Publications by authors named "Koen Boussery"

87 Publications

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

Appropriateness of direct oral anticoagulant dosing in patients with atrial fibrillation according to the drug labelling and the EHRA Practical Guide.

Int J Cardiol 2021 Apr 3;328:97-103. Epub 2020 Dec 3.

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

Background: This study aimed to evaluate the prevalence of potential drug-drug interactions (DDIs) and the appropriateness of direct oral anticoagulant (DOAC) dosing according to both the Summary of Product Characteristics (SmPC) and the European Heart Rhythm Association (EHRA) Practical Guide in a 'real-world' sample of non-valvular atrial fibrillation (NVAF) patients.

Methods And Results: Data of a cross-sectional observational study in a primary care sample of 654 long-term DOAC users were used for this sub-analysis. A total of 262 potential DDIs were identified in 220 patients (33.6%). Pharmacodynamic DDIs were present in 163 patients (24.9%) and pharmacokinetic DDIs in 82 patients (12.5%). One-third of patients (33.8%) received reduced DOAC dose. According to the dosing recommendations in the SmPC, 81.7% of DOACs were dosed appropriately. According to the EHRA recommendations, 76.6% of DOACs were dosed appropriately. Dosing recommendations were consistent for 90.7% of patients, with both the SmPC and EHRA Practical Guide considering DOACs dosed appropriately in 74.5% of patients, overdosed in 7.8%, underdosed in 7.6% and contraindicated in 0.8%. However, for the remaining 9.3% dosing recommendations differed between SmPC and EHRA.

Conclusions: This 'real-world' analysis of DOAC dosing demonstrated that in about one-third of NVAF patients potential DDIs were present. In 18.3% and 23.4% of patients, DOACs were dosed inappropriately according to the SmPC and EHRA Practical Guide respectively. In almost 10% of the study population dosing advice was inconsistent between both references. More research is needed to ensure appropriate DOAC dosing in this 'grey zone' population.
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http://dx.doi.org/10.1016/j.ijcard.2020.11.062DOI Listing
April 2021

Perspectives of Parents and Health Care Providers about (Non)Medical Treatment in Infants with Reflux.

Pharmacy (Basel) 2020 Nov 23;8(4). Epub 2020 Nov 23.

Department Pharmaceutical Sciences (FARM)-Laboratory Pharmaceutical Chemistry, Drug Analysis and Drug Information (FASC), Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Jette, Belgium.

Background: Reflux occurs in 50% of healthy infants at some point. This is most often a physiological condition and does not require drug treatment. Various studies have shown that the use of drugs affecting gastric acidity (DAGAs) in infants is increasing. This entails disadvantages such as unnecessary exposure of infants to medication and their side effects and a higher cost to society.

Objective: To get an image of the current practice in Flanders regarding diagnosis and treatment of gastro-oesophageal reflux disease (GORD) in infants and the associated use of DAGAs. To this end, we determined both parents' and health care providers' experiences and perceptions about these treatments.

Method: An observational cross-sectional study was conducted in April and May 2019. We developed a questionnaire for parents and three different questionnaires for health care providers (HCPs), including midwives, general practitioners, paediatricians and community pharmacists (CPs). The questionnaire for parents was only available through an online platform. HCPs were questioned face-to-face and through an online platform.

Results: This study made clear that the counselling of children with GORD is multidisciplinary as the median number of counselling HCPs is 3 (interquartile range (IQR) = 2-4). 63% of the included 251 parents also seek support through online forums and groups. 60% of parents report that no physical tests were performed before DAGAs were prescribed and 39% of parents additionally state they perceived no effect of the prescribed DAGAs. Although parents reported to understand HCPs well (average score 7.4/10), satisfaction with care and information provision was scored lower (between 4.8 and 6.1/10). On the other hand, 234 HCPs answered the questionnaire, of which 89 midwives, 78 community pharmacists and 67 physicians. Only 45 HCPs indicate that guidelines to diagnose or treat GORD are clear. Physicians confirm they perform very little physical testing before starting DAGAs. Provided nonmedical measures to patients are largely in line with the European guidelines, however perceived effectiveness is moderate.

Conclusion: Parents are in need for more information about tests, nutrition and (non)medical measures. HCPs on the other hand are in need for clear guidelines on diagnosing and treating GORD.
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http://dx.doi.org/10.3390/pharmacy8040226DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7712772PMC
November 2020

Self-Administration of Medication in Hospital: A Literature Review.

Nurs Sci Q 2020 07;33(3):249-257

Professor, Department of Nursing Science and Midwifery, Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium.

The idea of patients self-administering their medication in hospital is not new; it was first cited in literature in 1959. Up to date, there is a growing body of literature that recognizes the importance of this approach. In this current state of the literature, self-administration of medication in hospital is positioned in the context of the definition of health as proposed by Huber et al. and Orem's self-care deficit theory: first identify the concept of medication self-administration, as well as the prevalence, existing procedures, tools, and proven effects of interventions; then the findings should point the way forward for research, practice, and policy.
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http://dx.doi.org/10.1177/0894318420921155DOI Listing
July 2020

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

Heart 2020 Nov 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

ARIA digital anamorphosis: Digital transformation of health and care in airway diseases from research to practice.

