8 Oct 2018 Natasha Charlotte Rose Ednan-Laperouse · Prevention of Future Deaths report London (West)
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Concerns raised 4 Inadequate or unclear allergen labelling on packaging View source Failure to maintain a coherent and coordinated system for monitoring customer allergic reactions View source Inadequate adrenaline dose for anaphylaxis View source Use of adrenaline injector needles that fail to access muscle View source See 1 more concern
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Natasha Charlotte Rose Ednan-Laperouse · 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
Natasha Charlotte Rose Ednan-Laperouse, who was allergic to sesame, ate a baguette purchased from Pret-a-Manger that contained unlabelled sesame. She developed an anaphylactic reaction on a flight to Nice and died in hospital shortly after landing on 17 July 2016. The report raised concerns about inadequate allergen labelling, inadequate monitoring of customer allergic reactions, and the needle length and adrenaline dose of some autoinjectors used in emergency treatment.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inadequate or unclear allergen labelling on packaging
Wider context from the report “(1) That allergens were not labelled adequately or clearly on Pret-a-Manger packaging when prepared in their kitchens “pre-packed for direct sale” utilising regulation 5 of the Food Information Regulations. Regulation 5 allows for food outlets to avoid full food labelling requirements whether they prepare a small number of items in local shops or in the case of Pret, over 200 million items for sale by preparing these items in “local kitchens”. These items prepared in “local kitchens” are in fact “assembled” in large parts from items made in factory style outlets to Pret specifications. I was left with the impression that the “local kitchens” were in fact a device to evade the spirit of the regulation.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to maintain a coherent and coordinated system for monitoring customer allergic reactions
Wider context from the report “(2) In the case of Pret-a-manger there was no coherent or co-ordinated system for monitoring customer allergic reactions despite sales of more than 200 million items. In some cases concerns were notified to Customer Services and in some they were noted to the safety department. The two did not know what the other was responding to. It was clear that there was no overarching monitoring system in place . In response to questioning on this I was told that the manager responsible for safety now received all notifications and would monitor them. In my view this remains highly inadequate. In my view sales of 200 million items some with expressly commissioned but hidden allergens require a robust safety auditing system. The previous system was unsafe and the system proposed equally so in my view .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inadequate adrenaline dose for anaphylaxis
Wider context from the report “(4) The dose of adrenaline in Epipen is 300mcg . The UK Resuscitation Council recommends a standard emergency dose of 500mcg . Emerade contains a dose including 500mcg. The combination of what my expert told me was an inadequate dose of adrenaline for anaphylaxis and an inadequate length needle raises serious safety concerns.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Use of adrenaline injector needles that fail to access muscle
Wider context from the report “(3) In the Emergency treatment of anaphylactic reactions Guidelines for healthcare providers the preferred needle length is 25 mm for adrenaline injectors to access muscle in most people. I heard during expert evidence that Epipen needle length was 16mm - suitable according to the UK Resuscitation Council for “pre-term or very small infants”. The use of needles which access only subcutaneous tissue and not muscle is in my view inherently unsafe . An alternative autoinjector, Emerade has a 24 mm needle.
” 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 Evaluating clinical study data for each adrenaline auto-injector brand as submissions become available.
Verbatim wording from the response “The review of clinical study results for Epipen undertaken by the MHRA and other competent authorities throughout Europe commenced on 15th September 2018. The MHRA raised questions which the company is currently addressing and will result in further information being submitted for evaluation. Regulatory action will be taken as necessary on completion of the review.” Source location 2018-0279-Response-by-MHRA
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Implemented product-information changes covering two-injector use, repeat dosing, carer training, and exposed needle lengths for UK adrenaline auto-injectors.
Verbatim wording from the response “- Improvements to the product information for prescriber and patient, including strengthening of the recommendation that patients should carry two auto-injectors to enable a second injection if there has been an insufficient response within the first 15 minutes; and reinforcement of the need for family members, carers and teachers to be properly trained in use of the patient’s auto-injector.” Source location 2018-0279-Response-by-MHRA
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Conducting an overarching evaluation of all adrenaline auto-injector study data to determine whether further safety measures are needed.
Verbatim wording from the response “It is foreseen that the evaluation of results for all adrenaline auto-injectors marketed in the UK (Epipen, Jext and Emerade) will be completed during 2019. The availability of data on exposed needle length for all devices, together with the results of clinical studies, will allow an informed decision to be taken on prescribing and advice given to patients. When all study data are available, an over-arching evaluation is intended, to inform whether further measures may be required, that may include a recommendation for longer needle lengths.” Source location 2018-0279-Response-by-MHRA
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Conducted and progressed a European safety review of adrenaline auto-injectors, including assessment of needle length and clinical effectiveness evidence.
Verbatim wording from the response “You question whether the exposed needle length of Epipen (16 mm) is adequate to reach muscle in most patients. The adequacy of adrenaline auto-injector needle length was addressed by the MHRA as one aspect of a review in 2014. The available evidence was found to be lacking in some key aspects and the MHRA therefore took this forward as part of a wider European safety review that reported on 25 June 2015. As one of the legally binding conditions following the European safety review, manufacturers were required to disclose the exposed needle length of their adrenaline auto-injector devices in the product information to inform the healthcare professional and patient so they can take this in to account in deciding which device is appropriate for an individual patient.” Source location 2018-0279-Response-by-MHRA
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The 25 mm needle recommendation applies to healthcare professionals’ manual injections, not adrenaline auto-injectors intended for self-administration.
Verbatim wording from the response “For clarification, the preferred needle length of 25 mm that you refer to in your report is recommended by the UK Resuscitation Council in the context of anaphylaxis treatment by healthcare professionals, when adrenaline is recommended to be administered by manual intramuscular injection with a syringe” Source location 2018-0279-Response-by-MHRA
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The 500 microgram adrenaline recommendation applies to healthcare professionals’ manual injections, not auto-injector self-administration.
Verbatim wording from the response “A discrete, efficacious dose of adrenaline for the emergency treatment of anaphylaxis is not defined. The Resuscitation Council guidance for a 500 mcg dose refers to the dose administered by a healthcare professional (by manual intramuscular injection with a syringe and needle) and is not their recommended dose for adrenaline auto-injector self-administration. In a healthcare setting, a second dose of 500 mcg adrenaline is recommended to be administered after 5 minutes if the patient is not responding. An experienced specialist could also treat anaphylaxis with repeated bolus doses of 50mcg of intravenous adrenaline or may initiate intravenous infusion of adrenaline according to the response. In the healthcare” Source location 2018-0279-Response-by-MHRA
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8 Aug 2018 Ian Paul Wolstenholme · Prevention of Future Deaths report Manchester North
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Concerns raised 2 Potential for serious harm or death from combined drug toxicity associated with polypharmacy View source Lack of guidance for clinicians on prescribing highly addictive and potentially harmful drugs alongside one another View source
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AI-generated summary
Ian Paul Wolstenholme · 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
Ian Paul Wolstenholme was found collapsed at home on 17 December 2017 and died later that day. The medical cause of death was combined drug toxicity, with liver cirrhosis and diabetes mellitus also contributing. The report raised concern about the lack of guidance for prescribing highly addictive and potentially harmful drugs together, particularly in cases of polypharmacy.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Potential for serious harm or death from combined drug toxicity associated with polypharmacy
Wider context from the report “1. During the course of the evidence, it became apparent that there is no guidance – national or otherwise - available to Clinicians such as GPs, Hospital doctors etc. on the how best to approach the prescribing of highly addictive and potentially very harmful drugs alongside one another. In this case, the deceased had been legitimately prescribed three different types of neuropathic analgesia (including Pregabalin), alongside other opiate based medications. Whilst such drugs are almost always prescribed for very good clinical reason/s, this type of polypharmacy gives rise to the potential risk of serious harm/death . I believe that guidance would help to prevent future deaths from combined drug toxicity .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of guidance for clinicians on prescribing highly addictive and potentially harmful drugs alongside one another
Wider context from the report “1. During the course of the evidence, it became apparent that there is no guidance – national or otherwise - available to Clinicians such as GPs, Hospital doctors etc. on the how best to approach the prescribing of highly addictive and potentially very harmful drugs alongside one another . In this case, the deceased had been legitimately prescribed three different types of neuropathic analgesia (including Pregabalin), alongside other opiate based medications. Whilst such drugs are almost always prescribed for very good clinical reason/s, this type of polypharmacy gives rise to the potential risk of serious harm/death. I believe that guidance would help to prevent future deaths from combined drug toxicity.
” 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 Review opioid medicines product information and seek expert advice on benefit-risk and regulatory recommendations.
