Developing a quality framework for community pharmacy: a systematic review of international literature.

OBJECTIVE: To identify the defining features of the quality of community pharmacy (CP) services and synthesise these into an evidence-based quality framework. DESIGN: Systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. DATA SOURCES: International research evidence (2005 onwards) identified from six electronic databases (Embase, PubMed, Scopus, CINAHL, Web of Science and PsycINFO) was reviewed systematically from October 2022 to January 2023. Search terms related to 'community pharmacy' and 'quality'. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Titles and abstracts were screened against inclusion or exclusion criteria, followed by full-text screening by at least two authors. Qualitative, quantitative and mixed-method studies relevant to quality in CP were included. DATA EXTRACTION AND SYNTHESIS: A narrative synthesis was undertaken. Following narrative synthesis, a patient and public involvement event was held to further refine the quality framework. RESULTS: Following the title and abstract screening of 11 493 papers, a total of 81 studies (qualitative and quantitative) were included. Of the 81 included studies, 43 investigated quality dimensions and/or factors influencing CP service quality; 21 studies assessed patient satisfaction with and/or preferences for CP, and 17 studies reported the development and assessment of quality indicators, standards and guidelines for CPs, which can help define quality.The quality framework emerging from the global literature consisted of six dimensions: person-centred care, access, environment, safety, competence and integration within local healthcare systems. Quality was defined as having timely and physical access to personalised care in a suitable environment that is safe and effective, with staff competent in the dispensing process and pharmacy professionals possessing clinical knowledge and diagnostic skills to assess and advise patients relative to pharmacists' increasingly clinical roles. CONCLUSION: The emerging framework could be used to measure and improve the quality of CP services. Further research and feasibility testing are needed to validate the framework according to the local healthcare context.

Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.

BACKGROUND: Prompted by the Covid-19 pandemic and the need to ensure timely and safe access to medicines during a pandemic, the aim of this study was to compare and contrast the EU and US regulations, processes, and outcomes pertaining to the granting of accelerated Marketing Authorizations (MAs) for COVID-19 vaccines and treatments with a view to determining how effective these regulations were in delivering safe medicines in a timely manner. METHODS: MAs for medicines approved for Covid-related indications in the first two pandemic years (March 2020-February 2022) were identified using the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) websites. Authorization reports and utilized regulations were reviewed to determine and compare approval timelines, facilitated pathways, accepted clinical evidence, and effectiveness of the regulations by assessing them against time and safety standards. RESULTS: By the end of February 2022, the EMA and FDA had granted 12 and 14 MAs, respectively. Two EU and two US approvals were issued in relation to new indications for already-approved treatments; the remaining ones were first-time approvals of novel vaccines and treatments. The median time to approval was 24 days for the EMA's conditional MAs and 36 days for the USFDA's Emergency Use Authorizations (EUA) for all Covid-19 medicines. This is compared with 23 and 28 days, respectively, specifically for first-time novel vaccines and treatments authorized by both USFDA and EMA. The USFDA and EMA differed markedly in terms of the time taken to approve new indications of already-approved treatment; the USFDA took 65 days for such approval, compared with 133 days for the EMA. Where MAs were issued by both authorities, USFDA approvals were issued before EMA approvals; applications for approval were submitted to the FDA before submission to the EMA. Three EU and two US MAs were based on data from two or more phase 3 clinical trials; the remaining ones were based on single trial data. Only six EU and four US trials had been completed by the time of authorization. This was in line with regulations. While the applicable regulations shared many similarities, there were marked differences. For instance, the EU's conditional MA regulation pertains only to first approvals of new treatments. It does not cover new indications of already-approved treatments. This contrasts with the US, where the EUA regulation applies to both types of applications, something that may have impacted approval timelines. Overall, both EU and US utilized regulations were considered to be effective. For most cases, utilizing such regulations for Covid-19 MAs resulted in faster approval timelines compared to standard MAs. They were flexible enough to manage the process of granting emergency approvals while maintaining strict requirements and allowing comprehensive reviews of the supporting evidence. CONCLUSION: US and EU regulations were effective in ensuring timely accelerated market access to Covid-19 medicines during the pandemic without compromising the approval standards related to safety or efficacy. The population in both regions will receive comparable access to medicines during a pandemic if sponsors submit their applications to both authorities in parallel.

