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.

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.

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.

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.

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.

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.

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.

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.

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.

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 (AU)

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.

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.

A Presentation of Central Communication Aspects in the Patient-Provider Relationship-Potential Learnings for Community Pharmacists.

Several studies have shown that communication between patients and HCPs is still not optimal in integrating patients' perspectives on how best to manage their diseases and their medication. One such area where encounters between patients and professionals still needs to develop to better incorporate the patient's perspective is pharmacy practice. The aim of this study was therefore to explore and present new typologies and communication aspects of HCP-patient relationships since a comprehensive literature search in 1997 conducted by Sondell and Söderfeldt, and relate the findings to pharmacy practice. In total, 11 articles were identified by applying the techniques of a purposeful literature search. The articles covered aspects of: shifting and adapting roles during the encounter, techniques to ensure individualizing in the encounter, avoiding inappropriate routines, coping with internet-informed patients, achieving mutual goals, dealing with uncertainty including avoiding rigid preconceptions, using social conversation, incorporating patients' prior experiences, aligning language, adapting greetings and exploring the cultures and communication patterns of patients from other ethnic backgrounds. The variety of these communication aspects points to the immense complexity of communication as a practice discipline. This article has presented some of the literature that pharmacists can consult, in the endeavor of improving their communication practices.

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.

The antibiotic knowledge, attitudes and behaviors of patients, doctors and pharmacists in the WHO Eastern European region - a qualitative, comparative analysis of the culture of antibiotic use in Armenia, Georgia, Kazakhstan, Moldova, Russia and Tajikistan.

BACKGROUND: To reduce antimicrobial resistance (AMR), initiatives such as surveillance activities and activities to increase knowledge about how and why antibiotics (ABs) are (mis)used are needed. More surveillance systems are in place in the WHO Western European region than in the Eastern region, and only sparse knowledge exists about the current culture of AB use in the Eastern European countries. OBJECTIVE: To investigate AB knowledge, attitudes and behaviors in countries in the WHO Eastern European region in order to identify overall similarities and differences across the region and how AB knowledge, attitudes and behavior patterns may be influenced by the national health care system. METHODS: Semi-structured interviews were conducted in Armenia, Georgia, Kazakhstan, Moldova, Russia and Tajikistan with patients, doctors and pharmacists. In total, 80 interviews were carried out. A directed content analysis was applied, followed by a comparative analysis, identifying the similarities and differences in AB attitudes, knowledge and behaviors between the countries and discussing how the national health care systems might influence these patterns. RESULTS: Cross-national patterns were identified regarding patients seeking ABs over-the-counter (OTC), patient variations in their requests for ABs when consulting doctors, and, finally, doctors and pharmacists appearing knowledgeable about ABs and their uses, with doctors displaying careful attitudes towards AMR. Indications of national differences between the countries included the ability of patients to afford ABs, prescribing practices of doctors and pharmacist attitudes towards selling ABs without prescriptions. Multiple aspects involved in patient and pharmacist AB decision making were detected, such as various rationales involved in buying/selling ABs OTC, implying that these processes are more complex than previously reported in the literature. CONCLUSIONS: Similarities across the Eastern European region could be seen in patient needs and uses of antibiotics obtained OTC at community pharmacies, whereas doctors appeared more influenced by specific structures of the national healthcare system.

Culture of antibiotic use in Kosovo - an interview study with patients and health professionals.

BACKGROUND: Kosovo is a new state and has a high consumption of antibiotics in relation to other European countries. Existing quantitative studies have shown that practices exist that is not optimal when it comes to antibiotic use in Kosovo, this includes citizens' use of antibiotics, pharmacy practices of selling antibiotics without prescriptions and physicians' prescribing behaviours. To address these problems, there is a need for a deeper understanding of why antibiotics are handled in a suboptimal way. OBJECTIVE: The objective was to explore antibiotic users', community pharmacists' and prescribers' attitudes towards, experiences of, and knowledge about antibiotics in Kosovo. METHODS: Semi-structured interviews were conducted with patients who recently received an antibiotic prescription for an upper respiratory tract infection (URTI), patients who recently received antibiotics for a URTI without a prescription, community pharmacists, and physicians. Interviews were recorded, translated into English, and analysed using deductive content analysis. RESULTS: In total, 16 interviews were conducted in the period from 2015-2016. Five themes were identified: Obtaining antibiotics, Choice of antibiotics, Patient information, Patients' knowledge and views on when to use antibiotics, and Professionals' knowledge and attitudes towards antimicrobial resistance. Antibiotics were sometimes obtained without a prescription, also by patients who currently had received one. The specific antibiotic could be chosen by a physician, a pharmacist or the patient him/herself. Former experience was one reason given by patients for their choice. Patients' knowledge on antibiotics was mixed, however health professionals were knowledgeable about e.g. antimicrobial resistance. CONCLUSIONS: There is currently a culture of antibiotic use in Kosovo, including attitudes and behaviours, and hence also experiences, which is possibly underlying the high consumption of antibiotics in the country. The culture is reproduced by patients, pharmacists and physicians. There is, however, an awareness of the current problematic situation among practitioners and policy makers; and as Kosovo is a new country, opportunities to effectively tackle antimicrobial resistance exist.

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 (n = 6) and EMA representatives (n = 2) 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.

Culture of antibiotic use in Kosovo - an interview study with patients and health professionals

Background: Kosovo is a new state and has a high consumption of antibiotics in relation to other European countries. Existing quantitative studies have shown that practices exist that is not optimal when it comes to antibiotic use in Kosovo, this includes citizens' use of antibiotics, pharmacy practices of selling antibiotics without prescriptions and physicians' prescribing behaviours. To address these problems, there is a need for a deeper understanding of why antibiotics are handled in a suboptimal way. Objective: The objective was to explore antibiotic users', community pharmacists' and prescribers' attitudes towards, experiences of, and knowledge about antibiotics in Kosovo. Methods: Semi-structured interviews were conducted with patients who recently received an antibiotic prescription for an upper respiratory tract infection (URTI), patients who recently received antibiotics for a URTI without a prescription, community pharmacists, and physicians. Interviews were recorded, translated into English, and analysed using deductive content analysis. Results: In total, 16 interviews were conducted in the period from 2015-2016. Five themes were identified: Obtaining antibiotics, Choice of antibiotics, Patient information, Patients' knowledge and views on when to use antibiotics, and Professionals' knowledge and attitudes towards antimicrobial resistance. Antibiotics were sometimes obtained without a prescription, also by patients who currently had received one. The specific antibiotic could be chosen by a physician, a pharmacist or the patient him/herself. Former experience was one reason given by patients for their choice. Patients' knowledge on antibiotics was mixed, however health professionals were knowledgeable about e.g. antimicrobial resistance. Conclusions: There is currently a culture of antibiotic use in Kosovo, including attitudes and behaviours, and hence also experiences, which is possibly underlying the high consumption of antibiotics in the country. The culture is reproduced by patients, pharmacists and physicians. There is, however, an awareness of the current problematic situation among practitioners and policy makers; and as Kosovo is a new country, opportunities to effectively tackle antimicrobial resistance exist

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