Authors:
Jean Bousquet Josep M Anto Claus Bachert Tari Haahtela Torsten Zuberbier Wienczyslawa Czarlewski Anna Bedbrook Sinthia Bosnic-Anticevich G Walter Canonica Victoria Cardona Elisio Costa Alvaro A Cruz Marina Erhola Wytske J Fokkens Joao A Fonseca Maddalena Illario Juan-Carlos Ivancevich Marek Jutel Ludger Klimek Piotr Kuna Violeta Kvedariene Ltt Le Désirée E Larenas-Linnemann Daniel Laune Olga M Lourenço Erik Melén Joaquim Mullol Marek Niedoszytko Mikaëla Odemyr Yoshitaka Okamoto Nikos G Papadopoulos Vincenzo Patella Oliver Pfaar Nhân Pham-Thi Christine Rolland Boleslaw Samolinski Aziz Sheikh Mikhail Sofiev Charlotte Suppli Ulrik Ana Todo-Bom Peter-Valentin Tomazic Sanna Toppila-Salmi Ioanna Tsiligianni Arunas Valiulis Erkka Valovirta Maria-Teresa Ventura Samantha Walker Sian Williams Arzu Yorgancioglu Ioana Agache Cezmi A Akdis Rute Almeida Ignacio J Ansotegui Isabella Annesi-Maesano Sylvie Arnavielhe Xavier Basagaña Eric D Bateman Annabelle Bédard Martin Bedolla-Barajas Sven Becker Kazi S Bennoor Samuel Benveniste Karl C Bergmann Michael Bewick Slawomir Bialek Nils E Billo Carsten Bindslev-Jensen Leif Bjermer Hubert Blain Matteo Bonini Philippe Bonniaud Isabelle Bosse Jacques Bouchard Louis-Philippe Boulet Rodolphe Bourret Koen Boussery Fluvio Braido Vitalis Briedis Andrew Briggs Christopher E Brightling Jan Brozek Guy Brusselle Luisa Brussino Roland Buhl Roland Buonaiuto Moises A Calderon Paulo Camargos Thierry Camuzat Luis Caraballo Ana-Maria Carriazo Warner Carr Christine Cartier Thomas Casale Lorenzo Cecchi Alfonso M Cepeda Sarabia Niels H Chavannes Ekaterine Chkhartishvili Derek K Chu Cemal Cingi Jaime Correia de Sousa David J Costa Anne-Lise Courbis Adnan Custovic Biljana Cvetkosvki Gennaro D'Amato Jane da Silva Carina Dantas Dejan Dokic Yves Dauvilliers Giulia De Feo Govert De Vries Philippe Devillier Stefania Di Capua Gerard Dray Ruta Dubakiene Stephen R Durham Mark Dykewicz Motohiro Ebisawa Mina Gaga Yehia El-Gamal Enrico Heffler Regina Emuzyte John Farrell Jean-Luc Fauquert Alessandro Fiocchi Antje Fink-Wagner Jean-François Fontaine José M Fuentes Perez Bilun Gemicioğlu Amiran Gamkrelidze Judith Garcia-Aymerich Philippe Gevaert René Maximiliano Gomez Sandra González Diaz Maia Gotua Nick A Guldemond Maria-Antonieta Guzmán Jawad Hajjam Yunuen R Huerta Villalobos Marc Humbert Guido Iaccarino Despo Ierodiakonou Tomohisa Iinuma Ewa Jassem Guy Joos Ki-Suck Jung Igor Kaidashev Omer Kalayci Przemyslaw Kardas Thomas Keil Musa Khaitov Nikolai Khaltaev Jorg Kleine-Tebbe Rostislav Kouznetsov Marek L Kowalski Vicky Kritikos Inger Kull Stefania La Grutta Lisa Leonardini Henrik Ljungberg Philip Lieberman Brian Lipworth Karin C Lodrup Carlsen Catarina Lopes-Pereira Claudia C Loureiro Renaud Louis Alpana Mair Bassam Mahboub Michaël Makris Joao Malva Patrick Manning Gailen D Marshall Mohamed R Masjedi Jorge F Maspero Pedro Carreiro-Martins Mika Makela Eve Mathieu-Dupas Marcus Maurer Esteban De Manuel Keenoy Elisabete Melo-Gomes Eli O Meltzer Enrica Menditto Jacques Mercier Yann Micheli Neven Miculinic Florin Mihaltan Branislava Milenkovic Dimitirios I Mitsias Giuliana Moda Maria-Dolores Mogica-Martinez Yousser Mohammad Steve Montefort Ricardo Monti Mario Morais-Almeida Ralph Mösges Lars Münter Antonella Muraro Ruth Murray Robert Naclerio Luigi Napoli Leyla Namazova-Baranova Hugo Neffen Kristoff Nekam Angelo Neou Björn Nordlund Ettore Novellino Dieudonné Nyembue Robyn O'Hehir Ken Ohta Kimi Okubo Gabrielle L Onorato Valentina Orlando Solange Ouedraogo Julia Palamarchuk Isabella Pali-Schöll Peter Panzner Hae-Sim Park Gianni Passalacqua Jean-Louis Pépin Ema Paulino Ruby Pawankar Jim Phillips Robert Picard Hilary Pinnock Davor Plavec Todor A Popov Fabienne Portejoie David Price Emmanuel P Prokopakis Fotis Psarros Benoit Pugin Francesca Puggioni Pablo Quinones-Delgado Filip Raciborski Rojin Rajabian-Söderlund Frederico S Regateiro Sietze Reitsma Daniela Rivero-Yeverino Graham Roberts Nicolas Roche Erendira Rodriguez-Zagal Christine Rolland Regina E Roller-Wirnsberger Nelson Rosario Antonino Romano Menachem Rottem Dermot Ryan Johanna Salimäki Mario M Sanchez-Borges Joaquin Sastre Glenis K Scadding Sophie Scheire Peter Schmid-Grendelmeier Holger J Schünemann Faradiba Sarquis Serpa Mohamed Shamji Juan-Carlos Sisul Mikhail Sofiev Dirceu Solé David Somekh Talant Sooronbaev Milan Sova François Spertini Otto Spranger Cristiana Stellato Rafael Stelmach Michel Thibaudon Teresa To Mondher Toumi Omar Usmani Antonio A Valero Rudolph Valenta Marylin Valentin-Rostan Marilyn Urrutia Pereira Rianne van der Kleij Michiel Van Eerd Olivier Vandenplas Tuula Vasankari Antonio Vaz Carneiro Giorgio Vezzani Frédéric Viart Giovanni Viegi Dana Wallace Martin Wagenmann De Yun Wang Susan Waserman Magnus Wickman Dennis M Williams Gary Wong Piotr Wroczynski Panayiotis K Yiallouros Osman M Yusuf Heather J Zar Stéphane Zeng Mario E Zernotti Luo Zhang Nan Shan Zhong Mihaela Zidarn

Allergy 2021 01 23;76(1):168-190. Epub 2020 Oct 23.

University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

Digital anamorphosis is used to define a distorted image of health and care that may be viewed correctly using digital tools and strategies. MASK digital anamorphosis represents the process used by MASK to develop the digital transformation of health and care in rhinitis. It strengthens the ARIA change management strategy in the prevention and management of airway disease. The MASK strategy is based on validated digital tools. Using the MASK digital tool and the CARAT online enhanced clinical framework, solutions for practical steps of digital enhancement of care are proposed.
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http://dx.doi.org/10.1111/all.14422DOI Listing
January 2021

Managing Allergic Rhinitis in the Pharmacy: An ARIA Guide for Implementation in Practice.

