Views and perceptions of the public toward COVID-19 vaccine in Saudi Arabia.

Background: Numerous surveys studied individuals' decision to receive COVID-19 vaccine but the motives behind accepting or refusing COVID-19 vaccines are not yet fully understood. We aimed to more qualitatively explore the views and perceptions toward COVID-19 vaccines in Saudi Arabia to provide recommendations to mitigate the vaccine hesitancy issue. Methods: Open-ended interviews were conducted between October 2021-January 2022. The interview guide included questions about beliefs in vaccine efficacy and safety, and previous vaccination history. The interviews were audio-recorded, transcribed verbatim, and the content was analyzed using thematic analysis. Nineteen participants were interviewed. Results: All of the interviewees were vaccine acceptors; however, three participants were hesitant as they felt they were forced to receive it. Several themes emerged as the reasons to accept or refuse the vaccine. The key reasons behind vaccine acceptance were the sense of obligation to fulfill a governmental command, trust in the government decisions, vaccine availability, and the impact of family/friends. The main reason behind vaccine hesitancy was doubts regarding vaccine efficacy and safety and that vaccines were pre-invented, and the pandemic is made-up. Participants' sources of information included social media, official authorities, and family/friends. Conclusion: Findings from this study show that the convenience of receiving the vaccine, the abundance of credible information from the Saudi authorities, and the positive influence of family/friends were among the major factors that encouraged the public in Saudi Arabia to get vaccinated against COVID-19. Such results may inform future policies regarding encouraging the public to receive vaccines in cases of pandemic.

Use of prescription drugs in the older adult population-a nationwide pharmacoepidemiological study.

PURPOSE: Multi-morbidity and polypharmacy are common among older people. It is essential to provide a better understanding of the complexity of prescription drug use among older adults to optimise rational pharmacotherapy. Population-based utilisation data in this age group is limited. Using the Danish nationwide health registries, we aimed to characterise drug use among Danish individuals ≥ 60 years. METHODS: This is a descriptive population-based study assessing drug prescription patterns in 2015 in the full Danish population aged ≥ 60 years. The use of specific therapeutic subgroups and chemical subgroups and its dependence on age were described using descriptive statistics. Profiles of drug combination patterns were evaluated using latent class analysis. RESULTS: We included 1,424,775 residents (median age 70 years, 53% women). Of all the older adults, 89% filled at least one prescription during 2015. The median number of drug groups used was five per person. The most used single drug groups were paracetamol and analogues (34%), statins (33%) and platelet aggregation inhibitors (24%). Eighteen drug profiles with different drug combination patterns were identified. One drug profile with expected use of zero drugs and 11 drug profiles expected to receive more than five different therapeutic subgroup drugs were identified. CONCLUSION: The use of drugs is extensive both at the population level and increasing with age at an individual level. Separating the population into different homogenous groups related to drug use resulted in 18 different drug profiles, of which 11 drug profiles received on average more than five different therapeutic subgroup drugs.

Ethnic and migrant differences in the use of anti-asthmatic medication for children: the effect of place of residence.

BACKGROUND: Ethnic differences in the use of anti-asthmatic medication have been reported, with ethnic minorities being at a higher risk of suboptimal asthma control. As contextual socioeconomic characteristics may play a role, we analysed whether ethnic differences in the use of anti-asthmatic medication among children residing in the Capital Region of Denmark varied by place of residence. METHODS: Data were obtained from the Danish Civil Registration System, the Central Taxpayers' Register and the Danish National Prescription Register and were linked at the individual level. Population used was the entire child population in the Capital Region from 0 to 17 years old in 2008 (n = 342,403). Use of anti-asthma medicine was defined as at least one prescription having been filled in 2008. The analyses included multiple multilevel logistic regression models. RESULTS: Children living in low-income places of residence had lower odds of being prescribed preventive anti-asthmatics compared with children living in higher-income places of residence [odds ratio (OR) = 0.87, 95% confidence interval (CI) 0.84-0.91]. Immigrant children had the lowest OR of being prescribed anti-asthmatics medication, both relief (OR = 0.50, 95% CI 0.20-0.77) and preventive (OR = 0.47, 95% CI 0.24-0.82) compared with ethnic Danes. Similar associations were found among descendants of immigrant children (OR for preventive medication = 0.70, 95% CI 0.62-0.78). Place of residence contributed to but did not account for the ethnic differences in the use of anti-asthmatic medication. CONCLUSIONS: Ethnic differences in the use of anti-asthmatic medication were documented, and they cannot be explained by socioeconomic characteristics of place of residence. The lower prevalence of anti-asthmatic medication among ethnic minority children suggests poor asthma management control.

