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

Recommendations

Improving the governance of medicines homecare

Policy oversight

Recommendation 1: The Scottish Government has well-informed policy oversight of medicines homecare services to more effectively enable the Chief Pharmaceutical Officer to discharge their responsibility for overall strategy, leadership and governance of medicines homecare. This:

• is underpinned by appropriately resourced and robust reporting mechanisms,
• includes a strategic NHS Scotland governance group with appropriate membership, role, remit, and accountabilities, and
• is supported by enhanced Scottish representation on the National Homecare Medicines Committee.

There are several components which contribute to well-informed policy oversight. Performance of homecare services is discussed at length by the conclusions of the House of Lords report of 2023 [18] and indeed the Hackett Report previously [17]. This point is symptomatic of a wide disconnect between policy leaders and operational delivery which must be resolved. There is no criticism to be made of the professional links between leaders in this field – rather the issue surrounds development of reporting mechanisms which lack depth, particularly considering the growth of medicines homecare over the last five years. [3]

Revised reporting mechanisms must reflect the highly clinical nature of medicines homecare, the growth which has been seen over recent years, the complexity of contracting arrangements, the need for wider stakeholder management (particularly patient input), and the importance of cross professional oversight of delivery and development (reflecting wider changes in the relevant clinical fields and roles of professional groups). Scotland does not operate in a vacuum in this area and must be highly cognisant of developments at UK level, engaging and influencing this process.

The NHS Scotland Medicines Homecare National Governance and Management Group (MHNGMG) is comprised of pharmacy professionals from both territorial and special NHS boards in Scotland. This is a group with considerable expertise in the pharmacy component of medicines homecare and provides a forum for sharing of intelligence and best practice across NHS boards, alongside a key link between those with operational oversight in NHS boards and those managing contracts within NHS NSS.

Nevertheless, there is a gap in the strategic space across Scotland and a need to ensure this, or a revised forum, is opened across professional boundaries and is either informed by or inclusive of patient representation. Similarly, this must be linked to revised national oversight, considering both policy linkages (whether that is via attendance and/ or reporting), and regulatory linkages as the role of organisations including the Care Inspectorate, the GPhC and Health Improvement Scotland (HIS) is clarified and enhanced. The existing group provides a solid foundation which should be built upon, with due appreciation for the considerable contribution it continues to make.

It became clear in dialogue with homecare providers and commissioners, that while the medicines homecare market across the UK shares many commonalities, particularly around the design and aims of services, there are elements which are either unique to Scotland, or significantly more prevalent than in the other UK nations.

In this context, there was also a variety of views regarding the need for and benefit of a single identified individual within the policy landscape who should have overall responsibility for the direction of medicines homecare in Scotland. It is notable that the House of Lords recommended such a post for NHS England: “NHS England should designate a senior, named person with responsibility for the homecare system. That person should be given sufficient powers and resources to discharge that responsibility.” [18] NHS England in its response, accepted this recommendation. [25]

For Scotland, the Review has carefully considered a range of stakeholder views are accounted for in recommendation 1. The Chief Pharmaceutical Officer will continue to have a key oversight role and discharge this responsibility through other senior leaders in the system.

The NHMC is the UK-wide body which provides oversight and direction on development of medicines homecare services. Scotland is represented through one seat, held by NSS national procurement. This representation has provided valuable engagement, and the backwards feed is undertaken through the national procurement seat on the NSMHNGM Group. However, given the complexities unique to Scotland (for instance the rural geography, the policy differences, and the direction of clinical and professional development), there is a need to better represent Scottish interests on this group with appropriate additional seats. This should be seen as an opportunity for all parties to learn and collaborate, where clearly Scotland has a lot to offer in this area. Scotland must be a key collaborator in future development of the NHMC, working in close partnership with other UK nations and stakeholders.

"We … hope that this will result in homecare becoming part of the broader NHS Scotland health policy strategy with central accountability for homecare medicines.” (Homecare provider)

Clarity and leadership

Recommendation 2: A Once for Scotland approach must be taken to define and improve role clarity for senior leaders across organisations involved in medicines homecare including clarity of delegation, governance, accountabilities, and responsibilities.

