Comparative analysis of the scope of European Union paediatric investigation plans with corresponding orphan designations.

Background: Market forces may not be sufficient to stimulate research and development of medicines for small patient populations, such as children and patients with rare diseases. Both the European Union Orphan and Paediatric Regulations were introduced to address the unmet public health needs of these smaller patient populations through the use of incentives, rewards and obligations. Developers for new medicines for rare diseases must agree a paediatric investigation plan (PIP) or waiver with the European Medicines Agency's (EMA) Paediatric Committee (PDCO), and can also apply for an orphan designation (OD) from the EMA's Committee of Orphan Medicinal Products (COMP).

Increasing candidaemia incidence from 2004 to 2015 with a shift in epidemiology in patients preexposed to antifungals.

Candidaemia is an important health problem in immunocompromised patients with an epidemiology varying with region, period and patient population involved. The occurrence of candidaemia and the associated species distribution over a 12-year period at a large tertiary care centre in Belgium were analysed. The trend in incidence in the intensive care units (ICUs) and non-ICUs was investigated as well as the influence of antifungal exposure on the species distribution.

[The development of clinical practice algorithms for the appropriate use of psychotropic drugs in older persons with high risk of falls].

Psychotropic drugs (hypno-sedatives, antidepressants and antipsychotics) are commonly used in the older population. On the long term, psychotropic drug use in older persons is associated with several negative functional outcomes such as an increased risk of falls. Gradual withdrawal of psychotropic drugs in older persons is feasible and leads to a significant reduction of falls.

Time Investment in Drug Supply Problems by Flemish Community Pharmacies.

Drug supply problems are a known problem for pharmacies. Community and hospital pharmacies do everything they can to minimize impact on patients. This study aims to quantify the time spent by Flemish community pharmacies on drug supply problems.

Predictors for unintentional medication reconciliation discrepancies in preadmission medication: a systematic review.

Purpose: Discrepancies in preadmission medication (PAM) are common and potentially harmful. Medication reconciliation is able to reduce the discrepancy rate, yet implementation is challenging. In order for reconciliation efforts to be more cost-effective, patients at high risk for reconciliation errors should be identified.

A safety assessment of biological therapies targeting the IL-23/IL-17 axis in inflammatory bowel diseases.

Many different compounds targeting the interleukin 23/17 axis have been developed and successfully studied in several autoimmune diseases, including inflammatory bowel diseases. Nevertheless, interfering with key immunological pathways raises potential safety concerns. This review focuses on the safety profile of these novel biological therapies.

Developing a decision rule to optimise clinical pharmacist resources for medication reconciliation in the emergency department.

Background: The process of obtaining a complete medication history for patients admitted to the hospital from the ED at hospital admission, without discrepancies, is error prone and time consuming.

Objectives: The goal of this study was the development of a clinical decision rule (CDR) with a high positive predictive value in detecting ED patients admitted to hospital at risk of at least one discrepancy during regular medication history acquisition, along with favourable feasibility considering time and budget constraints.

Methods: Data were based on a previous prospective study conducted at the ED in Belgium, describing discrepancies in 3592 medication histories.

Evaluation of real-life dosing of oral medicines with respect to fluid and food intake in a Dutch-speaking population.

What Is Known And Objective: Oral drug administration is the most preferred route of drug administration. For some specific classes of drugs, recommendations regarding the intake of the drug product are provided by and approved in the summary of product characteristics (SmPC) after testing the oral drug product in clinical trials under strict and predefined conditions. The aim of this study was to investigate how certain classes of medicines are taken in a "real-life" setting in terms of concomitant fluid and food intake by a Dutch-speaking population in Flanders (Belgium).

Development of a risk score for QTc-prolongation: the RISQ-PATH study.

Background More than 170 drugs are linked with QTc-prolongation, which in extreme cases can lead to Torsade de Pointes. Monitoring of this potential side effect is an important challenge in clinical practice. Objective To investigate the risk of QTc-prolongation in hospital patients who started a QTc-prolonging drug, and to develop a risk score to identify patients at high/low risk for QTc-prolongation.

Determinants of the Magnitude of Interaction Between Tacrolimus and Voriconazole/Posaconazole in Solid Organ Recipients.

Administration of azole antifungals to tacrolimus-treated solid organ recipients results in a major drug-drug interaction characterized by increased exposure to tacrolimus. The magnitude of this interaction is highly variable but cannot currently be predicted. We performed a retrospective analysis of 126 solid organ recipients (95 lung, 31 kidney) co-treated with tacrolimus and voriconazole (n = 100) or posaconazole (n = 26).

