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BackgroundImplementation factors are hypothesised to moderate the implementation of innovations. Although individual barriers and facilitators have been identified for the implementation of different evidence-based services in pharmacy, relationships between implementation factors are usually not considered.ObjectivesTo examine how a network of implementation factors and the position of each factor within this network structure influences the implementation of a medication review service in community pharmacy.MethodsA mixed methods approach was used. Medication review with follow-up service was the innovation to be implemented over 12 months in community pharmacies. A network analysis to model relationships between implementation factors was undertaken. Two networks were created.ResultsImplementation factors hindering the service implementation with the highest centrality measures were time, motivation, recruitment, individual identification with the organization and personal characteristics of the pharmacists. Three hundred and sixty-nine different interrelationships between implementation factors were identified. Important causal relationships between implementation factors included: workflow-time; characteristics of the pharmacy-time; personal characteristics of the pharmacists-motivation. Implementation factors facilitating the implementation of the service with highest centrality scores were motivation, individual identification with the organization, beliefs, adaptability, recruitment, external support and leadership. Four hundred and fifty-six different interrelationships were identified. The important causal relationships included: motivation-external support; structure-characteristics of the pharmacy; demographics-location of the pharmacy.ConclusionNetwork analysis has proven to be a useful technique to explore networks of factors moderating the implementation of a pharmacy service. Relationships were complex with most implementation factors being interrelated. Motivation and individual identification with the organisation seemed critical factors in both hindering and facilitating the service implementation. The results can inform the design of implementation programs and tailored strategies to promote faster implementation of innovations in pharmacy.

Background Cardiovascular diseases are the leading cause of death. Pharmacist-led medication review with follow-up might be cost-effective preventing cardiovascular diseases. Objective To undertake a cost–utility analysis of the addition of pharmacist-led medication review with follow-up to usual care compared to usual care alone for cardiovascular outpatients. Materials and methods A state-transition microsimulation model was built to project outcomes over a lifetime time horizon. Inputs from a cluster randomized controlled trial conducted in primary health care centers in Chile with full-time pharmacists were used. Probabilities were estimated using patient-level data. Utilities and costs associated with each health state were obtained from the literature, whereas the intervention costs were retrieved from the trial. The public third-party payer perspective was used. Uncertainty was evaluated through one-way and probabilistic sensitivity analyses. Results For the base case analysis, an incremental cost-effectiveness ratio of $963 per quality-adjusted life-year was observed which was considered cost-effective. The results were robust to sensitivity analyses and were driven by decreased cardiovascular events resulting in lower mortality. Conclusions Medication review with follow-up was deemed a cost-effective addition to usual care with low uncertainty.

Background Implementation research has delved into barriers to implementing change and interventions for the implementation of innovation in practice. There remains a gap, however, that fails to connect implementation barriers to the most effective implementation strategies and provide a more tailored approach during implementation. This study aimed to explore barriers for the implementation of professional services in community pharmacies and to predict the effectiveness of facilitation strategies to overcome implementation barriers using machine learning techniques. Methods Six change facilitators facilitated a 2-year change programme aimed at implementing professional services across community pharmacies in Australia. A mixed methods approach was used where barriers were identified by change facilitators during the implementation study. Change facilitators trialled and recorded tailored facilitation strategies delivered to overcome identified barriers. Barriers were coded according to implementation factors derived from the Consolidated Framework for Implementation Research and the Theoretical Domains Framework. Tailored facilitation strategies were coded into 16 facilitation categories. To predict the effectiveness of these strategies, data mining with random forest was used to provide the highest level of accuracy. A predictive resolution percentage was established for each implementation strategy in relation to the barriers that were resolved by that particular strategy. Results During the 2-year programme, 1131 barriers and facilitation strategies were recorded by change facilitators. The most frequently identified barriers were a ‘lack of ability to plan for change’, ‘lack of internal supporters for the change’, ‘lack of knowledge and experience’, ‘lack of monitoring and feedback’, ‘lack of individual alignment with the change’, ‘undefined change objectives’, ‘lack of objective feedback’ and ‘lack of time’. The random forest algorithm used was able to provide 96.9% prediction accuracy. The strategy category with the highest predicted resolution rate across the most number of implementation barriers was ‘to empower stakeholders to develop objectives and solve problems’. Conclusions Results from this study have provided a better understanding of implementation barriers in community pharmacy and how data-driven approaches can be used to predict the effectiveness of facilitation strategies to overcome implementation barriers. Tailored facilitation strategies such as these can increase the rate of real-time implementation of innovations in healthcare, leading to an industry that can confidently and efficiently adapt to continuous change.

Background Community pharmacies provide an appropriate setting to deliver minor ailment services (MASs). Many community pharmacy services have been developed previously without stakeholder involvement. As a result, implementation of services may fail to produce the expected impact. The aim of this research was to co-design and test the feasibility of an Australian MAS for minor ailment presentations. Methods This study used co-design methodology which included two phases: (1) a focus group with stakeholders to allow the conceptualization of the service and agreement on service elements; (2) a literature review of clinical guidelines and three working meetings with a team of editors and general practitioners for the development of treatment pathways. Following this, a study evaluating the feasibility of the co-designed service was undertaken. The qualitative part of the methodology associated with the feasibility study comprised semi-structured interviews with MAS pharmacists, observation and completion of a tool by change facilitators identifying barriers and facilitators to service delivery. Qualitative data obtained for all phases were analysed using thematic analysis. Results The developed service included the following components: (i) an in-pharmacy consultation between the patient and pharmacist, (ii) treatment pathways accessible to pharmacists on the internet to guide consultations, (iii) existing digital communication systems used by general practice to exchange patient information, (iv) training, and (v) change facilitation. As a result of feasibility testing, twenty-six implementation factors were identified for practice change, with the main change being the simplification of the pharmacist-patient consultation and data collection processes. Conclusions An Australian MAS was generated as a result of co-design, while testing revealed that the co-designed service was feasible. As a result of integrating the views of multiple stakeholders, the designed MAS has been adapted to suit healthcare practices, which may increase the acceptance and impact of MAS when implemented into practice.

Many community pharmacists ideologically support recent changes to their roles in primary healthcare. However, their antithetical resistance towards practice change could have systemic causes (i.e. role stresses), which may account for increased job dissatisfaction, burnout, and job turnover in the profession. Deeper comprehension was sought using a role theory framework. Objective To identify factors leading to role stresses and strain responses for community pharmacists, and to create a framework for community pharmacist role management. Method PubMed, Scopus and Web of Science databases were searched for qualitative studies identifying community pharmacist role stress and strain using scoping review methodology from 1990 to 2019. Content and thematic analysis using the framework method was performed, and themes were reported using thematic synthesis. Results Screening of 10,880 records resulted in 33 studies identified, with 41 factors categorised into four domains: Interpersonal Interactions, Social Setting, Individual Attributes, and Extra-Role. All role stresses were present. Reported role strains suggest role system imbalance. Conclusion Community pharmacists are in a multifactorial transitional environment. Reported role stresses may be a function of past pharmacist roles and increased role expectations, amplified by many requisite interactions and individual pharmacist characteristics. Social science theories were found to be applicable to the community pharmacy setting.

espanolIntroduccion: la colaboracion entre medicos y farmaceuticos es necesaria en el manejo de los sintomas menores, ya que el paciente acude a ambos profesionales sanitarios para su tratamiento. El objetivo del estudio fue elaborar protocolos de trabajo consensuados entre farmaceuticos comunitarios y medicos de atencion primaria para el Servicio de Indicacion Farmaceutica (SIF). Material y metodo: se utilizaron dos metodologias: revision bibliografica y grupo de expertos para el consenso. Estos protocolos se actualizaron y disenaron a partir de un documento previo de 2008. En el grupo de expertos se incluyeron cuatro farmaceuticos comunitarios de SEFAC (2), MICOF (2) y cuatro medicos de atencion primaria de semFYC (2) y SEMERGEN (2). Resultados: se consensuaron protocolos de trabajo para 31 sintomas menores distribuidos en cinco grupos: respiratorios, dolor moderado, digestivos, dermatologicos y otros. Se anadieron cinco sintomas nuevos al documento de partida. Respecto a la estructura de cada sintoma se considero: concepto, causas mas frecuentes, criterios de derivacion al medico (edad, sintomas de alarma, duracion de los sintomas, otros problemas de salud y/o medicamentos y situaciones especiales), recomendaciones para la prevencion y tratamiento (no farmacologico y farmacologico). Conclusion: el documento desarrollado mediante colaboracion entre profesionales de la medicina y la farmacia es una herramienta que contribuye a la mejora de la actuacion del farmaceutico en el manejo de los sintomas menores desde la farmacia comunitaria, con enfasis en la definicion de indicadores que senalan la necesidad de derivar el paciente al medico de atencion primaria. EnglishBackground: To increase the collaboration between community pharmacists and medical practitioners working in primary care it is critical to have collaborative protocols in place. Minor ailments could be a good example where this collaboration would benefit patient care as patients are seeking treatment in both settings. These collaborative protocols would assist in diminishing the variability of treatments in both settings. The aim of the study was to develop care protocols for minor ailments agreed between medical practitioners and pharmacists. Methods: Two different methodologies were used to arrive at a consensus for the protocols: literature review and expert group. Some of the clinical protocols were updated from a previous document created in 2008. Expert group was composed of four community pharmacists (SEFAC, MICOF) and four medical practitioners (SemFyC y Semergen). Results: Thirty-one protocols for minor ailments were agreed and allocated to five groups (five new minor ailments protocols were added: respiratory tract-related conditions, gastrointestinal disturbance, pain, dermatological problems and others. Protocols were structured following: definition, more frequent causes, referral criteria (patient’s age, red flags, symptom’s duration, patient’s health problems and treatments and physiological situations), recommendations for management (prevention, non-pharmacological and pharmacological treatment) and references used. Conclusions: Clinical protocols agreed between health professionals of medicine and pharmacy are a tool that contribute to better management of minor ailments in community pharmacy.

Community pharmacies and pharmacists predominantly operate in a retail environment independently of other health care providers, and they are not often viewed as an integral member of the healthcare team. Thus, they remain overlooked or excluded during integration processes of health care systems. At the same time, there are calls by the profession at national and international levels for community pharmacy to be integrated within primary care systems. The COVID-19 pandemic appears to have further stimulated this desire. When pressing for integration, various terms, such as integration, integrated care, or interprofessional collaboration, are used in an interchangeable manner leading to lack of clarity, ambiguity and confusion for health care policy makers, planners, and other healthcare professionals. The literature was reviewed to identify critical components for community pharmacy to consider for integration. From the five selected articles describing integration of community pharmacies, four different constructs were identified: consensus, connectivity, communication and trust. The integration of community pharmacy into the health system may translate into better access for patients to primary care services, contribute to cost effectiveness, and promulgate the sustainability of the system. However significant political, economic, social, and practice change would be required by all stakeholders. Further research is needed to underpin a consensus for a definition, the type of integration, and the model optimally suited to integrate community pharmacy into primary care. These models, specific and adaptable to each national health care system and political environment, would need to be consensus-based by principal stakeholders to overcome a variety of barriers, including government resistance. Mere calls or demands by the pharmaceutical profession, although laudable, will not be sufficient to overcome the historical, cultural, and economic challenges.

This work was supported by a research grant from the Spanish Society of Community Pharmacy"and the Pharmaceutical Association of Valencia. Neither of these organisations influenced the study design, interpretation of data, writing of the manuscript, nor the decision to submit this manuscript for publication. The Pharmaceutical Association of Valencia assisted with initial selection of study locations and contacting community pharmacies., Background: Minor ailments are “self-limiting conditions which may be diagnosed and managed without a medical intervention”. A cluster randomised controlled trial (cRCT) was designed to evaluate the clinical, humanistic and economic outcomes of a Minor Ailment Service (MAS) in community pharmacy (CP) compared with usual care (UC). Methods: The cRCT was conducted for 6 months from December 2017. The pharmacist-patient intervention consisted of a standardised face-to-face consultation on a web-based program using co-developed protocols, pharmacists’ training, practice change facilitators and patients’ educational material. Patients requesting a non-prescription medication (direct product request) or presenting minor ailments received MAS or UC and were followed-up by telephone 10-days after the consultation. The primary economic outcomes were incremental cost-utility ratio (ICUR) of the service and health related quality of life (HRQoL). Total costs included health system, CPs and patient direct costs: health professionals’ consultation time, medication costs, pharmacists’ training costs, investment of the pharmacy and consultation costs within the 10 days following the initial consultation. The HRQoL was obtained using the EuroQoL 5D-5L at the time of the consultation and at 10-days follow up. A sensitivity analysis was carried out using bootstrapping. There were two sub-group analyses undertaken, for symptom presentation and direct product requests, to evaluate possible differences. Results: A total of 808 patients (323 MAS and 485 UC) were recruited in 27 CPs with 42 pharmacists (20 MAS and 22 UC). 64.7% (n = 523) of patients responded to follow-up after their consultation in CP. MAS patients gained an additional 0.0003 QALYs (p = 0.053). When considering only MAS patients presenting with symptoms, the ICUR was 24,733€/QALY with a 47.4% probability of cost-effectiveness (willingness to pay of 25,000€/QALY). Although when considering patients presenting for a direct product request, MAS was the dominant strategy with a 93.69% probability of cost-effectiveness. Conclusions: Expanding community pharmacists’ scope through MAS may benefit health systems. To be fully cost effective, MAS should not only include consultations arising from symptom presentation but also include an oversight of self-selected products by patients. MAS increase patient safety through the appropriate use of non-prescription medication and through the direct referral of patients to GP., Spanish Society of Community Pharmacy, Pharmaceutical Association of Valencia

© 2019, Springer-Verlag GmbH Germany, part of Springer Nature. Objectives: To evaluate the health economics evidence based on randomized controlled trials of pharmacist-led medication review in pharmacotherapy managed cardiovascular disease risk factors, specifically, hypertension, type-2 diabetes mellitus and dyslipidaemia in ambulatory settings and to provide recommendations for future evaluations. Methods: A systematic review was carried out according to the Cochrane Handbook for Systematic Reviews. PubMed (Medline), Scopus, Web of Science, National Health System Economic Evaluation Database (NHS EED), Cochrane Library, and Econlit were searched and screened by two independent authors. Incremental cost-effectiveness ratio was the main outcome. Risk of bias was assessed with the Effective Practice and Organisation of Care tool by the Cochrane Collaboration. Economic evaluation quality was assessed with the he Consensus Health Economic Criteria list (CHEC list). Results: 5636 records were found, and 174 were retrieved for full-text review yielding 11 articles. Eight articles deemed the intervention as cost effective and two as dominant. Two cost–utility analyses were performed yielding ICERs of $612.7 and $59.8 per QALY. Four articles were considered to perform a high-quality economic evaluation and four had a low risk of bias. Future economic evaluations should consider cost–utility analysis, to describe usual care thoroughly, and use time horizons that capture the effect of cardiovascular disease prevention, a societal perspective and uncertainty analysis. Conclusion: Pharmacist-led medication review has proven to be cost effective in various studies in different settings. Policy decision makers are advised to undertake local economic evaluations reflecting the gaps observed in this systematic review and published literature. If this is not possible, a transferability assessment should be conducted.

Background: Scarcity of prospective medication non-adherence cost measurements for the Australian population with no directly measured estimates makes determining the burden medication non-adherence places on the Australian health care system difficult. This study aims to indirectly estimate the national cost of medication non-adherence in Australia comparing the cost prior to and following a community pharmacy-led intervention. Methods: Retrospective observational study. A de-identified database of dispensing data from 20,335 patients (n=11,257 on rosuvastatin, n=6,797 on irbesartan and n=2,281 on desvenlafaxine) was analyzed and average adherence rate determined through calculation of PDC. Included patients received a pharmacist-led medication adherence intervention and had twelve months dispensing records; six months before and six months after the intervention. The national cost estimate of medication non-adherence in hypertension, dyslipidemia and depression pre- and post-intervention was determined through utilization of disease prevalence and comorbidity, non-adherence rates and per patient disease-specific adherence-related costs. Results: The total national cost of medication non-adherence across three prevalent conditions, hypertension, dyslipidemia and depression was $10.4 billion equating to $517 per adult. Following enrollment in the pharmacist-led intervention medication non-adherence costs per adult decreased $95 saving the Australian health care system and patients $1.9 billion annually. Conclusion: In the absence of a directly measured national cost of medication non-adherence, this estimate demonstrates that pharmacists are ideally placed to improve patient adherence and reduce financial burden placed on the health care system due to non-adherence. Funding of medication adherence programs should be considered by policy and decision makers to ease the current burden and improve patient health outcomes moving forward.

Background An international strategy designed to promote access to primary care is the utilisation of community pharmacy to deliver structured minor ailment services (MASs). An understanding of key implementation features of MASs will support effective service delivery and implementation, promote MAS viability, sustainability and overall improvement. Aim The aim of this study is to explore the views and experiences of a range of stakeholders concerning the implementation of MASs in the United Kingdom. Methods A qualitative approach was used to obtain data. Participants were recruited using purposeful and snowball sampling. Stakeholders from five different regions were included. Using the digital recordings of the interviews, thematic content analysis was undertaken. Results Thirty-three participants agreed to be interviewed. Twenty-nine semi-structured interviews were conducted. Thematic content analysis yielded three major themes, including (1) benefits of MASs, (2) structural challenges associated with MAS design and (3) other implementation factors associated with MAS delivery. Stakeholders recognised the positive impact of the service to improve patient access and care, promote efficiencies, and promote the professional role of the pharmacist. Nevertheless barriers do exist to service delivery and implementation. Stakeholders identified the need to potentially increase the population groups served by MASs, increase the conditions treated and widen their formulary lists. Similarly, marketing strategies needed to be improved to enhance consumer awareness. Stakeholders presented mixed views about whether pharmacists needed to complete clinical training and the need to increase pharmacist's remuneration. In addition the level of healthcare collaboration needed to improve. Conclusion Several concepts emerged from the investigation to facilitate service delivery. Barriers to service implementation had a variable impact on implementation. Service delivery should function to meet all stakeholder needs and can be achieved through stakeholder collaboration. However, improved marketing to promote consumer awareness together with better collaborative processes can potentially improve MAS implementation.

Background Poor medication adherence is associated with adverse health outcomes and higher costs of care. However, inconsistencies in the assessment of adherence are found in the literature. Objective To evaluate the effect of different measures of adherence in the comparative effectiveness of complex interventions to enhance patients' adherence to prescribed medications. Methods A systematic review with network meta-analysis was performed. Electronic searches for relevant pairwise meta-analysis including trials of interventions that aimed to improve medication adherence were performed in PubMed. Data extraction was conducted with eligible trials evaluating short-period adherence follow-up (until 3 months) using any measure of adherence: self-report, pill count, or MEMS (medication event monitoring system). To standardize the results obtained with these different measures, an overall composite measure and an objective composite measure were also calculated. Network meta-analyses for each measure of adherence were built. Rank order and surface under the cumulative ranking curve analyses (SUCRA) were performed. Results Ninety-one trials were included in the network meta-analyses. The five network meta-analyses demonstrated robustness and reliability. Results obtained for all measures of adherence were similar across them and to both composite measures. For both composite measures, interventions comprising economic + technical components were the best option (90% of probability in SUCRA analysis) with statistical superiority against almost all other interventions and against standard care (odds ratio with 95% credibility interval ranging from 0.09 to 0.25 [0.02, 0.98]). Conclusion The use of network meta-analysis was reliable to compare different measures of adherence of complex interventions in short-periods follow-up. Analyses with longer follow-up periods are needed to confirm these results. Different measures of adherence produced similar results. The use of composite measures revealed reliable alternatives to establish a broader and more detailed picture of adherence.

Background Collaboration between relevant stakeholders in health service planning enables service contextualization and facilitates its success and integration into practice. Although community pharmacy services (CPSs) aim to improve patients' health and quality of life, their integration in primary care is far from ideal. Key stakeholders for the development of a CPS intended at preventing cardiovascular disease were identified in a previous stakeholder analysis. Engaging these stakeholders to create a shared vision is the subsequent step to focus planning directions and lay sound foundations for future work. Objectives This study aims to develop a stakeholder-shared vision of a cardiovascular care model which integrates community pharmacists and to identify initiatives to achieve this vision. Methods A participatory visioning exercise involving 13 stakeholders across the healthcare system was performed. A facilitated workshop, structured in three parts (i.e., introduction; developing the vision; defining the initiatives towards the vision), was designed. The Chronic Care Model inspired the questions that guided the development of the vision. Workshop transcripts, researchers' notes and materials produced by participants were analyzed using qualitative content analysis. Results Stakeholders broadened the objective of the vision to focus on the management of chronic diseases. Their vision yielded 7 principles for advanced chronic care: patient-centered care; multidisciplinary team approach; shared goals; long-term care relationships; evidence-based practice; ease of access to healthcare settings and services by patients; and good communication and coordination. Stakeholders also delineated six environmental factors that can influence their implementation. Twenty-four initiatives to achieve the developed vision were defined. Conclusions The principles and factors identified as part of the stakeholder shared-vision were combined in a preliminary model for chronic care. This model and initiatives can guide policy makers as well as healthcare planners and researchers to develop and integrate chronic disease services, namely CPSs, in real-world settings.

This project was funded and supported by Laboratorios Cinfa., Background Non-adherence to medications continues to be a burden worldwide, with significant negative consequences. Community pharmacist interventions seem to be effective at improving medication adherence. However, more evidence is needed regarding their impact on disease-specific outcomes. The aim was to evaluate the impact of a community pharmacist-led adherence management intervention on adherence and clinical outcomes in patients with hypertension, asthma and chronic obstructive pulmonary disease (COPD). Methods A 6-month cluster randomised controlled trial was conducted in Spanish community pharmacies. Patients suffering from hypertension, asthma and COPD were recruited. Patients in the intervention group received a medication adherence management intervention and the control group received usual care. The intervention was based on theoretical frameworks for changing patient behaviour. Medication adherence, disease-specific outcomes (Asthma Control Questionnaire (ACQ) scores, Clinical COPD Questionnaire (CCQ) scores and blood pressure levels) and disease control were evaluated. A multilevel regression model was used to analyse the data. Results Ninety-eight pharmacies and 1186 patients were recruited, with 1038 patients completing the study. Patients receiving the intervention had an OR of 5.12 (95% CI 3.20 to 8.20, p, Laboratorios Cinfa

Aim: To assess the trial-based cost–effectiveness of medication review with follow-up compared with usual care in primary care. Materials & methods: A cluster randomized controlled trial included patients if they were independent older adults, receiving five or more prescriptions, with moderate or high cardiovascular risk. Costs were estimated from the public healthcare sector perspective, and health benefits were measured as quality-adjusted life years. Both of which were used to calculate the incremental cost–effectiveness ratio. Results: Twelve centers completed the study, six (146 patients) in the intervention group and six (145 patients) in the control group. The base-case analysis showed an incremental cost–effectiveness ratio of US$ (2019) 434.4/quality-adjusted life year (95% CI 64.20–996.03). Conclusion: The intervention was cost-effective in the public primary care setting.

Background Implementation of Professional Pharmacy Services (PPSs) requires a demonstration of the service’s impact (efficacy) and its effectiveness. Several systematic reviews and randomised controlled trials (RCT) have shown the efficacy of PPSs in patient’s outcomes in community pharmacy. There is, however, a need to determine the level of evidence on the effectiveness of PPSs in daily practice by means of pragmatic trials. To identify and analyse pragmatic RCTs that measure the effectiveness of PPSs in clinical, economic and humanistic outcomes in the community pharmacy setting. Methods A systematic search was undertaken in MEDLINE, EMBASE, the Cochrane Library and SCIELO. The search was performed on January 31, 2020. Papers were assessed against the following inclusion criteria (1) The intervention could be defined as a PPS; (2) Undertaken in a community pharmacy setting; (3) Was an original paper; (4) Reported quantitative measures of at least one health outcome indicator (ECHO model); (5) The design was considered as a pragmatic RCT, that is, it fulfilled 3 predefined attributes. External validity was analyzed with PRECIS- 2 tool. Results The search strategy retrieved 1,587 papers. A total of 12 pragmatic RCTs assessing 5 different types of PPSs were included. Nine out of the 12 papers showed positive statistically significant differences in one or more of the primary outcomes (clinical, economic or humanistic) that could be associated with the following PPS: Smoking cessation, Dispensing/Adherence service, Independent prescribing and MTM. No paper reported on cost-effectiveness outcomes. Conclusions There is limited available evidence on the effectiveness of community-based PPS. Pragmatic RCTs to evaluate clinical, humanistic and economic outcomes of PPS are needed.

The AdherenciaMED project was supported by the General Pharmaceutical Council of Spain through funds provided by Cinfa Laboratories. The sponsor did not have any role in the design, methods, protocol of the study, data collection and analysis. The provider pharmacists did not receive any remuneration for their participation in the study., Background: It is necessary to determine the cost utility of adherence interventions in chronic diseases due to humanistic and economic burden of non-adherence. Purpose: To evaluate, alongside a cluster-randomized controlled trial, the cost-utility of a pharmacist-led medication adherence management service (MAMS) compared with usual care in community pharmacies. Materials and Methods: The trial was conducted over six months. Patients with treatments for hypertension, asthma or chronic obstructive pulmonary disease (COPD) were included. Patients in the intervention group (IG) received a MAMS based on a brief complex intervention, whilst patients in the control group (CG) received usual care. The cost–utility analysis adopted a health system perspective. Costs related to medications, healthcare resources and adherence intervention were included. The effectiveness was estimated as quality-adjusted life years (QALYs), using a multiple imputation missing data model. The incremental cost–utility ratio (ICUR) was calculated on the total sample of patients. Results: A total of 1186 patients were enrolled (IG: 633; CG: 553). The total intervention cost was estimated to be €27.33 ± 0.43 per patient for six months. There was no statistically significant difference in total cost of medications and healthcare resources per patient between IG and CG. The values of EQ-5D-5L at 6 months were significantly higher in the IG [IG: 0.881 ± 0.005 vs CG: 0.833 ± 0.006; p = 0.000]. In the base case, the service was more expensive and more effective than usual care, resulting in an ICUR of €1,494.82/QALY. In the complete case, the service resulted in an ICUR of €2,086.30/QALY, positioned between the north-east and south-east quadrants of the cost–utility plane. Using a threshold value of €20,000/QALY gained, there is a 99% probability that the intervention is cost-effective. Conclusion: The medication adherence management service resulted in an improvement in the quality of life of the population with chronic disease, with similar costs compared to usual care. The service is cost-effective., General Pharmaceutical Council of Spain, Randox Laboratories

Aim To evaluate the clinical and humanistic patient outcomes of a community pharmacy (CP) Minor Ailment Service (MAS) compared to usual pharmacist care (UC). Methods A cluster randomised controlled trial was conducted over six months in CP. The pharmacist-patient intervention consisted of a standardised consultation on a web-based program using co-developed protocols pharmacists’ training, practice change facilitators and patients’ educational material. Patients were followed up ten days after initial consultation. Primary outcomes were appropriate medical referral and changes to direct product request. Secondary outcomes were symptom resolution, reconsultation rates for the same ailment and health related quality of life (HRQoL). Results A total of 808 patients were recruited by 27 CP (323 MAS and 485 UC). Patients visiting MAS pharmacies had higher odds for being referred to the general practitioner (OR=2.343, CI95%=[1.146-4.792]); a higher increase in HRQoL (OR=1.026, CI95%=[1.002-1.051]) and higher number of reconsultation (OR=1.833, CI95%=[1.151-2.919]) compared to UC. No significant differences were observed for symptom resolution and modification of treatments with direct product requests. Conclusions Patients with minor ailments are triaged and managed in a safe and effective way in CP, facilitating appropriate self-selection of non-prescription medicines. MAS reinforce pharmacists’ involvement with patient engagement.