Development, Feasibility, Impact and Acceptability of a Community Pharmacy-Based Diabetes Care Plan in a Low-Middle-Income Country.

Informed by existing research, mostly from high-income countries, this study aimed to develop and test the feasibility of a community pharmacy person-centred goal-setting intervention for people living with type 2 diabetes in a low-middle-income country-Nigeria. The Medical Research Council (MRC) guidance for developing complex interventions framed the intervention development. Patients participated in monthly community pharmacist consultations over six months. Self-reported and clinical outcome measures were collected at baseline and study completion and analysed in STATA V.14. Twenty pharmacists in 20 pharmacies completed the research and enrolled 104 patients. Of these, 89 patients had complete study data, and 70 patients also completed a post-study evaluation questionnaire. In addition, 15 patients and 10 pharmacists were interviewed. All outcome measures showed statistically significant improvements (p < 0.05). Clinical outcomes (BMI, waist circumference, and fasting plasma glucose) improved significantly. Mean patient activation measure (PAM©), quality of life (EQ-VAS©), and medication adherence improved from baseline to study completion. Eighty-eight per cent of questionnaire respondents were satisfied with the service. Interviews indicated care plan acceptability, patient satisfaction, empowerment, and service enthusiasm. Identified barriers to the consultations included time and technology. This study developed a feasible, effective, well-perceived community pharmacy diabetes care plan in Nigeria.

Pharmacy professionals' perceptions of educational supervision in primary care through the lens of Proctor's model.

BACKGROUND: Educational supervision plays a vital role in postgraduate medical education and more recently in pharmacy and advanced clinical practitioner training in England. Proctor's three-function model of clinical supervision (consisting of formative, restorative, and normative functions) is assumed to apply to educational supervision, but this has not been tested empirically. The aim of this study was to establish perceptions of the purpose of educational supervision from the perspective of primary care pharmacy professionals enrolled on a national training pathway in England. METHODS: Using a mixed methods design, data were collected using a validated 25-item online survey and respondents were invited to add comments explaining their responses. The survey was sent to all 902 learners enrolled on a postgraduate training pathway for pharmacy professionals working in primary care. Principal components analysis (PCA) was used to interpret patterns in the survey data, and framework analysis of qualitative free text comments was used to identify themes and aid interpretation of quantitative findings. RESULTS: One hundred eighty-seven pharmacy professionals responded (response rate 20.7%). PCA extracted three factors explaining 71.5% of the total variance. Factor 1 corresponded with survey items linked to the formative function of Proctor's model, while factor 2 corresponded with survey items linked to the restorative function. No items corresponded with the normative function. Framework analysis of qualitative free-text comments identified two themes: learning support, which corresponded with factor 1; and personal support, which corresponded with factor 2. CONCLUSIONS: This study identified that pharmacy professionals perceived educational supervision to perform two functions, formative (educational) and restorative (pastoral), but did not perceive it to perform a normative (surveillance) function. Educational supervision has the potential to support allied health professionals advancing their roles and we suggest the need for more research to develop models of effective educational supervision which can inform practice.

To be or not to be: The identity work of pharmacists as clinicians.

This study explores how pharmacists legitimise the expansion of their clinical work and considers its impact on pharmacists' professional identity work. In the context of pharmacy in the English NHS, there has been an ongoing policy shift towards pharmacists moving away from 'medicines supply' to patient-facing, clinical work since the 1950s. Pharmacists are continuously engaging in 'identity work' and 'boundary work' to reflect the expansion of their work, which has led to the argument that pharmacists lack a clear professional identity. Drawing insights from linguistics and specifically Van Leeuwen's 'grammar of legitimation', this study explains how the Pharmacy Integration Fund, a nationally funded learning programme, provides the discursive strategies for pharmacists to legitimise their identity work as clinicians.

