Effectiveness of pharmacist-led medication reconciliation on medication errors at hospital discharge and healthcare utilization in the next 30 days: a pragmatic clinical trial.

Transitions of care often lead to medication errors and unnecessary healthcare utilization. Medication reconciliation has been repeatedly shown to reduce this risk. However, the great majority of evidence is limited to the provision of medication reconciliation within clinical trials and countries with well-established clinical pharmacy. Thus, this pragmatic, prospective, controlled trial evaluated the effectiveness of routine pharmacist-led medication reconciliation compared to standard care on medication errors and unplanned healthcare utilization in adult general medical patients hospitalized in a teaching hospital in Slovenia. All patients hospitalized in a ward where medication reconciliation was integrated into routine clinical practice were included in the intervention group and received admission and discharge medication reconciliation, coupled with patient counselling. The control group consisted of randomly selected patients from the remaining medical wards. The primary study outcome was unplanned healthcare utilization within 30 days of discharge, and the secondary outcomes were clinically important medication errors at hospital discharge and serious unplanned healthcare utilization within 30 days of discharge. Overall, 414 patients (53.4% male, median 71 years) were included-225 in the intervention group and 189 in the control group. In the intervention group, the number of patients with clinically important medication errors at discharge was significantly lower (intervention vs control group: 9.3% vs 61.9%). Multiple logistic regression revealed that medication reconciliation reduced the likelihood of a clinically important medication error by 20-fold, while a higher number of medications on admission was associated with an increased likelihood. However, no significant differences were noted in any and serious unplanned healthcare utilization (intervention vs control group: 33.9% vs 27.8% and 20.3% vs 14.6%, respectively). The likelihood of serious healthcare utilization increased with the age of the patient, the number of medications on admission and being hospitalized for an acute medical condition. Our pragmatic trial confirmed that medication reconciliation, even when performed as part of routine clinical practice, led to a substantial reduction in the risk of clinically important medication errors at hospital discharge but not to a reduction in healthcare utilization. Medication reconciliation is a fundamental, albeit not sufficient, element to ensure patient safety after hospital discharge. Clinical Trial Registration: https://clinicaltrials.gov/search?id=NCT06207500, identifier NCT06207500.

Psychometric evaluation of the 5-item Medication Adherence Report Scale questionnaire in persons with multiple sclerosis.

The 5-item Medication Adherence Report Scale (MARS-5) is a reliable and valid questionnaire for evaluating adherence in patients with asthma, hypertension, and diabetes. Validity has not been determined in multiple sclerosis (MS). We aimed to establish criterion validity and reliability of the MARS-5 in persons with MS (PwMS). Our prospective study included PwMS on dimethyl fumarate (DMF). PwMS self-completed the MARS-5 on the same day before baseline and follow-up brain magnetic resonance imaging (MRI) 3 and 9 months after treatment initiation and were graded as highly and medium adherent upon the 24-cut-off score, established by receiver operator curve analysis. Health outcomes were represented by relapse occurrence from the 1st DMF dispense till follow-up brain MRI and radiological progression (new T2 MRI lesions and quantitative analysis) between baseline and follow-up MRI. Criterion validity was established by association with the Proportion of Days Covered (PDC), new T2 MRI lesions, and Beliefs in Medicines questionnaire (BMQ). The reliability evaluation included internal consistency and the test-retest method. We included 40 PwMS (age 37.6 ± 9.9 years, 75% women), 34 were treatment-naive. No relapses were seen during the follow-up period but quantitative MRI analysis showed new T2 lesions in 6 PwMS. The mean (SD) MARS-5 score was 23.1 (2.5), with 24 PwMS graded as highly adherent. The higher MARS-5 score was associated with higher PDC (b = 0.027, P<0.001, 95% CI: (0.0134-0.0403)) and lower medication concerns (b = -1.25, P<0.001, 95% CI: (-1.93-(-0,579)). Lower adherence was associated with increased number (P = 0.00148) and total volume of new T2 MRI lesions (P = 0.00149). The questionnaire showed acceptable internal consistency (Cronbach α = 0.72) and moderate test-retest reliability (r = 0.62, P < 0.0001, 95% CI: 0.33-0.79). The MARS-5 was found to be valid and reliable for estimating medication adherence and predicting medication concerns in persons with MS.

