Shanté Turay-Thomas

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.

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

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.