Pharmacy (Basel) 2020 May 16;8(2). Epub 2020 May 16.

MACVIA-France, 34295 Montpellier, France.

The paradigm of how we manage allergic rhinitis is shifting with a growing understanding that it is a complex process, requiring a coordinated effort from healthcare providers and patients. Pharmacists are key members of these integrated care pathways resolving medication-related problems, optimizing regimens, improving adherence and recommending therapies while establishing liaisons between patients and physicians. Community pharmacists are the most accessible healthcare professionals to the public and allergic rhinitis is one of the most common diseases managed by pharmacists. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines developed over the past 20 years have improved the care of allergic rhinitis patients through an evidence-based, integrated care approach. In this paper, we propose an integrated approach to allergic rhinitis management in community pharmacy following the 2019 ARIA in the pharmacy guidelines.
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http://dx.doi.org/10.3390/pharmacy8020085DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7355936PMC
May 2020

Benefits and harm of systemic steroids for short- and long-term use in rhinitis and rhinosinusitis: an EAACI position paper.

Clin Transl Allergy 2020 3;10. Epub 2020 Jan 3.

3Upper Airway Research Laboratory, Dep. of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium.

Because of the inflammatory mechanisms of most chronic upper airway diseases such as rhinitis and chronic rhinosinusitis, systemic steroids have been used for their treatment for decades. However, it has been very well documented that-potentially severe-side-effects can occur with the accumulation of systemic steroid courses over the years. A consensus document summarizing the benefits of systemic steroids for each upper airway disease type, as well as highlighting the potential harms of this treatment is currently lacking. Therefore, a panel of international experts in the field of Rhinology reviewed the available literature with the aim of providing recommendations for the use of systemic steroids in treating upper airway disease.
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http://dx.doi.org/10.1186/s13601-019-0303-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6941282PMC
January 2020

Studying the impact of a medication use evaluation by the community pharmacist (Simenon): Drug-related problems and associated variables.

Res Social Adm Pharm 2020 Aug 21;16(8):1100-1110. Epub 2019 Nov 21.

Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Herestraat 49 O&N2 Box 521, 3000, Leuven, Belgium. Electronic address:

Background: A medication use review (MUR) aims to optimize medication use, patient knowledge and can improve health outcomes. This pharmaceutical care service is not yet available in Belgium.

Objectives: To describe drug-related problems (DRPs) detected during a MUR, subsequent interventions proposed by pharmacists and evolution of DRPs until follow-up and to identify patient-related variables associated with the number of reported DRPs.

Methods: Belgian community pharmacists provided a MUR to older polymedicated ambulatory patients and registered DRPs, interventions and resolution at follow-up using the PharmDISC classification. The relationship between 14 patient-related variables and the number of reported DRPs was investigated with univariate analysis. A prediction model was developed with significant variables using negative binomial regression analysis.

Results: Across 56 pharmacies, 453 patients received a MUR and 1196 DRPs were registered (median 3DRPs/patient, range 0-10). Only for 11.7% of patients no problems were identified. The top-3 causes were interaction (15.2%), inappropriate timing or frequency (13.5%) and adverse effect (11.9%). The top-3 recommended interventions by pharmacists were transmission of information (25.1%), in-depth patient counselling (15.0%) and therapy stop (8.2%). After six weeks, 42.6% of DRPs were resolved; data was missing for 33.3%. A higher number of chronic drugs, female gender and living alone were associated with more DRPs. The prediction model found that per additional chronic drug, the number of problems increases by 4.3% (95% CI: 2.0-6.6%). Male gender decreases DRPs by 22.1% (95% CI: 10.4-32.0%). Living alone provided no additional predictive value in the prediction model. Confounding process- and pharmacist-related variables also influenced the number of reported DRPs.

Conclusion: A MUR appears an effective strategy to detect and resolve DRPs. The number of chronic medications and female gender predict a higher number of DRPs. These findings are a starting point for evidence-based eligibility criteria for a MUR service in Belgium.
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http://dx.doi.org/10.1016/j.sapharm.2019.11.008DOI Listing
August 2020

Eye drop technique and patient-reported problems in a real-world population of eye drop users.

Eye (Lond) 2020 08 5;34(8):1392-1398. Epub 2019 Nov 5.

Pharmaceutical Care Unit, Ghent University, Ghent, Belgium.

Objective: To assess eye drop technique and patient-reported problems with eye drop instillation in a primary care sample of eye drop users.

Methods: Cross-sectional observational study in 136 community pharmacies in Belgium. Patient inclusion criteria were being age ≥ 18 years and using eye drops for ≥ 1 month (to ensure that patients were already familiar with eye drop instillation). Participants demonstrated their eye drop technique and completed a self-administered questionnaire.

Results: Participants (n = 678) had a mean age of 68.9 ± 12.4 years. During the demonstration, almost everyone (98.0%) successfully instilled at least one drop in the eye, although 14% required multiple attempts to achieve this. Only 3% of the sample exhibited perfect drop technique, meaning that they performed correctly all the steps. Most common deviations were touching the bottle to the eye or eyelid (40.7% of patients), and failing to close the eye (67.8%) and perform nasolacrimal occlusion for at least 1 min (94.7%) after drop instillation. Importantly, we found that 20% of ophthalmic suspensions were not shaken before use. Forty percent of patients reported ≥ 1 problem with eye drop instillation. Most common problems were difficulties with getting a drop in the eye (18.3% of patients), too many drops coming out of the bottle (14.6%), and difficulty squeezing the bottle (12.2%). About half of the sample recalled having had education in eye drop instillation technique.

Conclusion: This study showed suboptimal eye drop technique in real-world clinical practice. A proactive role of community pharmacists in detecting and resolving these problems could be helpful.
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http://dx.doi.org/10.1038/s41433-019-0665-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376112PMC
August 2020

The perspectives of parents, general practitioners, and community pharmacists about treating an ill child in primary care: a comparative study.

Eur J Pediatr 2020 Jan 29;179(1):111-119. Epub 2019 Oct 29.

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

As children are unable to make health-related decisions themselves, parents play a central role in consultations with healthcare providers. Parents' perspectives are therefore the focus of this study. Our first aim was to determine parents' expectations of a healthcare visit with a general practitioner and a community pharmacist. The second aim was to determine the general practitioners' and community pharmacists' perspectives about consultations with children. An observational cross-sectional study was conducted in April and May 2018. We developed three questionnaires: one for parents, one for general practitioners, and one for community pharmacists. The questionnaire for parents was only available through an online platform. The healthcare providers were questioned face-to-face and through an online platform. The study included 380 respondents. Parents considered prescribing or proposing medication the least important action by a general practitioner or community pharmacist, respectively. As well, parents expect information in most cases from both healthcare providers. The questionnaire for general practitioners and community pharmacists revealed that prescribing or proposing medication was regarded the least important action.Conclusion: Considering parents' expectations for a consultation with a general practitioner or community pharmacist, there is a substantial resemblance with the healthcare providers' perspective.What is Known:• The previous studies focusing on parents' perspectives were carried out in a hospital setting or focused on a specific disorder.• Parents consider reassurance and advice from their general practitioner to be very important; the treatment is considered less important.What is New:• Parents considered for both general practitioners' and community pharmacists' verbal information, answers to their questions, and reassurance as more important than receiving pharmacological treatment, while general practitioners and community pharmacists consider prescribing/proposing medication and providing written information as less important.• The expectations of the different groups (parents in relation to not only the healthcare providers but also the general practitioners and community pharmacists compared to each other) know a great resemblance.
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http://dx.doi.org/10.1007/s00431-019-03476-8DOI Listing
January 2020

Application of the GheOPS-tool in nursing home residents: acceptance and implementation of pharmacist recommendations.

Acta Clin Belg 2020 Dec 26;75(6):388-396. Epub 2019 Jun 26.

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

: The prevalence of potentially inappropriate prescribing (PIP) among nursing home (NH) residents is high. This study aimed to investigate the acceptance and implementation of pharmacist recommendations based on a screening tool for PIP, the Ghent Older People's Prescriptions community Pharmacy Screening (GheOPS)-tool. : Prospective observational study in NH residents (≥ 70 years, using ≥ 5 medications) with a 3-month follow-up period. A pharmacist screened the medication lists using the GheOPS-tool and formulated recommendations to reduce PIP. The acceptance of recommendations discussed during face-to-face pharmacist-general practitioner (GP) meetings was recorded. Implementation was examined by comparing baseline and follow-up medication lists. A pre-post comparison of the number of chronic medications and GheOPS-criteria; the anticholinergic and sedative burden quantified by the Drug Burden Index (DBI); and medication costs was performed. : Screening with the GheOPS-tool resulted in 168 pharmacist recommendations for 50 NH residents, mainly to stop (78.0%) and to substitute (14.3%) medications. Ninety-three % (156/168) of recommendations were considered relevant. GPs acceptance rate was 44.9%. Fifty-four % of all accepted recommendations were implemented. At follow-up, the number of chronic medications (p = 0.007), and DBI scores (p = 0.004) significantly differed from baseline. There was no significant decrease in the number of GheOPS-criteria (p = 0.075) and medication costs (p > 0.05). : The acceptance and implementation of pharmacist recommendations were relatively low. Future studies should increase the involvement of patients and all health-care providers. Interdisciplinary collaboration with sufficient education for all disciplines and patients is essential.
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http://dx.doi.org/10.1080/17843286.2019.1634323DOI Listing
December 2020

Switchability of Gabapentin Formulations: A Randomized Trial to Assess Bioequivalence Between Neurontin and Gabasandoz on the Individual Subject Level.

Clin Pharmacol Ther 2019 07 2;106(1):195-203. Epub 2019 Mar 2.

Laboratory of Medical Biochemistry and Clinical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium.

Generic substitution of antiepileptic drugs is generally not advised by neurologists. The present study investigated the switchability of gabapentin 800 mg tablets (Neurontin and Gabasandoz) using an individual bioequivalence (IBE) study design with two batches of each product and assessed whether between-batch and between-formulation variability in exposure play a significant role in the within-subject variability. The trial was analyzed according to the US Food and Drug Administration (FDA) framework to establish IBE. The IBE was shown between both products with the 95% upper confidence bound of the IBE criterion being -2.01 and -2.31 for area under the concentration-time curve from zero to infinity (AUC ) and peak plasma concentration (C ), respectively. Subject-by-formulation variability (1.35%) was negligible compared with the within-subject variability of AUC with Neurontin (19.0%) and Gabasandoz (23.6%). Inclusion of an additional batch did not significantly change this within-subject variability (20.2% and 23.6%, respectively). This study shows that substitution of gabapentin 800 mg tablets of Neurontin and Gabasandoz should be possible without affecting clinical outcomes.
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http://dx.doi.org/10.1002/cpt.1353DOI Listing
July 2019

Pharmacokinetic evaluation of linezolid administered intravenously in obese patients with pneumonia.

J Antimicrob Chemother 2019 03;74(3):667-674

Laboratory of Medical Biochemistry and Clinical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, Ghent, Belgium.

Objectives: Altered linezolid pharmacokinetics (PK) in obese individuals has been hypothesized in previous studies. However, specific dosing recommendations for this population are still lacking. The main goal of this study was to evaluate PK/pharmacodynamic (PKPD) target attainment when using a 600 mg intravenous q12h linezolid dose against MRSA in obese patients with pneumonia.

Methods: Fifteen obese pneumonia patients with a confirmed or suspected MRSA involvement treated with 600 mg of intravenous linezolid q12h were studied for 3 days. Population PK modelling was used to characterize the PK variability and to screen for influential patient characteristics. Monte Carlo simulations were carried out to investigate the PTA and time to target attainment for linezolid dosing against MRSA.

Results: A two-compartment model with linear elimination adequately described the data. Body weight and age both have a significant effect on linezolid clearance. Simulations demonstrate that the probability of attaining PKPD targets is low. Moreover, the PTA decreases with weight, and increases with age. Standard linezolid dosing in obese pneumonia patients with MRSA (MICs of 1-4 mg/L) leads to unacceptably low (near zero to 60%) PTA for patients <65 years old.

Conclusions: Standard linezolid dosing is likely to provide insufficient target attainment against MRSA in obese patients. Body weight and especially age are important characteristics to be considered when administering linezolid to treat MRSA infections.
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http://dx.doi.org/10.1093/jac/dky500DOI Listing
March 2019

Self-Medication With Over-the-Counter Analgesics: A Survey of Patient Characteristics and Concerns About Pain Medication.

J Pain 2019 02 28;20(2):215-223. Epub 2018 Sep 28.

