Concerns raised 4 Lack of bottle warnings about unmeasured or excessive dosing View source Failure to counsel medication users on the use and risks of exceeding the prescribed dose View source Unmeasured dosing from the medication bottle View source Insufficient leaflet warnings about taking an excess dose View source See 1 more concern
Actions described in response An action is something this recipient says it has done, is doing, or plans to do in response to the concern raised. 2
Action
Request MHRA approval to strengthen and embolden the prescriber-direction warning on the Oramorph bottle label.
View source
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.
View source Respondent positions A position is what this recipient says about the concern when it does not describe a specific action. 5
Position
Existing dosing instructions and approved labelling were considered sufficiently clear despite lacking an explicit warning against drinking directly from the bottle.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed. View source
Position
Proposed changes to the leaflet, bottle label, and carton require review and approval by the MHRA and HPRA.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action. View source
Position
The existing Patient Information Leaflet sufficiently warns about excess-dose symptoms, risks, required medical help, and possible death, so no further action was taken.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed. View source
Position
Existing bottle and carton wording was considered sufficiently clear and compliant with statutory requirements, despite a proposal to strengthen and emphasise it.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed. View source
Position
Prescribing clinicians and other healthcare professionals are responsible for explaining dosing, risks, and consequences of exceeding prescribed doses.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action. View source See 4 more positions
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AI-generated summary
George Benjamin Rimmer · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
George Benjamin Rimmer was found deceased at home on 25 October 2018 after being prescribed Oramorph for pain following decompression surgery. The concerns included taking the medicine directly from the bottle rather than measuring doses, possible lack of counselling about exceeding the prescribed dose, and insufficient warnings about excess or cumulative dosing.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Boehringer Ingelheim Limited; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Boehringer Ingelheim Limited; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Boehringer Ingelheim Limited; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Boehringer Ingelheim Limited; that does 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.
” Open source report
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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 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
Open published response
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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 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
Open published response
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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 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
Open published response
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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 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
Open published response
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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 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
Open published response
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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 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
Open published response
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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 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
Open published response
Includes reports addressed to a minister or senior office-holder acting for this organisation.
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Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations