16 Aug 2023 Devon Drew Turner · Prevention of Future Deaths report Berkshire
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Concerns raised 7 Failure to ensure that SATS machines are suitable and easy to use at home View source Failure to train parents to use the particular SATS machine brand issued View source Failure of SATS machine alarm volume to wake sleeping parents View source Failure to ensure the reliability of SATS machines sent home with vulnerable patients View source Failure of SATS machine alarms to sound reliably View source Failure to provide accurate SATS machine event data and analysis View source Failure of SATS machine alarms to remain active or sound when required View source See 4 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
Devon Drew Turner · 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
Devon Drew Turner, who had Mosaic Trisomy 9 and significant respiratory vulnerability, died at hospital on 10 May 2022 after being found unresponsive at home. The report raises concerns about the reliability, suitability, alarm function and data recording of SATS monitoring machines provided for use by vulnerable babies at home, including whether parents were adequately trained on the particular device supplied.
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 ensure that SATS machines are suitable and easy to use at home
Wider context from the report “Matter of Concern 1:
3. On 25 April 2022 this second SATS machine, stopped working. It had some sort of error message on the screen. The parents contacted the community nurse team and Devon’s mother had to attend the hospital that night to pick up a new SATS machine.
4. Therefore the first concern is regarding the reliability of such SATS machines sent home with vulnerable patients.
5. If a safety plan is put in place which includes the use of a SATS machine to monitor the wellbeing of the patient, and that machine is less than at least 99% reliable, or has software issues, or is unsuitable for home use, or is complicated to use , this may result in a false sense of security from the family who will rely on the machine to alert them if the oxygen levels drop below a certain figure.
6. Therefore there is a risk that future deaths will occur if hospital trusts do not ensure that the SATS machines are reliable and easy to use and that parents are trained to use the particular brand they are issued with.
” 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 train parents to use the particular SATS machine brand issued
Wider context from the report “Matter of Concern 1:
3. On 25 April 2022 this second SATS machine, stopped working. It had some sort of error message on the screen. The parents contacted the community nurse team and Devon’s mother had to attend the hospital that night to pick up a new SATS machine.
4. Therefore the first concern is regarding the reliability of such SATS machines sent home with vulnerable patients.
5. If a safety plan is put in place which includes the use of a SATS machine to monitor the wellbeing of the patient, and that machine is less than at least 99% reliable, or has software issues, or is unsuitable for home use, or is complicated to use, this may result in a false sense of security from the family who will rely on the machine to alert them if the oxygen levels drop below a certain figure.
6. Therefore there is a risk that future deaths will occur if hospital trusts do not ensure that the SATS machines are reliable and easy to use and that parents are trained to use the particular brand they are issued with .
” 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 SATS machine alarm volume to wake sleeping parents
Wider context from the report “Matter of Concern 2:
8. The third machine was issued to the family on 25 April 2022, which remained with them until Devon’s death. It was manufactured by Medtronic (Model number MBB1920904). It is not known if this was the same brand as the second SATS machine mentioned above.
9. The concern is that this Medtronic machine was also either not functioning reliably or was not suitable for the home environment.
10. On 10 May 2022 Devon was given his 1am feed and the family settled down to sleep. At 4.30am Devon’s mother woke to find him unresponsive. The CPAP machine log confirms those two times.
11. The SATS machine was seized by the police on 10 May 2022.
12. Medtronic technician, ████████ made a statement dated 6/7/2022 which I append to this Report, in which he states that:
• The testing of the SATS machine revealed that it was functioning properly
• The data from the machine shows that from approximately 1.44am Devon’s oxygen saturations started to drop and continued to fall until approximately 2.00am when there was no pulse.
• The alarm would have been sounding throughout that time and that at the loss of pulse, at 2.00am a further alarm would have sounded.
• The machine alarm was at maximum volume
• There is a silence button on the machine but that it only silences the alarm for 60 seconds, after which interval the alarm would sound again throughout the whole period that the saturation levels were low.
13. Given the crucial role a SATS machine has in monitoring a vulnerable baby at home, with non-medically trained carers who need to sleep, there should be no doubt but that the alarm sound will sound reliably, that its volume will wake sleeping exhausted parents and should provide an accurate log of events.
14. The conclusions that the data from the SATS machine appear to provide do not accord with the other evidence provided to the inquest about the events in question. That gives cause for concern that either the analysis of the SATS machine has not been accurate or the SATS machine has not correctly recorded the data or that this SATS machine is not a suitable device for use at home.
15. For example, the community nurses would have noticed if the SATS machine was not working in the first weeks of Devon being at home and yet it has recorded that it was not used at all until 31 May 2022.
16. Secondly in order for the SATS machine data to have been correct about events of 10 May 2022, either both the parents would have had to sleep through an alarm sounding for at least 15 minutes at full volume as well as a second alarm after 15 minutes at the loss of pulse, or the parents would have had to have used the silence button on the alarm system every 60 seconds for that 15 minute period.
17. The SATS machine silence button was not within reach of Devon’s mother unless she sat up and reached up and over baby Devon in his cot. Devon’s father would have had to get out of bed altogether. A copy of the police photographs of the bedroom on 10 May 2022 is attached to this report. It is inconceivable that these concerned and careful parents, who had taken such an active role in Devon’s care, would have turned off this alarm in this way several times and failed to notice his respiratory distress, and when he was found unresponsive, would have forgotten that they had silenced the alarm in this way. Therefore either the SATS machine did not function as it should or was not sufficiently loud to wake either of these careful parents.
18. The potential for future deaths is that future parents will also rely on the SATS machine to alert them to a vulnerable child stopping breathing and taking action will not be alerted because either the alarm is too quiet , or it cuts out automatically before waking the parents, or it simply does not sound at all.
” 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 the reliability of SATS machines sent home with vulnerable patients
Wider context from the report “Matter of Concern 1:
3. On 25 April 2022 this second SATS machine, stopped working. It had some sort of error message on the screen. The parents contacted the community nurse team and Devon’s mother had to attend the hospital that night to pick up a new SATS machine.
4. Therefore the first concern is regarding the reliability of such SATS machines sent home with vulnerable patients .
5. If a safety plan is put in place which includes the use of a SATS machine to monitor the wellbeing of the patient, and that machine is less than at least 99% reliable , or has software issues, or is unsuitable for home use, or is complicated to use, this may result in a false sense of security from the family who will rely on the machine to alert them if the oxygen levels drop below a certain figure.
6. Therefore there is a risk that future deaths will occur if hospital trusts do not ensure that the SATS machines are reliable and easy to use and that parents are trained to use the particular brand they are issued with.
” 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 SATS machine alarms to sound reliably
Wider context from the report “Matter of Concern 2:
8. The third machine was issued to the family on 25 April 2022, which remained with them until Devon’s death. It was manufactured by Medtronic (Model number MBB1920904). It is not known if this was the same brand as the second SATS machine mentioned above.
9. The concern is that this Medtronic machine was also either not functioning reliably or was not suitable for the home environment.
10. On 10 May 2022 Devon was given his 1am feed and the family settled down to sleep. At 4.30am Devon’s mother woke to find him unresponsive. The CPAP machine log confirms those two times.
11. The SATS machine was seized by the police on 10 May 2022.
12. Medtronic technician, ████████ made a statement dated 6/7/2022 which I append to this Report, in which he states that:
• The testing of the SATS machine revealed that it was functioning properly
• The data from the machine shows that from approximately 1.44am Devon’s oxygen saturations started to drop and continued to fall until approximately 2.00am when there was no pulse.
• The alarm would have been sounding throughout that time and that at the loss of pulse, at 2.00am a further alarm would have sounded.
• The machine alarm was at maximum volume
• There is a silence button on the machine but that it only silences the alarm for 60 seconds, after which interval the alarm would sound again throughout the whole period that the saturation levels were low.
13. Given the crucial role a SATS machine has in monitoring a vulnerable baby at home, with non-medically trained carers who need to sleep, there should be no doubt but that the alarm sound will sound reliably , that its volume will wake sleeping exhausted parents and should provide an accurate log of events.
14. The conclusions that the data from the SATS machine appear to provide do not accord with the other evidence provided to the inquest about the events in question. That gives cause for concern that either the analysis of the SATS machine has not been accurate or the SATS machine has not correctly recorded the data or that this SATS machine is not a suitable device for use at home.
15. For example, the community nurses would have noticed if the SATS machine was not working in the first weeks of Devon being at home and yet it has recorded that it was not used at all until 31 May 2022.
16. Secondly in order for the SATS machine data to have been correct about events of 10 May 2022, either both the parents would have had to sleep through an alarm sounding for at least 15 minutes at full volume as well as a second alarm after 15 minutes at the loss of pulse, or the parents would have had to have used the silence button on the alarm system every 60 seconds for that 15 minute period.
17. The SATS machine silence button was not within reach of Devon’s mother unless she sat up and reached up and over baby Devon in his cot. Devon’s father would have had to get out of bed altogether. A copy of the police photographs of the bedroom on 10 May 2022 is attached to this report. It is inconceivable that these concerned and careful parents, who had taken such an active role in Devon’s care, would have turned off this alarm in this way several times and failed to notice his respiratory distress, and when he was found unresponsive, would have forgotten that they had silenced the alarm in this way. Therefore either the SATS machine did not function as it should or was not sufficiently loud to wake either of these careful parents.
18. The potential for future deaths is that future parents will also rely on the SATS machine to alert them to a vulnerable child stopping breathing and taking action will not be alerted because either the alarm is too quiet, or it cuts out automatically before waking the parents, or it simply does not sound at all.
” 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 accurate SATS machine event data and analysis
Wider context from the report “Matter of Concern 2:
8. The third machine was issued to the family on 25 April 2022, which remained with them until Devon’s death. It was manufactured by Medtronic (Model number MBB1920904). It is not known if this was the same brand as the second SATS machine mentioned above.
9. The concern is that this Medtronic machine was also either not functioning reliably or was not suitable for the home environment.
10. On 10 May 2022 Devon was given his 1am feed and the family settled down to sleep. At 4.30am Devon’s mother woke to find him unresponsive. The CPAP machine log confirms those two times.
11. The SATS machine was seized by the police on 10 May 2022.
12. Medtronic technician, ████████ made a statement dated 6/7/2022 which I append to this Report, in which he states that:
• The testing of the SATS machine revealed that it was functioning properly
• The data from the machine shows that from approximately 1.44am Devon’s oxygen saturations started to drop and continued to fall until approximately 2.00am when there was no pulse.
• The alarm would have been sounding throughout that time and that at the loss of pulse, at 2.00am a further alarm would have sounded.
• The machine alarm was at maximum volume
• There is a silence button on the machine but that it only silences the alarm for 60 seconds, after which interval the alarm would sound again throughout the whole period that the saturation levels were low.
13. Given the crucial role a SATS machine has in monitoring a vulnerable baby at home, with non-medically trained carers who need to sleep, there should be no doubt but that the alarm sound will sound reliably, that its volume will wake sleeping exhausted parents and should provide an accurate log of events .
14. The conclusions that the data from the SATS machine appear to provide do not accord with the other evidence provided to the inquest about the events in question. That gives cause for concern that either the analysis of the SATS machine has not been accurate or the SATS machine has not correctly recorded the data or that this SATS machine is not a suitable device for use at home.
15. For example, the community nurses would have noticed if the SATS machine was not working in the first weeks of Devon being at home and yet it has recorded that it was not used at all until 31 May 2022.
16. Secondly in order for the SATS machine data to have been correct about events of 10 May 2022, either both the parents would have had to sleep through an alarm sounding for at least 15 minutes at full volume as well as a second alarm after 15 minutes at the loss of pulse, or the parents would have had to have used the silence button on the alarm system every 60 seconds for that 15 minute period.
17. The SATS machine silence button was not within reach of Devon’s mother unless she sat up and reached up and over baby Devon in his cot. Devon’s father would have had to get out of bed altogether. A copy of the police photographs of the bedroom on 10 May 2022 is attached to this report. It is inconceivable that these concerned and careful parents, who had taken such an active role in Devon’s care, would have turned off this alarm in this way several times and failed to notice his respiratory distress, and when he was found unresponsive, would have forgotten that they had silenced the alarm in this way. Therefore either the SATS machine did not function as it should or was not sufficiently loud to wake either of these careful parents.
18. The potential for future deaths is that future parents will also rely on the SATS machine to alert them to a vulnerable child stopping breathing and taking action will not be alerted because either the alarm is too quiet, or it cuts out automatically before waking the parents, or it simply does not sound at all.
” 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 SATS machine alarms to remain active or sound when required
Wider context from the report “Matter of Concern 2:
8. The third machine was issued to the family on 25 April 2022, which remained with them until Devon’s death. It was manufactured by Medtronic (Model number MBB1920904). It is not known if this was the same brand as the second SATS machine mentioned above.
9. The concern is that this Medtronic machine was also either not functioning reliably or was not suitable for the home environment.
10. On 10 May 2022 Devon was given his 1am feed and the family settled down to sleep. At 4.30am Devon’s mother woke to find him unresponsive. The CPAP machine log confirms those two times.
11. The SATS machine was seized by the police on 10 May 2022.
12. Medtronic technician, ████████ made a statement dated 6/7/2022 which I append to this Report, in which he states that:
• The testing of the SATS machine revealed that it was functioning properly
• The data from the machine shows that from approximately 1.44am Devon’s oxygen saturations started to drop and continued to fall until approximately 2.00am when there was no pulse.
• The alarm would have been sounding throughout that time and that at the loss of pulse, at 2.00am a further alarm would have sounded.
• The machine alarm was at maximum volume
• There is a silence button on the machine but that it only silences the alarm for 60 seconds, after which interval the alarm would sound again throughout the whole period that the saturation levels were low.
13. Given the crucial role a SATS machine has in monitoring a vulnerable baby at home, with non-medically trained carers who need to sleep, there should be no doubt but that the alarm sound will sound reliably, that its volume will wake sleeping exhausted parents and should provide an accurate log of events.
14. The conclusions that the data from the SATS machine appear to provide do not accord with the other evidence provided to the inquest about the events in question. That gives cause for concern that either the analysis of the SATS machine has not been accurate or the SATS machine has not correctly recorded the data or that this SATS machine is not a suitable device for use at home.
15. For example, the community nurses would have noticed if the SATS machine was not working in the first weeks of Devon being at home and yet it has recorded that it was not used at all until 31 May 2022.
