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WHO Guidelines on Post Approval Changes- Appendix 1 Reporting categories and suggested review timelines
No full textEuropean antimicrobial resistance surveillance for Belgium (EARS-BE) 2022: Descriptive report
No full textIncidental findings: towards a casuistic or systemic approach?
No full textCAN.HEAL est un consortium européen qui se consacre à l’utilisation de la génomique en vue d’améliorer la prévention, le diagnostic et le traitement du cancer au bénéfice des patients et des citoyens. Au sein de ce projet, nous avons, d’une part, rassemblé les opinions des citoyens et des patients exprimées lors d’initiatives d’engagement public sur différentes thématiques majeures en génomique et, d’autre part, nous avons consulté les parties prenantes de CAN.HEAL sur ces mêmes thématiques. De cette façon, nous pouvions comparer leurs considérations, y compris leurs positions sur des questions éthiques et sociétales concernant la gestion des données incidentes.
Les citoyens et les experts abordent les données incidentes sous une perspective différente. Les citoyens envisagent généralement les données incidentes depuis une approche individuelle, considérant l’impact de ces données sur leur vie et leur famille. En conséquence, ils soulignent la valeur de l’autonomie, le droit de savoir ou ne pas savoir, et l’importance du consentement éclairé. Quant aux experts de CAN.HEAL, ils envisagent les données incidentes sous une perspective systémique, insistant davantage sur l’impact qu’auront ces données sur l’organisation des soins de santé. Ils estiment que le système actuel n’est pas prêt à assumer la recherche délibérée des résultats secondaires car cela risquerait de compromettre des valeurs telles que l’équité dans l’accès aux soins.
Ces différentes considérations se complètent et offrent une perspective enrichissante sur les données incidentes. Pour valoriser les opportunités créées par la médecine personnalisée en génomique, il convient d’aligner les positions des citoyens, des patients et des experts et de dépasser la tension suggérée entre la casuistique dans le traitement individuel et les principes plus généraux de santé publique. La recherche d’une compréhension mutuelle entre patients, citoyens et experts et la découverte des valeurs fondamentales qu’ils partagent constituent une étape indispensable vers une médecine génomique digne de confiance.</p
Thirty years of epidemiological surveillance of methicillin-resistant Staphylococcus aureus in Belgian hospitals: are we able to keep on lowering the curve?
No full textBackground
Sciensano, the Belgian institute for health, analyses data on antimicrobial resistance collected from Belgian acute carehospitals (n=103 mergers in 2022). The first national surveillance program for methicillin resistant
Staphylococcus aureus
(MRSA) was initiated in 1994. Initially, participation in this surveillance was voluntary, but became mandatory in 2006.
Methods
Data, aggregated at hospital level, are collected retrospectively in the following year by hospital’s microbiology laboratoriesand/or infection prevention and control (IPC) teams. Both invasive and non-invasive samples are included and each patientis counted only once per hospitalisation period. Healthcare-associated (HA-)MRSA is defined as MRSAcolonization/infection considered to be acquired in the hospital (first positive sample collected more than 48 hours afteradmission), and not known from the patient’s history (past 12 months).
Results
The incidence of MRSA peaked in 2005 (6.3 cases per 1000 admissions; Figure 1), but shows a decreasing trend ever since(2005-2022 incidence rate ratio (IRR)=0.915, 95%CI: 0.912-0.918; p<0.001). The incidence of HA-MRSA was highest at thestart of the surveillance (3.7 cases per 1000 admissions) with a second peak in 2004 (2.9 per 1000 admissions), but thendecreased year-on-year to 0.2 cases per 1000 admissions in 2022 (1994-2022 IRR=0.879, 95%CI: 0.876-0.882; p<0.001). Theproportion of HA-MRSA on the total number of MRSA fell from 78.6% in 1994 to 43.1% in 2006 and is currently at its lowest(15.6%).