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.

Medication persistence among people with multiple sclerosis in Slovenia treated with dimethyl fumarate.

Objective: Multiple sclerosis is a chronic, demyelinating inflammatory disease of the central nervous system. Medication persistence is defined as an interval between the initiation and last dose of the applied medication and presents a useful surrogate marker of a stable disease course. This observational study aimed to evaluate medication persistence and discontinuation reasons in Slovenian people with multiple sclerosis treated with dimethyl fumarate.Methods: Our retrospective cohort study evaluated people with relapsing-remitting multiple sclerosis treated with dimethyl fumarate as an initial monotherapy or switched from injectable disease-modifying therapy medication between 2014 and 2021. Medication dispenses were extracted from the Slovenian National Institute of Public Health Outpatient Medication Database. The medication persistence criterion was based on the treatment gap. Patients exceeding a 60-day gap were considered nonpersistent. The median time to discontinuation was assessed using survival analyses. Considering discontinuation reasons, patients were further divided into safety and inefficacy groups. Due to the high probability of adverse effects, patients exceeding a 60-day gap were included in the safety group, but definite discontinuation reason remains unknown. The impact of covariates was evaluated by Cox regression.Results: A total of 269 patients were included (183 women, mean age 37 years). During the 7-year follow-up period, 123 (45.7%) patients discontinued treatment. The median time to discontinuation was 5.6 years. After 1, 2, and 5 years of treatment, 84%, 77%, and 57% of patients were found to be persistent, respectively. All patients older than 30 years (p = 0.0013) and among them, those in the inefficacy group (p = 0.037) were more likely to be persistent.Conclusions: The results of our study proved a high persistence rate among our patients. The most frequent discontinuation reason was gastrointestinal adverse effects. Medication persistence requires interventions in younger patients with an unstable disease course.

Medication adherence and health outcomes in persons with multiple sclerosis treated with dimethyl fumarate.

BACKGROUND: Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system that particularly affects people in their 30s. Oral disease-modifying therapy (DMT) offers a simple dosage form, good efficacy and safety. Dimethyl fumarate (DMF) is a frequently prescribed oral DMT medication worldwide. The aim of this study was to evaluate the impact of medication adherence on health outcomes in Slovenian persons with MS treated with DMF. METHODS: Our retrospective cohort study included persons with relapsing-remitting MS on DMF treatment. The medication adherence was evaluated by AdhereR software package using the proportion of days covered (PDC) measure. The threshold was set at 90%. Health outcomes after treatment initiation were represented by relapse occurrence, disability progression and occurrence of active (new T2 and T1/Gadolinium (Gd) enhancing) lesions between first two outpatient visits and first two brain magnetic resonance imaging (MRI), respectively. For each health outcome a separate multivariable regression model was built. RESULTS: The study included 164 patients. Their mean age (SD) was 36.7 (8.8) years, and the majority of patients were women (114 or 70%). Eighty-one patients were treatment naive. The mean (SD) PDC value was 0.942 (0.08) and 82% of patients were considered adherent above the 90% threshold. Older age (OR 1.06 per one year, P = 0.017, 95% CI (1.01-1.11)) and treatment naivety (OR 3.93, P = 0.004, 95% CI (1.64-10.4)) were related to higher adherence. In the 6-year follow-up period after DMF treatment initiation, 33 patients experienced a relapse. Among those, 19 required an emergency visit. Sixteen patients had a 1-point disability progression on the Expanded Disability Status Scale (EDSS) score between two consecutive outpatient visits. Thirty-seven patients were found to have active lesions between first and second brain MRI. Medication adherence showed no impact on relapse occurrence or disability progression. Lower medication adherence (10% lower PDC) was associated with higher occurrence of active lesions (OR 1.25, P=0.038, 95% CI: 1.01-1.56). Higher disability prior to DMF initiation was related to a higher risk for relapse occurrence and EDSS progression. CONCLUSION: Our study showed high medication adherence among Slovenian persons with relapse-remitting MS on DMF treatment. Higher adherence was associated with lower incidence of the radiological progression of MS. Interventions for improving medication adherence should be intended for younger patients with higher disability prior treatment with DMF and those switching from alternative DMTs.

Pharmacist-led clinical medication review service in primary care: the perspective of general practitioners.

