Prevalence, country-specific prescribing patterns and determinants of benzodiazepine use in community-residing older adults in 7 European countries.

BACKGROUND: The use of benzodiazepines (BZDs) in older population is often accompanied by drug-related complications. Inappropriate BZD use significantly alters older adults' clinical and functional status. This study compares the prevalence, prescribing patterns and factors associated with BZD use in community-dwelling older patients in 7 European countries. METHODS: International, cross-sectional study was conducted in community-dwelling older adults (65 +) in the Czech Republic, Serbia, Estonia, Bulgaria, Croatia, Turkey, and Spain between Feb2019 and Mar2020. Structured and standardized questionnaire based on interRAI assessment scales was applied. Logistic regression was used to evaluate factors associated with BZD use. RESULTS: Out of 2,865 older patients (mean age 73.2 years ± 6.8, 61.2% women) 14.9% were BZD users. The highest prevalence of BZD use was identified in Croatia (35.5%), Spain (33.5%) and Serbia (31.3%). The most frequently prescribed BZDs were diazepam (27.9% of 426 BZD users), alprazolam (23.7%), bromazepam (22.8%) and lorazepam (16.7%). Independent factors associated with BZD use were female gender (OR 1.58, 95%CI 1.19-2.10), hyperpolypharmacy (OR 1.97, 95%CI 1.22-3.16), anxiety (OR 4.26, 95%CI 2.86-6.38), sleeping problems (OR 4.47, 95%CI 3.38-5.92), depression (OR 1.95, 95%CI 1.29-2.95), repetitive anxious complaints (OR 1.77, 95%CI 1.29-2.42), problems with syncope (OR 1.78, 95%CI 1.03-3.06), and loss of appetite (OR 0.60, 95%CI 0.38-0.94). In comparison to Croatia, residing in other countries was associated with lower odds of BZD use (ORs varied from 0.49 (95%CI 0.32-0.75) in Spain to 0.01 (95%CI 0.00-0.03) in Turkey), excluding Serbia (OR 1.11, 95%CI 0.79-1.56). CONCLUSIONS: Despite well-known negative effects, BZDs are still frequently prescribed in older outpatient population in European countries. Principles of safer geriatric prescribing and effective deprescribing strategies should be individually applied in older BZD users.

Emotional intelligence and pharmaceutical care: A systematic review.

BACKGROUND: Emotional intelligence (EI) can help perceive, understand, and manage emotions and positively impact performance in any profession, including pharmacists, and consequently may have positive influence on patient-related outcomes. Although there is strong body of evidence suggesting that developing EI in health professionals (HPs) can increase their capacity to successfully communicate and build relationships with patients, thus increasing patient satisfaction, little is known about it in pharmaceutical care (PhC). OBJECTIVES: This review aimed to synthesize available data on the probable impact of EI on PhC. METHODS: PubMed, Web of Science, and Embase databases were searched for papers in English dated between January 2000 and June 2021. Quantitative, qualitative, or mixed method studies on EI and PhC that involved practicing pharmacists were included. RESULTS: The inclusion criteria were met by 4 papers only. One reported positive impact of EI in reducing the negative correlation between autistic-like traits and empathy among hospital pharmacists. One study demonstrated that EI levels can be significantly enhanced through pharmacy leadership programs. Another study established a positive correlation between EI and entrepreneurial orientation in practicing community pharmacists. Higher EI scores were predictors of increased work innovation, proactivity, and risk-taking levels. One study reported comparative EI data between different HPs and found pharmacists' superiority in the EI subdomains of self-awareness, self-motivation, and social skills. CONCLUSION: Additional research is required to provide evidence on how EI and EI development programs can add value to the provision of PhC. Processes and resources ought to be developed and secured to support the implementation and follow-up of such programs to bring long-term benefits to practicing pharmacists and consequently positively impacting patient-reported health outcomes.

