Publications by authors named "Stephane Steurbaut"

30 Publications

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Non-vitamin K Antagonist Oral Anticoagulants (NOACs) Versus Warfarin in Patients with Atrial Fibrillation Using P-gp and/or CYP450-Interacting Drugs: a Systematic Review and Meta-analysis.

Cardiovasc Drugs Ther 2021 Oct 12. Epub 2021 Oct 12.

Department of Bioanalysis, Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium.

Purpose: Non-vitamin K antagonist oral anticoagulants (NOACs) are excreted by P-glycoprotein (P-gp) and some are metabolized by CYP450 enzymes such as CYP3A4. Although fewer drug interactions are present with NOACs, it is unclear whether NOACs should also be preferred over vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) using pharmacokinetically interacting drugs. Therefore, the benefit-risk profile of NOACs versus VKAs was investigated in AF patients treated with P-gp and/or CYP450-interacting drugs.

Methods: Using PubMed and Embase, randomized controlled trials and observational studies on the effectiveness and safety of NOACs versus VKAs in AF patients using P-gp and/or CYP450-interacting drugs were included. A meta-analysis was performed, calculating relative risks (RR) and 95% confidence intervals (CI) with the Mantel-Haenszel method.

Results: Twelve studies were included, investigating 10,793 NOAC and 10,096 VKA users treated with P-gp/CYP3A4 inhibitors, whereas no studies on P-gp and/or CYP450-inducing drugs were identified. Compared to VKAs, NOACs were associated with a borderline non-significantly lower stroke or systemic embolism (stroke/SE) risk (RR 0.85, 95%CI (0.72-1.01)), significantly lower intracranial bleeding (RR 0.47, 95%CI (0.34-0.65)) and all-cause mortality risks (RR 0.87, 95%CI (0.79-0.95), but significantly higher gastrointestinal bleeding risk (RR 1.74, 95%CI (1.06-2.86)). Among AF patients using amiodarone, NOACs were associated with significantly lower stroke/SE (RR 0.71, 95%CI (0.54-0.93)) and intracranial bleeding risks (RR 0.51, 95%CI (0.29-0.88)), but significantly higher gastrointestinal bleeding risk (RR 2.15, 95%CI (1.24-3.72)) than VKAs.

Conclusion: The benefit-risk profile of NOACs compared to VKAs was preserved in AF patients using P-gp/CYP3A4 inhibitors, including amiodarone.
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http://dx.doi.org/10.1007/s10557-021-07279-8DOI Listing
October 2021

A cross-sectional survey to map Clinical Pharmacy Education and Practice in Europe.

Int J Clin Pharm 2021 Sep 9. Epub 2021 Sep 9.

Research Institute for Medicines (iMED.ULisboa), Faculty of Pharmacy, University of Lisbon, Lisboa, Portugal, Av. Prof. Gama Pinto, 1649-003.

Background Clinical activities provided by pharmacists are increasing worldwide, including in Europe. However, an overview of clinical pharmacy education and practice is needed. Aim To map clinical pharmacy (CP) education and practice among European countries. Method A cross-sectional web-based survey led by the Education Committee of the European Society of Clinical Pharmacy (ESCP) was conducted. The survey comprised three domains focusing on: undergraduate education, postgraduate education, and practice. A multi-phased validation process was undertaken, attributing levels of evidence according to the number of information sources for each country. Triangulation was used to seek within country consensus. Main outcome measures included the number of hours of education in CP; existence of a specialization in CP and activities delivered in practice. Results Data from 40 European countries were included (response rate 95.2%). Most respondents (86.8%) agreed with the ESCP definition of CP. Almost every country (94.9%) reported CP topics at the undergraduate level [median number = 65 h/semester (IQR: 2.0-5.6)], including practical teaching [median = 30.0% (IQR: 17.0-42.0)]. At postgraduate level, 92.5% of countries reported PhD programmes including CP and 65.0% mentioned the existence of specific CP master/diploma degrees. Continuous professional development (CPD) courses were also reported by 63.9% of respondents. More than half the countries (52.5%; n = 21) recognized CP as an area of specialization, which for 60.0% of participants was applied solely in the hospital setting. Conclusion Although CP is embedded in education and practice in European countries, there is wide variability in education and practice patterns.
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http://dx.doi.org/10.1007/s11096-021-01321-3DOI Listing
September 2021

Determinants for under- and overdosing of direct oral anticoagulants and physicians' implementation of clinical pharmacists' recommendations.

Br J Clin Pharmacol 2021 Jul 31. Epub 2021 Jul 31.

Research Group Clinical Pharmacology and Clinical Pharmacy, Vrije Universiteit Brussel, Jette, Belgium.

Aims: To analyse the appropriateness of direct oral anticoagulant (DOAC) dosing and determinants for under-and overdosing as well as acceptance and implementation rates of pharmacists' interventions.

Methods: Cross-sectional study in a tertiary hospital in hospitalized patients with atrial fibrillation on DOACs in 2019 (n = 1688). Primary outcome was the proportion of patients with inappropriate DOAC prescribing with identification of determinants for under-and overdosing. Secondary outcomes included acceptance and implementation rates of pharmacists' recommendations and determination of reasons for nonacceptance/nonimplementation.

Results: Inappropriate prescribing was observed in 16.9% of patients (n = 286) with underdosing (9.7%) being more prevalent than overdosing (6.9%). For all DOACs considered together, body weight<60 kg (odds ratio [OR] 0.46 [0.27-0.77]), edoxaban use (OR 0.42 [0.24-0.74]), undergoing surgery (OR 0.57 [0.37-0.87]) and being DOAC naïve (OR 0.45 [0.29-0.71]) were associated with significantly lower odds of underdosing. Bleeding history (OR 1.86 [1.24-2.80]) and narcotic use (OR 1.67 [1.13-2.46]) were associated with significantly higher odds for underdosing. Determinants with a significantly higher odds of overdosing were renal impairment (OR 11.29 [6.23-20.45]) and body weight<60 kg (OR 2.34 [1.42-3.85]), whereas dabigatran use (OR 0.24 [0.08-0.71]) and apixaban (OR 0.18 [0.10-0.32]) were associated with a significantly lower odds of overdosing compared to rivaroxaban. Physicians accepted the pharmacists' advice in 179 cases (79.2%) consisting of 92 (51.4%) recommendations for underdosing, 82 (45.8%) for overdosing and 5 (2.8%) for contraindications.

Conclusion: Inappropriate DOAC prescribing remains common, although there is a slight improvement compared to our study of 2016. Clinical services led by pharmacists help physicians to reduce the number of inadequate prescriptions for high-risk medications such as DOACs.
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http://dx.doi.org/10.1111/bcp.15017DOI Listing
July 2021

The impact of underweight and obesity on outcomes in anticoagulated patients with atrial fibrillation: A systematic review and meta-analysis on the obesity paradox.

Clin Cardiol 2021 May 26;44(5):599-608. Epub 2021 Mar 26.

Department of Bioanalysis, Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium.