BACKGROUND: An advanced level medication review service (CMR) is systematically reimbursed and available nationwide in Slovenian primary care since 2016. CMR is performed by clinical pharmacists (CP). Close collaboration with general practitioner (GP) is required as they perform patient selection and make clinical decisions regarding patient's medication. METHODS: A prospective observational study was conducted in 2018 aiming to evaluate the perspective of GPs on the implementation of pharmacist-led medication review service in Community Health Care Centre Ljubljana, Slovenia. GPs of the patients, who provided written informed consent were invited for the interviews. The semi-structured interview consisted of 5 open ended questions addressing reasons for referral of the patients, implementation of CP recommendations and the GPs' perspective of the service in general. Interviews were audio recorded with GPs written consent, transcribed verbatim and inductive content analysis was performed in NVivo11 Pro. RESULTS: In total 38 interviews with 24 GPs were performed. The emerged themes were nested under 3 main domains representing Donabedian model of quality healthcare - structure, process, outcomes. The service structure is built on broad pharmacotherapy knowledge as the main CP competency, good accessibility, and complementarity of healthcare professions. Patients are mainly referred to the CMR due to polypharmacotherapy, however in majority there is a more in-depth reason behind (e.g., adverse events, etc.). Lack of time to recognize eligible patients and additional workload to study and implement the recommendations present the major challenges in the service process and therefore low number of referrals. CPs recommendations are mostly accepted, although the implementation time varies. When recommendation addresses medicines prescribed by a clinical specialist, the CMR report is forwarded to them for decision regarding implementation. The empowerment of the patients in medicines use was emphasized as the major benefit of the CMR, which consequently supports and enhances the quality of GP's patient care. Transferability of recommendations to similar cases and high satisfaction with the service of GPs and patients, were mentioned. CONCLUSION: GPs experiences with CMR are encouraging and supportive and present a base for further growth of the service.

Risk of lower extremity amputations in patients with type 2 diabetes using sodium-glucose co-transporter 2 inhibitors.

AIMS: To compare the influence of sodium-glucose co-transporter 2 inhibitors (SGLT2i) and dipeptidyl peptidase-4 inhibitors (DPP-4i) on the risk of lower extremity amputations in patients with type 2 diabetes in Slovenia. METHODS: This retrospective cohort study included patients aged 40 years or more who were administered a newly introduced SGLT2i or DPP-4i between June 2014 and June 2018. Patients treated with insulin at baseline and patients with a history of amputation were excluded. Patients were matched in a 1:1 ratio using propensity score matching. Survival analysis was performed; hazard ratio (HR) and ratios of cumulative hazards at 1, 2, 3, and 4 years were estimated. On-treatment and intention-to-treat approaches were used. RESULTS: The study cohort (mean age: 64 years) consisted of 2,939 new users of SGLT2i (empagliflozin, 59%; dapagliflozin, 41%) matched to 2,939 new users of DPP-4i. In the on-treatment analysis (median follow-up of 2 years), the incidence of amputations was higher in SGLT2i than in DPP-4i users (4.2 vs. 2.7 per 1,000 patient years), resulting in a HR of 1.58 (95% CI 0.85-2.92; p = 0.145). An intention-to-treat analysis yielded to similar HR of 1.86 (95% CI: 1.10-3.14; p = 0.020). There was no difference in amputation rates in the first two years, but SGLT2i users had a 2.81-fold higher (95% CI: 1.63-4.84; p = 0.007) cumulative hazard of amputation at 4 years than did DPP-4i users. CONCLUSIONS: Compared with DPP-4i use, SGLT2i use did not result in a statistically significant higher overall risk of lower extremity amputations. However, the results suggest that SGLT2i may increase the risk of amputation with long-term use.

Initiation of insulin therapy in patients with type 2 diabetes: An observational study.

The aim of the study was to assess the initiation of insulin therapy in patients with type 2 diabetes using health claims data on prescription medicines. The study evaluated time to insulin initiation and prescribing patterns of other anti-diabetic medicines before and after insulin initiation. Five years after starting non-insulin antidiabetic therapy, 6.4 % of patients were prescribed insulin, which is substantially lower compared to other similar studies. Among all patients who initiated insulin therapy in 2013, 30 % did not continue any other antidiabetic therapy. However, this proportion was lowered to 20 % in 2018. Before insulin initiation in 2018, metformin was prescribed in only 67 % of patients and sulfonylureas in 78 % of patients. Moreover, metformin and sulfonylureas were discontinued after insulin initiation in 26 and 37 % of patients, resp. More attention should be paid to the continuation of oral anti-diabetics, particularly metformin, after insulin initiation.

