 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

The Controlled Drugs Local Intelligence Network cannot support sharing information about non-controlled drugs under the 2013 Regulations.

Verbatim wording from the response

“The provisions of the Controlled Drugs (Supervision of Management and Use) Regulations 2013 (the “2013 Regulations”) relate to controlled drugs only. They provide the legal framework under which information should be shared about an individual working in health and/or social care, a “relevant person” (see Regulation 5). The Local Intelligence Network supports the sharing of this information and members have a duty to co-operate and share information concerning the safe use and management of controlled drugs. The Regulations do not, however, provide a framework to share information about patients.”

Source location

Response from NHS England
Page 1 · response
Published 12 December 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 safeguarding duties and Caldicott-compliant information sharing between healthcare teams should address relevant patient safety information needs.

Verbatim wording from the response

“However, all healthcare providers and healthcare professionals, have a duty to safeguard their patients. We would anticipate that relevant information would be shared with other clinical teams that may be involved in the provision of care to an individual patient, including community pharmacy contractors, in line with the Caldicott principles linked to above.”

Source location

Response from NHS England
Page 2 · response
Published 12 December 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

Concerns about pharmacy information and patient consultation should be raised with the GPhC or CQC, which regulate relevant services.

Verbatim wording from the response

“While we work closely with healthcare system partners, clinical practice is not within the remit of the MHRA. We would consider that concerns regarding the information provided by the pharmacy when patients request to purchase cyclizine without a prescription, and any consultation patients should receive, would be relevant to raise with the General Pharmaceutical Council, or GPhC, who are responsible for the regulation of the pharmacy profession, or the Care Quality Commission, or CQC, who regulate health and social care in the UK.”

Source location

Response from MHRA
Page 2 · response
Published 12 December 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

Clinical practice, including pharmacy information and patient consultation, is outside the respondent’s remit.

Verbatim wording from the response

“While we work closely with healthcare system partners, clinical practice is not within the remit of the MHRA. We would consider that concerns regarding the information provided by the pharmacy when patients request to purchase cyclizine without a prescription, and any consultation patients should receive, would be relevant to raise with the General Pharmaceutical Council, or GPhC, who are responsible for the regulation of the pharmacy profession, or the Care Quality Commission, or CQC, who regulate health and social care in the UK.”

Source location

Response from MHRA
Page 2 · response
Published 12 December 2023

Open published response

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.9

  1. 1

    Publish the joint action plan on improving mental health treatment for people with drug dependence.

    Stated by NHS EnglandStated plannedThe respondent said that this action was planned when they made their response on 12 December 2023.
  2. 2

    Routinely monitor service performance returns through Integrated Care Systems to track local progress.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 12 December 2023.
  3. 3

    Develop the Adult Community Mental Health Roadmap to support community mental health and eating disorder transformation.

    Stated by NHS EnglandStated in progressThe respondent said that this action was in progress when they made their response on 12 December 2023.
  4. 4

    Develop a joint action plan with the Department of Health and Social Care to improve mental health treatment for people with drug dependence.

    Stated by NHS EnglandStated in progressThe respondent said that this action was in progress when they made their response on 12 December 2023.
  5. 5

    Create an all-age eating disorder Clinical Reference Group to strengthen governance and collaboration across care settings.

    Stated by NHS EnglandStated in progressThe respondent said that this action was in progress when they made their response on 12 December 2023.
  6. 6

    Implement the joint action plan on improving mental health treatment for people with drug dependence.

    Stated by NHS EnglandStated plannedThe respondent said that this action was planned when they made their response on 12 December 2023.
  7. 7

    Discuss Prevention of Future Deaths reports through the Regulation 28 Working Group and share key learning across national and regional NHS services.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 12 December 2023.
  8. 8

    Present and share the Regulation 28 report and response with the Greater Manchester System Quality Group.

    Stated by NHS Greater Manchester Integrated Care BoardStated plannedThe respondent said that this action was planned when they made their response on 12 December 2023.
  9. 9

    Monitor key learning points and recommendations to ensure they become embedded in practice.

    Stated by NHS Greater Manchester Integrated Care BoardStated plannedThe respondent said that this action was planned when they made their response on 12 December 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

Publish the joint action plan on improving mental health treatment for people with drug dependence.

Verbatim wording from the response

“Drug and alcohol addiction/misuse are not automatic exclusion criteria for accessing NHS mental health services. NHS England are developing a joint action plan with the Department of Health and Social Care to improve the provision of mental health treatment for people with drug dependence. This will be published and implemented later in 2024.”

Source location

Response from NHS England
Page 3 · response
Published 12 December 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

Routinely monitor service performance returns through Integrated Care Systems to track local progress.

Verbatim wording from the response

“To support services to plan and implement improved pathways in alignment with the guidance, NHS England has undertaken, or is undertaking, the following:”

Source location

Response from NHS England
Page 2 · response
Published 12 December 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

Develop the Adult Community Mental Health Roadmap to support community mental health and eating disorder transformation.

Verbatim wording from the response

“To support services to plan and implement improved pathways in alignment with the guidance, NHS England has undertaken, or is undertaking, the following:”

Source location

Response from NHS England
Page 2 · response
Published 12 December 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

Develop a joint action plan with the Department of Health and Social Care to improve mental health treatment for people with drug dependence.

Verbatim wording from the response

“Drug and alcohol addiction/misuse are not automatic exclusion criteria for accessing NHS mental health services. NHS England are developing a joint action plan with the Department of Health and Social Care to improve the provision of mental health treatment for people with drug dependence. This will be published and implemented later in 2024.”

Source location

Response from NHS England
Page 3 · response
Published 12 December 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

Create an all-age eating disorder Clinical Reference Group to strengthen governance and collaboration across care settings.

Verbatim wording from the response

“To support services to plan and implement improved pathways in alignment with the guidance, NHS England has undertaken, or is undertaking, the following:”

Source location

Response from NHS England
Page 2 · response
Published 12 December 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

Implement the joint action plan on improving mental health treatment for people with drug dependence.

Verbatim wording from the response

“Drug and alcohol addiction/misuse are not automatic exclusion criteria for accessing NHS mental health services. NHS England are developing a joint action plan with the Department of Health and Social Care to improve the provision of mental health treatment for people with drug dependence. This will be published and implemented later in 2024.”

Source location

Response from NHS England
Page 3 · response
Published 12 December 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

Discuss Prevention of Future Deaths reports through the Regulation 28 Working Group and share key learning across national and regional NHS services.

Verbatim wording from the response

“I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around preventable deaths are shared across the NHS at both a national and regional level and helps us pay close attention to any emerging trends that may require further review and action.”

Source location

Response from NHS England
Page 3 · response
Published 12 December 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

Present and share the Regulation 28 report and response with the Greater Manchester System Quality Group.

Verbatim wording from the response

“Actions taken or being taken to share learning across Greater Manchester:”

Source location

Response from Greater Manchester NHS
Page 2 · response
Published 12 December 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

Monitor key learning points and recommendations to ensure they become embedded in practice.

Verbatim wording from the response

“In conclusion, key learning points and recommendations will be monitored to ensure they are embedded within practice.”

Source location

Response from Greater Manchester NHS
Page 2 · response
Published 12 December 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

Official responses located
4/4

Data last updated 7 September 2026