Development and feasibility testing of an evidence-based training programme for pharmacist independent prescribers responsible for the medicines-related activities within care homes

Introduction The UK pharmacists with independent prescribing rights (pharmacist independent prescribers [PIPs]) are authorised to prescribe within their areas of competence. To enable PIPs to provide pharmaceutical care to residents in care homes and assume responsibility for medicines management, a process for development and assessment of competence is required. The aim of this via viva. Feasibility testing demonstrated that the derived training programme was acceptable, practical and effective. Discussion The model seemed to work, but due to small numbers, larger-scale testing of the training programme is now required.


Introduction
Care homes, with or without nursing support, provide personal and/ or nursing care for individuals who are no longer able to live independently in their own home. Whereas the proportion of people over the age of 65 living within care homes has either stabilised or reduced in Europe and North America, the number of residents continues to increase as populations age. [1] With a wide range and number of co-morbidities, medicines are a central element of residents' care, with the average number of regular medicines/resident reported to be between 7 and 10. [2][3][4] The prevalence of medicines-related errors in care homes is reported to be high. One large observational study, in 2009, found that almost 70% of care home residents experienced at least one medication error on any given day. [2] A systematic review of interventions to improve medication use within care homes reported the most common medicines-related errors included unnecessary prolongation of therapy, drug-drug interactions, sub-therapeutic doses and inadequate monitoring of therapy. [5] The most commonly reported intervention to improve pharmaceutical care within care homes is pharmacist-led medication review. [5] The pharmacist role can also include care home staff training, [6] working in a multidisciplinary manner with the resident's doctor [7] and assuming responsibility for all elements of medicinesrelated care. [8] The current evidence base for such interventions suggests that none of these models are optimal. [5,9] Although improvements in medication appropriateness have been demonstrated, the impact on clinical outcomes is mixed. [5,9] One recent systematic review based on studies reporting secondary outcomes suggested that pharmacist interventions could potentially reduce falls, [10] with a more recent research review contradicting this, [7] and concluding that better models of care are required.
Legislative changes in the UK in 2006 enabled accredited pharmacists to independently prescribe [11] and enabled pharmacists to assume responsibility for pharmaceutical care in care homes, implementing their own interventions without secondary authorisation. Evidence is now emerging regarding the effectiveness of pharmacist prescribers in the provision of patient care. [12,13] Pharmacist independent prescribers (PIPs) in the UK are required to demonstrate competency against a national generic prescribing framework [14] and then practise only within their defined area of competence. Consequently, to be able to provide pharmaceutical care within the care home environment and prescribe for such residents, they would be expected to be competent to do so.
In 2012, the UK National Institute for Health Research (NIHR), funded a programme of work, the Care Home Independent Prescribing Pharmacist Study (CHIPPS), whereby pharmacists with prescribing rights were to be located within care homes and assume responsibility for providing pharmaceutical care. This was to be achieved largely through the development of pharmaceutical care plans and optimising prescribing through monthly authorisation of repeat medication, implementing prescription changes as needed, while also providing oversight for drug storage, ordering, management and dispensing within the care home by their staff. [15] The CHIPPS programme of research comprised six work packages one of which was to develop a training programme to support the enhancement of intervention fidelity within the trial and enable PIPs to operate within UK legislation. Early work identified the need for a formal accreditation process within this to reassure care homes and their associated medical practitioners of the safety of the proposal. [16] Using Eraut's definition of knowledge required for workplace learning, [17] we have previously reported a systematic review with narrative synthesis to identify the knowledge requirements for pharmacists operating within the care home environment. This was categorised as codified knowledge (written down), practical knowledge (required to perform tasks) and cultural knowledge (how things are done around here). [18] We acknowledged that publication bias was likely to limit the capture of more mundane roles. Furthermore, due to the limited consideration of the specific training needs for pharmacists to operate in care homes within the literature, we identified the need for further qualitative work with all stakeholders to obtain a more complete picture to inform our training programme.
The aim of the work package was therefore to develop, and feasibility test a training programme to enable PIPs to provide pharmaceutical care safely and effectively within the care home environment.
An Expert Advisory Panel (EAP), constituted from the research team, consisting of four pharmacists, three of whom had significant previous care home experience, a medical public health consultant, two geriatricians, a senior research nurse, a senior care home manager and two patient and public involvement representatives, oversaw the process. Recognising a priori that participating PIPs were likely to vary in their care home knowledge and experience, it was agreed that the training programme should include a Personal Development Framework to structure learning and enable the PIP to address any knowledge or skill gaps. The mode of assessment was to be determined. Competencies identified as necessary, but already demonstrated to achieve prescribing status, [19] were excluded.

