Independent Review of Medicines Homecare in Scotland: review report and recommendations

Service design and patient care

Manufacturer-commissioned homecare schemes

Recommendation 12: There is a review of manufacturer-commissioned homecare schemes in Scotland. This is assessed in the context of the complexity and volume of these schemes, clinical considerations, and geographical variation to ensure that there are optimal schemes available to patients and NHS boards.

A key first step is to reflect on the process for approval of new medicines homecare schemes, and ensuring these are sustainable not only in their provision, but in their management and support by NHS Scotland. New schemes should be approved only when they add value to patients and/or NHS boards and have appropriately resourced oversight at local and national level, alongside governance processes including a Central Legal Office approved contract and assurance on sustainability.

We should also be clear that the development of community pharmacy as an alternative model, discussed further in this report, will have a longer-term beneficial impact on this area through enhanced management and diversification of the model.

A detailed, cross-stakeholder review of the current schemes is necessary. However, Scotland should be cognisant of the reality that these schemes are part of the wider UK market, and the need to influence at that level as discussed above.

There is a need to bring the strength of NHS Scotland as a commissioning entity to bear, reducing complexity and ensuring that geographical equity is a key factor in service development. The proliferation of homecare providers is not sustainable, partly due to total available staffing especially in remote and rural areas – this requires careful strategic management and engagement.

MAH-funded homecare provision is assessed on a “Once for Scotland” basis by the NHS Scotland Medicines Homecare National Governance Group. The National Services Register of approved homecare providers means NHS boards work to an “approved list.” In Scotland, due to the reactive nature of the governance process, there can be some challenges with fast adoption of services.” (Other)

"Providing equal access to healthcare services for citizens regardless of their location can make service delivery in some remote areas a significant challenge, particularly when demand for such services in these areas is very low.” (Other)

"Manufacture funded services can be under-utilised in some geographically remote areas. The uptake of services is difficult to understand as there is not a national feedback mechanism once a service has been approved by the National Governance Group.” (Pharmaceutical company)

Reviewing the complexity and volume of patient support programmes

Recommendation 13: A plan is developed to minimise variation in access to patient support programmes and to address the sustainability of these.

Patient support programmes (PSPs) are initiatives which deliver complementary services to patients which can help them to manage their care more independently. These programmes tend to be funded by a pharmaceutical company and delivered by a homecare provider.

It is acknowledged that there is a degree of complexity regarding the funding of PSPs. While the cost to the NHS may not be direct, and ‘bundled’ with the drug price, on the occasions where there is no direct need for a service this could potentially inflate the overall cost to the NHS. This is closely linked to review of MAH schemes (recommendation 12) and should be seen in the same context of holistic review and consideration.

PSPs are agreed for use in Scotland, at a national level through the NHS Scotland MHNGMG will review additional service elements where they are part of the homecare service and within the expertise of the group. National procurement retain a coordinating role within this review process. The NHS Scotland MHNGMG are only able to make recommendations within the scope of their expertise, which is currently only pharmacy, as described in Recommendation 1. The group is therefore unable to make recommendations on areas such as standalone nursing services. There are a small number of services being proposed where there is no available national review arrangement.

Each NHS board is responsible for conducting a local risk assessment and deciding whether there is sufficient demand for adoption. An individual NHS board also has the flexibility to deploy a PSP in the absence of a national approach.

The reality is that, while these schemes undoubtedly have value, the uptake in NHS Scotland is lower than would be expected, particularly given the capacity challenges within clinical services across the country. A strategic approach to increasing use in targeted areas, in line with appropriate governance and risk considerations, is desirable. This should be seen in the context of the governance recommendations, described throughout this report, which will drive safety and assurance in the use of PSPs.

Many of the issues described in this Review are linked to this volume and the challenge of managing this – stakeholder engagement, complaints processes and geographical disparity. However, we must also acknowledge that in some cases patients and NHS boards are now reliant on these schemes to deliver care, and that much of the care provided is of a high standard.