Pharmaceutical Care Unit.

Pain is a common reason for self-medication with over-the-counter (OTC) analgesics. However, this self-treating population has remained largely uncharacterized. This cross-sectional observational study investigated individuals who self-medicate their pain with OTC analgesics to elucidate their pain characteristics and medication use. In addition, presence of and risk factors for concerns about pain medication were examined. The clinical profile of the participants (n = 1,889) was worse than expected with long-standing pain complaints (median pain duration of 9 years), pain located at multiple body sites (median of 4, and 13% with ≥10 painful body areas), about one-third suffering from daily pain and about 40% experiencing substantial pain-related disability. Head (58.6% of sample), low back (43.6%), and neck (30.7%) were the most common pain locations. About 73% had a physician diagnosis, mainly migraine and osteoarthritis. Paracetamol (used by 68.6% of patients) and nonsteroidal anti-inflammatory drugs (46.8%) were the most frequently used pain medications. About 40% of our sample showed substantial concern about the perceived need for pain medication and the perceived potential for harmful effects (eg, fear for addiction). These findings highlight the importance for health professionals to systematically probe pain patients about their self-medication practices and explore attitudes about pain medication. Perspective: This study found that the clinical picture of people who self-medicate their pain with OTC analgesics looked worse than expected. We also identified substantial concerns about pain medication. Therefore, we recommend that health professionals systematically probe pain patients about their self-medication practices and explore concerns about pain medication.
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http://dx.doi.org/10.1016/j.jpain.2018.09.003DOI Listing
February 2019

Implementation study of an intermediate medication review in Belgian community pharmacies.

Res Social Adm Pharm 2019 06 12;15(6):710-723. Epub 2018 Sep 12.

Department of Pharmacotherapy and Pharmaceutics, Faculté de Pharmacie, Université Libre de Bruxelles (ULB), Brussels, Belgium. Electronic address:

Background: The Association of Pharmacists in Belgium (APB) and local pharmacy associations launched a pilot project in collaboration with research teams from three Belgian universities to study the impact and implementation-related issues of a medication review (MR) service type 2a in Belgian community pharmacies.

Objective: The aim of this paper is to describe the implementation process of the MR service and to present the implementation evaluation of the pilot study (testing stage).

Methods: The pilot project was a prospective observational study using mixed methods. The implementation evaluation was based on the RE-AIM model and the framework for the implementation of services in pharmacy (FISpH). Collected implementation outcomes were classified into four dimensions: reach, adoption, implementation and intent of maintenance.

Results: During the testing stage, 80 pharmacies participated in the study, but 25 dropped out (31%), mainly because of a reported lack of time (adoption). The 55 remaining pharmacies included 457 patients. Recruiting patients into the service was challenging for pharmacists as 48.5% of patients refused the pharmacists' proposal (reach). Internal organizational factors were major barriers for pharmacists, followed by the lack of adoption by the pharmacy team. Large pharmacies in which pharmacy owner led the project were observed to be more proactive in implementing the MR service by integrating organizational strategies to assist the implementation process (implementation). Interviewed pharmacists perceived this new service as a professionally satisfying activity. Among participating pharmacists, 92.5% found this service feasible in practice, but believed it required adapted resources to reorganize the internal pharmacy workload, additional support, such as broad-based media campaigns to increase physicians' and patients' awareness and attitudes towards the service, and modified software (maintenance).

Conclusions: The medication review service was implemented in 68% of participating pilot Belgian community pharmacies but would require adapted resources and supports for larger scale implementation.
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http://dx.doi.org/10.1016/j.sapharm.2018.09.002DOI Listing
June 2019

A shared medication scheme for community dwelling older patients with polypharmacy receiving home health care: role of the community pharmacist.

Acta Clin Belg 2019 Oct 20;74(5):326-333. Epub 2018 Sep 20.

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

: An accurate medication scheme may be a useful tool to improve medication safety in primary care. This study aimed to identify (1) pharmacists' alterations to nurse medication schemes and (2) potential improvements to the contribution of the community pharmacist to a shared medication scheme within a multidisciplinary collaboration. Dosing frequency, potentially incorrect moments of intake, drug-drug interactions and medication complexity (quantified by the Medication Regimen Complexity Index, MRCI) were investigated. : Observational study in community dwelling older patients (≥70 years) with polypharmacy receiving home health care (i.e. medications being prepared and/or administered by home care nurses). Home care nurses provided the community pharmacist with the original medication scheme ('nurse medication scheme'), subsequently the community pharmacist generated a standardized 'pharmacist medication scheme' which was uploaded on an electronic health platform (Vitalink). The researcher recorded all pharmacists' alterations and looked for possible additional improvements ('researcher medication scheme'). : Pharmacists made 482 alterations to the nurse medication schemes of 31 patients. Most important alterations included adding indication (61%), generic or brand name (18%) and moment of intake (9%). Pharmacists did not reduce dosing frequency. MRCI scores (median [IQR]) significantly differed between pharmacist (38 [15]) and nurse medication schemes (32 [11]) ( < 0.001) and between nurse (32 [11]) and researcher medication schemes (40 [15]) ( < 0.001). : Alterations made by the community pharmacists enable more complete and accurate medication schemes; however, there is room for improvement in optimizing the patient's medication scheme in a multidisciplinary collaboration.
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http://dx.doi.org/10.1080/17843286.2018.1521903DOI Listing
October 2019

An Evidence-Based Procedure for Self-Management of Medication in Hospital: Development and Validation of the SelfMED Procedure.

Pharmacy (Basel) 2018 Jul 26;6(3). Epub 2018 Jul 26.

Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, 9000 Ghent, Belgium.

Aim: To develop and validate a procedure for self-management of medication by patients whilst in hospital.

Background: Self-management of medication allows patients to self-manage their medication in a controlled and supportive hospital environment. This practice is encouraged worldwide, yet an evidence-based procedure to evaluate the ability of patients to self-manage and to monitor and support self-management are absent.

Methods: The evidence-based procedure for self-management of medication (SelfMED) was developed based on previous conducted qualitative research, literature review, and the current regulation. It was validated by healthcare providers and a multidisciplinary expert meeting. Questions within the procedure that could be biased were tested for inter-rater reliability.