16. Secondly in order for the SATS machine data to have been correct about events of 10 May 2022, either both the parents would have had to sleep through an alarm sounding for at least 15 minutes at full volume as well as a second alarm after 15 minutes at the loss of pulse, or the parents would have had to have used the silence button on the alarm system every 60 seconds for that 15 minute period.
17. The SATS machine silence button was not within reach of Devon’s mother unless she sat up and reached up and over baby Devon in his cot. Devon’s father would have had to get out of bed altogether. A copy of the police photographs of the bedroom on 10 May 2022 is attached to this report. It is inconceivable that these concerned and careful parents, who had taken such an active role in Devon’s care, would have turned off this alarm in this way several times and failed to notice his respiratory distress, and when he was found unresponsive, would have forgotten that they had silenced the alarm in this way. Therefore either the SATS machine did not function as it should or was not sufficiently loud to wake either of these careful parents.
18. The potential for future deaths is that future parents will also rely on the SATS machine to alert them to a vulnerable child stopping breathing and taking action will not be alerted because either the alarm is too quiet, or it cuts out automatically before waking the parents, or it simply does not sound at all .
” Open source report
6 Jul 2023 Robert Newton Stevenson · Prevention of Future Deaths report West Yorkshire (Western)
View report summary
Concerns raised 3 Failure to reference the potential rare side effect when prescribing Ciprofloxacin and Quinolone antibiotics View source Lack of prescribing doctors’ awareness of the potential rare side effect View source Potential increased vulnerability of patients suffering from depression to the rare side effect 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
Robert Newton 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
Robert Newton Stevenson, a 63-year-old retired consultant cardiologist and general physician, left home on 30 May 2022 and was later found hanging; resuscitation attempts were unsuccessful. The report raised concern about a possible rare link between ciprofloxacin and suicidal behaviour, including whether prescribing doctors were sufficiently aware of and communicating this potential side effect.
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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 reference the potential rare side effect when prescribing Ciprofloxacin and Quinolone antibiotics
Wider context from the report “During the inquest I was referred by Mr Stevenson’s treating urologist to published literature relating to Ciprofloxacin and Quinolone antibiotics and a potential rare link to suicide behaviour in patients, although I found on the balance of probabilities that it remained unclear that he was suffering from this side effect, it remained possible for this to be the case.
• I heard evidence to suggest that the prescribing doctor did not reference this side effect at the time of issuing the prescription to Mr Stevenson , since it was not in accord with current advice.
• I also heard evidence to suggest that prescribing doctors may not be fully aware of this rare side effect, and that patient’s suffering from depression may be more vulnerable to it.
• I am therefore concerned that this potential risk has not been given sufficient emphasis and I would ask you to consider the appropriateness of reviewing the current guidelines as to the dispensation of the drug to patients by clinicians and increasing the awareness of the side effect in order to monitor and mitigate the risks.
” 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 prescribing doctors’ awareness of the potential rare side effect
Wider context from the report “During the inquest I was referred by Mr Stevenson’s treating urologist to published literature relating to Ciprofloxacin and Quinolone antibiotics and a potential rare link to suicide behaviour in patients, although I found on the balance of probabilities that it remained unclear that he was suffering from this side effect, it remained possible for this to be the case.
• I heard evidence to suggest that the prescribing doctor did not reference this side effect at the time of issuing the prescription to Mr Stevenson, since it was not in accord with current advice.
• I also heard evidence to suggest that prescribing doctors may not be fully aware of this rare side effect , and that patient’s suffering from depression may be more vulnerable to it.
• I am therefore concerned that this potential risk has not been given sufficient emphasis and I would ask you to consider the appropriateness of reviewing the current guidelines as to the dispensation of the drug to patients by clinicians and increasing the awareness of the side effect in order to monitor and mitigate the risks.
” 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 Potential increased vulnerability of patients suffering from depression to the rare side effect
Wider context from the report “During the inquest I was referred by Mr Stevenson’s treating urologist to published literature relating to Ciprofloxacin and Quinolone antibiotics and a potential rare link to suicide behaviour in patients, although I found on the balance of probabilities that it remained unclear that he was suffering from this side effect, it remained possible for this to be the case.
• I heard evidence to suggest that the prescribing doctor did not reference this side effect at the time of issuing the prescription to Mr Stevenson, since it was not in accord with current advice.
• I also heard evidence to suggest that prescribing doctors may not be fully aware of this rare side effect, and that patient’s suffering from depression may be more vulnerable to it .
• I am therefore concerned that this potential risk has not been given sufficient emphasis and I would ask you to consider the appropriateness of reviewing the current guidelines as to the dispensation of the drug to patients by clinicians and increasing the awareness of the side effect in order to monitor and mitigate the risks.
” Open source report
20 Jun 2023 Anita Graves · Prevention of Future Deaths report Manchester South
View report summary
Concerns raised 2 Risk of inadvertent carbimazole overdose from visual similarity of tablets View source Community dispensing processes failing to mitigate carbimazole overdose risk View source
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AI-generated summary
Anita Graves · 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
Anita Graves, who was aged 92, died on 4 January 2023 after an E. coli urinary tract infection following treatment for hyperthyroidism. The inquest found that she had inadvertently taken more than the prescribed dose of carbimazole, and concerns were raised about the visual similarity of different carbimazole strengths and aspirin, together with the community dispensing process.
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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 Risk of inadvertent carbimazole overdose from visual similarity of tablets
Wider context from the report “(1) That the visual similarity of tablets of differing strengths of carbimazole to each other and to aspirin presents a risk of inadvertent overdose ; and
(2) That the dispensing process in the community for carbimazole appears to contribute to rather than mitigating the risk
” 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 Community dispensing processes failing to mitigate carbimazole overdose risk
Wider context from the report “(1) That the visual similarity of tablets of differing strengths of carbimazole to each other and to aspirin presents a risk of inadvertent overdose; and
(2) That the dispensing process in the community for carbimazole appears to contribute to rather than mitigating the risk
” 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 authorised carbimazole products to assess whether different strengths are distinguishable by size or markings.
Verbatim wording from the response “Regulatory guidance¹ requests that different strengths of the same medicine should be distinguishable, and the following is stated in the guidance “In the case of applications for more than one tablet strength, the different tablet strengths should be distinguishable at a level sufficient to avoid mistakes between the different strengths by the final user. Distinguishing tablet strengths by colour / shape and marking / embossing is preferable.”” Source location Response from Medicines and Healthcare products Regulatory Agency
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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 Publish and update guidance for pharmaceutical companies on labelling and packaging medicines to reduce medication errors and differentiate products.
Verbatim wording from the response “We have been working very closely with the pharmaceutical companies to ensure that packaging is clear and unambiguous and that different products are adequately differentiated one from another. A guideline to the pharmaceutical industry² on how to improve medicines labelling to reduce the likelihood of medication errors has been published and recently updated, which includes amongst other things, a need to ensure that medicines which may be stored together or used concomitantly by patients are well differentiated from each other. Many companies have embraced the principles it contains and made changes to their packaging, employing the judicious use of colour to differentiate both active ingredient and strength to reduce the likelihood of medication errors.” Source location Response from Medicines and Healthcare products Regulatory Agency
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Work with pharmaceutical companies to improve packaging clarity and differentiate medicines, including by active ingredient and strength.
Verbatim wording from the response “We have been working very closely with the pharmaceutical companies to ensure that packaging is clear and unambiguous and that different products are adequately differentiated one from another. A guideline to the pharmaceutical industry² on how to improve medicines labelling to reduce the likelihood of medication errors has been published and recently updated, which includes amongst other things, a need to ensure that medicines which may be stored together or used concomitantly by patients are well differentiated from each other. Many companies have embraced the principles it contains and made changes to their packaging, employing the judicious use of colour to differentiate both active ingredient and strength to reduce the likelihood of medication errors.” Source location Response from Medicines and Healthcare products Regulatory Agency
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 General Pharmaceutical Council has no jurisdiction over manufacturers’ packaging supplied by pharmacies.
Verbatim wording from the response “The GPhC does not however have any jurisdiction over the manufacturers’ packaging that pharmacies supply. Wider issues such as medicines shortages could also potentially lead to different generic brands of medicines being supplied to patients at different periods in time. Carbimazole has unfortunately been subject to medicines shortages periodically, and whilst it is unclear if the shortages coincided with the case in hand, it is possible it may have contributed to the situation.” Source location Response from Medicines and Healthcare products Regulatory Agency
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Product labelling and packaging are considered the safest and sufficient means of identifying carbimazole and reducing confusion from tablet appearance.
Verbatim wording from the response “The issue of correct tablet identification is vital to avoid medication errors. For this reason, the primary purpose of medicines labelling is identification of the medicinal product contained within the packaging. The MHRA considers that the only reliable way for unambiguous identification of a particular medicine is via the information printed on the package labelling. The advice is always to read the label carefully as this is the only way to avoid confusion and potential medication errors. Even though the label is the most important and reliable way to identify medicines, we recognise that a final check by appearance can be reassuring. It is also recognised that medicines may be removed from their packaging for storage in pill organisers or compliance aids and that patients may be taking multiple medicines.” Source location Response from Medicines and Healthcare products Regulatory Agency
Open published response
6 Apr 2023 Alexandra Briess · Prevention of Future Deaths report Berkshire
View report summary
Concerns raised 9 Barriers to information sharing about deceased anaphylaxis patients View source Failure to mandate referral of fatal anaphylaxis cases View source Inadequate immediate investigation of suspected anaphylaxis deaths View source Lack of a national reporting and fatality-register system for anaphylaxis View source Lack of named accountability for allergy services and provision View source Lack of a clear UKFAR referral requirement after unsuccessful resuscitation View source Failure to robustly capture and record fatal and near-fatal anaphylaxis cases View source Insufficient funding for anaphylaxis data gathering and research View source Lack of national leadership for anaphylaxis work View source See 6 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.
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AI-generated summary
Alexandra Briess · 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
Alexandra Briess underwent tonsillectomy, later required surgery for post-operative bleeding, and suffered sudden deterioration and cardiac arrest during anaesthesia on 30 May 2021. She died on 31 May 2021, with the most likely cause identified as an anaphylactic reaction to Rocuronium; there were no concerns about her clinical management. The principal concerns were the lack of national leadership and funding for anaphylaxis work, mandatory reporting of fatal anaphylaxis, and improved national data gathering, research and information sharing.
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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 Barriers to information sharing about deceased anaphylaxis patients
Wider context from the report “5. Information sharing amongst the organisations referred to in this report should be straightforward . Confidentiality constraints are important, but not the same in the case of a deceased person as they are for a living person . I believe that a confidential advisory group has already started to consider this matter.
” 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 mandate referral of fatal anaphylaxis cases
Wider context from the report “It seems clear to all coroners in these cases, and those involved in this area of medical expertise, that the only way to improve understanding and prevent or reduce future deaths is to gather information nationally and fund appropriate research.
Appropriate organisations already exist, and there is a lot of goodwill towards improving understanding in this area. It does however require national leadership and “joining up” of these organisations.
1. I have tried to make my list of issues clear and succinct. Paragraph 2 below sets out the crux of this ongoing risk.
2. There is significant goodwill and desire to improve amongst numerous organisations involved in anaphylaxis work. What is lacking is national leadership and funding. In my view, consideration should be given to creating a leadership role and responsibility within NHS England to coordinate a national approach.
3. As considered by other coroners before me, it should be mandatory to refer fatal anaphylaxis cases . UKFAR has indicated that they would be prepared to take on the role of receiving these reports (to avoid duplication for reporting clinicians), with the responsibility to forward the relevant information to other organisations such as the MHRA, where appropriate. Whilst my focus is on fatal anaphylaxis, inclusion of non-fatal cases would be a matter for the lead role to consider.
4. Gathering data and using this to research and reduce the risk of future deaths requires funding, and this should be reviewed.
” 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 immediate investigation of suspected anaphylaxis deaths
Wider context from the report ““Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis , that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths , but that to achieve this, changes are required .
In relation to the Food Standards Agency, the UK Health Security Agency, and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxes, and specifically, fatal and near-fatal anaphylaxis…
• Such a system could involve, mandatory reporting of anaphylaxis presenting to hospital analogous to the current system for notifiable diseases… by registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the State of Victoria in Australia, and allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate public health 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 Lack of a national reporting and fatality-register system for anaphylaxis
Wider context from the report ““In my opinion action should be taken to consider establishing a national reporting system which includes timely reporting to local authority and FSA and maintenance of a register of fatalities and their investigations , and consideration be given to investigating the feasibility of wider access to AAI’s. I believe that the organizations would wish to learn of the circumstances of this death and are in a position to facilitate a collaborative process to mitigate or prevent future deaths.”
” 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 named accountability for allergy services and provision
Wider context from the report ““The issues within this Prevention of Future Deaths report are predominantly national issues, but I heard at inquest that there is no person with named accountability for allergy services and allergy provision at NHS England, or the Department of Health as a whole .”
” 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 clear UKFAR referral requirement after unsuccessful resuscitation
Wider context from the report “6. Consideration of including contact details for the UKFAR in algorithms used by doctors attempting to resuscitate patients – so that there is a clear requirement for referral to UKFAR in the event of an unsuccessful resuscitation . This is currently being considered by the Resuscitation Council UK.
” 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 robustly capture and record fatal and near-fatal anaphylaxis cases
Wider context from the report ““Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this, changes are required.
In relation to the Food Standards Agency, the UK Health Security Agency, and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxes, and specifically, fatal and near-fatal anaphylaxis …
• Such a system could involve, mandatory reporting of anaphylaxis presenting to hospital analogous to the current system for notifiable diseases… by registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the State of Victoria in Australia, and allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate public health 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 Insufficient funding for anaphylaxis data gathering and research
Wider context from the report “It seems clear to all coroners in these cases, and those involved in this area of medical expertise, that the only way to improve understanding and prevent or reduce future deaths is to gather information nationally and fund appropriate research.
Appropriate organisations already exist, and there is a lot of goodwill towards improving understanding in this area. It does however require national leadership and “joining up” of these organisations.
1. I have tried to make my list of issues clear and succinct. Paragraph 2 below sets out the crux of this ongoing risk.
2. There is significant goodwill and desire to improve amongst numerous organisations involved in anaphylaxis work. What is lacking is national leadership and funding. In my view, consideration should be given to creating a leadership role and responsibility within NHS England to coordinate a national approach.
