Prevention of Future Deaths reports · 2017
Regulation 28 report to prevent future deaths, reference 2017-0290, written 12 Oct 2017. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 12 Oct 2017 |
|---|---|
| Reference | 2017-0290 |
| Deceased | Douglas Hodges |
| Coroner | Heidi Connor |
| Coroner area | Nottinghamshire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Ms Sarah Wilkinson, CEO of NHS Digital 2. Mr Stephen Bradley, Managing Director, Cegedim rx 3. Mr John Nuttall, CEO of Wells Pharmacy 1 CORONER I am Mrs Heidi Connor, assistant coroner for the coroner area of Nottinghamshire. 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST On 17 May 2017 I commenced an investigation into the death of Douglas Hodges, aged 83. The investigation concluded at the end of the inquest on 5 October 2017. The conclusion of the inquest was natural causes. 4 CIRCUMSTANCES OF THE DEATH Professor Hodges had a past medical history which included stroke, vascular dementia, congestive cardiac failure, prostate cancer, atrial fibrillation and hypertension. He was seen at home by his GP on 27 March 2017. His family was concerned that he seemed more confused since starting to take medication (Bicalutamide), prescribed after his prostate cancer diagnosis. His GP thought Prof Hodges may have been suffering the beginnings of a lower respiratory tract infection. He said he was not sure of this – but prescribed antibiotics just in case. He prescribed 500mg Amoxicillin, to be taken 3 times a day, for 5 days. The GP issued this prescription electronically via the Electronic Prescription Service when he returned to the surgery. It was planned that the prescription would be delivered to Prof Hodges’ home address by Well Pharmacy in Chilwell, Nottingham (‘the pharmacy’), as had happened in the past. The pharmacy, along with many others nationally, uses a software system provided by Cegedim. Other software providers exist, which supply a similar service to other pharmacies. The prescription was sent to the NHS spine at 15.08, and was downloaded by the pharmacy at 15.33. The GP thought this would be actioned urgently, as an acute prescription, and that Prof Hodges would have his antibiotics that day or the day afterwards. Investigations have revealed that, after being downloaded, a paper token was sent to be printed at the pharmacy. We were told that paper tokens are kept in a basket (alphabetically by patient’s surname) to be dispensed at a later stage. This may be minutes, hours or days later. Paper tokens are shredded after use. No fault has been identified with this printer. Another prescription (for a different patient) was printed at the same time. There was no evidence to suggest that other prescriptions at the pharmacy have been sent to the printer but not in fact printed. The paper token has never been found. My conclusion was that the most likely sequence of events was that the paper token was printed, but somehow mislaid or accidentally disposed of. 1 Prof Hodges’ antibiotics were never dispensed. No label was created at the pharmacy. A later prescription for him (issued on 31 March) was received and later dispensed by the pharmacy (in fact after he had died). It was not appreciated at that time that the earlier prescription of antibiotics had not been dispensed. Prof Hodges died in hospital on 3 April 2017, following admission there the previous day. His cause of death (following post-mortem examination) was 1a multiple organ failure, 1b systemic sepsis. Given the short time between his admission to hospital and his death, no source of his infection could be found. He was not thought to have a chest infection. He was treated with antibiotics, administered within an hour of his admission, in line with sepsis protocols. I found it unlikely that, if Prof Hodges had received the antibiotics prescribed by his GP on 27 March 2017, the outcome would have been different. I am mindful however of my responsibilities (under paragraph 7(1), Schedule 5 of the Coroners and Justice Act 2009) to act where I am concerned there is a risk of “other deaths”. Put simply, a missed prescription could create a risk of future death in a different case. Although Prof Hodges had a supportive family, I am mindful in particular of vulnerable patients who do not always have this, who may be reliant on medication being delivered to them timeously. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The key areas of concern are : In relation to NHS Digital : 1. As matters stand, in a community pharmacy setting, there is no way of communicating clinical urgency between prescriber and pharmacy staff at the time the prescription is downloaded. A large number of prescriptions are downloaded every day by pharmacies. Urgent and non-urgent prescriptions look the same on the system. It is only at the labelling stage that any clinicians’ comments can be seen. 2. We were told that a different system (Vision) is used in scenarios where a pharmacy is run by a GP practice. This system is often used in rural settings. The Vision system allows for a prescription to be marked with a red exclamation mark at the point of downloading, where a prescription is urgent. 3. Where prescriptions go via the NHS Spine, such a system is not currently possible. 