Although obesity is associated with the development and progression of atrial fibrillation (AF), an obesity paradox may be present, illustrated by seemingly protective effects of obesity on AF-related outcomes. Body mass index (BMI) has an impact on outcomes in AF patients using oral anticoagulants. After searching Medline and Embase, meta-analysis of results of four randomized and five observational studies demonstrated significantly lower risks of stroke or systemic embolism (RR 0.80, 95%CI [0.73-0.87]; RR 0.63, 95%CI [0.57-0.70]; and RR 0.42, 95%CI [0.31-0.57], respectively) and all-cause mortality (RR 0.73, 95%CI [0.64-0.83]; RR 0.61, 95%CI [0.52-0.71]; and RR 0.56, 95%CI [0.47-0.66], respectively) in overweight, obese and morbidly obese anticoagulated AF patients (BMI 25 to <30, ≥30 and ≥40 kg/m , respectively) compared to normal BMI anticoagulated AF patients (BMI 18.5 to <25 kg/m ). In contrast, thromboembolic (RR 1.92, 95%CI [1.28-2.90]) and mortality (RR 3.57, 95%CI [2.50-5.11]) risks were significantly increased in underweight anticoagulated AF patients (BMI <18.5 kg/m ). In overweight and obese anticoagulated AF patients, the risks of major bleeding (RR 0.86, 95%CI [0.76-0.99]; and RR 0.88, 95%CI [0.79-0.98], respectively) and intracranial bleeding (RR 0.75, 95%CI [0.58-0.97]; and RR 0.57, 95%CI [0.40-0.80], respectively) were also significantly lower compared to normal BMI patients, while similar risks were observed in underweight and morbidly obese patients. This meta-analysis demonstrated lower thromboembolic and mortality risks with increasing BMI. However, as this paradox was driven by results from randomized studies, while observational studies rendered more conflicting results, these seemingly protective effects should still be interpreted with caution.
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http://dx.doi.org/10.1002/clc.23593DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8119828PMC
May 2021

Qualitative study of medication review in Flanders, Belgium among community pharmacists and general practitioners.

Int J Clin Pharm 2021 Oct 23;43(5):1173-1182. Epub 2021 Jan 23.

Laboratory of Physiopharmacology, Department of Pharmaceutical Sciences, University of Antwerp, Universiteitsplein 1, B-2610, Antwerp, Belgium.

Objective Examining the implementation barriers and facilitators of this service as provided by Belgian community pharmacists in collaboration with general practitioners. Setting Community pharmacies in Flanders. Method Qualitative study through interviews of pharmacists and general practitioners. Main outcome measure Opinions and experiences of pharmacists and general practitioners about type 3 medication review. Results Sixteen community pharmacists and thirteen general practitioners were interviewed and generally gave a positive assessment of the project. The general practitioners saw the pharmaceutical and pharmacotherapeutic recommendations of the pharmacists as an added value for the patients. The pharmacists indicated that performing an medication review was time-consuming, but that it improved their professional relationship with general practitioners and patients. They reported obstacles in obtaining information: cumbersome access to individual patient data (laboratory values) and difficulties in finding and choosing adequate medical information sources. Moreover, pharmacists indicated that there is a need for adequate reimbursement and additional training to make the implementation sustainable. Conclusion Both pharmacists and general practitioners were enthusiastic about medication reviews. The implementation improved the interprofessional collaboration. However, important barriers remain, such as the considerable investment of time and the difficulty in gathering all the necessary information. The sustainable implementation of type 3 medication review in Belgium requires adequate reimbursement and additional training.
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http://dx.doi.org/10.1007/s11096-020-01224-9DOI Listing
October 2021

Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) Versus Warfarin in Patients with Atrial Fibrillation and (Morbid) Obesity or Low Body Weight: a Systematic Review and Meta-Analysis.

Cardiovasc Drugs Ther 2021 Jan 11. Epub 2021 Jan 11.

Department of Bioanalysis, Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium.

Purpose: Oral anticoagulants are crucial for preventing systemic thromboembolism in atrial fibrillation (AF), with guidelines preferring non-vitamin K antagonist oral anticoagulants (NOACs) over vitamin K antagonists (VKAs) in the general AF population. However, as NOACs are administered in fixed doses, concerns of unintentional underdosing in morbidly obese patients and unintentional overdosing in underweight patients have emerged. Therefore, a critical appraisal of the benefit-risk profile of NOACs in AF patients across the body weight spectrum is needed.

Methods And Results: After searching Medline, this systematic review discusses the impact of body weight on the risk-benefit profile of NOACs versus VKAs. The meta-analysis demonstrated that NOAC use in obese and class III obese AF patients (body mass index (BMI) ≥ 30 and ≥ 40 kg/m, respectively) was associated with significantly lower stroke/systemic embolism (stroke/SE) risks (RR 0.82, 95%CI [0.71-0.96] and RR 0.75, 95%CI [0.64-0.87], respectively), similar to lower major bleeding risks (RR 0.83, 95%CI [0.69-1.00] and RR 0.74, 95%CI [0.57-0.95], respectively) and similar mortality risks (RR 0.92, 95%CI [0.73-1.15] and RR 1.17, 95%CI [0.83-1.64], respectively) compared to VKAs. In AF patients ≤ 60 kg, significantly lower stroke/SE (RR 0.63, 95%CI [0.56-0.71]) and major bleeding risks (RR 0.71, 95%CI [0.62-0.80]), but similar mortality risks (RR 0.68, 95%CI [0.42-1.10]), were observed for NOAC- versus VKA-treated patients.

Conclusion: The benefit-risk profile of NOACs seems preserved in (morbidly) obese AF patients and patients with low body weight. However, more data are needed on underweight AF patients (BMI < 18.5 kg/m) and on differences between NOACs in these patients.
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http://dx.doi.org/10.1007/s10557-020-07122-6DOI Listing
January 2021

Impact of a single non-sex-related stroke risk factor on atrial fibrillation and oral anticoagulant outcomes: a systematic review and meta-analysis.

Open Heart 2020 12;7(2)

Department of Bioanalysis, Pharmaceutical Care Unit, Ghent University, Ghent, Belgium.

Aims: Oral anticoagulants (OACs) are crucial for treating atrial fibrillation (AF) patients at high thromboembolic risk. However, in AF patients at intermediate thromboembolic risk with a single non-sex-related stroke risk factor (CHADS-VASc score 1 in men, 2 in women), guidelines advise to consider starting anticoagulation, which may result in OAC non-initiation due to underestimation of the thromboembolic risk of a single stroke risk factor and overestimation of the OAC-related bleeding risk. A critical appraisal of the role of OACs and the benefit-risk profile of non-vitamin K antagonist oral anticoagulants (NOACs) compared with vitamin K antagonists (VKAs) in this patient subgroup are needed.

Methods And Results: This systematic review provides an overview of literature on the effectiveness and safety of OACs in AF patients with a single non-sex-related stroke risk factor after searching Medline and Embase. Differences between individual stroke risk factors regarding the ischaemic stroke risk in non-anticoagulated AF patients are identified in a meta-analysis, demonstrating the highest increased risk in patients aged 65-74 years old or with diabetes mellitus, followed by heart failure, hypertension and vascular disease. Furthermore, meta-analysis results favour NOACs over VKAs, given their equal effectiveness and superior safety in AF patients at intermediate thromboembolic risk (HR 0.93, 95% CI 0.65 to 1.34 for stroke or systemic embolism; HR 0.60, 95% CI 0.45 to 0.80 for major bleeding; HR 0.48, 95% CI 0.14 to 1.59 for intracranial bleeding; HR 0.58, 95% CI 0.47 to 0.71 for mortality).

