Shanté Turay-Thomas
PFD Report
All Responded
Ref: 2020-0124
Community health care and emergency services related deaths
Emergency services related deaths (2019 onwards)
Other related deaths
All 9 responses received
· Deadline: 8 Oct 2020
Coroner's Concerns (AI summary)
GPs failed to ensure specialist allergy care, provided inadequate advice on carrying two adrenaline pens, and did not offer training for new auto-injector devices, compounded by deficient CCG guidance on dosage.
View full coroner's concerns
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.
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.
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.
(I assume the same is true of the EpiPen and the JEXT, but I heard no evidence about these at inquest.)
4. The Emerade AAI is sold singly. It could be sold in boxes of two as the norm and only singly in the alternative.
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.
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.
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.
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).
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.
10. I did not hear evidence that there is any NICE (National Institute for Health & Care Excellence) guidance on the point. It seems that the whole area would benefit from NICE review.
11. It would also benefit from review by NHS England, particularly in terms of the guidance given to CCGs and regarding consideration of incentives (CQUIN indicators etc.) to educate and train in the management of allergies.
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.
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.
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.
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.
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.
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.
18. I am unclear as to whether the Adastra 111 algorithm automatically prompts administering a second AAI five minutes after the first if there has been no improvement, but it should.
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.
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.
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.
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.
(I assume the same is true of the EpiPen and the JEXT, but I heard no evidence about these at inquest.)
4. The Emerade AAI is sold singly. It could be sold in boxes of two as the norm and only singly in the alternative.
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.
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.
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.
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).
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.
10. I did not hear evidence that there is any NICE (National Institute for Health & Care Excellence) guidance on the point. It seems that the whole area would benefit from NICE review.
11. It would also benefit from review by NHS England, particularly in terms of the guidance given to CCGs and regarding consideration of incentives (CQUIN indicators etc.) to educate and train in the management of allergies.
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.
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.
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.
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.
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.
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.
18. I am unclear as to whether the Adastra 111 algorithm automatically prompts administering a second AAI five minutes after the first if there has been no improvement, but it should.
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.
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.
Responses
Action Planned
NHS England will continue to work with HEE, the professional Royal Colleges, and other organizations to stay updated on new guidance and resources for managing severe allergies, and will explore using communication routes or commissioning levers to support their adoption. They also describe their assurance role for CCGs and commissioning of healthcare services. (AI summary)
NHS England will continue to work with HEE, the professional Royal Colleges, and other organizations to stay updated on new guidance and resources for managing severe allergies, and will explore using communication routes or commissioning levers to support their adoption. They also describe their assurance role for CCGs and commissioning of healthcare services. (AI summary)
View full response
Dear Ms Hassell,
Re: Regulation 28 Report to Prevent Future Deaths – Shante Turay-Thomas who died on 15 September 2018.
Thank you for your Regulation 28 Report (hereafter the ‘report’) dated 29/01/2020 concerning the tragic death of Shante Turay-Thomas on 15 September 2018. Firstly, I would like to express my deepest condolences to Shante’s family and all those touched by her death.
Your report concludes that Shante’s death was a result of acute anaphylaxis following an allergic reaction to nuts she had consumed. Your report covers many complex issues and expresses a number of concerns directed towards several different organisations. In preparing our response to your report, NHS England and NHS Improvement (hereafter ‘NHSEI’) has worked closely with the Department of Health, Enfield Clinical Commissioning Group (CCG), NHS Digital and the Medicines and Healthcare products Regulatory Agency (MHRA) to inform their responses and ours. I am aware that these organisations will address the points most relevant to them, therefore we have focused on responding to the concerns you have directed toward NHSEI and that are relevant to NHSEI’s statutory duties.
Following the inquest, you asked NHSEI to address your concern regarding guidance given to CCGs and regarding considerations of incentives (CQUINS indicators etc) to educate and train primary care staff on the management of allergies.
NHSEI has an assurance role for CCGs and their commissioning of healthcare services. NHSEI does not have any direct role in offsetting the curriculum content for health professionals’ education and training. However, I can set out the following which sets out NHSEI’s work and commitment in this area:
• We impose a contractual obligation on healthcare providers to employ staff who are appropriately trained and to require staff to stay up to date with lifelong learning. NHSEI works closely with Health Education England (HEE) and the professional Royal Colleges, who would be best placed to consider whether National Medical Director NHS England & NHS Improvement Skipton House 80 London Road London SE1 6LH
27th May 2020
under-graduate and professional training in relation to allergy management could be strengthened.
• I will ensure your report is sent to HEE and the Royal College of General Practitioners. Our commissioning teams will liaise directly with all relevant organisations to facilitate uptake of any new guidance and resource that would support better management of people with severe allergies.
• The use of incentives such as CQUIN have been set nationally for 2020/21 contracts. CQUIN as a route to provide incentives will be under review in future years, and decisions will be made in due course for 2021/22.
• The British Society for Allergy & Clinical Immunology (BSACI) provide training for primary care staff across the country (workshops and educational meetings). Additional training of primary care staff / establishing training requirements would be via their professional organisations (e.g. Royal College of GPs), Health Education England and CCGs.
• Allergists and Immunologists are Fellows/Members of the Royal College of Physicians. Allergy and Immunology training is the responsibility of the RCP through the JRCPTB (Joint Royal Colleges of Physicians Training Board). A CCT (Certificate of Completion of Training) in allergy and immunology is available to support specialist allergy care. The Royal College of Physicians also runs an accreditation scheme – Improving Quality in Allergy Services. BSACI also provide training for a range of professionals.
You also asked NHSEI to address your concern around there being no person with named accountability for allergy services and allergy provision. Allergy is a clinical speciality concerned with the identification and management of patients with a broad range of allergic conditions. These include asthma, eczema and acute food allergy. The patient group is broad, including paediatric and adult patients, and the acuity with which allergic reactions manifest is extremely varied. NHSEI has overall responsibility for the quality of allergy services across England. Most allergy services are commissioned locally through CCGs; however, to support patients with rare and complex conditions NHSEI directly commissions some specialised services. These include specialised allergy services through the Blood and Infection National Programme of Care. We have an established Clinical Reference Group (CRG) that provides clinical advice and leadership on the specialised immunology and allergy services. The relevant CRG is chaired by a consultant immunologist. Membership of the CRG is comprised of clinicians, commissioners, public health experts, patients and carers. They use their specific knowledge and expertise to advise NHS England on the best ways that specialised services should be provided. CRGs lead on the development of clinical commissioning policies, service specifications and quality standards. They also provide advice on innovation, horizon scanning, service reviews and guide work to reduce variation and deliver increased value. CRGs, through their Patient and Public Voice (PPV) members, also help ensure that any changes to the commissioning of specialised services involve patients and the public.
NHSEI also has a number of National Clinical Directors and National Specialty Advisers who are practicing clinicians from across England. They provide clinical leadership, advice, input and support across distinct areas of NHS conditions and services. We are deeply saddened by Shante’s death. We are grateful to have had the opportunity to respond to your concerns relevant to NHSEI. We will continue to work the with HEE, the professional Royal Colleges and the other organisations addressed in your report to keep abreast of any new guidance or resources that they produce that would support better management of people with severe allergies. We will consider whether any of our communication routes or commissioning levers can help with their uptake and embedding. Thank you for bringing this important patient safety issue to my attention and please do not hesitate to contact me should you need any further information.
Re: Regulation 28 Report to Prevent Future Deaths – Shante Turay-Thomas who died on 15 September 2018.
Thank you for your Regulation 28 Report (hereafter the ‘report’) dated 29/01/2020 concerning the tragic death of Shante Turay-Thomas on 15 September 2018. Firstly, I would like to express my deepest condolences to Shante’s family and all those touched by her death.
Your report concludes that Shante’s death was a result of acute anaphylaxis following an allergic reaction to nuts she had consumed. Your report covers many complex issues and expresses a number of concerns directed towards several different organisations. In preparing our response to your report, NHS England and NHS Improvement (hereafter ‘NHSEI’) has worked closely with the Department of Health, Enfield Clinical Commissioning Group (CCG), NHS Digital and the Medicines and Healthcare products Regulatory Agency (MHRA) to inform their responses and ours. I am aware that these organisations will address the points most relevant to them, therefore we have focused on responding to the concerns you have directed toward NHSEI and that are relevant to NHSEI’s statutory duties.
Following the inquest, you asked NHSEI to address your concern regarding guidance given to CCGs and regarding considerations of incentives (CQUINS indicators etc) to educate and train primary care staff on the management of allergies.
NHSEI has an assurance role for CCGs and their commissioning of healthcare services. NHSEI does not have any direct role in offsetting the curriculum content for health professionals’ education and training. However, I can set out the following which sets out NHSEI’s work and commitment in this area:
• We impose a contractual obligation on healthcare providers to employ staff who are appropriately trained and to require staff to stay up to date with lifelong learning. NHSEI works closely with Health Education England (HEE) and the professional Royal Colleges, who would be best placed to consider whether National Medical Director NHS England & NHS Improvement Skipton House 80 London Road London SE1 6LH
27th May 2020
under-graduate and professional training in relation to allergy management could be strengthened.
• I will ensure your report is sent to HEE and the Royal College of General Practitioners. Our commissioning teams will liaise directly with all relevant organisations to facilitate uptake of any new guidance and resource that would support better management of people with severe allergies.
• The use of incentives such as CQUIN have been set nationally for 2020/21 contracts. CQUIN as a route to provide incentives will be under review in future years, and decisions will be made in due course for 2021/22.
• The British Society for Allergy & Clinical Immunology (BSACI) provide training for primary care staff across the country (workshops and educational meetings). Additional training of primary care staff / establishing training requirements would be via their professional organisations (e.g. Royal College of GPs), Health Education England and CCGs.
• Allergists and Immunologists are Fellows/Members of the Royal College of Physicians. Allergy and Immunology training is the responsibility of the RCP through the JRCPTB (Joint Royal Colleges of Physicians Training Board). A CCT (Certificate of Completion of Training) in allergy and immunology is available to support specialist allergy care. The Royal College of Physicians also runs an accreditation scheme – Improving Quality in Allergy Services. BSACI also provide training for a range of professionals.
You also asked NHSEI to address your concern around there being no person with named accountability for allergy services and allergy provision. Allergy is a clinical speciality concerned with the identification and management of patients with a broad range of allergic conditions. These include asthma, eczema and acute food allergy. The patient group is broad, including paediatric and adult patients, and the acuity with which allergic reactions manifest is extremely varied. NHSEI has overall responsibility for the quality of allergy services across England. Most allergy services are commissioned locally through CCGs; however, to support patients with rare and complex conditions NHSEI directly commissions some specialised services. These include specialised allergy services through the Blood and Infection National Programme of Care. We have an established Clinical Reference Group (CRG) that provides clinical advice and leadership on the specialised immunology and allergy services. The relevant CRG is chaired by a consultant immunologist. Membership of the CRG is comprised of clinicians, commissioners, public health experts, patients and carers. They use their specific knowledge and expertise to advise NHS England on the best ways that specialised services should be provided. CRGs lead on the development of clinical commissioning policies, service specifications and quality standards. They also provide advice on innovation, horizon scanning, service reviews and guide work to reduce variation and deliver increased value. CRGs, through their Patient and Public Voice (PPV) members, also help ensure that any changes to the commissioning of specialised services involve patients and the public.
NHSEI also has a number of National Clinical Directors and National Specialty Advisers who are practicing clinicians from across England. They provide clinical leadership, advice, input and support across distinct areas of NHS conditions and services. We are deeply saddened by Shante’s death. We are grateful to have had the opportunity to respond to your concerns relevant to NHSEI. We will continue to work the with HEE, the professional Royal Colleges and the other organisations addressed in your report to keep abreast of any new guidance or resources that they produce that would support better management of people with severe allergies. We will consider whether any of our communication routes or commissioning levers can help with their uptake and embedding. Thank you for bringing this important patient safety issue to my attention and please do not hesitate to contact me should you need any further information.
Action Planned
Advanced states they will work with NHS Digital to develop a standard for electronic updating of ambulance systems to inform them when an ambulance has been recalled. They also suggest an independent review of clinical triage systems. (AI summary)
Advanced states they will work with NHS Digital to develop a standard for electronic updating of ambulance systems to inform them when an ambulance has been recalled. They also suggest an independent review of clinical triage systems. (AI summary)
View full response
Dear Ms Hassell, Re: Prevention of Future Deaths report - Shante Andree Marie Turay-Thomas Thank you for your Regulation 28 Report to prevent future deaths, detailing your concerns arising from the inquest into the death of Miss Shante Turay-Thomas. I would like to assure you that all matters related to patient safety are taken extremely seriously by Advanced. We employ a highly skilled Clinical Team who ensure that we fully comply with the NHS requirements on clinical safety in the manufacture of software (DCB 0129). Correction (section 18) I would like to make a correction to section 18. The algorithms embedded into the Adastra application are the NHS Pathways 111 algorithms, and Advanced have no editorial control over the content of these algorithms. Thus your comments around the second administration of adrenaline need to be directed to the NHS Pathways team. Errors made in collecting the address (section 14) The Adastra application allows the collection of two address fields, a home address and a current location address. The home address is checked against the Personal Demographic Service (PDS), the national record of every patient's demographic information. This includes the patient's NHS number and registered General Practitioner's details. The error made by.the call handler was not in failing to untick the boxes, as they should have remained ticked to record the correct home address, but in realising this address was not the same as the current location of the patient. If the patient is not at the registered home address the current location address can be recorded, and this is where the ambulance will be sent if one is required. The Adastra application allows the address fields to be changed, but the system has to depend on the user ensuring the recorded address details are correct with the caller. It is important that the patient's registered home address is recorded as this allows access to the Summary Care Record (SCR) which will often provide information on allergies and drugs taken - which would have been very useful in this case. It also allows the post event message to be sent to the GP, who can then provide onward care where needed. Advanced H03'1h and Care l 1m 1ed (trad ng os Advanced) 1s o compllny registered ,n Eng•and and Wa'es ln!9roompany number 2939302, Whoso reg,sterod office ,. o,non Park, R,d,ng Court Road Oatchet. SL3 9LL > Ditton Park Riding Court Road Oatchet Berkshire SL3 9LL > +44 (0) 845 160 6162 www oneadvanced.com
Access to the PDS was developed into Adastra in 2008 and there has been no changes to how this functionality works since. During that time, we estimate that over 100 million calls have been taken through Adastra, resulting in an estimated 12 million requests for ambulance despatch. The Adastra application sent the ambulance request to the correct address as displayed. There are already alerts in the application so that when performing a 111 assessment using the NHS Pathways algorithms, if a point is reached where an ambulance despatch is needed, the address is displayed in a pop up screen. The user must confirm with the caller that this is correct, before ticking to confirm the address is correct, to enable the electronic despatch request message to be sent. If the application cannot determine the correct ambulance service to send the case to, or if the address details are not sufficient or clear, a second pop up message is displayed. This pop up occupies almost the whole screen, and cannot be cleared from the screen, until the user has confirmed what actions they have taken to resolve the issue. These have been in the application from 2013 and were introduced to try and avoid this situation arising {ie ambulances being sent to the wrong address) when the functionality was designed. This Is the flrsttlme Advanced has been made aware of the scenario outlined In this case. This involved asecond user being asked verbally by the call handler to contact the ambulanee service and details from a different screen (that was not the screen in live use) were used. Within two-working days of being made aware ofthe scenario outlined In this case, Advanced Issued a reminder to all call handlers not to manually circumvent the software process and this was followed by asoftware update being released to prevent this manual override re- occurring ie a message is displayed if a second user opens the same user case, warning them that the address details may be out of date. This was deployed to all customers. Subsequently, and as a direct result of this case, we are currently making two changes to the Adastra application which are in development. These changes will ensure that the user will have to actively select, and tick, the address field that is required when there are differences between the locally recorded home address and the PDS registered home address. Also if any changes are made to the address during the course of the consultation they will be saved to the database immediately and will then be available contemporaneously to any other user, on any other screen. We anticipate these changes will be available to all Adastra customers by the end of April 2020. I hope that these measures we are undertaking provide you with the appropriate level of assurance in relation to our commitment to clinical safety. There are two further areas we would like you to consider: Review of the NHS 111 Ambulance Request message As part of his verbal statement to the inquest, Dr Alex Yeates spoke of the message structure used by Adastra and all ambulance system suppliers which was developed by the Health and Social Care Information Centre in 2013. This message structure works well and has been used by Adastra to request many millions of ambulances, but it could be improved. One of the issues raised at the inquest was that when LCW contacted the London Ambulance Service, they could not find the case on the ambulance system as they did not know the CAD reference number for it. It would also have been useful ifthere had been electronic updating of LCW to inform them that the initial Category II ambulance had been recalled. Advanced has spoken to several ambulance system suppliers and we are all happy to work with NHS Digital to develop this standard further, but it requires NHS Digital to lead. · W I nd any number 05965280 whose registered office is l ·m'ted -15 8 oompany registered ,n England and aes u er comp · Advanoed Computer Software Group 1 1 Ditton Park, Riding Court Road, Oatchel, SL3 9LL.