3. As considered by other coroners before me, it should be mandatory to refer fatal anaphylaxis cases. UKFAR has indicated that they would be prepared to take on the role of receiving these reports (to avoid duplication for reporting clinicians), with the responsibility to forward the relevant information to other organisations such as the MHRA, where appropriate. Whilst my focus is on fatal anaphylaxis, inclusion of non-fatal cases would be a matter for the lead role to consider.
4. Gathering data and using this to research and reduce the risk of future deaths requires funding , and this should be reviewed.
” 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 leadership for anaphylaxis work
Wider context from the report “It seems clear to all coroners in these cases, and those involved in this area of medical expertise, that the only way to improve understanding and prevent or reduce future deaths is to gather information nationally and fund appropriate research.
Appropriate organisations already exist, and there is a lot of goodwill towards improving understanding in this area. It does however require national leadership and “joining up” of these organisations.
1. I have tried to make my list of issues clear and succinct. Paragraph 2 below sets out the crux of this ongoing risk.
2. There is significant goodwill and desire to improve amongst numerous organisations involved in anaphylaxis work. What is lacking is national leadership and funding . In my view, consideration should be given to creating a leadership role and responsibility within NHS England to coordinate a national approach.
3. As considered by other coroners before me, it should be mandatory to refer fatal anaphylaxis cases. UKFAR has indicated that they would be prepared to take on the role of receiving these reports (to avoid duplication for reporting clinicians), with the responsibility to forward the relevant information to other organisations such as the MHRA, where appropriate. Whilst my focus is on fatal anaphylaxis, inclusion of non-fatal cases would be a matter for the lead role to consider.
4. Gathering data and using this to research and reduce the risk of future deaths requires funding, and this should be reviewed.
” Open source report
30 Dec 2022 Gavin Peter Pedleham · Prevention of Future Deaths report Surrey
View report summary
Concerns raised 2 Lack of requirements for safe community storage of Oramorph and prevention of access by others View source Lack of regulations governing Oramorph use in community settings View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Gavin Peter Pedleham · 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
Gavin Peter Pedleham inadvertently drank a dose of Oramorph left in a glass at a family Christmas party after consuming a significant quantity of alcohol. He was found dead the following morning, and the inquest recorded morphine and ethanol toxicity, concluding that his death was accidental. The substantive concern was that community use of Oramorph is not subject to similar safe-storage requirements as its use in institutional settings, allowing access by others.
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 requirements for safe community storage of Oramorph and prevention of access by others
Wider context from the report “1. Oramorph is a controlled drug the storage, handling and administration of which in institutional settings is highly regulated. However, there are no similar regulations which govern its use in a community setting. There is no requirement for the recipient of the drug in the community to keep it in a safe place and ensure that it cannot be accessed by others .
” 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 regulations governing Oramorph use in community settings
Wider context from the report “1. Oramorph is a controlled drug the storage, handling and administration of which in institutional settings is highly regulated. However, there are no similar regulations which govern its use in a community setting . There is no requirement for the recipient of the drug in the community to keep it in a safe place and ensure that it cannot be accessed by others.
” 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 Work with Marketing Authorisation holders to update Oramorph product information on secure storage and not leaving diluted medicine unattended.
Verbatim wording from the response “This was a tragic accident which was not circumvented by the warnings and guidance clearly present in the product information. However, it is evident that the glass containing Oramorph was left unattended. Therefore, we will work with the Marketing Authorisation holders to update the product information to highlight the need to keep the medicine in a secure place and not leave any diluted Oramorph unattended.” Source location Response from 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 Oramorph warnings and guidance were clear; the unintended recipient would not have seen the product information.
Verbatim wording from the response “The MHRA monitors the safety of all medicines to ensure that up-to-date information on the benefits and risks of a medicine is available for healthcare professionals and patients. The Summary of Product Characteristics (SmPC) for a medicine provides information for healthcare professionals (HCPs) about the medicine, including warnings and precautions of use in higher risk situations. The same information is provided to patients in a patient information leaflet, which is written in language that can be understood by the lay person and accompanies each medicine. However, this tragic event did not occur to a patient but to an unintended recipient, therefore, will not have seen the product information.” Source location Response from MHRA
Open published response
4 Aug 2022 Roy DRAPER · Prevention of Future Deaths report Derby and Derbyshire
View report summary
Concerns raised 3 Absence of a formal referral system for reporting adverse events and triggering consideration of unblinding View source Insufficient dissemination of the unblinding protocol View source Lack of a clear system and protocol for responsibility and procedure in triggering consideration of unblinding View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Roy DRAPER · 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
Roy Draper, who had mesothelioma linked to occupational asbestos exposure, became unwell after chemotherapy in a clinical trial, later developed bronchopneumonia and suffered a massive stroke, and died in hospital on 13 February 2020. Concerns were raised about the lack of a clear process and responsibility for requesting unblinding when a clinical-trial patient became acutely unwell at another hospital, and about the absence of a formal referral system for reporting adverse events to the trials team.
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 Absence of a formal referral system for reporting adverse events and triggering consideration of unblinding
Wider context from the report “The matters of concern arise in the context of patients who are undergoing a clinical trial but who become acutely unwell and are admitted to another hospital for treatment. In such circumstances the treating hospital wishes to know further information about the trial as it may be relevant to treatment decisions. At inquest the evidence was unclear as to whom bears responsibility for initiating unblinding requests and what the process is. The evidence was conflicting as to whether the treating hospital understood that unblinding requests were considered by the clinical trials team once they were notified of a suspected adverse event whereas the clinical trial hospital believed that unblinding would only be considered once a formal request was made from the treating hospital.
1. There is a lack of a clear system and protocol on whose responsibility it is to trigger consideration of the unblinding process and the correct procedure that should be followed by the treating hospital. If such a protocol in fact exists, then it does not appear to have been sufficiently disseminated.
2. There is no formal referral system for the treating hospital to use to report adverse events to the trials team and trigger consideration of the unblinding process. This means that conversations about the process between hospitals are not transparent.
” 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 dissemination of the unblinding protocol
Wider context from the report “The matters of concern arise in the context of patients who are undergoing a clinical trial but who become acutely unwell and are admitted to another hospital for treatment. In such circumstances the treating hospital wishes to know further information about the trial as it may be relevant to treatment decisions. At inquest the evidence was unclear as to whom bears responsibility for initiating unblinding requests and what the process is. The evidence was conflicting as to whether the treating hospital understood that unblinding requests were considered by the clinical trials team once they were notified of a suspected adverse event whereas the clinical trial hospital believed that unblinding would only be considered once a formal request was made from the treating hospital.
1. There is a lack of a clear system and protocol on whose responsibility it is to trigger consideration of the unblinding process and the correct procedure that should be followed by the treating hospital. If such a protocol in fact exists, then it does not appear to have been sufficiently disseminated.
2. There is no formal referral system for the treating hospital to use to report adverse events to the trials team and trigger consideration of the unblinding process. This means that conversations about the process between hospitals are not transparent.
” 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 clear system and protocol for responsibility and procedure in triggering consideration of unblinding
Wider context from the report “The matters of concern arise in the context of patients who are undergoing a clinical trial but who become acutely unwell and are admitted to another hospital for treatment. In such circumstances the treating hospital wishes to know further information about the trial as it may be relevant to treatment decisions. At inquest the evidence was unclear as to whom bears responsibility for initiating unblinding requests and what the process is. The evidence was conflicting as to whether the treating hospital understood that unblinding requests were considered by the clinical trials team once they were notified of a suspected adverse event whereas the clinical trial hospital believed that unblinding would only be considered once a formal request was made from the treating hospital.
1. There is a lack of a clear system and protocol on whose responsibility it is to trigger consideration of the unblinding process and the correct procedure that should be followed by the treating hospital. If such a protocol in fact exists, then it does not appear to have been sufficiently disseminated.
2. There is no formal referral system for the treating hospital to use to report adverse events to the trials team and trigger consideration of the unblinding process. This means that conversations about the process between hospitals are not transparent.
” 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 Publish guidance defining trial contact, out-of-hours coverage, emergency unblinding and testing arrangements.
Verbatim wording from the response “The MHRA has published the following information in the MHRA Good Clinical Practice Guide (2012) – section 11.4.8 Contact Details and Out-Of-Hours Arrangements and 11.4.9 Emergency Code Breaking:” Source location Response from 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 participant contact details, investigator responsibilities and trial protocols sufficiently enable emergency clinical-trial unblinding, so no further action is required.
Verbatim wording from the response “The MHRA propose that no action is required in relation to either of the matters of concern raised. A detailed response is provided for each point explaining the systems in place for unblinding of clinical trials and the responsibilities for executing those processes.” Source location Response from 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 patient information, emergency cards and documented contact arrangements sufficiently enable adverse-event reporting and unblinding without a formal referral system.
Verbatim wording from the response “The MHRA propose that no action is required in relation to either of the matters of concern raised. A detailed response is provided for each point explaining the systems in place for unblinding of clinical trials and the responsibilities for executing those processes.” Source location Response from MHRA
Open published response
7 Jul 2022 Seema Pravin HARIBHAI · Prevention of Future Deaths report Inner North London
View report summary
Concerns raised 12 Failure to advise immediate cessation of herbal remedies View source Failure to advise immediate attendance at a hospital emergency department View source Failure to identify prescribed drugs or drug combinations View source Failure to record relevant clinical history and symptoms View source Failure to recognise prescribed medicines as a possible cause of harm View source Lack of routine awareness of possible complications of Ayurvedic treatment View source Insufficient continuing professional development training for Ayurvedic practitioners View source Failure to arrange an in-person physical examination View source Lack of regulation of Ayurvedic practitioners View source Delay in responding to markedly abnormal blood test results View source Lack of quality control for medicines manufactured abroad View source Failure to advise immediate cessation of Ayurvedic medicines View source See 9 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Seema Pravin HARIBHAI · 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
Seema Haribhai, who had increasingly disabling psoriatic arthritis, took herbal remedies prescribed by an Ayurvedic practitioner and developed liver failure, dying some weeks later. The investigation determined that she died as a consequence of the administration of Ayurvedic medicines intended to treat psoriatic arthritis. Concerns included the practitioner’s failure to recognise the possible harm from the medicines or advise their immediate cessation, the lack of regulation and evidence of quality control, and shortcomings in the GP’s assessment and response to her symptoms and abnormal blood test.
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 advise immediate cessation of herbal remedies
Wider context from the report “However, when she first discovered that her patient had developed a yellow discolouration, whilst she recognised that the liver was probably responsible, she did not recognise that the cause might be her own prescription. She did not advise the only course of action with the potential to save Seema Haribhai’s life: an immediate cessation of all the herbal remedies.
Even when she gave evidence in court, the Ayurvedic practitioner did not seem to canvass the possibility that the medicines she had prescribed could have caused harm. She had at one stage advised her patient to have a routine blood test, but she had not at any stage advised immediate attendance at a hospital emergency department.
” 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 advise immediate attendance at a hospital emergency department
Wider context from the report “However, when she first discovered that her patient had developed a yellow discolouration, whilst she recognised that the liver was probably responsible, she did not recognise that the cause might be her own prescription. She did not advise the only course of action with the potential to save Seema Haribhai’s life: an immediate cessation of all the herbal remedies.
Even when she gave evidence in court, the Ayurvedic practitioner did not seem to canvass the possibility that the medicines she had prescribed could have caused harm. She had at one stage advised her patient to have a routine blood test, but she had not at any stage advised immediate attendance at a hospital emergency department .
” 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 identify prescribed drugs or drug combinations
Wider context from the report “I am aware that one of the treating hepatologists from the Royal Free Hospital attempted to report this matter to the MHRA under the yellow card scheme, but was in some difficulty because he could not identify which drugs or drug combinations had been prescribed and had caused the liver injury.
” 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 record relevant clinical history and symptoms
Wider context from the report “However, the GP did not record the detail of the history, he did not record exactly when the yellow discolouration first appeared, and he did not record the absence of any other signs and symptoms . He did not ask for attendance at the surgery so that he could perform a physical examination. He did not advise immediate cessation of the Ayurvedic medicines.
” 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 prescribed medicines as a possible cause of harm
Wider context from the report “However, when she first discovered that her patient had developed a yellow discolouration, whilst she recognised that the liver was probably responsible, she did not recognise that the cause might be her own prescription . She did not advise the only course of action with the potential to save Seema Haribhai’s life: an immediate cessation of all the herbal remedies.
Even when she gave evidence in court, the Ayurvedic practitioner did not seem to canvass the possibility that the medicines she had prescribed could have caused harm. She had at one stage advised her patient to have a routine blood test, but she had not at any stage advised immediate attendance at a hospital emergency department.
” 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 routine awareness of possible complications of Ayurvedic treatment
Wider context from the report “It appears from the evidence I heard in court that Ayurvedic practitioners do not necessarily have the possible complications of Ayurvedic treatment as part of their routine frame of reference . All medicines can cause harm, even those that are herbal based.
” 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 continuing professional development training for Ayurvedic practitioners
Wider context from the report “I heard evidence at inquest that Ayurvedic practitioners are not in any way regulated. Even those who are members of the Ayurvedic Professionals Association receive as little as two hours of continuing professional development training per annum .
” 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 arrange an in-person physical examination
Wider context from the report “However, the GP did not record the detail of the history, he did not record exactly when the yellow discolouration first appeared, and he did not record the absence of any other signs and symptoms. He did not ask for attendance at the surgery so that he could perform a physical examination . He did not advise immediate cessation of the Ayurvedic medicines.
” 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 regulation of Ayurvedic practitioners
Wider context from the report “I heard evidence at inquest that Ayurvedic practitioners are not in any way regulated . Even those who are members of the Ayurvedic Professionals Association receive as little as two hours of continuing professional development training per annum.
” 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 Delay in responding to markedly abnormal blood test results
Wider context from the report “The GP consultation was on 5 November, the blood test was conducted on 9 November, the results came back to the surgery on 10 and 11 November, and an appointment was booked for 15 November . Meanwhile, same day admission to hospital was arranged on 15 November solely because a nurse had noted the blood test result at a routine rheumatology appointment .
The blood test result was so abnormal that, even without examination, the consult rheumatologist saw no option but immediate admission .
” 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 quality control for medicines manufactured abroad
Wider context from the report “The medicines prescribed by Ayurvedic practitioners are manufactured abroad. I did not hear evidence of any quality control .
” 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 advise immediate cessation of Ayurvedic medicines
Wider context from the report “However, the GP did not record the detail of the history, he did not record exactly when the yellow discolouration first appeared, and he did not record the absence of any other signs and symptoms. He did not ask for attendance at the surgery so that he could perform a physical examination. He did not advise immediate cessation of the Ayurvedic medicines .