Pharmacists' role, work practices, and safety measures against COVID-19: A comparative study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic poses a great challenge to health systems and their most accessible assets-community pharmacies. Pharmacists faced many challenges such as incorporating safety measures, changes in working schedule and workload, and meeting specific patients' needs. OBJECTIVES: This study aimed to explore and compare the community pharmacists' roles, practices, implemented safety measures, and psychological toll in Croatia and Serbia during the COVID-19 pandemic. METHODS: A cross-sectional study employing an online survey was conducted in 2 countries over a period of 6 weeks during 2020. The survey consisted of 65 items that explored sociodemographic characteristics of participants and their workplaces, including safety measures, pharmaceutical care, and their psychology while working during the COVID-19 pandemic. RESULTS: In total, 574 pharmacists participated in the study, of which, 90% were female, with a mean age of 38 years (interquartile range 30.5-47). The study identified new pharmacists' roles that evolved during the COVID-19 pandemic: manufacturing hand sanitizers in community pharmacies, online patient counseling, and home delivery of medicines. Croatian and Serbian pharmacists exhibited disparities in their incorporated safety measures (higher for Croatia; P ≤ 0.001) and satisfaction with work organization and counseling activities (higher for Serbia; P < 0.001). Serbian participants were less satisfied with the public perception of their role during the pandemic, and overall satisfaction was low, with a negative impact on mood and productivity. CONCLUSIONS: The study revealed the implications for community pharmacists during the pandemic in both countries. The extent of systematic and logistical support provided to them during the pandemic could be an explanation for the highlighted differences. It is imperative to develop a more effective strategy to counter potential health crises to ensure a better response from primary care pharmacists in the future.

Patients' willingness to pay for cognitive pharmacist services in community pharmacies.

AIM: To determine the general population willingness to pay for cognitive pharmacist service in community pharmacy, describe the behavior of participants regarding health care issues, and evaluate correlation between participants' sociodemographic characteristics or attitudes and their willingness to pay. METHODS: A questionnaire-based survey was conducted among general population visiting community pharmacies. The participants were asked about receiving cognitive pharmacist services to identify and resolve potential medication therapy problems after the initiation of a new medicine to optimize health outcomes of the patients. A univariate and multivariate analysis were used to analyze associations between different variables and willingness to pay for pharmacy service. RESULTS: Of 444 respondents, 167 (38%) reported that they were willing to pay for a medication management service provided in the community pharmacy. Univariate analysis showed significant association between the willingness to pay for pharmacist-provided service and respondents' socio-demographic factors, health-related characteristics, and behavior, dilemmas, or need for certain pharmacist-provided service. The logistic regression model was statistically significant (χ2=4.599, P<0.001). CONCLUSIONS: The respondents expressed their willingness to pay for cognitive pharmacist services, which has not been fully recognized within the health care system. In future, pharmacists should focus on practical implementation of the service and models of funding.

An Ethical Issue Scale for Community Pharmacy Setting (EISP): Development and Validation.

Many problems that arise when providing pharmacy services may contain some ethical components and the aims of this study were to develop and validate a scale that could assess difficulties of ethical issues, as well as the frequency of those occurrences in everyday practice of community pharmacists. Development and validation of the scale was conducted in three phases: (1) generating items for the initial survey instrument after qualitative analysis; (2) defining the design and format of the instrument; (3) validation of the instrument. The constructed Ethical Issue scale for community pharmacy setting has two parts containing the same 16 items for assessing the difficulty and frequency thereof. The results of the 171 completely filled out scales were analyzed (response rate 74.89%). The Cronbach's α value of the part of the instrument that examines difficulties of the ethical situations was 0.83 and for the part of the instrument that examined frequency of the ethical situations was 0.84. Test-retest reliability for both parts of the instrument was satisfactory with all Interclass correlation coefficient (ICC) values above 0.6, (for the part that examines severity ICC = 0.809, for the part that examines frequency ICC = 0.929). The 16-item scale, as a self assessment tool, demonstrated a high degree of content, criterion, and construct validity and test-retest reliability. The results support its use as a research tool to asses difficulty and frequency of ethical issues in community pharmacy setting. The validated scale needs to be further employed on a larger sample of pharmacists.

Are antidepressants effective in quality of life improvement among children and adolescents? A systematic review.