"Patient Support Programmes and add on services are being increasingly offered by manufacturers alongside the core homecare service. Currently the evidence for patient support programmes is unclear with further evidence needing to be gathered to establish if these do add value for patient care … it has been difficult to identify a national governance approval route for add on services such as phlebotomy (e.g. genetic testing for rare diseases), nurse support for disease measure scoring and nurse support for patient assessments in hospital.” (Other)

"Many add on services could be considered for appropriateness at board level if there was a clear ‘Once for Scotland’ service development approval process.” (Other)

"There is already a significant shortage of nurses in general. Homecare providers need to ensure this valuable resource is maximised to best serve patients, for example training suitable patients remotely via video call rather than defaulting to in person visits for all patients. It should also be assessed as to the level of qualification / experience required to deliver a particular service. For example, could healthcare assistants support subcutaneous injection training, reserving nurse resource for more complex services such as IV administration.” (Pharmaceutical company)

Recommendation 14: The approach to design and delivery of new medicines homecare services in Scotland is based on a robust analysis of service needs, to ensure optimum value and sustainability for all parties.

Responses to the Review Call for Evidence indicated the variation in medicines supply routes, how they are contracted and how associated care is delivered. We heard that patients across Scotland under the same secondary care speciality can receive different models of care.

There is variation across Scotland in adoption of more complex medicines’ homecare patient support programmes, where these involve clinical care (generally nurse led). It is also notable that Scotland makes significantly less use of these programmes than other UK nations, following risk assessments and consideration. Industry feedback suggests that there is some frustration that well-designed services are not being used in Scotland.

"Accessing pharmaceutical company commissioned services can offer the NHS advantages, for example an ‘off-the-shelf’ solution to quickly increase capacity to provide a new service. However, outsourcing also introduces significant risks and potential costs for the NHS over the long-term.” (Other)

There are a range of reasons for this, including concerns over governance (and we should acknowledge the difference in this picture between Scotland and England), the availability of nursing staffing, and potentially the cost.

The RPS guidance states that the homecare organisation contracting the homecare service maintains overall responsibility. The homecare organisation is accountable for its actions and where services are sub-contracted by one homecare organisation to another there is a cascade of delegated accountability, which ensures within each level, there is a designated person responsible for homecare services. [23]

The importance of planning care based on the individual, not the disease, should always be a core principle in NHS Scotland. Patients may have multiple conditions supported by homecare medicines and providers must consider their needs as an individual both clinically and logistically, avoiding multiple deliveries for different clinical conditions.

Environmental sustainability must now have a significantly higher place in decision making. The NHS Scotland climate emergency and sustainability strategy: 2022-2026 states that to become an environmentally and socially sustainable health service we need to embrace a circular economy, using our purchasing power to encourage our suppliers to cut their greenhouse gas emissions to net-zero and limit the negative environmental and social impacts of our supply chain. [31]

Clearly Scotland must acknowledge its position in a UK based marketplace, but there is a need for a more collaborative approach between homecare providers, commissioners, and board teams in the design phase.

"Patient registration has been flagged by members as a potential issue. Delays in getting a patient on the homecare system can lead to delays in getting started on therapy. One member company suggested that initial administration of the therapy in hospital could almost wholly eradicate delays in homecare registration. Whilst this may not be convenient for all patients, being able to offer ‘in-house’ initial administration might offer a solution to the problem when delays are identified.” (Other)

"If an existing [Medicines Homecare Service] (MHS) is available then as soon as the patient is seen in clinic and the registration and prescription forms arranged, they can be processed and posted to the provider within 1-2 days during weekdays, but it can take longer e.g. if received late on a Friday. If there is a problem with the prescription which requires intervention by the clinical pharmacist or if there is a need for it to be returned to the clinic, this can delay processing and posting the prescription for up to two weeks depending on the nature of the query.” (NHS board)

"Access to treatment will vary depending on the services managed by the NHS Board and the pressures therein at any given time. Whilst everyone is doing their best to deliver a highly complex service, it can sometimes be difficult to manage. Local governance and risk assessment processes can be time consuming and are detailed…An ever-increasing number of patients in remote and rural areas can make managing the resources required for delivery more challenging.” (Other)

Medicines homecare as an appropriate model for patients

Recommendation 15: A national consensus is reached for when medicines homecare is an appropriate care approach, in line with professional guidance.

The increasing complexity of the landscape and the clinical conditions treated by medicines delivered via homecare services is a challenge both for those with overall responsibility, and the clinicians who prescribe for patients using these services.