Preparing pharmacists for the Community Pharmacist Consultation Service: a questionnaire survey.

OBJECTIVES: The Community Pharmacist Consultation Service launched in England in 2019. Patients requiring urgent care were referred from National Health Service-based telephone/digital triage or general practice to a community pharmacist, who provided a consultation, which could include a physical examination. The aim of the study was to evaluate the effectiveness of a learning programme to prepare community pharmacists for the service. METHODS: Learning programme participants were invited to complete an online survey shortly after the workshop and another survey 3 months later. The survey collected opinions on aspects of the programme, including Likert-type statements and free text questions. The 3-month follow-up survey explored how the programme had helped pharmacists change their practice. Data were analysed in SPSS (v.25; IBM) with inferential statistics used to compare subgroups. Open comments were analysed qualitatively. KEY FINDINGS: The learning programme addressed participants' learning needs including history-taking, clinically observing the patient, performing physical examinations, structuring a consultation, safety-netting, and documenting consultations. Barriers to using skills acquired included low service uptake and a lack of equipment to perform physical examinations. While many participants recognised the importance of skills to provide person-centred care, some participants did not appear to recognise the shift in policy to a more clinical role. CONCLUSIONS: The learning programme resulted in increased confidence and a recognition of a shift in the policy vision for community pharmacist roles. Although some pharmacists appeared to embrace this, others have yet to fully appreciate the need to adapt to be ready for the opportunities that this service can provide.

Using normalisation process theory to understand implementation of integrated multi-sector pre-registration trainee pharmacy technician training.

BACKGROUND: The pre-registration trainee pharmacy technician (PTPT) integrated training programme is a workforce intervention designed to train PTPTs in multiple sectors. The programme recruited 35 PTPTs to 2-year training posts which involved employment in one sector, and a minimum of 12 weeks' work-based training in ≥2 further settings each year. AIM: To identify facilitating and inhibiting factors to implementation of the PTPT integrated training programme and make recommendations on ways to embed and maintain PTPT integrated training in routine practice. METHODS: Normalisation Process Theory (NPT) constructs were used as a framework for analysis. Semi-structured interviews (14 PTPTs, 15 supervisors) explored PTPTs' learning and practice experiences over their 2-year training. A survey explored training outcomes (confidence and preparedness to practise) of integrated (n = 31) and single sector PTPTs (n = 39). RESULTS: Whilst some understood the intervention well, others had differing understandings of its purpose and potential benefits (coherence). Educational and practice supervisors acknowledged the importance of regular communication but reported difficulties implementing this due to time constraints (cognitive participation). PTPTs benefitted from having an educational supervisor oversee learning and progress over 2-years, and a practice supervisor for their day-to-day learning. PTPTs' experiences of supervision were inconsistent due to variation in supervisors' availability, knowledge, experience, and level of support (collective action). Participants perceived the PTPT integrated training as supporting development of a flexible pharmacy technician workforce able to work across sectors. The survey found that integrated PTPTs felt significantly more prepared than single-sector PTPTs to work in different settings (reflective monitoring). CONCLUSIONS: PTPTs on the programme had better ability to work in different sectors. Improving implementation requires clear understanding of the intervention's purpose by all stakeholders; clarity on supervisors' roles/contributions; and effective communication between supervisors to create effective learning opportunities. Findings can inform implementation of future multi-sector education and training globally.

Community Pharmacist Consultation Service: A Survey Exploring Factors Facilitating or Hindering Community Pharmacists' Ability to Apply Learnt Skills in Practice.

