British Society for Rheumatology - Written evidence (HMS0001)

Public Services Committee: Written Evidence from British Society for Rheumatology (BSR) on Homecare Medicines Services

About the British Society for Rheumatology (BSR)

BSR is the UK’s leading specialist medical society for rheumatology and MSK professionals. We support our members to deliver the best care for their patients to improve the lives of children, young people and adults with rheumatic and MSK disease. Our members represent the entire multidisciplinary team (MDT), and together they form a powerful voice for paediatric, adolescent and adult rheumatology in the UK.

Key messages

• The BSR has called for a review into the safety of Homecare Medicines Delivery providers.
• Patients report instances of missing or delayed doses of vital medicines, which are necessary for their well-being.
• These delays and missed doses raise concerns about irreversible long-term health damage, increased outpatient activity, and additional pressures on already stretched rheumatology teams. 
• BSR would like to see the recommendations and themes raised in this submission - around workforce, e-prescribing, accountability and enforcement, communication and sustainability – considered in said review.

Background and introduction

BSR is concerned with the safety and performance of homecare medicines services in the UK. In August 2022, BSR surveyed its members regarding their experiences of homecare medicines services. They reported:

• Paperwork being signed as received by the homecare provider and then going missing.
• Delays between receiving paperwork and then providers contacting patients.
• Delays in patients receiving medication.
• Delays in arranging a nurse visit.
• Deliveries or nurses not arriving when scheduled.
• Repeat prescriptions not requested by the provider.
• The provider app not working.
• Patient calls or email to providers not responded to.

Updated snapshot of BSR members experiences

We resurveyed members about their experiences of homecare care services between January - June 2023. We received 56 responses, from clinicians representing 48 (23%) of all NHS Trusts in England (not including Ambulance trusts). 84% of respondents said they had experienced issues, with most respondents as recently as June. Asked to rate the overall performance of homecare medicines services this sample awarded an average of two stars out of five.

Emerging themes in recent evidence:

• Patients still reporting missing or delaying doses, impacting psychological and physical wellbeing.
• The survey sample found:
• an average of 9 patients missing doses per month per submission (range from 0.5 to 70).
• A lack of contact with new patients and delays in registration and delivery, with an average delay of 6 weeks for patients starting new medications (responses ranged from 2 to 24 weeks)
• Members report that this has resulted in flares and less well controlled disease amongst those patients affected, increased anxiety, and an increased use of steroids.

“It’s ongoing issue with delays up to 6 weeks to start medication and patients calling and needing more bridging steroids to get them through” Anon member, 2023 BSR Survey.

• Continued impact upon clinical time

“We are a small service and deal with 2-3 calls a week sometimes more. Each call can take 30 mins to 1 hour by the time you get through and I only work 12 hours a week so seems like a waste of nursing time!” Member, BSR Survey

• The survey sample found:
• average of 7 patient queries per week relating to Homecare (range 1 to 25).
• over 5 complaints reported per month on average (0 – 15 range).
• Issues with issuing prescriptions and wrong devices being delivered also reported.
• There is a continuation in volume of distressed and anxious calls to the nurse advice lines, secretaries and other admin staff within teams, acting to increase the workload of already stretched clinicians, who are diverted away from critical clinical work to time consuming tasks such as chasing up referrals and arranging deliveries/nurse education that homecare services should be providing.
• The survey sample reports higher workloads, increased overtime and poorer mental health amongst clinical staff which has both well-being and patient safety implications.

“I have had around 5-10 patients where medicines delivery has been delayed or missed alongside repeat prescriptions not been sorted in time. these patients ring the helpline, and we direct their concerns to our pharmacist who is overwhelmed”. Member, BSR Survey.

• Teams forced to take steps to proactively mitigate and reduce systemic issues Hospitals are forced to take steps to proactively manage issues before they happen, including mitigation efforts such as issuing first treatments from the hospital and/or providing extra medications, employing courier services to deliver medications or starting treatment as an outpatient. Anticipating shortfalls and implementing workarounds is nether best practice nor an optimum use of resources, especially when it comes at additional financial and staff costs to the NHS. (See section on sustainability).

