Systematic review of pragmatic randomised control trials assessing the effectiveness of professional pharmacy services in community pharmacies.

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.

Stakeholder analysis in health innovation planning processes: A systematic scoping review.

Integrating health innovations into the health system is a complex endeavour that requires a well-designed planning process engaging key stakeholders. Stakeholder analyses lay the foundations to inform appropriate planning processes and undertake strategic actions. A systematic scoping review was performed to explore how stakeholder analyses are applied in health innovation planning processes and a guideline to report stakeholder analyses was developed. The literature search was conducted in PubMed, Scopus and DOAJ; grey literature was sought using Google. Articles reporting stakeholder analyses during the planning process of health policies, systems, products and technologies, and services and delivery methods were included. Fifty-one records were incorporated in the qualitative synthesis. Stakeholder analyses were conducted worldwide, used in all types of health innovations, applied in all phases of the planning process and conducted both prospectively and retrospectively. The steps followed to perform stakeholder analysis, the methods used, the stakeholder attributes analysed and how authors reported the analyses were heterogeneous. Forty-one studies reported the identification of stakeholders, 50 differentiated/categorised them and 25 analysed stakeholder relationships. Only some authors proposed future actions based on the results obtained in their stakeholder analysis. A list of Reporting Items for Stakeholder Analysis (i.e., the RISA tool) is proposed to contribute to the reporting guidelines to enhancing the quality and transparency of health research.

Collaborative health service planning: A stakeholder analysis with social network analysis to develop a community pharmacy service.

BACKGROUND: Stakeholder participation optimizes health planning, fostering the acceptability and integration of new health services. Collaborative approaches may help overcome existing challenges in the development, implementation and evaluation of community pharmacy services (CPSs). Stakeholder analyses lay the foundation for building collaboration in the integrated delivery of health care. OBJECTIVES: This stakeholder analysis was performed to organize a collaborative initiative to develop a CPS aimed at preventing cardiovascular diseases in Andalucía (Spain). It aimed to identify stakeholders, differentiate/categorize them, and analyze stakeholder relationships. METHOD: Stakeholders were identified using the snowballing technique. To differentiate/categorize stakeholders and analyze the relationships (i.e., collaboration) an online web-based questionnaire was sent to 186 stakeholders. Stakeholders were asked for: (1) their influence, interest and attitude toward the initiative; (2) stakes/interests; (3) capacity to contribute to the initiative; (4) desire for involvement; (5) concerns; (6) whom they considered a key stakeholder; and (7) the level of collaboration they had with other stakeholders. Data analysis combined descriptive qualitative content analysis, descriptive quantitative analysis and social network analysis. RESULTS: Of the 186 stakeholders approached, 96 (51.6%) participated. The identification process yielded 217 stakeholders (individuals, organizations or collectives), classified into 10 groups. Fifty-seven stakeholders were considered critical to the intended initiative. Most participant stakeholders supported the initiative and were willing to collaborate in the development of the CPS. Public health and science were the main driving interests. A collaboration network existed between the 96 stakeholders. CONCLUSION: This study revealed the magnitude of the social system surrounding the development of a CPS aimed at preventing cardiovascular disease. A large array of stakeholders was identified and analyzed, and a group of critical stakeholders selected. Stakeholder characteristics such as attitude toward the initiative, potential contribution, desire for involvement, and the existing collaboration network, provided complementary information that was helpful for planning the process and stakeholder engagement.

A stakeholder visioning exercise to enhance chronic care and the integration of community pharmacy services.

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.

Stakeholder analysis for the development of a community pharmacy service aimed at preventing cardiovascular disease.

BACKGROUND: Participatory approaches involving stakeholders across the health care system can help enhance the development, implementation and evaluation of health services. These approaches may be particularly useful in planning community pharmacy services and so overcome challenges in their implementation into practice. Conducting a stakeholder analysis is a key first step since it allows relevant stakeholders to be identified, as well as providing planners a better understanding of the complexity of the health care system. OBJECTIVES: The main aim of this study was to conduct a stakeholder analysis to identify those individuals and organizations that could be part of a leading planning group for the development of a community pharmacy service (CPS) to prevent cardiovascular disease (CVD) in Australia. METHODS: An experienced facilitator conducted a workshop with 8 key informants of the Australian health care system. Two structured activities were undertaken. The first explored current needs and gaps in cardiovascular care and the role of community pharmacists. The second was a stakeholder analysis, using both ex-ante and ad-hoc approaches. Identified stakeholders were then classified into three groups according to their relative influence on the development of the pharmacy service. The information gathered was analyzed using qualitative content analysis. RESULTS: The key informants identified 46 stakeholders, including (1) patient/consumers and their representative organizations, (2) health care providers and their professional organizations and (3) institutions and organizations that do not directly interact with patients but organize and manage the health care system, develop and implement health policies, pay for health care, influence funding for health service research or promote new health initiatives. From the 46 stakeholders, a core group of 12 stakeholders was defined. These were considered crucial to the service's development because they held positions that could drive or inhibit progress. Secondary results of the workshop included: a list of needs and gaps in cardiovascular care (n = 6), a list of roles for community pharmacists in cardiovascular prevention (n = 12) and a list of potential factors (n = 7) that can hinder the integration of community pharmacy services into practice. CONCLUSIONS: This stakeholder analysis provided a detailed picture of the wide range of stakeholders across the entire health care system that have a stake in the development of a community pharmacy service aimed at preventing CVD. Of these, a core group of key stakeholders, with complementary roles, can then be approached for further planning of the service. The results of this analysis highlight the relevance of establishing multilevel stakeholder groups for CPS planning.

Cost-effectiveness of professional pharmacy services in community pharmacy: a systematic review.

INTRODUCTION: The aim was to determine whether professional pharmacy services (PPS) provided to ambulatory patients attending community pharmacy are cost-effective compared with usual care (UC). Areas covered: MEDLINE, Web of Knowledge, Scopus, Cochrane Library and Centre for Reviews and Dissemination databases were searched, and the risk of bias of randomized controlled trials, and the methodological quality of economic evaluations was assessed. A total of 17 economic evaluations of 13 studies were included. Seven studies were classified as high-, three as medium- and three as low-quality. PPS were more effective and less costly than UC in four studies; seven studies concluded that PPS were more effective and more costly and two studies concluded that the service was as effective as the UC, with higher and lower costs. Expert commentary: Although the uncertainty was variable among the studies, a general trend towards the cost-effectiveness of PPS was observed. Decision makers are encouraged to consider the feasibility of implementing PPS.

Facilitators for practice change in Spanish community pharmacy.

OBJECTIVE: To identify and prioritise facilitators for practice change in Spanish community pharmacy. SETTING: Spanish community pharmacies. METHOD: Qualitative study. Thirty-three semi-structured interviews were conducted with community pharmacists (n = 15) and pharmacy strategists (n = 18), and the results were examined using the content analysis method. In addition, two nominal groups (seven community pharmacists and seven strategists) were formed to identify and prioritise facilitators. Results of both techniques were then triangulated. MAIN OUTCOME MEASURES: Facilitators for practice change. RESULTS: Twelve facilitators were identified and grouped into four domains (D1: Pharmacist; D2: Pharmacy as an organisation; D3: Pharmaceutical profession; D4: Miscellaneous). Facilitators identified in D1 include: the need for more clinical education at both pre- and post-graduate levels; the need for clearer and unequivocal messages from professional leaders about the future of the professional practice; and the need for a change in pharmacists' attitudes. Facilitators in D2 are: the need to change the reimbursement system to accommodate cognitive service delivery as well as dispensing; and the need to change the front office of pharmacies. Facilitators identified in D3 are: the need for the Spanish National Professional Association to take a leadership role in the implementation of cognitive services; the need to reduce administrative workload; and the need for universities to reduce the gap between education and research. Other facilitators identified in this study include: the need to increase patients' demand for cognitive services at pharmacies; the need to improve pharmacist-physician relationships; the need for support from health care authorities; and the need for improved marketing of cognitive services and their benefits to society, including physicians and health care authorities. CONCLUSION: Twelve facilitators were identified. Strategists considered clinical education and pharmacists' attitude as the most important, and remuneration of little importance. Community pharmacists, in contrast, considered remuneration as the most important facilitator for practice change.

Monitoring quality standards in the provision of non-prescription medicines from Australian Community Pharmacies: results of a national programme.

INTRODUCTION: Standards of practice have been developed by the pharmacy profession to address the provision of non-prescription medicines, using a consumer-focused and risk management approach. The application of these standards in Australian community pharmacies has been monitored since 2002 by the Quality Care Pharmacy Support Centre (QCPSC). METHODS: Between September 2002 and September 2005, 7785 standards maintenance assessment visits were conducted in 4282 pharmacies, using pseudo-patient methodology. 1909 were symptom-based requests (SBRs) and 5876 were direct product-based requests (DPRs), of which 2864 were for pharmacist-only medicines (POMs) and 3012 were for pharmacy medicines (PMs). 2756 pharmacies received two visits, and 747 received three visits. A pharmacy's performance was scored out of 10 at each visit (scores 0-3: "unsatisfactory"; 4-6: "satisfactory"; and 7-10: "excellent"). RESULTS: There was wide variation in performance at baseline, with 1453 (34%) of pharmacies scoring

Pharmaceutical care in community pharmacies: practice and research from around the world.

Pharmaceutical care models and practices differ in various countries. Reimbursement for cognitive services, for example, varies across countries in Europe, Asia, and the Americas. Practice-based research has blossomed in many countries, with different emphases and challenges. This international series will describe the organization of community pharmacy within the healthcare system and report the status of practice-based research. Each paper will focus on one country. The series will conclude with a summary by the series editors describing the key themes across the papers, outlining milestones yet to be achieved, and proposing a research agenda for community pharmacy practice.

Understanding practice change in community pharmacy: a qualitative study in Australia.

BACKGROUND: Much of the research on cognitive pharmaceutical services has focused on understanding or changing community pharmacist behaviour, with few studies focusing on the pharmacy as the unit of analysis or considering the whole profession as an organisation. OBJECTIVES: To investigate practice change and identify facilitators of this process in community pharmacy, with specific focus on the implementation of cognitive pharmaceutical services (CPS) and related programs. METHODS: Thirty-six in-depth, semistructured interviews were conducted with participants from 2 groups, community pharmacies and pharmacy "strategists," in Australia. The interview guide was based on a framework of organizational theory, with 5 subject areas: roles and goals of participants in relation to practice change; experiences with CPS; change strategies used; networks important to the change process; and business impacts of CPS. Interviews were transcribed verbatim and thematically content analyzed, using NVivo software for data management. RESULTS: Five key themes relating to the change process were derived from the interviews: change strategies (process- and behaviorally oriented); social networks (within and beyond the pharmacy); drivers of change (eg, government policy); motivators (eg, professional satisfaction); and facilitators of practice change (remuneration for implementation or service delivery, communication and teamwork, leadership, task delegation, external support or assistance, and reorganization of structure and function). CONCLUSION: The use of an organizational perspective yielded rich data from which an understanding of the practice change process in relation to CPS implementation was gained. Current programs for the implementation and delivery of CPS have not taken into account all of the factors that have the ability to facilitate change in community pharmacy. Not only do future programs need to be underpinned by these elements, but policy makers must include them when planning remuneration and dissemination strategies.

Efficacy and Tolerability of the Anti-inflammatory Throat Lozenge Flurbiprofen 8.75mg in the Treatment of Sore Throat : A Randomised, Double-Blind, Placebo-Controlled Study.

OBJECTIVE: This randomised, double-blind, parallel group study compared the efficacy and tolerability of flurbiprofen lozenges (8.75mg or 12.5mg) with demulcent placebo lozenges in the treatment of patients with sore throat due to upper respiratory tract infection. STUDY PARTICIPANTS: A total of 320 patients with objective and subjective evidence of sore throat were randomised to treatment with flurbiprofen 8.75mg (n = 128), flurbiprofen 12.5mg (n = 64) or placebo (n = 128) lozenges. MAIN OUTCOME MEASURES: Efficacy was assessed by changes in subjective ratings scales measuring pain relief, throat soreness and swollen throat at specified intervals over a 6-hour period following administration of a single dose. Tolerability was assessed over a 5-day multiple-dose regimen. RESULTS: Flurbiprofen 8.75mg lozenge was significantly superior to placebo for the primary efficacy variable, total pain relief summed over 15 to 120 minutes (TOTPAR15-120min), and for reducing throat soreness over 2 hours and swollen throat over 2 and 6 hours (p < 0.05). Flurbiprofen 12.5mg treatment was not significantly better than flurbiprofen 8.75mg. There were no significant differences between treatment groups in the incidence of adverse events when reports of taste perversion, which reflects an aspect of patient acceptability rather than tolerability, were removed from the analysis (p = 0.776). CONCLUSIONS: The efficacy and tolerability profile of flurbiprofen 8.75mg lozenges indicated that they provide a convenient treatment for patients with sore throat. Symptomatic relief was rapid, occurring within 15 minutes of administration due to lozenge demulcency, and statistically significant differences between active and placebo lozenges were detected within 30 minutes and sustained over 4 hours.

Economic impact of increased clinical intervention rates in community pharmacy. A randomised trial of the effect of education and a professional allowance.

OBJECTIVE: To determine the economic impact of an interventional programme aimed to increase the rate of clinical interventions undertaken in community pharmacy. STUDY DESIGN AND PERSPECTIVE: A randomised controlled trial of 4 parallel groups of pharmacies, conducted from a government perspective. Economic evaluations were based on savings/costs attributable to healthcare costs avoided, healthcare costs incurred by the pharmacists' actions, change in medication costs, pharmacy time and telephone calls made by the pharmacist. The study was conducted during November and December 1996 and costings were based on 1997 figures. INTERVENTIONS: A professional fee-for-service [10 Australian dollars ($A; $A1 = 6.50 US dollars) per intervention] and education (an intensive 1-week course or advanced education) were implemented in an attempt to increase clinical interventions by the pharmacists. Group A pharmacies (n = 10) served as a control group and received neither education nor remuneration; group B received education and professional remuneration (n = 9); group C had received prior continued education and now received advanced education and professional remuneration (n = 11); and group D received professional remuneration with no education. MAIN OUTCOME MEASURES AND RESULTS: The proactive clinical interventions in group C saved a mean of $A85.35 per 1000 prescriptions [95% confidence interval (CI)-$A157.11 to $A24.95). This was 4 times greater than savings generated by pharmacies in group B (mean savings of $A25.65 per 1000 prescriptions) and 6 times greater than control pharmacies. A sensitivity analysis which extrapolated results to Australian prescription figures showed that the control group was capable of generating savings in the order of $A2.4 million per year while pharmacists in group C would save the healthcare system $A15 million per year. CONCLUSIONS: These results provide the first economic estimates for the provision of clinical interventions in Australian community pharmacies. It is believed that they illustrate the value of pharmaceutical services to the healthcare system and to the Australian community in terms of both quality of care and savings.

Topical antimicrobial prophylaxis in minor wounds.

OBJECTIVE: To evaluate the ability of a novel topical antimicrobial gel containing cetrimide, bacitracin, and polymyxin B sulfate to prevent infections of minor wounds. DESIGN: A clinical trial compared the test preparation with placebo and a povidone iodine antiseptic cream. SETTING: Five primary schools in Sydney, Australia, participated in the study over a 6-week spring/summer school term. SUBJECTS: Children aged 5-12 years with parental consent were eligible for study participation. Accidental injuries occurring at school were treated in a standardized manner by nurses at each site. OUTCOME MEASURES: Wounds were evaluated by the medical practitioner after 3 days of topical treatment. The clinical outcome was classified as resolution or suspected infection. If a clinical infection was suspected, the injury was swabbed for microbiologic evaluation. Growth of a dominant microorganism was classified as a microbiologic infection. RESULTS: Of the 177 injuries treated, there were nine clinical infections. A comparison of these showed a significant difference among treatment groups (p < 0.05). This difference was associated with the test preparation and placebo; the test preparation reduced the incidence of clinical infection from 12.5% to 1.6% (p < 0.05; 95% CI, 0.011 to 0.207). A comparison of microbiologic infections showed no significant differences among treatment groups (p > 0.05). CONCLUSIONS: The novel gel preparation containing cetrimide, bacitracin, and polymyxin B sulfate showed therapeutic action and reduced the incidence of clinical infections in minor accidental wounds. It may be a suitable product for first aid prophylaxis.

In vitro interactions of neomycin sulfate, bacitracin, and polymyxin B sulfate.

BACKGROUND: Neomycin sulfate, bacitracin, and polymyxin B sulfate have been combined in topical preparations to provide a complementary antimicrobial spectrum for the prevention of minor wound infections. The advisability of the inclusion of neomycin sulfate has been questioned since it may cause contact sensitization. METHODS: To assess the value of neomycin, microdilution checkerboard titrations were used to determine the in vitro interactions between two-antibiotic and three-antibiotic combinations against reference strains of bacteria commonly associated with wound infections. Using Fractional Inhibitory Concentration (FIC) indices (< 0.5 indicates synergism with two-drug combinations), the combination of neomycin/bacitracin was synergistic for both S. aureus and Ps. aeruginosa; neomycin/polymyxin B was synergistic for E. faecalis, and the bacitracin/polymyxin B combination was synergistic against Ps. aeruginosa. A three-drug combination of neomycin/bacitracin/polymyxin B had FIC values of < 1 for all organisms, indicating synergy and substantiating the clinical role of neomycin sulfate in current topical formulations. RESULTS: Neomycin has the lowest safety profile of the drugs in this combination. A replacement agent should ideally have similar or superior synergistic capabilities with the remaining drugs and contribute to the therapeutic efficacy of the preparation. Additionally, because of the strongly synergistic tendencies displayed by the three-drug combination, it may be possible to reduce the antibiotic concentrations present in current formulations. CONCLUSION: By developing this concept, there is potential for the formulation of topical preparations to be based on a sound theoretical and clinical rationale.

Cardiovascular effects of a chlorpheniramine/paracetamol combination in hypertensive patients who were sensitive to the pressor effect of pseudoephedrine.

Twelve hypertensive patients who were classified as pseudoephedrine-sensitive in a preliminary trial were selected for further investigation with single doses of pseudoephedrine 60 mg, a combination of chlorpheniramine 4 mg with paracetamol 650 mg and placebo. A double-blind, randomised, crossover study design was followed. Treatment with pseudoephedrine produced significant effects on all the four variables measured (systolic, diastolic and mean arterial blood pressure, and heart rate). Effects of the chlorpheniramine/paracetamol combination were found to be not significantly different from placebo. It was concluded that the combination may be useful as a medication for 'colds' in hypertensive patients, since it does not induce cardiovascular effects such as those observed with pseudoephedrine.