Verbatim wording from the response “You will be interested to note that the MHRA is currently undertaking a review of the product information for all opioid medicines and will be seeking the advice of an Expert Working Group of the Commission on Human Medicines. The Expert Working Group will consider the benefit risk of opioid-containing medicines and make recommendations for regulatory action to better support appropriate use of prescription opioids, including educational initiatives to ensure awareness of risks for both patients and healthcare professionals.” Source location 2018-0272-Response-by-Department-of-Health
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29 May 2018 Brian Leonard Bicat · Prevention of Future Deaths report West Yorkshire (Western)
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Concerns raised 6 Unavailability of verbal fire-risk warnings from healthcare professionals for retail and online purchases View source Lack of accurate national data on fire incidents involving paraffin-based skin products View source Inconsistent fire-risk alerts and warnings across NHS prescribing systems View source Lack of healthcare professional awareness of the fire hazard from low-paraffin emollient creams View source Failure to display fire-risk warnings on all product packaging View source Fire hazard from paraffin-based ointments and low-paraffin emollient creams View source See 3 more concerns
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Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Brian Leonard Bicat · 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
Brian Leonard Bicat sustained severe burns at home on 22 September 2017 when his dressing gown caught fire while he was smoking a cigarette. He died later that day from his extensive cutaneous burns, with evidence indicating that paraffin-based emollient creams and ointments increased the speed and intensity of the fire. The principal concerns were that low-paraffin emollients may pose a fire hazard, that warnings were not displayed consistently on packaging or communicated by healthcare professionals, and that related prescribing alerts and incident data were inconsistent or incomplete.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Unavailability of verbal fire-risk warnings from healthcare professionals for retail and online purchases
Wider context from the report “Members of the public are able to purchase such products in retail outlets and online where verbal warnings from healthcare professionals are not given
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of accurate national data on fire incidents involving paraffin-based skin products
Wider context from the report “Consider a review of the current effectiveness of obtaining fire incident reports involving paraffin based skin products since there is currently a lack of accurate national data involving paraffin based skin products
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inconsistent fire-risk alerts and warnings across NHS prescribing systems
Wider context from the report “The NHS prescribing systems (system One and Optimise) appear to be updated by individual CCG’s resulting inconsistent alerts and warnings .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of healthcare professional awareness of the fire hazard from low-paraffin emollient creams
Wider context from the report “Health care professionals in both hospital and community setting may not be aware of the potential fire hazard poised by emollient creams which contain a low level of paraffin
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to display fire-risk warnings on all product packaging
Wider context from the report “Warnings of such risks are not displayed on all product packaging
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Fire hazard from paraffin-based ointments and low-paraffin emollient creams
Wider context from the report “Paraffin based ointments and emollient creams which contain a low level of paraffin pose a potential fire hazard risk
” 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 Issue safety reminders and warnings to healthcare professionals about fire risks from paraffin-based emollients.
Verbatim wording from the response “In March 2008 MHRA Devices issued a reminder to healthcare professionals of the potential risks associated with paraffin based emollients, as highlighted by the work of the National Patient Safety Agency (NPSA) in 2007. This reminder was in the form of a “One Liner” which was published in issue 56. Since, at that time, as no adverse incident reports had been received, it was not considered necessary to issue any further communication.” Source location 2018-0277-Response-by-MHRA
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Request UK manufacturers to review Class I devices and require Notified Bodies to ensure higher-risk devices undergo manufacturer review and risk assessment.
Verbatim wording from the response “Working in collaboration with colleagues in the medicines regulatory part of the Agency in Spring 2017 MHRA Devices wrote to UK manufacturers of Class I medical devices (the lowest risk category) directly and asked them to undertake a review of their products. In addition, we asked the UK Notified Bodies to ensure that a review and risk assessment was undertaken by manufacturers of higher risk classification medical devices.” Source location 2018-0277-Response-by-MHRA
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Notify European regulatory colleagues and request dissemination to Notified Bodies overseeing manufacturers supplying the European market.
Verbatim wording from the response “We also brought the issue to the notice of European regulatory colleagues to highlight the dangers internationally. All European Competent Authorities were asked to share the letter mentioned above to, with Notified Bodies they oversee to ensure coverage of all manufacturers with products in the European market.” Source location 2018-0277-Response-by-MHRA
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review evidence on risks from paraffin-containing medicines and devices and obtain ad hoc Expert Group recommendations on appropriate regulatory action.
Verbatim wording from the response “In response to more recent evidence regarding the risk with emollient products paraffin, including a number of fatalities reported since 2017 (many of which were historical), MHRA is reviewing the available evidence regarding the risk for a wider range of paraffin-containing medicines and devices and has convened an ad hoc Expert Group to advise on the appropriate regulatory action for both medicines and medical devices.” Source location 2018-0277-Response-by-MHRA
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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 manufacturers to include emollient fire risks in product risk analyses and provide packaging or instructions-for-use warnings.
Verbatim wording from the response “However, in addition, we have written to manufacturers to raise awareness of this potential risk. This highlighted the need for the risk of fire to be included in their product risk analysis and ensuring warnings of the potential risk were placed either on packaging or included in the device’s instructions for use. We have previously issued warnings regarding the dangers around smoking and bed fires (MDA/2013/073).” Source location 2018-0277-Response-by-MHRA
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Raise emollient fire risks with NHS Improvement, Medical Device Safety Officers and the Care Quality Commission for communication to relevant care staff and users.
Verbatim wording from the response “The issue has been raised with NHS Improvement and Medical Device Safety Officers (MDSOs). The latter are individuals in each NHS Trust in England who ensure safety information is made available to relevant staff. MHRA is also liaising with the Care Quality Commission to highlight the potential dangers to users within the care community.” Source location 2018-0277-Response-by-MHRA
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation No further communication was considered necessary in 2008 because no adverse incident reports had been received.
Verbatim wording from the response “In March 2008 MHRA Devices issued a reminder to healthcare professionals of the potential risks associated with paraffin based emollients, as highlighted by the work of the National Patient Safety Agency (NPSA) in 2007. This reminder was in the form of a “One Liner” which was published in issue 56. Since, at that time, as no adverse incident reports had been received, it was not considered necessary to issue any further communication.” Source location 2018-0277-Response-by-MHRA
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Concerns raised 1 Use of Ecolab sheaths creating increased resistance on insertion View source
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Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Margaret Elizabeth Clark · 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
Margaret Elizabeth Clark suffered an oesophageal tear during a transoesophageal echocardiogram on 9 May 2017 and later died of sepsis resulting from the tear on 12 August 2017. The report raised concern that Ecolab sheaths used for the procedure may have created increased resistance and contributed to fatal oesophageal tears, and suggested reviewing their use.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Use of Ecolab sheaths creating increased resistance on insertion
Wider context from the report “I was told that in 2017 the types of probes used for TOEs were changed, to a design which required covering with a sheath. Using that sheath, three fatal oesophageal tears had occurred in the space of 5 months, involving in each case experienced anaesthetists who had conducted TOEs routinely for many years without event. [I was told that there had been one previous incident in the preceding 16 years]. The sheaths used – Ecolab Ultracover for TEE – were replaced at Blackpool Victoria Hospital with alternative [softer] sheaths – Probetecion TOE/TEE Transducer Kit. Since the replacement sheaths have been used, there have been no incidents of tear. I was told that the Ecolab sheaths may still be used in other hospitals and Trusts. A Serious Incident Investigation Report expressed a concern that the tears may have resulted from the use of the Ecolab sheaths, which [it was felt] created more resistance on insertion than had been the case before their use.
(1) I believe you should review the use of the Ecolab sheaths and consider whether they should not be replaced in all hospitals and Trusts by the Protec[tion] sheaths.
” Open source report
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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 safety of TOE probe covers.
Verbatim wording from the response “The safety of TOE probe covers will continue to be monitored and appropriate regulatory action to protect public health will be taken as and when necessary.” Source location 2018-0050-Response-by-MHRA
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review adverse-incident reports relating to Ecolab sheaths and TOE probe covers.
Verbatim wording from the response “The MHRA performed a review of the adverse incident database, looking for incidents relating to Ecolab sheaths and found only two reports that relate to TOE probe covers splitting, this includes the report from Blackpool Victoria Hospital.” Source location 2018-0050-Response-by-MHRA
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Inability to compare sheath softness prevents recommending replacement of Ecolab sheaths across hospitals and trusts.
Verbatim wording from the response “The MHRA are unable to compare “softness” of sheaths on the market and therefore cannot recommend that Ecolab sheaths are replaced in all hospitals and Trusts by the Protection sheaths.” Source location 2018-0050-Response-by-MHRA
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Concerns raised 1 Unavailability in the UK of Andexanet alfa for severe bleeding during treatment with Factor Xa inhibitor anticoagulants View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
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Michael John Spencer · 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
Michael Spencer died from a fatal midbrain haemorrhage while being treated with Rivaroxaban as part of a clinical trial. The concern was that Andexanet alfa, a specific reversal agent for Factor Xa inhibitor anticoagulants, was not available in the UK, although the evidence stated that its availability would not have changed the outcome in Mr Spencer’s case.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Unavailability in the UK of Andexanet alfa for severe bleeding during treatment with Factor Xa inhibitor anticoagulants
Wider context from the report “Rivaroxaban is one of 4 Factor Xe inhibitor anticoagulants currently available. Potentially fatal bleeding can take place following overdose of these drugs or following even relatively injury when patients are taking them. A drug specifically designed to reverse the anti-coagulant effect of the Factor Xa antagonist, Andexanet alfa, is available in some countries which can be used in such circumstances to reverse the anticoagulant effect of the drugs. Evidence was given at the inquest to the effect It is not yet available in the UK, even for compassionate use , and that its availability could be lifesaving when severe bleeding occurs during treatment with Factor Xa inhibitor anti-coagulant drugs . For the avoidance of doubt, this evidence was given in the course of a general explanation of the action of Rivaroxaban and the management of pathological bleeding during its use. It was made clear that the ready availability of Andexanet alfa would not have changed the outcome in Mr Spencer’s case. The concern expressed was in relation to the current non-availability of this specific reversal agent in the face of the increasing clinical use of Factor Xa inhibitor anticoagulants.
