With an ageing population and consequent rise in adult mortality, the need for health and social care services to provide high quality, integrated end-of-life care (EoLC) is ever increasing (Age UK, 2019).
While 70% of people at the end of life (EoL) were reported to prefer to die at home given the right support (Department of Health and Social Care, 2008), the individual patient's decision-making with respect to their preferred place of death is complex and often changes during their disease trajectory (Hoare et al, 2015). Given these complexities, it is important that all health professionals involved in caring for patients at the EoL have the necessary skills to facilitate patients achieving their preferred place of death. Appropriate management of pain, anxiety and other symptoms should therefore be a crucial goal, shared by patients, their family and carers as well as health professionals (Bowers et al, 2019).
When a pharmacological approach is needed to manage one or more of the common symptoms at EoL, such as pain, anxiety, breathlessness or nausea, this can be facilitated using anticipatory prescribing, where patients are provided with injectable medicines in their home for when and if they are needed (Twycross and Wilcock, 2011). These just-in-case (JIC) medicines are prescribed preventively and stored in the patient's home for administration by a health professional such as a nurse, doctor or paramedic.
Within Wales, paramedics have been able to administer JIC medications where appropriate and following shared decision-making with a senior clinician since 2016 (Association of Ambulance Chief Executives (AACE), 2019). During the process of shared decision-making, the paramedic will contact the patient's GP, an out-of-hours GP or a palliative medicine doctor to discuss the clinical situation, seeking the doctor's opinion on whether administration of JIC medication is appropriate and, if so, at what dose (AACE, 2019).
Unfortunately, for many EoL patients for whom pharmacological symptom management is needed, JIC medications will not have been pre-emptively prescribed, so will not be available in their home. A study of 12 GP practices in England reported that anticipatory prescribing or JIC medications were available in only 16% of their predictable deaths in the community (Kemp et al, 2012).
This situation was exacerbated during the COVID-19 pandemic when patients without current EoL symptoms, who had high levels of frailty or comorbidity and for whom hospital admission was not considered appropriate or indeed possible, presented to the ambulance service with symptoms of severe COVID-19 infection.
These patients would require palliation within the community, especially at the outset of the pandemic, when the COVID-19 demand on NHS intensive care units was predicted to exceed capacity, and some people in the community became severely unwell due to COVID-19 or other illnesses while self-isolating (Association of Palliative Medicine (APM), 2020). Therefore, JIC medications were introduced in Welsh ambulances in May 2020 to respond to this urgent need in the community and allow paramedics to better manage symptoms commonly seen in patients at the EoL, whether because of severe COVID-19 infection or advanced terminal illness. The addition of ambulance JIC medicines was hoped to reduce delays in symptom management and increase the likelihood of patients remaining in their preferred place of care, preventing the need for hospital admission.
This paper discusses the process of introducing JIC medication on ambulances in Wales and its impact on patient care and costs during the first 12 months of operation.
Methods
A review of parenteral medicines commonly prescribed at the end of life (Johnstone, 2017) was undertaken. This identified the appropriate JIC medications to manage the symptoms of severe COVID-19 infection and/or symptoms associated with advanced end-stage illnesses. This was done using integration of both the APM (2020) COVID-19 symptom control guidance and the established all-Wales JIC bag policy (NHS Wales, 2018).
Medicines
The review identified five parenteral EoLC medicines: morphine sulphate; midazolam; haloperidol; levomepromazine; and hyoscine hydrobromide. Morphine sulphate, the recommended medication for palliation of pain and end-stage breathlessness, was already carried on all ambulances in Wales.
The APM (2020) COVID-19 symptom control guidance states: ‘Patients can rapidly deteriorate with acute respiratory distress syndrome; this can be extremely distressing for the patient and family.’ The APM guide indicated that some patients were experiencing moderate to severe breathlessness, combined with moderate to severe agitation. In such cases, the APM guidance recommended the administration of midazolam and morphine, which is more effective than morphine alone.
The APM (2020) advises that ‘delirium may be a direct symptom of COVID-19, therefore treatment options may be limited’. It recommends that haloperidol is generally the drug of choice for the pharmacological management of moderate to severe delirium.
In addition, for patients in their final days or hours, levomepromazine was highlighted as being useful, and occasionally levomepromazine combined with midazolam was necessary for palliative severe agitation (APM, 2020).
Regarding medication for respiratory secretions, hyoscine hydrobromide was already standard within the all-Wales JIC bag policy (NHS Wales, 2018) and included in established Welsh Ambulance Services NHS Trust (WAST) EoL care training.
Verbal order process
Having identified which JIC medicines to procure and stock on ambulances, it was necessary to ensure these prescription-only medicines could be legally prescribed and administered. For speed of introduction, a robust verbal order process was developed. Although a patient group directive is the standard legal framework to allow registered health professionals who are not prescribers to administer a medicine to a predefined group of patients, their development and introduction can take several months. A verbal order would allow a paramedic to legally administer a non-prescribed, prescription-only medication that does not come under schedule 17 exemptions of the Medicines Act 2012 (England, 2016).
Medicines that are carried and licensed for administration by UK paramedics come under schedule 17 of the exemptions of the Human Medicines Act 2012—they are specific medicines that can be administered to sick or injured people who require immediate treatment without the need for a prescription. These medicines are also ratified by the JRCALC and listed within the JRCALC guidelines (AACE, 2019). Paramedics often refer to guidelines before administering a medication and JRCALC guidelines are online, easily accessible via smartphone or tablet.
Morphine has a Schedule 17 exemption in the Medicines Act 2012 and is within the JRCALC list (AACE, 2019). All other JIC medicines introduced were neither exempt under Schedule 17 nor included in the JRCALC guidelines.
As no other UK ambulance service had parenteral JIC medications on frontline ambulances, there was no evidence-based model of care to follow or established practice regarding the administration of these medicines within UK law.
With respect to the legal requirement of prescribing JIC medicines, the verbal order process under regulation 214 of the Human Medicines Regulations 2012 (Box 1) was identified as a method for doctors to supply a verbal order prescription by telephone to the paramedic on scene.
The wording in Box 1 can be reframed as ‘When acting in accordance with a doctor—an appropriate practitioner is defined in regulation 213(3) as a doctor—a person may parentally administer a prescription-only medicine’. In other words, a paramedic may parenterally administer a prescription-only medicine when acting in accordance with the directions of a doctor.
With respect specifically to the administration of the controlled drugs morphine and midazolam, controlled drugs are regulated under the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001.
The Misuse of Drugs Regulations 2001 regulation 7 states:
As mentioned above, a paramedic does not need a prescription or the involvement of a prescriber to administer parenteral morphine. Morphine administration lies within the exemptions in part 3, Schedule 17 of the Human Medicines Regulations 2012 (England, 2016). A registered paramedic may administer all medicines that are listed in schedule 17 for the immediate, necessary treatment of sick or injured people (England, 2016).
In summary, a paramedic does not require a verbal order to administer morphine, but verbal orders were required for administration of all other ambulance JIC medicines.
Professional administration guidance issued by the Royal Pharmaceutical Society (2019) states that verbal orders must be used only in exceptional circumstances and when no prescriber can be accessed without resulting in a delay in administering. The COVID-19 pandemic was exceptional and delayed administration of symptom-control medicines would have been detrimental to patient care.
Although there is additional work for the supporting community doctor in terms of providing a verbal order, such professional shared decision-making between the paramedic and a doctor supports the paramedic in determining diagnosis, management plan and drug and dose to be administered (Pease et al, 2022).
Guidance for staff
Before the pilot went live, a standard operating procedure for JIC medicine administration was developed. Documents were also developed for symptom control and verbal order guidance and agreed with primary care and palliative care services across Wales.
Drug monographs detailing indications for use, duration of action and possible side effects for each of the ambulance JIC medicines were written and made available on ambulances.
In addition, the established WAST EoLC education modules were updated to include ambulance JIC medicine use. This EoLC education was made mandatory for all WAST paramedics.
Data capture
To ensure robust data capture of ambulance JIC medication use, drug codes specific to each new JIC medicine were introduced. Both drug code and dose were recorded on the patient clinical record (PCR) by the paramedic; this ensured accurate data capture of all uses of both ambulance and patients' own JIC medication.
This data recorded onto the PCR could then be retrieved by the WAST clinical audit team. The clinical audit team were already validating every PCR before uploading them onto the electronic storage database. At the time of validation, any PCR with a JIC drug code entered onto it would be added to an additional spreadsheet that had been set up. All PCRs added to this spreadsheet were then reviewed by the trust EoLC lead.
The review sought to capture the following data:
Capturing adverse events
Datix is the electronic data capture form used across the NHS. Datix is used to record any adverse incident or near miss.
The line manager of a person recording an incident automatically receives the Datix information, but the reporter may also select other staff members or departments to ensure they are also made aware of the incident. In the case of any JIC medication errors, in addition to the reporter's line manager, the reporter could add the EoLC lead. If the reporter chose not to add the EoLC lead, the reporter's line manager would forward on the Datix to the EoLC lead for comment or investigation.
Cost analysis
As a means of assessing the impact of the project, a cost analysis would need to be undertaken. The cost analysis would include both initial set-up costs (Table 1) and subsequent ongoing respond and review costs (Table 2).
| Set-up costs | |
|---|---|
| Development of guidelines to include: | Duration for document creation/adaptation: 5 hours |
| Symptom control guidance | |
| Verbal order guidance | |
| Verbal order prescriber form | |
| Drug monographs for: |
|
| Implementation | |
| Procured medications: |
£5.30/box of 5 amps (£1.06/vial) |
| JIC medicine boxes | |
| Total cost per ambulance JIC box | |
| Total cost of 300 stocked JIC boxes | |
| Education | |
| Development of educational material: |
Duration: 3 hours |
| Cost to upload onto established WAST digital platform | £900 (including VAT) |
| Continuing professional development hours (completed by paramedics and emergency medical technicians) | Duration: 6 hours |
JIC: just in case; WAST: Welsh Ambulance Services NHS Trust
| 999 emergency vehicle response | |
| Emergency ambulance with 2x paramedics (regardless of whether patient stays at home or is admitted to ED | £272.42* |
| Average on-scene time for ambulance at patient's place of care and associated cost | Mean: 2 hrs 25 mins (range 48 mins–5 hrs 51 mins) |
| Palliative care consultant time while providing on-scene advice | Duration: 15 mins |
| Hospital: assuming a patient is transferred from ED after 4 hours to a ward, and is likely to stay in hospital for at least a further 48 hours at a cost of £755.22** | |
| ED attendance: |
£495.22† |
| One-day hospital stay | £130.00†† |
| Transfer of patient back home following hospital stay. | £56.42 |
ED: emergency department; JIC: just in case
Broadly speaking, three set-up elements were necessary before rolling out the project: first, identification and procurement of necessary medication; second, establishment and documentation of procedures and guidelines including the verbal order process; and, finally, education, which involved a series of specifically developed educational videos uploaded to an existing digital platform.
To enable a cost analysis, several assumptions were necessary. Details of the assumptions made will allow readers to interpret the cost analysis and extrapolate to their working environment.
Results
A 12-month review (July 2020–June 2021) of ambulance PCRs documenting all episodes of ambulance JIC medication administration identified:
Although the primary driver for ambulance JIC medication introduction was the COVID-19 pandemic, from the project outset it was anticipated that data collection (including patient illness, symptoms managed and any adverse outcomes) could provide the evidence required regarding continuation of ambulance JIC medication after the pandemic.
No adverse events were identified from either Datix or PCR review.
Patients with symptoms associated with advanced cancer were the primary category for whom ambulance JIC medications were administered, accounting for 39% of cases, and given for distressing symptoms in COVID-19 patients, who comprised 11% of cases (Figure 1).
As mentioned above, patients may have their own parenteral JIC medications prescribed in anticipation of deterioration and for administration by a health professional such as a district nurse or paramedic. Where a patient's own JIC medicines were available, these were always administered in preference to ambulance JIC medication. Drug code data capture allowed comparison of symptoms managed using paramedic administration of ambulance JIC medication versus the patient's own JIC medicine (Figure 2).
Although breathlessness was the most common symptom requiring administration of JIC medicine, paramedics palliated the main five EoLC symptoms.
No adverse events or Datix events were recorded, indicating that paramedics are safe and confident in administering both patients' own JIC medicines and ambulance JIC medication.
The data suggest that there is insufficient anticipatory prescribing across all symptoms, with frequent reliance on ambulance JIC medicines.
Cost analysis
In 2020, using data on file, the WAST finance department calculated that a 999 emergency ambulance response cost £272.42, irrespective of whether the patient remained at home or was transferred to an emergency department (ED). This also includes the cost of administering ambulance JIC medications.
If the patient was conveyed by emergency ambulance to the ED, the national target, where clinically appropriate, is to discharge the patient from the ED within 4 hours (James, 2016). For patients who have presented because of sudden deterioration and require symptom management, anecdotal evidence across Wales suggests these patients are admitted into the hospital from the ED, with the majority remaining in hospital for 48 hours. The assumption of 48 hours includes the time during the ED admission, subsequent transfer of the patient to a medical assessment ward followed by the planning and facilitation of patient discharge. This will incur a minimum cost of £755.22, an amount calculated by the health board finance department. A breakdown of this is shown in Table 3.
| It was assumed a patient is transferred from the emergency department (ED) to a ward after 4 hours and was likely to remain in hospital for at least a further 48 hours at a cost of £755.22 | |
|---|---|
| ED: |
£495.22 |
| One-day hospital stay | £130.00 |
The secondary transfer cost to return the patient home or to another preferred place of care, via the non-emergency patient transport service adds a further £56.42; this figure was supplied by the WAST finance department.
The respond and admit to the ED data in Table 2 is based on a cost of £1084.06(for ambulance response to 999 call, discharge from ED after 4 hours, 48-hour hospital stay plus ambulance discharge to patient's preferred place of care.
The introduction of JIC medication in WAST resulted in an annual cost avoidance of £30 121.28 during the 12-month review period, with an average saving of £381.28 per patient (Figure 4).
Discussion
Although the primary trigger for introducing JIC medications onto ambulances in Wales was to support patients with severe COVID-19 infection in the community, results highlight that symptoms associated with end-stage cancer are the most common condition palliated. End-stage patients with frailty and/or dementia were the second highest group requiring symptom management from the JIC medicines, with those with severe COVID-19 infection being the third highest group.
It was widely reported during the COVID-19 pandemic that many cancer patients were being diagnosed at a later stage in their disease than would have happened before the pandemic, largely owing to cancer screening being suspended or delayed and routine diagnostic work being deferred (Maringe et al, 2020). It is possible that this impacted on the need for cancer patients to access 999 for symptom management.
The most common symptom requiring use of JIC medication by a paramedic was breathlessness. Morphine was the most frequently administered medication.
In circumstances necessitating urgent symptom control where ambulance or a patient's own JIC medications were administered, 67% and 69% respectively of such patients were in the last 48 hours of life, highlighting the crucial role paramedics have in supporting patients at a critical time, and that unscheduled care 999 calls are not uncommon as patients near death.
Figures on the relative frequency of ambulance versus patient's own JIC medications being administered during the review period indicates morphine and midazolam were the most commonly administered medications (Figure 3). This information, in combination with Figure 2 and acknowledging that 67% of patients died within 48 hours of accessing 999, would indicate that symptoms of pain, breathlessness and agitation in the last days of life are not uncommon, and should therefore be anticipated when supporting or discharging EoLC patients into the community.
A full health economic evaluation including costs, outcomes and downstream effects of the introduction of JIC medicines in ambulances will need to be undertaken in the future to evaluate all costs and benefits of the new service.
The data captured, in terms of adverse events and health economics, supports JIC medications remaining available on ambulances as a symptom control option after the pandemic. Outcomes of JIC medicine administration indicate it to be effective as no patient who received JIC medicine was transferred to hospital.
Bowers et al (2019) state that ‘GPs and community nurses frequently recall situations where drugs were not issued in a timely manner’, resulting in the medicines not being available when needed. The introduction of JIC medications onto ambulances reduces inequity of access to these vital medicines for patients.
A process change regarding verbal orders is required as the verbal order process is said to be acceptable only in exceptional circumstances. As the NHS moves out of COVID-19 pandemic measures and moves to a recovery phase, patient group directives will be developed, allowing paramedics to administer these medications in emergency situations without need for a verbal order. Shared decision-making with a doctor will still be encouraged before administration.