Home Care Patient's Experiences and Medication Burden Related to High-Risk Medication Use: A Cross-Sectional Study.

Background: Age, polypharmacy and comorbidity are examples of known factors that increase the risk of adverse drug reactions in patients. The use of high-risk medication also entails a heightened risk of harm. There is currently no information available on the home care patients' experiences and medication burden experienced due to their high-risk medication use and how they manage their medication.

A Prediction Model to Identify Clinically Relevant Medication Discrepancies at the Emergency Department (MED-REC Predictor): Development and Validation Study.

Background: Many patients do not receive a comprehensive medication reconciliation, mostly owing to limited resources. We hence need an approach to identify those patients at the emergency department (ED) who are at increased risk for clinically relevant discrepancies.

Objective: The aim of our study was to develop and externally validate a prediction model to identify patients at risk for at least 1 clinically relevant medication discrepancy upon ED presentation.

The Impact of Customized Screening Intervals on the Burden of Drug-Drug Interaction Alerts: An Interrupted Time Series Analysis.

Fixed and broad screening intervals for drug-drug interaction (DDI) alerts lead to false positive alerts, thereby contributing to alert fatigue among healthcare professionals. Hence, we aimed to investigate the impact of customized screening intervals on the daily incidence of DDI alerts. An interrupted time series analysis was performed at the University Hospitals Leuven to evaluate the impact of a pragmatic intervention on the daily incidence of DDI alerts per 100 prescriptions.

Bedside check of medication appropriateness (BED-CMA) as a risk-based tool for bedside clinical pharmacy services: A proof-of-concept study at the trauma surgery ward.

Background: Bedside clinical pharmacy prevents drug-related problems, but is not feasible in many countries due to limited resources. Hence, clinical rules using structural information in the electronic health record can help identifying potentially inappropriate prescriptions (PIPs). We aimed to develop and implement a risk-based clinical pharmacy service and evaluate its impact on prescribing at the trauma surgery ward.

Home care nurses' management of high-risk medications: a cross-sectional study.

Background: High-risk medications use at home entails an increased risk of significant harm to the patient. While interventions and strategies to improve medications care have been implemented in hospitals, it remains unclear how this type of medications care is provided in the home care setting. The objective was to describe home care nurses' management of high-risk medications.

High-Risk Medication in Home Care Nursing: A Delphi Study.

Aims: The aims of the study were to reach consensus on which medications in home care nursing should be considered high-risk medication (HRM) and to obtain recommendations about which interventions home care nurses can perform to improve quality of care and safety in managing these HRM.

Design: This is an international Delphi study with 13 purposively selected experts from 4 different countries.

Methods: A 3-round iterative Delphi survey was conducted from May 2018 to October 2018, based on a list of 32 medications previously reported as HRM in community care.

Overall performance of a drug-drug interaction clinical decision support system: quantitative evaluation and end-user survey.

Background: Clinical decision support systems are implemented in many hospitals to prevent medication errors and associated harm. They are however associated with a high burden of false positive alerts and alert fatigue. The aim of this study was to evaluate a drug-drug interaction (DDI) clinical decision support system in terms of its performance, uptake and user satisfaction and to identify barriers and opportunities for improvement.

Returning to Elective Orthopedic Surgery During the COVID-19 Pandemic: A Multidisciplinary and Pragmatic Strategy for Initial Patient Selection.

Objective: The aim of the study was to design an objective, transparent, pragmatic, and flexible workflow to assist with patient selection during the initial phase of return to elective orthopedic surgery during the COVID-19 pandemic with the main purpose of enhancing patient safety.

Methods: A multidisciplinary working group was formed consisting of representatives for orthopedics, epidemiology, ethics, infectious diseases, cardiovascular diseases, and intensive care medicine. Preparation for upcoming meetings consisted of reading up on literature and testing of proposed methodologies on our own waiting lists.

Sharing of Clinical Trial Data and Samples: The Cancer Patient Perspective.

Today, many initiatives and papers are devoted to clinical trial data (and to a lesser extent sample) sharing. Journal editors, pharmaceutical companies, funding agencies, governmental organizations, regulators, and clinical investigators have been debating the legal, ethical, and social implications of clinical data and sample sharing for several years. However, only little research has been conducted to unveil the patient perspective.

High-risk medication in community care: a scoping review.

Purpose: To review the international literature related to high-risk medication (HRM) in community care, in order to (1) define a definition of HRM and (2) list the medication that is considered HRM in community care.