Independent review of clinical triage systems One of the points raised at the inquest was the inconsistency in categorisations between AMPDS used by the London Ambulance Service for their 999 calls, and the NHS Pathways clinical decision support triage system used by the 111 service. There are alternative clinical decision support triage systems in use within other urgent care settings. The recent Care Quality Commission recommendations published in their 'Getting to the right care in the right way - digital triage in health services' report, states that there should be a 'fair test of clinical performance of digital triage solutions'. We would like to see you recommend that this is carried out and conducted by an independent body and not NHS Digital, the providers of the NHS 111 Pathways system, as this could be seen as a conflict of interest.
Access to the PDS was developed into Adastra in 2008 and there has been no changes to how this functionality works since. During that time, we estimate that over 100 million calls have been taken through Adastra, resulting in an estimated 12 million requests for ambulance despatch. The Adastra application sent the ambulance request to the correct address as displayed. There are already alerts in the application so that when performing a 111 assessment using the NHS Pathways algorithms, if a point is reached where an ambulance despatch is needed, the address is displayed in a pop up screen. The user must confirm with the caller that this is correct, before ticking to confirm the address is correct, to enable the electronic despatch request message to be sent. If the application cannot determine the correct ambulance service to send the case to, or if the address details are not sufficient or clear, a second pop up message is displayed. This pop up occupies almost the whole screen, and cannot be cleared from the screen, until the user has confirmed what actions they have taken to resolve the issue. These have been in the application from 2013 and were introduced to try and avoid this situation arising {ie ambulances being sent to the wrong address) when the functionality was designed. This Is the flrsttlme Advanced has been made aware of the scenario outlined In this case. This involved asecond user being asked verbally by the call handler to contact the ambulanee service and details from a different screen (that was not the screen in live use) were used. Within two-working days of being made aware ofthe scenario outlined In this case, Advanced Issued a reminder to all call handlers not to manually circumvent the software process and this was followed by asoftware update being released to prevent this manual override re- occurring ie a message is displayed if a second user opens the same user case, warning them that the address details may be out of date. This was deployed to all customers. Subsequently, and as a direct result of this case, we are currently making two changes to the Adastra application which are in development. These changes will ensure that the user will have to actively select, and tick, the address field that is required when there are differences between the locally recorded home address and the PDS registered home address. Also if any changes are made to the address during the course of the consultation they will be saved to the database immediately and will then be available contemporaneously to any other user, on any other screen. We anticipate these changes will be available to all Adastra customers by the end of April 2020. I hope that these measures we are undertaking provide you with the appropriate level of assurance in relation to our commitment to clinical safety. There are two further areas we would like you to consider: Review of the NHS 111 Ambulance Request message As part of his verbal statement to the inquest, Dr Alex Yeates spoke of the message structure used by Adastra and all ambulance system suppliers which was developed by the Health and Social Care Information Centre in 2013. This message structure works well and has been used by Adastra to request many millions of ambulances, but it could be improved. One of the issues raised at the inquest was that when LCW contacted the London Ambulance Service, they could not find the case on the ambulance system as they did not know the CAD reference number for it. It would also have been useful ifthere had been electronic updating of LCW to inform them that the initial Category II ambulance had been recalled. Advanced has spoken to several ambulance system suppliers and we are all happy to work with NHS Digital to develop this standard further, but it requires NHS Digital to lead. · W I nd any number 05965280 whose registered office is l ·m'ted -15 8 oompany registered ,n England and aes u er comp · Advanoed Computer Software Group 1 1 Ditton Park, Riding Court Road, Oatchel, SL3 9LL.
Independent review of clinical triage systems One of the points raised at the inquest was the inconsistency in categorisations between AMPDS used by the London Ambulance Service for their 999 calls, and the NHS Pathways clinical decision support triage system used by the 111 service. There are alternative clinical decision support triage systems in use within other urgent care settings. The recent Care Quality Commission recommendations published in their 'Getting to the right care in the right way - digital triage in health services' report, states that there should be a 'fair test of clinical performance of digital triage solutions'. We would like to see you recommend that this is carried out and conducted by an independent body and not NHS Digital, the providers of the NHS 111 Pathways system, as this could be seen as a conflict of interest.
Noted
NICE notes that the British National Formulary (BNF) and BNF for Children (BNFc) already contain detailed advice on adrenaline auto-injectors, including MHRA/CHM advice from 2017 and 2019. It will consider how best to make clear in CG134 the advice that 2 adrenaline auto-injectors should be prescribed, which patients should carry at all times. (AI summary)
NICE notes that the British National Formulary (BNF) and BNF for Children (BNFc) already contain detailed advice on adrenaline auto-injectors, including MHRA/CHM advice from 2017 and 2019. It will consider how best to make clear in CG134 the advice that 2 adrenaline auto-injectors should be prescribed, which patients should carry at all times. (AI summary)
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Dear Ms Hassell, I write in response to your correspondence, dated 28 January 2020, regarding the death of Shante Andree Marie TURAY-THOMAS. I was very sorry to read of Ms Turay-Thomas' death. We have considered the circumstances surrounding Ms Turay-Thomas· death, and the concerns raised in your report. In particular, the concerns that there is an absence of NICE guidance concerning:
• the dose of adrenaline in different adrenaline auto-injectors pens,
• the number of pens that should be carried, and
• training in how to use the devices We note that you say in point 10 of your report that 'the whole area would benefit from NICE review'. Having reviewed your concerns, we consider that the British National Formulary (BNF) and the BNF for Children (BNFc) already contain detailed advice on these aspects of care, including the following pieces of MHRA/CHM advice from 2017 and 2019, in the section on Adreneline/Epinephrine (https://bnf.nice.org.uk/drug/adrenalineepinephrine.html) : 'Adrenaline auto-injectors: updated advice after European review (August 2017) With intramuscular use Folfowing a European review of all adrenaline auto-injectors approved in the EU, the MHRA recommend that 2 adrenaline auto-injectors are prescribed, which patients should carry at all times. This is particularly important for patients with allergic asthma, who are at increased risk of a severe anaphylactic reaction. Patients with allergies and their carers should be trained to use the particular auto-injector they have been prescribed and encouraged to practise using a trainer device. Patients are advised to check the expiry date of the adrenaline auto-injectors and obtain replacements before they expire.
NICE
'Adtenallne a,,,to./n/ecfD, wtaction taken to supportsafety(Od.ober 2019} With lntratnuscular use Hea/tht:are professions/a.,. reminded to follow exiatlng advice on the uae ofadtenllllne auto-lnjectortl- also PrNorlblng and dispensing Information. Patients shouldbe enooursged to reed the MHRA advice sheetandto sign up for the Expiry alert NfVlce d theirauto-ln}e«ordevice an the manuladurer's website. Healthcare professkJnala ahould IIIBo beawan, d recent alerta and letters Issued about adrenaline auto-injeal.ors Including Iha activation failure iaue wfttl Emerade9 aul.o-/njector pens and the fol.r-month extension ofexpiry dates ofCfJl'laln batchN ofEpipen8and J..-. The MHRA has produced e letteron the EmetadeCl>actlvatlon Issue, which ahoUld be provided to patients and their caws.. The BNF and BNFc are both joint publcalions of the British Medlcal Aasoclation and the Royal Pharmaceullcal Society, and both fomlularfea are accesslble from the NICE website. Prescriber& ant expected to refer to lnfonnation within the BNF and the BNFc to help inform prescribing decisions made with Individual patlenta and carers. This expectation Is aet out in the Gena-al Meclcal Council's publlcaUon on 'Qgqd practice In presatinq and managing rnedJclnes and deyices'. within the section lllled: Keeping up to date and prescribing safely. We have publshed a clinical guideline on food allergy In under 19s: asessment and diagnosis (CG118), which we undendand would haw been relevant to Ms Turay-Thomas' assessment and diaanosis. However, it does not cover the management of anaphylactlc reactions and we therefore consider it not drectly relevant to the concams regarding t.r death. We have alao published a clnical guideline on anaphylaxie: assessment and referral after emergency treatment (00134) and we have a quality standard on anaphylaxla (0S119). Both this guldellne and qually standard cover care alter emergencytreatment for suspected anaphylaxls. Including assessment and referral to speclalst allergy services. That Is, they begin at the point In the clinical pathway immacllataly aftera health professional has started to manage a suspected anaphylactic raactlon. It Is not clear from Y0II" report whether Ma Turay-Thomas had ever e,cperlenced an anaphylactlc reaction before the one that caused her death, and it appears that she had died by the time any health professfonal attended her during the ratal episode. nis therefore undear whether either 00134 or QS119 would have been directly relevant to the Issues that contributed to her death. We do not conskler it appropriate for us to dupllcate the BNF advice raferrad to above. However, we will consider how best to make clear In CG134 the advice that 2 adrenaline auto-injectors should be prescribed, which patients should carry at 811 tfflls.
• the dose of adrenaline in different adrenaline auto-injectors pens,
• the number of pens that should be carried, and
• training in how to use the devices We note that you say in point 10 of your report that 'the whole area would benefit from NICE review'. Having reviewed your concerns, we consider that the British National Formulary (BNF) and the BNF for Children (BNFc) already contain detailed advice on these aspects of care, including the following pieces of MHRA/CHM advice from 2017 and 2019, in the section on Adreneline/Epinephrine (https://bnf.nice.org.uk/drug/adrenalineepinephrine.html) : 'Adrenaline auto-injectors: updated advice after European review (August 2017) With intramuscular use Folfowing a European review of all adrenaline auto-injectors approved in the EU, the MHRA recommend that 2 adrenaline auto-injectors are prescribed, which patients should carry at all times. This is particularly important for patients with allergic asthma, who are at increased risk of a severe anaphylactic reaction. Patients with allergies and their carers should be trained to use the particular auto-injector they have been prescribed and encouraged to practise using a trainer device. Patients are advised to check the expiry date of the adrenaline auto-injectors and obtain replacements before they expire.
NICE
'Adtenallne a,,,to./n/ecfD, wtaction taken to supportsafety(Od.ober 2019} With lntratnuscular use Hea/tht:are professions/a.,. reminded to follow exiatlng advice on the uae ofadtenllllne auto-lnjectortl- also PrNorlblng and dispensing Information. Patients shouldbe enooursged to reed the MHRA advice sheetandto sign up for the Expiry alert NfVlce d theirauto-ln}e«ordevice an the manuladurer's website. Healthcare professkJnala ahould IIIBo beawan, d recent alerta and letters Issued about adrenaline auto-injeal.ors Including Iha activation failure iaue wfttl Emerade9 aul.o-/njector pens and the fol.r-month extension ofexpiry dates ofCfJl'laln batchN ofEpipen8and J..-. The MHRA has produced e letteron the EmetadeCl>actlvatlon Issue, which ahoUld be provided to patients and their caws.. The BNF and BNFc are both joint publcalions of the British Medlcal Aasoclation and the Royal Pharmaceullcal Society, and both fomlularfea are accesslble from the NICE website. Prescriber& ant expected to refer to lnfonnation within the BNF and the BNFc to help inform prescribing decisions made with Individual patlenta and carers. This expectation Is aet out in the Gena-al Meclcal Council's publlcaUon on 'Qgqd practice In presatinq and managing rnedJclnes and deyices'. within the section lllled: Keeping up to date and prescribing safely. We have publshed a clinical guideline on food allergy In under 19s: asessment and diagnosis (CG118), which we undendand would haw been relevant to Ms Turay-Thomas' assessment and diaanosis. However, it does not cover the management of anaphylactlc reactions and we therefore consider it not drectly relevant to the concams regarding t.r death. We have alao published a clnical guideline on anaphylaxie: assessment and referral after emergency treatment (00134) and we have a quality standard on anaphylaxla (0S119). Both this guldellne and qually standard cover care alter emergencytreatment for suspected anaphylaxls. Including assessment and referral to speclalst allergy services. That Is, they begin at the point In the clinical pathway immacllataly aftera health professional has started to manage a suspected anaphylactic raactlon. It Is not clear from Y0II" report whether Ma Turay-Thomas had ever e,cperlenced an anaphylactlc reaction before the one that caused her death, and it appears that she had died by the time any health professfonal attended her during the ratal episode. nis therefore undear whether either 00134 or QS119 would have been directly relevant to the Issues that contributed to her death. We do not conskler it appropriate for us to dupllcate the BNF advice raferrad to above. However, we will consider how best to make clear In CG134 the advice that 2 adrenaline auto-injectors should be prescribed, which patients should carry at 811 tfflls.