Customer interest in and experience with various types of pharmacy counselling - a qualitative study.

BACKGROUND: Despite pharmacists' extensive knowledge in the optimization of patients' medical treatments, community pharmacies are still fighting to earn patients' trust with respect to medicinal counselling at the counter. OBJECTIVE: The aim was to investigate how patients perceive pharmacy counselling at the present time, in order to develop the patient-pharmacy relationship for the benefit of both patients and pharmacies. DESIGN: Short semi-structured interviews were carried out with pharmacy customers by pharmacy internship students. SETTING AND PARTICIPANTS: One hundred and eight customers in 35 independent pharmacies across Denmark were interviewed during the spring of 2011. MAIN VARIABLES STUDIED: Customers were interviewed about their expectations of pharmacies in general and their experiences with medical counselling in particular. RESULTS: Customers perceive community pharmacies very differently in terms of both expectations of and positive experiences with counselling. They appear to be in favour of pharmacy counselling with respect to over-the-counter medicine and first-time prescription medicine in contrast to refills. Customers find it difficult to express the health-care role of pharmacies even when experiencing and appreciating it. DISCUSSION: Lack of appreciation of pharmacy counselling for refill prescription medicine and the difficulty in defining the role of pharmacies might stem from the difficulties that customers have in understanding medicine and thus the role of counselling services with respect to medicine. The pharmacy staff does not seem to realize these barriers. CONCLUSIONS: For pharmacies to encourage customer interest in pharmacy counselling, the staff should start taking the identified barriers into account when planning communication strategies.

Exploring the reasons behind low COVID-19 vaccination coverage in ethnic minorities-A qualitative study among Arabic-speaking public in Denmark.

AIMS: In Denmark, COVID-19 infection rates have been higher, and vaccination coverage has been lower in areas with many residents from ethnic minority backgrounds. This study aimed to explore COVID-19 vaccination perceptions among Arabic-speaking minorities in Denmark. MATERIALS AND METHODS: A total of 16 individuals, varying in age, gender, education, employment, health, vaccination status, and the Arabic-speaking country of origin, were recruited and interviewed in Arabic. The interviews were transcribed verbatim, translated into English, and analyzed using directed thematic analysis. RESULTS: Most interviewees had some knowledge about how vaccines work to prevent infections; however, a wide spectrum of opinions about the effectiveness and safety of COVID-19 vaccines and vaccination policies in Denmark emerged. COVID-19 vaccination issues were extensively discussed in Arabic-speaking communities, but consensus was rarely reached. Many participants felt confused and only took vaccines for practical considerations, such as travel. Due to language barriers, some participants experienced difficulties in understanding vaccination-related information in electronic invitations from the health authorities and at vaccination centers, with family members often stepping in to provide translations. CONCLUSIONS: Systematic efforts to actively disseminate translated COVID-19 vaccination information are needed to support ethnic minority individuals in making informed decisions.

Empowering patients as co-researchers in social pharmacy: Lessons learned and practical tips for meaningful partnership and impact.

Engaging patients as co-researchers in health service research, involving them in the design, planning, and implementation rather than treating them as mere participants, can yield positive outcomes and generate value for patients' health. It also increases patients' health literacy and empowerment, leading to more meaningful studies and substantial research impact. However, deeper levels of engagement as partners throughout the research lifecycle come with ethical and methodological challenges. This commentary provides actionable advice for Patient Engagement and Involvement (PEI) in social pharmacy research through a rapid review of models, frameworks, and guidelines and by gathering lessons from four recent social pharmacy research initiatives conducted in Nordic settings. It also identifies and discusses ethical and methodological challenges to conducting authentic and sustained patient-driven research. Deeper levels of engagement where patients take the lead in shaping the social pharmacy research question(s) are rare due to the intensity of resources required. With these 24 tips and the lessons learned, we aim to make this approach more accessible to social pharmacy researchers interested in PEI.

