“Everyone needs to understand each other’s systems”: Stakeholder views on the acceptability and viability of a Pharmacist Independent Prescriber role in care homes for older people in the UK

Abstract The role of an innovative Pharmacist Independent Prescriber (PIP) for care homes to optimise medications has not been examined. We explored stakeholders’ views on issues and barriers that the PIP might address to inform a service specification for the PIP intervention in older people's care homes. Focus groups (n = 72 participants) and semi‐structured interviews (n = 13) undertaken in 2015 across four sites in the United Kingdom captured the views of doctors, pharmacists, care‐home managers and staff, residents and relatives. Stakeholders identified their expectations of what service should be provided by PIPs, what might affect their support for the role, and barriers and enablers to providing the service. Transcripts were analysed using the Theoretical Domains Framework to identify key components, which were reviewed by stakeholders in 2016. A PIP service was envisaged offering benefits for residents, care homes and doctors but stakeholders raised challenges including agreement on areas where PIPs might prescribe, contextual barriers in chronic disease management, PIPs’ knowledge of older people's medicine, and implementation barriers in integrated team‐working and ensuring role clarity. Introducing a PIP was welcomed in principle but conditional on: a clearly defined PIP role communicated to stakeholders; collaboration across doctors, PIPs and care‐home staff; dialogue about developing the service with residents and relatives, based on trust and effective communication. To embed a PIP service within increasingly complex care‐homes provision, the overarching theme from this research was that everyone must “understand each other's systems”.


| INTRODUC TI ON
It has been demonstrated that medicines management in residential settings for older people (hereafter referred to as "care homes") in the United Kingdom (UK), should be improved (Care Quality Commission, 2010;Furniss et al., 2000;Kirthisingha, 2014). Providing a designated individual with overall continuing responsibility for the medicines management of individual care-home residents might address identified shortcomings in medicine-related care ). Pharmacist-led medication reviews can achieve positive outcomes, such as reduced prescribing of inappropriate medications and resolving medication-related problems Roberts et al., 2001;Zermansky et al., 2006). Furthermore, a model which relocates medication-related decisions involving pharmacists more firmly within the context of care homes could improve resident-related outcomes (Alldred, Kennedy, Hughes, Chen, & Miller, 2016;Patterson et al., 2014). Guidelines from the UK's National Institute for Health and Care Excellence (NICE) recommend a holistic overview of medicines management (NICE, 2014), while a professional report proposes pharmacists having "overall responsibility for medicines and their use in care homes" and that a pharmacist and a family physician (in the UK called general practitioners [GPs]) share responsibility for medicines, "ensuring coordinated and consistently high standards of care" (Royal Pharmaceutical Society [RPS], 2016, p. 2). UK legislation (Department of Health, 2006) permits pharmacists to qualify as independent prescribers, able to diagnose and prescribe medicines, enabling them to implement changes following medication review, rather than recommending changes to a medical prescriber. Prescribing pharmacists may prescribe within their area of competence. For our study, the area of competence is "frail elderly residing in care homes". This paper reports an early-stage qualitative study which explored stakeholders' expectations and understandings of introducing a new service. This was part of the Care Homes Independent Pharmacist Prescribing Study (CHIPPS), a 5-year, National Institute for Health Research-funded research programme which is developing and evaluating the effectiveness and cost-effectiveness of a novel Pharmacist Independent Prescriber (PIP) role to take overall clinical responsibility for managing repeat prescriptions in older people's care homes, aiming to optimise their medicines management (ordering, storage, prescribing, monitoring, administration) for an enhanced quality of life. It is following the iterative process recommended by the Medical Research Council for the development and evaluation of complex interventions, finishing with a definitive trial (Medical Research Council, 2000). The qualitative study was designed to inform how this service should be introduced, to mitigate potential barriers and deliver an acceptable service. The research question asked what components stakeholders would specify in a PIP service they deemed feasible and acceptable and what they considered barriers and enablers to implementing such a service. Stakeholders were accessed in four study sites: England (two), Scotland and Northern Ireland (one in each), all differing in demographic and cultural make-up.

| Design
Qualitative methods drew on a phenomenological approach to enable us to explore less-known ideas and priorities of stakeholders in the context of their experiences of care-homes' work organisation. Our approach drew on the Theoretical Domains Framework (TDF; Cane, O'Connor, & Michie, 2012) to systematise our search for contextual practices which stakeholders might judge as relevant to their actions within organisations and potentially affected by a PIP initiative. Framework analysis of the data was informed by the TDF, and was used to identify key components for a potential service specification and barriers and facilitators to changes in clinical practice which might accommodate a PIP service in care homes (Kirk, Sivertesen, Petersen, Nilsen, & Petersen, 2016;McGoldrick, Crawford, Brown, Groom, & Crowther, 2016).

| Sampling
A purposive sampling approach to secure views of stakeholders with experience of living or working in or with care homes was taken to maximise the range of relevance of data collected to the research goals (Bryman, 2012). Stakeholders were GPs, pharmacists, carehome managers, care-home staff, care-home residents and residents' relatives, spanning urban and rural areas, single and multi-GP What is known about this topic • Medication errors are common in care-home environments.
• The current approach of pharmacists external to carehome settings reviewing older residents' medicines has demonstrated better medicines management but not improvement in clinical outcomes.
• To improve residents' medicine-related care, researchers recommend one person should take central responsibility for medicines management.