” Open source report
21 Jul 2017 Pauline Taylor · Prevention of Future Deaths report West Yorkshire (West)
View report summary
Concerns raised 9 Potential fire hazard from low-paraffin emollient creams View source Failure to verbally inform over-the-counter purchasers of fire hazards from low-paraffin emollient creams View source Fire escalation hazard from polyurethane coating on Nimbus 6 airflow mattress coverings View source Failure to provide private community-care companies with alerts about relevant medicines and medical devices View source Failure to offer a further fire-risk-assessment referral or review after a major change in circumstances View source Lack of healthcare professional awareness of fire hazards from low-paraffin emollient creams View source Lack of care-home awareness of fire hazards from low-paraffin emollient creams View source Failure to display fire-risk warnings on all product packaging View source Failure to undertake a further risk assessment after a significant change in circumstances View source See 6 more concerns
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Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Pauline Taylor · 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
Pauline Taylor, who was bedbound and living alone, died in her home after a fire developed around her bed on 30 May 2015. The report identified concerns about the fire risks of low-paraffin emollient creams, limited warnings and awareness of those risks, the contribution of the airflow mattress, and the absence of a further risk assessment after her circumstances changed.
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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. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Potential fire hazard from low-paraffin emollient creams
Wider context from the report “(1) Zerobase and other emollient creams which contain a low level of paraffin pose a potential fire hazard risk.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to verbally inform over-the-counter purchasers of fire hazards from low-paraffin emollient creams
Wider context from the report “(4) Members of the public are able to purchase emollient creams across the counter but are not verbally made aware of the potential fire hazards of emollient cream containing a low level of paraffin .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Fire escalation hazard from polyurethane coating on Nimbus 6 airflow mattress coverings
Wider context from the report “(7) The polyurethane coating used in the outer covering of the nimbus 6 airflow mattress appears to have contributed to the speed of the fires development and also its intensity.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to provide private community-care companies with alerts about relevant medicines and medical devices
Wider context from the report “(5) Private companies who provide carers in the community do not receive alerts with regard to medicines and medical devices which could impact on the risk assessments and the manner in which carers working in the private sector provide care.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to offer a further fire-risk-assessment referral or review after a major change in circumstances
Wider context from the report “(9) A further fire risk assessment referral/review was not offered to Mrs Taylor by Locala following a major change in her circumstance (she had become bedbound in March 2017.)
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of healthcare professional awareness of fire hazards from low-paraffin emollient creams
Wider context from the report “(3) Health care professionals both in a hospital and community setting may not be aware of the potential fire hazard posed by emollient creams which contain a low level of paraffin.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of care-home awareness of fire hazards from low-paraffin emollient creams
Wider context from the report “(6) Care homes (in both the local authority and private sector) who provide residential/nursing care may not be aware of the potential fire hazard risk of emollient creams which contain low levels of paraffin.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to display fire-risk warnings on all product packaging
Wider context from the report “(2) Warnings of such risks are not displayed on all product packaging.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to undertake a further risk assessment after a significant change in circumstances
Wider context from the report “(8) Following a significant change in Mrs Taylor's circumstances in March 2015 a further risk assessment had not been undertaken by Locala.
” 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 Raise emollient fire risks with NHS Improvement and Medical Device Safety Officers.
Verbatim wording from the response “The issue has been raised with NHS Improvement and Medical Device Safety Officers (MDSOs). The latter are individuals in each NHS Trust in England who ensure safety information is made available to relevant staff. MHRA is also liaising with the Care Quality Commission to highlight the potential dangers to users within the care community.” Source location 2017-0330-Response-by-MHRA
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 Undertake an in-depth review of emollient instructions for use and reported adverse incidents.
Verbatim wording from the response “It is recognised that there are differences in the labelling of these products and in light of this during 2017, both Medicines and Devices parts of MHRA are undertaking an in-depth review of instructions for use and reported adverse incidents.” Source location 2017-0330-Response-by-MHRA
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 reviewing methods for communicating important healthcare information to healthcare professionals and the public.
Verbatim wording from the response “MHRA is continually reviewing methods of communicating important healthcare information to healthcare professionals and members of the public. However, communication to the general public is a challenging area for all aspects of healthcare. The MHRA does publish Medical Device Alerts and Drug Alerts issued via the Central Alerting System (CAS). Within CAS there are thousands of subscribers from organisations in the independent/private sectors, with frequent requests received at the helpdesk to add new subscribers and alter existing records. This is a well-established and effective mechanism for communicating important safety information to healthcare professionals throughout the NHS and private health sectors.” Source location 2017-0330-Response-by-MHRA
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 Highlight published NPSA emollient-fire safety work to healthcare workers.
Verbatim wording from the response “MHRA received the first adverse incident reports of fires involving emollients in March 2017. However, we were aware of the work undertaken by the National Patient Safety Agency (NPSA) in 2007 and highlight this work to healthcare workers when it was published. In the form of a “One Liner” publication in March 2008, issue 56. Since that time, as no adverse incident reports were received, it was not considered necessary to issue any further communication.” Source location 2017-0330-Response-by-MHRA
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 Issue warnings about smoking and bed-fire dangers through a Medical Device Alert.
Verbatim wording from the response “Additionally, we have worked with manufacturers to raise awareness of this potential risk. This work highlighted the need for risk of fire to be included in their product risk analysis and ensuring warnings of the potential risk were placed either on packaging or included in the device’s instructions for use. We have previously issued warnings regarding the dangers around smoking and bed fires (MDA/2013/073).” Source location 2017-0330-Response-by-MHRA
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 Notify European regulatory colleagues about emollient fire dangers and request wider circulation to relevant notified bodies.
Verbatim wording from the response “We also brought the issue to the notice of European regulatory colleagues to highlight the dangers internationally. All European Competent Authorities were asked to share the letter mentioned above with Notified Bodies they oversee to ensure coverage of all manufacturers with products in the European market.” Source location 2017-0330-Response-by-MHRA
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 Liaise with the Care Quality Commission to highlight emollient fire dangers to care-community users.
Verbatim wording from the response “The issue has been raised with NHS Improvement and Medical Device Safety Officers (MDSOs). The latter are individuals in each NHS Trust in England who ensure safety information is made available to relevant staff. MHRA is also liaising with the Care Quality Commission to highlight the potential dangers to users within the care community.” Source location 2017-0330-Response-by-MHRA
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 Consider publishing additional safety advice after completing the emollient review, in conjunction with medicines colleagues.
Verbatim wording from the response “We aim to have completed our review by the end of 2017 and will consider the need for publication of any additional safety advice at this time in conjunction with our medicine colleagues.” Source location 2017-0330-Response-by-MHRA
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 Work with manufacturers to raise awareness of emollient fire risks.
Verbatim wording from the response “Additionally, we have worked with manufacturers to raise awareness of this potential risk. This work highlighted the need for risk of fire to be included in their product risk analysis and ensuring warnings of the potential risk were placed either on packaging or included in the device’s instructions for use. We have previously issued warnings regarding the dangers around smoking and bed fires (MDA/2013/073).” Source location 2017-0330-Response-by-MHRA
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 Ask manufacturers and notified bodies to review products and undertake relevant fire-risk assessments.
Verbatim wording from the response “In Spring 2017 MHRA wrote to UK manufacturers of Class I medical devices (the lowest risk category) directly and asked them to undertake a review of their products. In addition, we asked the UK Notified Bodies to ensure that a review and risk assessment was undertaken by manufacturers of higher risk classification medical devices.” Source location 2017-0330-Response-by-MHRA
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 mattress system’s therapeutic benefits generally outweigh fire risks, which are mitigated by labelling and instructions against smoking or naked flames.
Verbatim wording from the response “The therapeutic benefits of the mattress system will generally have been found to outweigh the likelihood and consequences of a fire, in part mitigated by the labelling and instructions for use, advising against smoking or using naked flames whilst in bed.” Source location 2017-0330-Response-by-MHRA
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 No further communication was considered necessary because no adverse incident reports had been received since the earlier safety publication.
Verbatim wording from the response “MHRA received the first adverse incident reports of fires involving emollients in March 2017. However, we were aware of the work undertaken by the National Patient Safety Agency (NPSA) in 2007 and highlight this work to healthcare workers when it was published. In the form of a “One Liner” publication in March 2008, issue 56. Since that time, as no adverse incident reports were received, it was not considered necessary to issue any further communication.” Source location 2017-0330-Response-by-MHRA
Open published response
16 Jun 2017 Aaron John Peter McCaffrey · Prevention of Future Deaths report Manchester South
View report summary
Concerns raised 1 Lack of limits on the amount of loperamide medication purchasable from a single store View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Aaron John Peter McCaffrey · 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
Aaron John Peter McCaffrey had a history of addiction to loperamide and regularly took large quantities. After taking around 250 tablets on 13 January 2017, he collapsed, was admitted to hospital, and died on 19 January 2017; the recorded conclusion was a drug-related death. The principal concern was that there was no apparent limit on the amount of loperamide that could be purchased from a single store, facilitating large-quantity purchases and creating a risk of overdose and death.
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 Medicines and Healthcare products Regulatory Agency; that does 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.
” Open source report
×
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
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 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
Open published response
14 Jun 2017 Mr Maurice Macdonnell · Prevention of Future Deaths report Inner South London
View report summary
Concerns raised 1 Failure to separate research investigators from decisions on further study drug administration View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Mr Maurice Macdonnell · 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
Mr Maurice Macdonnell had advanced liver cancer and participated in a clinical trial of Nivolumab. After developing ptosis and fatigue, he received a second dose before the cause of the ptosis had been diagnosed, later becoming progressively weaker and dying after cardiac arrest; the inquest recorded myocarditis and myositis associated with an immune-related adverse reaction. The principal concern was a potential conflict of interest where the doctor deciding whether to administer the treatment was also the research investigator.
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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to separate research investigators from decisions on further study drug administration
Wider context from the report “The decision to administer the second dose after fatigue and ptosis had developed was taken by the doctor who was also the investigator in the research study. There would appear to be a conflict of interest between the benefits of keeping the patient in the trial in the interests of research and the potential risks to health of the patient from receiving the second dose, if that decision is taken by the same doctor.
