Warfarin therapy can significantly affect patients' quality of life and cause therapy discontinuation. This study aimed to investigate the effect of the pharmacists' interventions on the ...health-related quality of life (HRQoL) in older rural patients on warfarin therapy. Eligible older patients from rural area of Croatian province Slavonia were randomized into the intervention and control groups and followed for six months. Repeated education and a follow-up plan were provided to the participants in the intervention group, and if needed, the pharmacist intervened to optimize warfarin therapy. Secondary analysis on HRQoL data are presented here. Main outcome measure was Duke anticoagulation satisfactions scale questionnaire score. In total, 131 participants finished the study (median age 73 years; 51.1% male). Participants in the intervention group scored significantly lower (median being 86.5 and 66.0 in the control and intervention groups, respectively; p < 0,001), indicating higher HRQoL. Adverse drug reactions and pharmacist's intervention were identified as predictive factors for patients' HRQoL (r
= 65.5%, P < 0.001). The study demonstrated that community pharmacist's interventions can improve HRQoL of older patients taking warfarin what is of particular significance for patients living in rural areas with less accessible healthcare and lower socio-economic status.Clinicaltrials.gov (ID: NCT03212898), 11/07/2017, retrospectively registered.
Objective
To understand primary care physicians’ perspectives on academic detailing from an antimicrobial stewardship team to combat antibiotic overuse for upper respiratory infections and bronchitis ...in the COVID-19 era, which will help prevent avoidable outpatient visits.
Methods
In this prospective study, 14 female Croatian physicians completed standardized qualitative interviews using a semi-structured guide. The data were analyzed using inductive methodology based on reflexive thematic analysis. We used a theoretically informed approach based on a conceptual framework of healthcare intervention implementability focused on three domains: acceptability, fidelity, and feasibility.
Results
We identified six key themes highlighting barriers to changing prescribing practices, with patient pressure and specialist recommendations having an impact on the effectiveness of academic detailing. Despite challenges, primary care physicians described appreciation of direct interaction with evidence-based practices and reported usefulness, effectiveness, and further need for academic detailing.
Conclusion
This study highlights the complex dynamics involved in implementing healthcare interventions and provides valuable insights for enhancing strategies directed at improving antibiotic prescribing practices. Specifically, our findings emphasize factors influencing behavior changes in physicians’ antibiotic prescribing. The authors advocate for a collaborative approach involving community and hospital-based professionals to provide tailored guidance and address questions, ultimately improving prescribing practices.
Abstract
Background
It is known that drug shortages represent a major challenge for all stakeholders involved in the process, but there is little evidence regarding insights into patients′ awareness ...and perspectives. This study aimed to investigate the patients-perceived drug shortages experience and their view on outcomes in different European hospital settings. Furthermore, we wanted to explore information preferences on drug shortages.
Methods
A retrospective, cross sectional, a mixed method study was conducted in six European hospital settings. One hospital (H) from each of this country agreed to participate: Bosnia and Herzegovina (H-BiH), Croatia (H-CR), Germany (H-GE), Greece (H-GR), Serbia (H-SE) and Poland (H-PO). Recruitment and data collection was conducted over 27 months from November 2017 until January 2020. Overall, we surveyed 607 patients which completed paper-based questionnaire. Questions related to: general information (demographic data), basic knowledge on drug shortages, drug shortages experienced during hospitalization and information preferences on drug shortage. Differences between hospital settings were analyzed using Chi-squared test or Fisher’s exact test. For more complex contingency tables, Monte Carlo simulations (N = 2000) were applied for Fisher’s test. Post-hoc hospital-wise analyses were performed using Fisher’s exact tests. False discovery rate was controlled using the Bonferroni method. Analyses were performed using R: a language and environment for statistical computing (v 3.6.3).
Results
6 % of patients reported experiences with drug shortages while hospitalized which led to a deterioration of their health. The majority of affected patients were hospitalized at hematology and/or oncology wards in H-BiH, H-PO and H-GE. H-BiH had the highest number of affected patients (18.1 %, N = 19/105,
p
< 0.001) while the fewest patients were in H-SE (1 %,
N
= 1/100,
p
= 0.001). In addition, 82.5 %, (
N
= 501/607) of respondents wanted to be informed of alternative treatment options if there was a drug shortage without a generic substitute available. Majority of these patients (66.4 %, N = 386/501) prefer to be informed by a healthcare professional.
