Published: 11/10/23

The Chief Pharmaceutical Officer for Scotland has commissioned a review of medicines homecare services. This is being led by Benjamin Hannan, Director of Pharmacy for NHS Fife.

For the purposes of this review, the term “medicines homecare” is used to describe the arrangements for on-going supply of medicines (and where necessary associated care) initiated by a hospital prescriber, directly to a patient’s home. Principally, this is delivered by either Manufacturer Pharma-funded or NHS-funded third party providers and cover a range of packages from simple supply up to complex services where there may be adaptations to the home environment and clinical responsibility can be delegated to the third party. Homecare services are provided regularly to around 38,000 patients in Scotland. Use of Homecare services frees up hospital pharmacy teams to deliver other work, and prevents patients from having to make journeys to hospital to pick up medication or to have it administered.

The review has been initiated in response to ongoing concerns over delays, continuity of supply, service levels and the general sustainability of the current model as reported by patients, patient groups and clinicians. The review group is looking for written views on the current model and potential alternatives from various stakeholders, and will follow up with focus group and one-to-one interviews with respondents before formulating recommendations and reporting these back to the Chief Pharmaceutical officer.

The CPS response to the call for evidence is below – please note that there are several questions aimed at individual practitioners/patients. These have not been answered or included, so the numbering of questions is not as you might expect.

Questions for organisations and stakeholders

Question 15.

Please outlay your involvement in medicines homecare. For example, in your role, area or organisation, how do you provide hospital-initiated medicines and any associated care to patients in the community setting (e.g. prescribing, dispensing, monitoring and any nurse training)

The Scottish community pharmacy network has been formally involved in medicines homecare arrangements since 2016, first taking on the dispensing for and pharmaceutical care of patients with Hepatitis C, an arrangement that has been instrumental in Scotland’s progress towards eradication to date. This work subsequently extended to include the dispensing of and pharmaceutical care associated with the medicines Abiraterone and Enzalutamide to enable patients to stay well as close to home as possible rather than make unnecessary journeys to and from hospital. The transfer of these medicines from secondary to primary care dispensing was managed under a national framework agreement that was ultimately agreed and implemented locally in each territorial Health Board.

We are also aware of some small-scale pilots looking at more complex service delivery e.g. Herceptin administration in the community pharmacy setting.

Although there were plans to gradually move the dispensing and support around more medicines across to community pharmacy on a national scale, the overall project was paused in 2018 until the following issues can be addressed (these are discussed in more detail in our answers to later questions):

• VAT liability

• Cash flow risks for contractors

• Agreement on a sustainable service and remuneration model

The community pharmacy network is keen to expand our role in homecare provision and is entirely capable of taking on the support of patients on low- to high-tech treatment packages – but the capacity to do so can only be made available with appropriate investment and management.

Question 16

What are the benefits of the current approaches to medicines homecare? Please give examples.

We are not in a position to comment extensively on the benefits that using standalone homecare providers offers to the NHS. What is clear is that no matter the vehicle, outsourcing supply and elements of support and care provides secondary care sites with the opportunity to operate more efficiently with the resources available to them.

To date, the feedback from patients, pharmacy teams and clinicians supports the use of community pharmacy as a homecare (or, more accurately, closer-to-home care) provider. For patients, the advantage is clear – supply of medicines closer to home with support from an accessible team that are generally already known to the patient and their family/carers.

The community pharmacy network also provides the following additional benefits:

• Expertise in medicines procurement and supply management

• Clinical environment for administration/other interventions

• Overview of patient medication and conditions

• Trained team and NHS services in place to support patients to manage identified side effects and complications

Question 17

What are the challenges associated with the current approaches to medicines homecare? Please give some examples.

As above, we are unable to comment extensively on the challenges presented by the current standalone provision as we do not have direct experience of this, receiving only ad-hoc feedback from patients via our members. However, we understand that significant concerns around continuity of supply and care have been raised by patients, patient groups and commissioners across the home nations. A very recent oral evidence session as part of a House of Lords inquiry into homecare medicines provision gave a reasonably succinct insight into the various challenges and insufficiencies that have been brought to light so far and is worth reviewing. This review was initiated in response to sustained campaigning by patient representative groups. Commenting on how widely evidence submissions from stakeholders about the performance of these services varied, the Chair summarised that the inquiry’s view so far is that “There is no conflicting evidence among those who receive the service; there is unanimity that it is awful. There is no conflict among those running the service; there is unanimity that it is all fine.”.

Question 18

How would you rate the quality of care provided to patients through the medicines homecare service? Please give examples.

On standalone providers, we refer to our answer to question 17 above.
For the part that community pharmacy plays, the size of the network’s involvement to date means that we are lacking formal evaluation. However, feedback from pharmacy teams and patients on their experience in comparison to alternative models has been overwhelmingly positive. What can be demonstrated more robustly is the value-add that the network can deliver – most clearly shown in various evaluations of the community-led dispensing and wraparound care related to Hepatitis C treatment in NHS Tayside (for example, see Preliminary analysis of SUPERDOT-C study)

Question 19

Do you agree or disagree that the consultation stage impact assessment gives a realistic indication of the likely costs, benefits and risks of the proposal?

