Dear Mr Golombeck,

I write in response to your regulation 28 report, dated 21 May 2021, regarding the death of Dyllon Shaun Graham Milburn. I would like to express my sincere condolences to Mr Milburn’s family.

We have reflected on the circumstances surrounding Mr Milburn’s death, and the concerns raised in your report, in relation to NICE’s work. You suggest that an automated alert be added to the EMIS system to remind people to request and collect their repeat prescription to encourage compliance. While NICE is not able to influence changes to the EMIS system, the following NICE guidelines contain recommendations relevant to this report.

In our guideline on medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence (CG76), we recommend considering ‘using records of prescription re˗ordering, pharmacy patient medication records and return of unused medicines to identify potential non˗adherence and patients needing additional support’.

We also recognise the importance of checking adherence in people being treated for depression in our guideline on the recognition and management of depression in adults (CG90).

NICE produces tools to support implementation of our recommendations, but they are put into practice locally. Therefore, we do not consider that any action is required by NICE in response to your report.

I hope the above information is helpful. Thank you for requesting our contribution.

Dear Mr Golombeck Regulation 28 Report to Prevent Future Deaths - touching on the death of Dyllon Milbum Thank you for your letter of 21 2021 Jm responding on behalf of the Royal College of General Practitioners as Joint Honorary Secretary to Council Firstly; can convey our condolerces to the family and friends of Dyllon Milbum was saddened t0 read of Dyllon $ passing The Royal College of General Practitioners (RCGP) is the largest membership organisation in the United Kingdom solely for GPs_ It aims to encourage and maintain the highest standards of medical practice and to act as the 'voice' of GPs on issues concerned with education; training; recearch; and clinical standards Founded in 1952 the RCGP has just over 54,000 members who are committed to improving patient care, develping their own skilks and promoting practice 3s a discipline NHS data shows that over 12 billion preccriptions are iscued in England per year Whilst accepting that practices are of different sizes, with approximately 7000 GP practices in England on average eachis authorising over 170,000 per annum Prescription errors are considered to be a common cause 0f complaint and potential litigation with rates of 8.9% and 4.9% in hospital settings and general practice respectively . Over years many approaches have taken place to reduce this error and in general practice the almost universal use of computers and electronic prescribing has significantly improved matters; previously prescription forms where hand written with little or no ability to audit how many prescriptions were issued t0 an indivdual patient all GP IT systems are able to monitor whether a medication is being under or Over However; there is no visibility in general practice on whether a prescription is actually hps: |[phamaceutical joumaLcomlanticle /dlthe-top-ten-prezcnbing-emor-practice-indchoultoz Moid_them accessed 12 July 21 Royal College of General Practitioners 30 Euston Square London NWI 2FB rcgporguk Patron HRH Duke of Edinburgh (1972-2021) Registered Charity Number 223106 May general general rate being led The [

collected or not_ In the past; one of the main medical defence organisations, The Medical Protection Society, did recommend a monthly meeting with the local phamacy to axcertain what prescriptions had been issued and not collected: the focus wa: particulary on patients wth psychozis such a5 schizophrenia The underlying reaconing was that such individuals might be at higher risk of self-harm However; sounding: | have had with other senior colleagues i: that none of currently do this not least with the universal use of electronic preccrbing in many cases it would not be feasible a: prescriptions are frequently cent to a large number of pharmacies To compound matters, the IT systems that Phammacies Uze are different to that in general practice: Given the above, recommend that RCGP opens 3 dialgue with our colleagues at the Royal Pharmaceutical Society to concider thiz matter in more detail. Ac above; Medical Protection Society has made recommendation: in the past and clearly the clinical question remains. However, cince then IT systems have become universal and the voluma of prescriptions issued annuallyhas markedly increased The RCGP view is that much greater integration of pharmacy and GP IT systems will lkely be needed not least that any approach must be automated given the scale of prescribing acrocs the country: trust that this reply is helpful and if you have any questions, pleace do not hesitate to contact me;