What this paper adds
• A prescribing pharmacist taking this central role is widely perceived as likely to reduce medication errors and improve residents' medicine-related care.
• For this innovation to work, everyone in care homes must understand each other's roles.
• Integrated team-working, knowledge of older people's health and effective communication with residents and relatives were identified as essential to make the prescribing pharmacist role acceptable.

| Data collection
Ethical approval was obtained from the NHS National Research Ethics Service on 10 April 2015 (REC reference, 15/YH/0172). A semi-structured topic guide informed by the TDF for Behaviour Change was used to develop questions linked to constituent domains so as to identify expected characteristics, barriers and benefits of the proposed PIP role (Table 2). These included topics relating to knowledge, skills, environment, beliefs about consequences, practice features in the pharmacy context, older people in residential settings and primary-care practice. We drew on the interdisciplinary research team's broad experience to identify both theory-and practice-related data-collection topics with context-relevance. For example, questions exploring current medicines management aimed to tap stakeholders' knowledge of scientific, procedural or environmental factors shaping care-home practices, how a PIP service might work, and its potential benefits and risks. Questions eliciting stakeholder views on how the GP-PIP partnership would work focused explicitly on social and professional roles and identity. Trainingrelated questions, while included on the topic guide, are reported in a separate paper.
Consent forms were distributed at each focus group and interview, where researchers also outlined their purpose and process.
Information sheets were also available at each episode of data-collection to help participants refresh their familiarity with the study.
Focus groups for residents and relatives included the option for residents to have a carer for support (with two focus groups including carers supporting residents). We took care to communicate clearly with residents, respecting any needs for time to consider the process or answer questions; we reassured them that, as with all study participants, they were free not to respond or to leave the focus group, without giving a reason. Participants having telephone or Skype © interviews received a consent form electronically, returning it to the research team prior to interview. All participants were given the opportunity to ask questions. Before commencing data-collection, researchers double-checked that participants understood that the discussion would be audio-recorded. Focus groups lasted 60-90 min for GPs and pharmacists and 60 min for others, except for one residents' and relatives' group (32 min) and one with carehome staff (21 min). Two researchers facilitated each focus group, one leading and the second note-taking. Interviews, conducted by one researcher, lasted 25-35 min; three face-to-face and ten telephone or Skype © .

| Analysis
All interviews were transcribed verbatim. Participants' identities were anonymised and personally identifying references removed.
Analysis began with repeated reading of the transcripts, to identify initial codes and themes from the data, then using the TDF-informed questions ( Table 2) to set up the framework analysis we had planned to use to identify key components relevant to our study design.
Consensus about identified and emergent codes, themes and subthemes and their relationships was reached by two qualitative researchers engaging in an iterative process, supported by rigorous re-reading of data. After the first round of analysis, an interventiondevelopment workshop was held at each site with invited local participants from mixed stakeholder groupings. The mixed-group participants were presented with themes and topics from focus group and interview findings, as a stimulus from which they identified their specific issues with shortcomings and benefits in managing medicines in care homes and in light of what PIP-related changes they foresaw. All of these were variously endorsed and elaborated in the stakeholder focus groups and interviews reported in the following findings.

| FINDING S
Thirteen stakeholder group-specific focus groups (n = 72 participants) and 13 interviews (n = 13 participants) were held with GPs, pharmacists, pharmacy technician, care-home managers, care-home staff, residents and residents' relatives in four study sites (Table 1).
Of 27 pharmacy professional participants, 15 pharmacists worked in primary care, 10 in the community and one in both sectors; one pharmacy technician worked in the community (Table 3). parties must "understand each other's systems", specifically in relation to: • chronic disease management (contextual) • knowledge of older people's medicine and care homes (contextual) • clarity of a PIP's role and responsibilities (implementation) • integrated social and professional team-working (implementation).
These are reflected in the organisation of findings now presented here.

| Contextual barriers and facilitators
Chronic disease management and knowledge of older people's medicine and of care homes were seen to underpin an effective PIP service. Where lacking, these constituted contextual barriers. The barriers encompassed current knowledge and understanding, the potential need to reframe aspects of these, key organisations and stakeholder groups involved, cultural practices within care homes, governance and policies.

