University Hospital Southampton

At UHS the first step was to write a standard operating procedure setting out how the service would work. Other trusts that had established a home self-administration service for denosumab, including UCLH, provided support for writing this by sharing their process. The standard operating procedure then went through trust governance and the trust’s drugs and therapies committee for approval.

A patient information leaflet was designed with the support of the UHS publications department. Funding support from Amgen enabled the creation of a patient training video demonstrating how to inject denosumab safely. A checklist that could be scanned into electronic patient records was also developed for nurses at the cancer treatment centre to use when training patients to inject denosumab safely.

These documents and resources were created through a collaboration between the systemic anticancer therapy (SACT) advanced nurse practitioner team, pharmacy staff, medical oncology and nursing colleagues in the hospital’s cancer treatment centre. To bring the documents together and make the transition to self-administration at home easier, a ‘survival guide’ for prescribers and nurse trainers was developed. This described the complete process, including identification of those who wish to use the service, training patients, prescribing practices, who to notify to ensure that medicines and equipment are delivered to patients’ homes and patient follow-up.

Dorset County Hospital

The experience at DCH was different because there was already a precedent for home self-administration of denosumab. DCH employs a community-based metastatic breast clinical nurse specialist (CNS) who, alongside providing psychological support, reviews and monitors patients who self-administer oral SACT and undertakes toxicity assessment. If a patient was receiving denosumab at home, the CNS would administer this. Before the COVID-19 pandemic, when patients stopped taking oral SACT but continued having subcutaneous denosumab, a small number were taught to administer it under the supervision of the CNS.

In spring 2020, when the pandemic was at a critical stage, the trust wanted to minimise footfall through the hospital to reduce the risk of infection of patients and staff while maintaining the patient treatment pathway. Therefore, a standard operating procedure for administration of subcutaneous denosumab at home was developed and agreed with trust governance, the therapeutic drug committee and oncology consultants.

Training materials for patients were developed alongside the standard operating procedure, including a self-administration training booklet and a training ‘mat’ – that is, a paper mat that can be laid on a table on which patients set out the equipment they need, and which details the process of administration in easy steps (Amgen 2020). Informally, patients reported to clinicians that these materials were user-friendly and visually simple for the layperson to follow. The materials also assisted the CNS to train patients and/or their relatives, and when used in conjunction with the CNS’s skills and knowledge were regarded as valuable in educating patients about the medicine, including administration, storage and disposal. Patients were also given administration equipment.

Training patients to self-administer denosumab at home

Staff at UHS and DCH worked in different ways to teach patients how to self-administer denosumab. At UHS, patients came to the cancer treatment centre for two injection administration appointments. At the first appointment nurses demonstrated the process of drawing up and injecting denosumab, and at the second appointment they supervised the patient self-administering the injection. If the patient and the nurse felt confident that administration would be safe, arrangements were made to have the treatment at home. If the patient believed they needed more time they could attend another appointment.

At DCH, the presence of a SACT CNS in addition to the metastatic breast CNS, who work across the community and secondary care sectors, meant that patients could be trained at home as well as in the outpatient chemotherapy unit. This eased the transition from hospital administration to home self-administration. After two training sessions, during which the patient drew up and administered denosumab under supervision from a nurse, they were signed off as competent if both parties were satisfied. Patients retained the original sign-off sheet and a copy was scanned and uploaded to the electronic patient record.

The SACT CNS set up an outreach SACT telephone clinic to monitor and record denosumab self-administration activity. All patients who use the self-administration service have bloods taken on a Monday either at their GP practice, at hospital or at home by community nurses, and have an appointment scheduled with the outreach SACT telephone clinic on a Tuesday. An assessment by phone is conducted by the SACT CNS, the patient’s blood results are reviewed and a decision is made on whether to proceed with the injection on the Thursday. At both trusts patients received ongoing indirect supervision by phone and/or video calls from expert healthcare professionals, which reduced their anxiety.

For both trusts the involvement of Amgen was valuable. The company provided its own patient information leaflets, adapted to include information about the closed-system drug-transfer device, to complement trust-specific leaflets. It also connected the two trusts with others at which self-administration of denosumab was established so they could share their experiences.