"Due to the increase in availability of medicines which are suitable for supply via homecare over the previous few years, the homecare team within our NHS board have struggled to keep up with the existing high workload alongside demand for new services. This led to lower priority services taking several months to set up, which in turn made some clinicians less likely to use these agents as they were only available directly through hospital pharmacy. Gladly his has now resolved and we can access homecare for all appropriate medicines.” (Individual healthcare professional)

There are varying views within and between clinical specialities regarding when medicines homecare is an appropriate approach for patients. A basic but revelatory example of this surrounds whether medicines homecare should be used during the initiation stage of a treatment – in some cases, clinicians only use medicines homecare services once a patient is stable. Others will begin treatment within a homecare service. The potential for delay in initiation, and the ramifications of this to patient care are well described above.

NHS Scotland should ensure that clinical groups identify best practice across the range of indications and circumstances in which medicines homecare is used. A uniform policy is unlikely to be appropriate, there are subtleties which require careful consideration by clinicians at the patient level. The need here is to identify and implement best practice, to the benefit of patient care.

"There are new products being launched constantly across all therapy areas, with an expectation in many areas that homecare should be offered as a supply option. Innovative new medicines have the potential to keep more patients out of the hospital setting and free up more hospital capacity. These medicines will need differing levels of homecare services to support their safe use, and to obtain their absolute potential. The NHS is in prime position to support levels of homecare appropriate to these solutions and to leverage the homecare services required to meet that potential.” (Pharmaceutical company)

Community Pharmacy and low technology schemes

Recommendation 16: Community pharmacy must be deployed as an alternative supply route within the medicines’ homecare model in Scotland. This should be developed based on clinical care provision and will require new contractual frameworks.

Recommendation 17: There must be no detriment to all stakeholders where community pharmacy is used as an alternative medicines’ homecare model.

Recommendation 18: There is a revised approach, designed with input from all stakeholders, to accepting manufacturer-approved low technology schemes in NHS Scotland. This should be implemented in parallel to developing and piloting alternative homecare models and should address service resilience issues.

Other UK nations have alternative models of supply, which are not available in Scotland. This limits the current options, particularly those which include the VAT saving described above.

In NHS England, the outsourced outpatients model involves a hospital contracting with a third-party pharmacy company to operate and dispense agreed medicines to outpatients and to provide homecare services. The benefit to this model includes reducing outpatient pharmacy waiting times, financial efficiencies, and the pharmacy staff redeployment to areas of need. [32]

Arrangements to support community pharmacy supply of secondary care prescribed medicines have been in place in the Republic of Ireland since 1996. Community pharmacies are supplied with specialist medicines free of charge for supply to patients. A central health service body pays the supplier directly after the medicines are dispensed. The arrangements have evolved over time; initially paper-based with no central oversight, there has been an online system since 2017 (known as the high-tech medicines hub) which supports electronic transmission of the prescription information from the hospital to the patient’s nominated community pharmacy, community pharmacy ordering of the medicines and financial reconciliation. [33]

The role of community pharmacy in the future of medicines homecare supply will be a key feature in ensuring a sustainable model. The increasing clinical role of community pharmacy, and its ongoing integration into the wider healthcare landscape (for instance, unscheduled care), makes the development of a community pharmacy homecare model an obvious solution to the complexity issues described, and a key component of a patient-centric model, given the spread of the ~1250 community pharmacies across Scotland.

However, there are several barriers which require to be removed before this becomes a viable option – and this should be seen as a notable change to existing contractual and operational arrangements. It is unlikely be a quick fix. Issues around cost, reimbursement, and tariff pricing must be addressed. But the potential of the model is extremely attractive.

Limited pilots have been undertaken over recent years, which shows that dispensing of specialist medicines in community pharmacy can be safe and effective, while improving patient care. One of the key components of a long-term model, will be ensuring that the acquisition cost of the medicine is at a similar level to the same cost in secondary care. This is a highly complex matter within the context of the drug tariff and the use of rebates, alongside other mechanisms previously tried. Indeed, in the case of the drug abiraterone, patients have been repatriated from community pharmacy to hospital pharmacy supply, due to acquisition cost issues. An alternative approach of central purchasing by the NHS with supply to community pharmacy would incur VAT and reduce the attractiveness of the model.