Dear Mr Golomback, With regard to the Regulation 28 report dated 21 May 2021 (the “Report”), we were saddened to read of this incident. We treat such matters with the utmost seriousness and an internal review has been undertaken, focusing on the issue of repeat medications and compliance. Firstly, we reviewed the functionality available within EMIS Web and confirmed that it was working as designed and in a manner that complies with the system requirements specified by NHS Digital. On review of the patient’s electronic record, it appears that the patient had been inconsistent in terms of medication compliance since commencing on Sertraline in December 2018. In the four months prior to being changed to electronic repeat prescriptions via EPS, the record shows that they had been non-compliant on a number of occasions, including 2 occasions where the patient failed to return to the GP Practice on time for a review and to obtain a further prescription. On the first occasion, there was a delay of 20 days and on the second occasion, a delay of 14 days. The patient was switched to repeat prescriptions on 11 July 2019 for 28-day quantities. On the 2 September 2019, when the patient requested the 2nd repeat prescription (approximately 24 days later than expected) the current and average percentage compliance with the repeat medication was as displayed below. This was a further indication of under use of the medication and this should have alerted the GP practice to the fact that the patient was non-compliant with his medication.

When a patient is placed on repeat prescriptions, the review date set is at the GP’s discretion (up to a maximum of 12 months). This supports the benefits of repeat prescribing for both the patient and GP whilst allowing the GP to set an appropriate interval for review, depending upon the patient’s clinical presentation and compliance with treatment. On commencing the patient on repeat prescriptions, the GP confirmed a review date of 12 months. A shorter time frame for review could have been chosen which may have alerted the GP to compliance issues earlier. In addition, prescribers have the ability to check the status of a prescription using the NHS’s Electronic Prescription Service (EPS) Prescription Tracker. This allows a prescriber to identify if EPS prescriptions have left the organisation, been downloaded by the dispensing pharmacy and/or been dispensed.

We recognise that medicines management and patient compliance is a highly complex area for practices to manage given the scale of repeat prescribing each undertakes. Practices should have robust policies in place to ensure that patients at risk through non-compliance are followed up and monitored closely; some practices will use other specific tools for at risk patients (e.g. diary entries or creating compliance reports) to help manage poor compliance. Furthermore, prescribers have the ability to check the status of a prescription using the NHS’s Electronic Prescription Service (EPS) Prescription Tracker. This allows a prescriber to identify if EPS prescriptions have left the organisation, been downloaded by the dispensing pharmacy and/or been dispensed. However, use of such tools varies across different areas and practices. We are presently considering a number of potential digital tools that we could look to develop so as to aid further patient compliance. We agree that patients at risk present a specific challenge in terms of ensuring medication compliance and would welcome a discussion with the profession, NHS England, NHS Digital and other system suppliers to create best practice for primary care to help manage this risk. Enhanced, robust practice processes alongside new IT capabilities are likely to be needed and these can then flow through to the relevant NHS Digital functional specifications in order to ensure compliance nationally. We trust that the details outlined above are of help. Finally, as a company we work very hard to support health care services across the UK and patient safety is of paramount importance to us. We were saddened to read of the issues relating to this particular incident and we would like to pass our condolences on to the family. If you have any further queries then please contact our Senior Clinical Director, (via in the first instance. Kind regards

Dr

Chief Medical Officer, EMIS Group

SUBMISSIONS FOR HM CORONER FOLLOWING THE INQUEST HEARING FOR DYLLON MILBURN

At the hearing on 29 April 2021, HM Coroner Zak Golombeck, raised questions over the repeat prescribing system at Bodey Medical Centre (“the practice”). Dr who appeared at the Inquest as a representative of the practice attended a meeting with her partners at the practice following the Inquest when there was a discussion about those matters which HM Coroner asked to be addressed. In providing this information, Dr has obtained the collective views of her three partners at the practice who endorse these comments.