Conclusions
Although drug shortages led to serious medical consequences, our findings show that most of the patients did not perceive shortages as a problem. One possible interpretation is that good hospital management practices by healthcare professionals helped to mitigate the perceived impact of shortages. Our study highlights the importance of a good communication especially between patients and healthcare professionals in whom our patients have the greatest trust.
Celotno besedilo
Dostopno za:
CEKLJ, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background
Respiratory syncytial virus (RSV) is one of the most important viral pathogens causing acute respiratory infections, resulting in about 3.4 million hospitalisations annually in children ...under five. Palivizumab is the only product approved for prevention of serious RSV disease, as motavizumab is no longer being developed for this condition. The efficacy and safety of palivizumab has been evaluated in randomized controlled trials (RCTs) and a large number of economic evaluations (EEs) have tested its cost‐effectiveness.
Objectives
To assess the effectiveness and safety of palivizumab prophylaxis in reducing the risk of complications (hospitalization due to RSV infection) in high‐risk infants and children. To assess the cost‐effectiveness (or cost‐utility) of palivizumab prophylaxis in infants and children in different risk groups.
Search methods
We searched CENTRAL (2012, Issue 7), MEDLINE (1996 to July week 4, 2012), EMBASE (1996 to August 2012), CINAHL (1996 to August 2012) and LILACS (1996 to August 2012) for RCTs. We searched the NHS Economic Evaluations Database (NHS EED 2012, Issue 4), Health Economics Evaluations Database (HEED, 9 August 2012), Paediatric Economic Database Evaluations (PEDE, 1980 to 2009), MEDLINE (1996 to July week 4, 2012) and EMBASE (1996 to August 2012) for EEs.
Selection criteria
We included RCTs comparing palivizumab prophylaxis with a placebo or another type of prophylaxis in preventing serious lower respiratory tract disease caused by RSV in paediatric patients at high risk. We included cost‐effectiveness analyses and cost‐utility analyses comparing palivizumab prophylaxis with no prophylaxis.
Data collection and analysis
Two review authors independently assessed risk of bias for the included studies and extracted data for both the RCTs and EEs. We calculated risk ratios (RRs) and their associated 95% confidence intervals (CIs) for dichotomous outcomes and for adverse events (AEs). For continuous outcomes, we provided a narrative summary of results due to missing data on standard deviations. We performed fixed‐effect meta‐analyses for the estimation of pooled effects whenever there was no indication of heterogeneity between included RCTs.
We summarised the results reported in included EEs, such as incremental costs, incremental effectiveness, and incremental cost‐effectiveness and/or cost‐utility ratios (ICERs), and we calculated ICER present values in 2011 Euros for all studies.
Main results
Of the seven available RCTs, three compared palivizumab with a placebo in a total of 2831 patients, and four compared palivizumab with motavizumab in a total of 8265 patients. All RCTs were sponsored by the drug manufacturing company. The overall quality of RCTs was good, but most of the outcomes assessed relied on data from only two studies. Palivizumab prophylaxis was associated with a statistically significant reduction in RSV hospitalisations (RR 0.49, 95% CI 0.37 to 0.64) and a statistically non‐significant reduction in all‐cause mortality (RR 0.69, 95% CI 0.42 to 1.15) when compared to placebo. When compared to motavizumab, palivizumab recipients showed a non‐significant increase in the risk of RSV hospitalisations (RR 1.36, 95% CI 0.97 to 1.90) and a non‐significant risk reduction in all‐cause mortality (RR 0.74, 95% CI 0.38 to 1.43). In both cases, the proportion of children with any AE or any AE related to the study drug was similar between the two groups.
We included 34 studies that reported cost‐effectiveness and/or cost‐utility data for palivizumab prophylaxis in high‐risk children with different underlying medical conditions. The overall quality of EEs was good, but the variations in modelling approaches were considerable across the studies, leading to large differences in the results. The cost‐effectiveness of palivizumab prophylaxis depends on the consumption of resources taken into account by the study authors, and on the cost‐effectiveness threshold set by the healthcare sector in each country.
Authors' conclusions
There is evidence that palivizumab prophylaxis is effective in reducing the frequency of hospitalisations due to RSV infection, i.e. in reducing the incidence of serious lower respiratory tract RSV disease in children with chronic lung disease, congenital heart disease, or those born preterm.
Results from economic evaluations of palivizumab prophylaxis are inconsistent across studies, ranging from highly cost‐effective to not cost‐effective, implying that economic findings must be interpreted with caution. The availability of low‐cost palivizumab would reduce its inequitable distribution, so that RSV prophylaxis would be available to the poorest countries where children are at greatest risk.
