General Practice Clinical Pharmacist Standards of Practice for Delivery of Polypharmacy and Chronic Disease Medication Reviews: A Consensus Study.

Background General practice in the UK is experiencing a crisis. Greater multidisciplinary working is a potential solution. The new general practice contract in Scotland encourages this and includes a new pharmacotherapy service to be delivered by General Practice Clinical Pharmacists (GPCPs). Consensus is lacking for the standards of practice for delivery of pharmacotherapy medication reviews (which are polypharmacy and chronic medication reviews) as part of this service. Aim To identify and validate standards of practice for polypharmacy and chronic disease medication (pharmacotherapy level 3) reviews conducted by GPCPs. Method A two-phased mixed-methods consensus methodology was used. Phase 1: An expert group of GPCPs (n=4) and clinical pharmacist managers (n=2) responsible for delivering the pharmacotherapy service used a Modied Nominal Group Technique to generate potential standards. Phase 2: Two-round Delphi survey involving GPCPs with ≥ 1 year of experience of working in general practice (n=159). The expert group identied 44 potential standards of practice for polypharmacy and chronic disease reviews. Practicing GPCPs indicated during the Delphi phase that the 44 standards were applicable to practice. The standards of practice covered seven main categories: skills, environment, qualications, qualities and behaviours, knowledge, process and experience. Practicing GPCPs indicated that the standards identied by the expert group are acceptable and valid for current practice and the delivery of polypharmacy and chronic medication reviews. The application of these standards to practice may help GPCPs and general practices to ensure equitable delivery of patient care. 70% before the second round. The results from the second round were analysed via the same method.


Introduction
The recruitment crisis of doctors in general practice in the United Kingdom (UK) is well documented [1][2][3]. In part this is due to an aging patient population with complex needs and advances in medical care intensifying workloads, demands and pressures that compromise patient-centred care diminishing General Practitioners' (GPs') job satisfaction and health [2][3][4]. All of this, along with added pressures of COVID-19 pandemic is driving GPs away from the National Health Service (NHS), away from their professions, and away from patients [3,5]. There is a need to redress these pressures; to enable a better work-life balance to allow GPs to ful l personal responsibilities and needs [5,6].
In the UK pharmacists have worked alongside GPs in general practices for over 20 years to improve patient care, outcomes and, more recently, free GP time and capacity [3,[7][8][9][10][11]. Consequently, across the UK, there is a drive to recruit more pharmacists to general practice and expand their roles to help general practice to continue to deliver patient services [12,13]. The demand for General Practice Clinical Pharmacists (GPCPs) in Scotland has become more urgent since the introduction of the new General Medical Services (GMS) contract in Scotland in 2018, for full implementation by 2021 dependent on workforce availability [14]. This new contract includes a new three-tiered pharmacotherapy service to be delivered by GPCPs. Level 1 -'core' service -includes authorising all prescription requests, immediate discharge letters, outpatient letters, medicine safety reviews and monitoring high risk medicines. Level 2 -'additional advanced' service-includes medication reviews of ≥ 5 medicines and resolving high risk medicine problems with level 3 -'additional specialist' service -including polypharmacy reviews and specialist clinics such as chronic pain, heart failure and diabetes clinics [14].
The GMS contract is clear on requirements to provide level 1 and 2 services, however, level 3 service necessitates de nition as to how this service will be provided to ensure uniformity of care and patient safety. One of the ways this can be achieved is by developing a set of standards a pharmacist has to meet, in order to perform these tasks. A standard is a statement that provides a broad framework and describes how safe and effective care is delivered, hence providing support for pharmacists to improve and shape services [15].
Several sets of standards for pharmacy professionals are available from national organisations within the UK, North America and Australasia. Internationally, in 2012 the International Pharmaceutical Federation has published Global Competency Framework for Pharmacists which provided the basis for national standards set by many pharmacy regulatory bodies around the globe [16][17][18][19]. In the UK, General Pharmaceutical Council, Royal Pharmaceutical Society and Pharmaceutical Society of Northern Ireland published standards for safe and effective pharmaceutical care [20][21][22][23]. In 2016 both, Centre for Postgraduate Pharmacy Education and NHS Education for Scotland have published standards speci cally for GPCPs and a GPCP competence framework respectively [24,25]. All these publications have common themes such as patient-centeredness, good communication, multidisciplinary working, professionalism and speaking up about concerns. While a range of specialist clinical pharmacy service standards and competencies have been de ned within the UK and elsewhere, a Canadian study is the only one that considered and developed competencies for pharmacists working in general practice [26][27][28][29][30][31][32][33][34]. This study however did not de ne standards of practice for the delivery of medication reviews, and hence more research is needed in this area.