Action Planned
Bausch & Lomb distributes trainer pens to allergy clinics and is currently reviewing the design of its trainer pens to incorporate a needle cover shield extension when activated, to more closely replicate the patient experience with the actual pen. (AI summary)
Bausch & Lomb distributes trainer pens to allergy clinics and is currently reviewing the design of its trainer pens to incorporate a needle cover shield extension when activated, to more closely replicate the patient experience with the actual pen. (AI summary)
View full response
Dear Madam: Regulation 28:Prevention of Future Deaths Report, Shante Andree Marie Turay- Thomas This letter is sent on behalf of Bausch & Lomb UK Ltd (Bausch) in response to your report dated 27 January 2020 under paragraph 7, Schedule 5, ofthe Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. You raise four matters of concern in relation to Bausch's product, Emerade at paragraphs 3, 4, 12 and 13 of your report. We respond to these below. Review of advice to patients that two pens should be carried at all times Paragraph 3 of your report states: "The Emerade AA! 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. (I assume the same is true c~fthe EpiPen and the JEXT, but I heard no evidence about these at inquest.)" [] Arnold & Porter Kaye Scholer (UK) LLP 25 Old Broad Street. Tower 42 I London, EC2N 1 HQ I United Kingdom I www.arnoldporter.com Arnold & Porter Kaye Scholer (UK) LLP is a limited liability partnership organised under the laws of the State of New York (F040202000739), is authorised and regulated by the Solicitors Regulation Authority under ID 259382 and practises as Arnold & Porter in England and Wales. Our professional rules may be accessed at www.sra.org.uk. It is an affiliate of Arnold & Porter Kaye Scholer LLP. a limited liability partnership organised under the laws of the State of Delaware. A list of the firm's partners and their professional qualifications is open to inspection at the web address above. The VAT registration number of Arnold & Porter Kaye Scholer (UK) LLP is GB 697 436 088. EU 210567506v1
Arnold Porter 16 March 2020 Page 2 Bausch believes, consistent with advice issued by MHRA 1, that the available evidence supports a recommendation that patients who are at risk of anaphylaxis should carry two adrenaline auto-injectors at all times and this is stated in the Patient Information Leaflet for Emerade. In contrast however, guidance issued by the British Society for Allergy and Clinical Immunology ("BSACI") states: "There is no good evidence that issuing two AAls is necessary or cost-effective in most cases. After an episode in A&E, awaiting proper risk assessment, the normal practice would be to issue one device" 2. Bausch supports a review of the recommendations issued by expert bodies to consider whether a consistent approach is possible in the interests of patients. With respect to information on the labelling of medicinal products, this is controlled by the Human Medicines Regulations 2012 and the addition of any text must be approved by the competent regulatory authority before it can be implemented. When considering the addition of information not specified in the regulations, it is necessary to take into account whether this can be included on the packaging in legible form without adversely impacting the essential information already required to be present. Despite the current inconsistency ofviews held by MHRA and the BSACI, Bausch will initiate discussions with MHRA in relation to whether it would be appropriate to add advice regarding the need to carry two pens, similar to that included in the Patient Information Leaflet for Emerade, on the outer packaging of adrenaline auto-injectors. Emerade supplied singly or in twin-packs Paragraph 4 of your report states: "The Emerade AA] is sold singly. It could be sold in boxes oftwo as the norm and only singly in the alternative. " Emerade, like other adrenaline auto-injectors is authorised for supply as twin-packs as well as single auto-injectors. There are a range of circumstances in which a single pen, rather than a twin-pack, may properly be prescribed and dispensed for a particular patient including:
european-review 2 Ewan P et al. BASCI Guideline: Prescribing an Adrenaline Auto-injector. Clinical and Experimental Allergy 2016; 46(10): 1258 EU 210567506v1
Arnold&Porter 16 March 2020 Page 3
• Where the patient needs to replace only a single pen which has been lost, damaged, used or has reached the end of its shelf-life; and
• Where the patient wishes to keep a further pen at, say, school (in addition to the pens carried with him/her). Furthermore, while guidance consistently recommends the prescription of at least two adrenaline autoinjectors for patients with multiple risk factors for severe anaphylaxis, the position for other patients is less clear. In circumstances where there will always be a need for single adrenaline auto-injectors to be dispensed in some situations and where the number of auto-injectors supplied depends on the prescription and not the pack size, Bausch & Lomb suggests that, even if packs of two auto-injectors are available, there will continue to be a parallel requirement for routine supply of packs containing a single auto-injector. Finally, supply of a twin-pack containing two auto-injectors may not prevent patients who should carry two auto-injectors, dividing the pack and keeping the pens in separate locations. Supply of a twin-pack cannot therefore replace the need for patient education in relation to the number of pens to be carried at all times. Reference to training by a healthcare professional in the patient information leaflet Paragraph 12 of your report states: "The Emerade AA! (and I assume the EpiPen and JEXT) leaflet does not specifically advise that trainingfrom a healthcare professional is needed in how to use this particular AA! as opposed to any other". However, the wording of the Patient Information Leaflet for Emerade includes the following information, specifically advising patients that training from a doctor or pharmacist is required: "Always use Emerade exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure". This reflects the information in the Summary of Product Characteristics, which is the "datasheet" provided for healthcare professionals: "All patients who are prescribed Emerade should be thoroughly instructed to understand the indications.for the use and the correct method ofadministration EU 210567506v1
Arnold&Porter 16 March 2020 Page4 (see section 6. 6 [Which provides detailed instructions on administration]). It is strongly advised also to educate the patient's immediate associates (e.g. parents, caregivers, teachers) for the correct usage ofEmerade in case support is needed in the emergency situation". The use of trainer pens Paragraph 13 of your report states: "I heard that the gold standard of training for use of any AA! 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 ofthis standard oftraining (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". Bausch distributes trainer pens to allergy clinics and further supplies may be accessed through the Emerade website by all patients for practice purposes. These trainer pens do not include a placebo as this would limit use of the trainer pen to single use and, by administering an apparent "dose", would present a risk of confusion, with implications for patient safety. Bausch is currently reviewing the design of its trainer pens and plans to incorporate a needle cover shield extension when activated, to more closely replicate the patient experience with the actual pen, albeit still capable of being used on multiple occasions for practice purposes. We trust that this letter addresses the concerns raised in your report in relation to adrenaline auto-injectors in general and Emerade in particular. Please contact us should you require any further information.
Arnold Porter 16 March 2020 Page 2 Bausch believes, consistent with advice issued by MHRA 1, that the available evidence supports a recommendation that patients who are at risk of anaphylaxis should carry two adrenaline auto-injectors at all times and this is stated in the Patient Information Leaflet for Emerade. In contrast however, guidance issued by the British Society for Allergy and Clinical Immunology ("BSACI") states: "There is no good evidence that issuing two AAls is necessary or cost-effective in most cases. After an episode in A&E, awaiting proper risk assessment, the normal practice would be to issue one device" 2. Bausch supports a review of the recommendations issued by expert bodies to consider whether a consistent approach is possible in the interests of patients. With respect to information on the labelling of medicinal products, this is controlled by the Human Medicines Regulations 2012 and the addition of any text must be approved by the competent regulatory authority before it can be implemented. When considering the addition of information not specified in the regulations, it is necessary to take into account whether this can be included on the packaging in legible form without adversely impacting the essential information already required to be present. Despite the current inconsistency ofviews held by MHRA and the BSACI, Bausch will initiate discussions with MHRA in relation to whether it would be appropriate to add advice regarding the need to carry two pens, similar to that included in the Patient Information Leaflet for Emerade, on the outer packaging of adrenaline auto-injectors. Emerade supplied singly or in twin-packs Paragraph 4 of your report states: "The Emerade AA] is sold singly. It could be sold in boxes oftwo as the norm and only singly in the alternative. " Emerade, like other adrenaline auto-injectors is authorised for supply as twin-packs as well as single auto-injectors. There are a range of circumstances in which a single pen, rather than a twin-pack, may properly be prescribed and dispensed for a particular patient including:
european-review 2 Ewan P et al. BASCI Guideline: Prescribing an Adrenaline Auto-injector. Clinical and Experimental Allergy 2016; 46(10): 1258 EU 210567506v1
Arnold&Porter 16 March 2020 Page 3
• Where the patient needs to replace only a single pen which has been lost, damaged, used or has reached the end of its shelf-life; and
• Where the patient wishes to keep a further pen at, say, school (in addition to the pens carried with him/her). Furthermore, while guidance consistently recommends the prescription of at least two adrenaline autoinjectors for patients with multiple risk factors for severe anaphylaxis, the position for other patients is less clear. In circumstances where there will always be a need for single adrenaline auto-injectors to be dispensed in some situations and where the number of auto-injectors supplied depends on the prescription and not the pack size, Bausch & Lomb suggests that, even if packs of two auto-injectors are available, there will continue to be a parallel requirement for routine supply of packs containing a single auto-injector. Finally, supply of a twin-pack containing two auto-injectors may not prevent patients who should carry two auto-injectors, dividing the pack and keeping the pens in separate locations. Supply of a twin-pack cannot therefore replace the need for patient education in relation to the number of pens to be carried at all times. Reference to training by a healthcare professional in the patient information leaflet Paragraph 12 of your report states: "The Emerade AA! (and I assume the EpiPen and JEXT) leaflet does not specifically advise that trainingfrom a healthcare professional is needed in how to use this particular AA! as opposed to any other". However, the wording of the Patient Information Leaflet for Emerade includes the following information, specifically advising patients that training from a doctor or pharmacist is required: "Always use Emerade exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure". This reflects the information in the Summary of Product Characteristics, which is the "datasheet" provided for healthcare professionals: "All patients who are prescribed Emerade should be thoroughly instructed to understand the indications.for the use and the correct method ofadministration EU 210567506v1
Arnold&Porter 16 March 2020 Page4 (see section 6. 6 [Which provides detailed instructions on administration]). It is strongly advised also to educate the patient's immediate associates (e.g. parents, caregivers, teachers) for the correct usage ofEmerade in case support is needed in the emergency situation". The use of trainer pens Paragraph 13 of your report states: "I heard that the gold standard of training for use of any AA! 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 ofthis standard oftraining (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". Bausch distributes trainer pens to allergy clinics and further supplies may be accessed through the Emerade website by all patients for practice purposes. These trainer pens do not include a placebo as this would limit use of the trainer pen to single use and, by administering an apparent "dose", would present a risk of confusion, with implications for patient safety. Bausch is currently reviewing the design of its trainer pens and plans to incorporate a needle cover shield extension when activated, to more closely replicate the patient experience with the actual pen, albeit still capable of being used on multiple occasions for practice purposes. We trust that this letter addresses the concerns raised in your report in relation to adrenaline auto-injectors in general and Emerade in particular. Please contact us should you require any further information.
Action Taken
NHS Digital details changes made to NHS Pathways following the incident, including improving the Anaphylaxis algorithm, developing an audit framework, and conducting a user satisfaction survey to improve call-handling and call prioritisation. (AI summary)
NHS Digital details changes made to NHS Pathways following the incident, including improving the Anaphylaxis algorithm, developing an audit framework, and conducting a user satisfaction survey to improve call-handling and call prioritisation. (AI summary)
View full response
Dear Ms. Hassel Inquest into the death of Shanté Andreé Marie Turay-Thomas I am writing in response to the Prevention of Future Deaths (“PFD”) Report received from HM Coroner dated 21st January 2020. This follows the death of Shanté Andreé Marie Turay–Thomas who sadly died on 15th September 2018. This was followed by an investigation and inquest which concluded on 13th January 2020. Firstly, we would like to express our sincere condolences to the family of Ms Turay-Thomas. NHS Pathways is the clinical decision support software (CDSS) used by all 111 service providers, and some 999 ambulance trusts. For information, we have included a short summary of the functions that NHS Pathways performs and the governance that underpins it (containing background information on NHS Pathways) in Appendix A. HM Coroner raised matters of concern numbered 1 - 20 in the PFD report. Matters of concern 1 – 14 and 20 are not applicable to NHS Pathways. We set out below our response to matters of concern 15 to 19.
1 Trevelyan Square Boar Lane Leeds LS1 6AE 0300 303 5678 0113 397 3614
1) Matter of Concern 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.
NHS Digital has developed an extensive audit framework that applies to providers using NHS Pathways. This was described in NHS Digital’s: supplementary second witness statement dated 20th December 2019; submissions on conclusion dated 3 January 2020; and PFD submissions dated 17 January 2020.
Clinical providers of services using NHS Pathways (‘providers’) must enter into a Licence Agreement with the Secretary of State for Health and Social Care, including requirements relating to implementation, operation, training and auditing. This licence and the supporting materials are managed by NHS Digital.
The detailed requirements for auditing call handlers (including clinicians) establish audit frequencies, and standards against which audits should occur. These include criteria for auditing and requirements by way of qualification and training of those carrying out any audit. NHS Digital also offers regular ‘audit levelling’ sessions to providers in order to achieve good and consistent practice.
Ensuring the proper operation of the audit system and management of failed call audits is the responsibility of the provider, within the framework provided by NHS Digital. NHS Digital remains available to support providers in this area.
2) Matter of Concern 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.
Ambulance response categorisation, and the alignment of different triage systems, is not the responsibility of NHS Digital. This was set out in the following submissions made on behalf of NHS Digital:
• letter to HM Coroner dated 22 July 2019
• letter to HM Coroner dated 9 October 2019
• witness statement dated 14 November 2019
• evidence given at inquest on 12 December 2019
• submissions on conclusion dated 3 January 2020
• PFD submissions dated 17 January 2020.
NHS Pathways and the Medical Priority Dispatch System (MPDS) – (the system used by ambulance trusts not using NHS Pathways) operate by prioritising patients based on symptoms. Although they work differently, neither is designed to make a diagnosis. NHS Digital does not have oversight or detailed knowledge of MPDS; it is a competing system provided by a commercial supplier.
The categorisation of certain symptoms, which may occur in anaphylaxis, as requiring a category 2 emergency ambulance within NHS Pathways was ratified in 2017 during NHS England’s review of ambulance standards called the “Ambulance Response Program”. This program was implemented from 2nd October 2017, and was approved by the Secretary of State following extensive piloting.
NHS Pathways’ ambulance response codes are also ratified by the National Ambulance Services Medical Directors (NASMED) (an advisory group consisting of medical director representatives from all ambulance services in England, Wales, Scotland and Northern Ireland) and the Emergency Call Prioritisation Advisory Group (ECPAG) (a further group of advisors to NHS England).