████████ Director BMS R&D advised that the research had received UK Ethics Committee Approval, but this approval was not received as evidence by the court. He advised in his experience in international drug trials, there was no such arrangement of different doctors to deal with this conflict of interest. He pointed out that the severity of reaction was not enough to require stopping the drug, according to the protocol, but he would want the drug stopped if it was likely the changes were related to drug administration. He encouraged clinical exploration of alternative diagnoses. The letter of response to the enquiry made of BMS by the research nurse advised “hold any further study drug administration”.
After the inquest the R&D director wrote to the coroner explained the extensive training of investigators and they have access to a medical monitor, who attends a committee to see if any modifications are required in the trial for safety reasons. He also informs the court that introducing an independent adjudicator could pose a risk of bias and a burden of bureaucracy.
” 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 Continue monitoring fatal events among UK nivolumab clinical-trial participants.
Verbatim wording from the response “MHRA does not consider that any further action is warranted at this time given that the fatal event is not considered a new safety signal and all appropriate mitigation steps are considered to be in place for nivolumab clinical trials. MHRA will continue to monitor all fatal events in the UK for patients participating in clinical trials and who are being treated with nivolumab. Conflict of interest will continue to be reviewed by the Ethics Committee for all clinical trials in line with the HRA guidance.” Source location 2017-0188-Response-by-MHRA
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 Review the trial’s conflict-of-interest concern through an Expert Good Clinical Practice Inspector.
Verbatim wording from the response “The conflict of interest concern for Mr Macdonnell was also reviewed by an Expert Good Clinical Practice Inspector who raised no concerns from the perspective of MHRA Inspectorate.” Source location 2017-0188-Response-by-MHRA
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 Conflict-of-interest matters lie outside MHRA’s remit for clinical trials.
Verbatim wording from the response “With regard to the possible conflict of interest in reporting the death of Mr Macdonnell and the balance between the risk to the patient from receiving further doses and the benefit from staying in the trial in the interests of research, MHRA has received an opinion from the Health Research Authority (HRA) as conflict of interest lies outside the remit of MHRA for clinical trials. The HRA confirmed that it is common practice for the Principal Investigator in a clinical trial to also be the patient's physician. The duty of care owed by a physician should always be the primary role, above the interests of the trial, and this is generally accepted by physicians participating in clinical trials. These aspects are considered by the Ethics Committee at the time of the initial application of the clinical trial to them, in accordance with the Declaration of Helsinki.” Source location 2017-0188-Response-by-MHRA
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 mitigation steps are considered sufficient for nivolumab clinical trials, so no further action is warranted at this time.
Verbatim wording from the response “MHRA does not consider that any further action is warranted at this time given that the fatal event is not considered a new safety signal and all appropriate mitigation steps are considered to be in place for nivolumab clinical trials. MHRA will continue to monitor all fatal events in the UK for patients participating in clinical trials and who are being treated with nivolumab. Conflict of interest will continue to be reviewed by the Ethics Committee for all clinical trials in line with the HRA guidance.” Source location 2017-0188-Response-by-MHRA
Open published response
Concerns raised 2 Potential defect in an implanted cardiac valve View source Conflicting assessments of an implanted cardiac valve defect View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Muriel Ann Brett · 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
Muriel Ann Brett underwent aortic valve replacement surgery on 11 March 2016, followed by a second operation the next day. After three transoesophageal echocardiographs, an oesophageal perforation was identified on 20 March 2016, and she died that day in hospital. Concerns included that the implanted valve was considered defective by the operating surgeon, although an independent review did not identify a defect.
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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Potential defect in an implanted cardiac valve
Wider context from the report “(1) It is of concern that a valve implanted at cardiac surgery was felt by the operating surgeon to be defective ;
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Conflicting assessments of an implanted cardiac valve defect
Wider context from the report “(2) It is further of concern that an independent review of the explanted valve did not reveal a defect, in contrast to the view of the operating surgeon .
” Open source report
30 Nov 2016 Marjorie Cybil Bassendine · Prevention of Future Deaths report Surrey
View report summary
Concerns raised 3 Failure to undertake an ECG before commencing QT-prolonging medication View source Failure to undertake regular ECG monitoring during continuing treatment with multiple psychotropic medication View source Failure to recognise the QT-prolonging potential of multiple psychotropic medication View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Marjorie Cybil Bassendine · 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
Marjorie Cybil Bassendine, aged 98, suddenly collapsed while eating breakfast at her care home on 2 October 2015 and died despite resuscitation. The inquest recorded cardiac arrhythmia, long QT syndrome and therapeutic drug use as the medical cause of death. The principal concern was that multiple medications capable of prolonging the QT interval had been prescribed without assessment of her cardiac status, including an ECG, or regular ECG monitoring.
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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to undertake an ECG before commencing QT-prolonging medication
Wider context from the report “2. To undertake an Electrocardiogram (ECG) prior to commencing such medication .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to undertake regular ECG monitoring during continuing treatment with multiple psychotropic medication
Wider context from the report “3. To undertake regular ECG's to ensure long QT syndrome has not developed and to help plan continuing treatment .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to recognise the QT-prolonging potential of multiple psychotropic medication
Wider context from the report “1. To recognise use of multiple psychotropic medication has the potential to prolong the QT interval .
” 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 the product information for olanzapine, mirtazapine and indapamide to assess QT-prolongation warnings.
Verbatim wording from the response “We have reviewed the product information (Summary of Product Characteristics [SmPC] and Patient Information Leaflet) of olanzapine, mirtazapine and indapamide and are satisfied that all three contain appropriate warnings regarding the risk of QT prolongation, particularly when used with other medication that also causes QT prolongation. Details of the relevant warnings are included in Annex A.” Source location 2016-0424-Response-by-MHRA
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 product warnings appropriately address QT-prolongation risks, so no regulatory changes are currently proposed.
Verbatim wording from the response “We have reviewed the product information (Summary of Product Characteristics [SmPC] and Patient Information Leaflet) of olanzapine, mirtazapine and indapamide and are satisfied that all three contain appropriate warnings regarding the risk of QT prolongation, particularly when used with other medication that also causes QT prolongation. Details of the relevant warnings are included in Annex A.” Source location 2016-0424-Response-by-MHRA
Open published response
26 Aug 2016 Raymond Charles Woodward · Prevention of Future Deaths report Birmingham and Solihull
View report summary
Concerns raised 3 Lack of widespread awareness of the risk of adverse reactions to Buscopan in coronary artery disease View source Failure of intravenous Buscopan cardiovascular warnings to specifically encompass ischaemic heart disease View source Failure to alert the wider medical community to potential cardiovascular problems with intravenous Buscopan View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Raymond Charles Woodward · 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
Raymond Charles Woodward suffered a cardiac arrest and died on 19 February 2016 while undergoing a colonoscopy after Buscopan was administered. The report identified concerns that the risk of adverse reactions to Buscopan in patients with coronary artery disease was not widely known and that existing prescribing information did not specifically address ischaemic heart disease.
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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of widespread awareness of the risk of adverse reactions to Buscopan in coronary artery disease
Wider context from the report “(1) The risk of an adverse reaction to Buscopan in the presence of coronary artery disease is not widely known despite the wide use of Buscopan.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of intravenous Buscopan cardiovascular warnings to specifically encompass ischaemic heart disease
Wider context from the report “(2) The SPC relating to the use of intravenous Buscopan references the following in relation to the cardiovascular system – ‘Buscopan Ampoules should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it may further accelerate the heart rate’.
(3) The term ‘cardiac insufficiency’ is unwieldy and does not immediately relate to a specific diagnosis, lacks specificity and does not necessarily encompass those patients with ischaemic heart disease.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to alert the wider medical community to potential cardiovascular problems with intravenous Buscopan
Wider context from the report “(4) ████████ the Deceased’s Consultant Physician and Gastroenterologist, gave firm evidence, having extensively researched the issue, that the wider medical community needs to be alerted to potential cardiovascular problems in using IV Buscopan and this could be achieved by incorporating into the SPC ‘additional caution should be exercised in administering IV Buscopan to patients with ischaemic heart disease’.
” 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 Communicate the revised Buscopan safety recommendations to healthcare professionals through the MHRA Drug Safety Update newsletter.
Verbatim wording from the response “We have also communicated these new recommendations to healthcare professionals through an article in our MHRA newsletter, Drug Safety Update, which is available at https://www.gov.uk/drug-safety-update” Source location 2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency2
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 Revise the Buscopan Ampoules Summary of Product Characteristics to strengthen warnings about serious adverse reactions in patients with cardiac disease.
Verbatim wording from the response “Further to my letter dated 7 December 2016 regarding the inquest into the death of Raymond Charles Woodward, I can confirm that the Summary of Product Characteristics (SmPC) for Buscopan Ampoules has been updated to more clearly communicate and minimise this risk of serious adverse reactions in patients with underlying cardiac disease. Section 4.4 of the SmPC has been revised with the following warning:” Source location 2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency2
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 Analyse reported UK deaths suspected to involve Buscopan Ampoules and review the current product information to determine necessary regulatory action.
Verbatim wording from the response “To determine what regulatory action, if any, is required with respect to Buscopan Ampoules we have analysed all the reported deaths in the UK that were suspected as being caused by Buscopan Ampoules and reviewed the current product information.” Source location 2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
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 the Buscopan Ampoules licence holder to revise product information to clarify cardiac risks and recommend monitoring and readily available emergency equipment and trained personnel.