| Chronic disease management
All stakeholders emphatically identified chronic disease management as a core issue in managing medicines in care homes, emphasising monitoring and reviewing concerns. They considered a viable PIP service would depend on successfully addressing the "many points in the circuit of prescribing where it can go wrong" All stakeholders prioritised regular, responsive medication reviews by PIPs as a way to address gaps in managing chronic disease and enhancing the safety of residents living with comorbidities. GPs' onerous workload limited their capacity for "time-consuming" procedures and "complexities" in reviewing and managing medication to "keep it right for this population" (GP8-FG). Pharmacists acknowledged these limitations: they saw medicines dealt with as "an after-thought" by time-pressed doctors, whose care-home visits were absorbed in treating acute problems, and argued that PIPs could do "more proactive work" (P10-FG).
For one GP, a PIP who helped "tie up all those loose ends" to ensure residents received appropriate medication and who liaised with GPs and community pharmacies "would be the answer to my prayers" (GP1-FG).
GPs admitted that they found it "difficult managing all the complexity and the co-morbidity" (GP6-FG) and that "GPs don't understand" how care homes obtain and administer medicines (GP7-FG).
Care-home systems incompatible with medicines supply were reported as impairing timely ordering and medicines supply. If a PIP oversaw and bridged gaps in these processes, the "mayhem" be- with cognitive impairment" (P1-FG). These skills included perceiving the whole person during medication reviews, such as noticing a resident's "hearing aid over on a table that they can't reach" (P5-FG).
One care-home manager imagined a PIP initiating "a little chat" as a medications expert with residents (CHM2-FG). For another manager, a PIP's capacity to talk "with … not down to" residents was as important as pharmacological expertise (CHM3-FG). GPs and pharmacists recommended that a PIP be sensitive to residents' vulnerabilities regarding medications. This surfaced separately when a resident reported feeling "nervous" when "the appearance of a tablet changes"; she suggested a PIP could answer residents' uncertainties about such changes (RR3-FG).

| Implementation barriers and facilitators
While stakeholders broadly accepted the proposed service, they questioned the PIP's specific responsibilities and queried how the role would be understood and incorporated into the care-home environment. Two implementation issues-clarity of the PIP's role and responsibilities and integrated team-working with the PIP-were seen to reflect the need to achieve effective multi-professional team-working. A relative stressed their need to be kept aware of the new service "because often the residents can't pass on the information that the relatives would like to know" (RR2-FG). Another relative saw a PIP meeting the significant need of transferring information from GPs to residents and of answering relatives' questions more speedily than time-pressed doctors, so that "everybody that needs to know is informed" (RR1-FG).

| Clarity of PIP role and responsibilities
Although no GP believed that the PIP's role should include diagnosis, no GPs attached risk to a PIP monitoring and reviewing medicines or attending to time-intensive matters such as synchronising residents' prescriptions. GPs expressed confidence in pharmacists' skills and applying these within the intervention, "looking at interactions and side-effects" (GP3-I) and bringing expertise "to guide us to things that we might have missed" (GP12-FG).
Pharmacists unequivocally shared GPs' reservations about diagnosing and endorsed the need for role clarity, including boundaries on expectations of the PIP's tasks. One pharmacist acknowledged that "an 'everything has to be done by a GP'-culture" (P2-I) among some care-home staff could be changed through good models of working and clear role definitions. As one GP advised, "it's about framing your service so that actually people understand what benefit it's going to be for them" (GP13-I). Stakeholders' emphasis on role clarity and appropriate communication is further examined within the second implementation challenge: integrated team-working.

| Integrated social and professional teamworking
Stakeholders believed that to embed the new service the PIP must establish communicative relationships with GP practices and care homes, from which shared understanding of roles, working co-operatively rather than independently, developing trust and providing continuity of service could result. This would take time and depend on the PIP acquiring relevant experience and knowledge of the context of older residents' health.
Many participants reflected on their positive experience of multi-professional working when debating the benefits of integrating a PIP into a team; one cited an "effective working relationship" between GPs and pharmacists (GP6-FG) and another valued pharmacists being linked to GP practices because "they're accountable to the GP" (P5-FG). One GP urged PIPs be practice-based because "nuances with managing the elderly [require] co-operative working" (GP14-FG) while another cautioned that a PIP acting independently of professionals involved with residents' care risked being a "recipe for disaster for … looking after patients" (GP7-FG).
Some GPs and care-home managers conjectured that PIPs might educate care-home staff to raise their awareness of medications.
One doctor believed that this could "improve patients' experience with tablets" (GP2-FG). This resonated with residents' desire to know about their medications:

…nobody [is there] to ask things about your medication, as the person giving you the drugs doesn't have much knowledge, so they can't explain (RR4-FG)
Pharmacists also envisaged benefits for staff and residents if a PIP were an in-house resource on medications. They suggested that a sensitive approach would increase the likelihood of collegial working if staff saw the PIP as part of a "care package" team for residents, rather than someone who might be "checking up on [staff]" (P6-FG).
Stakeholders' emphasis on clarity in the PIP role reinforced their need to establish whether and how this new role would add a distinctive and necessary new element to their multi-professional working environment. Clearly defined team-working for the benefit of residents would increase the new service's acceptability. Their attention to team-working suggested specific ways that distinctive PIP contributions could be integrated to strengthen, not complicate, the complex collaborations on which care homes depend.

| D ISCUSS I ON
Our study explored stakeholders' expectations of a feasible PIP service, the key components they specified for the role, the context of professional and multidisciplinary practices relating to care homes for the proposed service and the barriers and facilitators affecting its acceptability. Our TDF-informed approach then enabled us to identify what components stakeholders deemed key and what contextual practices they saw as relevant to mitigate implementation barriers and to promote PIP feasibility and acceptability. This recognised the complexity of care-home environments, with their many different players, organisational processes and systems and variations in resources providing care to frail older people.
Our comparative analysis revealed no specific inter-country differences across the study sites. Stakeholders welcomed this novel role on many fronts, beginning with their expectation that the PIP would help to address chronic disease management challenges, in which medication reviews were made complex and time-consuming by residents' multiple co-morbidities which complicated pharmacological interactions and side-effects. GPs and most pharmacists emphasised needing to understand the complexities in managing the health of older care-home residents and the impact of frailty and advancing age on their responses to drugs. Introducing a prescribing pharmacist in care homes was seen to offer specific potential benefits to residents, care homes and GPs.
Stakeholders believed that acceptability of the service would increase if the PIP offered the means to strengthen mechanisms to ensure efficient, effective prescribing in care homes. Repeated problems stemmed from no individual overseeing medication needs outside scheduled medicines management reviews. GPs and care-home managers were left with the task of repairing treatment discontinuities when professional and organisational procedures contradicted each other and, echoing previous research, identified the absence of a "whole team" approach, no one with overall responsibility for medicines management and a lack of coordination .
Of primary importance to GPs was that a PIP initiative giving scope to the PIP to conduct medication reviews would save GPs time and work most largely given to solving acute problems when visiting care homes. They would not support the innovation if it would likely make their already burdensome workload more complex, as reported elsewhere for other well-intended changes (Scott, Mannion, Davies, & Marshall, 2003). Potential benefits GPs identified were having better access to up-to-date knowledge on medication inter- We obtained comprehensive understanding from stakeholders of processes necessary to inform the intervention in order to maximise its chance of achieving a meaningful impact in practice (Davidoff, Dixon-Woods, Leviton, & Michie, 2015

| Limitations and strengths of this study
A limitation may have been the minimal representation of residents and relatives in intervention-development workshops, perhaps because these were held on university premises outside their usual residence. There may have been bias in that participants were selfselected and therefore perhaps had favourable expectations of the PIP role and may not have captured the views of individuals more likely to resist the innovation.
A particular strength was the independence of the qualitative researchers with no professional or clinical interest in this specific area of practice. Using the TDF to inform the approach for framing topics discussed with stakeholders strengthened the study by sensitising us to implementation issues relevant in the context of this proposed innovation. TDF use also facilitated stakeholders to reveal contextual and implementation barriers to defining, deploying and integrating a PIP role within existing services. It also drew comprehensively upon stakeholders' experiences and awareness of context, social and pharmaceutical relationships.

| CON CLUS IONS
For a new pharmaceutical care service to be effectively embedded, stakeholders' views highlighted that securing the acceptability and viability of the PIP role would mean taking steps to ensure that all those involved in delivering and using it could "understand each other's systems". Enabling such mutual understanding would address contextual and implementation barriers and be relevant to identifying feasible practices for addressing residents' medications-related safety and experience of medications. Current UK strategy aims to enhance care in care-home settings partially through prescribing pharmacists. This paper demonstrates the widespread articulation by professional and lay stakeholders of the need for these pharmacists to take time to understand care-home-related systems they will operate within, before trying to enhance resident safety in better managing their medicines.

ACK N OWLED G EM ENTS
This paper presents independent research funded by the National relatives who took part, as your voices and views are integral to the potential acceptability and viability of any such intervention as discussed in our paper.

CO N FLI C T O F I NTE R E S T
Professor David Wright is in receipt of unrestricted education grants and undertakes consultancy work for Rosemont pharmaceuticals.
No other authors have declared a conflict of interest.