Conclusion: Our systematic review with meta-analysis favours the use of anticoagulation in AF patients with a single non-sex-related stroke risk factor, especially when age ≥65 years or diabetes mellitus is present, with a preference for NOACs over VKAs.
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http://dx.doi.org/10.1136/openhrt-2020-001465DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7759963PMC
December 2020

Spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic.

Int J Clin Pharm 2021 Aug 27;43(4):948-957. Epub 2020 Nov 27.

Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Kralove, Charles University, Hradec Kralove, Czech Republic.

Background Oral anticoagulants are established drugs of choice for the prevention and treatment of thromboembolic events. However, monitoring their safety remains warranted. Objective The aim was to analyze spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic. Setting Retrospective observational pharmacovigilance study. Methods Adverse drug reaction reports were obtained from the State Institute for Drug Control between January 2005 and November 2017. Reports related to warfarin, dabigatran, apixaban, and rivaroxaban received from healthcare professionals and patients were analyzed. Main outcome measure Frequency and nature of adverse drug reactions reported to oral anticoagulants. Results In total, 297 reports containing 672 adverse drug reactions were received; 269 reports were sent by healthcare professionals (85% by physicians). In 65% of all reports, reactions were due to direct oral anticoagulants. A higher total number of adverse drug reactions was associated with direct oral anticoagulants than with warfarin [reporting odds ratio (ROR): 10.76; confidence interval (CI): 8.70-13.32; p < 0.001]. Along with the increasing utilization of direct oral anticoagulants, the reporting rate gradually declined over time, especially for rivaroxaban and apixaban. Fatal outcomes were reported in 7%, mostly for dabigatran. Hemorrhagic reactions were the most frequently reported adverse drug reactions (37% associated with dabigatran, 28% with apixaban, 24% with warfarin, and 23% with rivaroxaban), and compared to warfarin, they were significantly more often associated with direct oral anticoagulants (ROR: 14.36; CI: 9.57-21.54; p < 0.001). Conclusion The number of adverse drug reaction reports related to oral anticoagulants in the Czech Republic was relatively low, compared to other studies, but 96% of the cases were serious. Data from spontaneous adverse drug reactions reporting should be further analyzed in order to obtain additional information on the safety profile of oral anticoagulants.
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http://dx.doi.org/10.1007/s11096-020-01201-2DOI Listing
August 2021

Effectiveness and Safety of Oral Anticoagulants in Older Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis.

Front Pharmacol 2020 9;11:583311. Epub 2020 Sep 9.

Pharmaceutical Care Unit, Department of Bioanalysis, Ghent University, Ghent, Belgium.

Background And Objective: Atrial fibrillation (AF), the most common cardiac arrhythmia, typically increases with age. Oral anticoagulants (OACs) are the cornerstone of treatment to reduce the associated risk for systemic thromboembolism. Four large randomized controlled trials (RCTs) have shown that non-vitamin K antagonist oral anticoagulants (NOACs) are non-inferior to vitamin K antagonists (VKAs) in preventing stroke and systemic embolism, as well as regarding their risk for major bleeding. However, as vulnerable geriatric patients with AF were largely underrepresented in these trials, physicians are faced with the challenge of choosing the right anticoagulant for geriatric patients in real-life clinical practice. In this vulnerable patient group, NOACs tend to be underused or underdosed due to concerns of excessive fall-related intracranial bleeding, cognitive impairment, multiple drug-drug interactions, low body weight or impaired renal function. As life expectancy continues to rise worldwide, the number of geriatric patients substantially increases. Therefore, there is an urgent need for a critical appraisal of the added value of NOACs in geriatric patients with AF at high thromboembolic and bleeding risk.

Methods And Results: This systematic review provides an overview of the literature on the impact of increased age (≥75 years), multimorbidity, polypharmacy, increased falling risk, frailty and dementia on the effectiveness and safety of NOACs as compared to VKAs, after searching the Medline database. Moreover, a meta-analysis on the impact of increased age ≥75 years old was performed after pooling results from 6 analyses of RCTs and 6 longitudinal observational cohort studies, highlighting the superior effectiveness (hazard ratio (HR) 0.83, 95% confidence interval (CI) [0.74-0.94] for stroke/SE; HR 0.77, 95%CI [0.65-0.92] for mortality) and non-inferior safety (HR 0.93, 95%CI [0.86-1.01] for major bleeding; HR 0.58, 95%CI [0.50-0.67] for intracranial bleeding; HR 1.17, 95%CI [0.99-1.38] for gastrointestinal bleeding) of NOACs versus VKAs in older AF patients.

Conclusion: Across geriatric subgroups, apixaban was consistently associated with the most favourable benefit-risk profile and should therefore be preferred in geriatric patients with AF. However, research gaps on the impact of increased falling risk, frailty and baseline dementia were identified, requiring careful consideration while awaiting more results.
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http://dx.doi.org/10.3389/fphar.2020.583311DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7509201PMC
September 2020

Association of conflicting information from healthcare providers and poor shared decision making with suboptimal adherence in direct oral anticoagulant treatment: A cross-sectional study in patients with atrial fibrillation.

Patient Educ Couns 2021 01 20;104(1):155-162. Epub 2020 Jun 20.

Vrije Universiteit Brussel, Faculty of Medicine and Pharmacy, Centre for Pharmaceutical Research (CePhar), Brussels, Belgium; Department of Clinical Pharmacology and Pharmacotherapy, Universitair Ziekenhuis (UZ) Brussel, Brussels, Belgium.

Objective: To assess direct oral anticoagulant (DOAC) adherence and to determine possible determinants for suboptimal adherence in Dutch patients with atrial fibrillation (AF).

Methods: Cross-sectional study of DOAC users who completed a self-reported questionnaire. Adherence was measured with Morisky8-item Medication Adherence Scale (MMAS-8). Logistic regression analysis was conducted to investigate determinants affecting adherence.

Results: 398 DOAC users completed the questionnaire (mean age 70.6 ± 9.2years). Approximately one in four patients had suboptimal adherence (MMAS-8 < 8). Multivariable analysis showed that patients who felt to have received conflicting information about the treatment, patients with higher educational level and patients who were not sufficiently involved in the treatment choice had a higher odds of suboptimal adherence.

Conclusion: DOAC adherence was suboptimal. Conflicting information received from different healthcare providers (HCPs), lack of shared decision making and the patients' educational level were determinants negatively affecting DOAC adherence.

Practice Implications: Efforts towards identifying suboptimally adherent DOAC patients are needed since they are at higher risk to develop thromboembolic events. Adherence counselling should be systematically and repeatedly encouraged and shared decision making should become more mainstream. Moreover, reinforced education of both patients and HCPs combined with interprofessional collaboration are potential solutions to prevent knowledge gaps and communication of conflicting information.
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http://dx.doi.org/10.1016/j.pec.2020.06.016DOI Listing
January 2021

Community pharmacy-based study of adherence to non-vitamin K antagonist oral anticoagulants.