Cardiovascular morbidity and mortality in patients with type 2 diabetes using novel antidiabetic medicines as add-on therapy: an observational real-world study.

OBJECTIVE: To evaluate the effect of sodium-glucose co-transporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA), compared with dipeptidyl peptidase-4 inhibitors (DPP-4i) as add-on therapy on cardiovascular (CV) morbidity and mortality in patients with type 2 diabetes (T2D). DESIGN AND SETTING: A nationwide cohort study using three linked healthcare databases from Slovenia (outpatient prescription claims data, hospitalisation claims data and death registry data). PARTICIPANTS: Patients with T2D with newly introduced DPP-4i (n=3817), GLP-1RA (n=855) or SGLT2i (n=2851) add-on therapy between June 2014 and June 2018. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was a major adverse CV event (MACE), while the secondary outcomes were CV death and heart failure (HF). The effects of the antidiabetic medicine group on the risk of each outcome were estimated with Cox proportional hazards regression. Intention-to-treat and on-treatment approaches were used. RESULTS: In the intention-to-treat analysis, SGLT2i as add-on therapy, when compared with DPP-4i, was associated with lower risk of MACE (HR=0.66; 95% CI 0.50 to 0.85; p=0.002) and CV death (HR=0.46; 95% CI 0.30 to 0.73; p=0.001). On-treatment analysis revealed lower HF risk in patients initiating SGLT2i (HR=0.54; 95% CI 0.30 to 0.99; p=0.047). In the intention-to-treat analysis, GLP-1RA add-on therapy was associated with a lower MACE risk when compared with DPP-4i (HR=0.64; 95% CI 0.43 to 0.97; p=0.034), but it had a non-significant effect on CV death (HR=0.62; 95% CI 0.34 to 1.14; p=0.128) and HF (HR=1.39; 95% CI 0.88 to 2.21; p=0.157). The results of on-treatment analyses were in agreement with the results of intention-to-treat analyses. CONCLUSIONS: SGLT2i and GLP-1RA improved CV morbidity and mortality in patients with T2D when compared with DPP-4i as an add-on therapy. The results of this study may serve as a basis for the selection of an optimal add-on antidiabetic medicine to reduce CV morbidity and mortality in patients with T2D in clinical practice. TRIAL REGISTRATION NUMBER: EUPAS32558.

Prevalence and Incidence of Frailty Among Community-dwelling Older Adults in Slovenia.

INTRODUCTION: Frailty is recognized as one of the most important global health challenges as the population is aging. The aim of this study was to evaluate prevalence and incidence of frailty, and associated factors, among the population of older adults in Slovenia compared to other European countries. METHODS: The prevalence and 4-year incidence of frailty among older adults (≥65 years) were evaluated using data from the Survey of Health, Ageing and Retirement in Europe (SHARE). Frailty was defined by the SHARE operationalization of Frailty phenotype. Multiple logistic regression model was used to explore factors associated with frailty. RESULTS: Age-standardized prevalence (95% CI) of frailty and pre-frailty in Slovenia were 14.9% (13.3-16.5) and 42.5% (39.8-45.2), respectively. Factors (OR, 95% CI) associated with increased frailty in Slovenia included age (7584 years: 5.03 (3.08-8.22); ≥85 years 21.7 (10.6-44.7) vs. 65-74 years), self-rated health (fair: 4.58 (2.75-7.61), poor: 54.6 (28.1-105.9) vs. excellent/very good/good), number of chronic diseases (1.20 (1.03-1.40)), and polypharmacy (yes: 3.25 (1.93-5.48) vs. no). Female gender and lower education were significantly associated with pre-frailty, but not frailty, in the adjusted model. Independently of these characteristics, age-standardized prevalence of frailty varied among geographical regions. Age-standardized 4-year incidence of frailty and pre-frailty in Slovenia were 6.6% (3.0-10.1) and 40.2% (32.7-47.6), respectively. CONCLUSION: Among the Slovenian population of older adults aged 65 years and older, the age-standardized prevalence of frailty is 15% and 4-year incidence of frailty is 7%. Regional differences in Slovenia show the lowest prevalence in central Slovenian regions and the highest in northeastern Slovenian regions.

Uptake of new antidiabetic medicines in 11 European countries.

BACKGROUND: Several new antidiabetic medicines (GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors) have been approved by the European Medicines Agency since 2006. The aim of this study was to evaluate the uptake of new antidiabetic medicines in European countries over a 10-year period. METHODS: The study used IQVIA quarterly value and volume sales data January 2006-December 2016. The market uptake of new antidiabetic medicines together with intensity of prescribing policy for all antidiabetic medicines were estimated for Austria, Croatia, France, Germany, Hungary, Italy, Poland, Slovenia, Spain, Sweden, and the United Kingdom. The following measures were determined: number of available new active substances, median time to first continuous use, volume market share, and annual therapy cost. RESULTS: All countries had at least one new antidiabetic medicine in continuous use and an increase in intensity of prescribing policy for all antidiabetic medicines was observed. A tenfold difference in median time to first continuous use (3-30 months) was found. The annual therapy cost in 2016 of new antidiabetic medicines ranged from EUR 363 to EUR 769. Among new antidiabetic medicines, the market share of DPP-4 inhibitors was the highest. Countries with a higher volume market share of incretin-based medicines (Spain, France, Austria, and Germany) in 2011 had a lower increase in intensity of prescribing policy. This kind of correlation was not found in the case of SGLT-2 inhibitors. CONCLUSIONS: This study found important differences and variability in the uptake of new antidiabetic medicines in the included countries.

Improved adherence with Medicines Use Review service in Slovenia: a randomized controlled trial.

BACKGROUND: Based on several existing patient-oriented activities, Medicines Use Review (MUR) service was standardized and officially adopted in Slovenia in 2015. Service aims to provide adherence support and ensure safe and effective medicines use. Therefore, the aim of the study was to evaluate the benefits of MUR in Slovenia, primarily the impact on medication adherence. METHODS: A randomised controlled trial was performed in community pharmacies to compare MUR with standard care. Patients were randomised into either the test (patients received MUR by a certified MUR provider at visit 1), or control group. The study primary outcome was self-reported adherence to multiple medications, assessed by electronic ©Morisky Widget MMAS-8 Software at the first visit (V1) and after 12 weeks (V2). A sub-analysis of intentional and unintentional non-adherence was performed. MUR impact was defined as the relative difference in ©MMAS-8 score after 12 weeks between the test and control group. A multiple linear regression model was used to predict MUR impact based on baseline adherence (low versus medium and high). Several secondary outcomes (e.g. evaluation of drug-related problems (DRPs)) were also assessed. RESULTS: Data from 153 (V1) and 140 (V2) patients were analysed. Baseline adherence was low, moderate and high in 17.6, 48.4 and 34.0% patients, respectively. In the low adherence subpopulation, test group patients showed a 1.20 point (95% CI = 0.16-2.25) increase in total ©MMAS-8 score (p = 0.025) compared to control group patients. A 0.84 point (95% CI = 0.05-1.63) increase was due to intentional non-adherence (p = 0.038), and a 0.36 point (95% CI = - 0.23-0.95) was due to unintentional non-adherence (p = 0.226). Additionally, statistically significant decrease in the proportion of patients with manifested DRPs (p < 0.001) and concerns regarding chronic medicines use (p = 0.029) were revealed. CONCLUSION: MUR service in Slovenia improves low medication adherence and is effective in addressing DRPs and concerns regarding chronic medicines use. TRIAL REGISTRATION: ClinicalTrials.gov - NCT04417400 ; 4th June 2020; retrospectively registered.

The association between medication or alcohol use and the incidence of frailty: a retrospective cohort study.

