Summary
The Primary Care Recovery Plan set out that NHS England will commission a “Pharmacy First” service nationally in community pharmacy, with the aim that by Winter 2023 those signed up to deliver the service can supply prescription-only NHS medicines for seven common conditions, subject to consultation with Community Pharmacy England. The National Institute for Health and Care Research (NIHR) is interested in receiving high-quality research applications to undertake a robust wrap around evaluation of the planned “Pharmacy First” service to understand the impact, safety, cost effectiveness and acceptability of these services, as well as any implications for antibiotic use and antimicrobial resistance.
The NHS Community Pharmacist Consultation Service (CPCS) was launched in October 2019, allowing patients already registered with a General Practitioner (GP) to be referred to community pharmacies for minor illness advice and treatment, or urgent repeat prescriptions. Referrals could be made via NHS 111 initially, with general practice referrals beginning in November 2020. It was introduced as an advanced service, meaning any pharmacy that met criteria could sign up to deliver the service. The future Pharmacy First service will build on the clinical aspects of the CPCS but broaden its scope to include end-to-end management of seven common conditions, including walk-in self-referrals. Additionally, the aim is to implement the service as an advanced service across England (subject to consultation).
In May 2023 through the Delivery plan for recovering access to primary care NHSE and the Department of Health and Social Care (DHSC) announced ambitions for an expanded community pharmacy service offer for minor health problems and medication supply including contraception and increased blood pressure checks. Pharmacy First will allow pharmacists to manage and supply a wider range of medicines through the use of Patient Group Directions (and in the future through prescribing), potentially avoiding the need for a GP appointment or a prescription from a GP. Service-users will only be able to access Pharmacy First after self-care has been unsuccessful and the service will align with NICE guidelines and antimicrobial stewardship principles.
Pharmacy First has the potential to improve timely patient access to care and medication and could help reduce reliance and demand on GPs and non-urgent attendance at Accident and Emergency departments in England. Expanding the role of community pharmacy in supporting common conditions through delivering Pharmacy First, has the potential to save up to 10 million GP appointments a year and give the public more choice in where and how they access care.
Similar schemes have already been implemented in community pharmacies in both Scotland (July 2020) and Wales (April 2022) and some areas in England have already commissioned a local service (e.g. Liverpool). However, little is known about the impact of this new approach, especially with regard to its impact on antimicrobial resistance.
Scope
NHS England will commission a “Pharmacy First” service nationally in community pharmacy, with the aim that by January 2024 (exact date to be confirmed) pharmacists in those pharmacies signed up to deliver the service would be enabled to treat seven common health conditions without the need to visit a GP, and where appropriate supplying prescription-only NHS medicines under patient group directions (PGDs), including antibiotics and antivirals.
Research is needed to assess the quality of clinical care, patient safety, health resource utilisation and appropriate antibiotic use for a Pharmacy First scheme compared to treatment in general practice/standard care. Proposals must encompass the whole service in England and can include comparison with services provided elsewhere in the UK. Single region or pilot sites alone are out of scope for this call.
A further stage will be scoping and mapping work to understand the activity and services on offer. These are complex interventions, and the scope of schemes, workforce and pathways may differ. This foundation work will include evidence synthesis and reviews (including grey literature and completed service evaluations) of local schemes that are currently operating for instance in the Liverpool, Midlands, Cornwall and Isle of Wight as well as parallel initiatives in Scotland and Wales. Other activity in this first phase will include identifying availability and quality of data for measuring inputs, activity, and outcomes, as well as finding suitable comparators and controls for the full evaluation.
Proposals are likely to be for mixed-methods studies led by a team with a track record in national multi-site evaluations of complex organisational interventions, with range of qualitative and quantitative methodological expertise, including experience in accessing, analysis and linkage of routine datasets. The team should have experience of successful engagement with national and local health service decision-makers, staff and patients. The NIHR Health and Social Care Delivery Research (HSDR) Programme is looking for a well-designed national research study, with strong theoretical grounding, to deliver robust national and international learning, strengthen the evidence base on antibiotic prescribing and provide actionable findings for DHSC, the NHS and local decision makers.
The need is for a national evaluation of the future Pharmacy First scheme as a complex service change. This is both an impact and implementation study. It will involve assessing the effects in terms of change (or not) in volume of prescribing, especially in relation to antibiotic use, and in demand on services across the system. Other elements relate to acceptability, changes in ways of working and implications for workforce in pharmacy, general practices, and service users. In addition to assessing impact, it may be helpful for teams to identify tracer conditions (such as uncomplicated urinary tract infections, otitis media, or upper respiratory tract infections e.g., sinusitis) or presenting symptoms for closer analysis.
HSDR is looking to commission a research team to be on standby ahead of the planned roll out of Pharmacy First, which is anticipated to take place in January 2024 (exact date to be confirmed). Funding for this research will be contingent upon the roll out of the intervention. Successful applicants will be expected to contract and start work rapidly and to report meaningful intermediate data early in the contract period.
The successful applicants will be required to carry out an evaluation, alongside the roll out of the Pharmacy First walk-in service in England from January 2024 (exact date to be confirmed). The duration of this evaluation will be 2-3 years with interim findings expected at critical points to be agreed with stakeholders.
The evaluation may take different forms but is likely to include testing and investigating the following:
- Changes in volume and appropriateness of antibiotic use
- The reach and equity of service provision to meet local variation in health needs; accessibility to people not registered with a GP or underserved communities, e.g. Traveller community, homeless people, asylum seekers
- Costs to health services, and cost savings
- Capacity, capability, and skill mix of the workforce required for sustainable service delivery
- Associated reduction in GP consultations/workload/resource savings and other impact for practice staff (e.g., volume of calls and administrative duties for receptionists)
- Acceptability amongst GPs and practice staff, patients and pharmacists
- Patient safety issues including consent and access to electronic patient data/health records to enable safe prescribing, contraindications and adverse event potential
- Joined up electronic systems to support communication and shared record keeping across settings
- Impact on demand and drug use
- Service user perceptions of the service and changes in service user behaviour
- Analysis of case mix and profile of those using the scheme in relation to comparators
- Fidelity of scheme against original intention and service specification
Deadline for Proposals
The programme is likely to fund one study from this call.
Essential instructions for applicants
The application timeline has been shortened for this call to enable the successful research team(s) to start as soon as possible. Therefore, applicants will need to be aware of the following timeline:
Call open: 19 May 2023
Call close: 16 June 2023
Remit and competitive decision notification: early July 2023
Stage one outcomes: early to mid-August 2023
Stage two writing window: 11 August – 6 October 2023 (+/- few days)
Stage two outcomes: 30 November 2023
Study commencement: 1 December 2023 or 1 January 2024
Research Inclusion
The NIHR is committed to creating a diverse and inclusive culture, as outlined in our Equality, Diversity and Inclusion strategy 2022-2027. We, therefore, encourage applications from people from all backgrounds and communities. We are committed to having leadership and teams that contain diverse skills and experiences.
All NIHR research proposals need to demonstrate that they have met the requirements of the Equality Act (2010). Researchers should consider being diverse and inclusive in the design, planning, conduct, impact, and dissemination of their research study.
NIHR also welcomes partnerships between research active and other less active institutions and those located in geographical areas of deprivation. Applicants are also expected to pay attention to populations that have been underserved, to conduct research in locations where the need is greatest.
General Guidance
The HSDR Programme supports applied research with the aim of improving both health and social care services across the nation and is open to any appropriate methodological approaches to answer the proposed research question(s); the approach must be fully explained and justified. To enhance the success of a research proposal, a clear theory of change and pathway to impact, with links into the NHS and social care services delivery, is suggested. It is useful to consider in the research study design how outcomes could be scaled up to maximise impact and value for money across the NHS and social care services – the focus is on applied research with tangible impacts that improve the quality and organisation of health and social care services. This includes stakeholder engagement and the development of processes, tools, and guidelines to strengthen workforce capacity. Further general information about the HSDR Programme can be found on our programme webpage.
Research proposals should be co-produced with national organisations, professional bodies, health and social care service professionals, and service users. Links with health and social care planners and professional bodies are required to ensure impact and scaling up of research findings to benefit the wider health and social care system.
The COVID-19 pandemic is having a significant impact across the health and social care system. As this research may be conducted during the COVID-19 response and recovery period, applicants should consider how the impact of the COVID-19 response and recovery may affect the deliverability of their research.