Verbatim wording from the response “Given that the risk of serious cardiac side effects due to Buscopan Ampoules is more likely in patients with cardiac conditions, such as coronary heart disease, we agree that the product information should be updated to more clearly communicate and minimise this risk in these patients. We have therefore written to the Company who hold the licence for Buscopan Ampoules and requested that they update the product information accordingly. The Company has agreed to revise the warning in section 4.4 of the SmPC which you highlighted as not adequately describing the risk in patients with coronary heart disease. The warning will recommend caution when using Buscopan Ampoules in patients with cardiac disease, including coronary heart disease, because of the risk of tachycardia, hypotension and anaphylaxis.” Source location 2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
Open published response
27 Jul 2016 James Michael HEDGE · Prevention of Future Deaths report South Wales Central
View report summary
Concerns raised 2 Inadequate education on managing hyperglycaemia and its life-threatening progression View source Inadequate advice and guidance on insulin pump misuse dangers View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
James Michael HEDGE · 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
James Michael HEDGE, an 18-year-old type 1 insulin-dependent diabetic, was found deceased in his room at Cardiff University with an insulin pump connected to him. The pump’s insulin cartridge had been fitted incorrectly and leaked, and the inquest recorded diabetic ketoacidosis as the medical cause of death. Concerns included inadequate guidance about the dangers of insulin-pump misuse and insufficient education about the potentially rapid, life-threatening consequences of hyperglycaemia.
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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inadequate education on managing hyperglycaemia and its life-threatening progression
Wider context from the report “(2) The evidence showed that the education of diabetic patients does not adequately focus upon the potential consequences of failing to properly manage a hyperglycaemic state and in particular, how quickly such a state can become life threatening .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inadequate advice and guidance on insulin pump misuse dangers
Wider context from the report “(1) The evidence showed that the advice and guidance in relation to the use of the insulin pump, which is one of several on the market, does not adequately highlight the dangers of misuse and the potential consequences which may follow if the device is not used correctly – in this case, the incorrect insertion of the insulin cartridge leading to a leak and loss of insulin at a time when blood sugars were high.
” 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 Conduct a further risk assessment of the insulin pump safety message.
Verbatim wording from the response “In addition, MHRA conducted a further risk assessment and decided the manufacturer's safety message should be reinforced through centralised communication channels to the healthcare service. On 15 August 2016 MHRA published a Medical Device Alert (MDA) to ensure that healthcare providers were made aware of the new instructions for changing the insulin cartridge and the importance of communicating the risk to the patient's health, if the manufacturer's instructions are not followed. A copy of this MDA has been attached to this letter. Furthermore a press release highlighting key action points was also issued by MHRA.” Source location 2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
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 Disseminate reinforced cartridge-changing instructions through a Medical Device Alert, press release and National Medical Device Safety Officers’ Webex.
Verbatim wording from the response “In addition, MHRA conducted a further risk assessment and decided the manufacturer's safety message should be reinforced through centralised communication channels to the healthcare service. On 15 August 2016 MHRA published a Medical Device Alert (MDA) to ensure that healthcare providers were made aware of the new instructions for changing the insulin cartridge and the importance of communicating the risk to the patient's health, if the manufacturer's instructions are not followed. A copy of this MDA has been attached to this letter. Furthermore a press release highlighting key action points was also issued by MHRA.” Source location 2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
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 Training healthcare professionals and patients is outside the respondent’s remit; manufacturers and healthcare providers have related instructional and training responsibilities.
Verbatim wording from the response “In order to fulfil the requirements of the Medical Devices Directive and place a medical device on the market, the manufacturer must provide sufficient information and instructions to enable users of the device to operate it in accordance with its intended function. This should include any warnings and precautions to take and any undesirable side effects. The manufacturer should take into consideration the training and capacity of the intended user and, where appropriate, instructions should be provided in symbol form.” Source location 2016-0269-Response-by-Medicine-and-Healthcare-Products-Regulatory-Agency
Open published response
1 Jul 2016 Daniel James Paylor · Prevention of Future Deaths report Wiltshire and Swindon
View report summary
Concerns raised 3 Lack of peer supervision for drug control View source Insufficient regulatory safeguards and auditing for drugs View source Lack of dual authorisation for unlocking drug safes View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Daniel James Paylor · 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
Daniel James Paylor, a paramedic with a history of codeine addiction and bipolar disorder, died following an opiate overdose after consuming a bottle of Oramorph kept for his private paramedic work. The report raised concerns about the regulation and control of drugs in secondary paramedic employment, including limited safeguards, auditing, peer supervision and double authorisation.
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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. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of peer supervision for drug control
Wider context from the report “(1) I am concerned when comparing the regulation and control of drugs, say, within an hospital and in Dan’s case insofar as his primary employer is concerned, an ambulance service, that compared to the level of control in relation to his secondary employment that the degree of regulatory control including safeguards and auditing appear to be very much dependent on trust. There appears to be little requirement for peer supervision and say double authorisation for say unlocking a safe comprising of two locks. My experience in relation to local hospitals is that in relation to drugs cabinets procedures have developed that require more than 1 health care professional’s authority to remove drugs to administer them to a patient. There have been instances whereby health care professionals with histories that have had addictions to prescription drugs however at least in that environment there is a stiff regime for supervision which appears absent in the scenario outlined above. I fully accept that even with regulation unless it includes the use of double locked safes with separate key holders that even with the most rigorous regulation that Dan’s death may not have been avoided. I was satisfied on a balance of probabilities that he consumed the whole bottle of Oramorph within that 36 hour period prior to his death. I am, however, of the view that consideration ought to be given as regards improving the regulatory regime and control with a view to the prevention of future deaths in perhaps a slightly different scenario.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Insufficient regulatory safeguards and auditing for drugs
Wider context from the report “(1) I am concerned when comparing the regulation and control of drugs, say, within an hospital and in Dan’s case insofar as his primary employer is concerned, an ambulance service, that compared to the level of control in relation to his secondary employment that the degree of regulatory control including safeguards and auditing appear to be very much dependent on trust . There appears to be little requirement for peer supervision and say double authorisation for say unlocking a safe comprising of two locks. My experience in relation to local hospitals is that in relation to drugs cabinets procedures have developed that require more than 1 health care professional’s authority to remove drugs to administer them to a patient. There have been instances whereby health care professionals with histories that have had addictions to prescription drugs however at least in that environment there is a stiff regime for supervision which appears absent in the scenario outlined above. I fully accept that even with regulation unless it includes the use of double locked safes with separate key holders that even with the most rigorous regulation that Dan’s death may not have been avoided. I was satisfied on a balance of probabilities that he consumed the whole bottle of Oramorph within that 36 hour period prior to his death. I am, however, of the view that consideration ought to be given as regards improving the regulatory regime and control with a view to the prevention of future deaths in perhaps a slightly different scenario.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of dual authorisation for unlocking drug safes
Wider context from the report “(1) I am concerned when comparing the regulation and control of drugs, say, within an hospital and in Dan’s case insofar as his primary employer is concerned, an ambulance service, that compared to the level of control in relation to his secondary employment that the degree of regulatory control including safeguards and auditing appear to be very much dependent on trust. There appears to be little requirement for peer supervision and say double authorisation for say unlocking a safe comprising of two locks . My experience in relation to local hospitals is that in relation to drugs cabinets procedures have developed that require more than 1 health care professional’s authority to remove drugs to administer them to a patient. There have been instances whereby health care professionals with histories that have had addictions to prescription drugs however at least in that environment there is a stiff regime for supervision which appears absent in the scenario outlined above. I fully accept that even with regulation unless it includes the use of double locked safes with separate key holders that even with the most rigorous regulation that Dan’s death may not have been avoided. I was satisfied on a balance of probabilities that he consumed the whole bottle of Oramorph within that 36 hour period prior to his death. I am, however, of the view that consideration ought to be given as regards improving the regulatory regime and control with a view to the prevention of future deaths in perhaps a slightly different scenario.
” Open source report
Concerns raised 6 Failure to prescribe and record oxygen flow rates on the drug chart View source Failure to investigate oxygen concentrator incidents View source Failure to ensure administration of oxygen at the prescribed rate View source Failure to report oxygen concentrator incidents to the manufacturer View source Failure to specify action when an oxygen concentrator is not working correctly View source Failure to specify checks of oxygen concentrator output View source See 3 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Mr Matthews · 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
Mr Matthews, who had pneumoconiosis and COPD, was admitted to hospital after being found collapsed and later suffered further cardiac arrests before dying on 19 February 2016. The principal concerns were that oxygen was not prescribed or recorded at the required rate, and that there was no system to ensure the oxygen concentrator was working correctly or that damage to it was promptly reported and investigated.
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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. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to prescribe and record oxygen flow rates on the drug chart
Wider context from the report “(2) Notwithstanding the conclusion of the manufactuer that the oxygen was still being delivered by the device in the right concentration, I am concerned that there was no system in place to ensure that the oxygen was being administered at the prescribed rate. An oxygen concentrator had been set up for use by the patient and the flow rate had been set at 2 litres per minute. The Trust's policy states that all oxygen must be prescribed and the prescribed rate should be recorded on the drug chart. The oxygen was not prescribed on the drug chart and the flow rate was not recorded . This meant that staff were unaware of the prescribed rate and there was no means of checking that the concentrator was delivering the prescribed flow rate.
