PFD report

Mr Edward Jorge Capovila · Prevention of Future Deaths report

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Issued 25 Apr 2022•Cumbria

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
1

Raised in this report

Recipients
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
7

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 raised1

  1. Lack of information about unusual ways fentanyl can be misused or abused
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.1

  1. Action

    Issue a drug safety bulletin warning patients and healthcare professionals about heat exposure, overdose, death, and cutting fentanyl patches.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 29 April 2022.

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 information about unusual ways fentanyl can be misused or abused

Wider context from the report

“As indicated above, I was told that there is relatively little information available about the more unusual ways in which fentanyl can be misused or abused. Given the potential for fentanyl to be misused, as evidenced in Eddy’s inquest, I have concern that further deaths may occur in future if action is not taken. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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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

Issue a drug safety bulletin warning patients and healthcare professionals about heat exposure, overdose, death, and cutting fentanyl patches.

Verbatim wording from the response

“The MHRA became aware that if a patch is exposed to heat, it will increase the speed at which the fentanyl is absorbed into the body and therefore the patient is likely to be exposed to a higher initial dose than prescribed. In December 2014, the MHRA issued a drug safety bulletin¹ warning healthcare professionals and patients of the risk of overdose and death with exposure of the ████████ patch to increased heat including the instruction that the patch should not be cut.”

Source location

Response from Medicines & Healthcare products Regulatory Agency
Page 1 · response
Published 29 April 2022

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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.6

  1. 1

    Complete a benefit-risk review of opioid medicines for non-cancer pain, including dependence, addiction, and related risks.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 29 April 2022.
  2. 2

    Update product information for licensed medicines to clearly warn about concomitant CNS-depressant use and risks of coma or death.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 29 April 2022.
  3. 3

    Publish a drug safety bulletin article and update its linked patient leaflet on addiction and potentially fatal overdose risks.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 29 April 2022.
  4. 4

    Add addiction-risk warnings to healthcare-professional product information and patient information leaflets.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 29 April 2022.
  5. 5

    Continue monitoring the benefits and risks of 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 29 April 2022.
  6. 6

    Add opioid and addiction-risk warnings to medicine packaging and communicate them publicly through media outlets.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 29 April 2022.

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 benefit-risk review of opioid medicines for non-cancer pain, including dependence, addiction, and related risks.

Verbatim wording from the response

“In 2019 the MHRA undertook a review of the benefits and risks for all ████████ medicines in the treatment of non-cancer pain and risks associated with dependence and addiction and sought the advice of an ████████ Expert Working Group of the Commission on Human Medicines, the MHRA’s advisory body. The Expert Working Group considered the benefit-risk profile of ████████-containing medicines and made recommendations for regulatory action to better support appropriate use of prescription ████████ including ████████, with educational initiatives to increase the awareness of both patients and healthcare professionals of the risks of dependence, addiction, tolerance, withdrawal reactions, and risks of neonatal abstinence syndrome during pregnancy.”

Source location

Response from Medicines & Healthcare products Regulatory Agency
Page 1 · response
Published 29 April 2022

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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

Update product information for licensed medicines to clearly warn about concomitant CNS-depressant use and risks of coma or death.

Verbatim wording from the response

“The product information for all ████████ licences is currently being updated to ensure that the warning of concomitant administration of ████████ as further examples of CNS depressants is clearly stated with the risk of coma or death. This action is being taken to ensure that all relevant product information is consistent.”

Source location

Response from Medicines & Healthcare products Regulatory Agency
Page 2 · response
Published 29 April 2022

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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

Publish a drug safety bulletin article and update its linked patient leaflet on addiction and potentially fatal overdose risks.

Verbatim wording from the response

“warnings about the risk of addiction were included in the Summary of Product Characteristics for healthcare professionals and in the patient information leaflets. Further to this action, an article was published in the MHRA’s drug safety bulletin, Drug Safety Update (DSU) on 23 September 2020⁴ highlighting the risk of addiction with ████████ containing medicines and the potential for overdose which could be fatal. An additional patient leaflet that is linked to the DSU article was recently updated in August 2021 following user-testing to ensure that patients understood the messages.”

Source location

Response from Medicines & Healthcare products Regulatory Agency
Page 2 · response
Published 29 April 2022

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

Add addiction-risk warnings to healthcare-professional product information and patient information leaflets.

Verbatim wording from the response

“warnings about the risk of addiction were included in the Summary of Product Characteristics for healthcare professionals and in the patient information leaflets. Further to this action, an article was published in the MHRA’s drug safety bulletin, Drug Safety Update (DSU) on 23 September 2020⁴ highlighting the risk of addiction with ████████ containing medicines and the potential for overdose which could be fatal. An additional patient leaflet that is linked to the DSU article was recently updated in August 2021 following user-testing to ensure that patients understood the messages.”

Source location

Response from Medicines & Healthcare products Regulatory Agency
Page 2 · response
Published 29 April 2022

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

Continue monitoring the benefits and risks of opioid-containing medicines.

Verbatim wording from the response

“We continue to monitor the benefits and risks of opioid containing medicines and will take further prompt regulatory action when required.”

Source location

Response from Medicines & Healthcare products Regulatory Agency
Page 2 · response
Published 29 April 2022

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

Add opioid and addiction-risk warnings to medicine packaging and communicate them publicly through media outlets.

Verbatim wording from the response

“Following this review, in April 2019, warnings were added to the packaging of all ████████ to highlight that the medicine contains an opioid and the risk of addiction. This information was relayed to the public through several media outlets including the Guardian² and BBC news³. In 2020, additional”

Source location

Response from Medicines & Healthcare products Regulatory Agency
Page 1 · response
Published 29 April 2022

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
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Data last updated 7 September 2026