BACKGROUND: The NHS Community Pharmacist Consultation Service (CPCS) offers patients requiring urgent care a consultation with a community pharmacist, following referral from general practice or urgent care. The study explored the impact of undertaking a Centre for Pharmacy Postgraduate Education (CPPE) CPCS learning programme, and barriers and enablers to CPCS delivery. METHODS: CPPE distributed an online survey to those who had undertaken their CPCS learning. The survey explored participants' knowledge, confidence and application of taught skills/tools, including clinical history-taking, clinical assessment, record keeping, transfer of care, and Calgary-Cambridge, L(ICE)F and SBARD communication tools. Details on barriers and enablers to CPCS delivery were also included. RESULTS: One-hundred-and-fifty-nine responses were received (response rate 5.6%). Knowledge of, and confidence in, taught skills were high and respondents reported applying skills in CPCS consultations and wider practice. Barriers to CPCS included a lack of general practice referrals, staffing levels, workload, and GP attitudes. Enablers included a clear understanding of what was expected, minimal concerns over indemnity cover and privacy, and positive patient attitudes towards pharmacy. CONCLUSION: This study demonstrates that community pharmacists can extend their practice and contribute to the enhanced provision of urgent care in England. This study identified barriers, both interpersonal and infrastructural, that may hinder service implementation.

A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators.

BACKGROUND: In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing countries' PV systems' performance. METHODS: EMBASE, MEDLINE, CINAHL Plus and Web of Science were searched for peer-reviewed studies published in English between 2012 and 2021. Reference lists of included studies were screened. Included studies were quality assessed using Hawker et al.'s nine-item checklist; data were extracted using the WHO PV indicators checklist. Scores were assigned to each group of indicators and used to compare countries' PV performance. RESULTS: Twenty-one unique studies from 51 countries were included. Of a total possible quality score of 36, most studies were rated medium (n = 7 studies) or high (n = 14 studies). Studies obtained an average score of 17.2 out of a possible 63 of the WHO PV indicators. PV system performance in all 51 countries was low (14.86/63; range: 0-26). Higher average scores were obtained in the 'Core' (9.27/27) compared to 'Complementary' (5.59/36) indicators. Overall performance for 'Process' and 'Outcome' indicators was lower than that of 'Structural'. CONCLUSION: This first systematic review of studies evaluating PV performance in developing countries provides an in-depth understanding of factors affecting PV system performance.

Educational supervision to support pharmacy professionals' learning and practice of advanced roles.

Pharmacy professionals are increasingly moving into advanced roles, including in primary care. In England, the publicly funded Pharmacy Integration Fund (PhIF) enabled employment and training of pharmacy professionals in new patient-facing roles, including general practice and care homes. In recognition of the need for support and supervision during work-based learning and building on established support structures in medicine and nursing, one of the providers of PhIF funded learning developed a supervision structure which mirrors arrangements for postgraduate medical specialty training. This paper describes what informed this supervision model, with a particular focus on educational supervision, its delivery, and the training which was developed to support supervisors. This supervision enabled pharmacy professionals moving into primary care to practise safely, manage workplace challenges, extend their roles and make progress with their education. This model illustrates the benefits of supervision in supporting post-registration learning to facilitate the development of advanced patient-facing clinical roles.

Contribution of supervision to the development of advanced practitioners: a qualitative study of pharmacy learners' and supervisors' views.