There is some evidence indicating that psychotropic medications might lead to health-related quality of life (QOL) improvements among children and adolescents with psychiatric disorders. The aim of this systematic review is to assess evidence regarding whether antidepressant treatment improves QOL among children and adolescents with depressive or anxiety disorders. A comprehensive search resulted in 5 clinical trials to be included in this review: 4 trials with major depressive disorder (MDD) and 1 trial with social anxiety disorder (SAD). In one MDD trial, fluoxetine combined with cognitive behavior therapy (CBT) significantly improved QOL compared to fluoxetine or CBT alone (effect sizes were 0.53 and 0.69, respectively). In 2 combined trials, sertraline alone significantly improved QOL among adolescents with MDD (effect size was 0.29), but not among children with MDD. Essentially, it was observed that antidepressants in these trials had minor positive effects on QOL improvement, which were lower than their potential to improve depressive symptoms. Although fluoxetine with CBT or sertraline monotherapy were shown to have some potential to improve QOL, this systematic review found inconclusive evidence that antidepressant treatments improve QOL among children and adolescents with depressive or anxiety disorders. More research is required, considering that QOL is currently under-evaluated in clinical trials with antidepressants among children and adolescents and available trials have limited methodological quality when reporting QOL data.

Perceived importance of emotional intelligence for clinical pharmacy practice and suggested improvements: a focus group study of postgraduate pharmacists.

BACKGROUND: Emotional intelligence (EI) is a critical set of skills that impacts clinical pharmacists' well-being and positively influences high-level patient-centred care. Describing pharmacists' perceptions may support the integration of EI development approaches into their professional development continuum. AIM: The aim of this study was to analyse pharmacists' perceptions of the characteristics of emotionally intelligent clinical pharmacists, the importance of EI in clinical practice, and educational models and approaches to enhancing EI. METHOD: A qualitative study with a focus group methodology was conducted with pharmacy practitioners using a semi-structured guide grounded in the EI competency framework and existing qualitative research methodology practices. Purposive sampling was conducted until information and meaning saturation occurred. The focus group recordings were transcribed and independently coded by two researchers. The conventional content analysis of qualitative data was applied with the inductive thematic approach at its core. RESULTS: According to the 17 focus group participants, emotionally intelligent clinical pharmacists are perceived as self-confident communicators who control and manage emotions, work well under pressure, and handle every situation effectively. Emotional self-control, self-awareness, awareness of others, tolerance, understanding, and empathy have emerged as key EI competencies required for challenges in clinical practice. EI lectures with reflections from clinical applications, behaviour modelling, and behaviour-changing methods were perceived to be of particular importance for pharmacist education and development programmes. CONCLUSION: Postgraduate pharmacy practitioners perceived EI competencies as necessary for their professional success and high-quality patient-centred care. They suggested that EI competencies be a focal point in pharmacy professional development programmes.

Immediate and long-term effects of COVID-19 on antibiotic dispensing: increasing use of Watch antibiotics.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic affected antibiotic usage worldwide. However, there is limited data from Serbia. Dispensing of oral antibiotics in Serbian pharmacies was analyzed to calculate monthly and yearly changes between 2018-2021, and to explore immediate and long-term effects of COVID-19 on antibiotic dispensing during this period. METHODOLOGY: The number of antibiotic packages dispensed from pharmacies during the study period was analyzed with a Chi-square test to assess the average change in annual dispensing, and an interrupted time-series analysis was used to evaluate the impact of the pandemic on antibiotic dispensing. The data from 2018-2021 were retrieved from the database of a large community pharmacy chain in Serbia. RESULTS: The average number of antibiotic packages dispensed per day and per pharmacy was higher in 2021 compared to 2018 by one package. However, the dispensing of macrolides increased significantly; 17.7% (2018) vs. 22.5% (2021) (p < 0.05). In general, an increase in antibiotic dispensing was detected during COVID-19 for total antibiotics (16.4%), Watch antibiotics (44.8%), third-generation cephalosporins (80.4%), macrolides (45.5%) and azithromycin (83.7%). However, the immediate effect of COVID-19 was a decrease in the dispensing of Watch antibiotics, penicillin, and third-generation cephalosporins (p < 0.05); and a notable long-term COVID-19 effect was an increase in the dispensing of azithromycin (p < 0.05). CONCLUSIONS: In spite of a relatively stable trend of total antibiotic dispensing before and during COVID-19 pandemic, the use of Watch antibiotics, third-generation cephalosporins, and macrolides (particularly azithromycin) showed an increasing trend in dispensing that should be optimized.