Patients over 65 years of age on high-dose statins are most sensitive to the development of adverse effects of statins. The objective of this study is to analyze the consumption of high-dose statins ...in this patient group in Croatia in the period of 2005 - 2015.
For the period of January 1, 2005 to December 31, 2015, the Croatian Institute for Health Insurance provided us with the total number of: all insured, insured over 65 years of age, insured using statins, insured using high-dose statins, insured over 65 using statins, insured over 65 using high-dose statins, number of packages dispensed through all community pharmacies for all statins registered in Croatia divided by year and sex. Studied high-dose statins were: simvastatin 40 mg; atorvastatin 40 mg, 60 mg, 80 mg; fluvastatin 80 mg; rosuvastatin 40 mg. The yearly consumption of each form of statin was calculated in DDD/1,000 insured/day and was statistically processed.
The consumption of all statins increased by 194%, while the consumption of high-dose statins in patients over 65 increased by 296%. The number of all patients on statin therapy increased by 58%, the number of patients over 65 on statin therapy increased by 87%, and the number of patients over 65 on high-dose statins increased by 326%. 60% of all patients over 65 receiving high-dose statins were women. The most used high-dose statins were atorvastatin and simvastatin.
Consumption of all statins increased, mostly high-dose statins in the 65+ age group, the most sensitive population for adverse effects. The number of 65+ patients on high-dose statins grew much faster than the general statin user group, thus increasing the risk potential. Women are dominating all age and dose groups of statin users.
The aim of this study was to examine the association of depressive symptoms with medication adherence levels in a combined sample from Croatia and Slovenia. Participants in the study were adult ...patients with haemophilia receiving prophylaxis or on-demand treatment (N = 109). Their age was between 18 and 73 years (M = 43.86, SD = 14.89). Self-reported medication adherence (implementation phase) was measured with The Validated Haemophilia Regimen Treatment Adherence Scale, while depressive symptoms were measured with Beck Depression Inventory II. Comparison of adherence scores using t-test indicated that participants using prophylaxis were more adherent than participants using on-demand treatment on total scale and time and plan subscales. In hierarchical regression analyses depressive symptoms were a significant predictor for the total score and time subscale after controlling for sociodemographic and clinical variables. Screening for depressive symptoms and improving medication adherence of patients using on-demand treatment is recommended.
What is known and Objective
There is no optimal standardized model in the transfer of care between hospitals and primary healthcare facilities. Transfer of care is a critical point during which ...unintentional discrepancies, that can jeopardize pharmacotherapy outcomes, can occur. The objective was to determine the effect that an integrated medication reconciliation model has on the reduction of the number of post‐discharge unintentional discrepancies.
Methods
A randomized controlled study was conducted on an elderly patient population. The intervention group of patients received a medication reconciliation model, led entirely by a hospital clinical pharmacist (medication reconciliation at admission, review and optimization of pharmacotherapy during hospitalization, patient education and counselling, medication reconciliation at discharge, medication reconciliation as part of primary health care in collaboration with a primary care physician and a community pharmacist). Unintentional discrepancies were identified by comparing the medications listed on the discharge summary with the first list of medications prescribed and issued at primary care level, immediately after discharge. The main outcome measures were incidence, type and potential severity of post‐discharge unintentional discrepancies.
Results and discussion
A total of 353 patients were analysed (182 in the intervention and 171 in the control group). The medication reconciliation model, led by a hospital clinical pharmacist, significantly reduced the number of patients with unintentional discrepancies by 57.1% (p < 0.001). The intervention reduced the number of patients with unintentional discrepancies associated with a potential moderate harm by 58.6% (p < 0.001) and those associated with a potential severe harm by 68.6% (p = 0.039). The most common discrepancies were incorrect dosage, drug omission and drug commission. Cardiovascular medications were most commonly involved in unintentional discrepancies.
What is new and Conclusion
The integrated medication reconciliation model, led by a hospital clinical pharmacist in collaboration with all health professionals involved in the patient's pharmacotherapy and treatment, significantly reduced unintentional discrepancies in the transfer of care.
Elderly are especially vulnerable to the occurrence of medication errors at transition of health care. The integrated medication reconciliation model, led by a hospital clinical pharmacist in collaboration with all health professionals involved in the patient's pharmacotherapy and treatment, significantly reduced unintentional discrepancies in the transfer of care.