How patient-centredness takes place in pharmacy encounters: a critical common-sense interpretation of video-recorded meetings.

BACKGROUND: Counselling patients in community pharmacies is important to obtain the best usage of medicines. However, it does not seem to be sufficiently patient-centred. To become more patient-centred, communication guidelines could be used but the guidelines need to be supplemented with up-to-date research that specifies how patient-centredness takes place or could take place in the pharmacy encounters. AIM: To use a qualitative methodology to investigate how patient-centeredness unfolds in Danish pharmacy encounters by analysing video-recorded encounters. METHOD: A maximal variation sampling strategy was applied, including staff from 2 pharmacies. A preunderstanding of 'patient-centredness' guided the analyses with focus on the development of relationships, understanding the patient's situation, and coordination of care. Data were then subjected to a 'critical common-sense' interpretation. To validate identified themes, 'structural corroboration', 'researcher triangulation', and a 'meaning saturation process' were carried out. RESULTS: Nineteen encounters were included. Overall, the staff took responsibility for ensuring patients' optimal medicine use and focused on biomedical aspects of the treatment. Important messages conveyed by staff appeared to be that there is one correct way of taking medicines and that taking the medicine is an uncomplicated process. Patients were rarely invited to provide their perspective. CONCLUSION: Staff showed commitment to ensuring patients' optimal medicine use, but during this process, they predominantly relied on a reductionist approach to medicine. This must be addressed as it hampers patient-centredness. Suggestions for how to become more patient-centred are given.

What Are the Drug-Related Problems Still Faced by Patients in Daily Life?-A Qualitative Analysis at the Pharmacy Counter.

BACKGROUND: Drug-related problems (DRPs) affect many patients. Many activities in general practice, hospitals, and community pharmacies have been initiated to tackle DRPs. However, recent studies exploring what DRP patients are still facing in their daily lives are scarce. METHODS: Danish pharmacy staff registered DRPs in prescription encounters to understand what DRPs patients are still experiencing in daily life. They noted short descriptions of what happened in the encounter that qualified the incident as a DRP. The descriptions were subjected to an inductive content analysis. RESULTS: A wide range of DRPs that impacted patients' daily lives practically and healthwise were identified. In total, eighteen percent of patients with prescriptions had a DRP. Three overall stages of DRPs were identified: challenges in receiving the medications, not knowing how or why to take the medications, and not experiencing satisfactory effects. Patients were emotionally affected by these problems. CONCLUSIONS: DRPs are still widespread in patients' daily lives and influence their well-being. The identified DRPs illustrated the complexity of obtaining medications to work as intended and demonstrate that health professionals must take even the basics of medication intake much more seriously.

Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine.

BACKGROUND: Magistral compounding has always been an integral part of pharmacy practice. The increasing demand worldwide for personalized drug treatments might be accommodated by an increase in magistral compounding. The new, flexible technology of 3D medicine printing could advance this process even further. However, the issue of how 3D medicine printing can be implemented within the existing magistral compounding infrastructure has not been explored. AIMS: To investigate how 3D printing can be integrated into the existing compounding system by taking regulatory, economic, and profession-oriented aspects into account. METHODS: Semi-structured interviews were conducted with relevant Dutch stakeholders representing various health institutions, such as health ministries and boards, professional bodies, and different types of pharmacies. Participants were identified through purposeful sampling. Content analysis was applied to identify the main themes. RESULTS: A total of 15 Dutch stakeholders were interviewed. It was found that the prevalence of compounding in community pharmacies in the Netherlands has decreased as a result of the practice shifting to specialized compounding pharmacies due to higher costs, lack of space, and the need to fulfill quality requirements. All interviewees considered 3D printing to be a promising compounding technique for community pharmacies, as it offers an automated approach with high digital flexibility and enables adapted formulations, including 'polypills.' Regulatory and quality assurance challenges were considered comparable to those of normal magistral products; however, there remain pending regulatory issues regarding quality control, particularly for Active Pharmaceutical Ingredients containing intermediate feedstock materials (e.g., prefilled cartridges) in 3D printing. 3D printing was believed to become cost effective over time. CONCLUSION: In the Netherlands, specialized compounding pharmacies have largely taken over compounding activities. 3D printing could be introduced within this system; however, challenges regarding how to regulate prefilled cartridges have yet to be addressed. Compounding using 3D printing in regular community pharmacies could enhance patients' individualized treatment; however, this activity would require incentives to stimulate the return of compounding to normal pharmacy practice.

Quantitative hippocampal structural changes following electroconvulsive seizure treatment in a rat model of depression.

OBJECTIVE: The pathophysiology of depression and the effects of antidepressant treatment are hypothesized to be related to hippocampal structural changes. This study aims to investigate the effect of electroconvulsive seizures on behavior and hippocampal structure in a rat model of depression. METHODS: Flinders Sensitive Line (FSL) and Flinders Resistant Line (FRL) rats were treated daily for 10 days with either electroconvulsive seizures or sham treatment. The behavior was evaluated using the forced swim test. Design-based stereological methods were used to quantify the hippocampal volume and the numbers of neurons and glial cells in specific hippocampal subregions. RESULTS: The basal level of hippocampal volume and neuron number differed significantly between the two rat strains, and a trend toward the FSL strain having more glial cells was found. The structural differences found between the sham-treated animals were counteracted by electroconvulsive seizure (ECS) treatment, which also normalized the behavior. ECS treatment increased the number of glial cells in hilus significantly in the FRL rats and with the same tendency for the FSL rats. CONCLUSION: Our results indicate that along with hippocampal neurogenesis, gliogenesis may also be involved in the pathophysiology of depression and in the effect of antidepressant treatment. The underlying mechanisms remain unknown, and further investigations are required to clarify whether the structural changes are necessary to induce a therapeutic effect of antidepressant treatment or if they rather represent an epiphenomenon.

Ethnography and its potential for studying the social in social pharmacy: An example of autonomy and pharmaceuticals in eldercare.

Studying the social aspects of pharmaceuticals is an inherent part of the field of social pharmacy. Ethnography as a methodology provides a lens to guide researchers on this endeavor by offering richer insights into "real world practices" of professionals, patients and relatives compared to other methods. With a focus on meaning making, ethnography goes beyond descriptions and promotes theory-informed interpretations. Therefore, this methodology can lead to new understandings of medicine use in practice and in policy making. This article provides a brief introduction to ethnography, especially in relation to doing participant observation and fieldwork. An example from an ethnographic fieldwork on Danish home care for frail elderly is used to illustrate how ethnography can be applied, while focusing on three key features of ethnographic analysis: Thick descriptions, analytical generalizability and reflexivity.

A Qualitative Analysis of the Culture of Antibiotic Use for Upper Respiratory Tract Infections Among Patients in Northwest Russia.

Introduction: Due to the globally persistent threat of Antimicrobial Resistance (AMR), the purpose of this study was to gain an in-depth understanding of the antibiotic (AB) practices, knowledge and attitudes among patients residing in five regions in the northwest part of Russia. Given the high prevalence, this study focused on ABs for Upper Respiratory Tract Infections (URTI). Methods: The qualitative, semi-structured interviews followed a guide organized by major themes such as common symptoms, consultations with doctors and external influences in decision-making. Patient participants were recruited via convenience sampling. Fifty-five interviews were conducted among patients using ABs for URTIs purchased with or without prescription. Data was analyzed using a direct content analysis and validation rounds were conducted between interviewers and data analyzers. Results: Self-medication with ABs seemed a common practice across all five Russian regions; in some cases, patients tried to persuade pharmacists into selling them ABs without prescription. Factors, such as time spent going to the doctor, need of a sick leave or self-persuasion, influenced the decisions of whether or not to seek the doctor for symptoms of URTIs. Knowledge of ABs and AMR was generally low; however, some patients with seemingly good knowledge practiced self-medication from time to time. Family members and friends were often involved in decisions about how to handle symptoms of URTIs, especially among those patients using ABs without prescription. Few patients had noticed ABs awareness campaigns, and very few reported having learned something important from them. Conclusion: Despite enforced regulation of AB use in Russia, self-medication still exists. Knowledge is not always linked to appropriate use of AB, and the few campaigns conducted were not always noticed.

Online and Blended Learning Courses for Healthcare Professionals and Policymakers on Patients' Perspectives on Medicine: A Project Report.

In order for healthcare professionals to better engage with patients, they need to understand and integrate the perspectives of patients into their daily work. In this project, we developed two courses for healthcare professionals on patients' perspectives on medicine. One course was an online course that introduced the patients' perspectives on medicine and explained its importance for healthcare and health policy. The second course was a blended learning course, consisting of online modules and face-to-face webinars, which specified how to explore patients' perspectives in qualitative interviews, and how to develop implementation plans. Patients participated in the development, execution, and evaluation of both courses. Overall, more than 2000 healthcare professionals enrolled in the first course and, in just over a year, 191 participants completed the online course; 57 healthcare professionals registered in the second blended learning course and six participants completed both components of the course. The relevance of knowledge gained was positively evaluated. Participants especially appreciated the participation of patients. Based on the feedback, the second blended learning course was adapted to run online and both courses continue to be freely available to all interested healthcare professionals on the Coursera platform.

Why do general practitioners disregard direct to healthcare professional communication? A user-oriented evaluation to improve drug safety communication.

Post-approval drug risks are a significant public health problem. A central instrument to mitigate them in the European Union is direct to healthcare professional communications (DHPC), typically a letter sent from the manufacturer to prescribers. However, evaluations show that DHPCs have limited impact on prescribing behavior. Which factors influence prescribers' lack of adoption of DHPCs remains unknown. This article presents a think-aloud reading study of 17 Danish general practitioners' reading aloud a 2013 DHPC about new oral anticoagulants, interjecting their immediate reactions and associations to daily clinical routines concurrently. We found that interviewees inferred more from the DHPC than risk information. It was perceived to be commercially biased, which generally discouraged reading despite learning new safety information. DHPCs were also disregarded because they are isolated from routinely used clinical information sources. Furthermore, DHPCs were perceived as pre-emptive acts of legal defence aiming to relocate responsibility from the manufacturer onto prescribers. In conclusion, the study indicates that certain DHPCs may be disregarded because of the perceived motivations that prescribers attribute to the DHPC senders. While the specific letter itself was deemed unsatisfactory, its legitimacy among prescribers remains the central challenge. Further integration with trusted and established information structures is also needed.

Furthering patient-centered counseling: Exploring new aspects around pharmacists' experiences in pharmacy encounters through video-stimulated recall interviewing.

BACKGROUND: Studies on pharmacy communication have illustrated problems with patient-centeredness. Exploring pharmacists' experiences of pharmacy counseling in depth is essential to understand what hinders patient-centeredness. Existing studies, based primarily on surveys and qualitative interviews, tap into perceptions of pharmacy counseling that are informed by general conceptualizations rather than what participants actually experience during the encounters. Thus, important aspects of the dynamics of pharmacy encounters might be missed. OBJECTIVES: To explore the potential of the method video-stimulated recall interview (VSRI)( Wolters et al., 2017) 1 in a pharmacy setting to gain new insights into pharmacists' experiences of patient encounters. This includes: 1) to investigate the potential of VSRI to reveal accurate and immediate perceptions of pharmacy encounters, and 2) to identify specific perceptions that pharmacists report in VSRIs. METHODS: Seven VSRIs conducted in 2 different community pharmacies in Denmark were analyzed. Videos of at-the-counter meetings were recorded (interaction1), and then selected for replay in a VSRI between a researcher and the pharmacist featured in the video (interaction2). Descriptive categories that characterized pharmacists' experiences with the encounter were inferred from interview statements. RESULTS: New barriers to patient-centeredness were identified: pharmacists' experiences revealed that they were affected by patients' moods and that they found it inappropriate when patients disclosed personal perspectives. Also, pharmacists seemed to disregard that active listening requires responsiveness and should be seen as a process that pharmacists co-construct together with the patient. CONCLUSION: The method of VSRI proved useful in revealing new dynamics of pharmacy interaction and pinpointing shortcomings in how pharmacists communicate with patients. Based on the findings, suggestions for how to establish better patient-centered communication are provided.