Results: First, the SelfMED procedure was developed. It consists of a stepped assessment of patient's competencies for self-management performed by healthcare providers and the patient. When self-management is allowed, the SelfMED monitoring tool monitors the patient's intake of self-managed medication. Secondly, the procedure was revised for clarity, appropriateness, and face validity by five healthcare providers and a multidisciplinary expert meeting, resulting in the final version. Thirdly, three questions from the final version were tested for interrater reliability. Cohen's Kappa showed moderate to strong levels of agreement.

Conclusions: The developed SelfMED procedure provides an evidence based approach of facilitating self-management of medication. The content of the procedure was found valid to evaluate the patient's ability to self-manage and to monitor them while self-managing.
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http://dx.doi.org/10.3390/pharmacy6030077DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6164845PMC
July 2018

The willingness and attitude of patients towards self-administration of medication in hospital.

Ther Adv Drug Saf 2018 Jun 26;9(6):309-321. Epub 2018 Mar 26.

Department of Healthcare, Thomas More University College, Lier, Belgium.

Background: Literature suggests a positive impact of self-administration of medication during hospitalization on medication adherence and safety, and on patient satisfaction. However, self-administration is not a common practice in Belgian hospitals. The aim of this study was to describe patients' willingness towards self-administration of medication while in hospital.

Methods: A cross-sectional observational study was conducted in three Belgian hospitals in November and December 2015. All patients of 14 randomly selected wards were asked to participate. The structured questionnaire comprised patient characteristics, their willingness and attitude towards self-administration of medication, perceived ability to self-administer during hospitalization, and prerequisites and perceived consequences.

Results: In total, 124 patients participated (36% of all eligible patients). The main reasons not to participate were the patients' physical and mental condition (30%) and the absence of patients during the time of data collection (23%). The majority of the 124 participating patients had a positive attitude towards the implementation of self-administration; 83.9% were willing to self-administer their medication while in hospital. Most important prerequisites were self-administration at home before and after hospitalization, patients' motivation, and a regular evaluation of the patients' competences. Patients acknowledged benefits such as an increase in autonomy, independence and medication knowledge. Patients did not expect self-administration would cause important safety issues.

Conclusion: The majority of patients, capable of participating in the study, would want to self-administer medication during hospitalization. They had a positive attitude towards self-administration of medication. Nevertheless, patients stated important conditions which need to be considered in order to implement self-administration.
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http://dx.doi.org/10.1177/2042098618764536DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5971398PMC
June 2018

Development and Application of the GheOPS-Tool Addendum on Potentially Inappropriate Prescribing (PIP) of Renally Excreted Active Drugs (READs) in Older Adults with Polypharmacy.

Drugs Aging 2018 Apr;35(4):343-364

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

Background: Renal function progressively worsens with age. Potentially inappropriate prescribing (PIP) of renally excreted active drugs (READs) is common in older adults, leading to an increased rate of iatrogenic illness. The Ghent Older People's Prescription community Pharmacy Screening (GheOPS-) tool is an effective, explicit instrument that was developed for community pharmacists (CPs) to detect PIP. So far, this tool does not assess PIP of the frequently used READs in older patients with renal impairment.

Objectives: This study aimed to expand the GheOPS-tool with the first addendum to screen for PIP of frequently used READs, and to perform a cross-sectional analysis using the addendum and the medication history of a group of older adults with polypharmacy.

Methods: The addendum was developed in three steps: (1) collection of individual and combined READs, (2) collection of dose-adjustment recommendations, and (3) expert panel evaluation. Consequently, the addendum was applied retrospectively on the medication list of 60 older adults with polypharmacy and with four renal function-estimating equations.

Results: The addendum includes 61 READs recommendations for dose/drug-adjustment alternatives, laboratory test follow-ups, and patients' referral to specialists' care. In the cross-sectional analysis, 35-78% of patients were diagnosed with renal impairment, depending on the equations used for renal function estimation. Among patients with renal impairment, 21-46% of the prescribed READs were deemed potentially inappropriate by the GheOPS-tool addendum.

Conclusion: The GheOPS-tool was expanded with an addendum on PIP of READs in renal impairment for older patients. The cross-sectional analysis using the addendum suggests that PIP of READs is common in older patients with polypharmacy and renal impairment. Using this addendum, CPs might contribute to diminishing PIP of READs.
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http://dx.doi.org/10.1007/s40266-018-0530-xDOI Listing
April 2018

The Introduction of a Full Medication Review Process in a Local Hospital: Successes and Barriers of a Pilot Project in the Geriatric Ward.

Pharmacy (Basel) 2018 Feb 28;6(1). Epub 2018 Feb 28.

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

For the majority of Belgian hospitals, a pharmacist-led full medication review process is not standard care and, therefore, challenging to introduce. With this study, we aimed to evaluate the successes and barriers of the implementation of a pharmacist-led full medication review process in the geriatric ward at a local Belgian hospital. To this end, we carried out an interventional study, performing a full medication review on older patients (≥70 years) with polypharmacy (≥5 drugs) who had an unplanned admission to the geriatric ward. The process consisted of 3 steps: (1) medication reconciliation upon admission; (2) medication review using an explicit reviewing tool (STOPP/START criteria or GheOP³S tool), followed by a discussion between the pharmacist and the geriatrician; and (3) medication reconciliation upon discharge. Ethical approval was obtained from the Ethical Commission of the Ghent University Hospital. Outcomes included objective data on the interventions (e.g., number of drug discrepancies; number of potentially inappropriate prescriptions (PIP)); as well as subjective experiences (e.g., satisfaction with service; opinion on inter-professional communication). There was a special focus on communication aspects within the introduction of this process. In total, 52 patients were included in the study, taking a median of 10 drugs (IQR 8-12). Upon admission, 122 drug discrepancies were detected. During medication review, 254 PIPs were detected and discussed, leading to an improvement in the appropriateness of medication use. The satisfaction of community pharmacists concerning additional communication and the satisfaction of the patients after counselling at discharge were positive. However, several barriers were encountered, such as the time-consuming process to gather necessary information from different sources, the non-continuity of the service due to the lack of trained personnel or the lack of safe, electronic platforms to share information. The communicative and non-communicative successes and hurdles encountered during this project need to be addressed in order to improve the full medication review process and to strengthen the role of the clinical pharmacist.
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http://dx.doi.org/10.3390/pharmacy6010021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5874560PMC
February 2018

Self-management of medication during hospitalisation: Healthcare providers' and patients' perspectives.

J Clin Nurs 2018 Feb 20;27(3-4):753-768. Epub 2017 Nov 20.