1. The current electronic software system and the details of the provider

The practice software provider is EMIS Health. The version they use is EMIS Web and they use EMIS Web EPS (Electronic prescriptions Service) to prescribe at Bodey Medical Centre. The contact details the practice has for EMIS Health are:

EMIS support at https://www.emishealth.com/about-us/contact-us/

Head Office Leeds - Fulford Grange Fulford Grange Micklefield Lane, Rawdon Leeds LS19 6BA

or Regional offices Bolton - Aspinall House Aspinall House Aspinall Close Middlebrook, Horwich, Bolton BL6 6QQ

There are three methods by which patients of the practice can request their repeat prescriptions. Firstly, they can set up a system with their local pharmacy whereby the pharmacy requests the patient’s medication on a monthly basis on their behalf. Secondly, the patient can set up online registration and request their medications online through the practice website. Thirdly, the patient can fill in their paper repeat prescription slip and give this in manually either by giving it to one of the receptionists or by posting it in the repeat prescription slip box in the waiting room.

For each of these options, a prescription request takes at most 2 working days for the practice to review, sign and process the prescription. This has to be done by a doctor or qualified nurse prescriber. The practice therefore asks their patients to request their repeat prescriptions at least 2 days in advance. The requirement for a 2-day processing time is prominently displayed on the repeat prescribing section of the website and on the repeat prescription slip boxes in the reception area at the practice.

In this case the patient was set up for electronic prescriptions (option 2) that were sent automatically to a pharmacy. If a patient wishes to change their nominated pharmacy, they can do so by either arranging this in their new preferred pharmacy, or if they inform the practice of a new preferred pharmacy, the practice can change the details on their system in EMIS.

When an antidepressant is added to a repeat prescription, this is done in discussion with the patient and with their consent. The discussion includes how to take the medication, the expected duration of the course and the need to wean off the medication. The patient is "safety netted" i.e. they are advised to seek a consultation with a GP if there is a problem with their medication at any time or if they experience a deterioration in their mental health.

When electronically signing a repeat prescription, the number of prescription requests are mapped on the system to the patient's daily quantity so there is a percentage estimate visible to the signing clinician which might indicate if the patient was not requesting their medication as they should be. When adding a new repeat medication on EMIS the prescribing clinician must authorise how many times this repeat prescription can be issued. This authorisation number indicates the maximum number of times the prescriber can issue that medication from the patient’s repeats before they need a review of that medication. The maximum time before each review would be for one year (i.e.12 issues of a 28 day quantity of medication might be authorised when initiating a repeat prescription for a medication if it was appropriate for this medication to be continued for 1 year).

On an annual basis every patient has a medications review. This also applies to anti- depressants on repeat prescriptions. At the annual medication review, the reviewing GP would routinely check that any repeats were being regularly collected. If they were not, appropriate action is taken which could involve removing the medication from repeats, and either swapping the medication from “repeats” to “acutes” or it could trigger a patient to be requested to come in for a review with a GP.

2. Comments on how an alert in the system would work in practice

In discussion at the practice meeting, the clinicians commented that there is no electronic system that they are aware of which can alert them as to whether a patient is not requesting their repeat medications on a month-by-month basis. If such a system existed and were workable, there would need to be a protocol in place to clarify how the patient would be alerted to this. Possibilities discussed included by text message if the patient consents to this, by telephone (if so, the question arises as to who makes the call), or by letter for patients without access to phones (again raising the question as to who writes the letter). There would also need to be clarity as to what timeframe applied i.e. when such an alert would be triggered. What would be the appropriate timescale for alerting as to a late request for a prescription? Would this be days or weeks and if so, how many?. There would also need to be a protocol in place to detail what an appropriate response would be when such an alert was triggered. Given that an alert would have to apply to all medications to all patients across the practice, there are concerns about the volume of alerts that may be triggered and that the practice does not have sufficient resources to provide an appropriate response to such alerts either in terms of administrative or clinician staffing or time.

Finally it would seem that the possibility of alerts in a prescribing system would have far reaching consequences for GP practices nationally and that careful consideration would need to be given to the various medications issued on repeat prescription which are wide ranging. It may be that consultation with NICE is appropriate and any other relevant prescribing bodies in the UK.

, Legal Adviser, Medical Protection Society on behalf of Dr , Bodey Medical Centre

12 May 2021