” 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 No changes are proposed to the Yellow Card scheme because specific product details are necessary to assess the safety concern.
Verbatim wording from the response “No changes are proposed to the Yellow Card scheme as it is essential to have information about the specific products involved in order to assess the specific safety concern. The healthcare professional involved in the patients care did not have details of the herbal products taken and therefore could not complete the online form for the Yellow Card scheme. However, their concern about the safety of the herbal products could have been raised with the MHRA through multiple other routes while further details of the products were sought from the herbal practitioner either by the original reporter or the MHRA, if the MHRA were provided with the herbal practitioner’s details.” Source location Response from MHRA
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 MHRA cannot comment on the quality control or medicinal claims of products that are not licensed by it.
Verbatim wording from the response “However, it is important to note that the products referred to in the herbal practitioners statement are not licensed by the MHRA and therefore we are unable to comment on the quality control of the products taken by Seema Haribhai or any medicinal claims that may have been made for these products.” Source location Response from 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 MHRA has no regulatory oversight of herbal medicines produced and supplied under the statutory practitioner exemption.
Verbatim wording from the response “The exemptions in the Human Medicines Regulations 2012, allow herbal practitioners to produce and supply herbal medicines following a one to one consultation with the patient. The MHRA has no regulatory oversight over products provided under this exemption.” Source location Response from MHRA
Open published response
25 Apr 2022 Mr Edward Jorge Capovila · Prevention of Future Deaths report Cumbria
View report summary
Concerns raised 1 Lack of information about unusual ways fentanyl can be misused or abused View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Mr Edward Jorge Capovila · 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 Edward Jorge Capovila, known as Eddy, died on 30 October 2020 from the combined toxic effect of prescribed medication, after administering fentanyl by heating and inhaling it. The report raises concern that relatively little information is available about unusual ways fentanyl can be misused, creating a risk of further deaths if action is not taken.
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 information about unusual ways fentanyl can be misused or abused
Wider context from the report “As indicated above, I was told that there is relatively little information available about the more unusual ways in which fentanyl can be misused or abused . Given the potential for fentanyl to be misused, as evidenced in Eddy’s inquest, I have concern that further deaths may occur in future if action is not taken.
” 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 Issue a drug safety bulletin warning patients and healthcare professionals about heat exposure, overdose, death, and cutting fentanyl patches.
Verbatim wording from the response “The MHRA became aware that if a patch is exposed to heat, it will increase the speed at which the fentanyl is absorbed into the body and therefore the patient is likely to be exposed to a higher initial dose than prescribed. In December 2014, the MHRA issued a drug safety bulletin¹ warning healthcare professionals and patients of the risk of overdose and death with exposure of the ████████ patch to increased heat including the instruction that the patch should not be cut.” Source location Response from Medicines & Healthcare products Regulatory Agency
Open published response
16 Jul 2021 Chimezie DANIELS · Prevention of Future Deaths report Inner North London
View report summary
Concerns raised 2 Difficulty determining the cause of low oxygen saturations amid simultaneous CPAP alarms in medical wards View source Failure of CPAP alarms to distinguish minor mask leaks from total cessation of oxygen supply View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Chimezie DANIELS · 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
Chimezie Daniels died from SARS CoV-2 infection, with pulmonary sarcoidosis also recorded as a cause. At inquest, concern was raised that CPAP machines may use the same alarm for a minor mask leak and a complete cessation of oxygen supply. Multiple simultaneous alarms in a busy medical ward made it more difficult to identify the cause of Mr Daniels’ low oxygen saturations.
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 Difficulty determining the cause of low oxygen saturations amid simultaneous CPAP alarms in medical wards
Wider context from the report “At inquest, I heard that on most CPAP machines, the alarm that sounds for a very small leak from the mask is no different from the alarm that sounds for total cessation in oxygen supply.
Clinicians told me that it would be much more helpful if very serious matters were denoted by an urgent alarm, and less serious matters in another way.
When the alarm on Mr Daniels’ machine sounded, there were four other alarms sounding simultaneously for the four other patients in the bay where he was being nursed . This gave the determination of the cause of his low oxygen saturations an added complexity , particularly at a time in the pandemic when there was so much pressure on beds that CPAP patients were being nursed on medical wards rather than in the high dependency unit .
I appreciate that there will not always be an intention to connect to an oxygen supply. Nevertheless, I am sure that further consideration can be given to the issue that the inquest touching Mr Daniels’ death has highlighted.
” 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 CPAP alarms to distinguish minor mask leaks from total cessation of oxygen supply
Wider context from the report “At inquest, I heard that on most CPAP machines, the alarm that sounds for a very small leak from the mask is no different from the alarm that sounds for total cessation in oxygen supply .
Clinicians told me that it would be much more helpful if very serious matters were denoted by an urgent alarm, and less serious matters in another way .
When the alarm on Mr Daniels’ machine sounded, there were four other alarms sounding simultaneously for the four other patients in the bay where he was being nursed. This gave the determination of the cause of his low oxygen saturations an added complexity, particularly at a time in the pandemic when there was so much pressure on beds that CPAP patients were being nursed on medical wards rather than in the high dependency unit.
I appreciate that there will not always be an intention to connect to an oxygen supply. Nevertheless, I am sure that further consideration can be given to the issue that the inquest touching Mr Daniels’ death has highlighted.
” 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 Search the MHRA adverse-incident and corrective-action database for comparable ventilator alarm events.
Verbatim wording from the response “A search of the MHRA database of reported adverse incidents and corrective actions relating to all types of ventilators over the past 5 years has not identified any similar reports where an inability to identify the device fault from the audible alarm tone has been reported.” Source location 2021-0255-Response-from-MHRA_Published
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 Review the designated medical-equipment alarm standard and its application to alarm severity and prioritisation.
Verbatim wording from the response “1. We reviewed the designated standard available relating to alarms on medical equipment, ‘EN 60601-1-8:2007+A11:2017 Medical electrical equipment, Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems’. This standard provides guidance to medical device manufacturers on requirements for alarm systems, including how the alarms should sound to allow users to prioritise action by level of risk involved. Philips have confirmed that they used the international (ISO) version of this standard during the design of their product. The text is the same in both standards.” Source location 2021-0255-Response-from-MHRA_Published
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 Engage respiratory and anaesthesia professional bodies to explore training and healthcare-system measures addressing audible alarm prioritisation.
Verbatim wording from the response “4. We are engaging with the Association of Respiratory Nurse Specialists to explore how the current training programme addresses the issue of audible alarm prioritisation, and whether there may be more actions for the health care system to take to mitigate the risk. We are also engaging with the Royal College of Anaesthetists and Association of Anaesthetists for their input into how this issue can be addressed.” Source location 2021-0255-Response-from-MHRA_Published
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Existing internationally recognised alarm standards, user training and manufacturer guidance sufficiently mitigate residual risks, so wholesale audible alarm redesign is not justified.
Verbatim wording from the response “1. We reviewed the designated standard available relating to alarms on medical equipment, ‘EN 60601-1-8:2007+A11:2017 Medical electrical equipment, Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems’. This standard provides guidance to medical device manufacturers on requirements for alarm systems, including how the alarms should sound to allow users to prioritise action by level of risk involved. Philips have confirmed that they used the international (ISO) version of this standard during the design of their product. The text is the same in both standards.” Source location 2021-0255-Response-from-MHRA_Published
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 available evidence does not indicate a wider safety concern involving inability to identify ventilator faults from audible alarm tones.
Verbatim wording from the response “Information supplied by Philips Respironics states they are aware of 11 reports worldwide of events involving alarms which were not acknowledged or addressed during the last 3 years. Of these, 8 involved alarms which were not acknowledged by the caregiver, one concerned a device which alarmed but was not acted upon as the family were on another floor, one involved a patient who went into cardiac arrest before the caregiver acknowledged the alarm, and one involved a patient who desaturated before the caregiver acknowledged the alarm. None of these occurred in the UK and none involved failure of the device.” Source location 2021-0255-Response-from-MHRA_Published
Open published response
18 Jun 2021 Andrew Cook · Prevention of Future Deaths report Northamptonshire
View report summary
Concerns raised 4 Failure of clinicians to recognise PEG synonyms View source Under-reporting of PEG allergy View source Failure of medical product information to clearly identify PEG existence, dose and molecular weight View source Inconsistent PEG nomenclature View source See 1 more concern
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something this recipient says it has done, is doing, or plans to do in response to the concern raised. 10
Action
Appraise feedback from the public consultation, including feedback on proposed medical-device labelling requirements.
Stated plannedThe respondent said that this action was planned when they made their response on 3 August 2021. View source
Action
Work with UK Approved Bodies to communicate the importance of clear PEG labelling.
Stated plannedThe respondent said that this action was planned when they made their response on 3 August 2021. View source
Action
Engage medical-device manufacturers and other stakeholders to develop clear PEG/macrogol labelling guidelines.
Stated in progressThe respondent said that this action was in progress when they made their response on 3 August 2021. View source
Action
Publicise PEG safety messages through patient groups, medical societies, healthcare colleges, manufacturer associations and safety-message alerts.
Stated plannedThe respondent said that this action was planned when they made their response on 3 August 2021. View source
Action
Review requirements for disclosing PEG molecular weight and quantity, consulting patient representatives, clinical experts and industry.
Stated plannedThe respondent said that this action was planned when they made their response on 3 August 2021. View source
Action
Issue a Drug Safety Update linking to the Devices Safety Information webpage and highlighting PEG nomenclature variations in medicines.
Stated plannedThe respondent said that this action was planned when they made their response on 3 August 2021. View source
Action
Continue reviewing PEG exposure data, seek external expert views and use the findings to develop labelling advice for devices and medicines.
Stated in progressThe respondent said that this action was in progress when they made their response on 3 August 2021. View source
Action
Launch a Devices Safety Information webpage explaining PEG/macrogol risks in medical devices and nomenclature variations.
Stated plannedThe respondent said that this action was planned when they made their response on 3 August 2021. View source
Action
Appraise UK medical-device and medicines legislation on minimum ingredient-labelling requirements.
Stated in progressThe respondent said that this action was in progress when they made their response on 3 August 2021. View source
Action
Review PEG nomenclature challenges and engage global stakeholders, including WHO and the IMDRF.
Stated plannedThe respondent said that this action was planned when they made their response on 3 August 2021. View source See 7 more actions
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AI-generated summary
Andrew Cook · 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
Andrew Cook suffered anaphylaxis and cardiac arrest during percutaneous coronary intervention at Kettering General Hospital on 31 March 2019, and resuscitation was unsuccessful. The concerns included under-reporting and limited research into PEG allergy, lack of clear information about PEG in medical equipment and its dose and molecular weight, and inconsistent PEG nomenclature that could cause confusion for clinicians.
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 of clinicians to recognise PEG synonyms
Wider context from the report “(3) There is inconsistency and potential confusion in nomenclature. For example, PEG can be referred to as “Macrogol”, “polyethylene oxide” (PEO) or “polyoxyethylene” (POE). Nomenclature may also vary between countries. There was evidence that clinicians reviewing product information in urgent situations are not aware of the various synonyms.
” 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 Under-reporting of PEG allergy
Wider context from the report “(1) PEG allergy is rare but may be under-reported. PEGs are ubiquitous and more research into their effect as allergens is required.
” 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 medical product information to clearly identify PEG existence, dose and molecular weight
Wider context from the report “(2) Whether the existence, dose and molecular weight of PEG should be made clear on medical product information (such as the Instructions For Use, data sheets, packaging and marketing information).
The existence of PEG in the equipment (in this case, the Sion and Sion Blue guidewires manufactured by Asahi Intecc) was not apparent from the packaging or product information available to the clinicians.
PEGs are available in various molecular weights. There was expert evidence that reaction to PEG may depend on the dose and exact molecular weight to which an individual is exposed .
It was acknowledged that labelling can have negative effects and therefore needs to be considered with care. Labelling also requires coordination with other national regulators.
” 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 PEG nomenclature
Wider context from the report “(3) There is inconsistency and potential confusion in nomenclature. For example, PEG can be referred to as “Macrogol”, “polyethylene oxide” (PEO) or “polyoxyethylene” (POE). Nomenclature may also vary between countries. There was evidence that clinicians reviewing product information in urgent situations are not aware of the various synonyms.
” 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 Appraise feedback from the public consultation, including feedback on proposed medical-device labelling requirements.
Verbatim wording from the response “The MHRA will appraise the feedback received from the public consultation of the UK medical devices legislation including the Chapter relating to labelling so that we may create a world-leading regime that continues to prioritise patient safety. These actions combined with the measures above, will minimise risk associated with PEG allergy while ensuring continued access to devices from those patients who will benefit.” Source location 2021-0258-Response-from-MHRA_Published
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 Work with UK Approved Bodies to communicate the importance of clear PEG labelling.
Verbatim wording from the response “1. The MHRA will work with UK ABs to communicate the importance of appropriate clear labelling with respect to PEG.” Source location 2021-0258-Response-from-MHRA_Published
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 Engage medical-device manufacturers and other stakeholders to develop clear PEG/macrogol labelling guidelines.
Verbatim wording from the response “2. We will continue to engage with relevant stakeholders, in particular the medical device manufacturers, to develop clear guidelines on labelling requirements for PEG/macrogol.” Source location 2021-0258-Response-from-MHRA_Published
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 Publicise PEG safety messages through patient groups, medical societies, healthcare colleges, manufacturer associations and safety-message alerts.
Verbatim wording from the response “To further publicise these safety messages, the MHRA will utilise relevant patient representative groups, major medical professional societies/colleges, and appropriate healthcare manufacturer trade associations to further publicise this safety issue. In combination with standard alerts to subscribers of our safety message webpage, this will ensure a greater reach to patients, public and health care system.” Source location 2021-0258-Response-from-MHRA_Published
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 Review requirements for disclosing PEG molecular weight and quantity, consulting patient representatives, clinical experts and industry.
Verbatim wording from the response “3. Concerning the need for additional detail on the labelling of PEG regarding the its molecular weight and amount/quantity used, we will need to undertake a longer-term programme of review. The MHRA will discuss these points with patient representative groups, clinical experts, and industry.” Source location 2021-0258-Response-from-MHRA_Published
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 Issue a Drug Safety Update linking to the Devices Safety Information webpage and highlighting PEG nomenclature variations in medicines.