Heart 2020 11 23;106(22):1740-1746. Epub 2020 Jun 23.

Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium.

Objective: This study aimed to assess implementation adherence (how well the patient's actual intake matches the prescribed dosing regimen) to non-vitamin K antagonist oral anticoagulants (NOACs) and to explore experiences with and beliefs about NOACs in a real-world sample of long-term NOAC users.

Methods: A cross-sectional observational study was conducted in home-dwelling adults who started taking a NOAC at least 1 year prior to inclusion. Pharmacy dispensing data were used to calculate the Medication Possession Ratio (MPR). Patients were recruited in 158 community pharmacies in Flanders, Belgium. They completed a questionnaire collecting basic characteristics and exploring self-reported adherence to NOACs (using the Medication Adherence Report Scale, MARS) and experiences with and beliefs about NOACs (using the Beliefs about Medicines Questionnaire, BMQ).

Results: A total of 766 patients (mean age 76.2±8.8 years, median CHADS-VASc score 4 (IQR=3-4)) were included. The majority (93.5%) used NOAC for stroke prevention in atrial fibrillation. The median MPR was 95.2% (IQR=87.8-99.7) which corresponds with half of the study population not taking their NOAC on at least 17 cumulative days per year. Almost 21% of participants reported non-adherence on the MARS (score <25), with unintentional non-adherence (forgetfulness) most frequently reported (15.4%). Although two-thirds of NOAC users indicated to experience adverse drug reactions, the BMQ demonstrated a positive attitude towards NOAC therapy, where necessity beliefs outweigh the concerns.

Conclusions: Our data indicate that long-term NOAC users have high implementation adherence and a positive attitude towards NOAC therapy. However, taking into account patients' thromboembolic risk and NOACs' short half-lives, further optimisation of NOAC use seems warranted in this population.
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http://dx.doi.org/10.1136/heartjnl-2020-316781DOI Listing
November 2020

Health Economic Evaluations of Digital Health Interventions for Secondary Prevention in Stroke Patients: A Systematic Review.

Cerebrovasc Dis Extra 2019 7;9(1):1-8. Epub 2019 Jan 7.

Vrije Universiteit Brussel (VUB), Interuniversity Center for Health Economics Research (I-CHER), Brussels, Belgium.

Background: In the first 5 years after their stroke, about a quarter of patients will suffer from a recurrent stroke. Digital health interventions facilitating interactions between a caregiver and a patient from a distance are a promising approach to improve patient adherence to lifestyle changes proposed by secondary prevention guidelines. Many of these interventions are not implemented in daily practice, even though efficacy has been shown. One of the reasons can be the lack of clear economic incentives for implementation. We propose to map all health economic evidence regarding digital health interventions for secondary stroke prevention.

Summary: We performed a systematic search according to PRISMA-P guidelines and searched on PubMed, Web of Science, Cochrane, and National Institute for Health Research Economic Evaluation Database. Only digital health interventions for secondary prevention in stroke patients were included and all study designs and health economic outcomes were accepted. We combined the terms "Stroke OR Cardiovascular," "Secondary prevention," "Digital health interventions," and "Cost" in one search string using the AND operator. The search performed on April 20, 2017 yielded 163 records of which 26 duplicates were removed. After abstract screening, 20 articles were retained for full-text analysis, of which none reported any health economic evidence that could be included for analysis or discussion. Key Messages: There is a lack of evidence on health economic outcomes on digital health interventions for secondary stroke prevention. Future research in this area should take health economics into consideration when designing a trial and there is a clear need for health economic evidence and models.
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http://dx.doi.org/10.1159/000496107DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6489060PMC
February 2020

Appropriateness of DOAC Prescribing Before and During Hospital Admission and Analysis of Determinants for Inappropriate Prescribing.

Front Pharmacol 2018 30;9:1220. Epub 2018 Oct 30.

Centre for Pharmaceutical Research, Vrije Universiteit Brussel, Jette, Belgium.

Appropriate dosing of direct oral anticoagulants (DOACs) is required to avoid under- and overdosing that may precipitate strokes or thromboembolic events and bleedings, respectively. Our objective was to analyze the appropriateness of DOAC dosing according to the summaries of product characteristics (SmPC). Furthermore, determinants for inappropriate prescribing were investigated. Retrospective cohort study of hospitalized patients aged ≥60 years with at least one DOAC intake during hospital stay. Descriptive analyses were used to summarize the characteristics of the study population. Chi-square test was used to evaluate differences between DOACs. Binary logistic regression analysis was performed to assess determinants for inappropriate prescribing. For the 772 included patients, inappropriate dosing occurred in 25.0% of hospitalizations with 23.4, 21.9, and 29.7% for dabigatran, rivaroxaban, and apixaban, respectively ( = 0.084). Underdosing was most prevalent for apixaban (24.5%) compared to dabigatran (14.0%) and rivaroxaban (12.8%), < 0.001. In 67.1% (apixaban), 26.7% (dabigatran), and 51.2% (rivaroxaban) of underdosed DOAC cases according to the SmPC, the dose would be considered appropriate according to the European Heart Rhytm Association (EHRA) guidelines. Overdosing was observed in 4.5% (apixaban), 4.7% (dabigatran), and 7.7% (rivaroxaban) of patients. For all DOACs, our analysis showed an age ≥80 years ( = 0.036), use of apixaban ( = 0.026), DOAC use before hospitalization ( = 0.001), intermediate renal function ( = 0.014), and use of narcotic analgesics ( = 0.019) to be associated with a higher rate of inappropriate prescribing. Undergoing surgery was associated with a lower odds of inappropriate prescribing ( = 0.012). For rivaroxaban, use of medication for hypothyroidism ( = 0.027) and the reduced dose ( < 0.001) were determinants for inappropriate prescribing. Treatment of venous thromboembolism was associated with less errors ( = 0.002). For apixaban, severe renal insufficiency ( < 0.001) and initiation in hospital ( = 0.016) were associated with less and the reduced dose ( < 0.001) with more inappropriate prescribing. No determinants were found in the dabigatran subgroup. Inappropriate DOAC prescribing is frequent with underdosing being the most common drug related problem when using the SmPC as reference. More appropriate prescriptions were found when taking the EHRA guidelines into account. Analysis of determinants of inappropriate prescribing yielded insights in the risk factors associated with inappropriate DOAC prescriptions.
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http://dx.doi.org/10.3389/fphar.2018.01220DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218888PMC
October 2018

Clinical Decision Support Systems for Drug Allergy Checking: Systematic Review.

J Med Internet Res 2018 09 7;20(9):e258. Epub 2018 Sep 7.

Research Group Clinical Pharmacology and Clinical Pharmacy, Centre for Pharmaceutical Research, Vrije Universiteit Brussel, Brussels, Belgium.

Background: Worldwide, the burden of allergies-in particular, drug allergies-is growing. In the process of prescribing, dispensing, or administering a drug, a medication error may occur and can have adverse consequences; for example, a drug may be given to a patient with a documented allergy to that particular drug. Computerized physician order entry (CPOE) systems with built-in clinical decision support systems (CDSS) have the potential to prevent such medication errors and adverse events.