Phase 1: Initial stakeholder engagement
As part of the main programme of CHIPPS work, focus groups and interviews were undertaken primarily to define the PIP service specification while operating within the care homes. [16] The topic guides included a question regarding pharmacist-training needs for the content of the PIP training programme. These elements were extracted from the verbatim transcripts and content analysis used to group them into codified, practical or cultural knowledge, or for consideration within the training programme design.
The elements from the content analysis were combined with elements from the previously reported literature review, [18] individually numbered and categorised into: an expected behaviour (practical and cultural knowledge-based); a described activity to be undertaken in preparation for the role (to address identified cultural and practical knowledge needs. Expected behaviours were then combined by N.N. and D.J.W. into competencies, and these were then ordered into domains within the Personal Development Framework (Supplementary Appendix S1).
The first draft of the training programme with the proposed Personal Development Framework was presented to the EAP to review and amend to create Draft 2. This was then used within training-specific focus groups and interviews as described below.

Phase 2: Uni-professional focus groups and interviews
Focus groups with different healthcare professional groups were organised and located across four sites as follows: • Primary care pharmacists (Leeds) • General practitioners (Aberdeen) • Community pharmacists (Belfast) • Care home staff (Norwich) Additionally, within each site, an appropriate healthcare professional (local adviser) with significant local care home experience regarding medicines management was identified and recruited for participation in an interview to enable identification of local environmental and contextual factors (local cultural knowledge) which might require consideration.
All focus group and interview participants were identified purposively by local principal investigators. Before each focus group and interview, Draft 2 of the training programme including the Personal Development Framework was provided to participants. Focus groups and interviews were chaired or led by N.N. and moderated by D.J.W. The topic guide consisted of the following: • Initial views on the draft training programme • Therapeutic and clinical areas to be included • Care home-specific processes which pharmacists would need to be aware of • Knowledge required to be effective • Interprofessional-related knowledge • Any advice participants could provide relating to preparing pharmacists Focus groups/interviews were recorded digitally, transcribed verbatim and content analysed by D.J.W. and validated by N.N.
Where possible, consensus on any amendments and enhancements to the training programme and framework was identified, with a final decision sought from the EAP if needed.

Phase 3: Expert consensus
A consensus day was held at each study site primarily to develop the CHIPPS service specification but also to obtain feedback on the draft training programme. Participants included a primary care pharmacist (preferably a PIP), general practitioner (GP), community pharmacist, care home manager, care home staff member, resident and/or relative, plus any other relevant local stakeholder, for example, local primary care organisation Medicines Management Lead. The panel was asked to provide feedback on: • Their initial views on the draft training programme • Whether all competencies should be assessed or just those which had been agreed with the mentor as requiring development • The mode of assessment to be used • Points of dissonance identified within the stakeholder focus groups and interviews Detailed notes were taken from the consensus panels and used by N.N. and D.J.W. to create a final draft training programme for feasibility testing.

Phase 4: Feasibility testing
Four PIPs, GPs and care homes, each with 10 consented residents, were recruited, through local networks, to the feasibility phase of the study. [20] The training programme was implemented before the PIPs providing the service over a 3-month period. At the end of the feasibility phase, a focus group with the PIPs was convened to obtain feedback on the effectiveness and acceptability of the training programme. The topic guide consisted of questions regarding: • Personal development planning and support process • Personal Development Framework (Personal Development Framework) • Assessment process • Impact of the training • Elements which worked well and those which worked less well The focus group was recorded, transcribed verbatim and content analysed to refine the draft training programme for use within the main trial.

Phase 1: Initial stakeholder engagement
Thirteen interviews and 13 focus groups with 72 participants were undertaken. [16] Figure 1 shows the different types of knowledge identified as important for inclusion in the training.
The following training activities, in addition to face-to-face training, were included to develop identified cultural knowledge requirements, to support relationship development and enable identification of care home staff training needs: • Shadowing care staff and observing medicines' administration • Shadowing a GP and agreeing responsibilities and boundaries • Time within care home and medical practice to learn how to use Information Technology systems The practical knowledge identified as important was how to provide pharmaceutical care for older people with frailty. Supplementary Appendix S1 provides a copy of the first draft of the training programme.
The EAP identified the need for 'context' to be included as a domain within the Personal Development Framework and to change the 'chronic disease management' domain to 'managing complexity in late life'. Supplementary Appendix S2 provides Draft 2 of the training programme.

Phase 3: Expert consensus
Four consensus panels were held between 2 February 2016 and 2 December 2016 with 53 attendees (Aberdeen, n = 12; Yorkshire and Humber, n = 12; Norwich, n = 15; Belfast, n = 14). Across the consensus panels, there were 13 GPs, 3 care home managers, 7 care home staff, 4 care home resident/relatives, 13 primary care pharmacists, 10 community pharmacists, 1 individual responsible for medicines standards in care homes, 1 senior medicines management technician and 1 GP federation chair. Box 2 provides a summary of what was agreed within Phase 3. The underpinning knowledge identified as being required by PIPs is provided within Figure 2.
Draft 4 of the training programme, which was used in Phase 4, is provided in Figure 3.