Aim
To identify and validate standards of practice for polypharmacy and chronic disease medication reviews (pharmacotherapy level 3) conducted by GPCPs.

Ethics approval
This study received ethical approval from Robert Gordon University School of Pharmacy and Life Science Research Committee, approval number # S225, on 20/12/19.

Methods
Design Two-phase consensus study. Phase 1 applied a Modi ed Nominal Group Technique (NGT) to generate and achieve consensus of standards of practice for polypharmacy or chronic disease medication review via an expert group. Phase 2 was a 2-round Delphi questionnaire used to gain broader GPCP workforce consensus and validate the standards using Conducting and Reporting of Delphi Studies (CREDES) guidelines (supplementary le1) [35].

Setting
The UK NHS is a taxpayer funded healthcare system. NHS Greater Glasgow and Clyde (NHSGGC) health board provides healthcare services for a diverse population of 1.2 million people across a varied urban region containing 260 general practices. NHSGGC covers six Health and Social Care Partnerships (HSCPs) and in 2020 employed 159 GPCPs working in general practices.
A modi ed NGT was used, see Figure 1. The expert group was recruited from experienced GPCPs meeting the following inclusion criteria: experience running regular established clinics for ≥4 years and prescribing on a regular basis; and lead clinical pharmacists, responsible for service delivery were invited to participate as the expert group. Co-authors were excluded from participation to reduce bias. A study recruitment email was sent to all GPCPs via HSCP lead clinical pharmacists in January 2020. A reminder email was sent to encourage participation 2 weeks later. Purposive sampling was employed. The NGT was facilitated by the authors (KEP, PF, CJ and HH) Data generation. Consensus methods such as NGT are frequently used for structured idea generation and achieving agreements in healthcare research, especially when little is known on the subject and the opinions of the experts in the eld are sought with the bene t of equal participation [36,37]. A traditional NGT is a structured face-to-face method of generating consensus involving four key stages -idea generation, round robin, clari cation of ideas and voting/ranking [38,39].
This study employed a modi ed NGT, applying electronic voting/ranking after face-to-face silent idea generation, round robin and clari cation of ideas by the expert group ( Figure 1). Similar generated standards were then summarised into single standards between round 1 and 2 of ranking. A standardised data collection form for the silent idea generation phase was developed by the lead author (KEP) and this and the modi ed NGT process were piloted by KEP and two co-authors (PF and CJ).
Data Analysis. The standards generated by each participant during the face-to-face meeting populated an electronic Google forms questionnaire and sent to each participant for ranking. This involved 2 rounds of ranking ( Figure 1). A 5-point Likert-type scale ('strongly agree', 'agree', 'neutral', 'disagree' and 'strongly disagree') was used. Consensus was de ned as ≥80% of participants agreeing ('strongly agree' or 'agree') for a standard to be accepted. Where participants selected 'strongly disagree' or 'disagree', the -standard was rejected. Standards achieving consensus in round 2 populated the Delphi phase.
Delphi questionnaire allows for wide participation and anonymity with 2 rounds commonly used in the literature, because it is known that more than 2 rounds can create participation fatigue and reduce participation [40,41], therefore a 2-round Delphi was conducted. The rst round Delphi questionnaire was informed by the modi ed NGT compiled by KEP and piloted by PF and a GPCP working within NHSGGC.
All experienced GPCPs (≥1 year experience in primary care) were invited to participate. This was to allow for a broad and relevant consensus to be achieved.
Convenience sampling was employed. Co-authors were excluded from participation to reduce bias. A study recruitment email was sent to all GPCPs via HSCP lead clinical pharmacists for round 1 (March 2020) and round 2 (September 2020 -delayed due to COVID-19 pandemic). The email outlined the study, provided a link for the online Webropol questionnaire and requested that participants completed it within a 2 week timeframe. Participants consent to participate was sought prior to completing the questionnaire.
Data Analysis. The participants rated the presented standards for inclusion using a 5-point Likert scale (see above). Consensus setting varies between NGT and consensus studies, with most common ranges quoted between 70-90% [42][43][44]. Consensus was de ned as ≥70% of agreement (agree/strongly agreestandard accepted) or disagreement (disagree/strongly disagree -standard rejected). Standards achieving consensus (≥70% agree or disagree) were removed before the second round. The results from the second round were analysed via the same method.