Verbatim wording from the response “3. We recognise the need to raise awareness of this safety issue to patients, public and healthcare professionals relating to medical devices and medicines.
- The MHRA plan to launch a Devices Safety Information (DSI) webpage specifically on PEG/macrogol in medical devices to highlight its potential to illicit allergic type reactions, and to raise awareness of nomenclature variations.
- We also plan to issue a Drug Safety Update (DSU) that links directly to the DSI webpage (above) to reinforce this message as well as raise awareness of the different names for PEG compounds in medicines.” Source location 2021-0258-Response-from-MHRA_Published
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 Continue reviewing PEG exposure data, seek external expert views and use the findings to develop labelling advice for devices and medicines.
Verbatim wording from the response “Conclusion
The MHRA will continue to collect and review information from a range of data sources on PEG exposure including via our adverse incident (Yellow Card) reporting system and database, as well as independent scientific publications. This information will form part of an ongoing review in which we will seek views of external experts, that will aid us in the development of labelling advice for PEG in medical devices and medicines, specifically the balance of benefits and risks to patients and other users of medical devices.” Source location 2021-0258-Response-from-MHRA_Published
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 Launch a Devices Safety Information webpage explaining PEG/macrogol risks in medical devices and nomenclature variations.
Verbatim wording from the response “3. We recognise the need to raise awareness of this safety issue to patients, public and healthcare professionals relating to medical devices and medicines.
- The MHRA plan to launch a Devices Safety Information (DSI) webpage specifically on PEG/macrogol in medical devices to highlight its potential to illicit allergic type reactions, and to raise awareness of nomenclature variations.
- We also plan to issue a Drug Safety Update (DSU) that links directly to the DSI webpage (above) to reinforce this message as well as raise awareness of the different names for PEG compounds in medicines.” Source location 2021-0258-Response-from-MHRA_Published
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 Appraise UK medical-device and medicines legislation on minimum ingredient-labelling requirements.
Verbatim wording from the response “4. The MHRA will continue to perform ongoing appraisal of the current medical devices and medicines UK legislation with regards to expectations on minimum labelling requirements relating to ingredients.” Source location 2021-0258-Response-from-MHRA_Published
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 PEG nomenclature challenges and engage global stakeholders, including WHO and the IMDRF.
Verbatim wording from the response “Concern 3:
We will review the challenges relating to nomenclature.” Source location 2021-0258-Response-from-MHRA_Published
Open published response
14 Jun 2021 Ian Hall · Prevention of Future Deaths report Manchester South
View report summary
Concerns raised 1 Lack of pharmacy checks to prevent inadvertent dispensing to vulnerable adults 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
Ian Hall · 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 Hall, who had Alzheimer’s disease and was vulnerable, was admitted to hospital after a fall. A medicines reconciliation identified that amitriptyline had been dispensed instead of his prescribed atenolol; he subsequently choked on medication, developed aspiration pneumonia, tested positive for Covid-19, and died from aspiration pneumonia and Covid-19 pneumonitis. Concerns included the unclear cause of the dispensing error and the checks in place to prevent inadvertent dispensing to vulnerable adults whose carers administered the medication.
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 pharmacy checks to prevent inadvertent dispensing to vulnerable adults
Wider context from the report “2. It was unclear what checks the pharmacy in question had or any pharmacy has to avoid the inadvertent dispensing to a vulnerable adult where the carers role is to administer whatever medications are collected from the pharmacy in the name of the individual. The inquest was told that the carers in this situation generally will have no clinical training. Therefore, their role is to check the medication is in an individual’s name and give it to the individual in compliance with what is on the label. It is not part of their role to cross check previous medications or query changes to medication.
” 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 atenolol and amitriptyline packaging for potential improvements that could reduce future dispensing errors.
Verbatim wording from the response “The MHRA will review the packaging of these medicines and if we consider on assessment that improvements could be made we will contact any pharmaceutical manufacturers who supply these medicines and seek changes so that the likelihood of future errors of this nature may be reduced.” Source location 2021-0202-Response-from-MHRA_Redacted
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 Publish a Drug Safety Update article reminding healthcare professionals to remain vigilant for medicine-name confusion errors.
Verbatim wording from the response “We also issued an article in our 2018 Drug Safety Update (DSU) bulletin to remind healthcare professionals on the need for continued vigilance for these sorts of errors https://www.gov.uk/drug-safety-update/drug-name-confusion-reminder-to-be-vigilant-for-potential-errors. That guidance highlighted a known confusion between atenolol and amiodarone (another antihypertensive) but confusion between atenolol and amitriptyline has not been reported to us previously.” Source location 2021-0202-Response-from-MHRA_Redacted
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 Issue best-practice guidance recommending differentiated medicine packaging to reduce selection errors.
Verbatim wording from the response “The primary purpose of medicines labelling is the unambiguous identification of the medicinal product contained within the packaging. We have issued best practice guidance to the pharmaceutical industry which includes amongst other things, a need to ensure that medicines which may be stored together or used concomitantly by patients are well differentiated from each other by the judicious use of colour to reduce the likelihood of medication error.” Source location 2021-0202-Response-from-MHRA_Redacted
Open published response
Concerns raised 7 Failure to align product promotion with safety information about feeding and drainage suitability View source Insufficient product description of the tube bore restriction View source Failure to fully evaluate the size 14FR tube before replacing previous drainage tubes View source Lack of compulsory root cause analysis training for clinicians View source Failure to train sales marketing staff to recognise and communicate the tube bore restriction View source Failure to respond appropriately when NG tubes are not adequately draining View source Wider product labelling failure to communicate the connector-related bore restriction View source See 4 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
Stephen James Oakes · 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
Stephen James Oakes, aged 59, died in hospital on 23 December 2017 after a carefeed 14F nasogastric tube inadequately drained stomach contents, allowing vomit to pass the tube and leading to aspiration pneumonia in the context of metastatic bronchial carcinoma and small bowel obstruction. The principal concerns included inadequate product description and staff training, insufficient hospital evaluation of the tube, failure to recognise inadequate drainage or consider alternatives, and possible wider product-labelling problems.
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 align product promotion with safety information about feeding and drainage suitability
Wider context from the report “(6) Despite reports to the MHRA and issue of amended instructions for use and a field safety notice the product continues to be promoted as suitable to feeding and drainage . Please see attached link to the Nursing times. https://www.nursingtimes.net/clinical-archive/nutrition/selection-and-management-of-commonly-used-enteral-feeding-tubes-18-02-2019/
” 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 product description of the tube bore restriction
Wider context from the report “(1) The product description used by Enteral was insufficient to enable the end user to clearly identify that the tube marketed as a carefeed size 14FR feeding and drainage tube would not operate as a 14Fr tube due to the restricting en-fit connector .
” 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 fully evaluate the size 14FR tube before replacing previous drainage tubes
Wider context from the report “(3) The Hospital Trust did not fully evaluate the size 14FR tube prior to replacing all previous drainage tubes (Ryles) with the carefeed 14F feeding and drainage tube . Feedback was generally difficult to obtain .
” 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 compulsory root cause analysis training for clinicians
Wider context from the report “(5) There is no compulsory training of clinicians required to undertake root cause 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 Failure to train sales marketing staff to recognise and communicate the tube bore restriction
Wider context from the report “(2) Enteral sales marketing staff were not trained to recognise the new restriction in the bore of the tube and were consequently unable to advise the end user of the change .
” 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 respond appropriately when NG tubes are not adequately draining
Wider context from the report “(4) Nursing staff did not consider alternative action when the NG tubes were not adequately draining . There was no general recognition of the need to aspirate the tube .
” 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 Wider product labelling failure to communicate the connector-related bore restriction
Wider context from the report “(7) This was a joint inquest into the death of two patients who died in quick succession as a result of the Enteral 14F nasogastric tube being used for decompression in an emergency situation. Four similar (non-fatal) incidents followed. It was not clear to the hospital that the Enteral connector reduced the bore of the size 14Fr tube . The inquest was aware that other Hospital Trusts had also need to change the tubes. I am concerned that the product labelling problem identified during these inquests may not be limited to the University Hospital North Midlands but is in fact a much wider problem that merits wider industry investigation and changes.
” 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 Write to UK nasogastric-tube manufacturers about ENFit connector risks and request risk-assessment updates, with advice on applicable corrective actions, instructions and staff training.
Verbatim wording from the response “In relation to concerns 2, 6 and 7, we will continue to collaborate with NHS England and Improvement on the best way to address this issue, such as raising awareness on the Medical Devices Safety Officers’ (MDSO) network. We will write to UK manufacturers of nasogastric tubes to advise them of the risk associated with the use of the ISO standard ENFit connector in aspiration/decompression situations and ask them to update their risk assessment if not already done. We will advise that where applicable, they should conduct a Field Safety Corrective Action (FSCA) and update their IFU, ensuring that their staff are fully trained in the changes so that they can provide advice to clinicians where necessary. This action will be completed within 1 month.” Source location 2021-0114-Response-from-MHRA_Published
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 NHS England and Improvement is responsible for responding to concerns about Hospital Trust evaluation, nursing practice, and root-cause-analysis training.
Verbatim wording from the response “We understand from NHS England and Improvement that a separate response has been provided to yourself covering points 3, 4 and 5.” Source location 2021-0114-Response-from-MHRA_Published
Open published response
18 Jan 2021 Mrs Lynn Hadley · Prevention of Future Deaths report Black Country
View report summary
Concerns raised 3 Lack of user knowledge of oxygen-cylinder ignition mechanisms and their ramifications View source Risk of ignition within oxygen-cylinder valve components View source Failure to follow the safe valve-opening sequence for oxygen regulators 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
Mrs Lynn Hadley · 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
On 13 April 2020, paramedics attended Mrs Lynn Hadley at home for COVID-19-type symptoms and began administering oxygen. The oxygen cylinder sparked and caught fire, and despite efforts by family members and paramedics, Mrs Hadley could not be removed from the house and died from fatal burn injuries. The concerns included possible ignition caused by adiabatic compression or particle impact when the oxygen regulator was opened, limited awareness of these risks among equipment users, and other reported cases of ignition involving oxygen-cylinder valve components.
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 user knowledge of oxygen-cylinder ignition mechanisms and their ramifications
Wider context from the report “4. Evidence from the Fire Investigation Officer, confirmed that there was little if any knowledge of either adiabatic compression or particle impact and the ramifications of such an event when opening a cylinder incorrectly by those responsible for using the equipment .
” 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 Risk of ignition within oxygen-cylinder valve components
Wider context from the report “5. Evidence from the MHRA confirmed that they are aware of four cases of ignition within valve components of oxygen cylinders leading to fire since 2011 including this incident . The valve manufacturer VTI, Germany has subsequently reported nine cases of ignition . VTI are also examining a further 20 regulators. At present no defects have been found.
” 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 follow the safe valve-opening sequence for oxygen regulators
Wider context from the report “2. Although both of these phenomena are extremely rare, the sudden uncontrolled release of oxygen by rapidly opening the on/off valve of the regulator can expedite the occurrence of ignition .
3. Evidence from the paramedic confirmed that she opened the patient valve first before opening the on/off valve, thus increasing the chance of the reported phenomena occurring .
” 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 Engage additional professional, healthcare and emergency-service organisations to shape and disseminate oxygen-cylinder ignition and fire-safety messaging.
Verbatim wording from the response “We believe the MHRA is best placed to take specific leadership action in relation to the risk of incidents which can lead to ignition and fire in the context of oxygen cylinders. We will firstly engage with all the professional organisations who are the most likely to be involved in the administration of oxygen. Their members will be involved in the key stages of setting up of oxygen cylinders and accessory devices (required for the administration to a patient) and the monitoring of the progress of the patient when this has begun. It is hoped, in their professional leadership roles, they will be able to understand and shape the final messages needed to effect culture change amongst their membership, with our assistance where it is within our remit.” Source location 2021-0346-Response-from-MHRA_Published
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 Continue engaging the Association of Anaesthetists and Royal College of Anaesthetists on oxygen-cylinder ignition and fire-safety messaging.
Verbatim wording from the response “We believe the MHRA is best placed to take specific leadership action in relation to the risk of incidents which can lead to ignition and fire in the context of oxygen cylinders. We will firstly engage with all the professional organisations who are the most likely to be involved in the administration of oxygen. Their members will be involved in the key stages of setting up of oxygen cylinders and accessory devices (required for the administration to a patient) and the monitoring of the progress of the patient when this has begun. It is hoped, in their professional leadership roles, they will be able to understand and shape the final messages needed to effect culture change amongst their membership, with our assistance where it is within our remit.” Source location 2021-0346-Response-from-MHRA_Published
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 Issuing guidance on oxygen-cylinder operation and use is outside the respondent’s remit.
Verbatim wording from the response “The issuing of guidance is not within the remit of the MHRA, however, we are able to provide a degree of leadership as the Agency which had primacy in the latter stages of the investigation of this incident.” Source location 2021-0346-Response-from-MHRA_Published
Open published response
Concerns raised 1 Lack of immediate, prominent medication warnings about increased suicidal thinking risk in young adults 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
Samuel David Morgan · 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
Samuel David Morgan died at home on 16 January 2020 as a consequence of self-suspension. His risk of taking his own life had not been identified, and a review assessment was not set when citalopram was prescribed. Concerns included a change in mood after starting the medication and whether clearer warnings about the risk of suicidal thinking in young adults would better capture patients’ attention.
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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 Lack of immediate, prominent medication warnings about increased suicidal thinking risk in young adults
Wider context from the report “Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely and allows patients to read at their leisure. However, it has been suggested that the “Black Box Warning” (as developed by the Food and Drug Administration in the USA) would have a more immediate impact and capture some patient’s attention highlighting any risks . The simple and clear message in this specific case would be that there is an increased risk of suicidal thinking in young adults. The benefits of such simple and direct messaging extends to all prescribed medicines and associated major risks.
” 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 Implement and user-test prominent SSRI patient-information warnings about suicidal thoughts and behaviour.
Verbatim wording from the response “Citalopram is an antidepressant that belongs to the selective serotonin reuptake inhibitor (SSRI) class of medicines. The current warnings about the known risk of suicide with use of SSRI antidepressants were implemented following UK and European reviews of the evidence. The text agreed for the patient information leaflet (PIL) was developed with patients’ input and was subject to user testing.” Source location 2020-0276-Response-from-MHRA-Redacted
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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 Current UK headlines and emboldened patient-information warnings are considered sufficient because no evidence shows US black-box warnings communicate risk more effectively.