(3) The Trust's policy for oxygen states that oxygen must be prescribed and that the prescribed rate should be recorded on the drug chart. However, no such prescription was made in the drug chart and no record was made of the flow rate .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to investigate oxygen concentrator incidents
Wider context from the report “(4) The Clinical Engineering Team Leader and the manufacturer concur that the damage to the oxygen concentrator was caused by an accident and that the damage was not responsible for the death. Nevertheless, I am concerned that the incident was not reported to the manufacturer at the time and that no investigation was carried out . The Trust has subsequently reviewed its incident reporting policy and the manufacturer has reviewed its own policy.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to ensure administration of oxygen at the prescribed rate
Wider context from the report “(2) Notwithstanding the conclusion of the manufactuer that the oxygen was still being delivered by the device in the right concentration, I am concerned that there was no system in place to ensure that the oxygen was being administered at the prescribed rate . An oxygen concentrator had been set up for use by the patient and the flow rate had been set at 2 litres per minute. The Trust's policy states that all oxygen must be prescribed and the prescribed rate should be recorded on the drug chart. The oxygen was not prescribed on the drug chart and the flow rate was not recorded. This meant that staff were unaware of the prescribed rate and there was no means of checking that the concentrator was delivering the prescribed flow rate .
(3) The Trust's policy for oxygen states that oxygen must be prescribed and that the prescribed rate should be recorded on the drug chart. However, no such prescription was made in the drug chart and no record was made of the flow rate.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to report oxygen concentrator incidents to the manufacturer
Wider context from the report “(4) The Clinical Engineering Team Leader and the manufacturer concur that the damage to the oxygen concentrator was caused by an accident and that the damage was not responsible for the death. Nevertheless, I am concerned that the incident was not reported to the manufacturer at the time and that no investigation was carried out. The Trust has subsequently reviewed its incident reporting policy and the manufacturer has reviewed its own policy.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to specify action when an oxygen concentrator is not working correctly
Wider context from the report “(5) There was no system in place to ensure that the oxygen concentrator was working correctly. It does not state precisely how to check the amount of oxygen delivered by the device, nor does it state what action should be taken if the device is not working correctly .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to specify checks of oxygen concentrator output
Wider context from the report “(5) There was no system in place to ensure that the oxygen concentrator was working correctly . It does not state precisely how to check the amount of oxygen delivered by the device , nor does it state what action should be taken if the device is not working correctly.
” 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 Continue monitoring the situation and investigate further adverse incidents involving the flowmeter.
Verbatim wording from the response “The MHRA is continuing to monitor this situation and will investigate any further incidents that we receive.” Source location 2016-0276-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
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 Oxylitre instructions for use provide sufficient pre-use inspection guidance, making additional specific leak-test instructions unnecessary.
Verbatim wording from the response “The IFU states “No leaks are permissible on the device”, and advises the user to visually check the device for cracks before use. A user who identifies a crack should discard the product prior to patient use.” Source location 2016-0276-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
Open published response
10 Mar 2016 Christine Marie Stevenson · Prevention of Future Deaths report Manchester South
View report summary
Concerns raised 1 Failure to control the quantity of Oramorph solution prescribed View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
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AI-generated summary
Christine Marie Stevenson · 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
Christine Marie Stevenson, who had a history of illicit drug use and multiple medical issues, died at home on 21 July 2015. The inquest recorded the cause of death as combined drug toxicity from prescribed and illicit drug use. Concerns were raised about the lack of control over Oramorph prescribing, including the issue of 500 ml, equivalent to 1000 mg, without controls despite evidence that 50 ml could pose a risk to life in a naïve user.
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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. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to control the quantity of Oramorph solution prescribed
Wider context from the report “Concerns were raised at the Inquest as to the lack of control for Oramorph medication . A 10mgs per 5ml solution does not fall under the controlled drug requirements in the BNF.
It is noted that whilst the Misuse of Drugs Act 1971 lists morphine as a Schedule 2, Part 1, Class A Controlled drug, Section 5 gives an exemption for preparation that contain not more than 0.2% morphine
Oramorph (10 mg per 5 millilitres) has a morphine content that is under the 0.2% (as the 10 mg is present as morphine sulphate).
However even though the solution at this strength is not to be subject of control, should there be restrictions on the amount of the solution which can be prescribed? This lady was prescribed 500mls (a total available dose of 1000 mg) of this solution which poses as a dose serious risk to health.
The Court heard evidence that in a naïve user 50mls of the solution at this strength can be a risk to life .
Given that Oramorph has an increasing street value and is a commonly abused drug whilst the strength of the solution may not require control the issuing of 500mls without control seems a matter which requires consideration.
” Open source report
23 Jul 2015 Lynn POYSER · Prevention of Future Deaths report South Lincolnshire
View report summary
Concerns raised 2 Insufficient guidance on care and caution when co-prescribing ACEI drugs and Spironolactone View source Insufficient guidance to take a holistic view of patients' best interests when co-prescribing ACEI drugs and Spironolactone View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Lynn POYSER · 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
Lynn POYSER had impaired kidney function and was prescribed Lisinopril while already taking Spironolactone. She was admitted to hospital with severe hyperkalaemia and suffered a cardiac arrest from which she could not be resuscitated. The principal concern was whether guidance on co-prescribing these medicines sufficiently emphasised caution, review, and monitoring of renal function and electrolytes.
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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. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Insufficient guidance on care and caution when co-prescribing ACEI drugs and Spironolactone
Wider context from the report “1: Evidence was presented at the inquest to the effect that the interaction between Lisinopril and Spironolactone is well known, and that Lisinopril can precipitate deterioration in a patient's renal function. NICE published guidelines on initiation of Angiotensin converting enzyme inhibitor therapy indicates that patients should be reviewed one to two weeks after initiation of therapy and have their renal function and electrolyte status checked 10 – 14 days after initiation of ACEI therapy. This is re-iterated in LCHS guidance. The expert evidence at the inquest pointed out that, following a report of a trial in 1999 "The Randomised Aldactone Evaluation Study", there was an increase in the co-prescription of Spironolactone and Lisinopril in heart failure, immediately followed by an increase in hospital admissions and subsequent deaths associated with hyperkalaemia.
Those to whom I make this report may wish to consider whether or not the current guidance relating to the co-prescription of ACEI drugs, such as Lisinopril, and Spironolactone draws sufficient attention to the need for care and caution and the need to take a holistic view of the best interests of the patient.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Insufficient guidance to take a holistic view of patients' best interests when co-prescribing ACEI drugs and Spironolactone
Wider context from the report “1: Evidence was presented at the inquest to the effect that the interaction between Lisinopril and Spironolactone is well known, and that Lisinopril can precipitate deterioration in a patient's renal function. NICE published guidelines on initiation of Angiotensin converting enzyme inhibitor therapy indicates that patients should be reviewed one to two weeks after initiation of therapy and have their renal function and electrolyte status checked 10 – 14 days after initiation of ACEI therapy. This is re-iterated in LCHS guidance. The expert evidence at the inquest pointed out that, following a report of a trial in 1999 "The Randomised Aldactone Evaluation Study", there was an increase in the co-prescription of Spironolactone and Lisinopril in heart failure, immediately followed by an increase in hospital admissions and subsequent deaths associated with hyperkalaemia.
Those to whom I make this report may wish to consider whether or not the current guidance relating to the co-prescription of ACEI drugs, such as Lisinopril, and Spironolactone draws sufficient attention to the need for care and caution and the need to take a holistic view of the best interests of the patient .
” Open source report
17 Jun 2015 Andre Roderick Stewart MICKLEY · Prevention of Future Deaths report South Lincolnshire
View report summary
Concerns raised 2 Failure of medicines information to prompt prescribers to seek a history of substance misuse View source Failure of medicines information to instruct patients to exercise caution and seek advice before using medicines with potential interactions with drugs of misuse View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Andre Roderick Stewart MICKLEY · 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
Andre Roderick Stewart MICKLEY used heroin and cocaine on 17 February 2015, then collapsed with a massive subarachnoid haemorrhage and died on 23 February 2015 despite neurosurgical intervention. The report raised concern about potentially adverse interactions between cocaine and SSRI drugs, and that prescribing information may not prompt consideration of substance misuse or caution about interactions with drugs of misuse.
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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. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of medicines information to prompt prescribers to seek a history of substance misuse
Wider context from the report “1. There are clear potentially adverse pharmacokinetic interactions between Cocaine and the SSRI group of drugs, as well as case reports. (e.g. FU K et al. ). Journal of Analytical Toxicology. 24C7:648-50, 2000). In general, the Summary of Product Characteristics (SPC) and the Patient Information Leaflet (PIL) do not suggest prescribers seek a history of substance misuse or patients exert caution and seek advice before prescribing or using medicines that have the potential to interact adversely with drugs of misuse. This includes adverse interactions other than just those between SSRI and cocaine
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of medicines information to instruct patients to exercise caution and seek advice before using medicines with potential interactions with drugs of misuse
Wider context from the report “1. There are clear potentially adverse pharmacokinetic interactions between Cocaine and the SSRI group of drugs, as well as case reports. (e.g. FU K et al. ). Journal of Analytical Toxicology. 24C7:648-50, 2000). In general, the Summary of Product Characteristics (SPC) and the Patient Information Leaflet (PIL) do not suggest prescribers seek a history of substance misuse or patients exert caution and seek advice before prescribing or using medicines that have the potential to interact adversely with drugs of misuse . This includes adverse interactions other than just those between SSRI and cocaine
” Open source report
9 Jan 2015 Annette Charlton · Prevention of Future Deaths report Birmingham and Solihull
View report summary
Concerns raised 1 Almost identical medication boxes View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Annette Charlton · 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
Annette Charlton, who had emphysema and lung fibrosis requiring continuous oxygen therapy, was dispensed Naproxen instead of prescribed antibiotics and died on 28 September 2014. The principal concern was that medication manufacturers used almost identical packaging, which was considered likely to contribute to dispensing errors and potentially patient deaths.
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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. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Almost identical medication boxes
Wider context from the report “(1) Manufacturers are able to produce medication in almost identical boxes which is very likely to contribute to dispensing errors and potentially patient deaths.