Objective: The aim of this review is to provide a comprehensive overview regarding all aspects of CDSS for drug allergy, including documenting, coding, rule bases, alerts and alert fatigue, and outcome evaluation.

Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed as much as possible and searches were conducted in 5 databases using CPOE, CDSS, alerts, and allergic or allergy as keywords. Bias could not be evaluated according to PRISMA guidelines due to the heterogeneity of study types included in the review.

Results: Of the 3160 articles considered, 60 met the inclusion criteria. A further 9 articles were added based on expert opinion, resulting in a total of 69 articles. An interrater agreement of 90.9% with a reliability Κ=.787 (95% CI 0.686-0.888) was reached. Large heterogeneity across study objectives, study designs, study populations, and reported results was found. Several key findings were identified. Evidence of the usefulness of clinical decision support for drug allergies has been documented. Nevertheless, there are some important problems associated with their use. Accurate and structured documenting of information on drug allergies in electronic health records (EHRs) is difficult, as it is often not clear to healthcare providers how and where to document drug allergies. Besides the underreporting of drug allergies, outdated or inaccurate drug allergy information in EHRs poses an important problem. Research on the use of coding terminologies for documenting drug allergies is sparse. There is no generally accepted standard terminology for structured documentation of allergy information. The final key finding is the consistently reported low specificity of drug allergy alerts. Current systems have high alert override rates of up to 90%, leading to alert fatigue. Important challenges remain for increasing the specificity of drug allergy alerts. We found only one study specifically reporting outcomes related to CDSS for drug allergies. It showed that adverse drug events resulting from overridden drug allergy alerts do not occur frequently.

Conclusions: Accurate and comprehensive recording of drug allergies is required for good use of CDSS for drug allergy screening. We found considerable variation in the way drug allergy are recorded in EHRs. It remains difficult to reduce drug allergy alert overload while maintaining patient safety as the highest priority. Future research should focus on improving alert specificity, thereby reducing override rates and alert fatigue. Also, the effect on patient outcomes and cost-effectiveness should be evaluated.
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http://dx.doi.org/10.2196/jmir.8206DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6231757PMC
September 2018

Correction to: Pharmacists' confidence when providing pharmaceutical care on anticoagulants, a multinational survey.

Int J Clin Pharm 2018 02;40(1):202

Centro de Investigação Interdisciplinar Egas Moniz (CiiEM), Campus Universitário, Quinta da Granja, Monte da Caparica, 2829‑551, Caparica, Portugal.

In the original publication of this article, the article note has been missed and published online.
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http://dx.doi.org/10.1007/s11096-017-0586-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6829690PMC
February 2018

Pharmacists' confidence when providing pharmaceutical care on anticoagulants, a multinational survey.

Int J Clin Pharm 2017 Dec 14;39(6):1282-1290. Epub 2017 Nov 14.

Centro de Investigação Interdisciplinar Egas Moniz (CiiEM), Campus Universitário, Quinta da Granja, Monte da Caparica, 2829-551, Caparica, Portugal.

Background Guidelines on the management of orally anticoagulated patients are continuously evolving, leading to an increased need for pharmacists to be fully integrated in care provision. Objective To identify self-reported gaps in confidence among practicing pharmacists in the area of anticoagulation. Setting Pharmacists in different work settings in different countries. Method Cross-sectional international survey from October 2015 till November 2016 among pharmacists working in different settings to assess their level of confidence when delivering anticoagulants as well as to identify possible educational needs regarding this medication class. Validation of the survey was ensured. Results Responses from 4212 pharmacists originating from 18 countries were obtained. Pharmacists' level of confidence was significantly higher (p < 0.001) when advising patients on vitamin K antagonists (VKAs) versus non-vitamin K antagonists (NOACs). In general, hospital pharmacists displayed higher confidence levels compared to community pharmacists when advising patients on anticoagulation (p < 0.001). Two distinct patterns of confidence levels emerged relating to basic and advanced pharmaceutical care. Confidence levels when providing advanced pharmaceutical care were significantly higher for Oceania and lower for South America (p < 0.005). Conclusions Pharmacists felt more confident in supporting patients receiving VKAs compared to the more recently introduced NOACs. With the increasing use of NOACs and the risks pertaining to anticoagulation therapy, it is essential to invest in education for pharmacists to address their knowledge gaps enabling them to confidently support patients receiving oral anticoagulants.
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http://dx.doi.org/10.1007/s11096-017-0551-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5694509PMC
December 2017

A comparative study of medication use after stroke in four countries.

Clin Neurol Neurosurg 2016 Sep 4;148:96-104. Epub 2016 Jul 4.

Department of In Vitro Toxicology and Dermato-Cosmetology (IVTD), Centre for Pharmaceutical Research (CePhar), Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, B-1090 Brussels, Belgium. Electronic address:

Objectives: The use of medication plays an important role in secondary stroke prevention and treatment of post-stroke comorbidities. The Collaborative Evaluation of Rehabilitation in Stroke across Europe (CERISE) was set up to investigate the inpatient stroke rehabilitation process in four centres, each in a different European country: Belgium, Germany, United Kingdom and Switzerland.

Patients And Methods: Patients' medication use 5 years post-stroke was compared between countries. Focus was put on cerebrovascular secondary prevention, including (a) adequate antithrombotic treatment, (b) treatment of cardiovascular comorbidities and diabetes, and (c) the use of lipid-lowering drugs; as well as on the treatment of stroke-related disorders such as depression, anxiety and pain.

Results: Medication data were available for 247 patients. Data about depression and anxiety were available for 233.

Conclusion: There were no significant differences between the four centres in antithrombotic treatment and in the treatment of cardiovascular comorbidities and diabetes. However, significantly more patients from the UK were treated with lipid-lowering drugs compared to Belgian patients. Significant differences were also observed between the centres in the prevalence and treatment of depression. More Belgian patients suffered from depression compared to German patients and significantly more Belgian patients took antidepressants than patients in Germany. This was in contrast to the prevalence and treatment of anxiety and pain, for which no significant differences between the centres were seen. Related to pain treatment, it was observed that almost 40% of all patients suffering from pain, used no specific medication.
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http://dx.doi.org/10.1016/j.clineuro.2016.07.007DOI Listing
September 2016

Evaluating the implementation fidelity of New Medicines Service for asthma patients in community pharmacies in Belgium.

Res Social Adm Pharm 2017 Jan - Feb;13(1):98-108. Epub 2016 Feb 12.

Psychological Sciences Research Institute (IPSY), Université catholique de Louvain, Belgium.

Background: In October 2013, a New Medicines Service (NMS) was introduced in community pharmacies in Belgium to support asthma patients who are novice users of inhaler devices with corticosteroids. The protocol-based intervention used the Asthma Control Test (ACT) and the Medication Adherence Report Scale (MARS) to assess asthma control and medication adherence. The NMS is the first initiative that puts advanced pharmaceutical care into practice in Belgium. The present study evaluated the degree to which the NMS program is delivered as intended, drawing on the concept of implementation fidelity (IF).

Methods: The main dimensions of IF and potential moderating and facilitating factors for the implementation of NMS in community pharmacies were evaluated using telephone interviews with pharmacists (n = 497), semi-structured interviews with patients eligible for NMS (n = 30), focus groups among general practitioners (n = 72) and lung specialists (n = 5), and a work system analysis in community pharmacies (n = 19).