Verbatim wording from the response “We have taken note of your suggestion that the “black box” warnings in the US product information of suicide warnings for patients ‘would have a more immediate impact’, however we are unable to find evidence that this is more effective in communicating risk than the current practice in the UK of headlines and emboldened text supported by extensive user testing to shape the presentation of key safety messages. Should new data come to light we will review this and see what changes could be made to support risk communication in the future.” Source location 2020-0276-Response-from-MHRA-Redacted
Open published response
25 Sep 2020 Susan Warby · Prevention of Future Deaths report Suffolk
View report summary
Concerns raised 2 Insufficiently distinctive packaging and visual identification of intravenous fluids for arterial line transducer sets View source Failure to use the correct technique when drawing blood samples from arterial lines 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
Susan Warby · 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
Susan Warby was admitted to hospital with a perforated bowel and underwent emergency surgery. An incorrect intravenous fluid attached to an arterial line, combined with incorrect blood-sampling technique, produced erroneous results that led to unnecessary insulin treatment, hypoglycaemia and a brain injury; her death followed multi-organ failure, septicaemia and disseminated aspergillus pneumonia. The principal concerns were the lack of distinctive labelling for fluids used with arterial lines and inadequate blood-sampling technique and training.
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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 Insufficiently distinctive packaging and visual identification of intravenous fluids for arterial line transducer sets
Wider context from the report “1. During the evidence it was clear that packaging and visual identification aids available for intravenous fluids to be used in arterial line transducer sets were not sufficiently distinctive .
It was heard that following Mrs Warby's death that as far as possible the West Suffolk Hospital has asked its suppliers to change the labelling on the intravenous fluids it purchases. These were exhibited in court and even with the changes the manufacture was prepared to make, the packaging cannot be considered at all distinctive for fluids to be used in an arterial line .
In direct contrast, we saw that the tubing used on an arterial line transducer set has a solid red line running its length. This is to clearly indicate to staff that it is an arterial line therefore must not be used for the administration of drugs or medicinal fluids.
I am therefore concerned that the packaging of the 0.9% Sodium Chloride intravenous fluid to be used with an arterial line is not also so clearly distinguished. It was heard in evidence that there is currently no 0.9% Sodium Chloride intravenous fluid available which is specifically and clearly labelled for arterial line use only .
It is important to note that the issue identified in this inquest regarding the use of incorrect intravenous fluid in an arterial line is not a new one. In 2008 the UK National Patient Safety Agency issued a Rapid Response report highlighting problems with infusions and sampling from arterial lines. In that 2008 report the UK National Patient Safety Agency had already identified 84 incidents where the wrong infusion was attached to an arterial line with two of those cases proving fatal.
It is understood that the 0.9% Sodium Chloride intravenous fluid has a number of medicinal uses other than just as a flushing fluid in an arterial line. However, the number of cases identified where the incorrect fluid is being used in arterial lines, clearly demonstrates the confusion and errors which occur when using generally labelled intravenous fluids with an arterial line transusion set .
” 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 use the correct technique when drawing blood samples from arterial lines
Wider context from the report “2. The court was told that the medical staff taking blood samples from the arterial line transducer sets were not using the correct technique to ensure erroneous blood samples were not taken .
The court heard that even if the incorrect intravenous fluid is fitted to an arterial line, a good technique used by staff (ensuring to fully account for the ‘dead space’ when drawing the blood sample) would prevent false readings being obtained .
As such, in Mrs Warby's case the error of the incorrect intravenous fluid being fitted to her arterial line was exacerbated by medical staff using an incorrect technique when drawing her blood samples.
The court was told that training in drawing blood from an arterial line is given as part of standard training for staff caring for patients with an arterial line in place. However, there were a number of erroneous samples taken in Mrs Warby's case, these samples being taken by a number of different staff .
As such, the West Suffolk Hospital has already implemented new training and operational regimes for its staff.
However, given the apparent prevalence of errors regarding the incorrect use of intravenous fluids and incorrect blood sampling techniques involving arterial lines , a review of training and operational regimes may be considered necessary on a wider basis.
” 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 Consider improvements with the marketing authorisation holder to make statutory information easier for clinical staff to assimilate and reduce selection errors.
Verbatim wording from the response “Nonetheless, we will consider further with the marketing authorisation holder whether improvements could be made to assist clinical staff to more easily assimilate the statutory information to reduce the likelihood of errors of this nature in future.” Source location 2020-0188-Response-from-MHRA-Redacted.pdf
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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 Because Viaflo containers cannot use colour differentiation, local clinical areas must implement other measures to identify intravenous fluids correctly.
Verbatim wording from the response “Intravenous fluids as described in your report are supplied in bags known as ‘Viaflo’ which are composed of polyolefin/polyamide co-extruded plastic. The way that these containers are manufactured means that ‘judicious use of colour’ (as recommended in our best practice guidance) cannot be used within the labelling, to aid differentiation and reduce the likelihood of error at the point of selection. As a result, other risk minimisation measures must be employed locally within clinical areas to assist in the correct identification of intravenous fluids one from another.” Source location 2020-0188-Response-from-MHRA-Redacted.pdf
Open published response
5 Aug 2020 Alana Molly CUTLAND · Prevention of Future Deaths report Milton Keynes
View report summary
Concerns raised 1 Failure of drug information leaflets to mention psychotic reactions as a possible side-effect 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
Alana Molly CUTLAND · 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
Alana Molly CUTLAND, a 19-year-old student, died on 25 July 2019 after opening the door of a light aircraft flying in Madagascar and falling from it. The report states that she had taken doxycycline as an antimalarial and was believed to have experienced a psychotic or delirium event. The principal concern was that the drug information leaflet did not mention this possible reaction and should be reviewed.
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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 Failure of drug information leaflets to mention psychotic reactions as a possible side-effect
Wider context from the report “The deceased was prescribed doxycycline as an antimalarial medication for used whilst in
Madagascar. It was quite apparent from the evidence that she had a psychotic reaction as a result
of taking the drug and yet there is nothing on the drug information leaflet that either highlights or
mentions this possibility . If she or her parents have been aware of this possible side-effect they
may have been able to intervene earlier to avoid her death. In my view the information sent out with
the drug should be reviewed.
” 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 available evidence on doxycycline-associated psychotic reactions and obtain expert advice on whether product information should be amended.
Verbatim wording from the response “As you have noted, the product information for doxycycline does not mention psychotic reactions as a possible side effect. We have conducted a review of the available evidence concerning doxycycline and psychotic reactions and sought expert advice from the Commission on Human Medicine’s Pharmacovigilance Expert Advisory Group on the strength of the evidence and whether the doxycycline product information should reflect these events.” Source location 2020-0151-Response-from-the-Medicines-Healthcare-Products-Regulatory-Agency_Redacted.pdf
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Request that the lead marketing authorisation holder submit a proposal to gather further data on psychotic reactions following doxycycline.
Verbatim wording from the response “The CHM Pharmacovigilance Expert Advisory Group advised that overall, the evidence to support a causal association between doxycycline and psychotic disorder was limited considering the cumulative exposure to this drug in the UK which is likely to be in the order of tens of millions of people. The PEAG advised that prior to the possible addition of psychotic type reactions in the doxycycline product information, which may cause patient alarm, further data is needed to enable a more robust assessment. The EAG recommended that the marketing authorisation holder (MAH) for the brand-leader doxycycline product should be requested to propose how this additional data may be collected, for example by investigating the feasibility of conducting a study using electronic healthcare records which compares rates of psychotic reactions following doxycycline, with another antibiotic.” Source location 2020-0151-Response-from-the-Medicines-Healthcare-Products-Regulatory-Agency_Redacted.pdf
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 evidence does not establish a causal association between doxycycline and psychotic reactions.
Verbatim wording from the response “Overall, these spontaneous ADR reports provide limited evidence on which to base a thorough assessment of causality between doxycycline and psychotic reactions. While under-reporting is a common problem with spontaneous ADR reporting, given that in the context of malaria prophylaxis, doxycycline is often given to healthy people, it may be that we would expect to see more cases of a serious reaction like psychosis if it were a true ADR for doxycycline. In addition, there is no established biological mechanism to explain an association between doxycycline and clinical and psychotic reactions and there is little in the way of published literature suggesting a causal link, including a lack of any well-controlled studies.” Source location 2020-0151-Response-from-the-Medicines-Healthcare-Products-Regulatory-Agency_Redacted.pdf
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 Further data is needed before psychotic reactions can be added to doxycycline product information.
Verbatim wording from the response “The CHM Pharmacovigilance Expert Advisory Group advised that overall, the evidence to support a causal association between doxycycline and psychotic disorder was limited considering the cumulative exposure to this drug in the UK which is likely to be in the order of tens of millions of people. The PEAG advised that prior to the possible addition of psychotic type reactions in the doxycycline product information, which may cause patient alarm, further data is needed to enable a more robust assessment. The EAG recommended that the marketing authorisation holder (MAH) for the brand-leader doxycycline product should be requested to propose how this additional data may be collected, for example by investigating the feasibility of conducting a study using electronic healthcare records which compares rates of psychotic reactions following doxycycline, with another antibiotic.” Source location 2020-0151-Response-from-the-Medicines-Healthcare-Products-Regulatory-Agency_Redacted.pdf
Open published response
24 Feb 2020 Mary Nelson · Prevention of Future Deaths report Cumbria
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Concerns raised 2 Dangerous accumulation of fluoxetine causing risk of sudden cardiac rhythm disturbance View source Failure to report deaths through the Yellow Card system 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
Mary Nelson · 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
Mary Nelson, aged 75, was found deceased on her sofa at home after what appeared to be a sudden death during the night. The inquest concluded that she died from a combination of hypertensive heart disease and the toxic effect of a properly prescribed medication. Concerns included the very high post-mortem Fluoxetine level, possible accumulation during treatment, whether dosage guidance should be revised for older people, and the death not having been reported through the Yellow Card system.
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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 Dangerous accumulation of fluoxetine causing risk of sudden cardiac rhythm disturbance
Wider context from the report “(1) I am concerned that Fluoxetine accumulated in Mary’s body over the course of her treatment reaching a dangerous level that could trigger sudden cardiac rhythm disturbance [?torsades de pointes] and death . Should the guidance for dosage be revised [especially in the elderly], is there any indication to consider in life testing of drug 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 Failure to report deaths through the Yellow Card system
Wider context from the report “(2) This death has not been reported on the Yellow card system and clearly the MHRA needs to be aware of it.
” Open source report
27 Jan 2020 Shanté Andrée Marie TURAY-THOMAS · Prevention of Future Deaths report Inner North London
View report summary
Concerns raised 21 Provision of incorrect advice that an adrenaline auto injector switch is only a brand substitution View source Failure to reconsider adrenaline auto injector dose after switching device View source Inadequate and incorrect national training content for 111 call handlers on adrenaline auto injectors View source Failure to identify patients at particularly high risk from allergies and asthma View source Lack of named accountability for allergy services and provision View source Failure to assess patients’ access to and understanding of adrenaline auto injector advice View source Failure of the Adastra system to update location information across screens in real time View source Failure to establish whether specialist allergy care was being provided View source Inconsistency in anaphylaxis ambulance categorisation between 999 and 111 services View source Failure to explain the need for sequential administration of two adrenaline auto injectors in acute anaphylaxis View source Failure of 111 call audits to identify all significant call-handling failings View source Rare provision of practical placebo-device adrenaline auto injector training View source Failure to provide healthcare-professional training after an adrenaline auto injector switch View source Failure to communicate device-specific training requirements for adrenaline auto injectors View source Failure of NHS Digital to retain and act on previously identified call-handling safety issues View source Failure of AAI leaflets to specify the need for device-specific healthcare-professional training View source Failure of the 999 service to safety-net inappropriate 111 categorisation View source Single-sale availability of Emerade adrenaline auto injectors View source Failure to record and emphasise the need to carry two adrenaline auto injector pens View source Failure to advise prescribers to reconsider adrenaline auto injector dose after a device switch View source Failure to display the advice to carry two adrenaline auto injectors on the outside of the box View source See 18 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.
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AI-generated summary
Shanté Andrée Marie TURAY-THOMAS · 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
Shanté Andrée Marie Turay-Thomas ate hazelnuts on 18 September 2018 and died soon afterwards from acute anaphylaxis. The report identifies concerns about inadequate allergy care, advice and training concerning adrenaline auto-injectors, prescribing and clinical communication, and errors in the NHS 111 response and ambulance categorisation.
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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 Provision of incorrect advice that an adrenaline auto injector switch is only a brand substitution
Wider context from the report “7. The GPs relied upon the advice given by Enfield Clinical Commissioning Group (CCG) that the scriptswitch was simply the replacement of one branded product with another branded product of the same drug/device . This gave false reassurance. The CCG joint formulary committee introduced a new drug for GPs, but then gave the wrong advice to accompany this .
” 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 reconsider adrenaline auto injector dose after switching device
Wider context from the report “5. When Shanté’s AAI was changed from an EpiPen to an Emerade, her GPs failed to reconsider the prescription and to increase her dose from 300mgs to 500mcgs .
” 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 and incorrect national training content for 111 call handlers on adrenaline auto injectors
Wider context from the report “17. In terms of national training for 111 call handlers, the NHS Digital distance learning pack contains advice that is in part inadequate and in part wrong . It does not give the crucial information that one dose of adrenaline, by whichever device it is administered, is very unlikely to be sufficient in the case of acute anaphylaxis . It contains a photograph to illustrate the use of an AAI, but in the photograph the device is held incorrectly .
” 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 identify patients at particularly high risk from allergies and asthma
Wider context from the report “1. At the time of her death, Shanté was not receiving specialist care for her allergies. However, her general practitioners (GPs) failed to appreciate this. They assumed that she was being treated for her allergies at the transitional asthma clinic to which she had been referred following her paediatric discharge. This was an incorrect assumption.
The GPs had not identified Shanté (who had a high BMI and was severely allergic) as being at particularly high risk from her allergies and asthma, and had no awareness that they were the sole providers of Shanté’s allergy 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 Lack of named accountability for allergy services and provision
Wider context from the report “20. The issues within this prevention of future deaths report are predominantly national issues, but I heard at inquest that there is no person with named accountability for allergy services and allergy provision at NHS England or the Department of Health as a whole .
” 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 assess patients’ access to and understanding of adrenaline auto injector advice
Wider context from the report “2. Shanté’s GPs knew that she should carry two adrenaline auto injector (AAI) pens at all times, and they may have mentioned this to her, but they failed to record this and they did not emphasise it to her.