Department of Healthcare, Thomas More University College, Lier, Belgium.

Aims And Objectives: To explore healthcare providers' and patients' perspectives on self-management of medication during the patients' hospital stay.

Background: Self-administration of medications relates to the process in which hospitalised patients-instead of healthcare professionals-prepare and consume medications by themselves. Literature suggests possible advantages of medication self-management such as increased patient satisfaction, adherence to pharmacotherapy and self-care competence.

Design: A qualitative descriptive study design was adopted, using semistructured interviews and qualitative content analysis to examine data.

Methods: Six physicians, 11 nurses, six hospital pharmacists and seven patients were recruited from one regional hospital and two university hospitals, situated in Belgium. Interviews were conducted between October 2014-January 2015.

Results: Strengths of medication self-management were described by participants, relating to benefits of self-management for patients, time-saving benefits for nurses and benefits for better collaboration between patients and healthcare providers. Weaknesses were also apparent for patients as well as for nurses and physicians. Opportunities for self-management of medication were described, relating to the organisation, the patient and the process for implementing self-management. Threats for self-management of medication included obstacles related to implementation of self-managed medications and the actual process of providing medication self-management. A structured overview of conditions that should be fulfilled before allowing self-management of medication concerned patient-related conditions, the self-managed medication and the organisation of self-management of medication.

Conclusions: This study provides new insights on the strengths, weaknesses, opportunities and threats from the perspectives of key stakeholders. Interpretation of these findings resulted in an overview of adaptations in the medication management process to facilitate implementation of self-management of medication.

Relevance To Clinical Practice: A medication management process for self-management of medication was proposed. Further interventional studies are needed to test and refine this process before implementing it in daily practice.
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http://dx.doi.org/10.1111/jocn.14084DOI Listing
February 2018

SelfMED: Self-Administration of Medication in Hospital: A Prevalence Study in Flanders, Belgium.

J Nurs Scholarsh 2017 05 4;49(3):277-285. Epub 2017 Apr 4.

Department of Healthcare, Thomas More University College, Belgium and Department of Nursing Science and Midwifery, Centre for Research and Innovation in Care (CRIC), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium.

Background: Self-management is a key element in regaining and maintaining health. However, during hospitalization it becomes less obvious. Patient self-administration of medication during hospitalization is suggested to be beneficial to patient satisfaction, adherence to pharmacotherapy, and self-care competence.

Objectives: This study aimed to examine the prevalence of self-administration of medication during hospitalization, and possible contributing factors.

Design And Setting: A cross-sectional observational study was conducted in 12 Belgian hospitals from February 2015 until June 2015.

Participants: Data were collected on all hospitalized patients at 57 wards, based in 12 hospitals.

Data Collection: A structured questionnaire at ward level and patient level on medication management, self-administration of medication, and rationale for prohibiting or allowing patients to self-administer their medication was conducted in consultation with the head nurse.

Results: Of the 1,269 patients participating in this study, 22% self-administered at least one medicine during hospitalization and 13.8% self-administered at least 50% of their total amount of medication. In the opinion of the head nurse, 40.9% of the hospitalized patients would have been able to self-administer their medication during hospitalization. Only a few wards had an available procedure and screening tool to assess the competence of the patients to self-administer their medication. This did not affect the prevalence of self-administration. Self-administration occurred significantly more at surgical short-stay wards, compared to other wards. The self-administering patients were on average younger and female and had a lower number of different medications per day before and during hospitalization. These patients had a good health status and were independent to mildly dependent on nurses on the ward. Related factors were used to provide a multivariate logistic regression model.

Conclusions: Sometimes self-administration of medication was allowed. According to the surveyed nurses, however, more patients would be able to self-administer their medication during hospitalization. There seems to be a lack of procedures and screening tools to assess the competence or appropriateness of patients to self-administer their medication.

Clinical Relevance: This study provides new knowledge about the prevalence of self-administration of medication, contributing factors, the types of self-administered medications, and the organization of self-administration of medication on different wards.
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http://dx.doi.org/10.1111/jnu.12290DOI Listing
May 2017

Community pharmacists' evaluation of potentially inappropriate prescribing in older community-dwelling patients with polypharmacy: observational research based on the GheOP³S tool.

J Public Health (Oxf) 2017 09;39(3):583-592

Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, B-9000, Belgium.

Background: In this study, we aimed to (i) determine the prevalence of potentially inappropriate prescribing (PIP) in community-dwelling older polypharmacy patients using the Ghent Older People's Prescriptions community-Pharmacy Screening (GheOP³S) tool, (ii) identify the items that account for the highest proportion of PIP and (iii) identify the patient variables that may influence the occurrence of PIP. Additionally, pharmacist-physician contacts emerging from PIP screening with the GheOP³S tool and feasibility of the GheOP³S tool in daily practice were evaluated.

Methods: A prospective observational study was carried out between December 2013 and July 2014 in 204 community pharmacies in Belgium. Patients were eligible if they were (i) ≥70 years, (ii) community-dwelling, (iii) using ≥5 chronic drugs, (iv) a regular visitor of the pharmacy and (v) understanding Dutch or French. Community pharmacists used a structured interview to obtain demographic data and medication use and subsequently screened for PIP using the GheOP³S tool. A Poisson regression was used to investigate the association between different covariates and the number of PIP.

Results: In 987 (97%) of 1016 included patients, 3721 PIP items were detected (median of 3 per patient; inter quartile range: 2-5). Most frequently involved with PIP are drugs for the central nervous system such as hypnosedatives, antipsychotics and antidepressants. Risk factors for a higher PIP prevalence appeared to be a higher number of drugs (30% extra PIPs per 5 extra drugs), female gender (20% extra PIPs), higher body mass index (BMI, 20% extra PIPs per 10-unit increase in BMI) and poorer functional status (30% extra PIPs with 6-point increase). The feasibility of the GheOP³S tool was acceptable although digitalization of the tool would improve implementation. Despite detecting at least one PIP in 987 patients, only 39 physicians were contacted by the community pharmacists to discuss the items.

Conclusion: A high prevalence of PIP in community-dwelling older polypharmacy patients in Belgium was detected which urges for interventions to reduce PIP.
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http://dx.doi.org/10.1093/pubmed/fdw108DOI Listing
September 2017

Potentially inappropriate prescribing in nursing home residents detected with the community pharmacist specific GheOP(3)S-tool.