Community pharmacy must be appropriately resourced, reimbursed and staffed to make this both viable and safe. Due consideration will be vital around access to digital information, including patient records. The requirement for co-design of this solution alongside associated work on shared care is clear. Community pharmacy should be seen as a key and trusted partner – without this ethos there is a risk of additional complexity and failure to enhance the offering to patients. The network offers a route to developing the resilience of the affordable supply chain, which is vital to the security of patient care.

"There is scope to move supply of many of these medicines to community pharmacy with a view to more complex medicines being delivered via homecare companies. In general patients have a better experience when medicines are supplied by their chosen pharmacy.” (Other)

Low technology schemes are a reality of the medicines’ homecare landscape, but which require a mature and partnership-based approach to consideration and revision.

The pragmatic alternative is to view low technology schemes through the prisms of patient experience, workforce availability, fiscal impact and the opportunity for enhanced partnership working between organisations. The required development of the community pharmacy component of the overall model will undoubtedly be a crucial part of this solution. All stakeholders must consider workforce demands in this context – community pharmacy being well placed to support may relieve some of these concerns. Feedback has suggested that low technology schemes have been more susceptible to resilience issues – we have learned over the last five years just how robust and accessible the community pharmacy network is, and this strength should be brought to bear. Clearly this must be considered within the context of wider reform in community pharmacy, particularly around the extant contract and workforce planning.

This position is widely reflected in policy and strategy within NHS Scotland:

• By 2030, community pharmacies will be playing a more integral role in managing patients’ medicines for long-term conditions. [34]
• Over time community pharmacists will be enabled to play a greater role in managing people with long-term conditions by prescribing, monitoring, and adjusting medicines”. [8]

"Community pharmacy enhanced services, on the other hand, open up the possibility of the national network of pharmacies and can be individually tailored to the requirements of a given medication or patient group…Although there are issues that need to be overcome before these arrangements can be made … both the workload and the impact of residual cashflow following mitigations can be spread across a greater number of providers.” (Pharmaceutical, Medical, Nursing professional, regulatory or representative body).

Patient choice

Recommendation 19: Patient choice must be a key consideration when NHS Scotland and homecare providers work collaboratively to design models for medicines homecare services, in alignment with the varying delivery models and patient requirements.

Patients are at the heart of homecare services and should be listened to, offered choice on styles of homecare delivery, and be involved, to assist with monitoring of the quality of the service.” [17]

The above quote is from the Hackett report of 2011 and reflects the long-term requirement for patient choice within medicines homecare.

Organisations representing patients, including the ALLIANCE patient voice workstream, reported that the most common issues with medicines homecare relates to missed or incorrect deliveries and the timeliness of deliveries. This is multifaceted.

Logistically, someone needs to receive the medicine, and this is of particular importance in the case of refrigerated stock. Late or unscheduled deliveries cause issues both logistically and clinically for patients. While homecare providers will deliver to nominated locations, such as places of work, notification and communication must be to a high standard.

An understanding from all those involved in the supply process about the importance of peripherals, is of critical importance. Syringe-based medicines if provided without syringes, are effectively the same as having no medicine.

While many patients in Scotland live within a short distance of a secondary care centre which can support them in the case of a medicines related emergency, the design of services and indeed standards of care must be cognisant of those living in remote and rural areas. The standards demanded of homecare providers in these settings must meet the needs of vulnerable people who do not have easy access to appropriate secondary care.

There are several medicines which are used both as prophylaxis and in controlling a clinical exacerbation. In these instances, in particular, patients will retain a buffer stock of medicine. Consideration must be given however to the use during an exacerbation, when a supply of medicine which would ordinarily last four weeks, can be used in a matter of days. Prescribers and homecare providers must consider a patient focused context with an understanding of the patient’s clinical history, access to secondary care, and availability of deliveries which will naturally be different in (for example) the islands, versus the central belt.

