Marjorie Bassendine
PFD Report
Partially Responded
Ref: 2016-0424
2 of 3 responded · Over 2 years old
Sent To
Response Status
Responses
2 of 3
56-Day Deadline
16 Apr 2017
Over 2 years old — no identified published response
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Coroners Concerns
_ : To recognise use of multiple psychotropic medication has the potential to prolong the QT interval: To undertake an Electrocardiogram (ECG) prior to commencing such medication. To undertake regular ECG's to ensure long QT syndrome has not developed and to help plan continuing treatment:
Responses
Response received
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Dear Dr Henderson, Re: Mrs Marjorie Sybil Bassendine (Deceased), Regulation 28 Report to Prevent Future Deaths. Thank you for sending me a copy of this report and I note that copies have also been forwarded to Mr Jeremy Hunt (Department of Health) and the MHRA to whom I have also copied this reply. I begin by communicating my condolences to the family of Mrs Bassendine: I note the matters of concern detailed in your report, namely: 13 To recognise use of multiple psychotropic medication has the potential to prolong the QT interval; 2_ To undertake an Electrocardiogram (ECG) to commencing such medication; 3 To undertake regular ECG's to ensure long QT syndrome has not developed and to help plan continuing treatment I also note that you think that action should be taken to prevent future deaths and belive that the MHRA and the Royal Colleges of Psychiatrists and General Practitioners have the power to take such action. Actions planned by the Royal College of Psychiatrists: 13 I shall Ilaise with the Chair of our Special Committee for Psychopharmacology to publicize these matters to the members and fellows of the RCPsych;
2. I shall liaise with the Chair of the Faculty of Old-Age Psychiatry to determine the best to raise these issues with old-age psychiatrists; Royal College of Psychiatrists registcred ollce: 2/ Prescot Street; London; El 8B8 UX Tel: +44 (0)20 7235 235 / Fax; +44 (0)20 3701 2761 wwwrcpsychacuk The Royal College of Psychiatrists is charity registered in England and Wales (228636) ad in Scotland (SC038369) NO HEALTH WITHOUT MENTAL HEALTH May prior you way
3. We will review our continuing medical education initiatives to ensure that this issue is comprehensively covered in RCPsych material;
4. I shall inform the Presidents of the Royal Colleges of Physicians and General Practitioners, by copy of this letter, of our plans and will be ready to work with them in any suitable joint ventures. hope that these endevours will help reduce the risks of further deaths of this nature Kindest regards 3 Professor Sir Simon Wessely President WJene
2. I shall liaise with the Chair of the Faculty of Old-Age Psychiatry to determine the best to raise these issues with old-age psychiatrists; Royal College of Psychiatrists registcred ollce: 2/ Prescot Street; London; El 8B8 UX Tel: +44 (0)20 7235 235 / Fax; +44 (0)20 3701 2761 wwwrcpsychacuk The Royal College of Psychiatrists is charity registered in England and Wales (228636) ad in Scotland (SC038369) NO HEALTH WITHOUT MENTAL HEALTH May prior you way
3. We will review our continuing medical education initiatives to ensure that this issue is comprehensively covered in RCPsych material;
4. I shall inform the Presidents of the Royal Colleges of Physicians and General Practitioners, by copy of this letter, of our plans and will be ready to work with them in any suitable joint ventures. hope that these endevours will help reduce the risks of further deaths of this nature Kindest regards 3 Professor Sir Simon Wessely President WJene
Response received
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Dear Ms Henderson
Coroners and Justice Act 2009 – Regulation 28 Report following the Inquest into the death of Mrs Marjorie Cybil BASSENDINE
Thank you for your letter dated 30th November 2016, enclosing your Report under Regulation 28 following the Inquest into the death of Mrs Marjorie Cybil BASSENDINE.
I can confirm that the details of your report have been added onto our Adverse Drug Reaction database, under the reference number
In your report you raise concerns regarding the combination of olanzapine, mirtazapine and indapamide increasing the risk of developing long QT syndrome.
We have reviewed the product information (Summary of Product Characteristics [SmPC] and Patient Information Leaflet) of olanzapine, mirtazapine and indapamide and are satisfied that all three contain appropriate warnings regarding the risk of QT prolongation, particularly when used with other medication that also causes QT prolongation. Details of the relevant warnings are included in Annex A.
Although only the indapamide SmPC specifically mentions monitoring of patients, including conducting ECG monitoring, the SmPCs for mirtazapine and olanzapine both advise the use of “caution” when prescribing in patients with known risk factors for QT prolongation including concomitant use of other medication known to cause QT prolongation. The decision to prescribe a particular medicine or combination of medicines is the responsibility of the prescribing clinician who is in the best position to consider the balance of risks and benefits for the individual patient. The MHRA cannot comment on individual prescribing decisions.