Following the Ambulance Response Program, NHS England led (supported by NASMED and ECPAG) a “clinical coding review” in May 2019, reviewing the category 1 ambulance response definition. Consequently, it was decided that symptoms which may suggest life-threatening anaphylaxis should receive a category 1 ambulance response and the necessary changes were made by NHS Pathways. These were beta tested in September 2019 and deployed nationally from October 2019.
The Ambulance Response Program and clinical coding review applied equally to MPDS, whose ambulance dispositions were similarly reviewed and ratified.
Where an ambulance disposition is triggered by a 111 call, the NHS Pathways system is able to trigger ambulance dispatch (subject to local validation procedures which may be applied to category 3 and 4 ambulances). It would not be clinically safe to require re-triage or validation for category 1 and 2 ambulances due to the additional time this would take. As described in NHS Digital’s submissions the 111 and 999 questions and responses are identical where NHS Pathways is used (other than an additional first ‘nature of call’ question for 999). MPDS is an entirely different product with different operating rationale but with ambulance codes still
ratified in the same manner. The 999 service is not designed or intended to be a ‘safety net’ for 111.
NHS Digital contributes to ECPAG and will continue to support NHS England as far as it is able with the complex challenge of aligning the two very different systems. There is no evidence to suggest that prior to this incident, NHS Digital, through LCW or any other user of NHS Pathways, had been made aware of any issue or concern in respect of the ambulance response category for symptoms that may occur in anaphylaxis. If NHS Digital became aware of such an issue then its response would include raising this with NHS England, NASMED and ECPAG.
NHS England is the organisation charged with overseeing both NHS Pathways and MPDS, and has the remit and ability to review potential inconsistencies or change ambulance categorisation. Accordingly, concerns regarding ambulance categorisation or inconsistencies between MPDS and NHS Pathways can only be properly answered by NHS England.
3) Matter of Concern 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, whichever device it is administered, is very unlikely to be sufficient in the case of acute anaphylaxis. It contains a photograph to illustrate he use of an AAI, but in the photograph the device is held incorrectly.
As NHS Digital described in evidence and subsequent submissions, the distance learning pack is provided as a foundation of background information to all call handlers before they start training. It does not direct the progress of specific calls nor is it relied upon to communicate advice which a call handler should give. It would not be clinically safe or appropriate for non-clinical call handlers to be required to exercise knowledge or judgment, or act unprompted by the system, in this way. Call handlers are instead supported by the questions and care advice presented by the NHS Pathways system. The system contains ‘supporting information’ to help call handlers understand the clinical essence of what is being asked or advised. This is presented in ‘real-time’ so that the call handler has the required information in front of them, rather than having to rely on memory.
NHS Digital welcomed the evidence given by the expert witness, Professor Fox, at the inquest and immediately recognised that the distance learning pack could be improved, assuring the Coroner (in evidence and in the supplementary second witness statement dated 20th December
2019) that a review would be undertaken, in consultation with Professor Fox, to address the points raised during his evidence.
NHS Digital informed the Coroner in its PFD submissions, dated 17 January 2020, that the review had been completed and an amended version of the Distance Learning Pack had been produced and released to all organisations that use NHS Pathways to support telephone triage. The amendments were made in liaison with the expert witness. In summary the following changes have been made:
a) Anaphylaxis is now described as “a potentially life-threatening sudden, very severe
allergic reaction requiring urgent intervention”. b) A further section has been added in respect of AAIs which states “A person with anaphylaxis needs emergency treatment with an injection of intramuscular adrenaline and people who have previously had a serious allergic reaction often have an adrenaline autoinjector (AAI) for use in case of future reactions. The AAI should be used as soon as signs of anaphylaxis appear. Further doses are needed at 5-minute intervals if there is no clear sign of recovery.” c) Pictures of the Emerade, Jext, and Epipen AAI have been included. Information about the specific dose required in respect of each AAI has not been included. This is because the appropriate dose is a matter for the prescriber, not the call handler issuing system- generated instructions on how to administer the medication.
4) Matter of concern 18 I am unclear as to whether the Adastra 111 algorithm automatically prompts administering a second AAI Five minutes after the first if there has been no improvement, but it should. NHS Pathways has always prompted call handlers to give instructions in respect of a second administration of AAI if there is no improvement, as NHS Digital stated in the PFD submissions, dated 17 January 2020. This is NHS Pathways content and is not affected by the system into which NHS Pathways is embedded (e.g. Adastra in this case).
Currently, NHS Pathways content suggests that a second AAI is administered after 10 to 15 minutes if there has been no improvement in the patient’s condition. NHS Digital has reviewed this timeframe and it is being amended to 5 minutes in line with guidelines from the Resuscitation Council. These changes will be made in NHS Pathways Release 20, which was originally scheduled for deployment in May 2020, but has subsequently been delayed due to coronavirus.
5) Matter of concern 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.
For accuracy the Prevention of Future Death Report that the Coroner refers to was that for Mrs Susan Longden and not Mr David Longden.
Speaking to the Patient
In NHS Digital’s supplementary second witness statement, dated 20th December 2019, the following was addressed:
• The importance of call handlers speaking to the patient where safe and appropriate is a fundamental principle and core competency for NHS Pathways use. This is emphasised through initial training, call critiques, supervised practice, use of toolkits and completion of written and practical assessments.
• Speaking with the patient is also a competency indicator assessed during auditing of new and experienced call handlers.
• NHS Digital was not made aware of the inquest touching the death of Ms Susan Longden in advance and therefore was unable to assist Dr Harrowing in his inquiry. NHS Digital’s response to Dr Harrowing explained (as in the above bullets) the emphasis placed on the importance of speaking to a patient.
• NHS Digital consider that the NHS Pathways training materials and licence requirements sufficiently address the need and importance of call handlers speaking directly to patients and recognise that 111 and 999 providers should continue to enforce this with call handlers.
• In version 19.3.0 of NHS Pathways, which was released to 111 and 999 on the 13th January 2020, the following changes were made to the NHS Pathways content to further enhance and support call handlers in attempting to speak to the patient:
a) “Inclusion of a new question for calls received from 3rd party callers asking, “Is it possible for me to speak to them?”, which will follow establishing that the patient is conscious and breathing. This will force call handlers to ask this; and b) in questions asking, “[is the patient] so breathless that speaking more than a few words is impossible?” addition of a statement on the supporting information to remind call handlers to again try to speak with the patient, even if the 3rd party caller has refused in response to the question above. The supporting information now states (new language in capitals) “To find out if there are features of life-threatening breathing difficulty. THIS WILL BE EASIER TO ASSESS BY SPEAKING TO THE PATIENT.”
Appendix A BACKGROUND INFORMATION Function of NHS Pathways NHS Pathways is a programme providing the Clinical Decision Support System (CDSS) used in NHS 111 and half of English ambulance services. This triage system supports the remote assessment of over 16.7 million calls per annum. These calls are managed by non-clinical specially trained call handlers who refer the patient into suitable services based on the patient’s health needs at the time of the call. These call handlers are supported by clinicians who are able to provide advice and guidance or who can take over the call if the situation requires it. The system is built around a clinical hierarchy, meaning that life- threatening problems assessed at the start of the call trigger ambulance responses, progressing through to less urgent problems which require a less urgent response (or “ disposition”) in other settings. Governance of NHS Pathways The safety of the clinical triage process endpoints resulting from a 111 or 999 assessment using NHS Pathways, is overseen by the National Clinical Governance Group, hosted by the Royal College of General Practitioners. This group is made up of representatives from the relevant Medical Royal Colleges. Senior clinicians from the Colleges provide independent oversight and scrutiny of the NHS Pathways clinical content. Changes to the NHS Pathways clinical content cannot be made unless there is a majority agreement at NGCC. Alongside this independent oversight, NHS Pathways ensures its clinical content and assessment protocols are concordant with the latest advice from respected bodies that provide evidence and guidance for medical practice in the UK. In particular, we are concordant with the latest guidelines from:
• NICE (National Institute for Health and Clinical Excellence)
• The UK Resuscitation Council
• The UK Sepsis Trust
1 Trevelyan Square Boar Lane Leeds LS1 6AE 0300 303 5678 0113 397 3614
1) Matter of Concern 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.
NHS Digital has developed an extensive audit framework that applies to providers using NHS Pathways. This was described in NHS Digital’s: supplementary second witness statement dated 20th December 2019; submissions on conclusion dated 3 January 2020; and PFD submissions dated 17 January 2020.
Clinical providers of services using NHS Pathways (‘providers’) must enter into a Licence Agreement with the Secretary of State for Health and Social Care, including requirements relating to implementation, operation, training and auditing. This licence and the supporting materials are managed by NHS Digital.
The detailed requirements for auditing call handlers (including clinicians) establish audit frequencies, and standards against which audits should occur. These include criteria for auditing and requirements by way of qualification and training of those carrying out any audit. NHS Digital also offers regular ‘audit levelling’ sessions to providers in order to achieve good and consistent practice.
Ensuring the proper operation of the audit system and management of failed call audits is the responsibility of the provider, within the framework provided by NHS Digital. NHS Digital remains available to support providers in this area.
2) Matter of Concern 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.
Ambulance response categorisation, and the alignment of different triage systems, is not the responsibility of NHS Digital. This was set out in the following submissions made on behalf of NHS Digital:
• letter to HM Coroner dated 22 July 2019
• letter to HM Coroner dated 9 October 2019
• witness statement dated 14 November 2019
• evidence given at inquest on 12 December 2019
• submissions on conclusion dated 3 January 2020
• PFD submissions dated 17 January 2020.
NHS Pathways and the Medical Priority Dispatch System (MPDS) – (the system used by ambulance trusts not using NHS Pathways) operate by prioritising patients based on symptoms. Although they work differently, neither is designed to make a diagnosis. NHS Digital does not have oversight or detailed knowledge of MPDS; it is a competing system provided by a commercial supplier.
The categorisation of certain symptoms, which may occur in anaphylaxis, as requiring a category 2 emergency ambulance within NHS Pathways was ratified in 2017 during NHS England’s review of ambulance standards called the “Ambulance Response Program”. This program was implemented from 2nd October 2017, and was approved by the Secretary of State following extensive piloting.
NHS Pathways’ ambulance response codes are also ratified by the National Ambulance Services Medical Directors (NASMED) (an advisory group consisting of medical director representatives from all ambulance services in England, Wales, Scotland and Northern Ireland) and the Emergency Call Prioritisation Advisory Group (ECPAG) (a further group of advisors to NHS England).
Following the Ambulance Response Program, NHS England led (supported by NASMED and ECPAG) a “clinical coding review” in May 2019, reviewing the category 1 ambulance response definition. Consequently, it was decided that symptoms which may suggest life-threatening anaphylaxis should receive a category 1 ambulance response and the necessary changes were made by NHS Pathways. These were beta tested in September 2019 and deployed nationally from October 2019.
The Ambulance Response Program and clinical coding review applied equally to MPDS, whose ambulance dispositions were similarly reviewed and ratified.
Where an ambulance disposition is triggered by a 111 call, the NHS Pathways system is able to trigger ambulance dispatch (subject to local validation procedures which may be applied to category 3 and 4 ambulances). It would not be clinically safe to require re-triage or validation for category 1 and 2 ambulances due to the additional time this would take. As described in NHS Digital’s submissions the 111 and 999 questions and responses are identical where NHS Pathways is used (other than an additional first ‘nature of call’ question for 999). MPDS is an entirely different product with different operating rationale but with ambulance codes still
ratified in the same manner. The 999 service is not designed or intended to be a ‘safety net’ for 111.
NHS Digital contributes to ECPAG and will continue to support NHS England as far as it is able with the complex challenge of aligning the two very different systems. There is no evidence to suggest that prior to this incident, NHS Digital, through LCW or any other user of NHS Pathways, had been made aware of any issue or concern in respect of the ambulance response category for symptoms that may occur in anaphylaxis. If NHS Digital became aware of such an issue then its response would include raising this with NHS England, NASMED and ECPAG.
NHS England is the organisation charged with overseeing both NHS Pathways and MPDS, and has the remit and ability to review potential inconsistencies or change ambulance categorisation. Accordingly, concerns regarding ambulance categorisation or inconsistencies between MPDS and NHS Pathways can only be properly answered by NHS England.
3) Matter of Concern 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, whichever device it is administered, is very unlikely to be sufficient in the case of acute anaphylaxis. It contains a photograph to illustrate he use of an AAI, but in the photograph the device is held incorrectly.
As NHS Digital described in evidence and subsequent submissions, the distance learning pack is provided as a foundation of background information to all call handlers before they start training. It does not direct the progress of specific calls nor is it relied upon to communicate advice which a call handler should give. It would not be clinically safe or appropriate for non-clinical call handlers to be required to exercise knowledge or judgment, or act unprompted by the system, in this way. Call handlers are instead supported by the questions and care advice presented by the NHS Pathways system. The system contains ‘supporting information’ to help call handlers understand the clinical essence of what is being asked or advised. This is presented in ‘real-time’ so that the call handler has the required information in front of them, rather than having to rely on memory.
NHS Digital welcomed the evidence given by the expert witness, Professor Fox, at the inquest and immediately recognised that the distance learning pack could be improved, assuring the Coroner (in evidence and in the supplementary second witness statement dated 20th December
2019) that a review would be undertaken, in consultation with Professor Fox, to address the points raised during his evidence.
NHS Digital informed the Coroner in its PFD submissions, dated 17 January 2020, that the review had been completed and an amended version of the Distance Learning Pack had been produced and released to all organisations that use NHS Pathways to support telephone triage. The amendments were made in liaison with the expert witness. In summary the following changes have been made:
a) Anaphylaxis is now described as “a potentially life-threatening sudden, very severe
allergic reaction requiring urgent intervention”. b) A further section has been added in respect of AAIs which states “A person with anaphylaxis needs emergency treatment with an injection of intramuscular adrenaline and people who have previously had a serious allergic reaction often have an adrenaline autoinjector (AAI) for use in case of future reactions. The AAI should be used as soon as signs of anaphylaxis appear. Further doses are needed at 5-minute intervals if there is no clear sign of recovery.” c) Pictures of the Emerade, Jext, and Epipen AAI have been included. Information about the specific dose required in respect of each AAI has not been included. This is because the appropriate dose is a matter for the prescriber, not the call handler issuing system- generated instructions on how to administer the medication.
4) Matter of concern 18 I am unclear as to whether the Adastra 111 algorithm automatically prompts administering a second AAI Five minutes after the first if there has been no improvement, but it should. NHS Pathways has always prompted call handlers to give instructions in respect of a second administration of AAI if there is no improvement, as NHS Digital stated in the PFD submissions, dated 17 January 2020. This is NHS Pathways content and is not affected by the system into which NHS Pathways is embedded (e.g. Adastra in this case).