The British Society for Rheumatology has been the lead organisation campaigning for inquiries into the performance of the standalone homecare medicines market. Their findings show that delays to new patients starting treatment and interruptions for those already receiving treatment are common.

By comparison, although the journey of the paper prescription to the pharmacy can be a rate-limiting step, effective advance communication and measures to limit financial risk to contractors from ordering ahead of prescription mean there is a short turnaround between prescribing and treatment initiation in community pharmacy.

Question 20

Please provide examples of any geographical disparities that you are aware of in the medicines homecare service provision.

We do not have enough information to answer this question.

Question 21

How sustainable and valuable are the current supply routes? (consider financial and environmental sustainability)

Details on financial and environmental sustainability are not readily available to those not involved in routine delivery. However, commenting on the marketplace in general, the concerns raised as early as 2014 about the fragility of the market and the need for additional competition still remain. The reliance on the market on legitimate VAT savings is of particular concern – if and when this clear driver for contracting medicines homecare services disappears, the viability of some providers will be challenged.

Question 22

What challenges are you aware of relating to scalability?

As homecare medicines provision is often tied to specific manufacturers, in order to cover the needs of all patients an NHS Board is required to establish and manage a number of relationships with varying terms of service and performance. Managing this complexity comes with a direct cost in terms of personnel resource which will only grow as the range of new technologies continues to expand.

Question 23

What upcoming changes in the medicines pipeline are you aware of that might impact the demand for and delivery of these services?

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.

Question 24

How do any potential or future changes to VAT rules factor into your planning and delivery arrangements for these services? What impact could changes have on services?

Before we can answer this question, we need to fully understand the mechanism that the UK Government chooses to implement to address the inefficiencies that arise from public sector bodies being liable for VAT payment. We understand that a full refund model is the preferred method, but based on consultation feedback the government is considering adaptations to this. The main concern was around the administrative burden of this model in practice.

In general terms, a solution that delivers VAT efficiencies for the NHS without adding administrative burden or risk on contractors would encourage participation.

Question 25

What alternative supply models, including those from other countries, are you aware of for patients to access hospital-initiated medicines and associated care?

• Outsourcing hospital pharmacy outpatient dispensing √

• Community pharmacy enhanced services √

• Other X

The outsourcing of outpatient dispensing has been shown to deliver financial benefits for NHS trusts in England, but is an extremely complex affair that must be set up between the NHS legal entity and each individual provider. For this reason, most arrangements are 1:1 in nature with either an existing community pharmacy provider or an in-house subsidiary. Both have advantages, with the former bringing extensive experience and a commercial approach and the latter allowing “profits” to be retained within the NHS legal entity. The major disadvantage of direct outsourcing is that this generally limits patient choice to an on-hospital site or at best outlets of the same legal entity that is contracted to dispense, which may not be close to home for the patient.

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. In turn, the NHS legal entity and the community pharmacy network can negotiate and renegotiate fair remuneration on a drug-by-drug basis and track performance against each agreement in more granular detail. Although there are issues that need to be overcome before these arrangements can be made (see answers to question 15 and questions below), both the workload and the impact of residual cashflow following mitigations can be spread across a greater number of providers.

An example of an enhanced service that has been in place for a number of years and delivers for patients and the health service is the Irish Hi-Tech medicines scheme. This supports patients to have their medication dispensed at a pharmacy of their choice, with a standard level of pharmaceutical care and pharmacovigilance expectations set on the community pharmacy provider. The pharmacy is remunerated with a monthly fee for supporting the patient, which is higher in months where an item is dispensed than in those months where one is not.

There are also examples (notably in NHS Tayside) of shared-care agreements between secondary care and GP practices to generate primary care prescriptions to be dispensed in community pharmacy. Whilst this resolves the question of VAT liability, not involving community pharmacy in the managed transfer of these medications to primary care ignores the cumulative cashflow issues that will ultimately limit engagement as well as the opportunity for the community pharmacy team to add value and improve outcomes.

Question 26

How feasibly could these models be applied in the Scottish healthcare context?

We already have working experience of very successful individual drug transfers from secondary to primary care dispensing. Managed centrally and with the right contractual framework and mitigations in place, community pharmacy could take on much more to the benefit of patients across the country.

However, as stated in our answer to question 15, there are three main barriers which if left unresolved will limit further community pharmacy contractor engagement. Indeed, we have already seen an unfortunate but entirely necessary withdrawal from Hepatitis C dispensing from contractors who have been continually negatively impacted by cashflow complications.

Below is a short summary of these issues – Community Pharmacy Scotland team members will make themselves available to the review group to support more in-depth exploration of these factors and their potential solutions.

• VAT liability - specialist advice suggests that Health Boards must pay the VAT on supplies made against HBP forms. In the short term, a mechanism to support this and subsequently make clear the actions that contractors should take with respect to VAT reclaims on affected medicines must be put in place. We note that UK changes to how VAT is treated for public bodies may remove this issue longer term, but our understanding is that this is several years out and again the full implications for both NHS legal entities and independent contractors must be worked through (see VAT and Public Sector response paper – proposal is to implement a Full Refund Model).