"Since the end of the pandemic, the [Remote Nurse Training] service has expanded to enable patient choice in how they receive their training and has trained nearly 2,000 patients to self-inject medication remotely, to date, enabling over 20,000 additional hours of face-to-face nursing care, and saving an estimated 40,000 miles of travel, thus reducing our carbon footprint by four tonnes.” (Other)

Input from patients in design of services

Recommendation 20: Patients are fundamental to the design and delivery of medicines homecare services. A national patient forum must be established, which is embedded in revised governance and oversight approaches to medicines homecare in Scotland. This should align with wider work undertaken across the UK.

Throughout the valuable discussions with the Review Reference Group, and indeed conversations with a range of stakeholders, there was an emerging theme of the value of patient input into design of services, as a point of principle. However, it is equally clear that this requirement has not been optimised within the medicines’ homecare landscape. Pockets of good practice, particularly led by third sector partners and clinical groups, deliver valuable feedback and design input – but this is far from a ubiquitous feature of the services.

A significant part of the challenge in securing such input, is the broad range of patient stakeholder groups involved. There can be no doubt of the validity of this concern – when we consider the range of socio-economic groups, geography, clinical conditions, and accessibility requirements of patient groups even within a single medicines’ homecare service. Nevertheless, healthcare in Scotland (both NHS and commissioned in nature) must strive to meet this challenge and through enhanced and prioritised patient engagement, deliver improvements to existing services and more effective planning of future care provision.

“The Scottish Approach to Service Design states: “We seek citizen participation in our projects from day one”. [35]

“A single, overarching patient forum is certainly desirable. However, this must be linked to engagement at a service level and be accessible to all stakeholders (including territorial and national NHS boards, homecare providers, and commissioners), and be as inclusive as possible. It must also be engaged at both design and review stages. The Scottish Government Value Based Health and Care Action Plan states that “to deliver care that people really value, we must capture people’s experience of care and their interactions with their health and care professionals and act on their feedback to deliver more person-centred care”. [36]

"Following every tendering process, the transition from one homecare delivery service to another, is not/is minimally disruptive to patient care, and that the needs of the patients are always kept paramount when deciding, during the tendering process, on the most appropriate home delivery service.” (Individual healthcare professional)

Shared care

Recommendation 21: A Once for Scotland approach to shared-care of medicines is developed, agreed and implemented.

As noted above, the need for clear lines of governance and clinical oversight of care at a patient level has been established. Patients receiving medicines homecare often have complex needs, and the links between homecare providers, secondary care clinical services, primary care and community pharmacy must be appropriately robust to avoid clinical issues.

On shared care, the General Medical Council states: “Decisions about who should take responsibility for continuing care or treatment after initial diagnosis or assessment should be based on the patient’s best interests, rather than on convenience or the cost of the medicine and associated monitoring or follow-up”. [37] It is on this basis, that processes should be developed.

NHS Scotland continues to strive towards reducing unwarranted variation in services to patients, and medicines homecare must acknowledge the need to address this issue. In the context of this Review, the issue extends particularly within shared-care and clinical review. The existing variation in scope, scale and skill-mix of shared care identified across NHS boards and clinical areas, can be used as a strength as part of a rapid process to identify best practice in maintenance of clinical delivery at a patient level, and indeed the organisation design which supports this.

The role of primary care pharmacy (often referred to as pharmacotherapy) teams in this landscape will require detailed consideration and planning. On the surface, there has been multi-million-pound investment in the development of this service since the revised General Medical Services (GMS) contract of 2018. However, there is significant variation in deployment of this resource, both within and between NHS boards. Progress in development of systems, upstream process improvements, and in many cases the realisation of the clinical role of primary care pharmacy, has not kept pace with recruitment and expectation of the service. Nevertheless, this must remain a key component in the future model of shared care. A consistent national approach, with Scottish Government leadership, is likely to be required.

"I believe monitoring current homecare medicines in secondary care is feasible but if the patient numbers continue to rise there may need to be consideration given to alternative means of monitoring, whether in secondary or primary care.” (Individual healthcare professional)

"The patients may be monitored by their GP practice under a shared care agreement but due to issues with the GP contracts, some refuse this. They are therefore referred to ITRs (treatment rooms) to get their bloods taken by secondary care staff.” (Individual healthcare professional)

Regarding alternative supply routes

"Further develop the GMS contract to include shared care for appropriate medicines with medicine supply moved to GP10.” (NHS Board)

"Shifting services to primary care, potentially under shared care agreements could reduce pressure on acute services, release further efficiencies and improve patient care.”