Conclusions
Over the past three decades, the evolution of (HA-)MRSA in Belgium has mirrored global trends. Initially confined tohealthcare settings, MRSA presented a significant challenge in hospitals and long-term care facilities (LTCFs) during the1990s. Combined efforts of the IPC teams and targeted actions such as national hand hygiene campaigns (since 2005),specific guidelines (2004), more focused screening policies and multidrug resistant microorganism carrier studies in LTCFshave been pivotal in mitigating the impact of MRSA in Belgian healthcare facilities. From 2000 onwards, community- andlivestock-associated MRSA emerged. Recently, a virulent
eta/etb
impetigo-related MRSA resistant to fusidic acid, firstdescribed in the Netherlands, was detected in Belgium.</p
Resistance Profile, Terbinafine Resistance Screening and MALDI-TOF MS Identification of the Emerging Pathogen Trichophyton indotineae
No full textThe Belgian Inventory of Cancer Care and Control Policies: a state of play for 2023
No full textThis inventory compiles the latest publicly available data on the burden of cancer and cancer care control policies in Belgium, spanning prevention, early detection and screening, diagnosis, treatment, care organisation, quality of care and survivorship. It also details crosscutting topics such as patient centeredness and the reduction of inequalities in cancer care. Policies, including legal statues and mandates, that frame each part of cancer control activities, as well as the actors involved in each stage are also detailed in each of the inventory’s chapters. An analysis of gaps and needs was conducted for each of the thematic areas in cancer control. These analyses were based on a non-systematic review of grey and peer-reviewed literature, and were complimented by multi-stakeholder discussions with members of the Cancer Centre’s EBCP Belgian Mirror Groups (1).
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Sphaeropsidin A C15-C16 Cross-Metathesis Analogues with Potent Anticancer Activity.
No full textWe recently discovered that sphaeropsidin A (SphA), a fungal metabolite from Diplodia cupressi, overcomes apoptosis resistance in cancer cells by inducing cellular shrinkage by impairing regulatory volume increase. Previously, we prepared a pyrene-conjugated derivative of SphA by a cross-metathesis reaction involving the phytotoxin’s C15,C16-alkene. This derivative’s evaluation in a cancer cell panel revealed a significant increase in potency, with the IC values 5-10× lower than those displayed by the original natural product. Herein, we describe the preparation and anticancer evaluation of fifteen novel C15,C16-alkene cross-metathesis analogues in which the pyrene moiety was replaced with other aromatic or non-aromatic hydrophobic groups. The idea for this replacement was to prepare a family of compounds that would not be predicted to be mutagenic compared with the original pyrene analogue. We predict several of our new compounds to be non-mutagenic, while retaining the high potency of the original pyrene-containing analogues. Examples of these potential lead compounds included those containing pentamethylphenyl and triphenylethylene pendant groups. As an additional feature of the current investigation, we prepared several deuterated pyrene-containing compounds to overcome intellectual property issues associated with non-patentability of the original pyrene derivative.</p
Towards a more effective REACH legislation in protecting human health.
No full textThere is growing evidence indicating the substantial contribution of man-made products to an increase in the risk of diseases of civilization. In this article, the Belgian Scientific Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee gives a critical view on the working of REACH. The current regulatory framework needs to further evolve taking into account data generated using modern science and technology. There is a need for improved assessment process not only before but also after entering the market. Objectivity, transparency, and the follow-up after market access can be optimized. Additionally, no guidance documents exist for regulation of mixture effects. Further, the lengthiness before regulatory action is a big concern. Decision-making often takes several years leading to uncertainties for both producers and end users. A first proposed improvement is the implementation of independent toxicity testing, to assure objectivity, transparency, and check and improve compliance. A “no data, no market” principle could prevent access of hazardous chemicals to the market. Additionally, the introduction of novel testing could improve information on endpoints such as endocrine disrupting abilities, neurotoxicity, and immunotoxicity. An adapted regulatory framework that integrates data from different sources and comparing the outputs with estimates of exposure is required. Fast toxicology battery testing and toxicokinetic testing could improve speed of decision-making. Hereby, several improvements have been proposed that could improve the current REACH legislation.</p
Surveillance épidémiologique de la diphtérie : Corynebactéries toxinogènes - data 2024
No full textMessages clés:
Grâce à une couverture vaccinale élevée dans toutes les régions du pays, la diphtérie est devenue et reste une maladie rare en Belgique. En 2024, 14 cas ont été enregistrés : 8 à C. diphtheriae et 6 à C. ulcerans. Aucun décès n’est survenu en 2024.
Depuis 2022, une épidémie d’infections à C. diphtheriae toxinogène est survenue chez les demandeurs d’asile et touche aussi d’autres pays européens. En 2024, 3 cas uniquement ont été diagnostiqués parmi des demandeurs d’asile.
En dehors des cas chez les demandeurs d’asile, 5 autres cas d’infection à C. diphtheriae ont été diagnostiqués dont 2 parmi des personnes sans domicile fixe à Bruxelles.
La grande majorité des cas de C. ulcerans étaient autochtones, avec pour la plupart, une clinique de diphtérie cutanée. L’âge médian des cas était de 60 ans.
De l’antitoxine diphtérique a dû être administrée une fois en 2024.
La diphtérie est une urgence médicale et de santé publique. Dès lors, tout cas suspect doit être déclaré le plus rapidement possible aux autorités sanitaires régionales, afin de mettre en place les mesures nécessaires.
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