BACKGROUND: Understanding potentially modifiable factors that influence the risk of frailty is a key concern for the management of this urgent contemporary public health challenge. This study evaluates the association between the use of various medications or alcohol and the incidence of frailty among older adults. METHODS: This study was a retrospective cohort study on older adults (≥ 65 years) using data from the longitudinal Survey of Health, Ageing and Retirement in Europe (SHARE survey, 28 countries). Medication use was measured as taking several different groups of medications. Alcohol use was assessed with SHARE questions corresponding to AUDIT-C. The outcome measure was the incidence of frailty after two years, defined by frailty index (FI) and frailty phenotype (FP). A multiple logistic regression model was used to evaluate the association with adjustment for several potential confounding factors. RESULTS: Of the 14,665 FI-population participants, 1800 (12.3%) developed frailty within two years. Of the 8133 FP-population participants, 2798 (34.4%) developed pre-frailty and 247 (3.0%) developed frailty within two years of baseline. After adjustment for potential confounding variables, non-hazardous alcohol use (adjusted OR; 95% CI for the FI-population: 0.68; 0.60-0.77) and hazardous alcohol use (0.80; 0.68-0.93) are associated with lower incidence of frailty compared to no alcohol use. The odds of frailty are increased when taking medications; the largest effect size was observed in older adults taking medication for chronic bronchitis (adjusted OR; 95% CI for the FI-population: 2.45; 1.87-3.22), joint pain and other pain medication (2.26; 2.00-2.54), medication for coronary and other heart disease (1.72; 1.52-1.96), medication for diabetes (1.69; 1.46-1.96), and medication for anxiety, depression and sleep problems (1.56; 1.33-1.84). Additionally, the risk of frailty was increased with stroke, Parkinson's disease and dementia. CONCLUSIONS: Taking certain groups of medication was associated with increased incidence of frailty and pre-frailty, which might be due to either medication use or the underlying disease. Alcohol use was associated with a lower risk of pre-frailty and frailty compared to no alcohol use, which might be due to reverse causality or residual confounding. There was no significant interaction effect between medication groups and alcohol use on frailty incidence.

Development, validation and performance of a newly designed tool to evaluate functional medication literacy in Slovenia.

Background Medication literacy refers to the ability of individuals to safely and appropriately access, understand and act on basic medication information. It is vital for correctly and safely using medications. General health literacy measures do not adequately address specific skills for medication literacy, and there are no general, self-administered, performance-based instruments for assessing patients' medication literacy. Objective The aim was to develop and validate a self-administered performance-based questionnaire measuring functional medication literacy and to evaluate functional medication literacy among the Slovenian general population. Setting A random sample of adult Slovenian residents received the questionnaires at their home addresses. Method The initial content was derived from medication counselling literature. Thirteen patients and 14 healthcare professionals provided feedback about its comprehensibility, comprehensiveness, and difficulty thus supporting content and face validity. The developed questionnaire, comprising 30 items divided into 5 categories (dosage, adverse effects, interactions, precautions, and other information), was sent to a random sample of 1500 adult Slovenian residents. The overall validity of the questionnaire was assessed via reliability, criterion and discriminant validity using the Kuder-Richardson Formula 20, multiple linear regression and Mann-Whitney test. Descriptive statistics were used to evaluate medication literacy. Main outcome measure The psychometric properties of the questionnaire (reliability, content, face, criterion, and discriminant validity); level of functional medication literacy. Results A total of 402 residents returned eligible questionnaires (26.8% response rate). The Kuder-Richardson Formula 20 reliability coefficient for the whole questionnaire was 0.823. One item that did not demonstrate discriminant validity was deleted. Criterion validity was supported by a significant association between age and medication literacy (ß = - 0.303). Income (ß = 0.243) and current self-perceived health (ß = 0.187) also were associated with medication literacy. The median of medication literacy score was 24 out of 29 points. Dosage-related items requiring understanding of long text instructions and the use of numeracy skills received the most incorrect answers. Conclusion A performance-based questionnaire measuring functional medication literacy among a general population with supported validity was developed. Slovenian residents encountered difficulties when dealing with items requiring prose literacy and numeracy skills, especially related to dosing. Special attention should be paid to low-income elderly with poor self-perceived health.

Anticholinergic Burden in Children, Adults and Older Adults in Slovenia: A Nationwide Database Study.