“Huge delays in getting drugs out to patients, they promise it is within 10 working days, but this doesn't happen.  Rheumatology Nurses have to start all treatment in hospital now and issue an 8-week supply of medication to prevent flare of disease. Impact on nursing team and prescribing team is immense” Anon member, 2023 BSR Survey

What impact do these issues have?

These innovative, expensive and highly controlled medications treat incurable conditions like Arthritis, Lupus and AxSpa and give children and adults their quality of life back. They’re usually prescribed to unstable patients with moderate to severe disease when other first line treatments have not worked, or when the side effects of other medicines are unmanageable. The medicines help to bring about remission or better manage symptoms, enabling people to learn, work or raise families, as well as reduce pain and fatigue. The efficacy of the medicines depends on them being taken at regular intervals. Delays in taking medication can affect how well they work or increase the likelihood they may stop working. 

Gaps in medicine supply significantly increase the risk of flares in disease activity, particularly in patients early in their treatment. Early and timely treatment is vital in establishing disease control; untreated disease or delays in initiating treatment/switching drugs can lead to long-term and irreparable joint damage and, in severe cases, can permanently affect a patient’s quality of life. This is turn can increase avoidable outpatient activity and in severe cases leads to expensive hospital admissions, as well as time off work and inability to undertake caring responsibilities.

Missed or delayed treatment cause the immuno-suppressant qualities of their biologic medicine to wane and the immune system to return to its previous activity of attacking a patient’s healthy cells. A study of biological adherence in Inflammatory Bowel Disease (IBD) patients found that those who delayed refills of their subcutaneous biologics >2 days on average every 2 weeks had significantly increased risk of flare (relapse).6 Flares can be treated with steroid therapies in the interim as a bridging gap, but these therapies come with their own risks (osteoporosis, psychosis) and can only be effective in limiting damage if administered quickly.

THEMES FOR THE COMMITTEE TO EXPLORE

Standards and codes of practice

In the wake of the Hackett review (2011)[1] and since 2014 the following standards and codes of practice have governed homecare medicines services:

We believe it is timely to revisit and review the 2014 RPS Standards to reflect a different health and social care landscape, innovation in medicines and digital transformation. We therefore welcome their recent announcement to review Standards. As part of this review, we would ask that the Standards defining and framing patient safety are given particular attention. As currently presented, standards around patient safety are framed in terms of monitoring adverse reactions, as well as medication and device safety. BSR would like to see a greater and more equal emphasis on patient safety in terms of missed or delayed doses of medications, and lengthy waits for new medications to be started based on evidence outlined above.

Recommendations:

• In consultation with stakeholders, the Royal Pharmaceutical Society revise the current standards with a greater emphasis on reducing missed doses and reducing delays in new medication initiation.

Questions:

• Do the Standards reflect what matters most to patients?
• Do the Standards adequately address the safety concerns about missed doses and long-waits for treatment initiation?

Accountability and enforcement

The current model of both procurement and delivery of homecare medicines services is characterised by an excessive level of complexity. This has led to a lack of clarity regarding accountability and the enforcement of standards in relation to the quality, cost effectiveness, safety, and reliability of care at both a national, regional and local level.

Clinicians feel this most when relating the difficulties they face when trying to navigate some homecare customer services and being passed from one department to another. Where services are poor, clinicians say that they are seeing the same issues time and again and can feel there is no sign of resolution in sight.

When Key Performance Indicators (KPIs) indicate that service levels are not to the standard expected across multiple NHS Trusts, the National Homecare Medicines Committee (NHMC) enacts a Supplier Engagement Escalation Process notifying each Chief Pharmacist (responsible officer) and if necessary, the regulators. A provider’s position may be suspended or terminated. We understand that the NHMC has exercised its escalation powers several times over recent years, with a provider only recently coming out of this process. However, our sample survey indicates problems in the system across the country persist as recently as June. Given that the NHMC does not hold any enforcement powers, there are questions to be asked about how effective this escalation process is.[2]

This is further complicated by the way in which services are commissioned. The contracting of Manufacturer Funded Homecare Services (MAH) is established through a contract with one or more homecare providers. These are confidential commercial agreements, and the NHS is not a direct party, creating ‘a chain whereby the homecare provider must operate in accordance with agreements with both the NHS trust and the Marketing Authorisation Holder: this can present challenges from time to time’.[3] However, manufacturers are not expected to play any enforcement role in the contractual relationship between a Clinical Referring Centre and their selected Homecare Provider.