AKIpredictor, an online prognostic calculator for acute kidney injury in adult critically ill patients: development, validation and comparison to serum neutrophil gelatinase-associated lipocalin.

Purpose: Early diagnosis of acute kidney injury (AKI) remains a major challenge. We developed and validated AKI prediction models in adult ICU patients and made these models available via an online prognostic calculator. We compared predictive performance against serum neutrophil gelatinase-associated lipocalin (NGAL) levels at ICU admission.

Effect of the Direct Oral Anticoagulants Rivaroxaban and Apixaban on the Disposition of Calcineurin Inhibitors in Transplant Recipients.

Background: Calcineurin inhibitors (CNIs) and direct oral anticoagulants (DOACs) share certain metabolic pathways, but whether DOACs influence CNI exposure has not been assessed.

Methods: A single-center retrospective analysis was performed including 39 organ recipients treated with the combination of a CNI and rivaroxaban (n = 29) or apixaban (n = 10). Dose-corrected CNI trough concentrations (C0/D) during 200 days before and after DOAC initiation were recorded (n = 261), together with covariates known to influence CNI disposition such as steroid dose and hematocrit.

Different Vancomycin Immunoassays Contribute to the Variability in Vancomycin Trough Measurements in Neonates.

Substantial interassay variability (up to 20%) has been described for vancomycin immunoassays in adults, but the impact of neonatal matrix is difficult to quantify because of blood volume constraints in neonates. However, we provide circumstantial evidence for a similar extent of variability. Using the same vancomycin dosing regimens and confirming similarity in clinical characteristics, vancomycin trough concentrations measured by PETINIA (2011-2012, n = 400) were 20% lower and the mean difference was 1.

Epidemiological trends for hospital admissions for acute rotavirus gastroenteritis in Belgium following the introduction of routine rotavirus vaccination and the subsequent switch from lyophilized to liquid formulation of Rotarix™.

This study describes epidemiological trends for acute rotavirus gastroenteritis (RVGE) in Belgium in children aged ⩽5 years during the period June 2007 to May 2014 after the introduction of routine rotavirus (RV) vaccination. This period encompassed the switch from lyophilized to the liquid formulation of Rotarix™ (GlaxoSmithKline, Belgium) in August 2011. Uptake of RV vaccine remained consistently high throughout the study period with Rotarix the brand most often used.

Industry Perspectives on Market Access of Innovative Drugs: The Relevance for Oncology Drugs.

Key Points - Representatives of the pharmaceutical industry call for a broader recognition of value within the assessment and appraisal of innovative drugs- Focus on value within the assessment and appraisal of drugs is jeopardized by financial drives as the side of industry and at the side of the payers- A well-considered value-framework, with attention for patient reported outcomes, societal preferences and dynamic approach on the drug life cycle, needs to be incorporated in assessment and appraisal at national and European level in order to coordinate the views of different stakeholders and allow efficient resource allocation This study presents industry perspectives on the challenges related to market access of innovative drugs in general and oncology drugs in specific. Fifteen interviews were conducted with representatives of pharmaceutical companies and industry associations. Interviewees call for a broader recognition of value within the assessment and appraisal of drugs.

Posaconazole plasma exposure correlated to intestinal mucositis in allogeneic stem cell transplant patients.

Purpose: Low posaconazole plasma concentrations (PPCs) are frequently encountered in allogeneic hematopoietic stem cell transplant (HSCT) patients, due to variable gastrointestinal absorption. In this study, the impact of intestinal mucositis on posaconazole exposure is investigated.

Patients And Methods: A prospective pharmacokinetic study was performed including allogeneic HSCT patients receiving posaconazole prophylaxis with the oral suspension or tablets.

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

Qualitative study on custodianship of human biological material and data stored in biobanks.

Background: Balancing the rights and obligations of custodians and applicants in relation to access to biobanks is of utmost importance to guarantee trust and confidence. This study aimed to reveal which issues divide different stakeholders in an attempt to determine the rights and/or obligations held on human biological materials (HBM) and data.

Methods: Twenty-eight informants in the Benelux and Scandinavia were interviewed in order to capture the perspectives of experts and stakeholders in relation to the rights and obligations held by custodians and applicants with respect to access to HBM and data.