Anticholinergic burden has been widely studied in specific patient populations with specific conditions. However, the prevalence in the general population is poorly understood. This retrospective cross-sectional study was a nationwide database analysis of outpatient prescriptions of anticholinergic medications. The study was based on Slovenian health claims data of all outpatient prescriptions in 2018. Anticholinergic burden was evaluated using the Anticholinergic Cognitive Burden scale. Three age groups were analysed: children (≤18 years), adults (19-64 years) and older adults (≥65 years). Anticholinergic medications were prescribed to 29.8% of the participants; 7.6% were exposed to a clinically significant anticholinergic burden. The proportion of patients exposed to anticholinergic burden was highest in older adults (43.2%), followed by adults (25.8%) and children (20.7%). The most frequently prescribed medications with the highest anticholinergic activity were antipsychotics and medications for urinary diseases (42.8% and 40.2%, respectively). Medications with second highest activity were mostly antiepileptics (87.3%). Medications with possible anticholinergic activity included diverse therapeutic groups. Anticholinergic burden is highest in older adults but is also considerable among adults and children. Medications with anticholinergic activity belong to diverse therapeutic groups. Further research is needed on safe use of these medications in all age groups.

A survey to assess the availability, implementation rate and remuneration of pharmacist-led cognitive services throughout Europe.

BACKGROUND: Pharmacist-led cognitive services (PLCS) are increasingly necessary in primary care as a response to patient-centered care. However, the implementation rate and remuneration models of PLCS are either absent or superficially described in the literature. OBJECTIVE: The aim of this study is to review the implementation of PLCS in primary care across Europe and explore the associated third-party paid remuneration models. METHODS: A cross-sectional study was conducted using an online survey sent to representatives of 44 European countries. The survey listed 21 PLCS and asked respondents to report the availability of the service, the rate of implementation and the existence of remuneration. To ensure credible data, data triangulation was sought using three representatives per country, representing backgrounds of community pharmacy, pharmacy practice research and health policy. Subsequently, data was validated, and consensus sought. RESULTS: Data were collected between November 2016 and October 2017 from 34 different countries across Europe (79%). Provision of medicines' information (94.1%), generic substitution (85.3%), provision of emergency oral contraception (70.6%) and point-of-care testing (67.7%) were the services reported as the most widely disseminated in European primary care. Medication review was the most disseminated among advanced services (55.9%). Medication review, adherence support and monitoring, prescription renewal, opioid substitution and travel medicine had the highest implementation rates reported. Half of the participating countries mentioned models of remuneration, predominantly based on a fee-for-service, with less frequent reports of pay-for-performance or mixed models of remuneration. CONCLUSIONS: The availability of PLCS is increasing and varying in scope across Europe. There is wide variation in the implementation level of services across Europe and a lack of valid data. Remuneration of PLCS is also spreading but no clear pattern was found that relates service provision to payment.

Inhalation technique and asthma outcomes with different corticosteroid-containing inhaler devices.

Objective: Inhaler devices must be used correctly to ensure the effectiveness of the asthma treatment. This study evaluated inhalation technique across different types of corticosteroid-containing inhaler devices as well as health outcomes in patients with asthma. Methods: In a cross-sectional study, we evaluated inhaler technique by observing patients' handling of the inhaler devices and using checklists for four inhaler types, namely Diskus (n = 52), pressure metered dose inhalers (pMDIs; n = 41), Turbuhaler (n = 36) and Twisthaler (n = 16). We also collected data on patients' characteristics, asthma therapy, exacerbations, medication adherence (8-item Morisky Medication Adherence Scale), asthma control (Asthma Control Test) and quality of life (Saint George Respiratory Questionnaire). Results: In total, we included 145 patients. The mean (SD) age of the patients was 54.5 (18.9) years and 57% were female. The majority of the patients (70%) made at least one error in their inhalation technique. Patients using Turbuhaler performed the highest number of elements correctly, followed by pMDIs, Twisthaler and Diskus. Patients with Diskus or Twisthaler had better adherence compared with patients using pMDIs or Turbuhaler. Patients using Twisthaler had better asthma outcomes than patients using the other device types. Conclusions: Most patients with asthma made mistakes when handling their inhaler devices, especially those using Diskus. However, in addition to the device type being used, patients' characteristics, asthma therapy and medication adherence also played an important role in achieving good health outcomes.

Community pharmacist-led medication review procedures across Europe: Characterization, implementation and remuneration.