They failed to emphasise to Shanté and her family that the reason for carrying two pens is primarily because in the event of severe acute anaphylaxis, the very strong likelihood is that both pens will need to be administered, one five minutes after the other, to keep the patient alive until the arrival of an emergency ambulance.
The GPs did not explore with Shanté the reason for her erratic requests for a pen . They did not explore with her where she kept her pens . They did not test her understanding of medical advice .
” 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 the Adastra system to update location information across screens in real time
Wider context from the report “14. When Shanté became ill following the ingestion of nuts, her mother rang NHS 111 and got through to the London Central & West (LCW) service. However, the call handler incorrectly recorded Shanté’s location: he failed to untick a box and so her grandmother’s address was recorded as her location, rather than her mother’s address where she was staying at the time.
In an example of good practice, this error was recognised by the clinician who later took over the call. However, what nobody at LCW realised was that the Adastra computer system would not then update in real time for any screens save that of the particular clinician inputting the information .
The staff at LCW have since been made aware of this and have been trained to walk over and look at the primary screen to check the address, but it is not clear to me that there is now a national understanding of that element of the 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 Failure to establish whether specialist allergy care was being provided
Wider context from the report “1. At the time of her death, Shanté was not receiving specialist care for her allergies. However, her general practitioners (GPs) failed to appreciate this . They assumed that she was being treated for her allergies at the transitional asthma clinic to which she had been referred following her paediatric discharge. This was an incorrect assumption.
The GPs had not identified Shanté (who had a high BMI and was severely allergic) as being at particularly high risk from her allergies and asthma, and had no awareness that they were the sole providers of Shanté’s allergy 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 Inconsistency in anaphylaxis ambulance categorisation between 999 and 111 services
Wider context from the report “16. The individuals making these errors were working within the context of NHS Digital’s categorisation of anaphylaxis as needing a category 2 ambulance rather than a category 1 ambulance, on the Adastra computer system that supports the LCW 111 service.
This was the wrong categorisation and not the categorisation that the call would have received if 999 had been called and the London Ambulance Service contacted in the first instance. Acute anaphylaxis is immediately life threatening and must be treated as a category 1.
I heard at inquest that NHS Digital has since changed its categorisation. However, I also heard that for those areas (I think approximately half the country, though this is not completely clear to me), where the 999 service and the 111 service are supported by different computer systems rather than the same system being common to both services, there could remain inconsistencies of categorisation between 999 and 111 .
Even where there are inconsistencies in categorisation, the 999 service will not re-categorise following a 111 clinician’s categorisation, unless a 999 clinician has spoken to the patient, so inappropriate 111 categorisation will not be safety netted by the 999 service. This must be recognised and factored in.
” 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 explain the need for sequential administration of two adrenaline auto injectors in acute anaphylaxis
Wider context from the report “2. Shanté’s GPs knew that she should carry two adrenaline auto injector (AAI) pens at all times, and they may have mentioned this to her, but they failed to record this and they did not emphasise it to her.
They failed to emphasise to Shanté and her family that the reason for carrying two pens is primarily because in the event of severe acute anaphylaxis, the very strong likelihood is that both pens will need to be administered, one five minutes after the other , to keep the patient alive until the arrival of an emergency ambulance.
The GPs did not explore with Shanté the reason for her erratic requests for a pen. They did not explore with her where she kept her pens. They did not test her understanding of medical advice.
” 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 111 call audits to identify all significant call-handling failings
Wider context from the report “15. During the course of the 111 call, a number of errors were made. These were the errors of LCW individuals. When LCW audited the call in the first instance, the audit identified the problem with the address, but failed to recognise how badly the call had gone in other ways . Without effective audit and recognition of failings, it is difficult to see how there can be effective improvement .
” 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 Rare provision of practical placebo-device adrenaline auto injector training
Wider context from the report “13. I heard that the gold standard of training for use of any AAI is to give the patient the relevant pen (whichever that patient is prescribed) containing a placebo rather than adrenaline and, following appropriate instruction, ask the patient actually to administer a dose.
I heard at inquest that the incidence of this standard of training (in any setting) is rare . That may be for good reasons, but it seems that revisiting best practice training at a national level would be helpful.
” 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 healthcare-professional training after an adrenaline auto injector switch
Wider context from the report “6. Following the scriptswitch, the GPs failed to ask Shanté to come in to the surgery for training in use of the Emerade . This would also have presented an ideal opportunity to explore Shanté’s understanding of the use of her pens and to ensure that she understood she needed to carry two at all times.
” 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 device-specific training requirements for adrenaline auto injectors
Wider context from the report “9. The CCG failed to inform prescribers that the Emerade pen requires different training to the EpiPen because different AAIs do not operate in the same way. In fact, the CCG gave the opposite advice .
” 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 NHS Digital to retain and act on previously identified call-handling safety issues
Wider context from the report “19. One of the errors made by the first 111 call handler was a failure to ask to speak direct to the patient. This was the error of an individual.
However, this is not the first time that the issue has been brought to the attention of NHS Digital. At inquest, I asked the witness who appeared on behalf of NHS Digital, and indeed had been chosen by NHS Digital as the person best able to assist the court, if this had been an issue in the past. He said no. However, on 18 December 2018, Peter Harrowing, HM Assistant Coroner for Avon, sent a prevention of future deaths report to NHS Digital following the inquest touching the death of David Longden.
It was only when I asked the witness appearing on behalf of NHS Digital specifically about Coroner Harrowing’s report in respect of Mr Longden, pointing out that Coroner Harrowing had raised the need for NHS Digital to place greater emphasis on the call handler speaking to the patient, that the witness remembered that he had indeed seen that report.
I choose to characterise this as a memory lapse rather than as an intention wilfully to mislead the court. (A witness who lies whilst giving evidence on oath at inquest may be found in contempt of court and may even be prosecuted for the crime of perjury.) Nevertheless, if NHS Digital does not have a grasp of this sort of detail, specifically brought to its attention by a coroner in a prevention of future deaths report, it is difficult to see how there can be effective improvement .
” 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 AAI leaflets to specify the need for device-specific healthcare-professional training
Wider context from the report “12. The Emerade AAI (and I assume the EpiPen and JEXT) leaflet does not specifically advise that training from a healthcare professional is needed in how to use this particular AAI as opposed to any other .
” 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 the 999 service to safety-net inappropriate 111 categorisation
Wider context from the report “16. The individuals making these errors were working within the context of NHS Digital’s categorisation of anaphylaxis as needing a category 2 ambulance rather than a category 1 ambulance, on the Adastra computer system that supports the LCW 111 service.
This was the wrong categorisation and not the categorisation that the call would have received if 999 had been called and the London Ambulance Service contacted in the first instance. Acute anaphylaxis is immediately life threatening and must be treated as a category 1.
I heard at inquest that NHS Digital has since changed its categorisation. However, I also heard that for those areas (I think approximately half the country, though this is not completely clear to me), where the 999 service and the 111 service are supported by different computer systems rather than the same system being common to both services, there could remain inconsistencies of categorisation between 999 and 111.
Even where there are inconsistencies in categorisation, the 999 service will not re-categorise following a 111 clinician’s categorisation, unless a 999 clinician has spoken to the patient , so inappropriate 111 categorisation will not be safety netted by the 999 service . This must be recognised and factored in.
” 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 Single-sale availability of Emerade adrenaline auto injectors
Wider context from the report “4. The Emerade AAI is sold singly . It could be sold in boxes of two as the norm and only singly in the alternative.
” 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 record and emphasise the need to carry two adrenaline auto injector pens
Wider context from the report “2. Shanté’s GPs knew that she should carry two adrenaline auto injector (AAI) pens at all times, and they may have mentioned this to her, but they failed to record this and they did not emphasise it to her .
They failed to emphasise to Shanté and her family that the reason for carrying two pens is primarily because in the event of severe acute anaphylaxis, the very strong likelihood is that both pens will need to be administered, one five minutes after the other, to keep the patient alive until the arrival of an emergency ambulance.
The GPs did not explore with Shanté the reason for her erratic requests for a pen. They did not explore with her where she kept her pens. They did not test her understanding of medical advice.
” 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 advise prescribers to reconsider adrenaline auto injector dose after a device switch
Wider context from the report “8. The CCG failed to draw prescribers’ attention to the need, following scriptswitch from EpiPen to Emerade, to reconsider the dose and to prescribe the higher dose of 500mcgs for patients at higher risk (which would have included Shanté).
” 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 the advice to carry two adrenaline auto injectors on the outside of the box
Wider context from the report “3. The Emerade AAI accompanying leaflet does include the advice that two pens should be carried at all times, but the advice is not re-iterated on the outside of the box . Consideration will need to be given to whether this is the appropriate advice in all cases, but it seems worthwhile to review the issue as a whole.
” Open source report
5 Dec 2019 Gemma Louise Macdonald · Prevention of Future Deaths report Suffolk
View report summary
Concerns raised 3 Lack of a system for establishing purchaser suitability View source Lack of a verification process limiting transaction amounts and ordering frequency View source Availability of large quantities of medication for online purchase by an individual 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
Gemma Louise Macdonald · 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
Gemma Louise Macdonald died on 22 July 2019 after taking a massive overdose of medication at home, including medicines purchased online. The report raised concerns about the availability of large quantities of medication online, whether purchaser suitability was assessed, and whether transactions were limited by quantity and ordering frequency.
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 a system for establishing purchaser suitability
Wider context from the report “(2) Whether there is a system for establishing the suitability of the purchaser ;
” 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 verification process limiting transaction amounts and ordering frequency
Wider context from the report “(3) Whether there is verification process enabling the limiting of transactions to the amount of medicine and frequency of ordering
” 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 Availability of large quantities of medication for online purchase by an individual
Wider context from the report “(1) The availability of large quantities of medication to purchase on online by an individual ;
” Open source report
16 Oct 2019 Victor James Hall · Prevention of Future Deaths report Manchester West
View report summary
Concerns raised 5 Failure of pharmacy-to-ward medication transfer procedures to require receipt checks against packaging, labelling and prescription charts View source Failure to contemporaneously document medication packaging, labelling and prescription checks View source Failure to check medication packaging and labelling against the prescription chart before administration View source Phosphate Polyfusor product design failing to distinguish the medication clearly View source Insufficient training, auditing, supervision and monitoring of nursing and pharmacy staff on medication checking controls View source See 2 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
Victor James Hall · 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
Victor James Hall died at Salford Royal Hospital on 29 June 2018 after being admitted with shortness of breath and an exacerbation of chronic obstructive pulmonary disease. He was mistakenly administered Phosphate Polyfusor instead of prescribed sodium bicarbonate after dispensing, pharmacy checking and ward checking errors, although the post-mortem and toxicology evidence concluded that the medication error played no role in his death. Concerns were raised about the similar Polyfusor product design and about medication-checking, recording, dispensing, training and supervision procedures.
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 of pharmacy-to-ward medication transfer procedures to require receipt checks against packaging, labelling and prescription charts
Wider context from the report “During the Inquest, evidence was heard that:-
1.Salford Royal Hospital had undertaken an internal investigation and concluded that one of the root causes for the medication error, was the Phosphate Polyfusor product design.
i. The Pharmacy and Nursing Matron Lead, concurred that the staff involved in the incident had relied on the word Polyfusor, without actually checking the medication packaging against the prescription chart and label. Salford Royal Hospital, wrote to the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018, requesting the word Polyfusor be removed from the Phosphate design product packaging to prevent future medication errors. Despite repeated requests from Salford Royal Hospital for an MHRA update, the product design for Phosphate Polyfusor remains the same.
2. I request that The Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA) reviews the:
i. Product design on the Polyfusors in question
3.The Chief Executive, Nursing & Midwifery Council, 23 Portland Place, London W1B 1PZ reviews the:
i.Guidance given to their members in relation to the administration of medication to consider and include the simplest of steps, namely that a Healthcare Professional should check the name of the medication on the prescription chart against the name of the medication on the packaging and labelling of the medication at the time of each administration of medication to ensure that the correct medication is always administered to a patient.
ii.Guidance given to their members in relation to their duties, to accurately record and contemporaneously document the packaging, label an prescription checks they have undertaken to ensure the correct medication is always administered to a patient.
4.The Chief Executive, Salford Royal Hospital, NHS Trust Hospital, Stott Lane, Salford M6 8HD reviews the:
i.Guidance and procedures in relation to the dispensing and transfer of medications from the Pharmacy Department to a ward, to include a system of checking medications against the packaging, labelling and prescription chart at the time of receipt by the ward . Furthermore, to consider documentary evidence of the fact that the medication packaging has been checked against the prescription chart and an acknowledgement of receipt of the correct medication by the pharmacy and ward staff, evidenced by a signature of the recipient.
ii.Training, Auditing, Supervision and monitoring of all staff, particularly Nursing and Pharmacy staff, in relation to the above issues.
” 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 contemporaneously document medication packaging, labelling and prescription checks
Wider context from the report “During the Inquest, evidence was heard that:-
1.Salford Royal Hospital had undertaken an internal investigation and concluded that one of the root causes for the medication error, was the Phosphate Polyfusor product design.
i. The Pharmacy and Nursing Matron Lead, concurred that the staff involved in the incident had relied on the word Polyfusor, without actually checking the medication packaging against the prescription chart and label. Salford Royal Hospital, wrote to the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018, requesting the word Polyfusor be removed from the Phosphate design product packaging to prevent future medication errors. Despite repeated requests from Salford Royal Hospital for an MHRA update, the product design for Phosphate Polyfusor remains the same.
2. I request that The Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA) reviews the:
i. Product design on the Polyfusors in question
3.The Chief Executive, Nursing & Midwifery Council, 23 Portland Place, London W1B 1PZ reviews the:
i.Guidance given to their members in relation to the administration of medication to consider and include the simplest of steps, namely that a Healthcare Professional should check the name of the medication on the prescription chart against the name of the medication on the packaging and labelling of the medication at the time of each administration of medication to ensure that the correct medication is always administered to a patient.
ii.Guidance given to their members in relation to their duties, to accurately record and contemporaneously document the packaging, label an prescription checks they have undertaken to ensure the correct medication is always administered to a patient.