Demographics
The NGT expert group participants consisted of 4 GPCPs and 2 lead clinical pharmacists. All participants were female; median age 42 (range 37 to 53) years old, with a median of 13 years (range 7 to 20) experience working in general practice. All had additional postgraduate quali cations and were independent prescribers with experience of running a range of medication review clinics; 67% (n=4) currently delivered patient facing clinics.
The Delphi phase captured responses from 59 (37%) and 86 (54%) GPCPs practicing in NHSGGC, for round 1 and 2 respectively (Table 1). Respondent characteristics were similar for round 1 and 2. They were of similar ages, the majority were female, had gained extra postgraduate quali cations and were prescribers. A similar proportion of GPCPs had experience in running clinics in both groups. In round 2 fewer clinicians reported that they currently ran medication review clinics.
The expert group initially generated 121 standards during the silent generation and the round robin phases. Clari cation of ideas and the rst round of ranking rejected 25 standards: 13 due to duplication; 8 relating to medication review 'time'; 4 that related to governance (supplementary le 2).
The rst round was completed by 59 (37%) GPCPs, and the second-round by 86 (54%). Consensus was reached during the second-round, all 44 standards proposed by the expert panel being accepted.
'Skills' was the largest category with 11 standards. These focused on, but were not limited to, taking a holistic patient-centred view when carrying out level 3 reviews, as well as demonstrating the ability to manage complex patients and balance risk and bene ts when prescribing and deprescribing. There was also emphasis on signposting and non-pharmacological interventions, the ability to interpret test results for relevant conditions and good time management.
'Environment' was the next largest category (n=8). These standards focused mainly on 2 areas, rstly, peer support and mentoring for all GPCPs from pharmacists and the wider multidisciplinary team. Secondly, a culture of support within practice 'to allow full polypharmacy reviews to be conducted' that incorporated exibility for repeat appointments within practices and the capacity to conduct reviews in the setting that was 'most suitable for patients' e.g. the patients home.
The 'Quali cations' category (n=7), indicated that the GPCPs performing level 3 polypharmacy reviews should be quali ed independent prescribers, with up-todate knowledge and be competent prescribers. Participants demonstrated consensus that GPCPs should have relevant postgraduate quali cations and undertake appropriate additional training such as consultation, communication and relevant clinical examination skills training, suicide prevention training and behaviour skills training.
'Qualities and Behaviours' standards (n=6) focused on GPCPS demonstrating self-awareness, self-motivated and the ability to work independently, but were aware of their own limitations and sought help appropriately. Demonstrating good team working and drawing on individual multidisciplinary team members' strengths and knowledge was also considered to be important. 'Knowledge' standards (n=5) highlighted the importance of understanding the GPCP role within wider general practice and healthcare team, and the ability to work within different general practice structures and systems. A knowledge of local/national formularies, guidelines and resources to support clinical practice. However, 'Process' (n=4) orientated standards focused on quality improvement, for the GPCP service and personal development through selfre ection and audit practice, as well as ensuring that good documentation was in place. Lastly, 'Experience' standards (n=3) concentrated on relevant experience that the pharmacists should have in order to deliver effective and e cient service, such as GPCPs having relevant experience in clinical assessment and examination, running clinics and managing caseloads.

Key ndings
This study identi ed and validated 44 standards of practice speci c to performing polypharmacy and chronic disease medication reviews in general practice.
All 44 standards identi ed by the expert panel reached consensus and were accepted by the Delphi participants, who were experienced GPCPs that are expected to deliver these medication reviews.
The standards covered seven main categorises: skills, environment, quali cations, qualities and behaviours, knowledge, process and experience and concentrated on good communication and patient centeredness with ability to manage complex patients, leadership and team work as well as the ability to work independently. Some new standards, speci c to complex polypharmacy and chronic disease medication reviews in general practice were also identi ed.