Methods: Scoping review: Five databases were systematically searched (MEDLINE, Scopus, CINAHL, Web Of Science, and Cochrane) and extended with a hand search of cited references. Two researchers reviewed the papers independently.

What Does Society Value About Cancer Medicines? A Discrete Choice Experiment in the Belgian Population.

Background: Debate on pricing and reimbursement of cancer medicines highlights the need to establish the value of cancer medicines.

Objective: This study aims to elicit the trade-offs in cancer medicine characteristics that the Belgian population is willing to make.

Methods: A discrete choice experiment used six attributes with three levels each, based on literature and focus group discussions.

Development and implementation of "Check of Medication Appropriateness" (CMA): advanced pharmacotherapy-related clinical rules to support medication surveillance.

Background: To improve medication surveillance and provide pharmacotherapeutic support in University Hospitals Leuven, a back-office clinical service, called "Check of Medication Appropriateness" (CMA), was developed, consisting of clinical rule based screening for medication inappropriateness. The aim of this study is twofold: 1) describing the development of CMA and 2) evaluating the preliminary results, more specifically the number of clinical rule alerts, number of actions on the alerts and acceptance rate by physicians.

Methods: CMA focuses on patients at risk for potentially inappropriate medication and involves the daily checking by a pharmacist of high-risk prescriptions generated by advanced clinical rules integrating patient specific characteristics with details on medication.

Tamoxifen Metabolism and Efficacy in Breast Cancer: A Prospective Multicenter Trial.

Levels of endoxifen, the most active metabolite of tamoxifen, vary by the highly polymorphic cytochrome P450 (CYP) 2D6 enzyme. We prospectively investigated tamoxifen efficacy by serum endoxifen levels and the tamoxifen activity score (TAS). A prospective observational multicenter study included postmenopausal women with an estrogen receptor-positive breast cancer receiving first-line tamoxifen, 20 mg daily in the neoadjuvant or metastatic setting, recruited between February 2009 and May 2014.

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.

It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North-South collaborative trials.

The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP.

Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future.

The aim of this study is to conduct an analysis on the regulation and application of managed entry agreements (MEA) for oncology drugs across different European countries. Literature search and document analysis were performed between September 2015 and June 2016 to collect information on the regulatory framework and practice of MEA in Belgium, The Netherlands, Scotland, England and Wales, Sweden, Italy, Czech Republic and France. An overview of the content and typology of MEA applied for oncology drugs between 2008 and 2015 was generated based on publically available sources and contributions by national health authorities.

Time spent by Belgian hospital pharmacists on supply disruptions and drug shortages: An exploratory study.

Introduction: Supply problems of drugs are an increasing and worldwide problem, also in Belgium. Hospital pharmacists try to manage drug supply problems to minimize the impact on patient care. This study aims to quantify in a detailed manner how much time employees of 17 Belgian hospital pharmacies spend on drug supply problems.

Are products with an orphan designation for oncology indications different from products for other rare indications? A retrospective analysis of European orphan designations granted between 2002-2012.

Background: Orphan designated medicinal products benefit from regulatory and economic incentives for orphan drug development. Approximately 40% of orphan designations target rare neoplastic disorders, referring to rare cancers. In order to provide more insights in drugs for rare neoplastic disorders that are under development and to better understand the role of orphan designation in the development of oncology drugs, this study investigates the characteristics of the product, the indication and the applicants as well as the stage of development of products with an orphan designation for rare neoplastic disorders and compares them with products with an orphan designation for other rare indications.

Clinical, Economic and Policy Implications of Drug Shortages in the European Union.

Drug shortages are an international problem, which seems to worsen. In this paper, the clinical, economic and policy implications of drug shortages are discussed, based on data available for the EU. Research on the clinical impact is scarce.

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.

Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines.

Background: Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial's scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions.

Toward a European definition for a drug shortage: a qualitative study.

Background: Drug shortages are currently on the rise. In-depth investigation of the problem is necessary, however, a variety of definitions for 'drug shortages' are formulated in legislations, by different organizations, authorities, and other initiatives. For international comparison, the underlying definition for drug shortages is important to allow appropriate interpretation of national databases and the results of scientific studies.

Predictors for reimbursement of oncology drugs in Belgium between 2002 and 2013.

Background: Price setting and reimbursement decisions regarding drugs are competence of individual member states in Europe. These decisions involve important trade-offs between social, ethical, clinical and economic criteria. The aim of this study was to investigate the relative importance of criteria for reimbursement of oncology drugs in Belgium.