Digital medication management in healthcare settings

On the 29 November, health managers, patients, healthcare professionals and the medical technology industry have forces under the Alliance for the Digitalisation of Medication Management in European Hospitals to issue recommendations to the European Commission, the European Parliament and the Member States on fostering the digitalisation of medication management. EAHP Vice President Darija Kuruc Poje participated in a lively discussion in the European Parliament.

The White Paper provides insights into the complexity of hospitals’ medication management pathways and shares evidence of the low penetration of digitalisation in this field. There are several benefits of upscaling the digitalisation of hospitals’ medication management pathways, namely improving the resilience of hospital systems and increasing their capabilities, providing access to more reliable information about the availability of medicines, ensuring access to real-world data in interoperable systems and supporting antimicrobial stewardship.

The Alliance calls for action from European policy makers to

1. Support the implementation of electronic medication management systems in EU hospitals as a critical success factor and key digital enabler for the effective, and efficient, functioning of the future European Shortages Monitoring Platform.

2. Include in the future Digital Europe work programmes specific objectives supporting hospitals to update their IT infrastructure for the digitalisation of the medication management pathway.

3. Include in the 2023 EU4Health work programme a specific funding mechanism, incorporating support for change management and building cultures of safety in hospitals, to support member states to implement digitised medication management systems in hospitals.

4. Support the development of digital skills of the EU’s health workforce and ensure that trained experts will support change management to implement the digital transition of European hospitals with sustained investments from the EU4Health Programme.

5. Include medication treatment data from ambulatory care and hospitals as key data to be generated and shared by Member States within the European Health Data Space. Standardise medication treatment data collection within interoperable systems by introducing digital medication management systems in ambulatory care and hospital settings.

6. Include a measure recommending the digitalisation of hospitals’ medication management pathways to enhance patient safety and the resilience of hospitals’ pharmaceutical systems within the new pharmaceutical legislative framework.

EMA/HMA joint statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint statement confirming that biosimilar medicines approved in the European Union are interchangeable with their reference medicine or with an equivalent biosimilar. This joint statement brings more clarity for healthcare professionals and consequently will improve patients’ access to biological medicines across the EU.

Since 2006, EMA has been at the forefront of biosimilar medicines and so far, has approved 86 of them. EMA’s position is based on the experience gained in clinical practice, where it has become common that doctors switch patients between different biological medicinal products. Approved biosimilars have demonstrated similar efficacy, safety and immunogenicity compared with their reference medicines, and analysis of more than one million patient-treatment years of safety data did not raise any safety concerns. Thus, EU experts considered that when a biosimilar is granted approval in the EU, it can be used instead of its reference product (or vice versa) or replaced by another biosimilar of the same reference product. Decisions regarding substitution at pharmacy-level (the practice of dispensing one medicine instead of another without consulting the prescriber) are managed by individual Member States. EMA plans to update its communication materials on biosimilars for patients and healthcare professionals to integrate the new joint statement.

Preventing antimicrobial resistance together

This year’s World Antimicrobial Awareness Week (WAAW) kicked off on the 18^th of November which also marks the date of the European Antibiotic Awareness Day (EAAD). Under the theme “Preventing Antimicrobial Resistance Together” healthcare professionals, patients, supply chain actors and other stakeholders came together to raise awareness around this silent pandemic.

On the occasion of EAAD, the European Centre for Disease Prevention and Control (ECDC) released new data on antibiotic consumption showing a decrease in the total antibiotic consumption in humans by more than 15% between 2019 and 2020. This has been seen in most EU/EEA countries, mostly in primary care, and most likely as a result of the COVID-19 pandemic. Nevertheless, ECDC stressed that antimicrobial resistance levels remain high for several important combinations of bacterial species and antimicrobial groups, with the highest percentages generally reported by countries in the south and east of Europe. By contrast, the number of deaths attributable to infections with antimicrobial-resistant bacteria has risen. According to estimates, more than 35 000 people die from antimicrobial-resistant infections in the EU/EEA each year.

EAAD is a European health initiative coordinated by European Centre for Disease Prevention and Control (ECDC). It provides a platform and support for national campaigns on the prudent use of antibiotics in the EU/EEA and takes place each year across Europe. Also for the 15^th edition of the EAAD, healthcare professionals around Europe were encouraged to produce social media content around the prudent use of antibiotics. Like every year, EAHP contributed with a social media campaign focusing on the importance of antibiotic stewardship teams and encouraged its members to share how they keep antibiotics working.

Global health strategy released

On the 30^th of November, the European Commission published its new EU Global Health Strategy which focuses on improving global health security and delivering better health for all in a changing world. It positions global health as an essential pillar of EU external policy, a critical sector geopolitically and central to EU strategic autonomy.

The new EU Global Health Strategy – applicable from 2022 to 2023 – puts forward three key interrelated priorities in dealing with global health challenges:

• deliver better health and well-being of people across the life course;

• strengthen health systems and advance universal health coverage;

• prevent and combat health threats, including pandemics, applying a One Health approach.

Also, a new approach to global cooperation will be pursued. Stronger ties with the WHO with the European Union as a full observer at WHO is being fostered. Global governance without duplication and strong political attention to health is being pushed for and international partnerships based on co-ownership and co-responsibility under Global Gateway are being expanded.

European Health Union: Adoption of EU4Health work programme 2023

In November, the European Commission adopted the 2023 EU4Health work programme. Actions that will be prioritised by the programme link to the strengthening of the EU’s resilience to cross-border health threats, the implementation of the European Health Data Space, the Pharmaceutical Strategy for Europe and Europe’s Beating Cancer Plan, as well as financing for the European Reference Networks. The work programme will also support health-related urgencies in Ukraine.

With a €5.3 billion budget during the 2021–27 period, the EU4Health programme is an unparalleled EU financial support in the health area. It will bring a contribution to long-term health challenges by building stronger, more resilient and more accessible health systems.