OBJECTIVE: To apply educational theory to explore how supervision can contribute to the development of advanced practitioners using the example of several postregistration primary care training pathways for pharmacy professionals (pharmacists and pharmacy technicians). DESIGN: Qualitative semistructured telephone interviews applying Billet's theory of workplace pedagogy for interpretation. SETTING: England. PARTICIPANTS: Fifty-one learners and ten supervisors. PRIMARY OUTCOME: Contribution of clinical and educational supervision to the development of advanced practitioners in primary care. RESULTS: Findings were mapped against the components of Billet's theory to provide insights into the role of supervision in developing advanced practitioners. Key elements for effective supervision included supporting learners to identify their learning needs (educational supervision), guiding learners in everyday work activities (clinical supervision), and combination of regular prearranged face-to-face meetings and ad hoc contact when needed (clinical supervision), along with ongoing support as learners progressed through a learning pathway (educational supervision). Clinical supervisors supported learners in developing proficiency and confidence in translating and applying the knowledge and skills they were gaining into practice. Learners benefited from having clinical supervisors in the workplace with good understanding and experience of working in the setting, as well as receiving clinical supervision from different types of healthcare professionals. Educational supervisors supported learners to identify their learning needs and the requirements of the learning pathway, and then as an ongoing available source of support as they progressed through a pathway. Educational supervisors also filled in some of the gaps where there was a lack of local clinical supervision and in settings like community pharmacy where pharmacist learners did not have access to any clinical supervision. CONCLUSIONS: This study drew out important elements which contributed to effective supervision of pharmacy advanced practitioners. Findings can inform the education and training of advanced practitioners from different professions to support healthcare workforce development in different healthcare settings.

Cross-sector pre-registration trainee pharmacist placements in general practice across England: A qualitative study exploring the views of pre-registration trainees and education supervisors.

The Pharmacy Integration Fund commissioned 95 cross-sector pre-registration trainee pharmacist placements across England, which incorporated trainees spending 3-6 months in general practice (GP), whilst employed in hospital or community pharmacy. Delivery models varied (blocks or split weeks/days); trainees had pharmacist tutors at the employing/base (hospital/community pharmacy) organisation and in GP. This study aimed to evaluate implementation of cross-sector pre-registration placements, and to identify barriers and enablers of a "successful" placement that achieved its intended outcomes. A qualitative study was undertaken, using semi-structured interviews with triads/dyads of trainee and pharmacist tutors at base and/or GP site. Interviews explored trainees' and tutors' GP placement experiences, and the contribution of GP placements to achieving intended learning outcomes. Data were thematically analysed. Thirty-four interviews (14 trainees, 11 base tutors, 9 GP tutors) were completed in 11 study sites (5 GP/hospital; 6 GP/community pharmacy). GP placements were perceived as valuable and producing well-rounded pre-registration trainees with a good understanding of two settings. Key benefits of GP placements were trainees' ability to work within multidisciplinary teams, and improved clinical and consultation skills. Contingency planning/flexibility was important when setting up cross-sector placements. GP tutor supervision which supported a gradual transition from shadowing to more independent clinical practice with feedback was perceived as valuable. Good collaboration between tutors at the base and GP site ensured joined-up learning across settings. All participants considered 13 weeks in GP an appropriate minimum duration; community trainees preferred longer duration (26 weeks) for more opportunities for clinical and consultation skills learning. Base and GP tutors would welcome clarity on which pre-registration competencies should be achieved in GP placements, which would also aid quality and consistency across providers. Findings from this study identified key attributes of a successful pre-registration cross-sector training experience. These findings can inform policy reforms including changes to initial education and training of pharmacists.

Strengths and Weaknesses of the Pharmacovigilance Systems in Three Arab Countries: A Mixed-Methods Study Using the WHO Pharmacovigilance Indicators.

Using the WHO pharmacovigilance (PV) indicators as a framework, this study aimed to explore the structures, processes, and outcomes of three Arab countries' (Jordan, Oman, and Kuwait) PV systems to inform recommendations for countries with nascent PV systems. A mixed-methods design involving document review, semi-structured interviews, and a questionnaire was employed. Fifty-six key informants from the three countries' national PV centres (NPVCs) and pharmaceutical industry were interviewed. The questionnaire collecting quantitative measures was only completed by Oman and Kuwait's NPVCs. Using the framework, system strengths were attributed to the presence of "core" structural indicators, including a dedicated and officially recognised NPVC, PV legislation, and a national PV advisory committee, as well as "complementary" structural indicators, e.g., a computerised case-report management system. Contrastingly, weaknesses were attributed to the absence of these indicators plus other "core" structural indicators, namely, regular financial provision and adequate staff. Other weaknesses were attributed to low performance in "core" process and outcome indicators including reporting rates, reporter awareness, and signal detection. Greater governmental prioritisation through the provision of legislative enforcements, resources, and expertise as part of a well-structured system is required. More regional coordination efforts are needed to allow for sharing of expertise in order to bolster nascent systems.