Int J Clin Pharm 2016 Oct 8;38(5):1063-8. Epub 2016 Aug 8.

Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemstesteenweg 460, 9000, Ghent, Belgium.

Background The Ghent Older People's Prescriptions community Pharmacy Screening (GheOP³S-)tool was recently developed to screen for potentially inappropriate prescribing (PIP). Objective We aimed (1) to determine PIP prevalence in older nursing home (NH) residents with polypharmacy using the GheOP³S-tool and (2) to identify those PIPs that are most frequently detected. Method A cross-sectional study was carried out between February and June 2014 in 10 NHs in Belgium, supplied by a community pharmacy chain. For each NH, 40 residents (≥70 years, using ≥5 chronic drugs) were included. PIP prevalence was determined using the GheOP³S-tool. Results 400 NH residents were included [mean age (±SD) 86.2 (±6.3) years; median number of drugs (±IQR) 10 (7-12)]. A total of 1728 PIPs were detected in 387 (97 %) participants (Median 4; IQR 2-6). The most prevalent items can be assigned to three categories: long-term use of central nervous system drugs (i.e. benzodiazepines, antidepressants and antipsychotics), use of anticholinergic drugs (mutual combinations and with underlying constipation/dementia) and underuse of osteoporosis prophylaxis. Conclusion Screening for PIP by means of the GheOP³S-tool revealed a high prevalence of PIP among older NH residents with polypharmacy. This finding urges for initiatives on the patient-level, but also on a broader, institutional level.
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http://dx.doi.org/10.1007/s11096-016-0366-6DOI Listing
October 2016

Are antihistamines effective in children? A review of the evidence.

Arch Dis Child 2017 Jan 22;102(1):56-60. Epub 2016 Jun 22.

Department of Paediatrics and Medical Genetics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.

Background And Aims: During the last decades, much attention has been paid to off-label and unlicensed prescriptions in paediatrics. However, on-label prescribing can also cause health issues. In this paper, the case of first-generation H-antihistamines is investigated, notably the range of indications for which products are licensed in different European countries and the evidence base (or lack thereof) for each indication, as well as reported adverse drug reactions.

Methods: Review of the Summary of Product Characteristics of first-generation H-antihistamines with a focus on paediatric use. This is plotted against the evidence available in the literature.

Results: This investigation shows a large variability in labelled indications and licensing ages when compared in five different European countries. Moreover, most of the indications are not based on clinical trials evaluating efficacy and safety of these drugs in children.

Conclusions: Many of the licensed indications of first-generation antihistamines do not appear to be evidence based.
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http://dx.doi.org/10.1136/archdischild-2015-310416DOI Listing
January 2017

Strategies for Determining Correct Cytochrome P450 Contributions in Hepatic Clearance Predictions: In Vitro-In Vivo Extrapolation as Modelling Approach and Tramadol as Proof-of Concept Compound.

Eur J Drug Metab Pharmacokinet 2017 Jun;42(3):537-543

Laboratory of Medical Biochemistry and Clinical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium.

Background And Objective: Although the measurement of cytochrome P450 (CYP) contributions in metabolism assays is straightforward, determination of actual in vivo contributions might be challenging. How representative are in vitro for in vivo CYP contributions? This article proposes an improved strategy for the determination of in vivo CYP enzyme-specific metabolic contributions, based on in vitro data, using an in vitro-in vivo extrapolation (IVIVE) approach. Approaches are exemplified using tramadol as model compound, and CYP2D6 and CYP3A4 as involved enzymes.

Methods: Metabolism data for tramadol and for the probe substrates midazolam (CYP3A4) and dextromethorphan (CYP2D6) were gathered in human liver microsomes (HLM) and recombinant human enzyme systems (rhCYP). From these probe substrates, an activity-adjustment factor (AAF) was calculated per CYP enzyme, for the determination of correct hepatic clearance contributions. As a reference, tramadol CYP contributions were scaled-back from in vivo data (retrograde approach) and were compared with the ones derived in vitro. In this view, the AAF is an enzyme-specific factor, calculated from reference probe activity measurements in vitro and in vivo, that allows appropriate scaling of a test drug's in vitro activity to the 'healthy volunteer' population level. Calculation of an AAF, thus accounts for any 'experimental' or 'batch-specific' activity difference between in vitro HLM and in vivo derived activity.

Results: In this specific HLM batch, for CYP3A4 and CYP2D6, an AAF of 0.91 and 1.97 was calculated, respectively. This implies that, in this batch, the in vitro CYP3A4 activity is 1.10-fold higher and the CYP2D6 activity 1.97-fold lower, compared to in vivo derived CYP activities.

Conclusion: This study shows that, in cases where the HLM pool does not represent the typical mean population CYP activities, AAF correction of in vitro metabolism data, optimizes CYP contributions in the prediction of hepatic clearance. Therefore, in vitro parameters for any test compound, obtained in a particular batch, should be corrected with the AAF for the respective enzymes. In the current study, especially the CYP2D6 contribution was found, to better reflect the average in vivo situation. It is recommended that this novel approach is further evaluated using a broader range of compounds.
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http://dx.doi.org/10.1007/s13318-016-0355-0DOI Listing
June 2017

PK/PD Modelling of the QT Interval: a Step Towards Defining the Translational Relationship Between In Vitro, Awake Beagle Dogs, and Humans.

AAPS J 2016 07 26;18(4):1000-12. Epub 2016 Apr 26.

Laboratory of Medical Biochemistry and Clinical Analysis, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium.

Inhibiting the human ether-a-go-go-related gene (hERG)-encoded potassium ion channel is positively correlated with QT-interval prolongation in vivo, which is considered a risk factor for the occurrence of Torsades de Pointes (TdP). A pharmacokinetic/pharmacodynamic model was developed for four compounds that reached the clinic, to relate drug-induced QT-interval change in awake dogs and humans and to derive a translational scaling factor a 1. Overall, dogs were more sensitive than humans to QT-interval change, an a 1 of 1.5 was found, and a 10% current inhibition in vitro produced a higher percent QT-interval change in dogs as compared to humans. The QT-interval changes in dogs were predictive for humans. In vitro and in vivo information could reliably describe the effects in humans. Robust translational knowledge is likely to reduce the need for expensive thorough QT studies; therefore, expanding this work to more compounds is recommended.
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http://dx.doi.org/10.1208/s12248-016-9920-3DOI Listing
July 2016