Background Minor ailments are “self-limiting conditions which may be diagnosed and managed without a medical intervention”. A cluster randomised controlled trial (cRCT) was designed to evaluate the clinical, humanistic and economic outcomes of a Minor Ailment Service (MAS) in community pharmacy (CP) compared with usual care (UC). Methods The cRCT was conducted for six months from December 2017. The pharmacist-patient intervention consisted of a standardised face-to-face consultation on a web-based program using co-developed protocols, pharmacists’ training, practice change facilitators and patients’ educational material. Patients requesting a non-prescription medication (direct product request) or presenting minor ailments received MAS or UC and were followed-up by telephone 10-days after the consultation. The primary economic outcomes were incremental cost-effectiveness ratio (ICER) of the service and health related quality of life (HRQoL). Total costs included health system, CPs and patient direct costs: health professionals’ consultation time, medication costs, pharmacists’ training costs, investment of the pharmacy and consultation costs within the ten days following the initial consultation. The HRQoL was obtained using the EuroQoL 5D-5L at the time of the consultation and at 10-days follow up. A sensitivity analysis was carried out using bootstrapping. There were two sub-group analyses undertaken, for symptom presentation and direct product requests, to evaluate possible differences.Results A total of 808 patients (323 MAS and 485 UC) were recruited in 27 CPs with 42 pharmacists (20 MAS and 22 UC). 64.7% (n=523) of patients responded to follow-up after their consultation in CP. MAS patients gained an additional 0.0003 QALYs (p=0.053). When considering only MAS patients presenting with symptoms, the ICER was 24,733€/QALY with a 47.4% probability of cost-effectiveness (willingness to pay of 25,000€/QALY). Although when considering patients presenting for a direct product request, MAS was the dominant strategy with a 93.69% probability of cost-effectiveness.Conclusions Expanding community pharmacists’ scope through MAS may benefit health systems. To be fully cost effective, MAS should not only include consultations arising from symptom presentation but also include an oversight of self-selected products by patients. MAS increase patient safety through the appropriate use of non-prescription medication and through the direct referral of patients to GP.Trial registrationThe study was not registered but it was approved by the University of Granada Ethics Committee (approval number 331/CEIH/2017) and Xátiva-Ontinyent Ethics Committee “Lluís Alcanyís”.

ObjectivesTo evaluate an implementation programme of a community pharmacy medication review with follow-up (MRF) service using a hybrid effectiveness-implementation study design, and to compare the clinical and humanistic outcomes with those in a previously conducted cluster randomised controlled trial (cRCT).SettingCommunity pharmacies in Spain.Participants135 community pharmacies and 222 pharmacists providing MRF to polymedicated patients aged 65 or over.InterventionThe intervention was an implementation programme for the MRF service. A national level group was established, mirrored with a provincial level group. A series of interventions were defined (1) to engage pharmacy owners with the implementation model and (2) to provide training to pharmacists consisting of clinical case studies, process of MRF, communication skills and data collection methods and (3) practice change facilitators.Primary and secondary outcome measuresThe primary outcomes for the implementation programme were progress, reach, fidelity and integration. The secondary outcomes were number of medications, non-controlled health problems, emergency visits, hospitalisations and health-related quality of life, which were compared with a previous 6-month cluster RCT.Results55% of pharmacies reached the implementation phase and 35.6% remained in the testing phase at 12 months. A reach of 89.3% (n=844) was achieved. Fidelity average score was 8.45 (min: 6.2, max: 9.3) out of 10. The integration mean score was 3.39 (SD: 0.72) out of 5. MRF service outcomes were similar to the cluster RCT study; however, the magnitude of the outcomes was delayed.ConclusionsThe implementation of pharmacy services is a complex multifactorial process, conditioned by numerous implementation factors. In the absence of remuneration, the implementation of the MRF service is a slow process, taking at least 12 months to complete.Trial registration numberCGFTRA-2017-01.

Background Strategies to improve medication adherence are widespread in the literature; however, their impact is limited in real practice. Few patients persistently engage long-term to improve health outcomes, even when they are aware of the consequences of poor adherence. Despite the potential of mobile phone apps as a tool to manage medication adherence, there is still limited evidence of the impact of these innovative interventions. Real-world evidence can assist in minimizing this evidence gap. Objective The objective of this study was to analyze the impact over time of a previously implemented digital therapeutic mobile app on medication adherence rates in adults with any chronic condition. Methods A retrospective observational study was performed to assess the adherence rates of patients with any chronic condition using Perx Health, a digital therapeutic that uses multiple components within a mobile health app to improve medication adherence. These components include gamification, dosage reminders, incentives, educational components, and social community components. Adherence was measured through mobile direct observation of therapy (MDOT) over 3-month and 6-month time periods. Implementation adherence, defined as the percentage of doses in which the correct dose of a medication was taken, was assessed across the study periods, in addition to timing adherence or percentage of doses taken at the appropriate time (±1 hour). The Friedman test was used to compare differences in adherence rates over time. Results We analyzed 243 and 130 patients who used the app for 3 months and 6 months, respectively. The average age of the 243 patients was 43.8 years (SD 15.5), and 156 (64.2%) were female. The most common medications prescribed were varenicline, rosuvastatin, and cholecalciferol. The median implementation adherence was 96.6% (IQR 82.1%-100%) over 3 months and 96.8% (IQR 87.1%-100%) over 6 months. Nonsignificant differences in adherence rates over time were observed in the 6-month analysis (Fr(2)=4.314, P=.505) and 3-month analysis (Fr(2)=0.635, P=.728). Similarly, the timing adherence analysis revealed stable trends with no significant changes over time. Conclusions Retrospective analysis of users of a medication adherence management mobile app revealed a positive trend in maintaining optimal medication adherence over time. Mobile technology utilizing gamification, dosage reminders, incentives, education, and social community interventions appears to be a promising strategy to manage medication adherence in real practice.