Evaluating the Serbian version of the KIDSCREEN quality-of-life questionnaires: reliability, validity, and agreement between children's and parents' ratings.

PURPOSE: To evaluate the psychometric properties of the Serbian set of the KIDSCREEN questionnaires: KIDSCREEN-52, KIDSCREEN-27, and KIDSCREEN-10 index. METHODS: The study included 330 children (8-18 years) and 314 parents. All completed the KIDSCREEN and KINDL questionnaires. Psychometric analyses included internal consistency reliability (Cronbach's coefficient), criterion, convergent and discriminant validity, and agreement between children and parents (the intraclass correlation coefficient-ICC). RESULTS: Cronbach's α of 0.7 and above was found for all except for the self-perception scale of the KIDSCREEN-52, being 0.58 for the child and 0.63 for the parent version. Correlations between similar scales in the KIDSCREEN and KINDL were substantial (ranging 0.45-65) and higher than correlations between theoretically different scales. Moderate to excellent agreement existed between children's and parents' ratings in all KIDSCREEN scales (ICC ranged 0.44-0.63), except for the moods and emotions from the longer (ICC = 0.34) and the social support and peers from the shorter version (ICC = 0.38). CONCLUSIONS: Levels of internal consistency reliability and validity of all KIDSCREEN questionnaires in Serbian are appropriate, as well as agreement between children's and parents' ratings.

A cross-sectional study comparing emotional intelligence and perceived stress amongst community pharmacists delivering and not delivering a new service.

BACKGROUND: Community pharmacists contribute substantially to public health and person-centred care. Emotional intelligence (EI) may help health professionals better engage with patients, handle stress in challenging situations and, presumably, better introduce and implement new services. AIM: The study's aims were to compare the EI and perceived stress (PS) levels of community pharmacists who provided a new service to patients with diabetes with their controls who provided standard pharmaceutical services and to test the correlations between the two constructs. METHOD: This study used a survey methodology. Well-validated instruments were distributed electronically to all participating pharmacists. To compare the continuous EI and PS data between the two study groups, the paired-samples t test was used. Pearson and Spearman's correlations were used to test the associations between EI and PS and their respective subdomains. RESULTS: A total of 86 pharmacists participated in the study (n = 43 in each group). The study groups did not differ by any characteristic except gender. Their mean EI and PS levels were 120.95 ± 11.53 and 17.45 ± 4.55, respectively, with no difference between the groups. In both study groups, inverse correlations were found between PS and EI levels, with statistical significance in the control group and in the overall study population (r = - 0.611 and r = - 0.370, respectively). CONCLUSION: Our results suggest that the introduction of the EI agenda into certification programmes for new community pharmacy services should be considered. The results also suggest that higher EI may have protective effects against PS. Additional research would clarify the need to invest more in such programmes.

Antimicrobial utilization and resistance in Pseudomonas aeruginosa using segmented regression analysis: a comparative study between Serbia and eight European Countries.

BACKGROUND: In Europe, Serbia occupies a high position in antibiotic utilization and antimicrobial resistance (AMR). AIM: The aim was to analyse utilization trends of meropenem, ceftazidime, aminoglycosides, piperacillin/tazobactam and fluoroquinolones (2006-2020), and the reported AMR in Pseudomonas aeruginosa (2013-2020) in Serbia and to compare with data from eight European countries (2015-2020). METHOD: Joinpoint regression was used to analyse antibiotic utilization data (2006-2020) and the reported AMR in Pseudomonas aeruginosa (2013-2020). Data sources were relevant national and international institutions. Antibiotic utilization and AMR in Pseudomonas aeruginosa data in Serbia were compared with eight European countries. RESULTS: There was a significantly increased trend for ceftazidime utilization and reported resistance in Pseudomonas aeruginosa, Serbia (p < 0.05) (2018-2020). For ceftazidime, piperacillin/tazobactam, and fluoroquinolones resistances in Pseudomonas aeruginosa an increased trend was observed, Serbia (2013-2020). A decrease in both the utilization of aminoglycosides, Serbia (p < 0.05) (2006-2018) and contemporaneous Pseudomonas aeruginosa resistance (p > 0.05) was detected. Fluoroquinolone utilization (2015-2020) was highest in Serbia compared to Netherlands and Finland, 310 and 305% higher, similar compared to Romania, and 2% less compared to Montenegro. Aminoglycosides (2015-2020) were 2550 and 783% more used in Serbia compared to Finland and Netherlands, and 38% less regarding Montenegro. The highest percentage of Pseudomonas aeruginosa resistance was in Romania and Serbia (2015-2020). CONCLUSION: The use of piperacillin/tazobactam, ceftazidime and fluoroquinolones should be carefully monitored in clinical practice due to increased Pseudomonas aeruginosa resistance. The level of utilization and AMR in Pseudomonas aeruginosa is still high in Serbia compared to other European countries.