Currently, NHS Pathways content suggests that a second AAI is administered after 10 to 15 minutes if there has been no improvement in the patient’s condition. NHS Digital has reviewed this timeframe and it is being amended to 5 minutes in line with guidelines from the Resuscitation Council. These changes will be made in NHS Pathways Release 20, which was originally scheduled for deployment in May 2020, but has subsequently been delayed due to coronavirus.
5) Matter of concern 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.
For accuracy the Prevention of Future Death Report that the Coroner refers to was that for Mrs Susan Longden and not Mr David Longden.
Speaking to the Patient
In NHS Digital’s supplementary second witness statement, dated 20th December 2019, the following was addressed:
• The importance of call handlers speaking to the patient where safe and appropriate is a fundamental principle and core competency for NHS Pathways use. This is emphasised through initial training, call critiques, supervised practice, use of toolkits and completion of written and practical assessments.
• Speaking with the patient is also a competency indicator assessed during auditing of new and experienced call handlers.
• NHS Digital was not made aware of the inquest touching the death of Ms Susan Longden in advance and therefore was unable to assist Dr Harrowing in his inquiry. NHS Digital’s response to Dr Harrowing explained (as in the above bullets) the emphasis placed on the importance of speaking to a patient.
• NHS Digital consider that the NHS Pathways training materials and licence requirements sufficiently address the need and importance of call handlers speaking directly to patients and recognise that 111 and 999 providers should continue to enforce this with call handlers.
• In version 19.3.0 of NHS Pathways, which was released to 111 and 999 on the 13th January 2020, the following changes were made to the NHS Pathways content to further enhance and support call handlers in attempting to speak to the patient:
a) “Inclusion of a new question for calls received from 3rd party callers asking, “Is it possible for me to speak to them?”, which will follow establishing that the patient is conscious and breathing. This will force call handlers to ask this; and b) in questions asking, “[is the patient] so breathless that speaking more than a few words is impossible?” addition of a statement on the supporting information to remind call handlers to again try to speak with the patient, even if the 3rd party caller has refused in response to the question above. The supporting information now states (new language in capitals) “To find out if there are features of life-threatening breathing difficulty. THIS WILL BE EASIER TO ASSESS BY SPEAKING TO THE PATIENT.”
Appendix A BACKGROUND INFORMATION Function of NHS Pathways NHS Pathways is a programme providing the Clinical Decision Support System (CDSS) used in NHS 111 and half of English ambulance services. This triage system supports the remote assessment of over 16.7 million calls per annum. These calls are managed by non-clinical specially trained call handlers who refer the patient into suitable services based on the patient’s health needs at the time of the call. These call handlers are supported by clinicians who are able to provide advice and guidance or who can take over the call if the situation requires it. The system is built around a clinical hierarchy, meaning that life- threatening problems assessed at the start of the call trigger ambulance responses, progressing through to less urgent problems which require a less urgent response (or “ disposition”) in other settings. Governance of NHS Pathways The safety of the clinical triage process endpoints resulting from a 111 or 999 assessment using NHS Pathways, is overseen by the National Clinical Governance Group, hosted by the Royal College of General Practitioners. This group is made up of representatives from the relevant Medical Royal Colleges. Senior clinicians from the Colleges provide independent oversight and scrutiny of the NHS Pathways clinical content. Changes to the NHS Pathways clinical content cannot be made unless there is a majority agreement at NGCC. Alongside this independent oversight, NHS Pathways ensures its clinical content and assessment protocols are concordant with the latest advice from respected bodies that provide evidence and guidance for medical practice in the UK. In particular, we are concordant with the latest guidelines from:
• NICE (National Institute for Health and Clinical Excellence)
• The UK Resuscitation Council
• The UK Sepsis Trust
Action Taken
The Winchmore Hill Practice undertook an audit of patients prescribed Emerade to ensure dosage was in accordance with the BNF, reviewed AAI pen doses, and contacted patients with up-to-date advice from the MHRA. The practice has shared learning with the CCG medicine management team and amended the message on scriptswitch; any proposed changes to be made by CCG Pharmacist, will need to be approved by a Senior doctor at the practice. (AI summary)
The Winchmore Hill Practice undertook an audit of patients prescribed Emerade to ensure dosage was in accordance with the BNF, reviewed AAI pen doses, and contacted patients with up-to-date advice from the MHRA. The practice has shared learning with the CCG medicine management team and amended the message on scriptswitch; any proposed changes to be made by CCG Pharmacist, will need to be approved by a Senior doctor at the practice. (AI summary)
View full response
Dear Madam Inquest Touching the death of Ms Shante Turay-Thomas Response to Regulation 28 report We continue to be instructed to act on behalf of the three G.Ps that were interested persons in the above matter. We are writing in response to the Learned Coroner’s Prevention of Future Deaths Report dated 27 January 2020, issued pursuant to Regulation 28 of the Coroner’s (Investigations) Regulations 2013. We note the matters of concern that the Coroner has identified. As the Coroner is aware, we set out the action that has been taken by the Winchmore Hill Practice (“the Practice”) and that proposed, within the witness statements of the GPs (particularly the supplementary statement of Dr Takla) and the PFD submissions (enclosed.) We summarise these below and also set out the additional steps that have and will be taken in response to this matter as follows:
1. Following Ms Turay-Thomas’ death, the Practice undertook an audit in October 2019 of all patients who were being prescribed Emerade to ensure that the dosage was in accordance with the BNF based on the respective patients’ weight and age. Indeed, all patients who use AAI pens have had their doses reviewed. Patients have been contacted to ensure that they have the correct dose and appropriate knowledge about the use and storage of the pen. Letters were sent to patients on Emerade, which included up to date advice from the MHRA in July 2019, December 2019 and March 2020. In respect of patients taking Jext and Epipen, letters were sent to them in January 2020.
2. All prescriptions for AAIs are now dealt with as acute prescriptions, as opposed to repeat prescriptions. This ensures that each prescription is scrutinised in detail to ensure that the type of pen and dose of adrenalin is appropriate for the patient. On the face of any AAI prescription, it is expressly stated for the avoidance of any doubt that a patient should carry two AAI pens on their person at all times and ensure that they are familiar with the use of the pen. There is also some safety netting advice in the event of an emergency. We have enclosed a sample prescription to illustrate this change. In addition, each prescription is accompanied by an AAI brand specific letter to the patient providing the most important details about the AAI pens to enable a patient to use it safely and effectively. We have also enclosed a copy of a standard letter in this regard.
Mrs Mary Hassell 16 March 2020 Page 2
3. The Practice has taken significant steps to ensure that it is up to date with anaphylaxis management and the use of AAI pens. It arranged in-house training for all clinical staff on 9 December 2019, which was delivered by a Nurse, This training included demonstrations as to how to use the three most common AAI pens, namely Emerade, JEXT and EpiPen, advice as to the different dosages available, instructions and demonstrations as to the different methods of administration for each brand. This was all based on the respective brands’ advice/instruction on their own explanatory posters and the demonstrations were done by Nurse She has since confirmed that she has also seen a few patients who have attended the Practice to obtain some training on the use of their AAI. Following this training, the Practice has ensured that there are sample pens for all three brands available to the Practice nurses in order so that they are able to demonstrate to any patient who has been prescribed an AAI pen for the first time or those that are unsure as to how to use the pens the correct method of administration. The Practice actively encourages all patients who are prescribed AAIs to arrange an appointment with the practice nurse or pharmacist in order to obtain proper training in the use of the pen.
4. In addition to the in-house training, mandatory basic life support training was held at the Practice on 27 February 2020. This was delivered by an external provider, Mr of
and Associates Healthcare Training and Education. The basic life support training always includes a segment on anaphylaxis management. However, the Practice contacted the training provider prior to the course in order to emphasise that a more extensive section was required on anaphylaxis management. We enclose a copy of the e-mail in this regard. The basic life support training lasted two and a half hours in duration. It included a 40 minute section on anaphylaxis management which encompassed recognising symptoms, the imperative of carrying two pens at all times and the different administration of the three types of pens available.
5. The Practice has received a number of alerts from the MHRA explaining defects pertaining to the Emerade AAIs. All relevant information has been disseminated to patients who have been prescribed Emerade. The Practice recently received a further alert from the MHRA confirming that all Emerade 150mcg AAIs are to be recalled as a result of the potential for the pen to malfunction. The Practice has ensured that all patients who were prescribed Emerade 150mcg have been switched to an alternative brand. Patients were sent letters with an alternative script on 9 March 2020.
6. It was recognised by the Practice that some patients will not be inclined to attend the Practice in order to obtain advice and training in the use of an AAI pen. To mitigate this, links to training videos and the relevant websites have been included within the letters to patients to encourage them to check that they are familiar with AAI self-administration and advice. Furthermore, all clinical staff at the Practice have been instructed to ensure that any patient who attends (regardless of the purpose of their attendance) and who is being prescribed adrenalin has their AAI prescription as well as their understanding in relation to the use of the pen reviewed. This includes checking whether the patient is receiving appropriate care and support from secondary care.
7. In addition, whenever a patient who has an allergy turns eighteen, the Practice will ensure that as part of any medication review, a check is undertaken as to whether the patient is appropriately transitioned into the care of adult allergy specialists if this is deemed necessary. This will guard
Mrs Mary Hassell 16 March 2020 Page 3
against the possibility that a patient is left without specialist allergy care, which is crucial to safeguarding their health and well-being.
8. The Practice recruited an in-house pharmacist who commenced work in December 2020. This appointment will prove conducive in ensuring that both patients and clinicians have up to date information in relation to AAI awareness. The pharmacist is also on hand to provide training to any patients in relation to the correct use of an AAI. There is accordingly now two layers of protection in that guidance is offered to a patient when prescribing the AAI as well as when dispensing it.
9. The Practice has undertaken a rigorous review of all patients that have been prescribed AAI pens so as to ensure that the correct dose and pen is being prescribed. The Practice has nominated one of the Pharmacists to act as the ‘Practice Anaphylaxis Champion.’ This role will include ensuring staff awareness, training and regular surveillance of appropriate prescribing practices and adherence to practice protocols. The Pharmacist will also contact all patients prescribed AAIs to undertake regular reviews of their condition, treatment and training.
10. The Practice has cascaded the learning from this matter to other practices within the Primary Care Network. The AAI policy together with patient information leaflets and messages on prescriptions have been shared.
11. The Practice has shared learning with the CCG medicine management team and the message on scriptswitch has been amended as follows: All strengths of Emerade devices will be unavailable for the foreseeable future. Review patient to ensure Adrenaline auto-injector (AAI) appropriate according to current guidelines Alternative brand of AAI must be prescribed (Epipen or Jext) Dose should be checked to ensure it is appropriate for the patient especially in children as they age and increase in weight, or for patients whose condition changes. Patients should be given robust training about carrying two AAI pens with them at all times, and administering the second dose 5-15 minutes after the first if their condition does not improve. (Document in patient notes that this advice has been given). Patient (or representative where appropriate) must be counselled on change of device and trained on how to use the new device. For children - ensure an allergy action plan is in place and to ensure patient/carer can follow: https://www.bsaci.org/about/download-paediatric-allergy-action-plans Any proposed changes to be made by CCG Pharmacist, will need to be approved by a Senior doctor at the practice.
Mrs Mary Hassell 16 March 2020 Page 4
The Practice has also continued to liaise closely with the CQC and has co-operate fully with its investigation. The Practice will also provide the CQC with a copy of this response. The Practice is firmly of the view that the actions undertaken thus far and those proposed moving forward will serve to minimise the likelihood of any similar unfortunate incidents occurring in the future and will also enable them to provide an enhanced service to any patients requiring anaphylaxis management. There have been valuable lessons learned from the tragic death of Ms Turay-Thomas. Please do not hesitate to contact us if you have any queries.
1. Following Ms Turay-Thomas’ death, the Practice undertook an audit in October 2019 of all patients who were being prescribed Emerade to ensure that the dosage was in accordance with the BNF based on the respective patients’ weight and age. Indeed, all patients who use AAI pens have had their doses reviewed. Patients have been contacted to ensure that they have the correct dose and appropriate knowledge about the use and storage of the pen. Letters were sent to patients on Emerade, which included up to date advice from the MHRA in July 2019, December 2019 and March 2020. In respect of patients taking Jext and Epipen, letters were sent to them in January 2020.
2. All prescriptions for AAIs are now dealt with as acute prescriptions, as opposed to repeat prescriptions. This ensures that each prescription is scrutinised in detail to ensure that the type of pen and dose of adrenalin is appropriate for the patient. On the face of any AAI prescription, it is expressly stated for the avoidance of any doubt that a patient should carry two AAI pens on their person at all times and ensure that they are familiar with the use of the pen. There is also some safety netting advice in the event of an emergency. We have enclosed a sample prescription to illustrate this change. In addition, each prescription is accompanied by an AAI brand specific letter to the patient providing the most important details about the AAI pens to enable a patient to use it safely and effectively. We have also enclosed a copy of a standard letter in this regard.
Mrs Mary Hassell 16 March 2020 Page 2
3. The Practice has taken significant steps to ensure that it is up to date with anaphylaxis management and the use of AAI pens. It arranged in-house training for all clinical staff on 9 December 2019, which was delivered by a Nurse, This training included demonstrations as to how to use the three most common AAI pens, namely Emerade, JEXT and EpiPen, advice as to the different dosages available, instructions and demonstrations as to the different methods of administration for each brand. This was all based on the respective brands’ advice/instruction on their own explanatory posters and the demonstrations were done by Nurse She has since confirmed that she has also seen a few patients who have attended the Practice to obtain some training on the use of their AAI. Following this training, the Practice has ensured that there are sample pens for all three brands available to the Practice nurses in order so that they are able to demonstrate to any patient who has been prescribed an AAI pen for the first time or those that are unsure as to how to use the pens the correct method of administration. The Practice actively encourages all patients who are prescribed AAIs to arrange an appointment with the practice nurse or pharmacist in order to obtain proper training in the use of the pen.
4. In addition to the in-house training, mandatory basic life support training was held at the Practice on 27 February 2020. This was delivered by an external provider, Mr of
and Associates Healthcare Training and Education. The basic life support training always includes a segment on anaphylaxis management. However, the Practice contacted the training provider prior to the course in order to emphasise that a more extensive section was required on anaphylaxis management. We enclose a copy of the e-mail in this regard. The basic life support training lasted two and a half hours in duration. It included a 40 minute section on anaphylaxis management which encompassed recognising symptoms, the imperative of carrying two pens at all times and the different administration of the three types of pens available.