• Cash flow risk – these items are generally either very high cost, or high cost and moderate volume, which can have a detrimental impact on contractor cashflow. These medicines are bought by community pharmacy businesses direct from manufacturers at full market prices on 30-day or end-of-month terms, being reimbursed (generally with no margin) over two months later. There are advance payment mechanisms in place in each Health Board, but these are manually-driven, prone to human error and impossible to track particularly as there is no associated electronic claim for the prescription. As an illustration, each month of Hepatitis C treatment costs in the region of £15k. Over a three month course of treatment, the contractor will outlay around £45k before any reimbursement is made, with the total amount not returned to them until month 5. This is a challenging situation which is amplified and made more complex when supporting more than one patient, potentially on different timelines. Whilst this is an extremely high-cost example, the exact same impact is felt when supporting a greater number of patients on a relatively lower-cost medication.
  Practitioner and Counter Fraud Services colleagues are currently working on proposals to mitigate/negate this issue which are likely to feature payments closer to real-time, but our understanding is that this will take some time.

•  Agreed service and remuneration model – We believe that this body of work is best delivered through the community pharmacy network for the benefit of patients. However, it is new work for the network and needs to be supported with an appropriate, separate funding stream. There is currently no opportunity for margin in these lines, and simple dispensing would only attract a standard dispensing pool payment per item. Our current dispensing and reimbursement arrangements are designed to handle items with an average item value just over double digits rather than values in the thousands per pack. There are also more detailed matters which would need explored fully – for example, community pharmacy delivery service costs are borne entirely by the contractor, so if there is an expectation to deliver a given medicine, this would also need to be resourced.
  Most importantly, there is potential for the network to add enormous value beyond just dispensing close to home, and we would be keen to establish a framework approach that recognised and rewarded this value on a medicine-by-medicine basis.

Question 27

What are the prevalent contractual arrangement issues or challenges for medicines homecare services?

Please refer to our answers to questions 15 and 26.

Question 28

Are you aware of the required standards for medicines homecare service provision?

Yes

Question 29

Please outlay how service standards are utilised by your body, if applicable

N/A

Question 30

Are you aware of the enforcement mechanisms available to maintain medicines homecare service provision standards?

No

Question 31

What enforcement mechanisms are available to ensure high standards of service delivery in the current system?

N/A 

Question 32

How effective are these methods for verifying a provider’s ability to meet quality and safety standards?

We are unable to comment directly on this question, but from recent UK government inquiry evidence sessions, it is clear that enforcement mechanisms are lacking. 

Question 33

What do you perceive as barriers to new homecare providers entering the market?

The market has been shown to be fragile at best. Although very large sums of money are spent on homecare provision by the NHS, the challenges and limited reward facing standalone providers make the prospect of entering the market less attractive.

From a community pharmacy perspective, our answers to questions 15 and 26 outline the main barriers to further involvement.

In addition, we have experienced two occasions (one national, one regional) where secondary care medicines that had been being dispensed in the community pharmacy setting were pulled back into secondary care provision following patent expiry. This is challenging for the patient, but if on a larger scale would makes business owners hesitant to invest in the resource required to deliver projects like this, as the income stream can disappear overnight.

Question 34

Is the information currently available to the public and professionals adequate and informative?

Assuming that the question relates to information about how Homecare medicines services work, this is entirely dependent on the provider. There appears to be a lack of resources that explain in general terms how homecare arrangements work for patients.

Question 35

What improvements or additional details would you like to have access to?

It would be useful to have sight of all the medicines/technologies that are currently and could be delivered via a homecare or similar programme.

Question 36

What are the potential future uses for medicines homecare services?

The community pharmacy sector is, very broadly speaking, a generalist service and one that in particular excels at relatively short, sharp but impactful interventions. With this in mind, it is likely that there will always remain a need for bespoke specialist/very hi-tech services.

Question 37

What factors might enhance a provider's ability to deliver effective medicines home care services?

We can only comment on the community pharmacy sector.

• Long-term commitment to the use of the sector for this purpose

• A national approach for consistency of delivery – this could be in the form of a national framework that individual Health Boards can take advantage of as opposed to having 14 different arrangements for each medication.

• A sustainable and fair funding model

• Resolutions to currently understood barriers and support to resolve emergent issues

• Investment where required (e.g. premises/consultation room standards to support administration/infusion etc)

• Clear service standards

• Collaborative working to maximise the value-add that community pharmacy can offer

• Centrally managed transfer of and ongoing support for medicines from secondary care to community

  • Individual NHS Boards will choose whether to use the network, but the order and rate of transfer should be set nationally.

• Having access to NHS education and training that supports professionals to provide the best possible care to those being prescribed medicines by secondary care is crucial.

Question 38

What factors might hinder a provider's ability to deliver effective medicines home care services and how might these be addressed?

Not having the requirements laid out in our answer to question 37.