Using communities of practice as a lens for exploring experiential pharmacy learning in general practice: Are communities of practice the way forward in changing the training culture in pharmacy?

BACKGROUND: Currently, there is little experiential learning in general practice (GP) during UK undergraduate and postgraduate pharmacy education and training. AIM: To apply educational theories to explore pharmacy stakeholders' perceptions of placements in general practice and contribute to the development of a model of experiential learning for pharmacy. METHODS: Qualitative, semi-structured interviews, conducted as part of two studies exploring experiential learning in general practice, with learners and their GP based supervisors. Interviews explored experiences of learning and practice, and what aided or hindered this. An abductive approach to analysis combined inductive coding with deductive, theory-driven interpretation using Lave and Wenger's concept of "Communities of Practice". RESULTS: Forty-four interviews were conducted, with learners and placement supervisors. Participants valued placements for providing authentic patient-facing learning experiences in the workplace, facilitated through legitimate peripheral participation by supervisors and supported by the use of pre- and de-briefing. Learners benefitted from support from their supervisor(s) and other staff during their day-to-day learning (informal learning), whilst also having protected time with their supervisors to discuss learning needs or go through workplace-based assessments (formal learning). Lack of clarity regarding which and how competencies should be assessed / demonstrated in general practice challenged monitoring progress from peripheral to full participation. Findings suggest that GP placements provide opportunities for learning about the patient journey between care settings; to work effectively with multidisciplinary teams; and consolidation and application of consultation / communication skills learning. CONCLUSIONS: The learning culture of GP supports learners' development, providing time and opportunities for meaningful and authentic workplace learning, with healthcare professionals acting as supervisors and mentors. These findings can usefully inform implementation of meaningful learning opportunities in primary and secondary care for those involved in pharmacy education and training.

The development, feasibility and acceptability of a coach-led intervention to ease novice community pharmacists' transition to practice.

BACKGROUND: Despite reported benefits of transition support programmes for other healthcare professionals, no evidence-based support interventions exist to ease newly-registered novice community pharmacists' (NCPs) transition into practice. OBJECTIVES: To develop an intervention to provide psychosocial support, support the development of professional behaviours and skills of novice pharmacists in community pharmacy and conduct an evaluation. METHODS: The Medical Research Council (MRC) guidance for developing complex interventions was applied to develop a 17-week, pharmacist coach-led intervention, using a social media group, a face-to-face introductory workshop, two webinars, weekly case studies, portfolios (reflective logs and development plans) and a handbook. Twelve newly-registered NCPs participated. A coach log and semi-structured interviews collected data on feasibility, acceptability and perceived impact. RESULTS: Findings suggest the intervention was feasible and highly acceptable to NCPs, who perceived the coach and social media group to be the most valuable components. The coach was described as non-judgemental, approachable and collaborative. Provision of guided one-to-one reflection was viewed as useful for debriefing, feedback and meaningful reflection, and supported development of reflection-in-action. The face-to-face workshop was considered important for establishing rapport and trust. The social media group was most valued for providing an accessible, confidential and responsive support network, in which NCPs felt psychologically safe to learn. This component was reported to present opportunities for developmental discourse and shared reflection with peers, thus reducing the sense of professional isolation. NCPs reported that the intervention led to increases in meaningful learning, confidence, critical reasoning, self-awareness and self-reflection. The webinars and handbook were identified as the least valuable components. CONCLUSIONS: A transition-support intervention using an experienced pharmacist coach, delivered within a safe, supportive, albeit online facilitated learning environment, appeared feasible and valuable in supporting guided reflection and developmental discourse. This facilitates transformative learning, and supports NCPs to gain proficiency and become independent reflective practitioners.

