PFD report

George Benjamin Rimmer · Prevention of Future Deaths report

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Issued 16 Aug 2019•West Sussex

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
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
7

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 raised4

  1. Lack of bottle warnings about unmeasured or excessive dosing
    Part of recurring concern: Inadequate safety warnings on medication packagingPart of recurring concern: Toxicity risks from excessive or combined medication use
  2. Failure to counsel medication users on the use and risks of exceeding the prescribed dose
    Part of recurring concern: Unreliable medication dosage verification and communication
  3. Unmeasured dosing from the medication bottle
    Part of recurring concern: Unsafe medication administration
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

    Request MHRA approval to strengthen and embolden the prescriber-direction warning on the Oramorph bottle label.

    Stated by Boehringer Ingelheim LimitedStated plannedThe respondent said that this action was planned when they made their response on 18 October 2019.
  2. Action

    Request MHRA approval to add an explicit warning against drinking Oramorph directly from the bottle and describe overdose risks in the patient information leaflet.

    Stated by Boehringer Ingelheim LimitedStated plannedThe respondent said that this action was planned when they made their response on 18 October 2019.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.5

  1. Position

    Existing dosing instructions and approved labelling were considered sufficiently clear despite lacking an explicit warning against drinking directly from the bottle.

    Stated by Boehringer Ingelheim LimitedExisting 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 bottle warnings about unmeasured or excessive dosing

Wider context from the report

“(1) Mr Rimmer was known to swig out of the bottle rather than take a measured dose as many patient do; (2) Mr Rimmer self medicated as required; (3) Mr Rimmer’s GP did not recall advising him of the possible consequences of exceeding the prescribed dose. (4) There was no evidence to show that anyone had counselled Mr Rimmer with regards to the use of this drug. (5) The leaflet that comes with the bottle does not provide a sufficient warning of the dangers of taking an excess dose. (6) There is no mention of the dangers of drinking from the bottle and not measuring the dose. (7) There is no warning on the bottle to act as a reminder of the dangers of taking an excess dose or of the cumulative effect of taking more than the prescribed amount. ”

Is this part of a recurring concern?

Yes — Inadequate safety warnings on medication packaging; Toxicity risks from excessive or combined medication use.

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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

Failure to counsel medication users on the use and risks of exceeding the prescribed dose

Wider context from the report

“(1) Mr Rimmer was known to swig out of the bottle rather than take a measured dose as many patient do; (2) Mr Rimmer self medicated as required; (3) Mr Rimmer’s GP did not recall advising him of the possible consequences of exceeding the prescribed dose. (4) There was no evidence to show that anyone had counselled Mr Rimmer with regards to the use of this drug. (5) The leaflet that comes with the bottle does not provide a sufficient warning of the dangers of taking an excess dose. (6) There is no mention of the dangers of drinking from the bottle and not measuring the dose. (7) There is no warning on the bottle to act as a reminder of the dangers of taking an excess dose or of the cumulative effect of taking more than the prescribed amount. ”

Is this part of a recurring concern?

Yes — Unreliable medication dosage verification and communication.

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

Unmeasured dosing from the medication bottle

Wider context from the report

“(1) Mr Rimmer was known to swig out of the bottle rather than take a measured dose as many patient do; (2) Mr Rimmer self medicated as required; (3) Mr Rimmer’s GP did not recall advising him of the possible consequences of exceeding the prescribed dose. (4) There was no evidence to show that anyone had counselled Mr Rimmer with regards to the use of this drug. (5) The leaflet that comes with the bottle does not provide a sufficient warning of the dangers of taking an excess dose. (6) There is no mention of the dangers of drinking from the bottle and not measuring the dose. (7) There is no warning on the bottle to act as a reminder of the dangers of taking an excess dose or of the cumulative effect of taking more than the prescribed amount. ”

Is this part of a recurring concern?

Yes — Unsafe medication administration.

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

Insufficient leaflet warnings about taking an excess dose

Wider context from the report

“(1) Mr Rimmer was known to swig out of the bottle rather than take a measured dose as many patient do; (2) Mr Rimmer self medicated as required; (3) Mr Rimmer’s GP did not recall advising him of the possible consequences of exceeding the prescribed dose. (4) There was no evidence to show that anyone had counselled Mr Rimmer with regards to the use of this drug. (5) The leaflet that comes with the bottle does not provide a sufficient warning of the dangers of taking an excess dose. (6) There is no mention of the dangers of drinking from the bottle and not measuring the dose. (7) There is no warning on the bottle to act as a reminder of the dangers of taking an excess dose or of the cumulative effect of taking more than the prescribed amount. ”

Is this part of a recurring concern?

Yes — Inadequate safety warnings on medication packaging.

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

Request MHRA approval to strengthen and embolden the prescriber-direction warning on the Oramorph bottle label.

Verbatim wording from the response

“However, we propose to strengthen and emphasise the wording on both the bottle label and carton label:”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 8 · response
Published 18 October 2019

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

Request MHRA approval to add an explicit warning against drinking Oramorph directly from the bottle and describe overdose risks in the patient information leaflet.

Verbatim wording from the response

“However, we will propose to the MHRA that we include within the ‘HOW TO TAKE ORAMORPH ORAL SOLUTION’ section the following statement (or words to that effect to be agreed with the MHRA):”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 7 · response
Published 18 October 2019

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 dosing instructions and approved labelling were considered sufficiently clear despite lacking an explicit warning against drinking directly from the bottle.