Workforce planning

Recommendation 22: NHS boards and homecare providers must review their current workforce planning to ensure that there are appropriately resourced homecare teams (based on established evidence and best practice) to provide patients with high quality and person-centred services. This is underpinned by quality standards to ensure patient safety.

There is significant variation in the composition of NHS board teams managing medicines homecare. The Review notes that there does not seem to be clear correlation between the size and shape of the team, and either the population served by the board, or the volume of patients receiving medicines homecare. There are planning tools available, and it is important these are deployed, best practice identified, and consideration given to regional working where appropriate.

NHS boards should also be aware of the Health and Care (Staffing) (Scotland) Act 2019, which comes into force from 1 April 2024. [38] This specifies the duties and responsibilities which NHS boards must ensure that staffing is at a safe level, and that there are processes in place to oversee this and escalate where required.

The same must be true for homecare providers and commissioners of medicines homecare. The closure of a provider’s call centre previously located in Scotland (co-located with the company’s homecare dispensary) caused a level of anxiety for some patients. The centralisation to a centre in London has potential benefits around scale, particularly when considering feedback that the previous call centre often had delays in answering calls. However, the existing approach aligned call handlers to clinical conditions which allowed for development of expertise along with a relationship between patients and individual call handlers, which has now been lost. Naturally, a move where the call centre is no longer co-located with the dispensary is likely to reduce efficiency in resolving issues.

While much of the service provided to patients is at a high standard, there is a responsibility on all parties to ensure robust staffing and appropriate skill-mix is always in place, and that this continues to reflect the increasing volume of medicines homecare work.

"Challenges include the future growth of homecare services in health boards (both patient growth and new services) and capacity of homecare providers. There is already strong evidence that homecare providers do not have sufficient capacity to manage current workload and that there are challenges in staff retention and recruitment. Therefore, it seems likely that any further upscaling of services will further exacerbate these problems.” (NHS board)

"Current operational models are highly resource dependent and service levels can be impacted significantly by loss of resource. During the last couple of years, we have seen vendors experience significant operational disruption due to loss of call centre staff and logistics resource post Brexit, and loss of pharmacist resource. Nursing shortages have also impacted clinical services with one provider unable to accept referrals for nursing services for >6 months due to lack of capacity. Resource shortages can be short lived; however, it often takes significant time for the service levels to recover. This results in a general state of instability within the homecare market with all providers periodically experiencing operational challenges.” (Pharmaceutical Company)

One consequence of having multiple homecare providers can be a lack of service equity for patients depending on which provider they are referred to. There can also be variance in the level of service patients receive from the same provider depending on factors such as geographical location, impacting availability and timeliness of delivery and clinical services.

There is a need to reduce the time from referral to treatment initiation. In some cases, this is caused by the capacity issues and geographical variances described previously. The lack of e-prescribing across homecare also introduces avoidable delays and introduces a significant admin burden.

"If homecare company is experiencing challenges with supply or staffing this impacts on a large number of patients and it is challenging for us to revert to hospital supply. We have a number of examples of complaints raised with homecare companies regarding delayed treatment as a result of their internal issues which include workforce, processes and workload.” (NHS Board)

"Undertake evaluation of workforce needs to ensure there are sufficient specialist pharmacists in post to respond to clinical queries and achieve medicines optimisation, and pharmacy homecare technicians to handle administrative queries.” (Pharmaceutical, medical or nursing professional, regulatory or representative body)

"Patient numbers being registered constantly increasing with no review of capacity/services/drug use… Quantity of prescriptions generates significant administrative workload that is unfunded by the board.” (NHS board)

"I think homecare has the potential to work, but it seems to have grown too quickly without the appropriate infrastructure to support.” (Individual healthcare professional)

"Dedicated services would help with appropriate staffing levels to ensure clinical governance standards are set high and maintained.” (Individual healthcare professional)

"The rapid expansion of biologics and biosimilar medicines, medicines for orphan and ultra-orphan conditions and personalised medicines in the next decade will no doubt increase demand on homecare medicines services as it is likely that oversight and accountability for treatment will still sit with NHS secondary care.” (Pharmaceutical, medical, nursing professional, regulatory or representative body)