ObjectivePharmacists have been increasing patient-focused care through the implementation and provision of professional services. However, there is a lack of evidence on how to achieve long-term sustainability of the service once it is implemented. A framework identifying the factors affecting the sustainability of professional pharmacy services was developed. The objectives of this study were to explore the experiences of community pharmacists providing professional services to contextualize and assess the applicability in practice of the sustainability framework.MethodsA qualitative study was undertaken across Australia. Community pharmacists were identified using snowball sampling. Data were collected through semistructured interviews. Eighteen interviews were conducted and analyzed using framework methodology in NVivo 12 (QSR International).ResultsA range of major sustainability factors was identified and organized in social, economic, and environmental domains. In the social domain, most of the interviewees stated the importance of motivating staff to increase service promotion and patients' demand. Most of the participants emphasized that having an adequate number of trained staff is required to enhance and maintain services over time. The perceived reluctance of some patients to spend more time than usual at the community pharmacy was another factor highlighted as affecting service sustainability. In the economic domain, the concern about lack of remuneration for service provision was highlighted by most of the interviewees. Having economic support was seen as essential for achieving sustainable services. In the environmental domain, the necessity of government recognition of the pharmacists' role and value to the health care system was identified as a new key sustainability driver.ConclusionThe applicability of the framework for the sustainability of professional services was evaluated in practice. The identified factors will guide pharmacists to maintain implemented services and achieve their sustainability. Future research should focus on designing a tool to measure the sustainability of pharmacy services.

The interrelationship between governmental policies and objectives in primary health care and community pharmacy/pharmacists’ strategic plans are of the outmost importance, having significant professional, economic and practical consequences for the future of the pharmacy profession, research, education and health care. Sharing information of the potential and real impact on current and future practice of community pharmacy/pharmacists, be it in product or service, in primary care would benefit many stakeholders. In order to create and focus professional and scientific debate the journal has commissioned key experts to contribute a series of country case studies. The aim of the series is to promulgate and disseminate country-based information on primary health care and community pharmacy/pharmacist.

BackgroundCommunity pharmacists are well positioned to support patients’ minor ailments. The objective was to evaluate the clinical and humanistic impact of a minor ailment service (MAS) in community pharmacy compared with usual pharmacist care (UC).MethodsA cluster randomised controlled trial was conducted. Intervention patients received MAS, which included a consultation with the pharmacist. MAS pharmacists were trained in clinical pathways and communication systems mutually agreed with general practitioners and received monthly support. Control patients received UC. All patients were followed up by telephone at 14 days. Clinical and humanistic impact were defined by primary (appropriate referral rate and appropriate non-prescription medicine rate) and secondary outcomes (clinical product-based intervention rate, referral adherence, symptom resolution, reconsultation and EuroQol EQ-5D visual analogue scale (VAS)).ResultsPatients (n=894) were recruited from 30 pharmacies and 82% (n=732) responded to follow-up. Patients receiving MAS were 1.5 times more likely to receive an appropriate referral (relative rate (RR)=1.51; 95% CI 1.07 to 2.11; p=0.018) and were five times more likely to adhere to referral, compared with UC (RR=5.08; 95%CI 2.02 to 12.79; p=0.001). MAS patients (94%) achieved symptom resolution or relief at follow-up, while this was 88% with UC (RR=1.06; 95% CI 1 to 1.13; p=0.035). MAS pharmacists were 1.2 times more likely to recommend an appropriate medicine (RR 1.20, 95% CI 1.1 to 1.3; p=0.000) and were 2.6 times more likely to perform a clinical product-based intervention (RR=2.62, 95% CI 1.28 to 5.38; p=0.009), compared with UC. MAS patients had a greater mean difference in VAS at follow-up (4.08; 95% CI 1.23 to 6.87; p=0.004). No difference in reconsultation was observed (RR=0.98; 95% CI 0.75 to 1.28; p=0.89).ConclusionThe study demonstrates improved clinical and humanistic outcomes with MAS. National implementation is a means to manage minor ailments more effectively in the Australian health system.Trial registration numberACTRN12618000286246.

Pharmacists have a societal duty of care. How to best provide that type of care requires scientific study. Pharmacy practice is a scientific discipline that studies the different aspects of the practice of pharmacy, and its impact on health care systems, medicine use, and patient care. Its scope has expanded globally to encompass clinical, behavioural, economic, and humanistic implications of the practice of pharmacy, as well as practice change and implementation in routine practice of innovations such as health interventions and patient-care services. The development, impact evaluation, implementation, and sustainability of health interventions and patient-care services represents a key research area for pharmacy practice. An approach for conducting these is provided. There is evidence that collaborative national and international research in this area is growing, showing an increased contribution to global health research. The role of universities and pharmacy professional associations in supporting the advancement of pharmacy through pharmacy practice research is also discussed. Finally, a call to action for pharmacy practice research, education, and practice is made.