Results: The uptake of NMS in Belgian community pharmacies remains low. In addition to practical barriers, pharmacists found it difficult to identify new asthmatic patients when they were not informed about the diagnosis. A lack of commitment from physicians, patients and pharmacists was noted in the early start-up phase of the program. Many pharmacists did not see how NMS differed from existing pharmaceutical care. Physicians considered this service as part of their own tasks and discouraged ACT for asthma follow-up in the community pharmacy.

Conclusions: The introduction of the NMS program was not sufficiently embedded in the Belgian health care organization, causing low uptake and resistance to its implementation by pharmacists, patients, and other health care professionals. To increase the uptake of this type of service and its possible extension to other patient groups, more collaboration among the different health care professionals during design and implementation is necessary, as well as systematic data collection to monitor the quality of the service, better training of pharmacists, and more information for patients and physicians.
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http://dx.doi.org/10.1016/j.sapharm.2016.02.001DOI Listing
July 2017

Pilot evaluation of an optimized context-specific drug-drug interaction alerting system: A controlled pre-post study.

Int J Med Inform 2015 Sep 22;84(9):617-29. Epub 2015 May 22.

Research Group Clinical Pharmacology & Clinical Pharmacy (KFAR), Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium.

Objectives: Clinical decision support (CDS) systems are frequently used to reduce unwanted drug-drug interactions (DDIs) but often result in alert fatigue. The main objective of this study was to investigate whether a newly developed context-specific DDI alerting system would improve alert acceptance.

Methods: A controlled pre-post intervention study was conducted in 4 departments in a university hospital. After a 7-month pre-intervention period, the new system was activated in the intervention departments, while the old system remained activated in the control departments. Post-intervention data was collected for a 7-month period.

Results: A significant increase of the overall acceptance rate was observed between the pre- and post-intervention period (2.2% versus 52.4%; p<0.001) for the intervention departments and between the intervention and control departments (2.5% versus 52.4%; p<0.001) in the post-intervention period. There were no significant differences in acceptance rates between the pre- and post-intervention period in the control departments and also not between the control and intervention departments in the pre-intervention period.

Conclusions: The improvement was probably related to several optimization strategies including the customization of the severity classification, the creation of individual screening intervals, the inclusion of context factors for risk assessment, the new alert design and the creation of a follow-up system. The marked increase in alert acceptance looks promising and should be further evaluated after hospital wide implementation. System aspects that require further optimization were identified and will be developed. Further research is warranted to develop context-aware algorithms for complex class-class interactions.
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http://dx.doi.org/10.1016/j.ijmedinf.2015.05.005DOI Listing
September 2015

Pharmacovigilance: empowering healthcare professionals and patients.

Int J Clin Pharm 2014 Oct 5;36(5):859-62. Epub 2014 Sep 5.

Department of Clinical Pharmacology and Pharmacotherapy, UZ Brussel and Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090, Jette, Brussels, Belgium.

The European Union has thoroughly reformed its pharmacovigilance legislation in July 2012. Despite the changes, underreporting of adverse drug reactions remains a concern. This underreporting seems to be partially associated with incorrect customs and beliefs by healthcare professionals. Therefore, strengthening teaching and training in drug safety monitoring and reporting are essential. Sustained campaigns and education on pharmacovigilance are key elements to enhance its performance and effectiveness. In general, all healthcare professionals as well as patients should be more sensitized and empowered to contribute to pharmacovigilance programmes in order to improve drug safety.
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http://dx.doi.org/10.1007/s11096-014-0004-0DOI Listing
October 2014

Determinants of medication use in a multi-ethnic population of pregnant women: a cross-sectional study.

Eur J Contracept Reprod Health Care 2014 Apr 4;19(2):108-20. Epub 2014 Mar 4.

* Department of Clinical Pharmacology and Pharmacotherapy, UZ Brussel and Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel , Brussels , Belgium.

Objectives: To investigate determinants of medication use among multi-ethnic pregnant women.

Methods: A total of 641 pregnant women participated in this cross-sectional study in a Brussels university hospital. A questionnaire was used to obtain data on socio-demographic characteristics and medication use. Chi-squared tests and binary logistic regression analyses were performed using SPSS 19.

Results: Medication use during pregnancy (37%) was positively associated with age older than 35 years, Western origin, being born in Belgium, high education and employment status. Highly educated Western women had a greater exposure to drugs with an unknown safety profile than Arab/Turkish and 'Other (non-Western) origins' women. In the latter two groups, low education and nulliparity were the most important determinants of lower drug use. Nulliparous Arab/Turkish women used significantly less medications (17%) during pregnancy than parous women with the same ethnic background (34%; p = 0.024).

Conclusions: Medication use during pregnancy is considerable but differs according to ethnicity. Age, parity, educational level, occupational status and duration of stay in Belgium are important determinants that should be taken into account for risk assessment and preventive measures targeting pregnant women.
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http://dx.doi.org/10.3109/13625187.2013.879568DOI Listing
April 2014

Performance of a clinical decision support system and of clinical pharmacists in preventing drug-drug interactions on a geriatric ward.

Int J Clin Pharm 2014 Jun 25;36(3):519-25. Epub 2014 Feb 25.

Faculty of Medicine and Pharmacy, Research Group Clinical Pharmacology and Clinical Pharmacy (KFAR), Vrije Universiteit Brussel, 1090, Brussels, Belgium,

Background: Drug-drug interactions (DDIs) can lead to adverse drug events and compromise patient safety. Two common approaches to reduce these interactions in hospital practice are the use of clinical decision support systems and interventions by clinical pharmacists.

Objective: To compare the performance of both approaches with the main objective of learning from one approach to improve the other.

Setting: Acute geriatric ward in a university hospital.

Methods: Prospective single-centre, cohort study of patients admitted to the geriatric ward. An independent pharmacist compared the clinical decision support alerts with the DDIs identified by clinical pharmacists and evaluated their interventions. Contextual factors used by the clinical pharmacists for evaluation of the clinical relevance were analysed. Adverse drug events related to DDIs were investigated and the causality was evaluated by a clinical pharmacologist based on validated criteria.

Main Outcome Measure: Number of alerts, interventions and the acceptance rates.

Results: Fifty patients followed by the clinical pharmacists, were included. The clinical pharmacists identified 240 DDIs (median of 3.5 per patient) and advised a therapy change for 16 of which 13 (81.2 %) were accepted and three (18.8 %) were not. The decision support system generated only six alerts of which none were accepted by the physicians. Thirty-seven adverse drug events were identified for 29 patients that could be related to 55 DDIs. For two interactions the causality was evaluated as certain, for 31 as likely, for ten as possible and for 12 as unlikely. Mainly intermediate level interactions were related to adverse drug events. Contextual factors taken into account by the clinical pharmacists for evaluation of the interactions were blood pressure, international normalised ratio, heart rate, potassium level and glycemia. Additionally, the clinical pharmacists looked at individual administration intervals and drug sequence to determine the clinical relevance of the interactions.