At UHS it was felt useful to embed the denosumab self-administration service into existing processes. Setting up a separate clinic for patients self-administering denosumab at home was considered, but there was no capacity for this in the trust’s SACT advanced nurse practitioner or CNS teams. Therefore, it was decided that patients using this service would remain in their existing tumour-specific clinics. The clinicians who run these, who are either oncologists or SACT advanced nurse practitioners, retained responsibility for monitoring patients’ bloods and prescribing treatment.

Support from the oncology pharmacy at UHS was also valuable, as the project team could make use of processes that had been set up in response to the COVID-19 pandemic, for example an expanded courier service. Pharmacy staff could also assist with practicalities such as how to ensure that the screening pharmacist – who reviews and checks prescriptions – could identify self-administering patients. This was important to ensure that treatment was sent to patients’ homes. An icon was used on the electronic prescribing system to identify these patients and the prescriber would write a note on the tumour-specific clinic electronic outcome document – which is used to plan the next appointment – to alert administrative staff that the patient self-administered at home and therefore did not require a treatment clinic appointment. The expansion of remote monitoring by phone and video clinics in general in response to the COVID-19 pandemic meant that it was easier to support home self-administration of denosumab.

DCH subcontracted a separate pharmacy service to deliver medication and equipment to patients’ homes. A colour code was used on the electronic prescribing system to identify that a treatment was for home delivery. The pharmacy and SACT CNS would communicate weekly about which patients were due a delivery, or if there were concerns or delays.

Patient feedback

To assess the effectiveness of the process of self-administering denosumab at home, patients at the two trusts were asked to complete a short questionnaire after they had done it at least once. The questionnaire was developed with the assistance of the patient experience team at UHS using a template, with permission, from Cornwall Partnership NHS Foundation Trust. Patients were sent an electronic link to the questionnaire by email or text but could request a paper copy from the cancer treatment centre if they preferred.

Patients were asked about their experience of having denosumab before and after self-administering at home. There was also space for free-text responses. The number of patients who were sent the questionnaire link is unknown, but 14 completed and returned the questionnaire, which was anonymous. Table 1, accessed from rcni.com/denosumab-questionnaire, shows the denosumab self-administration questionnaire and results.

The project was considered a pilot of a service development and therefore research ethics committee approval was neither sought nor required.

Most respondents found travelling to hospital for their denosumab injection inconvenient and it sometimes caused them stress and/or anxiety. They also felt they often had to spend a long time in the hospital waiting for their injection. For one respondent, from leaving home until returning after their injection at the hospital took more than four hours. Some respondents had to take time off work to attend hospital for their denosumab injection and sometimes the person who accompanied them also had to do so. Respondents often had to pay for petrol, parking or public transport.

At DCH all respondents were retired, therefore attending hospital did not require them to take time off work or find childcare. However, many came a long distance because of the rural nature of Dorset and commented on the inconvenience of a long journey to attend a short appointment.

In contrast, most respondents found that waiting for denosumab to be delivered to their home was not inconvenient. Most respondents did not feel stressed and/or anxious about self-injecting at home, although some were nervous at the start of the process, and none believed that self-administration was time-consuming. Not all respondents administered the injections themselves and the task was often undertaken by family members. In general, respondents felt supported by the training process and all of them said they would prefer to continue self-administering at home rather than returning to hospital for injections. Some of the reasons for this are shown in Box 1.

Some challenges were highlighted by the patient feedback questionnaire. For example, at UHS the main issue for patients was obtaining administration equipment such as needles and syringes. One respondent stated:

‘Need to have an easier way of obtaining syringes and needles as always proves difficult in getting someone to arrange.’

The medicine is dispensed and couriered to the patient’s home directly from pharmacy, but this is not the case with the equipment. Patients reported having to visit the hospital to collect supplies, or even having to purchase the equipment themselves:

‘I have subsequently purchased my own needles and syringes as getting hold of new ones from hospital involved stress and needless trips to chemotherapy ward.’

To avoid these issues in future the equipment will be sent to the patient with the medication. One patient who has been self-administering for a long time reported that the processes had much improved since the pandemic, which is likely due to improvements in the remote provision of care in general since the pandemic.