Background Pharmacists‐led medication reviews ( MRs ) are claimed to be effective for the control of cardiovascular diseases; however, the evidence in the literature is conflicting. The main objective of this meta‐analysis was to analyze the impact of pharmacist‐led MRs on cardiovascular disease risk factors overall and in different ambulatory settings while exploring the effects of different components of MRs . Methods and Results Searches were conducted in PubMed, Web of Science, Embase, the Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Library Central Register of Controlled Trials database. Randomized and cluster randomized controlled trials of pharmacist‐led MRs compared with usual care were included. Settings were community pharmacies and ambulatory clinics. The classification used for MRs was the Pharmaceutical Care Network Europe as basic (type 1), intermediate (type 2), and advanced (type 3). Meta‐analyses in therapeutic goals used odds ratios to standardize the effect of each study, and for continuous data (eg, systolic blood pressure) raw differences were calculated using baseline and final values, with 95% CI s. Prediction intervals were calculated to account for heterogeneity. Sensitivity analyses were conducted to test the robustness of results. Meta‐analyses included 69 studies with a total of 11 644 patients. Sample demographic characteristics were similar between studies. MRs increased control of hypertension (odds ratio, 2.73; 95% prediction interval, 1.05–7.08), type 2 diabetes mellitus (odds ratio, 3.11; 95% prediction interval, 1.17–5.88), and high cholesterol (odds ratio, 1.91; 95% prediction interval, 1.05–3.46). In ambulatory clinics, MRs produced significant effects in control of diabetes mellitus and cholesterol. For community pharmacies, systolic blood pressure and low‐density lipoprotein values decreased significantly. Advanced MRs had larger effects than intermediate MRs in diabetes mellitus and dyslipidemia outcomes. Most intervention components had no significant effect on clinical outcomes and were often poorly described. CIs were significant in all analyses but prediction intervals were not in continuous clinical outcomes, with high heterogeneity present. Conclusions Intermediate and advanced MRs provided by pharmacists may improve control of blood pressure, cholesterol, and type 2 diabetes mellitus, as statistically significant prediction intervals were found. However, most continuous clinical outcomes failed to achieve statistical significance, with high heterogeneity present, although positive trends and effect sizes were found. Studies should use a standardized method for MRs to diminish sources of these heterogeneities.

Introduction The Global Network of Age-friendly Cities is a project promoted by the World Health Organization as a response to demographic ageing and urbanization process. San Sebastian, Spain, is one of these Age-friendly Cities and community pharmacies of the city joined the initiative. Objective To define and implement the Age-friendly Pharmacy concept to promote active ageing, optimize the contribution of community pharmacies of San Sebastian to the friendliness of the city and to the improvement of quality of life of the ageing population. Method A bottom-up participative approach was undertaken. A focus group was conducted to determine elderly people’s opinions and expectations of community pharmacy. The information obtained was analysed using content analysis and validated for reliability, usefulness and applicability through three expert groups of community pharmacy owners and staff. Key findings Fifteen requirements were agreed, covering four main areas: relationships, pharmacy layout, pharmaceutical services and communication of services. Initially, 18 community pharmacies committed to become Age-friendly Pharmacies by pledging to these requirements and the Official Pharmacist Association of Gipuzkoa supported pharmacies in the implementation of the initiative. Conclusion This study suggests that there is demand for a patient-centred community pharmacy to support older people, in which pharmaceutical care services are required. The 18 Age-friendly Pharmacies together with the Official Pharmacist Association of Gipuzkoa have publicly committed to actively work on social and patient-centred care to meet the needs of the ageing population.

© 2017 Elsevier Inc. Implementation of professional pharmacy services is a complex process, in which multi-level factors interact and influence implementation process and outcomes at various levels or domains. In this paper the terms that have been used to describe the factors that influence implementation of evidence-based services and their domains are presented. The complex ‘cause-and-effect’ interactions by which implementation factors appear to interact throughout the implementation process are also discussed. Identifying and understanding these complex and causal relationships between different implementation factors, represents a key process in the implementation of any service, in order to assist in the development of tailored implementation strategies. Future research should be directed to gain an understanding of the nature of individual implementation factors, their cause-and-effect interactions, and their relationships. Implementation strategies are less likely to succeed unless these are identified and targeted to the causes identified when designing and planning an implementation strategy.

© 2019, © 2019 Informa UK Limited, trading as Taylor & Francis Group. To improve patient outcomes, healthcare practices undergo constant implementation of innovations. An implementation intervention that considers organizational and behavioural aspects is facilitation. Change Facilitators help individuals and groups realize what they need to change and how to make change happen. However, behavioural change trials require more sufficient details to improve delivery, fidelity and evaluation. The aim of this paper was to identify facilitation strategies used during the implementation of innovations in health care, determine those most frequently used and their relation to study outcomes. For this systematic review, randomized controlled trials reporting an onsite facilitator to aid in innovation implementation in a healthcare setting were identified. The database search yielded 2,350 articles, from which 35 studies were included. From these, 51 facilitation strategies were identified. Nine of the strategies appeared in more than 50% of studies and those reporting positive results included: goal-setting, assessing progress and outcomes, and providing tools and resources. These findings provide facilitators with evidence-based strategies to deliver in practice and to ensure consistency in facilitation training. Future research should aim to provide further tools that recommend the most effective facilitation strategies and a model to improve the effectiveness, efficiency and evaluation of the change facilitation process. MAD statement This article sets out to make a difference for those implementing innovations in the healthcare industry, by arming change facilitators with practical, evidence-based strategies to facilitate change more effectively. Furthermore, this article highlights the need for specific tools and models that improve the efficiency and effectiveness of the change facilitation process and its evaluation.