BACKGROUND: Pharmaceutical Care Network Europe (PCNE) proposed a definition and classification system (type 1, 2a, 2b, 3) for medication review in 2016. However, to date, a description of the implementation and remuneration of such procedures across Europe is lacking. OBJECTIVE: The aim of this study was to describe the medication review procedures and the level of implementation and remuneration in community pharmacies across Europe. METHODS: An online survey was developed to characterize medication review procedures (PCNE classification), level of implementation (considering regional or national) and remuneration by a third party. This survey was sent to a purposive sample of three individuals per country, with a working background in community pharmacy, pharmacy practice research, or health policy to ensure reliable data. Data triangulation was used and consensus sought between the responses. RESULTS: Data were received from 34 out of 44 targeted European countries (November 2016-October 2017) [response rate = 77%]. Overall, 55.9% of the countries provided at least one type of medication review as an implemented service or project. Type 1 medication review (based on the medication history) was provided in 13 countries, type 2a (medication history + patient interview) in 14, type 2b (medication history + clinical data) in two, and type 3 medication review (medication history + patient interview + clinical data) in four countries. Ten of the mentioned services or projects were remunerated by a third-party. CONCLUSION: Substantial heterogeneity was observed across Europe in various aspects, including the procedures, implementation level and remuneration obtained. Type 1 and 2a medication review services seem to be more feasible to implement in the community pharmacy than type 2b and 3. A large number of medication review projects were ongoing in community pharmacies, which suggests that new medication review services could become implemented in the coming years.

Pharmacy-supported interventions at transitions of care: an umbrella review.

Background Medication discrepancies arising at care transitions are prevalent and are linked with adverse drug events and increased healthcare utilization. Evidence is lacking about which pharmacy-supported interventions at care transitions are most effective for both the patient and the healthcare system. Aim of the review To invesitigate the content and effect of pharmacy-supported interventions at transitions of care. Method The PubMed, Ovid/Medline and Cochrane Database of Systematic Reviews databases were used. The search was limited to systematic reviews and meta-analyses published in English up to May 2018. Included reviews investigated any intervention related to medication therapy performed by pharmacists or multiple healthcare professionals, including a pharmacist, at transition points in any healthcare setting. Reviews were excluded if interventions were not clearly defined or were not performed at care transitions or were not related to medications. A quality assessment was performed using the PRISMA guidelines. The data extracted included general characteristics, methodology, point of transition, pharmacy-supported interventions and outcomes. For systematic reviews, narrative conclusions were extracted. For meta analyses, reported relative risks or odds ratios were extracted along with the 95% confidence intervals. Results Nine systematic reviews and 5 meta-analyses reporting 162 studies were included. The interventions analysed included medication reconciliation (7 reviews) and composite interventions (7 reviews). Six studies reviewed interventions performed by pharmacists alone, while 8 studies explored interventions by different healthcare professionals, including a pharmacist. A positive effect on either medication discrepancies or (potential) ADEs was observed in all reviews. Mixed effects were observed for hospitalizations rates (9 reviews) and costs (4 reviews), regardless of the intervention applied. Mixed effects were also observed for both medication reconciliation and composite interventions on the number of emergency department visit. Interventions showed no significant effect on mortality (4 reviews). The quality of the reviews showed significant variability. Conclusion Pharmacy-supported interventions at transitions of care are heterogeneous and potentially improve medication safety, but show no significant effect on mortality. The effect on healthcare utilization and costs is inconclusive.

Review of studies reporting actual prices for medicines.

BACKGROUND: Medicine purchasing and pricing decisions usually rely on officially published prices. Literature has reported evaluations of publicly stated prices. However, due to the frequent use of confidential price arrangements there are indications for paucity of data on actual medicine prices. Therefore, the study aimed to systematically review literature with regard to availability of information on actual medicine prices. AREAS COVERED: The Medline database was searched systematically to identify studies addressing actually paid prices of medicines used in-patient or out-patient care from the health care payer, health provider, or patient perspective, published during 2007-2017. A total of 33 observational studies were included in the analysis. EXPERT COMMENTARY: The review confirmed the paucity of studies on actual medicine prices, with only few studies evaluating differences between official and actually paid prices. The included studies are heterogeneous and differ in their design and focus. Non-availability of actual price data in several non-European countries results from lack of price regulation, which usually coincides with variation in actual prices for the same medicines between different dispensaries. In high-income, mostly European countries, transparency of actual prices is limited due to increased use of confidential medicine price arrangements.