"A little bit more looking listening and feeling" A qualitative interview study exploring advanced clinical practice in primary care and community pharmacy.

Background Growing demands on healthcare globally, combined with workforce shortages, have led to greater skill mix in healthcare settings. Pharmacists are increasingly moving into complex areas of practice, a move supported by policy and education/training changes. Aim To understand the nature of extended roles for pharmacists practising at an advanced level in primary care and community pharmacy settings, to explore how clinical and physical examination was incorporated into practice and to understand the impact of providing such examination on practice and on patient relationships. Method Telephone interviews (N = 15) were conducted with a purposive sample of pharmacists using clinical and physical examination in their practice in Great Britain. The sample included primary care pharmacists (N = 5), community pharmacists (N = 4), pharmacists working across settings (N = 5) and one working in another primary care setting. Participants were recruited through professional networks, social media and snowballing. Results Primary care pharmacists and community pharmacists were utilising clinical and physical examination skills in their practice. Some community pharmacists were operating locally-commissioned services for low acuity conditions. Incorporating such examinations into practice enabled pharmacists to look at the patient holistically and enhanced pharmacist/patient relationships. Barriers to practise included lack of timely sharing of patient data and perceived reluctance on the part of some pharmacists for advanced practice. Conclusion With growing opportunities to provide patient-focussed care, it remains to be seen whether pharmacists, both in Great Britain and elsewhere, are able to overcome some of the organisational, structural and cultural barriers to advanced practice that currently exist in community pharmacy.

A qualitative exploration of pharmacovigilance policy implementation in Jordan, Oman, and Kuwait using Matland's ambiguity-conflict model.

BACKGROUND: As Arab countries seek to implement the 'Guideline on Good Pharmacovigilance Practice (GVP) for Arab countries', understanding policy implementation mechanisms and the factors impacting it can inform best implementation practice. This study aimed to explore the mechanisms of and factors influencing pharmacovigilance policy implementation in Arab countries with more established pharmacovigilance systems (Jordan, Oman), to inform policy implementation in a country with a nascent pharmacovigilance system (Kuwait). RESULTS: Matland's ambiguity-conflict model served to frame data analysis from 56 face-to-face interviews, which showed that policy ambiguity and conflict were low in Jordan and Oman, suggesting an "administrative implementation" pathway. In Kuwait, policy ambiguity was high while sentiments about policy conflict were varied, suggesting a mixture between "experimental implementation" and "symbolic implementation". Factors reducing policy ambiguity in Jordan and Oman included: decision-makers' guidance to implementors, stakeholder involvement in the policy's development and implementation, training of policy implementors throughout the implementation process, clearly outlined policy goals and means, and presence of a strategic implementation plan with appropriate timelines as well as a monitoring mechanism. In contrast, policy ambiguity in Kuwait stemmed from the absence or lack of attention to these factors. Factors reducing policy conflict included: the policy's compliance with internationally recognised standards and the policy's fit with local capabilities (all three countries), decision-makers' cooperation with and support of the national centre as well as stakeholders' agreement on policy goals and means (Jordan and Oman) and adopting a stepwise approach to implementation (Jordan). CONCLUSIONS: Using Matland's model, both the mechanism of and factors impacting successful pharmacovigilance policy implementation were identified. This informed recommendations for best implementation practice in Arab as well as other countries with nascent pharmacovigilance systems, including increased managerial engagement and support, greater stakeholder involvement in policy development and implementation, and undertaking more detailed implementation planning.

The current and potential role of community pharmacy in asset-based approaches to health and wellbeing: a qualitative study.