We must be clear on the difference between accountability and responsibility in the context of healthcare. While clinicians, and NHS boards as organisations, can delegate responsibility of care provision to commissioners, they cannot delegate accountability for the overarching safety and efficacy of these services. In this context, role clarity for service leaders is necessary in the design of medicines homecare governance.

Currently, while there is an expectation that Directors of Pharmacy (Chief Pharmacists) have accountability for provision of medicines within their respective NHS board areas, the way this accountability manifests is variable, and the actual oversight and associated mechanisms lack cohesion. While good practice exists, this must be identified and made uniform across the country such that all patients in Scotland benefit from a robust and consistent standard of oversight.

Similarly, there is a need to deliver clarity and consistency in the roles of nursing and medical leaders within NHS boards and Scottish Government, in the context of medicines homecare, ensuring alignment between professional groups and their respective responsibilities.

The next logical step is to align this oversight and accountability to the delegated responsibility given to homecare providers. This requires a review of the existing contractual approaches within the context of the oversight described above – all parties must fully understand what they are signing up to.

This leads finally to the requirement for failure standards and associated remedies to be clear, and enforceable. Moreover, all parties should be in no doubt as to how these will be enforced, by what measurements and crucially by whom. This measurement approach must be built into the development of KPIs, discussed in detail below.

"Review, streamline and establish clear lines of accountability that include greater enforcement mechanisms to improve the overall safety, efficiency and effectiveness of the regulatory system.” (Pharmaceutical, medical, nursing professional, regulatory or representative body)

"There is no accountability for poor performance from homecare providers.” (NHS board)

Regulatory model

Recommendation 3: A well-defined and transparent regulatory model is agreed for medicines homecare in Scotland with robust governance and clear delegation, accountabilities and responsibilities, at all levels.

There is contrast in the regulatory landscape between the UK nations. The GPhC and Care Inspectorate (CI) have clear roles in pharmacy and nursing/ agency regulation respectively, but the role of the CQC to regulate homecare providers in England, is not appropriately covered by an agency in Scotland. The CI regulates the small number of medicines homecare services that also function as a nurse agency service and it is noted that where there is a concern about a service’s ability to meet required standards it can make requirements and areas for improvement to the service but not to the wider health professional team [26]. The CI has no role or remit in the regulation of the medicines provision and supply of these services. This is a clear gap which affects the standards and assurance for Scottish patients.

More broadly, the House of Lords inquiry 2023 found that “the regulatory model for homecare is failing to ensure the safety and quality of patient care” and advised that “the Secretary of State should review the regulatory regime for homecare medicines services”. [18] The inquiry report makes clear the need to have a lead regulator overseeing the full picture of services, which is currently lacking. [18] The UK Government noted in response that they will set out further steps in this area in summer 2024.

There is little evidence that the regulatory position in Scotland is any stronger than in England – indeed the gap relating to the CQC role strongly suggests that it is weaker. However, the solution to regulatory reform is unlikely to be resolved by a solely Scottish solution, and ongoing cooperation between UK nations is required, lest an uncoordinated set of changes lead to greater confusion and disparity for organisations and patients. Within this context, there are links to complaints processes, also discussed further in this Review. The confusion experienced by patients in knowing which regulator to contact with a complaint is a significant concern and strengthens the case for an overarching sense of clarity in regulation, through a lead regulator.

Healthcare Improvement Scotland

Healthcare Improvement Scotland (HIS) is a national special NHS board, whose role is to “enable the people of Scotland to experience the best quality of health and social care”. HIS undertakes regulation of independent hospitals and clinics, inspects NHS services and sites, supports the engagement of people in shaping health and care services, and provides quality assurance to NHS Scotland. [27] HIS currently has a limited role in the oversight and governance of medicines homecare in Scotland.

"There is a lack of clarity regarding accountability and enforcement of standards in relation to the quality, cost effectiveness, safety, and reliability of homecare medicines services at a national, regional and local level.” (Patient group)

"There is limited engagement between the NHS and regulators. With multiple regulatory bodies having a role in the regulation of homecare, there would be value in exploring options for a more joined-up approach both across the regulators and working with the NHS.” (NHS board)

Key performance indicators

Recommendation 4: Scotland should take a key role in the development of medicines homecare Key Performance Indicators at UK level which focus on the quality of patient care and are linked to enhanced governance and stakeholder engagement and management.