4. We heard evidence about a recent survey conducted by NHS Digital, in which pharmacists made it clear that this was the change they most wanted to see. It is clear that agreed guidelines will need to be considered, in line with any such change, to define what is meant by the term ‘urgent’. 5. 6. Prof Hodges’ case makes the case for this change very clearly, and I consider there is a real risk of future deaths if this is not addressed. In relation to Cegedim : 1. During the investigation, an experienced clinical pharmacist who works at the GP practice attended the pharmacy and looked at the system in question. When 2 accessing the ‘help section’ of the software, the information she saw suggested that the red exclamation mark system was available and she questioned why this was not being used. It is not clear why this information is included in the ‘help section’ of software that does not currently support this function. It clearly led to confusion. I ask that Cegedim review this and consider clarifying it. In relation to Wells Pharmacy : 1. I heard evidence from the patient safety manager of Wells Pharmacy Group, who told us they are trialling a system which includes the following provisions : a. Downloading prescriptions only up to 2.30pm each day, with the aim of labelling all prescriptions downloaded on that day. We were told that urgency and delivery instructions would then be picked up at the labelling stage. b. Pharmacists are required to check at the end of each day whether there are prescriptions which have been sent to print but not yet got to the labelling stage. If a patient or representative comes in to collect prescribed medication, only one prescription will be downloaded at a time, to avoid any confusion. c. d. Local GPs will be made more aware of likely / realistic timescales between prescription and the medication going to patients. 2. I note that this trial will end in November. Whilst it is entirely appropriate to trial any change like this, there is no guarantee that changes will be implemented after the trial. I would like to know what the intention of the pharmacy is after the trial period ends, and how it proposes to reduce this risk in future. 6 ACTION SHOULD BE TAKEN In my opinion, action should be taken to prevent future deaths and I believe you / your organisation have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 7 December 2017. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons : 1. Professor Hodges’ family. 2. The GP surgery I am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. 9 12.10.17 H.J.Connor 3
2 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
1 Trevelyan Square Boar Lane Leeds LS1 6AE 0300 303 5678 Ref: LT0981 6 December 2017 Private and Confidential Mrs Heidi Connor Assistant Coroner HM Coroner’s Service Old Market Square Nottingham NG21 2DT Dear Mrs Connor Thank you for your response to my last letter and for your patience. I have now completed my analysis of the internal review which took place of the concerns described in your Regulation 28 letter. I have responded to each of your concerns below. 1. As matters stand, in a community pharmacy setting, there is no way of communicating clinical urgency between prescriber and pharmacy staff at the time the prescription is downloaded. A large number of prescriptions are downloaded every day by pharmacies. Urgent and non-urgent prescriptions look the same on the system. It is only at the labelling stage that any clinicians’ comments can be seen. Currently there is no mention in the GMC’s Good Practice in Prescribing and Managing Medicines and Devices on communicating clinical urgency. For most GP prescribers the normal way to communicate clinical urgency is to speak to the pharmacist, usually by phone, or directly and provide information about the patient; the medication/s that need to be dispensed; who will collect the medication, or whether it will need to be delivered and how they will receive the prescription (patient/carer, fax/post or collect from surgery). The GP may delegate this to a member of his staff. This communication is normally in response to the need for the delivery of medicines, but can also be in relation to early notice to order a special medicine as these can have a longer lead in time. The EPS system was designed to transmit prescriptions electronically reducing the need for paper prescriptions. Pharmacies use their IT systems to request (pull) prescriptions from the NHS Spine which releases all the available prescriptions for that pharmacy and adds them to the existing prescription queue. All EPS prescriptions look the same on pharmacy screens and there is no means to currently distinguish urgent from routine. The prescription list can be sorted by time or surname. Well Pharmacy sort their prescriptions by surname to prevent the risk of missing multiple prescriptions for the same patient. GP’s also have access to an ‘Additional Instructions’ field which could be used to add a note for the dispenser to highlight urgency, but the presence of the note is not visible on the main list view and it is only visible on screen when the prescription is processed and additionally not all pharmacy systems conform to this requirement. 2. We were told that a different system (Vision) is used in scenarios where a pharmacy is run by a GP practice. This system is often used in rural settings. The Vision system allows for a prescription to be marked with a red exclamation mark at the point of downloading, where a prescription is urgent. This functionality is only used by sixteen Dispensing Doctor practices in England who use the Vision clinical system in the consulting rooms and Cegedim Pharmacy Manager dispensing system in the dispensary. These two systems are owned by the same company Cegedim and they have functionality to highlight an urgent prescription to the dispenser. These practices are not using EPS and the NHS Spine but the practice local area network so the solution cannot be scaled to form a national solution. 3. Where prescriptions go via the NHS Spine, such a system is not currently possible. EPS connects all prescribing and dispensing systems to the NHS Spine and an EPS prescription can flow from any prescribing site to any community pharmacy in England. The current prescription message does not contain an urgency flag. Any solution that would allow transmission of a flag from prescriber to dispenser would require a change in the prescribing and dispensing systems, prescription message and the NHS Spine. NHS Digital is already exploring this option as part of the EPS enhancements for prescribers and dispensers. To be fully operational, this would require changes to all prescribing and dispensing systems as well as the NHS Spine. NHS Digital would have to work collaboratively with prescribing and dispensing systems suppliers to implement this change and it could take up to 24 months for it to be developed and deployed due to the complexity of the primary care provider environment and the need to implement business change within the NHS. 4. We heard evidence about a recent survey conducted by NHS Digital, in which pharmacists made it clear that this was the change they most wanted to see. The EPS Enhancements survey took place in August 2017 and a “High Priority Alert” was most desired enhancement for dispenser and the second most desired for prescribers. NHS Digital are undertaking further work with users to elaborate the requirements and explore how such an alert would work. NHS Digital are also evaluating the introduction of an extra prompt in Urgent and Emergency Care for a prescriber to contact the pharmacy if required when an urgent prescription is issued. 5. It is clear that agreed guidelines will need to be considered, in line with any such change, to define what is meant by the term ‘urgent’. As mentioned above there no existing guidance or definition of urgency in relation to prescriptions. User interviews and discussion on communicating clinical urgency have indicated that the spectrum of time can be anything from two hours up to and including the following or next working day as in your inquest. As EPS extends in to new care settings such as Urgent Care, there may need to be different definitions of urgency dependent on the care setting. NHS Digital continue to work with stakeholders and held a national risk workshop with health professionals and their professional bodies to explore this and more work needs to be done in this area including discussions with regulators where appropriate to agree any guidance on best practice. I personally favour a set time frame (4 hours) by which the medicine should be in the hands of the patient or representative so there is one standard, which aligns to the standard set by A&E waiting time, but this will need buy-in from the prescribing and dispensing professionals. 6. Prof Hodges’ case makes the case for this change very clearly, and I consider there is a real risk of future deaths if this is not addressed. NHS Digital are working with all stakeholders to mitigate the risks associated with communicating clinical urgency recognising that technology solutions are only one part of this multi-dimensional and complex system. Conclusions Following our review, I have come to the same conclusion as you in that I believe there is a strong case for a technical change to highlight an urgent prescription. This is a very significant undertaking impacting prescribing and dispensing systems as well as the NHS Spine. The urgency flag will currently impact patient care in GP, Out of Hours and NHS 111 settings. For this to be implemented successfully such a change would require significant changes to professional practice and behaviours and would need the backing of the professional bodies. NHS Digital only has powers to direct GP IT system supplier and the Spine, whereas NHS England has power to influence other IT suppliers and professional groups. Such a major undertaking has considerable costs and business change requirements and will require a decision to be taken at the highest level. I have formally written to Senior Responsible Owner for funding major IT programmes to seriously consider commissioning a programme of work to enable the technical flagging of urgent prescriptions and enable sound professional use and gain support from professional trade, professional standards and professional regulatory bodies and for this to be able to be implemented systemically within two years. , Chief Clinical Information Officer and In the short term you would also expect actions to be taken to mitigate risk during this intermediate period, assuming there is a positive response to my request. I have divided the mitigating actions into two broad actions: 1. Mitigating actions in the roll out of EPS into urgent and emergency care settings: • When a prescriber sends an urgent prescription via EPS, the mitigating methodology is that the prescriber will not be able to send the prescription to the pharmacy until (s)he has made a declaration to confirm that (s)he understands there is a requirement for the pharmacy to be contacted for all urgent prescriptions. • The effect of the above process is that the prescriber will have notified the pharmacy of the fact of an urgent prescription at or before the point at which the prescription is downloaded by the pharmacy, which we respectfully suggest meets the concern you have raised within the Report. This has the same effect as the red exclamation mark system and is appropriate mitigation until a technological flag can be delivered, if that is the agreed strategic solution. The above system is the subject to a pilot scheme in respect of Urgent Care services (i.e. NHS 111 service and GP Out of Hours services) and is due to be implemented across a controlled geographical area, namely London Central West, with respect to Urgent Care services within the next month. Upon further analysis of its performance it may then be subject to a wider geographical roll-out. 2. Mitigating actions in the prescribing of GPs Your inquest demonstrated that there was not a standard practice amongst GPs. I have written a letter to go to all General Practices in England which draws attention to this case, points out normal practice and which highlights high risk cases when a phone call to the pharmacist should be made, namely those cases: • When the prescriber views the prescription as urgent and • When the patient relies on home delivery for the medication as this is outside the contractual obligations of a community pharmacist and/or • When the prescription is issued within normal working hours as the urgent prescription will not be visible within the large numbers of repeat prescriptions and/or • When there is any doubt about the prescription will be collected in the desired time frame by the patient or representative in the case of a vulnerable patient. This letter is liable to be considered more seriously if it has the support of the RCGP, BMA and RPS so I have asked that it gains that support before it is sent. Kind regards cc
Private and Confidential Mrs Heidi Connor, Assistant Coroner HM Coroner’s Service Old Market Square Nottingham NG21 2DTY By secure email to: coroners.office@nottinghamcity.gcsx.gov.uk 28th March 2018 Dear Mrs Connor, Inquest touching the death of Professor Douglas Hodges Regulation 28 Report to Prevent Future Deaths Further to my previous response dated 28th November 2017 I am now writing to provide a final update on the actions we have implemented. Our pilot has concluded and we are now rolling out Best in Class Prescription Management across the estate. 652 stores have had a visit by a member of the field operations management team to check on the implementation of the agreed process and provide coaching, support and guidance. An improved reporting mechanism has been developed to record actions and results of the audit and support the ongoing maintenance of the changes which have been implemented. The Best in Class audit contains 2 specific questions linked to reducing the risk of a similar incident that occurred at Chilwell. “Do you check the e-messages tab for prescriptions which have been printed but not labelled each day?”’ 85% of recorded audits scored YES Any prescriptions which have been downloaded that day, but not labelled, will be highlighted on the e-message tab and the whereabouts can be investigated. “If a patient presents to collect a EPS prescription do you download and print that prescription only?” 1 82% of recorded audits scored YES This action reduces the likelihood of any other prescriptions downloaded and printed at the same time from being mislaid. The specific outcome for the complete audit for our Chilwell store was 85% and answered YES to the two specific questions. It’s also been agreed that the field operations management team will re-audit on each branch visit to keep the focus on the process change a business priority. The outcome and learning will be shared at the quarterly divisional team meetings, A model day process has been developed and includes checking the e-message screen at the end of the day, labelling all prescriptions by the end of the day and therefore removing the need for the A-Z files. SOP14 has been updated and re-launched to reflect these changes and the completion rate is currently 88%. My Professional and Regulatory Standards Manager has been involved in the NHS Digital workshop meetings relating to their investigation into highlighting urgent prescriptions electronically, using the knowledge acquired during the investigation to help with any solution. I trust this final update reassures you that Well has taken a very proactive stance following this tragic incident and that we are committed to enhancing patient safety across our estate. Regards, Pharmacy Superintendent Well 2
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