Background Asset-based approaches seek to positively mobilise the strengths, capabilities, and resources of individuals and communities. To date, limited consideration has been given to the potential value of this approach in relation to community pharmacy practice, yet this is important and timely given community pharmacy's expanding role and contribution to public health initiatives. Objectives This qualitative study aimed to explore the current and potential role of community pharmacy in asset-based approaches. Methods Fifteen semi-structured telephone interviews were undertaken with community pharmacists and project leads, and public health policy and strategic leads in the UK. Transcripts were analysed using simultaneous inductive open and deductive coding using an applied Theory of Change as an illustrative lens. Results The shift towards patient-facing roles in community pharmacy was felt to offer expanded relational opportunities to engage and collaborate with individuals, communities, and other stakeholders. However, only a small number of respondents described examples of systemic asset-based working within the pharmacy sector. The adoption of asset-based approaches was challenged or enabled by several factors including the availability of protected time/resources, workplace and organisational culture/values, strategic leadership, commissioning, and funding arrangements. Conclusions The study provides valuable insights into the potential for community pharmacy, a previously unconsidered sector, to further adopt and contribute to asset-based approaches and play a more central role in the improvement of public health and reduction of health inequalities.

High-fidelity simulation-based education in pre-registration healthcare programmes: a systematic review of reviews to inform collaborative and interprofessional best practice.

Simulation-based education (SBE) is recognized as an effective interprofessional teaching and learning method. Whilst there is a large volume of research evidence concerning elements of SBE there is a lack of clarity concerning foundational principles of best practice. This is important for educators wishing to utilize high-quality SBE to deliver interprofessional education. The aim of this review is to synthesize review evidence of SBE best practice in a broad range of pre-registration healthcare programs and contextualize findings in light of relevant educational theory. A systematic search of PubMed, Scopus, Medline/Ovid, British Nursing Index, and the Cochrane Library databases was undertaken in February 2020. Data extraction and quality evaluation were undertaken by two authors. Fifteen reviews were included. In addition to identifying barriers and enablers to implementation, three interdependent themes regarding SBE best practice were found: curriculum level integration and planning (curriculum level integration, the opportunity for deliberate repeated practice, distribution, and sequencing); simulation design and delivery (clearly defined learning outcomes and benchmarks, pre-brief, multiple learning strategies, interactivity and individualized learning, feedback, and debrief); and resources (facilitator competency, controlled environments). These themes broadly align with the social constructivist theory of experiential learning whereby structured opportunities to learn via concrete experience, reflective observation, abstract conceptualization, and active experimentation are provided through effective planning, design, and delivery of SBE. Interdependencies suggest that integration of SBE at curriculum-level enables planning and implementation of best practice principles which are associated with effective learning, which also inform and facilitate the availability of adequate simulation resources.

Implementing, embedding and sustaining simulation-based education: What helps, what hinders.

OBJECTIVES: Although there is much evidence to support the use of simulation-based education (SBE) in undergraduate education of health care professionals, less attention has been paid to how SBE, viewed as a complex intervention, is implemented and becomes embedded and sustained. This paper aims to explore factors that inhibited or promoted SBE becoming normal practice in undergraduate health care professional programmes. METHODS: Participants involved in the organisation, design and delivery of SBE in the north of England were recruited purposefully from higher education institutions (HEI) and National Health Service (NHS) Trusts through local networks for qualitative telephone interviews. Transcripts were analysed inductively using a hybrid approach involving simultaneous inductive open coding and deductive coding using normalisation process theory (NPT) as a theoretical lens. FINDINGS: A total of 12 NHS staff from 11 trusts and seven individuals from four HEIs were interviewed. There was considerable variation in the approach taken to implementation across organisations, which resulted in varying degrees of embeddedness. Implementation was challenged or enabled by organisational leadership, professional buy-in and the development and maturity of the strategic approach. Variation in understanding of the scope and pedagogical aims of SBE led to inequity between professions and organisations in investment and participation, as well as design and delivery of SBE. CONCLUSIONS: Given the complexity of SBE, best practice in implementation should be considered fundamental to the successful delivery of SBE. The findings provide an explanation of how contextual factors can support or hinder implementation to maximise potential benefits and learning outcomes; this understanding can be used to better inform development of SBE strategies and highlight potential factors needed to navigate contextual barriers so that learning outcomes can be maximised.