Verbatim wording from the response

“Whilst there is no explicit warning in the PIL not to drink directly from the bottle, the wording of the ‘HOW TO TAKE ORAMORPH ORAL SOLUTION’ is also consistent with other oral morphine solutions (ref 9,10) available in the UK. These also provide specific instructions about measuring the correct dose but, like Oramorph®, they do not have an explicit warning not to drink directly from the bottle.”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 7 · response
Published 18 October 2019

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

Proposed changes to the leaflet, bottle label, and carton require review and approval by the MHRA and HPRA.

Verbatim wording from the response

“Please be advised that any proposed additions and amendments to the PIL, bottle and outer carton labelling will need to be reviewed and approved by both the MHRA (UK) and the Healthcare and Products Regulatory Agency (HPRA) in Ireland, since we maintain a joint pack for both countries.”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 9 · response
Published 18 October 2019

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 existing Patient Information Leaflet sufficiently warns about excess-dose symptoms, risks, required medical help, and possible death, so no further action was taken.

Verbatim wording from the response

“Conclusion 4 We feel the wording of the PIL (both current and June 2015 version) is sufficient to warn the patient of the need to take only the dose the doctor has prescribed, to seek medical help if too much is taken and the warning signs/symptoms and associated risks of taking too much and therefore we took no further action to this matter of concern.”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 6 · response
Published 18 October 2019

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 bottle and carton wording was considered sufficiently clear and compliant with statutory requirements, despite a proposal to strengthen and emphasise it.

Verbatim wording from the response

“Please be aware the space to include additional information on the bottle label is limited and guidance to the patient is covered in detail in the PIL (see response to matter of concern 4 confirming that the warning symptoms/signs and risks of an excess dose, including death, are clearly stated).”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 8 · response
Published 18 October 2019

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

Prescribing clinicians and other healthcare professionals are responsible for explaining dosing, risks, and consequences of exceeding prescribed doses.

Verbatim wording from the response

“We view this matter of concern as more pertinent to Mr Rimmer’s prescribing clinician and other healthcare professionals.”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 3 · response
Published 18 October 2019

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.5

  1. 1

    Update the Oramorph SmPC and patient information leaflet with EMA-recommended safety information.

    Stated by Boehringer Ingelheim LimitedStated completedThe respondent said that this action was complete when they made their response on 18 October 2019.
  2. 2

    Add boxed addiction and opioid warnings to the Oramorph bottle label.

    Stated by Boehringer Ingelheim LimitedStated completedThe respondent said that this action was complete when they made their response on 18 October 2019.
  3. 3

    Submit the proposed leaflet, bottle-label and carton-label changes to UK and Irish regulators, including a redacted copy of the coroner’s letter, by December 2019.

    Stated by Boehringer Ingelheim LimitedStated plannedThe respondent said that this action was planned when they made their response on 18 October 2019.
  4. 4

    Request MHRA approval to strengthen and embolden the prescriber-direction warning on the Oramorph outer carton label.

    Stated by Boehringer Ingelheim LimitedStated plannedThe respondent said that this action was planned when they made their response on 18 October 2019.
  5. 5

    Add boxed addiction and opioid warnings to the Oramorph outer carton label.

    Stated by Boehringer Ingelheim LimitedStated completedThe respondent said that this action was complete when they made their response on 18 October 2019.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    The existing Patient Information Leaflet clearly instructs patients about prescribed dosing, maximum doses, and seeking advice when treatment is ineffective.

    Stated by Boehringer Ingelheim LimitedExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

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 the Oramorph SmPC and patient information leaflet with EMA-recommended safety information.

Verbatim wording from the response

“Boehringer Ingelheim Limited (BIL) takes the safety of our medicines extremely seriously and ensures compliance with all regulations with respect to the monitoring of safety, packaging, labelling and provision of information to healthcare professionals (via the Summary of Product Characteristics (SmPC) and patients (via the Patient Information Leaflet [PIL]).”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 1 · response
Published 18 October 2019

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 boxed addiction and opioid warnings to the Oramorph bottle label.

Verbatim wording from the response

“In addition, following a request by the MHRA to the manufacturers of opioid containing medicines in a letter dated 7th May 2019, the outer carton labelling (ref 3) and bottle label (ref 4) have been updated to contain the following boxed statement:”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 2 · response
Published 18 October 2019

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

Submit the proposed leaflet, bottle-label and carton-label changes to UK and Irish regulators, including a redacted copy of the coroner’s letter, by December 2019.

Verbatim wording from the response

“Please be advised that any proposed additions and amendments to the PIL, bottle and outer carton labelling will need to be reviewed and approved by both the MHRA (UK) and the Healthcare and Products Regulatory Agency (HPRA) in Ireland, since we maintain a joint pack for both countries.”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 9 · response
Published 18 October 2019

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

Request MHRA approval to strengthen and embolden the prescriber-direction warning on the Oramorph outer carton label.

Verbatim wording from the response

“However, we propose to strengthen and emphasise the wording on both the bottle label and carton label:”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 8 · response
Published 18 October 2019

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 boxed addiction and opioid warnings to the Oramorph outer carton label.

Verbatim wording from the response

“In addition, following a request by the MHRA to the manufacturers of opioid containing medicines in a letter dated 7th May 2019, the outer carton labelling (ref 3) and bottle label (ref 4) have been updated to contain the following boxed statement:”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 2 · response
Published 18 October 2019

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 existing Patient Information Leaflet clearly instructs patients about prescribed dosing, maximum doses, and seeking advice when treatment is ineffective.

Verbatim wording from the response

“We have carefully reviewed the current and June 2015 version of the PIL and consider both versions provide clear instruction on the intended dosing (amount and frequency) in the section entitled “HOW MUCH TO TAKE” by reminding the patient:”

Source location

2019-0269-Response-by-Boehringer-Ingelheim
Page 4 · response
Published 18 October 2019

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