” Open source report
5 Jan 2015 James Wilson Fyfe · Prevention of Future Deaths report Berkshire
View report summary
Concerns raised 2 Failure to highlight the cot-side locking problem in all trolley maintenance schedules View source Failure to escalate and notify trolley users of the known cot-side locking risk View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
James Wilson Fyfe · 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
James Wilson Fyfe died on 21 April 2011 from pneumonia significantly contributed to by a cervical spine fracture sustained when he fell from a hospital trolley after its cot side gave way. Concerns related to the trolley remaining raised but unlocked due to design, maintenance and use issues, and to uncertainty about whether the known hazard had been communicated to other users of the trolley.
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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. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to highlight the cot-side locking problem in all trolley maintenance schedules
Wider context from the report “(1) It was the Jury’s determination on the evidence that the cot side was able to remain in a raised but unlocked position due in part to both the design and maintenance of the trolley. While evidence was given that the Trust had subsequently introduced improved service sheets and had involved the assistance of Anetic Aid Limited in maintenance, repair and training of use of the trolley, it was unclear as to whether this specific problem had been highlighted as needing careful attention in all maintenance schedules for the trolley .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to escalate and notify trolley users of the known cot-side locking risk
Wider context from the report “(2) The Jury were informed that MHRA were aware of the investigations of the incident trolley but that it did not appear that the issue had been escalated and notified to all Hospital Trusts and agencies that used this type of trolley . The MHRA’s actions in being informed of this potential hazard remain unclear, with particular reference to passing on the known risk to such trolley users .
” Open source report
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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 MHRA considered a Medical Device Alert unnecessary because evidence and risk assessment did not justify additional safety messaging.
Verbatim wording from the response “MHRA did not publish a Medical Device Alert (MDA) concerning the QA3 Patient Trolley. At the time of the incident 11,090 QA3 trolleys had been produced with the same design of locking mechanism for the side rails. There were no prior related incidents reported to either MHRA or Anetic Aid Ltd for the period the trolley had been placed on the market, 1998 to 2011. It is important to note that not all incidents result in the issue of a MDA. MHRA received 10,984 incident reports (relating to 21,729 incidents) in 2011 and issued 114 MDAs. There would be a real risk of diluting the impact and importance of alerts if the system were to be used to distribute large numbers of alerts. In addition, Government agencies are trying to reduce the burden on the NHS and are working with fewer resources themselves.” Source location 2015-0099-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
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 Available reports indicated the QA3 side-rail problem was local to RBH rather than a wider problem across hospitals.
Verbatim wording from the response “MHRA review of incident - 2015
The current version of the QA3 trolley uses the same type of locking mechanism and it is essentially unchanged, having the same characteristics. Anetic Aid Ltd state that QA3 sales now total 11,680 units. Since the incident in 2011 there have been no further reports to MHRA or to the manufacturer of any users other than RBH experiencing problems with the side rails not locking when they are raised. RBH sent us reports in March 2013 and November 2014 which were added to the surveillance database, each detailing one failure.” Source location 2015-0099-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Open published response
12 Nov 2014 Patricia Ann Mellor · Prevention of Future Deaths report Nottinghamshire
View report summary
Concerns raised 6 Failure to include warnings about cardiac arrest risks in inhalational anaesthetic product information for patients with LQTS View source Failure to update guidance to require specific examination of the QTc interval in all pre-operative ECGs View source Failure to update pre-operative assessment guidance to require consideration of drug-induced LQTS before omitting a 12 lead ECG View source Failure to include warnings about cardiac arrest risks in product information for other drugs used during inhalational anaesthesia in patients with LQTS View source Failure to update guidance to require 12 lead ECG recording and QTc examination for patients receiving drugs at high or intermediate risk of inducing cardiac arrest in LQTS View source Failure to highlight issues involving antidepressant agents and LQTS in regular agency bulletins View source See 3 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Patricia Ann Mellor · 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
Patricia Ann Mellor suffered a cardiac arrest during general anaesthesia in 2004, resulting in a hypoxic brain injury and severe disability. She died from aspiration pneumonia on 24 January 2014. The investigation identified acquired Long QT Syndrome associated with a combination of citalopram, nortriptyline and ranitidine, and concerns were raised about the need to identify and manage this risk before anaesthesia.
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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. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to include warnings about cardiac arrest risks in inhalational anaesthetic product information for patients with LQTS
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to update guidance to require specific examination of the QTc interval in all pre-operative ECGs
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to update pre-operative assessment guidance to require consideration of drug-induced LQTS before omitting a 12 lead ECG
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to include warnings about cardiac arrest risks in product information for other drugs used during inhalational anaesthesia in patients with LQTS
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to update guidance to require 12 lead ECG recording and QTc examination for patients receiving drugs at high or intermediate risk of inducing cardiac arrest in LQTS
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to highlight issues involving antidepressant agents and LQTS in regular agency bulletins
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Open source report
14 Jul 2014 Shayla Anne Walmsley · Prevention of Future Deaths report Inner North London
View report summary
Concerns raised 3 Lack of post-mortem analysis of medical devices in unexplained deaths View source Inconsistent issuing of FSNs to appropriate NHS Trust recipients View source Delays in Medtronic providing safety data on request View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Shayla Anne Walmsley · 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
Shayla Anne Walmsley was found deceased at her home on 9 May 2013; she had diabetes and used a Medtronic insulin pump. The cause of death remained unascertained, and the report raised concerns about delays in providing safety data, inconsistent distribution of Field Safety Notices, and failure to analyse the medical device during the post-mortem investigation.
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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of post-mortem analysis of medical devices in unexplained deaths
Wider context from the report “(3) Non-analysis of medical devices at post mortem - I am concerned that future investigations into the deaths of medical device users could be impaired by the lack of analysis of medical devices at post mortem . It is clear that these devices are increasingly being used by patients and, if death is unexplained in such a patient, appropriate analysis should be considered . As such, I believe that it is necessary to emphasise, to those involved in death investigation, the potential importance of device analysis.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inconsistent issuing of FSNs to appropriate NHS Trust recipients
Wider context from the report “(2) Inconsistency in issuing FSNs - I am concerned that the apparently ad hoc nature by which FSNs are issued applies inappropriate individuals within NHS Trusts being aware of safety concerns and that this could result in future deaths. It is clear the CAS distributes MDAs to NHS Trust governance departments in a reliable manner. I believe that consideration should be made as to whether CAS could be used also to distribute FSNs.
I heard evidence from the governance department representative that this would not lead to ‘alert fatigue’ (where receipt of numerous alerts results in less attention being paid to them). This is because governance departments should be receiving these FSNs in any case and taking steps to distribute as appropriate. I heard concerns from the MHRA that this view may not be shared by all governance departments but, in my judgement, there should be consideration of the use of CAS for FSN distribution.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Delays in Medtronic providing safety data on request
Wider context from the report “(1) Interval to availability of Medtronic data - I am concerned that the investigatory role of non-US regulators could be hampered by the timescale within which Medtronic can provide data on request . Given the potential consequences of a delay in production of this safety data , I believe that future deaths could result and that this warrants consideration by Medtronic.
” Open source report
11 Jul 2014 Maria De Oliveria Alva LOPES · Prevention of Future Deaths report Surrey
View report summary
Concerns raised 19 Lack of daily creatine kinase monitoring during propofol infusions View source Lack of national understanding and acceptance of safe propofol amounts View source Lack of consultant ward rounds in weekend urology on-call arrangements View source Delays in urology review of emergency admissions View source Failure to act on or escalate elevated Early Warning Scores View source Undue reliance on outdated admission blood tests for clinical assessment View source Failure to create and adhere to guidelines or protocols for propofol use View source Lack of active management to expedite physician review and ITU admission View source Failure to recognise and treat sepsis in accordance with national guidelines View source Lack of continual assessment for complications of propofol-related infusion syndrome View source Lack of clarity about propofol infusion duration, volume and dose View source Inadequate assessment of renal stone size and hydronephrosis View source Lack of a protocol for propofol use in ITU View source Inadequate supervision of out-of-hours urology trainees View source Lack of medical supervision and control of propofol use in ITU View source Lack of knowledge or implementation of published on-call national guidelines View source Lack of understanding that propofol-related infusion syndrome is a complication of prolonged propofol sedation View source Lack of understanding of atypical adult presentation of propofol-related infusion syndrome View source Failure of critical care outreach to recognise and escalate concerns of sepsis View source See 16 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Maria De Oliveria Alva LOPES · 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
Maria De Oliveria Alva LOPES died on 9 September 2012 after developing severe sepsis from an obstructing ureteric stone, followed by septic shock, multiorgan failure and rhabdomyolysis associated with propofol-related infusion syndrome. The principal concerns included delayed recognition and escalation of sepsis, delays in intensive care admission and treatment, inadequate supervision and control of propofol use, and insufficient monitoring for propofol-related complications.
