PFD report

Anita Graves · Prevention of Future Deaths report

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Issued 20 Jun 2023•Manchester South

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
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
4

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

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Report evidence summary

Concerns raised2

  1. Risk of inadvertent carbimazole overdose from visual similarity of tablets
  2. Community dispensing processes failing to mitigate carbimazole overdose risk
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

    Review authorised carbimazole products to assess whether different strengths are distinguishable by size or markings.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 22 June 2023.
  2. Action

    Publish and update guidance for pharmaceutical companies on labelling and packaging medicines to reduce medication errors and differentiate products.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 22 June 2023.
  3. Action

    Work with pharmaceutical companies to improve packaging clarity and differentiate medicines, including by active ingredient and strength.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 22 June 2023.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.2

  1. Position

    The General Pharmaceutical Council has no jurisdiction over manufacturers’ packaging supplied by pharmacies.

    Stated by Medicines and Healthcare products Regulatory AgencyOutside remitThe respondent said that this matter was outside its role or authority.

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

Risk of inadvertent carbimazole overdose from visual similarity of tablets

Wider context from the report

“(1) That the visual similarity of tablets of differing strengths of carbimazole to each other and to aspirin presents a risk of inadvertent overdose; and (2) That the dispensing process in the community for carbimazole appears to contribute to rather than mitigating the risk ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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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

Community dispensing processes failing to mitigate carbimazole overdose risk

Wider context from the report

“(1) That the visual similarity of tablets of differing strengths of carbimazole to each other and to aspirin presents a risk of inadvertent overdose; and (2) That the dispensing process in the community for carbimazole appears to contribute to rather than mitigating the risk ”

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

Review authorised carbimazole products to assess whether different strengths are distinguishable by size or markings.

Verbatim wording from the response

“Regulatory guidance¹ requests that different strengths of the same medicine should be distinguishable, and the following is stated in the guidance “In the case of applications for more than one tablet strength, the different tablet strengths should be distinguishable at a level sufficient to avoid mistakes between the different strengths by the final user. Distinguishing tablet strengths by colour / shape and marking / embossing is preferable.””

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 2 · response
Published 22 June 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

Publish and update guidance for pharmaceutical companies on labelling and packaging medicines to reduce medication errors and differentiate products.

Verbatim wording from the response

“We have been working very closely with the pharmaceutical companies to ensure that packaging is clear and unambiguous and that different products are adequately differentiated one from another. A guideline to the pharmaceutical industry² on how to improve medicines labelling to reduce the likelihood of medication errors has been published and recently updated, which includes amongst other things, a need to ensure that medicines which may be stored together or used concomitantly by patients are well differentiated from each other. Many companies have embraced the principles it contains and made changes to their packaging, employing the judicious use of colour to differentiate both active ingredient and strength to reduce the likelihood of medication errors.”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 3 · response
Published 22 June 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 pharmaceutical companies to improve packaging clarity and differentiate medicines, including by active ingredient and strength.

Verbatim wording from the response

“We have been working very closely with the pharmaceutical companies to ensure that packaging is clear and unambiguous and that different products are adequately differentiated one from another. A guideline to the pharmaceutical industry² on how to improve medicines labelling to reduce the likelihood of medication errors has been published and recently updated, which includes amongst other things, a need to ensure that medicines which may be stored together or used concomitantly by patients are well differentiated from each other. Many companies have embraced the principles it contains and made changes to their packaging, employing the judicious use of colour to differentiate both active ingredient and strength to reduce the likelihood of medication errors.”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 3 · response
Published 22 June 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

The General Pharmaceutical Council has no jurisdiction over manufacturers’ packaging supplied by pharmacies.

Verbatim wording from the response

“The GPhC does not however have any jurisdiction over the manufacturers’ packaging that pharmacies supply. Wider issues such as medicines shortages could also potentially lead to different generic brands of medicines being supplied to patients at different periods in time. Carbimazole has unfortunately been subject to medicines shortages periodically, and whilst it is unclear if the shortages coincided with the case in hand, it is possible it may have contributed to the situation.”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 4 · response
Published 22 June 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

Product labelling and packaging are considered the safest and sufficient means of identifying carbimazole and reducing confusion from tablet appearance.

Verbatim wording from the response

“The issue of correct tablet identification is vital to avoid medication errors. For this reason, the primary purpose of medicines labelling is identification of the medicinal product contained within the packaging. The MHRA considers that the only reliable way for unambiguous identification of a particular medicine is via the information printed on the package labelling. The advice is always to read the label carefully as this is the only way to avoid confusion and potential medication errors. Even though the label is the most important and reliable way to identify medicines, we recognise that a final check by appearance can be reassuring. It is also recognised that medicines may be removed from their packaging for storage in pill organisers or compliance aids and that patients may be taking multiple medicines.”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 2 · response
Published 22 June 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.1

  1. 1

    Continue closely monitoring carbimazole and inadvertent overdose reports.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 22 June 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

Continue closely monitoring carbimazole and inadvertent overdose reports.

Verbatim wording from the response

“I hope this has provided clarification on the range of risk minimisation measures in place and future changes to protect patients and enable them to correctly identify their medicines. We will continue to keep the issue of carbimazole and inadvertent overdose of this product under close monitoring.”

Source location

Response from Medicines and Healthcare products Regulatory Agency
Page 5 · response
Published 22 June 2023

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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