Agreement between children and parents when reporting anxiety and depressive symptoms in pediatric epilepsy.

The levels of agreement between self- and parent/proxy-reports of anxiety and depressive symptoms in pediatric epilepsy were evaluated. Data were drawn from 56 pairs of children with epilepsy and at least one parent. Anxiety symptoms were assessed using the Screen for Child Anxiety Related Emotional Disorders (SCARED), while depressive symptoms were assessed using the Mood and Feeling Questionnaire (MFQ). Moderate to substantial levels of agreement between raters when reporting various anxiety symptoms, such as panic/somatic disorder, generalized anxiety disorder, separation anxiety disorder, social phobia, and school phobia symptoms, were observed. Levels of agreement between raters were substantial when reporting depressive symptoms. However, levels of agreement differed if raw or criterion-referenced questionnaires' scores were used. In case of using raw questionnaire scores, substantial agreements appeared when reporting overall anxiety and depressive symptoms. On the other hand, moderate agreements appeared when reporting particular anxiety symptoms with raw questionnaire scores or when using criterion-referenced scores that indicate the presence of certain symptoms in a clinical range. Therefore, it is advisable to include both raters when assessing anxiety and depressive symptoms in pediatric epilepsy.

Validation of the osteoporosis quality of life questionnaire QUALEFFO-41 for the Serbian population.

BACKGROUND: Vertebral fractures could lead to reduced physical, social and mental functioning, and loss of personal independence. Therefore, during the treatment of osteoporosis, it has become necessary to examine the changes in everyday functioning, well-being and health related quality of life (HRQOL). To that effect, this study aims to translate, culturally adapt, and validate the Serbian version of Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) for patients with vertebral fractures. METHODS: Nine female patients with osteoporosis participated in the pre-validation study. A validation, case-control study included two groups of female patients: one that consisted of 50 female patients with osteoporosis, and with at least one vertebral fracture, and another one that consisted of 50 control patients with osteoporosis but without fractures. They completed the QUALEFFO-41 and the EuroQol group questionnaire with five dimensions (EQ-5D) twice within a month. The validation study examined internal consistency, concurrent validity, test-retest reliability, sensitivity and specificity. RESULTS: During the pre-validation study, three of the items in the QUALEFFO-41 were slightly changed. Afterwards, during the validation study, the statistically significant differences (adjusted for: age, duration of menopause, current employment and marital status) in the mean values of all domains and total scores between the groups were noted. For the case group, the internal consistency of the QUALEFFO-41 domains and of total questionnaire was above 0.70. The test-retest reliability was tested by the intraclass correlation coefficients (ICC) that were in range 0.87 - 0.96 for the case, and 0.15 - 0.83 for the control group. Correlations between the total scores of the QUALEFFO-41 and the EQ-5D health state value, for both groups were negative and statistically significant (r = -0.78, p<0.001 and r = -0.73, p<0.001, respectively). The QUALEFFO-41 had a better prediction of the value of HRQOL of cases compared to the generic questionnaire EQ-5D (the AUC difference was 0.099, p = 0.013). CONCLUSIONS: The Serbian QUALEFFO-41 version is reliable, valid, sensitive and predictive for examinations of HRQOL in patients with prevalent vertebral fractures and can be used in further studies.

Development of a shorter version of the osteoporosis knowledge assessment tool.