Background
Community pharmacists can play an important role in optimizing warfarin treatment, which is very important in vulnerable patient groups such as the elderly patients in rural areas.
...Objective
To evaluate the impact of a community pharmacist’s interventions on the quality of anticoagulation in elderly rural patients receiving warfarin.
Setting
A community pharmacy in Donji Miholjac in Croatia’s province of Slavonia.
Method
We conducted a prospective randomized trial. Eligible patients were recruited at the pharmacy and randomized into two groups. All participants were followed up monthly for a period of 6 months. Repeated education and a follow up plan were provided to the participants in the intervention group, and their general practitioners were contacted to correct the warfarin dose or to avoid drug interactions.
Main outcome measure
Time in therapeutic range (TTR) calculated by the Rosendaal method.
Results
A total of 140 patients were randomized and 131 patients finished the study, 65 patients in the intervention group. Median age was 73 years. At the end of the follow-up period, the median TTR was significantly higher in the intervention group (93 vs. 31.2% for intervention and control, respectively;
P
< 0.001). The proportion of patients with TTR ≥ 65% was also significantly higher in the intervention group (86.2 vs. 7.6% for intervention and control, respectively;
P
< 0.001). Factors independently associated with TTR ≥ 65% were intervention (
P
< 0.001), less frequent dose change (
P
= 0.005), better adherence (
P
< 0.001) and less variable vitamin K intake (
P
= 0.010).
Transfer of care is a sensitive process, especially for the elderly. Polypharmacy, potentially inappropriate medications (PIMs), drug-drug interactions (DDIs), and renal risk drugs (RRDs) are ...important issues in the elderly. The aim of the study was to expand the use of the Best Possible Medication History (BPMH) and to evaluate polypharmacy, PIMs, DDIs, and inappropriately prescribed RRDs on hospital admission, as well as to determine their mutual relationship and association with patients’ characteristics. An observational prospective study was conducted at the Internal Medicine Clinic of Clinical Hospital Dubrava. The study included 383 elderly patients. Overall, 49.9% of patients used 5−9 prescription medications and 31.8% used 10 or more medications. EU(7)-PIMs occurred in 80.7% (n = 309) of the participants. In total, 90.6% of participants had ≥1 potential DDI. In total, 43.6% of patients were found to have estimated glomerular filtration rate < 60 mL/min/1.73 m2, of which 64.7% of patients had one or more inappropriately prescribed RRDs. The clinical pharmacist detected a high incidence of polypharmacy, PIMs, DDIs, and inappropriately prescribed RRDs on hospital admission. This study highlights the importance of early detection of pharmacotherapy problems by using the BPMH in order to prevent their circulation during a hospital stay. The positive correlations between polypharmacy, PIMs, DDIs, and inappropriately prescribed RRDs indicate that they are not independent, but rather occur simultaneously.
Background
The potentially inappropriate medications (PIMs) and drug–drug interactions (DDIs) can significantly affect patient safety in the elderly, especially at transition of health care.
...Objective
The aim of this study is to evaluate PIMs involved in potentially clinically significant DDIs in prescribed pharmacotherapy of elderly patients at hospital discharge.
Setting
Internal Medicine Clinic of University Hospital Dubrava, Zagreb, Croatia.
Method
During a 16-month period, the pharmacotherapy data were assessed using Lexicomp Online screening software to identify category C (monitor drug therapy), D (consider therapy modification) and X (avoid combination) DDIs. The European Union (EU)(7)-PIM criteria were applied to detect inappropriately prescribed medications involved in DDIs. Clinical pharmacists obtained data from patients’ medical records and patient/caregiver interviews.
Main outcome measure
The incidence of PIMs involved in potentially clinically significant DDIs.
Results
A total of 364 consecutive elderly patients were enrolled in the study. The mean number of prescription medications at discharge was 9.3. Overall, 2833 potentially clinically significant DDIs were identified: 2445 (86.3%) of them were category C, 347 (12.3%) category D and 41 (1.4%) were category X interactions. A total of 1164 PIMs were involved in 31.2% of category C interactions, 60.2% of category D interactions and 43.9% of category X interactions. The most frequent PIMs involved in potentially clinically significant DDIs were tramadol, benzodiazepines, moxonidine, vildagliptin and metoclopramide.
Conclusion
A very high incidence of DDIs in elderly patients and a high incidence of PIMs involved in DDIs was determined at hospital discharge.