It is appropriate for NHS Scotland, to fully exercise its duties in ensuring that the people of Scotland have optimal outcomes. This is particularly important in its relationship with external partners. However, both industry and NHS leaders have been clear on the importance of a UK-wide approach to development of KPIs for medicines homecare. Rather than being discounted due to the relative proportion of patients served by homecare in Scotland, Scotland should play a leading role in this development at UK level, linked (as described above) to enhanced representation on the UK-wide group.

KPIs cannot be viewed in isolation from the wider homecare performance monitoring framework which includes other sources of information, for example, complaints and patient satisfaction data. This is of course linked to the organisations and individuals with responsibility for oversight, described above.

The current KPIs are widely viewed as not fit for purpose. Their development appears to have been based on data currently and relatively readily available, rather than what is required for modern, care-centric oversight of such a critical service. The sheer volume of them also speaks to an uncoordinated approach.

The ethos for renewed KPIs should start with the quality of care provided to patients, and the overall patient experience, consider the key business requirements of NHS boards and Scottish Government as the funding organisations, and provide oversight of the efficiency and sustainability of those delivering the service. Crucially, they should be openly available to all partners including the public and meet the needs of commissioning companies also. There must be thought given to the work of NHS boards in initiating medicines homecare, and indeed on the delivery of clinical review by NHS teams.

Stepwise changes should be delivered in this area. Undoubtedly development, particularly around data capture, will be required – but this should not delay rapid improvement within a revised framework and ethos as described above. We can do better immediately, and we can continue to improve over the coming months and years.

"Make data publicly available on the quality, reliability and safety of homecare medicines services and that information around patient safety is independently verified. KPIs should record missed doses and time it takes to initiate new treatments.” (Pharmaceutical, medical, nursing professional, regulatory or representative body)

"To build confidence and improve accountability, a framework of metrics coproduced with patients and clinicians with a transparent reporting mechanism should be developed. The KPIs should include patient choice, patient involvement in procuring, operational delivery and service monitoring, clear information and communication to patients.” (Patient representative group)

"It is currently impossible to ascertain a clear picture of the reliability and safety of services provided.” (Patient representative group)

"Coming to an objective and holistic view of access to medicines for patients is challenging, due to the lack of publicly available and verified performance information. However, one thing is clear – that both patients and clinicians report corroborating experiences of poor access to medicines across the country.” (Pharmaceutical, medical, nursing professional, regulatory or representative body)

Appropriate new opportunities for medicines homecare schemes

Recommendation 5: In line with a reviewed access to medicines policy, service planning related to horizon scanning of new medicines, changes to the licensing of existing medicines, and supply routes is undertaken nationally to ensure that new opportunities are exploited to the benefit of patients and all other stakeholders, in a coordinated and robust manner.

One of the benefits of medicines homecare from the perspective of medicines management, is the ability to rapidly deploy new products through this route. However, this can result in medicines being supplied through homecare where another route may be more sustainable in the medium and longer term.

There should be an appreciation that medicines homecare is not a silver bullet for implementation of new medicines and that the resource and opportunity to exploit it is not infinite. Part of an improved overall model will be greater planning and horizon scanning around new medicines, coupled with an enhanced level of cross-system consideration before new medicines homecare schemes are launched in this context. This extends to whether new indications for existing medicines should be included in medicines homecare services.

The issue is significantly wider than governance of medicines homecare, extending to wider access to medicines. The current system whereby approval of a medicine for use in Scotland by the Scottish Medicines Consortium (SMC) is followed by a 90-day period for territorial NHS boards to consider local access, is undoubtably challenging. Improvement is likely to be led by enhanced horizon scanning and planning functions within NHS boards’ medicines management teams. Additionally, a review of the current CEL 17 position [28] is needed regarding access to medicines and the affordability considerations.

"In future, attention should be given to NHS commissioned services, as by using generic and biosimilar medicines effectively will further reduce costs. Shifting services to primary care, potentially under shared care agreements could reduce pressure on acute services, release further efficiencies and improve patient care.” (NHS board)