Conclusion: Clinical pharmacists performed better than the decision support system mainly because the system screened only for high level DDIs and because of the low specificity of the alerts. This specificity can be increased by including contextual factors into the logic and by defining appropriate screening intervals that take into account the sequence in which the drugs are given.
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http://dx.doi.org/10.1007/s11096-014-9925-xDOI Listing
June 2014

Discrepancies in medication information for the primary care physician and the geriatric patient at discharge.

Ann Pharmacother 2012 Jul-Aug;46(7-8):983-90. Epub 2012 Jul 24.

Department of Clinical Pharmacology and Pharmacotherapy, Universitair Ziekenhuis Brussel, Jette, Belgium.

Background: Medication discrepancies in discharge medication lists can lead to medication errors and adverse drug events following discharge.

Objective: To determine the incidence and type of discrepancies between the discharge letter for the primary care physician and the patient discharge medication list as well as identify possible patient-related determinants for experiencing discrepancies.

Methods: A retrospective, single-center, cohort study of patients discharged from the acute geriatric department of a Belgian university hospital between September 2009 and April 2010 was performed. Medications listed in the discharge letter for the primary care physician were compared with those in the patient discharge medication list. Based on the clinical pharmacist-acquired medication list at hospital admission and the medications administered during hospitalization, we determined for every discrepancy whether the medication listed in the discharge letter or the patient discharge medication list was correct.

Results: One hundred eighty-nine discharged patients (mean [SD] age 83.9 [5.7] years, 64.0% female) were included in the study. Almost half of these patients (90; 47.6%) had 1 or more discrepancies in medication information at discharge. The discharge letters were often more complete and accurate than the patient discharge medication lists. The most common discrepancies were omission of a brand name in the patient discharge medication list and omission of a drug in the discharge letter. Increasing numbers of drugs in the discharge medication list (OR 1.19; 95% CI 1.07 to 1.32; p = 0.001) and discharge letter (OR 1.18; 95% CI 1.07 to 1.32; p = 0.001) were associated with a higher risk for discrepancies.

Conclusions: Discrepancies between the patient discharge medication list and the medication information in the discharge letter for the primary care physician occur frequently. This may be an important source of medication errors, as confusion and uncertainty about the correct discharge medications can originate from these discrepancies. Increasing numbers of drugs involve a higher risk for discrepancies. Medication reconciliation between both lists is warranted to avoid medication errors.
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http://dx.doi.org/10.1345/aph.1R022DOI Listing
December 2012

Effect of medication reconciliation at hospital admission on medication discrepancies during hospitalization and at discharge for geriatric patients.

Ann Pharmacother 2012 Apr 13;46(4):484-94. Epub 2012 Mar 13.

Universitair Ziekenhuis (UZ) Brussel, Department of Clinical Pharmacology and Pharmacotherapy, Jette, Belgium.

Background: Medication discrepancies have the potential to cause harm. Medication reconciliation by clinical pharmacists aims to prevent discrepancies and other drug-related problems.

Objective: To determine how often discrepancies in the physician-acquired medication history result in discrepancies during hospitalization and at discharge. Secondary objectives were to determine the influence of clinical pharmacists' interventions on discrepancies and to investigate possible patient-related determinants for experiencing discrepancies.

Methods: This was a retrospective, single-center, cohort study of patients who were admitted to the acute geriatric department of a Belgian university hospital and followed up by clinical pharmacists between September 2009 and April 2010. Patients were limited to those 65 years or older who were taking 1 or more prescription drug. Medication reconciliation at admission, during hospitalization, and at discharge was conducted by an independent pharmacist who gathered information via chart reviews.

Results: The reconciliation process at admission identified 681 discrepancies in 199 patients. Approximately 81.9% (163) of patients had at least 1 discrepancy in the physician-acquired medication history. The clinical pharmacists performed 386 interventions, which were accepted in 279 cases (72.3%). A quarter of the medication history discrepancies (165; 24.2%) resulted in discrepancies during hospitalization, mostly because the intervention was not accepted. At discharge, 278 medication history discrepancies (40.8%) resulted in discrepancies in the discharge letter, accounting for 50.2% of all 554 discrepancies identified in the discharge letters. The likelihood for experiencing discrepancies at admission increased by 47% for every additional drug listed in the medication history.

Conclusions: Discrepancies in the physician-acquired medication history at admission do not always correlate with discrepancies during hospitalization because of clinical pharmacists' interventions; however, discrepancies at admission may be associated with at least half of the discrepancies at discharge. Clinical pharmacist-conducted medication reconciliation can reduce these discrepancies, provided the erroneous information in the physician-acquired medication history is corrected and each intentional change in the medication plan is well documented during hospitalization and at discharge.
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http://dx.doi.org/10.1345/aph.1Q594DOI Listing
April 2012

Determinants of folic acid use in a multi-ethnic population of pregnant women: a cross-sectional study.

J Perinat Med 2011 11 29;39(6):685-92. Epub 2011 Jul 29.

Department of Pharmacology, Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Laarbeeklaan 103, Belgium.

Aims: To investigate the possible differences in folic acid use and to identify the determinants of antenatal folic acid use among multi-ethnic pregnant women.

Methods: Three hundred and fifty pregnant women participated in this cross-sectional study in a university hospital in Brussels, Belgium. A questionnaire was used to obtain data on socio-demographic characteristics and folic acid use. χ(2)-tests and binary logistic regression analyses were performed using SPSS 17.

Results: In the overall cohort, 59.2% used folic acid supplements during pregnancy. This supplement use was associated with an age of 26-35 years, being of Western origin, with high education and employment status, understanding physician's instructions, and early booking for antenatal care. Education (odds ratio, OR: 2.24; 95% confidence interval, CI: 1.08-4.63) and early booking for antenatal care OR: 2.45; 95% CI: 1.11-5.40) were the most important determinants. In particular for Arab/Turkish women, a lower employment status OR: 0.42; 95% CI: 0.24-0.73) was associated with a higher risk of not using folic acid supplements.

Conclusions: The lower use of folic acid supplements in Arab/Turkish ethnicities, which may be associated with an increased risk of neural tube defects, is related to socio-economic factors rather than to lower educational attainment. As recommended by other studies, fortification of ethnic minority food may be warranted to reduce the risk of neural tube defects.
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http://dx.doi.org/10.1515/jpm.2011.085DOI Listing
November 2011

Medication history reconciliation by clinical pharmacists in elderly inpatients admitted from home or a nursing home.

Ann Pharmacother 2010 Oct 24;44(10):1596-603. Epub 2010 Aug 24.

Department of Clinical Pharmacology and Pharmacotherapy, Universitair Ziekenhuis Brussel, Brussels, Belgium.

Background: Accurate medication histories at hospital admission are an important element of medication safety. Discrepancies may have clinically significant consequences, especially in the elderly population.

Objective: To assess the clinical pharmacist's performance in obtaining patients' medication histories and in reconciling these data with the medical records and medication orders and whether the patients' residential situation prior to hospitalization influences the number of drug discrepancies.

Methods: A prospective observational study was conducted at a 29-bed acute geriatric ward of a Belgian university hospital. Medication histories acquired by clinical pharmacists were compared with those documented in the medical records by the attending physicians. All discrepancies were identified and categorized by an independent pharmacist and were scored for their clinical relevance in consensus by a senior internist and a senior geriatrician.