Adding to this complicated emerging picture of homecare services is several regulators – the CQC (focused on care and nursing), General Pharmaceutical Council (prescribing) and MHRA (medicines) - each with their own very distinct responsibilities and enforcement powers. The CQC has exercised their powers on several occasions in recent years (working with GPhC). However, it is unclear how these bodies work and share information at a local and regional level, and with the NHMC. We welcome the Committee’s exploration of the effectiveness of these arrangements.

Furthermore, as our evidence will demonstrate, that although some issues are localised, there are a number of striking policy and systemic issues - such as IT and workforce - that must be driven and resolved at a national level, and again it is unclear who is holds ultimate accountability for these broader issues.

The overall picture suggests a vacuum of holistic oversight and a toothless enforcement culture. The consequences of which are a cyclical pattern of dysfunction and a failure to build a resilience within the sector that delivers excellent standards for every patient and every NHS trust.

Recommendations:

• Government commits to reviewing, streamlining and establishing clear lines of accountability that include greater enforcement mechanisms to improve the overall safety, efficiency and effectiveness of the system.

Questions:

• What steps are taken to ensure that homecare providers are accountable for maintaining the required standards, and what are the consequences for non-compliance?
• Is the current system effectively holding providers who do not meet standards to account?

Communication & Customer Service Culture

Communication between patient and provider, and rheumatology teams is poor, according to surveyed BSR members. This has compromised the reliability of the service, leading to inconsistent information from providers and further delaying response times to incidents and complaints.

Patients, unable to get a timely response from homecare providers, are increasingly redirecting their queries to hospital email and telephone helplines (as previously outlined). These hospital emails and telephone helplines are intended to serve patients requiring urgent advice. These communication issues with the providers are putting further pressure on teams, especially clinical nurse specialists and pharmacists, and adding to existing workloads.

Clinicians are often asked to chase prescriptions that have already been submitted and our members have told us that when prescriptions get delayed or go missing call centre staff in Homecare Services attribute blame to the prescriber for the lack of a script. This is undermining patient’s confidence in the service and ultimately the NHS. Clinicians are then going to extreme lengths to prove that prescriptions have been issued and sent to get the patient’s medication dispensed by the provider – often for the provider to later find the prescription was on their premises, but not processed.

Recommendations:

• Government should review the system to reduce the number of complaints that are misdirected to clinical teams. Ensure there are sufficient complaints reporting and resolution processes in place, ideally digitally (e.g., Electronic Prescribing and Medicines Administration (EPMA), that resolve customer/clinician concerns whilst reducing the extensive administrative burden on clinical teams.

Suggested questions:

• What are the current providers’ response time targets for patient complaints and incidents and to what extent are they meeting these targets?

Complaints system

Recent Guardian and ITV reports have shone a light on widespread patient complaints, as well as how difficult it is for patients to get these complaints formally recognised. Formal complaints and incidents (for the purpose of KPI reporting) are defined as “where a written response is requested and/or direct notification of the incident to a regulatory body (e.g. CQC, HSCIC) or escalation to an outside agency (e.g. child protection, police) is required”.[4] The process (as pictured above) categorises some patient complaints as ‘incidents’ rather than formal complaints, which means they are not escalated to ensure timely and satisfactory resolution of the issues. Patient issues raised on Trustpilot or NHS website reviews (as referenced by the Guardian[5]) or complaints via the provider’s customer service phoneline are unlikely to be captured as complaints for reporting purposes.

Formal complaints are also counted “as "1" irrespective of the number of specific incident type definitions that are triggered within that C/I (complaint/incident)”.[6] If one patient makes multiple complaints, the system will only capture it as one complaint with additional incidents going uncounted.

Currently, the formal complaint system vastly underestimates the problem with many complaints going uncounted in the KPI reporting process. This means that the CQC and its partner agencies are not getting a full picture of the extent of the issues, and this compromises their ability to assess the service. This process needs to be more transparent to ensure patients and clinicians understand how to raise a formal complaint and so KPI reporting is reflective of patient and clinical experience.

