Managing cardiovascular risk factors in patients with chronic kidney disease: pharmacological and non-pharmacological interventions in the Copenhagen CKD Cohort.

Background: Although cardiovascular morbidity and mortality are substantial in patients with chronic kidney disease (CKD), guideline-directed treatment of cardiovascular risk factors remains a challenge. Methods: Observational, cross-sectional study including patients aged 30-75 years with CKD stage 1-5 without kidney replacement therapy from a tertiary hospital outpatient clinic. Data were obtained through patient interview, clinical examination, biochemical work-up, and evaluation of medical records and prescription redemptions. Guideline-directed treatment was evaluated as pharmacological interventions: antihypertensive and lipid-lowering therapy including adverse effects and adherence estimated as medication possession ratio (MPR); and non-pharmacological interventions: smoking status, alcohol consumption, body mass index (BMI), and physical activity. Results: The cohort comprised 741 patients, mean age 58 years, 61.4% male, 50.6% CKD stage 3, 61.0% office blood pressure ≤140/90 mmHg. Antihypertensives were prescribed to 87.0%, median number of medications 2 (IQR 1;3), 70.1% received renin-angiotensin system inhibition, 25.9% reported adverse effects. Non-adherence (MPR < 80%) was present in 23.4% and associated with elevated blood pressure (OR 1.53 (95% CI 1.03;2.27)) and increased urinary albumin excretion, P < 0.001. Lipid-lowering treatment was prescribed to 54.0% of eligible patients, 11.1% reported adverse effects, and 28.5% were non-adherent, which was associated with higher LDL cholesterol, P = 0.036. Overall, 19.2% were current smokers, 16.7% overconsumed alcohol according to Danish health authority recommendations 69.3% had BMI ≥ 25 kg/m2, and 38.3% were physically active <4 hours/week. Among patients prescribed antihypertensives, 51.9% reported having received advice on non-pharmacological interventions. Conclusions: Improved management of cardiovascular risk in patients with CKD entails intensified medical treatment and increased focus on patient adherence and non-pharmacological interventions.

Public's perspective on COVID-19 adenovirus vector vaccines after thrombosis with thrombocytopenia syndrome (TTS) reports and associated regulatory actions - A cross-sectional study in six EU member states.

OBJECTIVE: In 2021, thrombosis with thrombocytopenia syndrome (TTS) was confirmed by the European Medicines Agency (EMA) as a rare side effect of the COVID-19 adenovirus vector vaccines Vaxzevria® and Jcovden®. This study aimed to describe the public's knowledge of TTS and how it affected the willingness to be vaccinated with COVID-19 vaccines and other vaccines in six European countries. METHODS: From June to October of 2022, a multi-country cross-sectional online survey was conducted in Denmark, Greece, Latvia, Netherlands, Portugal, and Slovenia. The minimum target of participants to be recruited was based on the size of the country's population. The results were analysed descriptively. RESULTS: In total, 3794 respondents were included in the analysis; across the six countries, 33.3 %-68.3 % reported being familiar with signs and symptoms of TTS, although 3.1-61.4 % of those were able to identify the symptoms correctly. The reported changes in willingness to be vaccinated against COVID-19 and with other vaccines varied per country. The largest reported change in the willingness to be vaccinated with Vaxzevria® and Jcovden® was observed in Denmark (61.2 %), while the willingness to be vaccinated with other COVID-19 vaccines changed most in Slovenia (30.4 %). The smallest decrease in willingness towards future vaccination against COVID-19 was reported in the Netherlands (20.9 %) contrasting with the largest decrease observed in Latvia (69.1 %). CONCLUSION: Knowledge about TTS seemed to have influenced the public's opinion in Europe resulting in less willingness to be vaccinated with Vaxzevria® and Jcovden®. Willingness for vaccination against COVID-19 with other vaccines and widespread use of vaccines to prevent other diseases also differed and seemed to be determined by the approaches taken by national health authorities when reacting to and communicating about COVID-19 vaccination risks. Further investigation of optimal risk communication strategies is warranted.

The patients' perspective on multimorbidity and polypharmacy and how do we accommodate it in the healthcare system.

Patients living with multimorbidity, and polypharmacy can have difficulties handling the treatment burden they face daily. They often experience disjointed treatment courses and demand a more holistic approach to their multimorbidity and to be involved in decisions about their treatments. In the healthcare system, there are examples of new initiatives that go beyond the classic diagnostic silo thinking. However, this review finds that further development of new structures, approaches, and collaboration models in the healthcare system, as well as research, is still necessary to meet the needs of these patients.

Comparison of prioritisation algorithms for the selection of patients for medication reviews in the emergency department: a cross-sectional study.

BACKGROUND: Risk prioritisation algorithms provide patients with a risk category that guides pharmacists to choose those needing medication reviews (MRs) the most. For this study the Medicine Risk Score (MERIS) and a modified Assessment of Risk Tool (ART) were used. AIM: To examine how the selection of patients by the clinical pharmacists in an emergency department for MRs compared with the categorisation provided by MERIS and a modified version of ART (mART). Furthermore, examine the agreement between MERIS and mART. METHOD: A cross-sectional study was conducted using data on all admitted patients during a two-month period. Data were entered into the prioritisation algorithms and independently ranked by the six pharmacists who were observed as they selected patients for MR. Risk scores and categorisations were compared between the algorithms and the pharmacists' ranking using t-test, Z-test, Chi square, Kruskal Wallis H-test, or Kappa statistics. RESULTS: The study included 1133 patients. Significant differences were found between the pharmacists and the algorithms. The sensitivity and specificity of MERIS were 37.8% and 73.6%, for mART, 33.0% and 75.9%. Kappa was 0.58, showing moderate agreement. No significant differences were observed between the individual pharmacists' selection, but differences were significant between how pharmacists ranked the importance of the provided MRs. CONCLUSION: Pharmacists disagreed with the risk categorisation provided by MERIS and mART. However, MERIS and mART had similar sensitivity, specificity, and moderate agreement. Further research should focus on how clinical algorithms affect the selection of patients and on the importance of the MRs carried out by pharmacists.

The Awareness and Adherence of the Valproate Pregnancy Prevention Program: A Questionnaire Survey among Healthcare Professionals, Pharmacists, and Patients in Denmark.

BACKGROUND: The European Medicine Agency (EMA) provided additional recommendations regarding the use of valproate during pregnancy in 2018 by introducing a pregnancy prevention program (PPP). This study aimed to investigate the adherence and the impact of the PPP and the awareness of valproate teratogenicity among Danish healthcare professionals (HCPs) and patients. METHODS: As part of the EMA initiated multi-country survey, web-based questionnaires were distributed among Danish general practitioners (GPs), medical specialists, pharmacists, and patients. RESULTS: A total of 90 prescribers, 98 pharmacists, and 103 patients were included in the study. Some 95.0% of the prescribers, 78.6% of the pharmacists, and 81.6% of the patients were aware of the teratogenic risks of valproate. The patient guide (27.8%), the HCP guide (23.3%), direct healthcare professional communication (23.3%), and the warning sign on the outer medication package (23.5%) were the most applied measures from the PPP. A total of 54.4% of the prescribers and 32.7% of the pharmacists informed patients about the importance of effective contraception during the use of valproate. CONCLUSION: The study showed that in Denmark HCPs and patients are highly aware of the teratogenic effects of valproate. However, adherence to and the impact of the measures included in the PPP were low.

Prioritizing patients for medication review by emergency department pharmacists: a multi-method study.

BACKGROUND: Little is known about how pharmacists think and act in the situation when they need to prioritize patients without prioritization tools. AIM: To understand how Emergency Department (ED) pharmacists prioritize patients for medication review. METHOD: A multi-method study with pharmacists working in one ED in Denmark. At the start of the study, non-clinical prioritization rules had been implemented at the ED to ensure that medication histories were available quickly. Qualitative participant observations of all seven pharmacists who work at the ED were carried out. Semi-structured interviews with six of the pharmacists were held near in time to the observations. Observations for each pharmacists' patients were analysed inductively looking for patterns and themes. The interviews were audiotaped, transcribed verbatim and analysed inductively. RESULTS: The interviews shed light on the kinds of considerations pharmacists processed when prioritizing patients and how they used the ground rules (as set out in the PDSA process). The observations supplemented these data by showing some notable differences between pharmacists' prioritization procedures that linked to their clinical experience. The interviews highlighted the importance of collaboration with physicians and how pharmacists could be better integrated in the ward team. CONCLUSION: Although the ward-established rules increased efficiency, they were handled differently by the pharmacists according to experience, and were not deemed helpful in detecting the clinically meaningful ED patients. A prioritization tool and sitting near to the physicians at the ward would enable pharmacists to become further integrated into patient care and improve prioritization of patients for medication reviews.

Developing a pharmacist-led intervention to provide transitional pharmaceutical care for hospital discharged patients: A collaboration between hospital and community pharmacists.

Background: Patients who transfer from the hospital back to the community are at risk of experiencing problems related to their medications. Hospital pharmacists (HPs) and community pharmacists (CPs) may play an important role and provide transitional pharmaceutical care in transition of care interventions. Objective: To describe how a pharmacist-led intervention to provide transitional pharmaceutical care for hospital discharged patients was developed, utilizing already existing pharmacist interventions in the hospital and community pharmacy. Methods: A mixed-method approach to intervention development was applied. Existing evidence was identified through a literature review of effective transitional care interventions and existing services in the hospital and community pharmacy. Focus group interviews and a workshop were carried out with HPs and CPs to identify their perceived facilitators and uncertainties in relation to intervention development. The final intervention and the expected outcomes were developed in an expert group workshop. Finally, the hospital part of the intervention was tested in a small-scale feasibility study to assess what type of information the HP would transfer to the CP for follow up. Results: Five components were identified through the 209 systematic reviews: pharmacist-led medication reconciliation, pharmacist-led medication review, collaboration with general practitioners (GPs), post discharge pharmacist follow up and patient counseling or education. HPs and CPs identified uncertainties related to the relevance of the information sent from the HP to the CP, identification of patients at the community pharmacy and communication. The expected outcomes for the patients receiving the intervention were an experience of increased safety and satisfaction and less use of healthcare resources. The feasibility study led to optimization of language and structure of the pharmacist referrals that were used to transfer information from the HP to the CP. Conclusion: A patient centered intervention to provide transitional pharmaceutical care for hospital discharged patients was developed using existing evidence in transition of care, HPs and CPs, an expert group, and a small-scale feasibility study. A full-scale feasibility test of the intervention should be carried out for it to be further refined.

"Biosimilar, so it looks alike, but what does it mean?" A qualitative study of Danish patients' perceptions of biosimilars.

Biosimilars are highly similar follow-on products for biologics that can foster biologics competition. Questionnaire studies have attempted to gauge the patient perspective on biosimilars, but none have delved deeper into how patients view biologics and switching of these. Considering Denmark has one of the highest biosimilar uptakes worldwide, the aim of this study was to investigate how Danish patients with psoriasis, arthritic diseases or inflammatory bowel disease perceive biosimilars. Twelve participants were semi-structurally interviewed in either a focus group or an internet-based, individual interview between May 2019 and July 2019. Content analysis was inductively applied. Participants on originators voiced more reluctance towards using biosimilars than those already using them. Both participants using originator and biosimilar products expressed concerns about reoccurrence of disease symptoms due to differences in effectiveness and safety. Participants generally struggled with understanding biosimilarity, and they voiced a need to be well-informed about switching. They were all aware of and accepted how healthcare budget restrictions played a role in the push to use biosimilars. To improve biosimilar uptake and willingness to switch to a biosimilar, patient-centred information on efficacy and safety and explanation of the societal benefits of the savings from using biosimilars must be carefully communicated.

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.

Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution.

Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.

Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators.

