PFD report

Aaron John Peter McCaffrey · Prevention of Future Deaths report

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Issued 16 Jun 2017•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
1

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 raised1

  1. Lack of limits on the amount of loperamide medication purchasable from a single store
    Part of recurring concern: Failure to secure and control medication
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

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

  1. Position

    Responsible patients’ benefit from unrestricted retail access outweighs harms to the small number who deliberately misuse loperamide.

    Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

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 limits on the amount of loperamide medication purchasable from a single store

Wider context from the report

“The concern is that there is no apparent limit on the amount of loperamide medication that can be purchased from a single store. This makes the medication easier to purchase in large quantities. I am concerned that action should be taken to limit the amount of loperamide medication that can be purchased from a single store, due to the fact that it is apparently being used (on occasion) to fuel addiction and due to the risk of overdose and death. ”

Is this part of a recurring concern?

Yes — Failure to secure and control medication.

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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

Responsible patients’ benefit from unrestricted retail access outweighs harms to the small number who deliberately misuse loperamide.

Verbatim wording from the response

“In particular, we have reflected on whether restricting the amount which can be purchased would have deterred a determined individual from obtaining such large quantities as in Mr McCaffrey’s case. On the evidence available to date, we consider that the benefit of access in retail outlets for those patients who use this medicine responsibly, outweighs the harms which may come to the very small number of individuals who deliberately misuse these medicines.”

Source location

2017-0195_Redacted
Page 2 · response
Published 9 August 2017

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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

There is insufficient evidence that loperamide is frequently misused enough to warrant prescription-only classification.

Verbatim wording from the response

“Loperamide is available as a General Sale List (GSL) medicine and as a Pharmacy medicine under the supervision of a pharmacist. There are no restrictions on the numbers of packs which can be purchased. Pack sizes of up to 12 tablets/capsules are available GSL and larger packs are available in pharmacies. One of the criteria for Prescription Only classification is that a medicine is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health. We do not consider that there is sufficient evidence that this criterion applies to loperamide. We have checked the report of the Advisory Council on Misuse of Drugs on Diversion and Illicit Supply of Medicines (DISM) from December 2016 and this has no mention of loperamide. The DISM report is available following this link:”

Source location

2017-0195_Redacted
Page 1 · response
Published 9 August 2017

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

    Write to marketing authorisation holders whose loperamide product information has not been updated.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 9 August 2017.
  2. 2

    Publish an MHRA Drug Safety Update article alerting healthcare professionals to loperamide overdose risks.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 9 August 2017.
  3. 3

    Update product information for loperamide-containing medicines with maximum-dose and overdose cardiac-risk warnings.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 9 August 2017.
  4. 4

    Keep loperamide risks under review and consider further regulatory action in light of new evidence.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 9 August 2017.

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

Write to marketing authorisation holders whose loperamide product information has not been updated.

Verbatim wording from the response

“As part of the PRAC update to include the cardiac warnings we are writing to the marketing authorisation holders who have not updated their Summary of Product characteristics (SmPCs) and Patient Information Leaflets (PILs). We will also publish an article in the MHRA’s Drug Safety Update Bulletin to alert healthcare professionals to the risks.”

Source location

2017-0195_Redacted
Page 2 · response
Published 9 August 2017

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 an MHRA Drug Safety Update article alerting healthcare professionals to loperamide overdose risks.

Verbatim wording from the response

“As part of the PRAC update to include the cardiac warnings we are writing to the marketing authorisation holders who have not updated their Summary of Product characteristics (SmPCs) and Patient Information Leaflets (PILs). We will also publish an article in the MHRA’s Drug Safety Update Bulletin to alert healthcare professionals to the risks.”

Source location

2017-0195_Redacted
Page 2 · response
Published 9 August 2017

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

Update product information for loperamide-containing medicines with maximum-dose and overdose cardiac-risk warnings.

Verbatim wording from the response

“Turning to the medical cause of death, we note that this was hypoxic brain injury, multiple cardiac arrests and loperamide overdose. As part of an EU-wide review the cardiac toxicity of loperamide was assessed in March 2017. The EU Pharmaceutical Risk Assessment Committee (PRAC) considered that there was the potential for loperamide in doses significantly in excess of the maximum therapeutic dose to cause cardiac problems. As a result of that review the product information is being updated for all loperamide-containing products to advise patients not to exceed the labelled dosing instructions along with warning statements about the risk of cardiac effects in overdose.”

Source location

2017-0195_Redacted
Page 2 · response
Published 9 August 2017

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

Keep loperamide risks under review and consider further regulatory action in light of new evidence.

Verbatim wording from the response

“We will keep this issue under review and will consider whether any further regulatory action is needed in the light of any new evidence.”

Source location

2017-0195_Redacted
Page 2 · response
Published 9 August 2017

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