4.The Chief Executive, Salford Royal Hospital, NHS Trust Hospital, Stott Lane, Salford M6 8HD reviews the:
i.Guidance and procedures in relation to the dispensing and transfer of medications from the Pharmacy Department to a ward, to include a system of checking medications against the packaging, labelling and prescription chart at the time of receipt by the ward. Furthermore, to consider documentary evidence of the fact that the medication packaging has been checked against the prescription chart and an acknowledgement of receipt of the correct medication by the pharmacy and ward staff, evidenced by a signature of the recipient.
ii.Training, Auditing, Supervision and monitoring of all staff, particularly Nursing and Pharmacy staff, in relation to the above issues.
” 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 check medication packaging and labelling against the prescription chart before administration
Wider context from the report “During the Inquest, evidence was heard that:-
1.Salford Royal Hospital had undertaken an internal investigation and concluded that one of the root causes for the medication error, was the Phosphate Polyfusor product design.
i. The Pharmacy and Nursing Matron Lead, concurred that the staff involved in the incident had relied on the word Polyfusor, without actually checking the medication packaging against the prescription chart and label . Salford Royal Hospital, wrote to the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018, requesting the word Polyfusor be removed from the Phosphate design product packaging to prevent future medication errors. Despite repeated requests from Salford Royal Hospital for an MHRA update, the product design for Phosphate Polyfusor remains the same.
2. I request that The Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA) reviews the:
i. Product design on the Polyfusors in question
3.The Chief Executive, Nursing & Midwifery Council, 23 Portland Place, London W1B 1PZ reviews the:
i.Guidance given to their members in relation to the administration of medication to consider and include the simplest of steps, namely that a Healthcare Professional should check the name of the medication on the prescription chart against the name of the medication on the packaging and labelling of the medication at the time of each administration of medication to ensure that the correct medication is always administered to a patient.
ii.Guidance given to their members in relation to their duties, to accurately record and contemporaneously document the packaging, label an prescription checks they have undertaken to ensure the correct medication is always administered to a patient.
4.The Chief Executive, Salford Royal Hospital, NHS Trust Hospital, Stott Lane, Salford M6 8HD reviews the:
i.Guidance and procedures in relation to the dispensing and transfer of medications from the Pharmacy Department to a ward, to include a system of checking medications against the packaging, labelling and prescription chart at the time of receipt by the ward. Furthermore, to consider documentary evidence of the fact that the medication packaging has been checked against the prescription chart and an acknowledgement of receipt of the correct medication by the pharmacy and ward staff, evidenced by a signature of the recipient.
ii.Training, Auditing, Supervision and monitoring of all staff, particularly Nursing and Pharmacy staff, in relation to the above issues.
” 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 Phosphate Polyfusor product design failing to distinguish the medication clearly
Wider context from the report “During the Inquest, evidence was heard that:-
1.Salford Royal Hospital had undertaken an internal investigation and concluded that one of the root causes for the medication error, was the Phosphate Polyfusor product design .
i. The Pharmacy and Nursing Matron Lead, concurred that the staff involved in the incident had relied on the word Polyfusor, without actually checking the medication packaging against the prescription chart and label. Salford Royal Hospital, wrote to the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018, requesting the word Polyfusor be removed from the Phosphate design product packaging to prevent future medication errors. Despite repeated requests from Salford Royal Hospital for an MHRA update, the product design for Phosphate Polyfusor remains the same .
2. I request that The Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA) reviews the:
i. Product design on the Polyfusors in question
3.The Chief Executive, Nursing & Midwifery Council, 23 Portland Place, London W1B 1PZ reviews the:
i.Guidance given to their members in relation to the administration of medication to consider and include the simplest of steps, namely that a Healthcare Professional should check the name of the medication on the prescription chart against the name of the medication on the packaging and labelling of the medication at the time of each administration of medication to ensure that the correct medication is always administered to a patient.
ii.Guidance given to their members in relation to their duties, to accurately record and contemporaneously document the packaging, label an prescription checks they have undertaken to ensure the correct medication is always administered to a patient.
4.The Chief Executive, Salford Royal Hospital, NHS Trust Hospital, Stott Lane, Salford M6 8HD reviews the:
i.Guidance and procedures in relation to the dispensing and transfer of medications from the Pharmacy Department to a ward, to include a system of checking medications against the packaging, labelling and prescription chart at the time of receipt by the ward. Furthermore, to consider documentary evidence of the fact that the medication packaging has been checked against the prescription chart and an acknowledgement of receipt of the correct medication by the pharmacy and ward staff, evidenced by a signature of the recipient.
ii.Training, Auditing, Supervision and monitoring of all staff, particularly Nursing and Pharmacy staff, in relation to the above issues.
” 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 training, auditing, supervision and monitoring of nursing and pharmacy staff on medication checking controls
Wider context from the report “During the Inquest, evidence was heard that:-
1.Salford Royal Hospital had undertaken an internal investigation and concluded that one of the root causes for the medication error, was the Phosphate Polyfusor product design.
i. The Pharmacy and Nursing Matron Lead, concurred that the staff involved in the incident had relied on the word Polyfusor, without actually checking the medication packaging against the prescription chart and label. Salford Royal Hospital, wrote to the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018, requesting the word Polyfusor be removed from the Phosphate design product packaging to prevent future medication errors. Despite repeated requests from Salford Royal Hospital for an MHRA update, the product design for Phosphate Polyfusor remains the same.
2. I request that The Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA) reviews the:
i. Product design on the Polyfusors in question
3.The Chief Executive, Nursing & Midwifery Council, 23 Portland Place, London W1B 1PZ reviews the:
i.Guidance given to their members in relation to the administration of medication to consider and include the simplest of steps, namely that a Healthcare Professional should check the name of the medication on the prescription chart against the name of the medication on the packaging and labelling of the medication at the time of each administration of medication to ensure that the correct medication is always administered to a patient.
ii.Guidance given to their members in relation to their duties, to accurately record and contemporaneously document the packaging, label an prescription checks they have undertaken to ensure the correct medication is always administered to a patient.
4.The Chief Executive, Salford Royal Hospital, NHS Trust Hospital, Stott Lane, Salford M6 8HD reviews the:
i.Guidance and procedures in relation to the dispensing and transfer of medications from the Pharmacy Department to a ward, to include a system of checking medications against the packaging, labelling and prescription chart at the time of receipt by the ward. Furthermore, to consider documentary evidence of the fact that the medication packaging has been checked against the prescription chart and an acknowledgement of receipt of the correct medication by the pharmacy and ward staff, evidenced by a signature of the recipient.
ii.Training, Auditing, Supervision and monitoring of all staff, particularly Nursing and Pharmacy staff, in relation to the above issues .
” Open source report
10 Oct 2019 Liane Davenport · Prevention of Future Deaths report Cumbria
View report summary
Concerns raised 1 Failure to consider and recommend blood-level monitoring for powerful antipsychotics in older, frail patients receiving long-term high-dose treatment 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
Liane Davenport · 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
Liane Davenport had chronic schizophrenia treated with high doses of two antipsychotic medicines, alongside significant coronary artery disease and left ventricular dysfunction, and died at home in Cumbria on 4 December 2019. The principal concern was whether blood-level monitoring should be considered for patients receiving long-term high-dose antipsychotic treatment, particularly as they become older and more frail.
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 consider and recommend blood-level monitoring for powerful antipsychotics in older, frail patients receiving long-term high-dose treatment
Wider context from the report “(1) Should monitoring of blood levels of powerful antipsychotics be considered and recommended for patients on long term high dose treatment, particularly as they become older & more frail?
” Open source report
19 Sep 2019 Irene Collins · Prevention of Future Deaths report Manchester South
View report summary
Concerns raised 2 Failure to restrict residents’ access to bins containing used clinical examination gloves View source Failure to restrict vulnerable people’s access to clinical examination gloves 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
Irene Collins · 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
Irene Collins, who had advanced dementia and other significant health problems, was found dead at her care home on 16 June 2018 with a latex clinical examination glove obstructing her upper airway. The principal concern was that clinical examination gloves were readily accessible to residents, including those with cognitive impairment, and could be disposed of in easily accessible bins.
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 restrict residents’ access to bins containing used clinical examination gloves
Wider context from the report “The court heard evidence that at Firbank House, there was unrestricted access to clinical examination gloves and other personal protective equipment intended to be used by those delivering care from wall-mounted dispensers in corridors. Additionally, at that time, once used the clinical examination gloves could be disposed of in a variety of bins, which were again easily accessible to residents .
Whilst significant steps have now been undertaken at Firbank House to restrict the access of clinical examination gloves to residents with cognitive impairment, it is a matter of concern that in many settings where care is provided to vulnerable people, they are extremely easy to access.
It is considered an alert or authoritative guidance as to the storage and disposal of clinical examination gloves in care settings may prevent future deaths.
” 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 restrict vulnerable people’s access to clinical examination gloves
Wider context from the report “The court heard evidence that at Firbank House, there was unrestricted access to clinical examination gloves and other personal protective equipment intended to be used by those delivering care from wall-mounted dispensers in corridors . Additionally, at that time, once used the clinical examination gloves could be disposed of in a variety of bins, which were again easily accessible to residents.
Whilst significant steps have now been undertaken at Firbank House to restrict the access of clinical examination gloves to residents with cognitive impairment, it is a matter of concern that in many settings where care is provided to vulnerable people, they are extremely easy to access .
It is considered an alert or authoritative guidance as to the storage and disposal of clinical examination gloves in care settings may prevent future deaths.
” Open source report
Concerns raised 1 Lack of an alarm or other warning for developing air-mattress deflation 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
Jeanette Ann Robinson · 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
Jeanette Ann Robinson, who had morbid obesity and type II diabetes, suffered a fall, developed a sacral pressure ulcer, and was admitted to hospital in a septic condition. She died in hospital on 21 December 2016. The report raised concerns that an accidentally deflated pressure-relieving mattress had no alarm or other warning system, and that an unsuccessful attempted transfer to a community hospital contributed to the outcome.
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 an alarm or other warning for developing air-mattress deflation
Wider context from the report “Mrs Robinson was using a nimbus 3 air mattress and a Toto (electronic turning device) at the time the mattress was found to be accidentally deflated. The mattress became deflated when the power cable into the pump was dislodged. I understand there was no alarm fitted to the system or any other warning to alert Mrs Robinson to the developing problem .
” Open source report
8 May 2019 Mr Edward Hearn · Prevention of Future Deaths report Inner South London
View report summary
Concerns raised 2 Lack of definitive cardiac-monitoring requirements in Carfilzomib prescribing information View source Failure of laboratory abnormal-result repeating, alerting and follow-up 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
Mr Edward Hearn · 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 Edward Hearn died in hospital after a cardiac arrest, with the medical cause of death including sepsis, bronchopneumonia and multiple myeloma treated with chemotherapy. The report identified concerns that a high globulin result was not followed up, that he was discharged without a safe care plan to minimise fall risk during chemotherapy, and that cardiac monitoring requirements for Carfilzomib may not have been sufficiently definitive.
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 definitive cardiac-monitoring requirements in Carfilzomib prescribing information
Wider context from the report “2. The expert pharmaceutical physician gave a recommendation that the need for cardiac monitoring was made more definitive in the drug prescribing information for Carfilzomib (and possibly others) , which was prescribed in the Cardamon Trial.
” 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 laboratory abnormal-result repeating, alerting and follow-up
Wider context from the report “1. The finding of a high globulin by a laboratory from a blood test in A&E was not followed up by either the laboratory or A&E department. It was not in College guidelines of tests which required urgent notification. It was indicative of a fatal disease, which was not diagnosed for approximately another 4 months. I accept the professional opinion of the haematologist that this was a system failure, which is not acknowledged by the Trust. The laboratory suggested an additional action to have an automated comment but that would still not deal with the problem of reports returning to physicians in secondary care. Evidence was heard that there is inconsistency in laboratory repeating and alerting of clinicians even between hospitals in the jurisdiction, and insufficient evidence of a safe system within the Trust .
” 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 Publish a Drug Safety Update article reminding prescribers and cardiologists to monitor patients for cardiac disorders before and during carfilzomib treatment.
Verbatim wording from the response “However, as we have reports of a total of 10 cases (including the case of Mr Hearn) of cardiac arrest, myocardial infarction or cardiac failure with carfilzomib, the PEAG has recommended that doctors prescribing the drug and cardiologists should be reminded of the requirements to monitor patients for cardiac disorders before and during treatment with carfilzomib. This information will be provided via an article in the MHRA’s electronic bulletin for healthcare professionals, Drug Safety Update, in the next 2–3 months. We will keep you informed.” Source location Response from 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 statutory safety information for carfilzomib, cyclophosphamide and dexamethasone and seek pharmacovigilance expert advice on cardiac-arrest risk controls.
Verbatim wording from the response “Further to the information provided on this tragic case, and in accordance with your request, we have considered whether the statutory information currently provided by the marketing authorisation holder for prescribers (and patients) on the safe use of carfilzomib, is adequate, and whether any other regulatory measures could be taken to minimise the risk of cardiac arrest in subjects exposed to this drug. The statutory product information for cyclophosphamide and dexamethasone, used in combination with carfilzomib to treat Mr Hearn, was also considered. To this end, we have sought the advice of the Pharmacovigilance Expert Advisory Group (PEAG), an independent advisory group to the Commission on Human Medicines on matters of drug safety.” Source location Response from 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 statutory product information adequately highlights serious cardiac disorder risks for the medicines concerned.
Verbatim wording from the response “Therefore, on review of the available information, and in relation to actions within the remit of the MHRA, we are satisfied that the statutory SmPC and PIL for the medicines concerned in the case of Mr. Hearn currently provide relevant information to highlight the risk of serious cardiac disorders.” Source location Response from MHRA
Open published response
Concerns raised 1 Failure to provide clearly differentiated packaging for stent sizes 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
Ronald 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
Ronald CLARK underwent insertion of a stent in his common hepatic duct, but an incorrectly sized stent was inserted and significantly contributed to his death at Queen Alexandra Hospital on 2 April 2018. The report raised concern that identical packaging for different stent sizes made them difficult to identify and could lead to use of the wrong-sized stent.
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 provide clearly differentiated packaging for stent sizes
Wider context from the report “1. I was told in evidence that the stents used at the hospital are all supplied in identical packaging with only a small label identifying the size of the stents inside . I was also told that stents in this sort of packaging are in general use in most, if not all, NHS hospitals.
2. I believe action should be taken by the purchasing agencies of the NHS to ensure that stent manufacturers should supply different sizes of stents in different coloured packaging to make it easier for them to be identified during medical procedures and to obviate the risk of the wrong-sized stent being used , as was the case with Mr Clark.
” 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