BACKGROUND: A biosimilar is a biological medicine highly similar to another already approved biological medicine (reference product). The availability of biosimilars promotes competition and subsequently lower prices. Changing the current biosimilar clinical comparability trial requirements may lead to lower biosimilar development costs that potentially could increase patients' access to biologics. OBJECTIVE: The aim was to determine the perceptions of industry and medicines agency regulators regarding the value, necessity, and future developments of the European biosimilar clinical comparability trial requirements for establishing biosimilarity. METHODS: Semi-structured interviews were conducted with eight European national medicines agency regulators and 17 pharmaceutical company employees or consultants with experience in biologics between September 2018 and August 2019. Data were subjected to content analysis. RESULTS: In general, the participants expected that clinical comparability trial requirements will continue to be reduced, in particular based on advancements in analytical testing and knowledge generated from prior biosimilar approvals. However, there are also competing issues at play, such as competition, physician's trust, and ethical considerations. Participants also reported that any new initiative to reduce or waive biosimilar clinical requirements needs to be scientifically sound and could potentially lower biosimilar development costs. CONCLUSION: The main findings are that biosimilar clinical comparability trial requirements are likely to change in the near future. Clarity is needed on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamic studies, and the drugs' performance in the clinic, as well as how to continue sufficient immunogenicity assessment. Obtaining this clarity can facilitate regulatory assessment of the next biosimilars.

Community pharmacists' preparedness for substituting biologics and dispensing biosimilars - Lessons learned from a multinational survey.

Interchangeability between biological medicines and biosimilars, and subsequent substitution by pharmacists represent an important opportunity for costs savings for health care systems. Because biological medicines are complex products, the expert role of the pharmacist to inform patients and support physicians is indispensable. However, regulations on substitution of biosimilars differ around the globe, such that a substitution that is allowed in one country may be forbidden in another. Overall, pharmacists' knowledge of biosimilar medicines is incomplete and hesitancy to engage in substitutions is perceptible. As counter-balancing remedy, continued education about biosimilars is needed among practicing community pharmacists.

Translation and psychometric validation of a Danish version of the medication-related quality of life scale.

Background Generic and disease specific health-related quality of life scales have been found to be non-responsive to changes in medications in polypharmacy patients. The Taiwanese medication-related quality of life (MRQoL) scale aims to measure the effect of medication use on patients' quality of life. Objective To evaluate the psychometric properties of the Danish translation of MRQoL in a population of patients with polypharmacy. Setting Polypharmacy patients waiting for services at a community pharmacy or hospital in Denmark. Method The original MRQoL included 14 items. It was forward-translated into Danish and backward-translated into Chinese according to a modified translation protocol proposed by Sousa and Rojjanasrirrat et al. The translation was pre-tested, adjusted, and administered to polypharmacy patients. The factor structure was examined using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). Internal consistency reliability was evaluated, and criterion validity assessed using the beliefs about medicines questionnaire (BMQ) and SF-12v2. Known-group validity was carried out on age, number of medicines and setting. Main outcome measure Validity of the Danish version of the MRQoL-scale. Results 164 patients completed the questionnaire. EFA of all 14 items resulted in a two-factor structure, accounting for 72.8% of the total variance. The two factors were named "Energy/Concentration" (7 items) and "Feelings/Social" (7 items). Items correlating over 0.80 were removed leaving 11 items (Model 1). This model was further reduced to 8 items (Model 2) based on Cronbach's alpha. CFA confirmed the two-factor structure of both models. Model 2 fitted data without having to define covariations between error terms. Both factors showed high internal consistency reliability (Cronbachs' alpha 0.901-0.932). Ceiling effects were detected for both factors. Criterion validity was demonstrated via its significant correlations with SF-12vs2 subscales (Spearman's rho 0.340-0.353) and BMQ Concern (Spearman's rho - 0.451 to - 0.347). There was a statistically significant difference in relation to total scores of the MRQoL for age and number of drugs taken, indicating known-group validity. Conclusion The Danish translation of the MRQoL instrument showed measurement properties indicating a well-defined two-factor structure with high internal reliability, concurrent criterion validity, and known group validity. However, challenges remain with ceiling effects and efforts should be put into further development of the instrument.

Hospital and Community Pharmacists' Views of and Perspectives on the Establishment of an Intraprofessional Collaboration in the Transition of Care for Newly Discharged Patients.