In conclusion, all three medicines’ SmPCs already include warnings regarding the risk of QT prolongation, particularly when these medicines are used in combination with other medicines which also cause QT prolongation. On review of the warnings we consider them to be appropriate and to reflect the available data for the individual products.
Therefore we are not currently proposing any regulatory action to change these warnings. However we will keep this issue under review, and consider the need for further action or communications should the picture change.
Coroners and Justice Act 2009 – Regulation 28 Report following the Inquest into the death of Mrs Marjorie Cybil BASSENDINE
Thank you for your letter dated 30th November 2016, enclosing your Report under Regulation 28 following the Inquest into the death of Mrs Marjorie Cybil BASSENDINE.
I can confirm that the details of your report have been added onto our Adverse Drug Reaction database, under the reference number
In your report you raise concerns regarding the combination of olanzapine, mirtazapine and indapamide increasing the risk of developing long QT syndrome.
We have reviewed the product information (Summary of Product Characteristics [SmPC] and Patient Information Leaflet) of olanzapine, mirtazapine and indapamide and are satisfied that all three contain appropriate warnings regarding the risk of QT prolongation, particularly when used with other medication that also causes QT prolongation. Details of the relevant warnings are included in Annex A.
Although only the indapamide SmPC specifically mentions monitoring of patients, including conducting ECG monitoring, the SmPCs for mirtazapine and olanzapine both advise the use of “caution” when prescribing in patients with known risk factors for QT prolongation including concomitant use of other medication known to cause QT prolongation. The decision to prescribe a particular medicine or combination of medicines is the responsibility of the prescribing clinician who is in the best position to consider the balance of risks and benefits for the individual patient. The MHRA cannot comment on individual prescribing decisions.
In conclusion, all three medicines’ SmPCs already include warnings regarding the risk of QT prolongation, particularly when these medicines are used in combination with other medicines which also cause QT prolongation. On review of the warnings we consider them to be appropriate and to reflect the available data for the individual products.
Therefore we are not currently proposing any regulatory action to change these warnings. However we will keep this issue under review, and consider the need for further action or communications should the picture change.
Action Should Be Taken
In my opinion action should be taken to prevent future deaths and believe you and your organisation: MHRA and the Royal Colleges of Psychiatrists and General Practitioners have the power to take such action;
Report Sections
Investigation and Inquest
On 9th October 2015 commenced an investigation into the death of Marjorie Cybil Bassendine, 98 years of age. The investigation concluded at the end of the inquest on 13h October 2016. The medical cause of death given was; 1a. Cardiac Arrhythmia 1b. Long QT Syndrome Ic Therapeutic drug use 2, My conclusion was: Died from a recognised complication of necessary therapeutic agents:
Circumstances of the Death
Despite her advanced age, Mrs Bassendine was a relatively fit 98 year old lady who lived independently in a care home_ On the 2nd October 2015 Bassendine was eating breakfast in the room of her residence when she was observed by several fellow residents sitting at the same table to suddenly collapse Despite active and prompt resuscitation by the care home staff and subsequently by the paramedics who attended, Mrs Bassendine did not recover and she was declared dead at the care home shortly thereafter A Post mortem examination was undertaken and it was thought the cause of death was a consequence of choking by the pathologist finding food in the lungs and airways. However, during the hearing heard no evidence ihat there was any choking prior to the collapse. The collapse was sudden and Mrs Bassendine appeared to die immediately: There was no further signs of Iife despite active and prompt resuscitation by the staff at the care home and subsequently by the paramedics who attended after a 999 call was made_ Mrs Bassendine had no history of choking and was able to eat what she wanted, when she wanted heard evidence that Mrs Bassendine had been prescribed Olanzapine and Mirtazapine as well as Indapamide and that this combination of drugs can cause long QT syndrome_ It was also noted that her dose of Mirtazapine had recently increased, In the absence of any circumstantial evidence and with direct eyewitness accounts of the nature of the collapse concluded that it was more likely than not Mrs Bassendine's collapse was a consequence of a cardiac arrhythmia rather than by choking and the arrhythmia was more likely than not to have arisen as a consequence of long QT syndrome from the combination of drugs she was to control her distressing depression_ and dining Mrs taking also heard evidence that there had been no assessment of her cardiac status including an ECG despite this combination of Olanzapine; Mirtazapine and Indapamide medication increasing the risk of developing long QT syndrome
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.