Recommendations:

• Government to review system of complaints and make data publicly available on the providers’ websites.
• Provider to review with stakeholders how they communicate their escalation process to satisfactorily resolve issues.
• Patients and clinicians need to be made aware when speaking with provider’s customer service teams when their complaints are not registered as formal complaints and categorised as incidents and therefore not being formally escalated.

Suggested questions:

• How effective is the current system in addressing and resolving complaints in a timely manner?
• How is the complaints system integrated with broader efforts to improve the overall governance and regulation of homecare medicines services?
• What role do regulatory bodies, such as the Care Quality Commission and the General Pharmaceutical Council, play in overseeing and addressing complaints within the homecare medicines services sector?
• Are there any efforts to improve the transparency and public reporting of complaints, outcomes, and actions taken by the homecare medicines services providers?

IT interoperability and e-prescribing

BSR members report that many homecare medicines services still rely on a paper based prescribing system and the postal service. The administrative burden of paper-based prescribing takes clinicians away from patients, and pharmacy professionals away from medicines optimisation and safety oversight. Homecare medicines services have also been affected by recent postal strike action. This has implications for efficiency, quality and safety, and contributes significantly to some of the issues raised above.

Currently, relevant prescribing information is not linked to electronic health records or shared between secondary care or primary care (this raised issues when GPs were trying to identify clinically vulnerable people during COVID). This impedes the ability of those working in the NHS to track longitudinal data linked to outcomes and safety.[7] The NCHA state that this state of affairs reflects that “existing guidance and regulation were never intended to cover clinical and medicines homecare services, and this provides an interoperability challenge”.[8]

BSR are calling on the government to enable homecare medicines services to move en masse to an Electronic Prescribing System. According to a response to a parliamentary question, this work is at an ‘advanced stage in preparation for consultation with NHMC during 2023’.[9] While this is welcome, it is unclear when e-prescribing will become a reality for clinicians. While waiting for the NHS to implement a system, individual homecare companies are trying to work on e-portal prescription submission, but this needs to come from the NHS centrally. Clinicians are concerned about the proliferation of non-interoperable databases, apps and IT systems, creating a need for constant education and training. The NHMC which states that it does not normally recommend nor endorse the development and provision of Manufacturer bespoke IT platforms.[10]

Recommendations:

• Government commits to publish a firm timetable to move homecare medicines services away from a paper based prescribing system, addressing any outstanding regulatory barriers that currently stand in the way.
• Where electronic prescribing is made available, training and new processes are co-produced and delivered with clinicians.
• Registration (at the point of care) and prescribing processes use digital solutions that reduce the administrative burden upon clinicians.

Suggested questions:

• What percentage of Trusts can use an electronic prescribing system which is interoperable with a homecare medicines services provider?
• When will rheumatology teams be able to use e-prescribing for prescriptions for homecare medicines services?
• What are the current barriers to implementing e-prescribing in a homecare setting?

Workforce

There are widespread workforce issues within homecare medicines services, which contribute to many of the issues. There is a high attrition rate among providers’ trained customer service staff. Providers have reported that employing and retaining delivery drivers has been challenging, and that the availability of vehicles post-Brexit has complicated this. Like the NHS, providers also struggle to employ and retain nursing, pharmacy and technical clinical staff. This is because both the NHS and homecare medicine providers are recruiting from the same limited pool of clinically trained staff.

Within NHS trusts, specialist clinical pharmacists need to be focussed on clinical duties and medicines optimisation, but issues with providers’ services have led to an increasing number of administrative duties, detracting from clinical work. The Carter review found that the more time hospital pharmacists spend on clinical services rather than infrastructure or back-office services, the more likely medicine use is optimised.[11] More specialist clinical pharmacists are needed to make informed medicine choices, secure better value, and deliver better patient outcomes.[12]

Recommendations

• Government should undertake a review of workforce capacity, including in Homecare Services to ensure that it matches current demand and predicted growth in the market.
• NHS ICBs should 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.

Suggested questions:

• What impact do shortages and vacancies have on homecare medicines services?
• Will the Long-term Workforce plan consider workforce planning vacancies and shortages in healthcare roles within homecare medicines services?