The aim of the authors of this study was to develop a short version of the Osteoporosis Knowledge Assessment Tool to be used for the target population of young adult Serbian females as an easily implemented add-on questionnaire. The 20-item Osteoporosis Knowledge Assessment Tool was translated and culturally adapted using the Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes Measures. The validation study was conducted on a sample of 250 female students studying at the Faculty of Pharmacy at the University of Belgrade, during a two-month period (November-December 2010). The difficulty index, item-total correlations, and internal consistency were calculated first. Afterward, confirmatory factor analysis was applied to test the structure of the Osteoporosis Knowledge Assessment Tool models and develop a short version. The mean total Osteoporosis Knowledge Assessment Tool score was 8.31 (possible range 0-20). The confirmatory factor analysis fit indices indicated poor fit of the data to the originally hypothesized structure. The confirmatory factor analysis fit indices, difficulty indices, and content validity allowed trimming of the original model and development of a short version with nine items. The average chi-square value for the Osteoporosis Knowledge Assessment Tool short version was 31.79 (p = 0.240, SE = 0.176) with Bollen-Stine bootstrap p = 0.249, Tucker-Lewis Index = 0.925, Comparative Fit Index = 0.944 and Root Mean Square Error of Approximation = 0.027. The Osteoporosis Knowledge Assessment Tool thus had acceptable characteristics and may be used for osteoporosis knowledge assessment.

Dietary Supplements Use among Serbian Undergraduate Students of Different Academic Fields.

The rising popularity of dietary supplements as a part of self-care practice increases interest in monitoring their usage in the general and specific population groups. This study investigated the prevalence and patterns of dietary supplement use among Belgrade University undergraduate students and its variations across different academic study fields. Of the 914 online survey students, 55.7% used dietary supplements during the past year. Female gender, eating behavior, and academic field were significant predictors of dietary supplement use. For all students, the most commonly used dietary supplements were vitamins and minerals, alone or in combination. Magnesium, vitamin C, and B vitamins were the most frequently supplemented micronutrients. The reasons for using, place of purchase, and source of information regarding dietary supplements significantly varied among students of different fields of study. Adverse effects related to dietary supplement use, including gastrointestinal symptoms, skin flushing, dizziness, and heart palpitation, were reported in 4.5% of students. Insufficient knowledge about these products was self-reported by 16.5% of users, more common among non-medical students. Thus, public health interventions are needed to improve students' knowledge regarding rational and safe dietary supplement use.

Developing a medication adherence technologies repository: proposed structure and protocol for an online real-time Delphi study.

INTRODUCTION: An online interactive repository of available medication adherence technologies may facilitate their selection and adoption by different stakeholders. Developing a repository is among the main objectives of the European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE) COST Action (CA19132). However, meeting the needs of diverse stakeholders requires careful consideration of the repository structure. METHODS AND ANALYSIS: A real-time online Delphi study by stakeholders from 39 countries with research, practice, policy, patient representation and technology development backgrounds will be conducted. Eleven ENABLE members from 9 European countries formed an interdisciplinary steering committee to develop the repository structure, prepare study protocol and perform it. Definitions of medication adherence technologies and their attributes were developed iteratively through literature review, discussions within the steering committee and ENABLE Action members, following ontology development recommendations. Three domains (product and provider information (D1), medication adherence descriptors (D2) and evaluation and implementation (D3)) branching in 13 attribute groups are proposed: product and provider information, target use scenarios, target health conditions, medication regimen, medication adherence management components, monitoring/measurement methods and targets, intervention modes of delivery, target behaviour determinants, behaviour change techniques, intervention providers, intervention settings, quality indicators and implementation indicators. Stakeholders will evaluate the proposed definition and attributes' relevance, clarity and completeness and have multiple opportunities to reconsider their evaluations based on aggregated feedback in real-time. Data collection will stop when the predetermined response rate will be achieved. We will quantify agreement and perform analyses of process indicators on the whole sample and per stakeholder group. ETHICS AND DISSEMINATION: Ethical approval for the COST ENABLE activities was granted by the Malaga Regional Research Ethics Committee. The Delphi protocol was considered compliant regarding data protection and security by the Data Protection Officer from University of Basel. Findings from the Delphi study will form the basis for the ENABLE repository structure and related activities.

Using an online nominal group technique to determine key implementation factors for COVID-19 vaccination programmes in community pharmacies.