Strengths
To the authors' knowledge, this is the rst study to identify and validate standards of practice and hence standardise polypharmacy and chronic disease medication reviews in general practice. Groups of maximum seven participants have been recommended for NGT [35]. The purposive sample of six participants was small enough to have a close face-to-face discussion, yet large enough to include a broad range of expertise. All the standards generated by the expert group (NGT) were accepted by the GPCPs (Delphi) which adds to the study's validity. The participant demographic in this study was in keeping with the recent Scottish survey of the pharmacy workforce in general practice which described mostly female GPCP population (82%) with two thirds being IPs (68%) [9]. We report comparable 86-90% female population, with a higher percentage of IPs (83-90%), which may be explained by further encouragement for independent prescriber quali cations in recent years and the fact that we selected more experienced pharmacists for our study.

Limitations
The response rate to Delphi of 37% (n=59) (round 1) and 54% (n=86) (round 2) may be considered low but is comparable to previous studies [34,40]. The study was conducted during COVID pandemic which affected participation. In round 2 of Delphi much lower number of pharmacists reported current experience of clinics (32%) compared to round 1 (69%) and this can be explained by second round being conducted in the middle of pandemic, where many routine clinics had been cancelled. This study did not include the multidisciplinary team within the GP practice. Interpretation.
There are a number of implications for policy and practice. The standards generated in our study were similar to those published by FIP, American College of Clinical Pharmacy and those from Canada and Australia as well as locally in the UK and the Canadian study where the competencies generated for pharmacists working in primary care focussed on patient care speci cally in relation to medication related needs [16][17][18][19]34]. They listed patient-centeredness and effective communication and collaboration with MDT, colleagues' professionalism and up to date knowledge.
Some of the standards presented in this study are, however, differed from the above publications, likely due to this study concentrating on identifying standards of practice speci cally for conducting of polypharmacy and chronic disease reviews in general practice setting. The 'Quali cations' and 'Knowledge' categories for standards necessitated the pharmacist performing polypharmacy and chronic disease medication reviews to be a quali ed independent prescriber, having completed speci c examination and assessment courses as well as consultation skills training and suicide prevention training. Although relevant to UK practice, such skills may not be relevant in other healthcare systems. Additional communication standards in the skills section were also identi ed such as the use of motivational techniques, brief interventions and understanding that sometimes no change is appropriate and 'planting a seed' to prepare for the future changes may be just as important. The Scottish Government's policy for achieving excellence in pharmaceutical care aligns closely to similar policies in North America and Australasia [45][46][47][48]. These policies focus on the utilisation of pharmacist's expertise in medicines to allow their full integration into multidisciplinary health care teams thus delivering the best therapeutic outcomes for patient's health and quality of life [45][46][47][48]. The standards that the participants identi ed and validated in this study may aid the successful implementation of integrated multidisciplinary working to meet these local, national and international vision.
Research from America, Canada and the UK suggests there are several factors affecting pharmacist's ability to take on new responsibilities such as independent prescribing in particular (in the UK) and integrating new roles of pharmacists into multidisciplinary teams [49][50][51][52][53][54]. These are lack of con dence due to lack of clear role de nition and lack of peer and management/ structure support and/ or integration into multi-disciplinary team. There is also initial nervousness from medical colleagues with regards to pharmacists' training and ability [1]. Recent evidence shows that the appropriate use of competency frameworks can improve the performance of pharmacists [55]. Thus, the production of GPCP standards may provide the rst step needed to maximise the performance and effectiveness of the pharmacist clinics, by ensuring uniformity and consistency of how these clinics are delivered.

Further research
Further work would be required to establish optimal implementation processes for these and other standards by assessing and providing the environmental and professional conditions necessary for evidencing the standards and also linking them to nationally approved competency frameworks for advanced pharmacists [25,28]. Additionally, further research is required to explore how to standardise the time resource needed for these reviews, as no consensus was reached on this.

Conclusions
This study identi ed the standards of practice for polypharmacy and chronic disease medication reviews in general practice. The identi ed standards covered seven categories -skills, environment, quali cations, qualities and behaviours, knowledge, process and experience. Similarly, to other standards for pharmacists within the UK and internationally, they concentrated on good communication and patient centeredness with ability to manage complex patients, leadership, team work as well as the ability to work independently. Some new standards, speci c to polypharmacy and chronic disease medication reviews in general practice were also identi ed.
The production of GPCP standards will likely maximise the performance and effectiveness of the pharmacy service, as well as ensuring uniformity and consistency of service delivered. Further research is required into how to standardise the time resources needed for the delivery of the polypharmacy and chronic disease medication reviews.

Declarations
We declare we have no con ict of interests. We have received no external funding.