BACKGROUND: Hospital and community pharmacists are increasingly involved in patients' medication interventions related to the transition of care from the hospital to a patient's home. These interventions may enable pharmacists to collaborate across healthcare sector boundaries. However, little is known about pharmacists' views on intraprofessional collaboration across healthcare sectors and what affects the establishment of such collaboration. OBJECTIVES: The aim of this study was to understand the views and perspectives of hospital pharmacists (HPs) and community pharmacists (CPs) on establishing an intraprofessional collaboration in relation to newly discharging patients. METHODS: Joint focus group interviews with HPs and CPs in the Zealand region of Denmark were conducted. The HPs were employed at the only hospital pharmacy in the region (Region Zealand Hospital Pharmacy). Five HPs and six CPs participated in two focus groups. The focus groups were analyzed using theoretical thematic analysis. RESULTS: Three themes and seven subthemes were identified. The first theme, "Context", was divided into two subthemes: "Prioritization of new tasks in the intraprofessional collaboration" and "The lack of insight into the patient's hospital stay". The second theme, "The hospital physicians and GPs as the focal points for the HPs' and CPs' work", was divided into three subthemes: "The limitation of the CPs and HPs based on current roles and organizations", "Lack of regular access to the physician gives the patients more responsibility" and "Lack of support from the GPs for the work conducted by HPs and CPs". The last theme, "Individuals", had two subthemes: "The motivation for working intraprofessionally" and "CPs' hesitancy towards the new tasks in the intraprofessional collaboration". CONCLUSION: Both HPs and CPs are highly influenced by their work context in regard to establishing a new intraprofessional collaboration. Limited resources for intraprofessional collaboration should be taken into account. Likewise, the collaboration should fit into daily routines, which may eliminate hesitancy towards new forms of collaboration and tasks shared between HPs and CPs. The physician was identified as an important key professional, since the work tasks of both HPs and CPs depend on the physician, which in turn limits the capability and success of solely intraprofessional collaboration.

Patients', Pharmacy Staff Members', and Pharmacy Researchers' Perceptions of Central Elements in Prescription Encounters at the Pharmacy Counter.

Background: Studies suggest that the way pharmacy counselling takes place does not fully support patients in obtaining optimal medicine use. To understand the basis of current challenges in pharmacy counselling, we investigated which selected related cues, i.e., objects, sounds, or circumstances in prescription encounters, patients, and pharmacy staff notice, and how they interpret these cues. Pharmacy practice researchers' cue orientation was also investigated to explore possible differences to those of staff and patients. Methods: Twelve focus group interviews representing 5 community pharmacies (staff and patients) and 2 universities (researchers) were conducted during 2017-2018 in Denmark. A total of 20 patients, 22 pharmacy staff, and 6 pharmacy researchers participated. A theoretical analysis based on cue orientation and social appraisal was conducted. Results: Pharmacy staff, patients and researchers noticed different selected related cues in prescription encounters. Staff particularly noticed 'types of patients'. Patients were more divided and grouped into three overall categories: 'types of staff', medical content, and the situation around the encounter. Pharmacy researchers noticed multiple cues. Different emotions were integrated in the construction of the cues. Conclusion: Differences in the cue orientation between all three groups were identified. The identified types of cues and emotions can explain an underlying dissatisfaction with the encounters. Patients lack, in particular, more personal contact. Staff need to consider these aspects to provide relevant counselling.

Frequency of undocumented medication discrepancies in discharge letters after hospitalization of older patients: a clinical record review study.

Transitions of care may result in medication errors, when information about a patient's medications is not communicated sufficiently. In this clinical record review study, we aimed to evaluate the frequency of undocumented medication discrepancies at discharge from hospital and evaluate which patient characteristics could be associated with undocumented medication discrepancies. Preadmission medication lists were compared against the medication list in the discharge letters, taking into account medication changes documented in the patient record throughout the inpatient stay and in the discharge summary. Out of 200 patients, 174 (87%) were affected by at least one undocumented medication discrepancy, mostly for regular medication. Of the 1972 medications used, 744 (38%) medications were changed without documentation in the patient record, the majority being over-the-counter supplements and herbal medications. Polypharmacy at admission and discharge was associated with increased undocumented medication discrepancies. This study indicates a lack of medication reconciliation during inpatient stay. Correct and complete medication lists at admission and discharge may resolve many of these discrepancies, supporting patient safety at transitions of care.