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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of daily creatine kinase monitoring during propofol infusions
Wider context from the report “12. Consideration for the use of daily Creatine Kinase levels when propofol infusions are given
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of national understanding and acceptance of safe propofol amounts
Wider context from the report “15. Lack of national understanding and acceptance of the amount of propofol that can be given and the importance of creating and adhering to guidelines or protocols for its use and to implement continual assessment to look for the complications of PRIS (serial CK levels)
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of consultant ward rounds in weekend urology on-call arrangements
Wider context from the report “1. The consultant urologist’s on call arrangements covering three hospitals at the weekend has no provision for consultant ward rounds , in contravention of suggested national guidelines
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Delays in urology review of emergency admissions
Wider context from the report “4. The review of emergency admissions by urology (not on day of admission, once daily )
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to act on or escalate elevated Early Warning Scores
Wider context from the report “9. Failure to act on or escalate elevated Early Warning Scores as per hospital protocol
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Undue reliance on outdated admission blood tests for clinical assessment
Wider context from the report “6. The assessment and size of the renal stone and hydronephrosis, and undue reliance on blood tests taken on admission (18 hours previously) to assess Mrs Lopes’s condition
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to create and adhere to guidelines or protocols for propofol use
Wider context from the report “15. Lack of national understanding and acceptance of the amount of propofol that can be given and the importance of creating and adhering to guidelines or protocols for its use and to implement continual assessment to look for the complications of PRIS (serial CK levels)
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of active management to expedite physician review and ITU admission
Wider context from the report “7. The lack of active management to expedite physician’s review and to facilitate admission to ITU
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to recognise and treat sepsis in accordance with national guidelines
Wider context from the report “5. The recognition and treatment of sepsis as per national guidelines
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of continual assessment for complications of propofol-related infusion syndrome
Wider context from the report “15. Lack of national understanding and acceptance of the amount of propofol that can be given and the importance of creating and adhering to guidelines or protocols for its use and to implement continual assessment to look for the complications of PRIS (serial CK levels)
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of clarity about propofol infusion duration, volume and dose
Wider context from the report “10. Lack of clarity to the length, volume and dose of propofol infusion to be given in ITU
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inadequate assessment of renal stone size and hydronephrosis
Wider context from the report “6. The assessment and size of the renal stone and hydronephrosis , and undue reliance on blood tests taken on admission (18 hours previously) to assess Mrs Lopes’s condition
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of a protocol for propofol use in ITU
Wider context from the report “11. Lack of medical supervision and control of the use of propofol in ITU (no protocol in place )
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inadequate supervision of out-of-hours urology trainees
Wider context from the report “3. The overall supervision of out of hours urology trainees within the current system
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of medical supervision and control of propofol use in ITU
Wider context from the report “11. Lack of medical supervision and control of the use of propofol in ITU (no protocol in place)
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of knowledge or implementation of published on-call national guidelines
Wider context from the report “2. A general lack of knowledge or implementation of published ‘on call’ national guidelines
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of understanding that propofol-related infusion syndrome is a complication of prolonged propofol sedation
Wider context from the report “13. Lack of understanding and acceptance Propofol related infusion syndrome (PRIS) is an accepted albeit rare, complication of the use of prolonged propofol for sedation in Intensive Care Units
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of understanding of atypical adult presentation of propofol-related infusion syndrome
Wider context from the report “14. Lack of understanding that PRIS may have an atypical presentation in adults and should always be a consideration when propofol is used for a protracted period of time
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of critical care outreach to recognise and escalate concerns of sepsis
Wider context from the report “8. Failure to recognise and therefore escalate concerns of sepsis by critical care outreach team
” Open source report
26 May 2014 Miss Akua Anokye-Boateng · Prevention of Future Deaths report Inner South London
View report summary
Concerns raised 1 Lack of clear best-practice guidance on gastro-intestinal protection during brief NSAID use in children with sickle disease View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Miss Akua Anokye-Boateng · 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
Miss Akua Anokye-Boateng, who had well-managed sickle cell disease, suffered a three-day illness, collapsed suddenly, and died on 16 January 2013. The inquest recorded acute peritonitis and shock due to a perforated duodenum associated with NSAID ingestion and Helicobacter-associated chronic ulceration. Concerns included uncertainty about best practice and whether guidance or additional precautions are needed when NSAIDs are used in children with sickle cell disease.
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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of clear best-practice guidance on gastro-intestinal protection during brief NSAID use in children with sickle disease
Wider context from the report “Expert evidence was heard from an experienced academic pathologist that one dose of NSAID was sufficient to damage the GI mucosa in children, which, coupled with a presumed Helicobacter infection, led in this case to the perforation. The consultant paediatrician with responsibility for haemoglobinopathies was unaware of the risk of a single dose in the past and gave evidence that Ibuprofen was an important drug in the management of sickle cell patients, having less side effects than opiates. He reported that it is not current practice to routinely give gastro-intestinal protection when NSAIDs are used briefly in children with sickle disease . Thus it is unclear what is best practice or whether the scientific evidence suggests that guidance is needed for clinicians about further precautions or prevention such as Proton pump inhibitors being routinely used alongside NSAIDs in children , to minimize the risk of similar deaths.
” Open source report
×
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 Current warnings and prescribing guidance are considered sufficient; the case does not warrant routine gastroprotection or changed warnings for children using NSAIDs.
Verbatim wording from the response “The SPCs for all POM non-selective NSAIDs include a recommendation to use gastro-protective agents (proton pump inhibitors or misoprostol) when prescribing NSAIDs to those at high risk of gastrointestinal side-effects, as follows:” Source location 2014-0211-Response-by-Medicine-Healthcare-Products-Regulatory-Agency
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 NSAID product information is considered sufficient to alert readers that serious gastrointestinal toxicity can occur early in treatment.
Verbatim wording from the response “The SPCs for POM, P and GSL NSAIDs including ibuprofen state the following in section 4.4 (Special warnings and precautions for use):” Source location 2014-0211-Response-by-Medicine-Healthcare-Products-Regulatory-Agency
Open published response
14 Apr 2014 Paul Michael Ashton · Prevention of Future Deaths report Manchester West
View report summary
Concerns raised 3 Lack of protocols and guidelines for perioperative management of heart transplant patients undergoing non-cardiac surgery View source Unavailability of Isoprenaline for resuscitation of heart transplanted patients View source Failure to communicate the source and importance of Isoprenaline use for resuscitation of heart transplanted patients View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Paul Michael Ashton · 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
Paul Michael Ashton died during a right knee arthroscopy under general anaesthesia after suffering a cardiac arrest. The concerns included the absence of hospital protocols for the perioperative management of heart-transplanted patients undergoing non-cardiac surgery, and issues concerning the availability and use of Isoprenaline during resuscitation.
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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of protocols and guidelines for perioperative management of heart transplant patients undergoing non-cardiac surgery
Wider context from the report “(2) I have concerns with regard to the following:-
i. The absence of protocols and guidelines in Hospitals dealing with the perioperative management of heart transplanted patients due to undergo or undergoing non cardiac surgery . Such a protocol or guidelines could summarise issues that need to be considered when assessing and caring for a patient with a transplanted heart and the elements of such protocol or guidelines could include the following:
a) Pre-operative assessment
b) Liaising with the transplant unit the patient is under for follow up.
c) Guidance on risk
d) Benefit discussion with the patient and consent process
e) Perioperative management (anaesthetic technique(s), monitoring, drugs and their doses and fluid balance etc.)
f) Postoperative care
g) Strategies for perioperative complications including resuscitation procedures and the use of Isoprenaline.
ii. The source, availability and the use of Isoprenaline in Hospitals and by health professionals in relation to the resuscitation of heart transplanted patients. Isoprenaline is a drug that is considered to be the best anti-bradycardic agent in denervated or transplanted patients and disappeared from the United Kingdom formulary about 10 years ago. It is therefore assumed that it is not available anymore and that Adrenaline is the only drug effective in bradycardia in denervated hearts.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Unavailability of Isoprenaline for resuscitation of heart transplanted patients
Wider context from the report “(2) I have concerns with regard to the following:-
i. The absence of protocols and guidelines in Hospitals dealing with the perioperative management of heart transplanted patients due to undergo or undergoing non cardiac surgery. Such a protocol or guidelines could summarise issues that need to be considered when assessing and caring for a patient with a transplanted heart and the elements of such protocol or guidelines could include the following:
a) Pre-operative assessment
b) Liaising with the transplant unit the patient is under for follow up.
c) Guidance on risk
d) Benefit discussion with the patient and consent process
e) Perioperative management (anaesthetic technique(s), monitoring, drugs and their doses and fluid balance etc.)
f) Postoperative care
g) Strategies for perioperative complications including resuscitation procedures and the use of Isoprenaline.
ii. The source, availability and the use of Isoprenaline in Hospitals and by health professionals in relation to the resuscitation of heart transplanted patients . Isoprenaline is a drug that is considered to be the best anti-bradycardic agent in denervated or transplanted patients and disappeared from the United Kingdom formulary about 10 years ago . It is therefore assumed that it is not available anymore and that Adrenaline is the only drug effective in bradycardia in denervated hearts.
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to communicate the source and importance of Isoprenaline use for resuscitation of heart transplanted patients
Wider context from the report “v. The supply of Isoprenaline is not available in the United Kingdom and the source of the supply and the importance of the use of Isoprenaline in the resuscitation of heart transplanted patients should be brought to the attention of all hospitals and health professionals in the United Kingdom .
” Open source report
27 Feb 2014 Victoria Meppen-Walter · Prevention of Future Deaths report Manchester North
View report summary
Concerns raised 3 Risk of chloroquine misuse View source Failure to regulate chloroquine View source Failure to ensure safe availability of chloroquine View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Victoria Meppen-Walter · 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
Victoria Meppen-Walter underwent a dermatological procedure in September 2011 and subsequently experienced constant pain, scarring, social withdrawal and declining mental health. She researched assisted suicide and was later found deceased at her home with a do-not-resuscitate note and white powder residue; the inquest concluded that she had taken her own life, with chloroquine toxicity recorded as the medical cause of death. The principal concerns were the availability and regulation of chloroquine and the risk of associated misuse.
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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Risk of chloroquine misuse
Wider context from the report “1) The availability and regulation of chloroquine
&
2) The risk of associated misuse
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to regulate chloroquine
Wider context from the report “1) The availability and regulation of chloroquine
&
2) The risk of associated misuse
” 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 Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to ensure safe availability of chloroquine
Wider context from the report “1) The availability and regulation of chloroquine
&
2) The risk of associated misuse
” Open source report
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Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations