Minimisation of bleeding risks due to direct oral anticoagulants

Direct oral anticoagulants (DOAC) are used in several indications for the prevention and treatment of thrombotic events. As highlighted by data from clinical trials and case studies, all DOAC carry the risk of bleeding despite careful selection and patient management. Previous publications have demonstrated the limited knowledge of many physicians concerning the indications for, and correct management of,these anticoagulants. Health institutions should develop risk minimisation strategies and educational materials to prevent major adverse events related to DOAC administration. Major bleeding events are reported in clinical practice and specific antidotes are emerging from Phase III trials. Some antidotes are licensed but their high cost might limit routine use. We therefore illustrate approaches and tools that can help physicians prescribe DOAC appropriately. We focus on screening for modifiable bleeding risk factors and adapting doses according to the individual benefit-risk profile. We also provide recommendations on managing a missed dose, switching, bridging, and resumption

Facile Method for Obtaining Gold-Coated Polyester Surfaces with Antimicrobial Properties

The antimicrobial and antifungal activity of polymers used in medical devices has been extensively studied due to the growing impact of hospital-related infections in patients. The ideal biocidal polymeric materials should be very effective in the microorganism’s inhibition, not toxic to the human body, and environmentally friendly. In this context, this work is aimed at obtaining antimicrobial and antifungal properties at the polyester film surfaces without introducing toxic effects. Poly (ethylene terephthalate) (PET) films were functionalized with Ar plasma and then immersed in a solution containing gold nanoparticles (AuNps). The results demonstrated the appearance of the hydrophilic groups on the film surface after modification of PET film by plasma Ar treatment and the formation of the polar groups such as C=O, COO-, and OH, which then reacted with AuNps. The changes induced in the treated polymer samples were investigated in terms of AuNp adsorption efficiency on polyester film by contact angle, profilometry, Scanning Electron Microscopy (SEM), Attenuated Total Reflectance Spectroscopy-Fourier Transform Infrared (ATR-FTIR), and X-ray Photoelectron Spectroscopy (XPS) measurements. The morphological and structural analyses have shown a good adhesion of AuNps at treated film surfaces. The results of biocompatibility antimicrobial and antifungal tests proved the nontoxic behavior of the sample and its good antimicrobial and antifungal activity

Andexanet alfa for the reversal of factor Xa inhibitors

Andexanet alfa is a recombinant modified factor Xa protein that has been developed to reverse factor Xa inhibitors. Since May 2018, the FDA has approved its utilization in patients treated with apixaban and rivaroxaban in case of life-threatening or uncontrolled bleeding. On 28 of February 2019, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a conditional marketing authorization for andexanet alfa in Europe. Area covered: The authors provide an overview of andexanet alfa development and its pharmacokinetic and pharmacodynamic properties. The results of the clinical phase III trial ANNEXA as well as current limitations related to andexanet alfa are also discussed. Expert opinion: Although phase I and II studies have proven that andexanet alfa can be effective in reversing the effect of factor Xa inhibitors, its efficacy in major bleeding patients has only been shown for apixaban and rivaroxaban, without any comparator group. Well-designed studies comparing the efficacy and safety of andexanet alfa to other reversal strategies are required to confirm preliminary data. The benefit of andexanet alfa in specific settings needs to be investigated and its use in clinical practice needs to be facilitated by the implementation of international guidelines