Sustainability & Resilience

Since 2011, the utilisation of homecare medicine services in England has surged by 150%, with an estimated 500,000 individuals currently using these services. It now accounts for approximately £2.1bn or 30% of the NHS secondary care medicines budget and it is estimated that this would rise to 60% if extended to all medicines known to be suitable for homecare. It has been over 10 years since the last review of the sector and since Government is committed to deliver more services closer to home for patients, it is vital to reflect on the current sustainability of the sector:

• Cost-effectiveness:

Much has been said about the cost effectiveness of homecare medicine services, but this hinges on their efficiency and effectiveness. If rheumatology teams are repeatedly pulled away from clinical work to deal with the administration of homecare and pharmacists taken away from medicines optimisation and safety, as our members tell us they are, these predicted cost savings in reducing outpatient activity will not and cannot be achieved. It is essential to ensure that these services are efficient, productive and deliver value for money.

 “Prescriptions are taking up to 8 weeks to arrive with the patient meaning delays in starting / switching medication. This impacts on nursing team who have to start all patients on treatment and supply medication from hospital.” Anonymous member, BSR survey

“I have lost count of the amount of patients we have had to start on our own hospital pharmacy supplies” Anonymous member, 2023 BSR survey.

“We have resorted to prescribing from pharmacy on a number of occasions, a cost that then is increased to the NHS through VAT … but also pushing increased administrative and dispensing burden further to the NHS and pharmacies who shouldn't need to hold stock of these items.” Anonymous Member, BSR Survey 2023

• Patient satisfaction and positive health outcomes:

If patients become increasingly dissatisfied or experience poorer health outcomes, there may be a higher likelihood of individuals seeking alternative treatment options outside the homecare medicine system. To promote sustainability, it is crucial to continuously monitor patient feedback and strive for patient-centred care that improves service quality and overall health outcomes.

“a lot of patients are reporting that this has happened multiple times and one patient has stated that he would rather change a medication that is working well for him than deal with the homecare company” Anon Member, BSR Survey 2023

• Sustainable workforce:

“We have a pharmacist in post for the last year that has managed to decrease the volume of complaints”. Anonymous Member, BSR Survey 2023

The availability of an adequate and sustainable workforce is essential. Shortages and vacancies in the homecare medicines sector, NHS homecare medicines teams and rheumatology teams can hinder its sustainability and resilience. To address this, innovation and the development of administrative and clinical roles within homecare medicine teams can help optimise the MDT workforce and ensure its long-term viability.

• Adequate infrastructure:

Ensuring that the necessary infrastructure is in place is vital for the long-term sustainability of the system. This includes robust systems for medication storage, transportation, and handling, as well as effective communication channels among healthcare providers, patients, and caregivers.

Recommendation:

• Government undertakes an assessment of both the current resilience and long-term sustainability of the sector to ensure that providers can keep up with the pace of expansion.
• Government to examine the VAT issues that clinicians have raised around the in-house provision of homecare medicines services.

Suggested questions:

• Is the current rate of growth in demand for homecare medicines services sustainable?
• What do you see as the greatest risks to the sustainability of homecare medicines services?
• How can greater resilience within Homecare Services be delivered as the patient pool and introduction of new medicines and devices continues to grow?

Data transparency

We have found limited public data on the performance of homecare medicines services, making it difficult to get a clear picture of the reliability and safety of services provided. The KPIs agreed within the RPS Standards are currently not publicly available. Best practice guidance recommends that providers undertake a patient satisfaction survey yearly to ‘allow benchmarking between organisations and homecare providers’.[13] However, finding a complete picture of these survey results is challenging.

Recommendations:

• Government commits to review and co-produce with stakeholders a simplified framework of KPIs.
• Government commits to making data publicly available on the quality, reliability and safety of homecare medicines services and that information around patient safety is independently verified.
• Providers commit to investing in gathering feedback from patients and increasing survey return numbers.

Suggested questions:

• Are there any plans to increase the availability of data in the public domain?
• What is the scale and impact of missed and delayed medication doses?

• What is the common contractual agreement for new prescription registration and processing? What percentage of services/customers meet this contractual agreement?
• When problems arise in the system how long does it take to fix them and how long are their affects felt by clinicians and patients?

Contact:

Sarah Berry, BSR Public Affairs Manager, sberry@rheumatology.org.uk

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