Using qualitative methods to explore the dynamics of patients' perspective sharing in community pharmacy counseling- conversation analysis and video-stimulated recall interviews.

Background: For patient centered counseling to take place in community pharmacies, patients should feel encouraged to share their perspectives, yet studies show that this rarely happens. The process of patient perspective sharing relies on the interactional details that unfold during an encounter i.e. how patients verbally and nonverbally are encouraged to share their perspective, which in turn is affected by patients' and pharmacy staff members' psychological processes in the situation, i.e. how they perceive and feel when acting. Therefore, employing complimentary methods that study both interactional and psychological processes could deepen the understanding of the dynamics governing patients' perspective sharing in pharmacy encounters. Objective: The objective of this study is twofold: 1) a methodological consideration of the benefits of employing Conversation Analysis (CA) and Video-Stimulated Recall Interviews (VSRI) in parallel, 2) to use the methodological combination to understand patient perspective sharing in community pharmacy interactions. Method: A single case study of one pharmacy encounter to explore the objectives in-depth. This was done through video recording of pharmacy encounters and subsequent CA-analysis; VSRIs were conducted with the involved patient and pharmacy staff member and analyzed using a qualitative thematic approach. Results: By exploring detailed interactional and psychological processes in parallel, specific occurrences which might hinder patients' perspective sharing were revealed. CA demonstrated that staff member's listening activities restricted the patient's perspective sharing. VSRIs with patient and staff member supported this result: the staff member had a narrow conception of what counted as suitable answers and did not consider listening an active process. The patient harbored shame about needing to take the medication which affected her behavior during the encounter. Conclusion: The novelty of the methodological combination is promising in order to grasp the complex process of patient perspective sharing in pharmacy encounters, as it affords aspects such as emotionality to be considered a central part of pharmacy encounters. As a consequence, it is suggested that the psychological concept of mentalizing is added to pharmacy education, as it is a trainable capacity enabling staff to become aware of the mental states that affect both patients and staff themselves during the pharmacy encounter.

Scenarios for 3D printing of personalized medicines - A case study.

Background: 3D printing is a promising new technology for medicines' production. It employs additive manufacturing techniques, and is ideal for producing personalized medicines (e.g., patient-tailored dose, dosage form, drug release kinetics). Objective: To investigate how 3D printing technologies can be implemented in a European pharmaceutical system, by suggesting different scenarios and assessing aspects that could affect its implementation. Method: Qualitative, semi-structured interviews were conducted with key stakeholders (e.g., from ministry, authorities, research organizations, pharmacies) in the Netherlands to elicit perspectives on 3D printing of personalized medicines. The Netherlands were chosen since it has a strong tradition in compounding. Five general scenarios were investigated: placing the 3D printers in industry, community pharmacies, hospital pharmacies, compounding facilities, and in patients' homes. Content analysis was used, building on verbatim transcripts. Results: Fifteen stakeholders were interviewed. Regulatory, economic, ethical and organizational challenges were identified to varying degrees in the different scenarios. The industry and home scenarios were associated with the most challenges, hospital pharmacies and compounding facilities with the least. Other important aspects identified were the role of community pharmacies, and who should design the tablets to be printed. Conclusion: All potential scenarios for 3D printing of personalized medicines include challenges. These should be taken into account when pursuing the use of 3D printing of medicine.

Development of a qualitative exploratory case study research method to explore sustained delivery of cognitive services.

OBJECTIVE: To develop, apply and evaluate a new research method to establish relationships between structural and process elements of the provision of cognitive services. In-depth knowledge about how local organisational structural elements of community pharmacies shape the implementation process of cognitive services is needed to develop targeted quality assurance systems to ensure that the services are continuously provided to the patients who need them. The first publicly reimbursed cognitive service in Denmark, the Inhaler Technique Assessment Service (ITAS) is used as the case. SETTING: The research method was developed at the Faculty of Pharmaceutical Sciences at the University of Copenhagen and later applied to seven community pharmacies geographically spread around Denmark. METHODS: A pilot study as well as a subsequent literature review was conducted to determine which structure-process elements to focus on in the research method as well as to select appropriate theories and methods. RESULTS: The developed research method was a qualitative exploratory multi-case study, that was based on method triangulation of field observations, semi-structured interviews, group interviews as well as collection of documentary material. The three main themes of the research method were: the administration of tasks, leadership style and professional values. We integrated the organisational theories of Mintzberg, Bolman and Deal as well as Sørensen to support and clarify the data collection process and analyses. A cross-case analysis and an exploratory contextual analysis relating the leadership style of the pharmacy owner to the ITAS provision were applied to the collected data. CONCLUSION: The developed qualitative exploratory multi-case study research method was satisfactory with regard to achieving nuanced and in-depth results of some relationships between structural and process elements of provision of cognitive services. The research method can be considered an important supplement to the existing literature on the sustainability of cognitive services.

Sustaining delivery of the first publicly reimbursed cognitive service in Denmark: a cross-case analysis.

OBJECTIVES: The aim was to identify local organisational factors that affect sustained delivery of the first Danish publicly reimbursed cognitive service, the Inhaler Technique Assessment Service (ITAS). The ITAS is a 10-min interactive counselling session during which pharmacy staff assess the inhalation technique of individual asthma patients at the pharmacy counter, and correct any errors. Knowledge of how the organisation of a local pharmacy influences ITAS provision will be used to develop quality indicators as part of a targeted quality-assurance system to support the sustainability of the service in all Danish community pharmacies. METHODS: Qualitative methods included field observations, semi-structured interviews, group interviews and the collecting of documentary material. Data-source and method triangulation were applied. Seven pharmacies were included in the study. A cross-case analysis compared pharmacies with sustained and reduced numbers of services based on three selected themes: administration of the ITAS, leadership interventions and professional values of pharmacy owner and staff. KEY FINDINGS: Pharmacies with sustained delivery had introduced systematic evaluations of the local delivery of the ITAS and made ongoing efforts to improve staff competencies. They dealt with individual barriers such as lack of knowledge of rarely distributed inhalation devices and communication techniques. Pharmacy staff in general rarely assessed patients' clinical needs before offering the service and rarely provided follow-up. Thus, pharmacy staff failed to utilise the full clinical potential of the ITAS. CONCLUSIONS: In order to achieve and support further ITAS sustainability, the knowledge, skills and professional values of pharmacy staff must be developed. Human resource leadership techniques would be useful in achieving this aim, as would focusing on the service by providing systematic evaluations.

Preparation of Direct Healthcare Professional Communication: An Exploratory Study on the Experiences and Perceptions of European Pharmaceutical Companies and the EMA.

BACKGROUND: Despite the regulatory requirement for cooperation between marketing authorization holders (MAHs) and European Medicines Agency (EMA) in the direct healthcare professional communication (DHPC) preparation, no literature has explored DHPCs from an industry-regulator perspective. This constitutes a significant knowledge gap as any possibility of improving current DHPC effectiveness depends on decisions in the cooperative preparation phase. Thus, this EU-centered study explores differences in perceptions and experiences of DHPCs of European MAHs and EMA. METHODS: European MAHs ([Formula: see text]) and EMA representatives ([Formula: see text]) were interviewed. The verbatim transcripts were coded into themes using NVivo software. Interview analysis was performed following a phenomenological approach of meaning condensation. RESULTS: The DHPC process was perceived as burdensome by the industry. One company stated the process was time-consuming either due to EMA's internal lengthy approval process or the translation activities with local company affiliates and national competent authorities. Three companies stated that DHPCs were not effective. One company stated that DHPCs are sent out due to legal Obligations and not because of their use as a risk minimization measure (RMM). Newly emerged safety concerns were found difficult to phrase. Optimization proposals included improved timelines, scrutinization of healthcare professionals and better communication tools in clinical practice. CONCLUSION: DHPCs were not perceived as optimal, although the most effective intervention as it targets healthcare professionals directly. Continuous evaluation by EMA of DHPCs and evaluation on how to reach healthcare professionals are necessary. It is believed that industry perceptions from this study can support EMA with improved regulatory decision making to benefit public health.