Phase 4: Feasibility testing
The four PIPs were all female, all had previously worked as pharmacists within the care home environment and two of them already had a working relationship within the recruited medical practice. None had worked previously with the recruited care homes.
The training was viewed positively by all four PIPs, reported to be motivational and enhanced their confidence to operate within the role.
It's had a really positive impact, the fact that it has made you more motivated and certainly more clued in and more confident in going in and making changes to a patient's medications. (PIP 4) The mentor was seen as a valuable support as well as an experienced advisor for the PIPs. It was thought that a face-to-face meeting with the independent evaluator would have been preferable but overall, the combination of mentor and GP assessor was considered helpful, and it generated ideas and confidence.
The process of working on the personal development plans was reported as being effective in consolidating existing knowledge as well as revealing knowledge gaps. It was considered to be valid, relevant, necessary and aided reflection. However, the process of collecting evidence against the Personal Development Framework could have been less time-consuming if there had been better guidance on expectations regarding this from the outset.

Codified Knowledge Frailty Harmful drugs in older people
Capacity and how to support residents without it End of life care Role and boundaries of self and others Management of geriatric condiƟons Medicines regulaƟons in care homes Importance of involving residents and relaƟves in decision making

PracƟcal knowledge
Know limitaƟons and to work within them How to integrate into team Good communicaƟon with team, with residents and relaƟves Need for use of IT systems in home and medical pracƟce

Cultural knowledge
Develop relaƟonships with everyone involved in team How medical pracƟce servicing the home operates Care home culture with respect to medicines Impact of medicines within the care home Medicines ordering and supply processes to enable effecƟve access to medicines

Training delivery design
To support integraƟon into team Ensure includes effecƟve communicaƟon of PIP role to home and wider team members Mentoring and/or shadowing as part of training. Doctors and care workers PIPs to communicate to staff the importance of managing medicines effecƟvely PIPs to understand and support good medicines administraƟon pracƟses While all elements were viewed positively, the elements of the face-to-face training that were perceived as particularly effective were the case studies surrounding the management of complexity, legal issues and covert administration and the session on the management of psychotropic medication.
The most useful ones were certainly the case studies that were discussed with the geriatrician, so that was really good to work things through and discuss things as well, because I guess you just learn more from real life cases and commonly used drugs that you would see in elderly patients, particularly in relation to things like dementia. And also the antipsychotic training was excellent as well. The standard of training was all very good but those are ones that sort of like really stand out above. (PIP 4) Following Phase 4, no major changes were made to the training programme.

Discussion
This systematic and iterative development and testing of a training programme for pharmacists with prescribing rights to provide pharmaceutical care for care home residents resulted in a product that was relevant and equipped participants for their care home role. The model of using a Personal Development Framework, mentor and assessor, supported with an underpinning knowledge pack and specific face-to-face training, was shown to be acceptable and practical. Implementation resulted in PIPs who were motivated to undertake the role and confident to do so.
The process of data collection was robust, encompassing the full range of stakeholders. Development of the training programme was systematic, iterative and guided by an EAP. Although the literature review identified much of the codified and practical knowledge required by the PIPs, it was the qualitative data collection undertaken here, which identified the cultural knowledge requirements.
The training programme was only tested on four PIPs who could be seen as early adopters who may not fully represent the range of abilities and experiences of other pharmacist prescribers wishing to develop competence within care homes. Consequently, without implementation and testing in a wider population, its practicability and acceptability need to be further established. We used the same mentor and medical assessor for all four PIPs and again, if the role were to expand, training for the mentors would be required to ensure consistency with respect to both support and assessment.
The feasibility stage lasted for only 3 months and its appropriateness for delivery long term is also unknown. Testing in over 20 PIPs undertaking this role over 6 months will occur within the main trial. [21] A key area of agreement through our findings was the recognised need for the PIP to develop relationships with the care home staff, medical practice and community pharmacist. Activities to be undertaken when spending time with each were identified to ensure that the PIPs developed an understanding of local cultures, communication preferences and the expected boundaries for their prescribing practice. Consequently, training time was allocated for this purpose within the training programme. Interestingly, the four PIPs at the feasibility stage did not refer explicitly to time spent undertaking preparatory activities and we did not formally monitor adherence to this requirement. We therefore have limited insight into its effectiveness or appropriateness. As 'early adopters', they may represent more confident and outgoing individuals for whom relationship development occurs more readily. Within the planned definitive trial, there will be over 20 PIPs and at this stage, we will need to monitor and evaluate the effectiveness of providing time to develop relationships, integrate into local teams and understand local cultures.
The model of using Personal Development Frameworks to enable individuals to identify their learning needs is commonplace within the healthcare professional literature. [22][23][24] Mentors are seen as necessary as they can support the learning need identification process, identify experiential opportunities to develop the required knowledge and help with collation of evidence. [25,26] Mentors are also frequently used to both support and sign-off trainees as competent within their role, [27] however, the appropriateness of this model has been questioned due to the mentor developing a relationship with the mentee and recognition that this may adversely affect their judgement. [28] Consequently, we used an independent assessor in addition to the mentor.

