PFD report

John Abrahams (Jack) · Prevention of Future Deaths report

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Issued 14 Feb 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
2

Raised in this report

Recipients
1

Named on the report

Responses found
2

Of 1 recipient

Stated actions
6

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. Failure to convene the working group required to consider implementation of the IEWG recommendations
    Part of recurring concern: Failure to reliably translate safety recommendations into actionable changes
  2. Failure to implement Isotretinoin prescribing recommendations
    Part of recurring concern: Failure to implement identified safety actions
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.2

  1. Action

    Continue the Implementation Working Group’s work to develop the practical arrangements for safely introducing the isotretinoin recommendations.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 24 February 2023.
  2. Action

    Establish and convene an Implementation Working Group to develop the practical implementation of isotretinoin safety recommendations.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 24 February 2023.

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 convene the working group required to consider implementation of the IEWG recommendations

Wider context from the report

“The Commission for Human Medicine (CHM) established an Isotretinoin Expert Working Group (IEWG) in response to concerns about psychiatric events. The IEWG considered oral and written evidence over 2020 and 2021. The findings and recommendations of the IEWG were presented in a report to the CHM at the end of 2021 and include a recommendation which relates to prescribing for patients under the age of 18. It is now over a year since the IEWG report was completed and the recommendations have still not been implemented. In that time there have been 45 adverse Isotretinoin events reported to the Medicines Healthcare products Regulatory Agency (MHRA) comprising of 81 psychiatric adverse events, one of which was an attempted suicide. The Court heard that a second working group is required to consider how to implement the IEWG recommendations and that this group has yet to meet. ”

Is this part of a recurring concern?

Yes — Failure to reliably translate safety recommendations into actionable changes.

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 implement Isotretinoin prescribing recommendations

Wider context from the report

“The Commission for Human Medicine (CHM) established an Isotretinoin Expert Working Group (IEWG) in response to concerns about psychiatric events. The IEWG considered oral and written evidence over 2020 and 2021. The findings and recommendations of the IEWG were presented in a report to the CHM at the end of 2021 and include a recommendation which relates to prescribing for patients under the age of 18. It is now over a year since the IEWG report was completed and the recommendations have still not been implemented. In that time there have been 45 adverse Isotretinoin events reported to the Medicines Healthcare products Regulatory Agency (MHRA) comprising of 81 psychiatric adverse events, one of which was an attempted suicide. The Court heard that a second working group is required to consider how to implement the IEWG recommendations and that this group has yet to meet. ”

Is this part of a recurring concern?

Yes — Failure to implement identified safety actions.

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

Continue the Implementation Working Group’s work to develop the practical arrangements for safely introducing the isotretinoin recommendations.

Verbatim wording from the response

“The CHM further advised in August 2022 that, in order to ensure the safe and effective introduction of the recommendations, an Implementation Working Group should be established with representation from the wider healthcare system in addition to relevant”

Source location

Response from Medicines and Healthcare products Regulatory Agency 1
Page 1 · response
Published 24 February 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

Establish and convene an Implementation Working Group to develop the practical implementation of isotretinoin safety recommendations.

Verbatim wording from the response

“The CHM further advised that, in order to ensure the safe and effective introduction of the recommendations, an Implementation Working Group should be established with representation from the wider healthcare system in addition to relevant healthcare professionals. This was due to concerns raised around the logistical implementation of the recommendations which may delay treatment for those that need it.”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 2 · response
Published 24 February 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.4

  1. 1

    Publish the report of the isotretinoin safety review.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 24 February 2023.
  2. 2

    Issue a Drug Safety Update Bulletin to healthcare professionals describing new isotretinoin safety measures.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 24 February 2023.
  3. 3

    Make the Implementation Working Group’s output publicly available.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 24 February 2023.
  4. 4

    Publish the isotretinoin expert review report.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 24 February 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 report of the isotretinoin safety review.

Verbatim wording from the response

“The report of this review will be published shortly. We will advise you of the publication date when it is confirmed.”

Source location

Response from Medicines and Healthcare products Regulatory Agency 1
Page 2 · response
Published 24 February 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

Issue a Drug Safety Update Bulletin to healthcare professionals describing new isotretinoin safety measures.

Verbatim wording from the response

“The report of this review was published 26 April 2023. A link to the published report is here: Isotretinoin: an expert review of suspected psychiatric and sexual side effects - GOV.UK (www.gov.uk). It was accompanied by a Drug Safety Update Bulletin, sent to healthcare professionals: Isotretinoin (Roaccutane▼): new safety measures to be introduced in the coming months, including additional oversight on initiation of treatment for patients under 18 years - GOV.UK (www.gov.uk).”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 2 · response
Published 24 February 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

Make the Implementation Working Group’s output publicly available.

Verbatim wording from the response

“The Implementation Working Group has had two meetings in March 2023 and is making good progress with a further meeting planned in mid-May 2023. The output of the Group’s work will be made public in due course.”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 2 · response
Published 24 February 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

Publish the isotretinoin expert review report.

Verbatim wording from the response

“The report of this review was published 26 April 2023. A link to the published report is here: Isotretinoin: an expert review of suspected psychiatric and sexual side effects - GOV.UK (www.gov.uk). It was accompanied by a Drug Safety Update Bulletin, sent to healthcare professionals: Isotretinoin (Roaccutane▼): new safety measures to be introduced in the coming months, including additional oversight on initiation of treatment for patients under 18 years - GOV.UK (www.gov.uk).”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 2 · response
Published 24 February 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