5. The Practice has received a number of alerts from the MHRA explaining defects pertaining to the Emerade AAIs. All relevant information has been disseminated to patients who have been prescribed Emerade. The Practice recently received a further alert from the MHRA confirming that all Emerade 150mcg AAIs are to be recalled as a result of the potential for the pen to malfunction. The Practice has ensured that all patients who were prescribed Emerade 150mcg have been switched to an alternative brand. Patients were sent letters with an alternative script on 9 March 2020.
6. It was recognised by the Practice that some patients will not be inclined to attend the Practice in order to obtain advice and training in the use of an AAI pen. To mitigate this, links to training videos and the relevant websites have been included within the letters to patients to encourage them to check that they are familiar with AAI self-administration and advice. Furthermore, all clinical staff at the Practice have been instructed to ensure that any patient who attends (regardless of the purpose of their attendance) and who is being prescribed adrenalin has their AAI prescription as well as their understanding in relation to the use of the pen reviewed. This includes checking whether the patient is receiving appropriate care and support from secondary care.
7. In addition, whenever a patient who has an allergy turns eighteen, the Practice will ensure that as part of any medication review, a check is undertaken as to whether the patient is appropriately transitioned into the care of adult allergy specialists if this is deemed necessary. This will guard
Mrs Mary Hassell 16 March 2020 Page 3
against the possibility that a patient is left without specialist allergy care, which is crucial to safeguarding their health and well-being.
8. The Practice recruited an in-house pharmacist who commenced work in December 2020. This appointment will prove conducive in ensuring that both patients and clinicians have up to date information in relation to AAI awareness. The pharmacist is also on hand to provide training to any patients in relation to the correct use of an AAI. There is accordingly now two layers of protection in that guidance is offered to a patient when prescribing the AAI as well as when dispensing it.
9. The Practice has undertaken a rigorous review of all patients that have been prescribed AAI pens so as to ensure that the correct dose and pen is being prescribed. The Practice has nominated one of the Pharmacists to act as the ‘Practice Anaphylaxis Champion.’ This role will include ensuring staff awareness, training and regular surveillance of appropriate prescribing practices and adherence to practice protocols. The Pharmacist will also contact all patients prescribed AAIs to undertake regular reviews of their condition, treatment and training.
10. The Practice has cascaded the learning from this matter to other practices within the Primary Care Network. The AAI policy together with patient information leaflets and messages on prescriptions have been shared.
11. The Practice has shared learning with the CCG medicine management team and the message on scriptswitch has been amended as follows: All strengths of Emerade devices will be unavailable for the foreseeable future. Review patient to ensure Adrenaline auto-injector (AAI) appropriate according to current guidelines Alternative brand of AAI must be prescribed (Epipen or Jext) Dose should be checked to ensure it is appropriate for the patient especially in children as they age and increase in weight, or for patients whose condition changes. Patients should be given robust training about carrying two AAI pens with them at all times, and administering the second dose 5-15 minutes after the first if their condition does not improve. (Document in patient notes that this advice has been given). Patient (or representative where appropriate) must be counselled on change of device and trained on how to use the new device. For children - ensure an allergy action plan is in place and to ensure patient/carer can follow: https://www.bsaci.org/about/download-paediatric-allergy-action-plans Any proposed changes to be made by CCG Pharmacist, will need to be approved by a Senior doctor at the practice.
Mrs Mary Hassell 16 March 2020 Page 4
The Practice has also continued to liaise closely with the CQC and has co-operate fully with its investigation. The Practice will also provide the CQC with a copy of this response. The Practice is firmly of the view that the actions undertaken thus far and those proposed moving forward will serve to minimise the likelihood of any similar unfortunate incidents occurring in the future and will also enable them to provide an enhanced service to any patients requiring anaphylaxis management. There have been valuable lessons learned from the tragic death of Ms Turay-Thomas. Please do not hesitate to contact us if you have any queries.
Noted
LAS clarifies the division of responsibilities for triage systems, stating that ECPAG and NHS Digital are responsible for setting categories and addressing inconsistencies between systems. LAS will discuss the PFD report at relevant user groups. (AI summary)
LAS clarifies the division of responsibilities for triage systems, stating that ECPAG and NHS Digital are responsible for setting categories and addressing inconsistencies between systems. LAS will discuss the PFD report at relevant user groups. (AI summary)
View full response
Dear Ms Hassell Regulation 28: Prevention of Future Deaths Report for Shante Andree Marie Turay- Thomas Thank you for your Regulation 28 Prevention of Future Deaths Report ("PFD") dated 27 January
2020. I would like to take this opportunity at the outset of my letter to offer my condolences to Ms Turay-Thomas's family. Following the conclusion of the above inquest, the London Ambulance Service ("LAS") understands that the learned Coroner has raised a query as to whether the LAS would be able to assist in relation to the latter two sub-paragraphs (3 and 4) of paragraph 16 of the PFD report. Those paragraphs provide as follows: "I heard at this inquest that NHS Digital has since changed its categorisation [of calls relating to acute anaphylaxis]. 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 seryice 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". The learned Coroner is correct that, as per the evidence of the LAS as given in this inquest, in parts of the United Kingdom different triage systems are in use by the 999 and 111 services. NHS 111 only use NHS Pathways (owned and designed by NHS Digital) whereas UK Ambulance Trusts can use either NHS Pathways or MPDS (owned and designed by Priority Dispatch Corp. ("PDC")). Had the LAS triaged the call made by-through its 999 system, as the LAS stated in their evidence, it would have been~ the MPDS algorithms in use by the LAS. 1
The LAS use the MPDS algorithm and supporting software on licence from PDC. We refer the learned Coroner to Appendix 2 attached to these for further details of the MPDS algorithm itself and its operation. The Response Priority for each MPDS determinant descriptor - being the Category of ambulance it requires - is set by ECPAG. This is because final decisions about categorisation are made by ECPAG on behalf of NHS England. It is, therefore, this organisation (if any) who has the power to take the action the learned Coroner is seeking at sub-paragraph 3 above and, where possible, would be capable of identifying any inconsistencies between the categories of ambulance assigned to dispositions within the NHS Digital system on the one hand and PDC on the other, in relation to acute anaphylaxis and otherwise. The LAS, as an MPDS user for its 999 services and an NHS Pathways user for its 111 services, attend the relevant user groups with other ambulance trusts and fully participate in such meetings, where there is the opportunity to share data back and forth, discuss cases of note and share learning in order to make continual improvements through the feedback mechanisms to NHS Digital and the Academy at PDC process. The LAS will discuss the findings of PFD report at such user groups. Ultimately, however, changes to how the triage system operates are a matter for the International Academies of Emergency Dispatch (IAED) where MPDS (owned by PDC) is concerned, or for NHS Digital under their national clinical governance group where NHS Pathways is concerned. From the LAS's understanding however, there are limitations to ECPAG's ability to align the two systems - NHS Pathways and MPDS - as they operate differently and have two different methodologies for reaching a triage decision. In order to assist the learned Coroner, as indicated, the LAS attaches as Appendix 2- a detailed summary from the LAS formally setting out how it is UK Ambulance Services manage 999 calls and the national system for prioritisation of those calls. I hope this reply is helpful in explaining the actions undertaken by the LAS.
2020. I would like to take this opportunity at the outset of my letter to offer my condolences to Ms Turay-Thomas's family. Following the conclusion of the above inquest, the London Ambulance Service ("LAS") understands that the learned Coroner has raised a query as to whether the LAS would be able to assist in relation to the latter two sub-paragraphs (3 and 4) of paragraph 16 of the PFD report. Those paragraphs provide as follows: "I heard at this inquest that NHS Digital has since changed its categorisation [of calls relating to acute anaphylaxis]. 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 seryice 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". The learned Coroner is correct that, as per the evidence of the LAS as given in this inquest, in parts of the United Kingdom different triage systems are in use by the 999 and 111 services. NHS 111 only use NHS Pathways (owned and designed by NHS Digital) whereas UK Ambulance Trusts can use either NHS Pathways or MPDS (owned and designed by Priority Dispatch Corp. ("PDC")). Had the LAS triaged the call made by-through its 999 system, as the LAS stated in their evidence, it would have been~ the MPDS algorithms in use by the LAS. 1
The LAS use the MPDS algorithm and supporting software on licence from PDC. We refer the learned Coroner to Appendix 2 attached to these for further details of the MPDS algorithm itself and its operation. The Response Priority for each MPDS determinant descriptor - being the Category of ambulance it requires - is set by ECPAG. This is because final decisions about categorisation are made by ECPAG on behalf of NHS England. It is, therefore, this organisation (if any) who has the power to take the action the learned Coroner is seeking at sub-paragraph 3 above and, where possible, would be capable of identifying any inconsistencies between the categories of ambulance assigned to dispositions within the NHS Digital system on the one hand and PDC on the other, in relation to acute anaphylaxis and otherwise. The LAS, as an MPDS user for its 999 services and an NHS Pathways user for its 111 services, attend the relevant user groups with other ambulance trusts and fully participate in such meetings, where there is the opportunity to share data back and forth, discuss cases of note and share learning in order to make continual improvements through the feedback mechanisms to NHS Digital and the Academy at PDC process. The LAS will discuss the findings of PFD report at such user groups. Ultimately, however, changes to how the triage system operates are a matter for the International Academies of Emergency Dispatch (IAED) where MPDS (owned by PDC) is concerned, or for NHS Digital under their national clinical governance group where NHS Pathways is concerned. From the LAS's understanding however, there are limitations to ECPAG's ability to align the two systems - NHS Pathways and MPDS - as they operate differently and have two different methodologies for reaching a triage decision. In order to assist the learned Coroner, as indicated, the LAS attaches as Appendix 2- a detailed summary from the LAS formally setting out how it is UK Ambulance Services manage 999 calls and the national system for prioritisation of those calls. I hope this reply is helpful in explaining the actions undertaken by the LAS.
Action Planned
The Department of Health and Social Care notes several actions, including the FSA working to get emerging trend information and alert local authorities, and working to identify means of access to relevant datasets so they can be included for analysis of food-related cases of anaphylaxis. The Healthcare Safety Investigation Branch (HSIB) will consider the matters of concern in the report and whether these meet its criteria for national investigation when the situation allows. (AI summary)
The Department of Health and Social Care notes several actions, including the FSA working to get emerging trend information and alert local authorities, and working to identify means of access to relevant datasets so they can be included for analysis of food-related cases of anaphylaxis. The Healthcare Safety Investigation Branch (HSIB) will consider the matters of concern in the report and whether these meet its criteria for national investigation when the situation allows. (AI summary)
View full response
Dear Ms Hassell
Thank you for your correspondence of 27 January 2020 to Matt Hancock about the death of Shanté Turay-Thomas. I am replying as my Ministerial portfolio covers Long Term Conditions, including allergies and I am grateful for the additional time in which to respond.
I would like to start by saying how very sorry I was to read of the circumstances around the death of Shanté. Her loss, at such a young age, must be extremely distressing for her family and loved ones and I offer my heartfelt condolences to them. I agree that it is essential that we learn from this tragic event to prevent future deaths.
Your report raises several serious matters of concern and has been sent to a number of health-related organisations at local and national level that have a role to play to ensure the safety of people with allergies. My reply will focus on the response to your concerns by national level organisations. However, I want to make clear that the failings relating to primary care and urgent unscheduled care services in north London as described in your report are unacceptable. I expect the NHS to thoroughly review the circumstances of Shanté’s death and your findings and take robust action to put in place learnings to prevent such deaths from occurring again.
Departmental officials have made enquiries with the organisations to which you issued your report to understand the system-wide response to the matters of concern. I am assured that your concerns have been carefully considered. I will not repeat the detail of the responses you will receive which are the responsibility of others. However, I wish to highlight the actions being taken at a national level that are relevant to the concerns you have raised.
I welcome the action agreed by the Commission on Human Medicines (that provides expert, independent advice to the Medicines and Healthcare products Regulatory Agency (MHRA)) to convene an Expert Working Group (EWG) on Adrenaline Auto-Injectors (AAIs) that will provide independent clinical advice on matters relating to the safe and effective
use of AAIs, including several of the issues highlighted in your report such as AAI product labelling; training in the use of AAIs; and whether AAIs should be available to the market in dual packs as the norm.
In addition, the AAI EWG will help to inform a planned communication campaign being developed by the MHRA to raise awareness of the key messaging on the safe and effective use of AAIs. As you will know, the key messages are:
• The need for patients to carry two AAIs with them at all times; and,
• In cases of acute anaphylaxis, to administer a second AAI five to fifteen minutes after the first if there has been no sign of improvement.
It is vital that these messages are understood by patients, their carers’ and healthcare professionals to prevent future tragedies.
As to whether dual packs of AAIs should be available as the norm, I note that all AAI brands in the UK are authorised to supply AAIs in single or dual packs. Companies are not required to market all pack configurations and at present, only Epipen is available to the market as a dual pack. The MHRA intends to write to the manufacturers of Jext and Emerade to encourage the marketing of dual packs.
While the MHRA agrees that the availability of AAIs in packs of two would support the aim of ensuring that patients always have access to two AAIs, there are important considerations, such as the need for flexibility. The MHRA will seek the expert advice of the AAI EWG on this matter.
On the emergency response to cases of anaphylaxis, I am advised that a clinical coding review, conducted in May 2019, led by NHS England and NHS Improvement (NHSEI), concluded that symptoms suggesting life-threatening anaphylaxis should receive a Category 1 response. This change came into effect for NHS Pathways (used by NHS 111 providers and around half of ambulance trusts in England) in October 2019 and equally applied to the Medical Priority Dispatch System (MPDS) used by other ambulance trusts. I am advised that NHSEI has oversight of both the NHS Pathways and MPDS clinical decision support systems and the NHSEI-led Emergency Call Prioritisation Advisory Group provides governance and approval of any change to clinical code sets.
In relation to NHS Pathways specifically, I am advised that there are established governance systems in place to capture, review and resolve issues relating to clinical coding (including from Prevention of Future Deaths reports); and to ensure latest clinical advice and guidance is reflected in call categorisation. Independent clinical scrutiny of NHS Pathways is provided by a National Clinical Governance Group that includes representatives of medical Royal Colleges.
The commissioning and management of general allergy services is a local matter. For most patients (around 95 per cent) allergic diseases can be managed by primary or other non-specialist allergy services with routine therapies. Approximately five per cent of patients with allergies require treatment in a secondary service, and of those, around
20,000 (0.1 per cent) require referral to a specialist centre. These specialist services are commissioned at a national level by NHSEI to an agreed delivery specification.
The National Institute for Health and Care Excellence (NICE) develops evidence-based guidance to support clinicians in managing allergy and related disorders. Guidance is routinely subjected to an evidence surveillance exercise to establish whether an update is available. However, guidance will be reviewed and updated at any time if important new evidence comes to light.