Sustainability through public procurement: the way forward - Reform proposals

Public procurement amounts to about 16 per cent of the EU Member States’ GDP. A major contribution to the achievement of the Sustainable Development Goals is possible by enhancing sustainable procurement practices. The 2014 EU Public Procurement Directives (Directives 2014/23/EU, 2014/24/EU and 2014/25/EU) have largely clarified the scope for permissible sustainable procurement decisions, but the adoption of Sustainable Public Procurement (SPP) is still limited. The rules could be more permissive and thoroughly take into account all the different aspects of sustainability. Even more urgent and essential is to push for behavioural and organisational changes in the ways contracting authorities perform their buying functions to maximise positive, sustainable impacts. It is critical to change procurement management practices so that the sustainability demanded in contracts is properly verified along the entire supply chain and remedial actions are taken where non-compliance is detected. Solution: We make three main proposals: 1. That the EU invest significantly in the professionalisation of contracting officials, procurement strategists and financial auditors by (a) encouraging the institution of SPP knowledge centres at the EU, national and regional levels following the model already provided by various Central Purchasing Bodies; (b) creating a network of knowledge centres working closely together in developing and disseminating best practices on SPP, including through training materials, and in collecting information and data on the adoption of SPP and the difficulties encountered in applying the relevant EU rules, and (c) providing financial and technical assistance targeted to specific SPP formation for ground-level contracting officials. 2. That the EU make it mandatory for contracting authorities to map and monitor their supply chains for risks of breaches of environmental and social rules, including those protecting human rights. That the EU take those breaches seriously, mandating the exclusion from award procedures of those found in violation and appropriate remedial actions in case of violations during contract performance. That the EU make it easier for contracting authorities to know about economic operators that have breached environmental and social rules, including those protecting human rights. 3. That the EU make the legislative environment more ‘SPP friendly’. Contracting authorities must be allowed to require suppliers to have effective sustainability policies in place. A shift is needed from enabling the Member States to pursue SPP to requiring them to buy sustainably by increasing the amount of mandatory sectoral legislation and by requiring contracting authority to take into account the life-cycle costs associated with their purchases. Non-solution: Simply relying on the goodwill of individual procurement officers or policy makers without providing training and networking opportunities on SPP and information and communication tools; leaving the regulatory burden of pushing SPP forward on the shoulders of Member States. Instruments: The Commission, including DG Devco in its procurement activities in Official Development Assistance (ODA), and other EU institutions should lead by example concerning the professionalisation of procurement officials and the creation of competence centres. The Commission should act as a catalyst for the network of competence centres, and adequate funds should be released to fund the actions recommended under solution point 1 above. The Commission, possibly together with OECD, should collect data on breaches of environmental and social rules, including those protecting human rights, and make that data available to contracting authorities. The other solutions under points 2 and 3 mainly require amendments to Directives 2014/23/EU, 2014/24/EU and 2014/25/EU. Ad hoc rules need to be adopted to enact further sectoral mandatory legislation

Sustainability through public procurement: the way forward - Reform proposals

Public procurement amounts to about 16 per cent of the EU Member States’ GDP. A major contribution to the achievement of the Sustainable Development Goals is possible by enhancing sustainable procurement practices. The 2014 EU Public Procurement Directives (Directives 2014/23/EU, 2014/24/EU and 2014/25/EU) have largely clarified the scope for permissible sustainable procurement decisions, but the adoption of Sustainable Public Procurement (SPP) is still limited. The rules could be more permissive and thoroughly take into account all the different aspects of sustainability. Even more urgent and essential is to push for behavioural and organisational changes in the ways contracting authorities perform their buying functions to maximise positive, sustainable impacts. It is critical to change procurement management practices so that the sustainability demanded in contracts is properly verified along the entire supply chain and remedial actions are taken where non-compliance is detected. Solution: We make three main proposals: 1. That the EU invest significantly in the professionalisation of contracting officials, procurement strategists and financial auditors by (a) encouraging the institution of SPP knowledge centres at the EU, national and regional levels following the model already provided by various Central Purchasing Bodies; (b) creating a network of knowledge centres working closely together in developing and disseminating best practices on SPP, including through training materials, and in collecting information and data on the adoption of SPP and the difficulties encountered in applying the relevant EU rules, and (c) providing financial and technical assistance targeted to specific SPP formation for ground-level contracting officials. 2. That the EU make it mandatory for contracting authorities to map and monitor their supply chains for risks of breaches of environmental and social rules, including those protecting human rights. That the EU take those breaches seriously, mandating the exclusion from award procedures of those found in violation and appropriate remedial actions in case of violations during contract performance. That the EU make it easier for contracting authorities to know about economic operators that have breached environmental and social rules, including those protecting human rights. 3. That the EU make the legislative environment more ‘SPP friendly’. Contracting authorities must be allowed to require suppliers to have effective sustainability policies in place. A shift is needed from enabling the Member States to pursue SPP to requiring them to buy sustainably by increasing the amount of mandatory sectoral legislation and by requiring contracting authority to take into account the life-cycle costs associated with their purchases. Non-solution: Simply relying on the goodwill of individual procurement officers or policy makers without providing training and networking opportunities on SPP and information and communication tools; leaving the regulatory burden of pushing SPP forward on the shoulders of Member States. Instruments: The Commission, including DG Devco in its procurement activities in Official Development Assistance (ODA), and other EU institutions should lead by example concerning the professionalisation of procurement officials and the creation of competence centres. The Commission should act as a catalyst for the network of competence centres, and adequate funds should be released to fund the actions recommended under solution point 1 above. The Commission, possibly together with OECD, should collect data on breaches of environmental and social rules, including those protecting human rights, and make that data available to contracting authorities. The other solutions under points 2 and 3 mainly require amendments to Directives 2014/23/EU, 2014/24/EU and 2014/25/EU. Ad hoc rules need to be adopted to enact further sectoral mandatory legislation