Background One vital strategy to fight the COVID-19 pandemic is the rapid roll-out of vaccination programmes. In a number of countries pharmacists are joining the vaccination programme workforce, including plans to involve community pharmacies. Objectives (1) to determine key implementation factors for rapid roll-out of COVID-19 vaccination programmes in European community pharmacies and (2) to trial an online nominal group technique to generate ideas and reach consensus on the first aim. Setting In February 2021, during a workshop at the 12th Working Conference of the Pharmaceutical Care Network Europe. Method An online nominal group technique workshop over 10 hours was conducted. Identified implementation factors were mapped to the Framework for the Implementation of Services in Pharmacy and assessed in terms of importance and changeability. Main outcome measure Consensus of key implementation factors. Results In total, 85 implementation factors were identified. The top 3 factors were the same for both criteria: "(Regular) Staff training on correct vaccination procedure/to perform hands-on injection technique"; "Training in basic life support/first aid (Cardiopulmonary resuscitation)", and; "Definition of process, roles and responsibilities in the team". Conclusion An online nominal group technique enabled international collaboration to gather diverse perspectives on the implementation of COVID-19 vaccination programmes in a time and cost-efficient manner. "Staff training on correct vaccination procedure", "training in basic life support" and "definition of process, roles and responsibilities in the team" were deemed the most important and changeable implementation factors. Online nominal group technique may be a suitable method for other implementation problems.

Pharmacist's Perspectives on Administering a COVID-19 Vaccine in Community Pharmacies in Four Balkan Countries.

Community pharmacists expanded their roles and engaged in vaccination services in many countries around the world, but not in Balkan countries. This research aimed to assess the perceptions of pharmacists on involvement in the coronavirus disease (COVID-19) vaccine administration in four Balkan countries (Albania, Bulgaria, Romania, and Serbia). A cross-sectional survey was conducted using an online questionnaire that was distributed to community pharmacists across these countries between February and March 2021. A total of 636 community pharmacists were included in the analysis of the survey. The willingness to administer vaccines for COVID-19 (or other vaccines well established in the practice, like a flu vaccine) in community pharmacies is significantly different among the countries: the pharmacists from Albania were more willing to administer vaccines. The factors associated with the eagerness to vaccinate are almost the same among the countries: the lack of training in the faculty classes and the lack of a special place where to administer vaccines. Additional significant factors were found in Bulgaria (pharmacists from independent pharmacies wanted more than the pharmacists working in chain pharmacies to administer vaccines) and in Serbia (male pharmacists agreed more with administering vaccines than female pharmacists). Further national reforms are needed for adopting the expanding role of community pharmacists.

COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines' Side Effects.

BACKGROUND: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. METHODS: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses' side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. CONCLUSIONS: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.

Long-term effects of immunosuppressive therapy on lung function in scleroderma patients.

The study aims to analyze the effects of induction treatment with cyclophosphamide (CYC) pulse therapy followed by maintenance treatment with other mild immunosuppressive agents on lung function in scleroderma (SSc) patients. Thirty patients with SSc (mean age 52 years, mean disease duration < 2 years) with forced vital capacity (FVC) ≤ 80% and/or diffusing capacity of carbon monoxide (DLco) ≤ 70% were included. Monthly CYC pulses were given for 6 months (induction treatment), followed by 3-monthly maintenance pulses for the next 18 months, and during the next 5 years patients received other mild immunosupressive therapy brought by the competent rheumatologist. The efficacy was evaluated by comparing FVC% and DLco% after 6, 24, and 84 months from the baseline. All patients completed induction and maintenance treatment with CYC. Three patients were lost to follow-up. The rest of 27 patients, during the next 5 years, received other immunosupressive agents (14 azathioprine, 9 methotrexate, and 4 mycophenolate mofetil). Three patients died in the 4 years of follow-up. By 6, 24, and 84 months, the mean FVC and DLco changes were + 0.47 and + 2.10, + 3.30 and - 2.49, and + 1.53 and - 3.76%, respectively. These changes were not significantly different from the baseline values. CYC does not appear to result in clinically significant improvement of pulmonary function but fulfilled criteria of stable disease. Maintenance treatment with other mild immunosupressive agents preserves the benefits achieved during CYC treatment.