Results: Of the 215 screened geriatric (aged ≥65 years) patients admitted between October 27, 2007, and September 23, 2008, 197 were enrolled in the study. For patients living in the community, as well as those residing in a nursing home prior to hospitalization, clinical pharmacists identified significantly more preadmission drugs compared with physicians, with a median number of 8 correctly identified medications versus 6, respectively (p < 0.001). Extra identified drugs consisted of over-the-counter as well as prescription medications. Furthermore, 117 other medication discrepancies were noted, mainly related to erroneous drug identification and incorrect drug dose. In all, the clinical pharmacists identified 379 (24.2%) medication discrepancies, of which 188 (49.6%) were judged clinically relevant.

Conclusions: Pharmacist-acquired medication histories enhance the medication reconciliation process, both in patients residing at home and in a nursing home prior to hospitalization. A focus should be placed on seamless care procedures that facilitate the transfer of medication histories between primary and secondary care in both of these populations.
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http://dx.doi.org/10.1345/aph.1P192DOI Listing
October 2010

Modulation of viral replication in macrophages persistently infected with the DA strain of Theiler's murine encephalomyelitis virus.

Virol J 2008 Aug 4;5:89. Epub 2008 Aug 4.

Department of Pharmaceutical Biotechnology and Molecular Biology, Vrije Universiteit Brussel, Brussels, Belgium.

Background: Demyelinating strains of Theiler's murine encephalomyelitis virus (TMEV) such as the DA strain are the causative agents of a persistent infection that induce a multiple sclerosis-like disease in the central nervous system of susceptible mice. Viral persistence, mainly associated with macrophages, is considered to be an important disease determinant that leads to chronic inflammation, demyelination and autoimmunity. In a previous study, we described the establishment of a persistent DA infection in RAW macrophages, which were therefore named DRAW.

Results: In the present study we explored the potential of diverse compounds to modulate viral persistence in these DRAW cells. Hemin was found to increase viral yields and to induce cell lysis. Enviroxime and neutralizing anti-TMEV monoclonal antibody were shown to decrease viral yields, whereas interferon-alpha and interferon-gamma completely cleared the persistent infection. We also compared the cytokine pattern secreted by uninfected RAW, DRAW and interferon-cured DRAW macrophages using a cytokine protein array. The chemokine RANTES was markedly upregulated in DRAW cells and restored to a normal expression level after abrogation of the persistent infection with interferon-alpha or interferon-gamma. On the other hand, the chemokine MCP-1 was upregulated in the interferon-cured DRAW cells.

Conclusion: We have identified several compounds that modulate viral replication in an in vitro model system for TMEV persistence. These compounds now await further testing in an in vivo setting to address fundamental questions regarding persistent viral infection and immunopathogenesis.
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http://dx.doi.org/10.1186/1743-422X-5-89DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2515842PMC
August 2008

Theiler's virus strain-dependent induction of innate immune responses in RAW264.7 macrophages and its influence on viral clearance versus viral persistence.

J Neurovirol 2007 ;13(1):47-55

Department of Pharmaceutical Biotechnology and Molecular Biology, Vrije Universiteit Brussel, Brussels, Belgium.

Infection of susceptible mice with the DA strain of Theiler's murine encephalomyelitis virus (TMEV) induces a persistent central nervous system infection accompanied by demyelination that resembles multiple sclerosis. In contrast, Theiler's GDVII strain does not persist, because infected animals either clear the virus or die. Previously, the authors have shown that in vitro infection of RAW264.7 macrophages displays a similar strain-dependent outcome, resulting in the establishment of a persistent infection with the DA strain and clearance of the GDVII strain. Here, the authors show that when RAW264.7 cells were infected with both strains, the antiviral response triggered by the GDVII virus interfered with the DA virus' ability to induce a persistent infection. Treatment of cells with 2-aminopurine, a protein kinase R inhibitor, increased GDVII virus yields in contrast to DA virus yields. By comparing the antiviral activity of RAW264.7 macrophages against TMEV, it was found that GDVII-infected macrophages mounted a five times more potent antiviral response than the DA-infected ones, indicating that there are strain-dependent differences in the induction of host innate immune responses. Measurements of interferon (IFN) production confirmed this finding. In addition, it was found that the macrophages' antiviral response is dependent on the multiplicity of infection. The antiviral activity resulting from GDVII-infected macrophages could be partially neutralized with antibodies against IFN-alpha or IFN-gamma, but not with an anti-IFN-beta antibody. Because only a partial neutralization was reached, the authors speculate that apart from the investigated IFNs, other cellular factors contribute to the observed antiviral activity. Taken together, these results demonstrate the importance of host innate immune responses in determining the balance between viral clearance and viral persistence.
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http://dx.doi.org/10.1080/13550280601145357DOI Listing
July 2007

Persistent infection of RAW264.7 macrophages with the DA strain of Theiler's murine encephalomyelitis virus: An in vitro model to study viral persistence.

J Neurovirol 2006 Apr;12(2):108-15

Department of Pharmaceutical Biotechnology and Molecular Biology, Vrije Universiteit Brussel, Brussels, Belgium.

Theiler's murine encephalomyelitis virus (TMEV) is a member of the Picornaviridae family and causes a virus strain dependent pathology in the central nervous system of mice. The GDVII strain induces an acute and mostly fatal encephalomyelitis. In the few mice that survive, the virus is cleared by the immune system. In contrast, infection with the DA strain leads to a persistent infection, marked by inflammation and demyelination that resembles multiple sclerosis. In the DA-induced disease, macrophages play a crucial role because they contribute to demyelination by the secretion of toxic mediators. Moreover, they represent the main viral reservoir, hereby also underlining their essential role in TMEV persistence. The mechanism of this persistence is not yet understood and tools to investigate it directly, without the complexity imposed by experimental animals, are largely missing. By studying TMEV infection of RAW264.7 macrophages, we found that the DA strain establishes a persistent infection in these cells, in contrast to the neurovirulent GDVII strain. Whereas the GDVII strain was cleared within 4 to 5 days post infection, DA virions were still present after 1 year of cell cultivation. This persistently DA-infected macrophage cell line, which we have called DRAW, provides a model to investigate the interactions between the cellular and viral factors influencing persistence and to screen for anti-TMEV agents.
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http://dx.doi.org/10.1080/13550280600714120DOI Listing
April 2006

Replication of Theiler's murine encephalomyelitis virus in Xenopus laevis oocytes.

Virus Res 2005 Jan;107(1):35-8

Department Microbiologie en Hygiëne, Vrije Universiteit Brussel, Laarbeeklaan 103, B-1090 Brussel, Belgium.

Xenopus laevis oocytes can be used as an alternative system to study replication of Theiler's murine encephalomyelitis virus (TMEV). We have shown that transcript RNA, containing full-length viral genome, can be directly used to programme the oocytes. In the programmed oocytes, there is correct viral translation, polyprotein processing and assembly of capsid proteins leading to the production of infectious TMEV. The vast majority of de novo synthesised virions were found in the medium in which the programmed oocytes were incubated and not in the oocytes.
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http://dx.doi.org/10.1016/j.virusres.2004.06.009DOI Listing
January 2005
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