NIICE has published clinical guidelines in this area covering food allergy in children and young people under 191; drug allergy2; anaphylaxis3; eczema4; and asthma5. In addition, NICE has produced a range of technology appraisals for drugs and interventions to relieve symptoms of these conditions as well as diagnostic assessment tools.
You will know from NICE’s response to your report that information is already contained in the British National Formulary (BNF) and the BNF for children (BNFc) that two AAIs should be prescribed; that patients should carry two AAIs at all times; and the importance of training in the use of the particular AAI prescribed. Prescribers are expected to be alert to safety information in relation to the medicines they prescribe and to refer to the BNF and BNFc when making prescribing decisions with their patients. NICE will consider how it can make more clear in its guideline on Anaphylaxis: assessment and referral after emergency treatment, the advice that two AAIs should be prescribed and that patients should carry two AAIs with them at all times.
In relation to the training of primary healthcare professionals in the management of allergies, curricula and training is available through the relevant professional bodies (such as Royal College of Physicians and Royal College of General Practitioners (RCGPs)) and organisations, such as the British Society for Allergy & Clinical Immunology (BSACI), that provide educational, training and research resources. I am advised that NHSEI has undertaken to bring the matters of concern in your report to the attention of Health Education England (HEE) and the RCGPs to consider what action might be taken to strengthen training in this area and where possible, NHSEI will help to facilitate the uptake of any new guidance or resource.
We recognise the key role played in the wider primary care workforce by dietitians, to whom people with a variety of nutritional issues, including food allergies and intolerances, can be referred.
Last year, a system of Primary Care Networks (PCNs), each formed from different GP practices working together, was established across England. They are designed to bridge the historic divide between primary and community health services and provide an
1 https://www.nice.org.uk/guidance/cg116
2 https://www.nice.org.uk/guidance/cg183
3 https://www.nice.org.uk/guidance/cg134
4 https://www.nice.org.uk/guidance/cg57
5 https://www.nice.org.uk/guidance/ng80
extended range of community-based services. PCNs are recruiting extra dietitians and other specialists, with funding being made available through an Additional Roles Reimbursement Scheme. The NHS Long Term Plan6, published last year, has guaranteed a minimum investment of £4.5billion extra per year for primary medical and community care by 2023/24. On top of this, an extra £1.5billion has been committed to general practice over the next four years for growing the workforce by 6,000 doctors and 26,000 other staff.
In relation to accountability for allergies, my Ministerial portfolio covers long term conditions, including allergies and the provision of allergy services. Ministers are held to account by Parliament and that accountability is supported by several directorates within the Department of Health and Social Care that have relevance to policy on allergens. This includes primary care; population health; oversight of the Food Standards Agency (FSA); environmental hazards and NHSEI sponsorship. Although there is no single, named individual with oversight of all aspects of allergy policy, individuals and teams work closely together in the Department on all aspects of policy relating to allergies.
Following the reforms initiated by the Health and Social Care Act 20127, NHSEI is responsible for clinical policy and strategy in the NHS in England (including for allergies) and NHSEI is held to account through the annual NHS mandate8. NHSEI has a clinical reference group (CRG) for Specialised Immunology and Allergy Services9, that provides advice on specialised services and commissioning policies and quality standards. The CRG is chaired by a consultant immunologist, specialising in clinical Immunology and allergy and expert clinicians are among the membership. I hope this provides assurance of the clinical leadership and policy oversight of allergy services.
Although not directly relevant to the matters of concern in your report, you may wish to note that as part of its food hypersensitivity strategy, the FSA, which is responsible for protecting the health of the public in relation to food, is exploring how it can build a better picture of allergic consumer experience. This includes exploring how to develop a reporting link that a range of stakeholders (e.g., consumers, businesses and potentially medical professionals) can use to facilitate the identification of emerging trends and where necessary, alert local authorities so that they can take appropriate investigative and enforcement action.
To support this project and increase the data available to the FSA on food-related cases of anaphylaxis, including deaths and near fatal incidents, the Department is working to identify means of access to relevant data sets so they can be included for analysis.
6 https://www.england.nhs.uk/long-term-plan/
7 http://www.legislation.gov.uk/ukpga/2012/7/contents/enacted
8
framework-to-nhse-and-nhsi-2019-to-2020.pdf
9 https://www.england.nhs.uk/commissioning/spec-services/npc-crg/blood-and-infection-group-f/f06/
Finally, I am aware that this is not the first time you have issued a Prevention of Future Deaths report following the inquest into the death of a child where there are concerns about the use of AAIs and the emergency response to cases of acute anaphylaxis.
I am assured that national health organisations are taking important action to ensure the safety and quality of health services related to allergies and my response has referred to some of that work. However, given the potential for systemic learning, Departmental officials have brought your concerns to the attention of the Healthcare Safety Investigation Branch (HSIB) that conducts independent investigations of patient safety concerns in NHS-funded care across England, to ask if it will consider the matters of concern in your report and whether these in part, or in whole, meet its criteria for national investigation. Due to the Covid-19 pandemic, HSIB’s consideration of this referral will be conducted when the situation allows.
I am grateful to you for bringing these matters to my attention. I hope this reply is helpful.
HELEN WHATELY
Thank you for your correspondence of 27 January 2020 to Matt Hancock about the death of Shanté Turay-Thomas. I am replying as my Ministerial portfolio covers Long Term Conditions, including allergies and I am grateful for the additional time in which to respond.
I would like to start by saying how very sorry I was to read of the circumstances around the death of Shanté. Her loss, at such a young age, must be extremely distressing for her family and loved ones and I offer my heartfelt condolences to them. I agree that it is essential that we learn from this tragic event to prevent future deaths.
Your report raises several serious matters of concern and has been sent to a number of health-related organisations at local and national level that have a role to play to ensure the safety of people with allergies. My reply will focus on the response to your concerns by national level organisations. However, I want to make clear that the failings relating to primary care and urgent unscheduled care services in north London as described in your report are unacceptable. I expect the NHS to thoroughly review the circumstances of Shanté’s death and your findings and take robust action to put in place learnings to prevent such deaths from occurring again.
Departmental officials have made enquiries with the organisations to which you issued your report to understand the system-wide response to the matters of concern. I am assured that your concerns have been carefully considered. I will not repeat the detail of the responses you will receive which are the responsibility of others. However, I wish to highlight the actions being taken at a national level that are relevant to the concerns you have raised.
I welcome the action agreed by the Commission on Human Medicines (that provides expert, independent advice to the Medicines and Healthcare products Regulatory Agency (MHRA)) to convene an Expert Working Group (EWG) on Adrenaline Auto-Injectors (AAIs) that will provide independent clinical advice on matters relating to the safe and effective
use of AAIs, including several of the issues highlighted in your report such as AAI product labelling; training in the use of AAIs; and whether AAIs should be available to the market in dual packs as the norm.
In addition, the AAI EWG will help to inform a planned communication campaign being developed by the MHRA to raise awareness of the key messaging on the safe and effective use of AAIs. As you will know, the key messages are:
• The need for patients to carry two AAIs with them at all times; and,
• In cases of acute anaphylaxis, to administer a second AAI five to fifteen minutes after the first if there has been no sign of improvement.
It is vital that these messages are understood by patients, their carers’ and healthcare professionals to prevent future tragedies.
As to whether dual packs of AAIs should be available as the norm, I note that all AAI brands in the UK are authorised to supply AAIs in single or dual packs. Companies are not required to market all pack configurations and at present, only Epipen is available to the market as a dual pack. The MHRA intends to write to the manufacturers of Jext and Emerade to encourage the marketing of dual packs.
While the MHRA agrees that the availability of AAIs in packs of two would support the aim of ensuring that patients always have access to two AAIs, there are important considerations, such as the need for flexibility. The MHRA will seek the expert advice of the AAI EWG on this matter.
On the emergency response to cases of anaphylaxis, I am advised that a clinical coding review, conducted in May 2019, led by NHS England and NHS Improvement (NHSEI), concluded that symptoms suggesting life-threatening anaphylaxis should receive a Category 1 response. This change came into effect for NHS Pathways (used by NHS 111 providers and around half of ambulance trusts in England) in October 2019 and equally applied to the Medical Priority Dispatch System (MPDS) used by other ambulance trusts. I am advised that NHSEI has oversight of both the NHS Pathways and MPDS clinical decision support systems and the NHSEI-led Emergency Call Prioritisation Advisory Group provides governance and approval of any change to clinical code sets.
In relation to NHS Pathways specifically, I am advised that there are established governance systems in place to capture, review and resolve issues relating to clinical coding (including from Prevention of Future Deaths reports); and to ensure latest clinical advice and guidance is reflected in call categorisation. Independent clinical scrutiny of NHS Pathways is provided by a National Clinical Governance Group that includes representatives of medical Royal Colleges.
The commissioning and management of general allergy services is a local matter. For most patients (around 95 per cent) allergic diseases can be managed by primary or other non-specialist allergy services with routine therapies. Approximately five per cent of patients with allergies require treatment in a secondary service, and of those, around
20,000 (0.1 per cent) require referral to a specialist centre. These specialist services are commissioned at a national level by NHSEI to an agreed delivery specification.
The National Institute for Health and Care Excellence (NICE) develops evidence-based guidance to support clinicians in managing allergy and related disorders. Guidance is routinely subjected to an evidence surveillance exercise to establish whether an update is available. However, guidance will be reviewed and updated at any time if important new evidence comes to light.
NIICE has published clinical guidelines in this area covering food allergy in children and young people under 191; drug allergy2; anaphylaxis3; eczema4; and asthma5. In addition, NICE has produced a range of technology appraisals for drugs and interventions to relieve symptoms of these conditions as well as diagnostic assessment tools.
You will know from NICE’s response to your report that information is already contained in the British National Formulary (BNF) and the BNF for children (BNFc) that two AAIs should be prescribed; that patients should carry two AAIs at all times; and the importance of training in the use of the particular AAI prescribed. Prescribers are expected to be alert to safety information in relation to the medicines they prescribe and to refer to the BNF and BNFc when making prescribing decisions with their patients. NICE will consider how it can make more clear in its guideline on Anaphylaxis: assessment and referral after emergency treatment, the advice that two AAIs should be prescribed and that patients should carry two AAIs with them at all times.
In relation to the training of primary healthcare professionals in the management of allergies, curricula and training is available through the relevant professional bodies (such as Royal College of Physicians and Royal College of General Practitioners (RCGPs)) and organisations, such as the British Society for Allergy & Clinical Immunology (BSACI), that provide educational, training and research resources. I am advised that NHSEI has undertaken to bring the matters of concern in your report to the attention of Health Education England (HEE) and the RCGPs to consider what action might be taken to strengthen training in this area and where possible, NHSEI will help to facilitate the uptake of any new guidance or resource.
We recognise the key role played in the wider primary care workforce by dietitians, to whom people with a variety of nutritional issues, including food allergies and intolerances, can be referred.
Last year, a system of Primary Care Networks (PCNs), each formed from different GP practices working together, was established across England. They are designed to bridge the historic divide between primary and community health services and provide an
1 https://www.nice.org.uk/guidance/cg116
2 https://www.nice.org.uk/guidance/cg183
3 https://www.nice.org.uk/guidance/cg134
4 https://www.nice.org.uk/guidance/cg57
5 https://www.nice.org.uk/guidance/ng80
extended range of community-based services. PCNs are recruiting extra dietitians and other specialists, with funding being made available through an Additional Roles Reimbursement Scheme. The NHS Long Term Plan6, published last year, has guaranteed a minimum investment of £4.5billion extra per year for primary medical and community care by 2023/24. On top of this, an extra £1.5billion has been committed to general practice over the next four years for growing the workforce by 6,000 doctors and 26,000 other staff.
In relation to accountability for allergies, my Ministerial portfolio covers long term conditions, including allergies and the provision of allergy services. Ministers are held to account by Parliament and that accountability is supported by several directorates within the Department of Health and Social Care that have relevance to policy on allergens. This includes primary care; population health; oversight of the Food Standards Agency (FSA); environmental hazards and NHSEI sponsorship. Although there is no single, named individual with oversight of all aspects of allergy policy, individuals and teams work closely together in the Department on all aspects of policy relating to allergies.
Following the reforms initiated by the Health and Social Care Act 20127, NHSEI is responsible for clinical policy and strategy in the NHS in England (including for allergies) and NHSEI is held to account through the annual NHS mandate8. NHSEI has a clinical reference group (CRG) for Specialised Immunology and Allergy Services9, that provides advice on specialised services and commissioning policies and quality standards. The CRG is chaired by a consultant immunologist, specialising in clinical Immunology and allergy and expert clinicians are among the membership. I hope this provides assurance of the clinical leadership and policy oversight of allergy services.
Although not directly relevant to the matters of concern in your report, you may wish to note that as part of its food hypersensitivity strategy, the FSA, which is responsible for protecting the health of the public in relation to food, is exploring how it can build a better picture of allergic consumer experience. This includes exploring how to develop a reporting link that a range of stakeholders (e.g., consumers, businesses and potentially medical professionals) can use to facilitate the identification of emerging trends and where necessary, alert local authorities so that they can take appropriate investigative and enforcement action.
To support this project and increase the data available to the FSA on food-related cases of anaphylaxis, including deaths and near fatal incidents, the Department is working to identify means of access to relevant data sets so they can be included for analysis.
6 https://www.england.nhs.uk/long-term-plan/
7 http://www.legislation.gov.uk/ukpga/2012/7/contents/enacted
8
framework-to-nhse-and-nhsi-2019-to-2020.pdf
9 https://www.england.nhs.uk/commissioning/spec-services/npc-crg/blood-and-infection-group-f/f06/
Finally, I am aware that this is not the first time you have issued a Prevention of Future Deaths report following the inquest into the death of a child where there are concerns about the use of AAIs and the emergency response to cases of acute anaphylaxis.
I am assured that national health organisations are taking important action to ensure the safety and quality of health services related to allergies and my response has referred to some of that work. However, given the potential for systemic learning, Departmental officials have brought your concerns to the attention of the Healthcare Safety Investigation Branch (HSIB) that conducts independent investigations of patient safety concerns in NHS-funded care across England, to ask if it will consider the matters of concern in your report and whether these in part, or in whole, meet its criteria for national investigation. Due to the Covid-19 pandemic, HSIB’s consideration of this referral will be conducted when the situation allows.
I am grateful to you for bringing these matters to my attention. I hope this reply is helpful.