Overall training programme
• PIPs identify support available for the home from other healthcare professionals and how to refer residents to them • Include 'identification of red flags', 'management of antidepressants' and 'anticholinergic burden' in face-to-face training • PIPs visit a care home with partner GP to undertake medication reviews together to identify expectations and boundaries • Include an induction period to meet: community pharmacist, community matron, Care Quality Commission lead, consultant geriatrician, district nurse, local safety expert, care home pharmacists, as appropriate to local setting

Personal Development Framework
Include the following competency: • Responds appropriately to medicines-related errors and critical incidents Include the following behaviours (those things which underpin the related competencies): • Ensures that resident nutritional needs are regularly reviewed and related prescribing is in line with local policy and guidance • Ensures patient rights under Mental Capacity Act, for example, covert administration, right of refusal • Supports effective transfer of medicines-related information when residents are hospitalised • Ensures that medicines-related information transferred from hospital to the care home is accurate and complete • Ensures that prescribing and monitoring practices relating to high-risk therapy, for example, anti-platelet and anticoagulant therapy, are appropriate • Reviews and rationalises therapy in light of risk and benefits in a complex older person Reword the following: • Formal assessment of competence is unusual as PIPs in the UK are allowed to self-certify competence. The requirement for independent external assessment resulted from medical practitioner concerns regarding the safety of this model. With no safety net for the pharmacist who is now making final prescribing decisions for a population who are likely to be frail and have complex conditions, it was believed necessary to attach this extra layer of quality assurance. It is also appropriate to assess for competency in a trial where interventions to enhance fidelity are required [29] and assessment can be used to ensure that those who deliver the main trial intervention do operate at the expected level. Within the four PIPs in the feasibility stage, the inclusion of assessment was seen as positive and effective at enhancing individual confidence. Whether it would be included in any future commissioned service would need to be decided, but evidence suggests that while it is likely to add to expense, additional benefits would be derived from this.
Due to cost and recognition that PIPs will all have different learning needs, face-to-face training was limited to those topics deemed to be most important for patient safety and PIP effectiveness. Understanding of managing complexity and frailty was seen as core knowledge for pharmacists in care homes and consequently, we chose to deliver training on this element via case studies with a geriatrician and a pharmacist with expertise in managing medicines in older people leading the session jointly. This element of the training was appreciated by the PIPs and was seen to enhance their confidence. The experience of Covid-19 may promote training to be undertaken virtually, rather than face-to-face, thereby reducing travel and accommodation costs experienced within this programme of research. The identification of knowledge required by PIPs to undertake their role and underpin their competencies created some concern for the team anticipating the time required to develop the materials. However, recognition that such materials were already available and in the public domain enabled us to rapidly produce a document consisting of web links to relevant guidelines, pages and documents. A model of this nature is also relatively easy to regularly update.
The overall model we have developed here, is very similar to that which was subsequently used to underpin a concurrent national initiative to integrate pharmacists into care homes for medicines optimisation purposes. Face-to-face training, support materials, competency framework and mentoring were similarly provided. [30] Consequently, demonstrating the potential feasibility of our training programme for preparing pharmacists to undertake the central medicines management role within care homes.
Although pharmacist prescribing is still limited to a minority of countries, the opportunity for direct transferability of these results is small. However, with the training programme underpinned by extensive international literature regarding pharmacist activities within care homes, we believe that it could transfer across countries and to pharmacists without prescribing rights. With all frameworks of this nature, they are, however, more likely to be effective if adapted to the context and target audience. Furthermore, to enhance ownership of, and engagement with, any training programme of this nature it is always best to involve the users in its design.

Conclusion
This novel and extensive approach has produced a comprehensive training programme to enable PIPs to provide pharmaceutical care within care homes. Comprehensive engagement with key stakeholders within the process should engender greater buy-in when the intervention is delivered.
The feasibility of the training programme was demonstrated with PIPs feeling confident and competent to perform their role. Larger scale testing of our package is now required before broader dissemination.