HELEN WHATELY
Action Taken
Enfield CCG distributed a Medicines Safety Bulletin on Adrenaline Auto Injectors (AAIs) to GPs and other primary care healthcare professionals on 30th January 2020 and has contacted all GP practices. They are implementing a post-incident review and a report will be completed to ensure all actions identified are implemented to prevent a recurrence, including a review of governance processes and decision-making points. (AI summary)
Enfield CCG distributed a Medicines Safety Bulletin on Adrenaline Auto Injectors (AAIs) to GPs and other primary care healthcare professionals on 30th January 2020 and has contacted all GP practices. They are implementing a post-incident review and a report will be completed to ensure all actions identified are implemented to prevent a recurrence, including a review of governance processes and decision-making points. (AI summary)
View full response
Enfield CCG Medicines Management Team Action Update: Prevention of Future Death Notice - Shanté Andreé Marie TURAY-THOMAS
Prevention of Future Death Notice Matters of Concern
CCG Actions taken
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.
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).
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.
27th August 2015 - North Central London Joint Formulary Committee (NCL JFC) agreed to replace Epipen with Emerade on the joint formulary.
1. The narrative verdict was discussed at the NCL Medication Safety Officer (MSO) Local Network on 17th January 2020. The network agreed that a Medicines Safety Bulletin on Adrenaline Auto Injectors (AAIs) would be distributed to GPs and other primary care healthcare professionals. The NCL Medicines Safety Bulletin on Adrenaline Auto Injectors (AAI) dated 24th January 2020 is attached as appendix 1. The bulletin was approved virtually by NCL Medication Safety Officer (MSO) Local Network following the meeting on 17th January 2020 and distributed to Enfield GP practices on 30th January 2020.
The Prevention of Future Death notice will be discussed at the next NCL Medication Safety Officer (MSO) Local Network on 4th April 2020 to consider if there is anything further that should be done.
2. The Prevention of Future Deaths report has been shared with the Chair of the NCL Joint Formulary Committee (JFC) with a request that the committee ensures that they address the matters of concern at the next meeting on 20th April 2020.
3. Information circulated to GPs by Enfield CCG:
i) 16th January 2017 - Scriptswitch message:
“Please switch EpiPen solution for injection auto-injectors 300 micrograms/0.3ml (1in 1,000) to Emerade solution for injection auto-injectors 300 micrograms/0.3ml (1 in 1,000). The Emerade® adrenaline auto-injector currently has the longest shelf life of all the Adrenaline auto-injector pens currently available 2.5 years (30 months) from date of manufacture compared to others that are 18 months from date of manufacture. If patients are switched to Emerade, it is advised that they are offered training in the use of the device. An on-line instruction video is available at the official Emerade® website along with a ‘request button’ for free training”.
8 and 9 contd
ii) 2nd Sept 2017 – newsletter to GP practices distributed
The Enfield CCG Newsletter emailed to all GP practices included a link to Adrenaline auto- injectors updating advice after a European review - https://www.gov.uk/drug-safety- update/adrenaline-auto-injectors-updated-advice-after-european-review. The link references advice to healthcare professionals to “ensure that people with allergies and their carers have been trained to use the particular auto-injector that they have been prescribed—technique varies between injectors”.
iii) 28th September 2018 – supply distribution alert
Supply Disruption Alert was emailed to all GP surgeries
The alert stated “The different brands of adrenaline auto-injectors are not used in exactly the same way and therefore specific training and advice is required for each of the devices- please see information on these alternative devices below”. This alert helped to reinforce the view that training was required if a patient was changed from one device to another.
iv) 17th July 2019 – policy statement approved by Enfield CCG Medicines Management Committee
Policy Statement agreed by Enfield CCG Medicines Management Committee on the prescribing of adrenaline auto injectors (Appendix 2) was put on Enfield GP intranet and discussed with GPs at all the GP locality events.
v) 19th July 2019 – scriptswitch message
A Scriptswitch message on 300mcg AAIs was issued stating “Consider prescribing Emerade 500mcg if risk of severe anaphylaxis (for self-administration patients at risk of severe anaphylaxis).
vi) 30th January 2020 – Medicines Safety Bulletin
Following receipt of the narrative verdict Medicines Safety Bulletin (Appendix 1- as above) was circulated to Enfield GP practices and community pharmacists, and, was uploaded on the Enfield GP intranet site. The bulletin advises GPs to review the dosage and ensure it is appropriate for the patient’s age and weight, and to seek specialist advice for high-risk patients.
8 and 9 contd.
vii) 4th March 2020 - scriptswitch message update was issued advising practices: All strengths of Emerade devices will be unavailable for the foreseeable future. Review patients to ensure Adrenaline auto-injector (AAI) appropriate according to current guidelines An alternative brand of AAI must be prescribed (Epipen or Jext) Dose should be checked to ensure it is appropriate for the patient especially in children as they age and increase in weight or for patients whose condition changes. Patients should be given robust training about carrying two AAI pens with them at all times, and administering the second dose 5-15 minutes after the first if their condition does not improve. (Document in patient notes that this advice has been given). Patient (or representative where appropriate) must be counselled on change of device and trained on how to use the new device. For children - ensure an allergy action plan is in place and to ensure patient/carer can follow: https://www.bsaci.org/about/download-paediatric-allergy-action-plans viii)
The Prevention of Future Deaths Report is included on the agenda of Enfield CCG’s Medicines Management Committee for discussion with GPs and pharmacists on 31st March 2020.
ix) Ongoing Actions
Matters of Concern and opportunities for shared learning from incidents are raised during face to face practice meetings with GPs, community pharmacists, Primary Care Network pharmacists and other prescribers; GP Locality meetings and GP protected learning time events.
Enfield CCG has requested the Prevention of Future Deaths Notice is discussed at the following meetings to ensure that this incident can be shared and reviewed further and learning identified and shared across North Central London:
Medicines Safety Officers and Medical Devices Safety Officers (MDSO) meeting on 4th April 2020. This meeting is attended by Medicines Safety Officers from primary care and hospital trusts and is chaired by a GP; this group will help share learning across healthcare sectors.
8 and 9 contd. Enfield Medicines Management Committee 31st March 2020. North Central London Joint Formulary Committee on 20th April 2020.
CCG pharmacists to check what action they have taken regarding the NCL Medicines Safety Bulletin on Adrenaline Auto Injectors (AAI) have contacted all GP practices. This is being followed up with individual practice meetings, training meetings for GPs, training sessions for Primary Care Network pharmacists, and by CCG pharmacists working in practices. A record is in the process of being collated to capture actions by individual practices to ensure all patients regularly receive appropriate training in the use of their device and dosages have been reviewed. This process is due to complete by 30th April 2020.
An analysis of CCG actions that may have been contributory to this incident were lack of governance around scriptswitch messaging and newsletters sent to practices from the CCG Medicines Management team. Following the review of this case, it was identified that a more robust governance and decision making process was needed. Current measures to stop any reoccurrence include:
checking and approval of scriptswitch messaging by senior pharmacists newsletters to be checked and approved by GP Clinical Lead
NCL primary care group has been set up to review the local formulary and scriptswitch messaging to standardize messages across NCL CCGs.
The CCG will now implement a post incident review and a report will be completed to ensure that all actions identified are implemented to prevent a recurrence of this nature. This will include a review of governance processes and decision-making points This report will go to the Quality and Safety Committee, which will oversee any recommendations and ensure implementation of all actions.
Prevention of Future Death Notice Matters of Concern
CCG Actions taken
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.
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).
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.
27th August 2015 - North Central London Joint Formulary Committee (NCL JFC) agreed to replace Epipen with Emerade on the joint formulary.
1. The narrative verdict was discussed at the NCL Medication Safety Officer (MSO) Local Network on 17th January 2020. The network agreed that a Medicines Safety Bulletin on Adrenaline Auto Injectors (AAIs) would be distributed to GPs and other primary care healthcare professionals. The NCL Medicines Safety Bulletin on Adrenaline Auto Injectors (AAI) dated 24th January 2020 is attached as appendix 1. The bulletin was approved virtually by NCL Medication Safety Officer (MSO) Local Network following the meeting on 17th January 2020 and distributed to Enfield GP practices on 30th January 2020.
The Prevention of Future Death notice will be discussed at the next NCL Medication Safety Officer (MSO) Local Network on 4th April 2020 to consider if there is anything further that should be done.
2. The Prevention of Future Deaths report has been shared with the Chair of the NCL Joint Formulary Committee (JFC) with a request that the committee ensures that they address the matters of concern at the next meeting on 20th April 2020.
3. Information circulated to GPs by Enfield CCG:
i) 16th January 2017 - Scriptswitch message:
“Please switch EpiPen solution for injection auto-injectors 300 micrograms/0.3ml (1in 1,000) to Emerade solution for injection auto-injectors 300 micrograms/0.3ml (1 in 1,000). The Emerade® adrenaline auto-injector currently has the longest shelf life of all the Adrenaline auto-injector pens currently available 2.5 years (30 months) from date of manufacture compared to others that are 18 months from date of manufacture. If patients are switched to Emerade, it is advised that they are offered training in the use of the device. An on-line instruction video is available at the official Emerade® website along with a ‘request button’ for free training”.
8 and 9 contd
ii) 2nd Sept 2017 – newsletter to GP practices distributed
The Enfield CCG Newsletter emailed to all GP practices included a link to Adrenaline auto- injectors updating advice after a European review - https://www.gov.uk/drug-safety- update/adrenaline-auto-injectors-updated-advice-after-european-review. The link references advice to healthcare professionals to “ensure that people with allergies and their carers have been trained to use the particular auto-injector that they have been prescribed—technique varies between injectors”.
iii) 28th September 2018 – supply distribution alert
Supply Disruption Alert was emailed to all GP surgeries
The alert stated “The different brands of adrenaline auto-injectors are not used in exactly the same way and therefore specific training and advice is required for each of the devices- please see information on these alternative devices below”. This alert helped to reinforce the view that training was required if a patient was changed from one device to another.
iv) 17th July 2019 – policy statement approved by Enfield CCG Medicines Management Committee
Policy Statement agreed by Enfield CCG Medicines Management Committee on the prescribing of adrenaline auto injectors (Appendix 2) was put on Enfield GP intranet and discussed with GPs at all the GP locality events.
v) 19th July 2019 – scriptswitch message
A Scriptswitch message on 300mcg AAIs was issued stating “Consider prescribing Emerade 500mcg if risk of severe anaphylaxis (for self-administration patients at risk of severe anaphylaxis).
vi) 30th January 2020 – Medicines Safety Bulletin
Following receipt of the narrative verdict Medicines Safety Bulletin (Appendix 1- as above) was circulated to Enfield GP practices and community pharmacists, and, was uploaded on the Enfield GP intranet site. The bulletin advises GPs to review the dosage and ensure it is appropriate for the patient’s age and weight, and to seek specialist advice for high-risk patients.
8 and 9 contd.
vii) 4th March 2020 - scriptswitch message update was issued advising practices: All strengths of Emerade devices will be unavailable for the foreseeable future. Review patients to ensure Adrenaline auto-injector (AAI) appropriate according to current guidelines An alternative brand of AAI must be prescribed (Epipen or Jext) Dose should be checked to ensure it is appropriate for the patient especially in children as they age and increase in weight or for patients whose condition changes. Patients should be given robust training about carrying two AAI pens with them at all times, and administering the second dose 5-15 minutes after the first if their condition does not improve. (Document in patient notes that this advice has been given). Patient (or representative where appropriate) must be counselled on change of device and trained on how to use the new device. For children - ensure an allergy action plan is in place and to ensure patient/carer can follow: https://www.bsaci.org/about/download-paediatric-allergy-action-plans viii)
The Prevention of Future Deaths Report is included on the agenda of Enfield CCG’s Medicines Management Committee for discussion with GPs and pharmacists on 31st March 2020.
ix) Ongoing Actions
Matters of Concern and opportunities for shared learning from incidents are raised during face to face practice meetings with GPs, community pharmacists, Primary Care Network pharmacists and other prescribers; GP Locality meetings and GP protected learning time events.
Enfield CCG has requested the Prevention of Future Deaths Notice is discussed at the following meetings to ensure that this incident can be shared and reviewed further and learning identified and shared across North Central London:
Medicines Safety Officers and Medical Devices Safety Officers (MDSO) meeting on 4th April 2020. This meeting is attended by Medicines Safety Officers from primary care and hospital trusts and is chaired by a GP; this group will help share learning across healthcare sectors.
8 and 9 contd. Enfield Medicines Management Committee 31st March 2020. North Central London Joint Formulary Committee on 20th April 2020.
CCG pharmacists to check what action they have taken regarding the NCL Medicines Safety Bulletin on Adrenaline Auto Injectors (AAI) have contacted all GP practices. This is being followed up with individual practice meetings, training meetings for GPs, training sessions for Primary Care Network pharmacists, and by CCG pharmacists working in practices. A record is in the process of being collated to capture actions by individual practices to ensure all patients regularly receive appropriate training in the use of their device and dosages have been reviewed. This process is due to complete by 30th April 2020.
An analysis of CCG actions that may have been contributory to this incident were lack of governance around scriptswitch messaging and newsletters sent to practices from the CCG Medicines Management team. Following the review of this case, it was identified that a more robust governance and decision making process was needed. Current measures to stop any reoccurrence include:
checking and approval of scriptswitch messaging by senior pharmacists newsletters to be checked and approved by GP Clinical Lead
NCL primary care group has been set up to review the local formulary and scriptswitch messaging to standardize messages across NCL CCGs.
The CCG will now implement a post incident review and a report will be completed to ensure that all actions identified are implemented to prevent a recurrence of this nature. This will include a review of governance processes and decision-making points This report will go to the Quality and Safety Committee, which will oversee any recommendations and ensure implementation of all actions.
Sent To
- Advanced Health & Care Ltd
- Association of Ambulance Chief Executives
- Bausch & Lomb UK Ltd
- Department of Health & Social Care
- Enfield Clinical Commissioning Group
- London Ambulance Service NHS Trust
- London Central & West Unscheduled Care Collaborative
- Medicines & Healthcare Products Regulatory Agency
- National Institute for Health & Care Excellence
- NHS Digital
- NHS England & NHS Improvement
- Winchmore Hill Practice
Response Status
Linked responses
9 of 12
56-Day Deadline
8 Oct 2020
All responses received
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 18 September 2018, I commenced an investigation into the death of Shanté Andreé Marie Turay-Thomas. The investigation concluded at the end of the inquest on 13 January 2020. I made a narrative determination made at inquest, a copy of which I attach.
Circumstances of the Death
Shanté was allergic to nuts and on 18 September 2018 told her mother that she had eaten hazelnuts. She died soon after of acute anaphylaxis.
Copies Sent To
Professor Chris Whitty, Chief Medical Officer (CMO) for England
Care Quality Commission for England (CQC)
Dr Clare Dollery, Executive Medical Director, Whittington Health
Professor Adam Fox, allergist (independent of Shanté’s care)
Thomas
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.