The EAHP EU Monitor is a regular round up of news relevant to hospital pharmacy in Europe.

EAHP's General Assembly adopted a new position paper on the workforce!

This year's EAHP General Assembly adopted a new Position Paper on the Hospital Pharmacy Workforce. Healthcare workforce shortages are not a new phenomenon triggered by the COVID-19 pandemic. They were simply exacerbated by it. Shortages of nurses or physicians in hospitals, particularly in rural areas are frequently featured in news outlets across Europe. However, not only these professions are affected but also the pharmacy workforce, including pharmacists, technicians and others. Especially those working in hospitals have to cope with staffing that is insufficient to meet patients' needs.

There is a growing need for highly educated and specialised hospital pharmacists in medication and medication-related processes that can ensure the seamless transfer of patients between healthcare settings. High-quality education in all European countries is of utmost importance for addressing the workforce problems of pharmacists to ensure that the profession remains an integral part of healthcare. Education needs to go hand in hand with hiring enough pharmacy personnel, including support staff, and training a sufficient number of students each year to robustly grow the pharmacy profession in each country.

In this position paper, EAHP puts forward actions that should be taken at the local and national levels, including short-term measures for improving pharmacy staffing and long-term plans for securing a resilient workforce.

Have a look at the Position Paper on the Hospital Pharmacy Workforce HERE

EAHP joins the WHO AMR platform

EAHP has been selected to join the WHO AMR Multi-Stakeholder Partnership Platform that brings together actors across the human-animal-environmental interface to assist in preserving antimicrobials as lifesaving medicines and ensuring their responsible use under a One Health approach.

It is a voluntary, collaborative coordination mechanism established by the Quadripartite to catalyse a global movement for action against antimicrobial resistance (AMR) and to contribute to the implementation of the Global Action Plan and National Action Plans on AMR.

The network aims to promote not only a shared perspective for action to tackle AMR by engaging stakeholders on building a global vision and targets for specific actions to combat this "silent pandemic", but also information-sharing and networking to enable coordination of activities between the different sectors. Also, the network will support concrete actions that substantially advance progress in containing, combating and, ultimately, reversing AMR.

Combating infections is a policy priority for EAHP. Leveraging the role of hospital pharmacists in combating infectious diseases is key and being part of this network will contribute to shaping the international agenda in this area. Due to their specialized background and knowledge in all medicines-related processes, hospital pharmacists play a pivotal role in multi-professional antimicrobial stewardship teams. These teams are paramount for curbing the inappropriate use of antibiotics and fostering their prudent use to preserve, for example, last-resort antibiotics.

More information is available HERE

Council adopted a Recommendation on strengthening the fight against AMR 

The Council of the EU adopted on 13 June 2023 a Recommendation to strengthen EU action against antimicrobial resistance (AMR). This document considers the human, animal and environmental health fields that are part of what a One Health approach envisages.

It focuses on infection prevention and control, surveillance and monitoring, innovation and availability of efficient antimicrobials, prudent use and cooperation among Member States. It also points out the international dimension by asking the European Commission and the Member States to cover AMR in the negotiation of the future pandemic treaty.

The proposal for this Council Recommendation was put forward by the European Commission on 26 April alongside the package for the revision of the general pharmaceutical legislation that aims to tackle AMR not only by fostering the development of new antimicrobials but also to guarantee their prudent use and mitigate their impact on the environment.

Read the Council Recommendation HERE

HTA Stakeholder Network had its inaugural meeting on 14 June!

The first meeting of the Health Technology Stakeholder (HTA) Network took place on 14 June which is a milestone for the creation of a formal stakeholder body under the Health Technology Assessment Regulation.

EAHP has been represented in the meeting by Despoina Makridaki, Director of Professional Development of the Association. The meeting was important to exchange information and the role of stakeholders regarding the implementation of the EU Health Technology Assessment Regulation. Also, the draft terms of reference of the network were discussed. The participants were divided into breakout rooms according to the four strands of the joint work: developing methodological and procedural guidance, joint clinical assessments, joint scientific consultations and identification of emerging health technologies.

The network will be involved in the activities foreseen in the new Health Technology Assessment Regulation. Its work will require providing input to consultations in preparation or amendment of the HTA Coordination Group's annual work programme and having meetings with the HTA Coordination Group at least once a year. The HTA Coordination Group – comprised of representatives from Member States – will provide expertise on HTA for both medicinal products and medical devices. The next meeting of the network is planned to take place before the end of 2023.

Find more information HERE

ACT EU multi-stakeholder platform kick-off workshop on 22-23 June!

The Accelerating Clinical Trials in the EU (ACT EU) Priority Action 3 aims to advance the clinical trial landscape in the EU by establishing a platform that includes stakeholders involved in the design, regulation, performance and participation in clinical trials. The platform will be kicked off on 22 and 23 June at EMA premises in Amsterdam and via a live broadcast that can be followed by all interested parties.

The agenda for this 2-day event contains a discussion on the Clinical Trial Regulation implementation and the role of ethics committees in clinical trials. Other priority areas for the discussion include transparency of clinical trials, supporting non-commercial clinical trials and reinforcing coordination between scientific advice and clinical trials approval. It also mentions the optimisation of EU infrastructure for methodology guidance. In the context of pandemic preparedness, it foresees a presentation on clinical trials in situations of public health emergency.

A series of workshops will be organised in 2023 and 2024 to further discuss priority topics by efficiently incorporating stakeholders' views and needs in the clinical trial process.

Find more information about this event HERE

 

EJHP: A retrospective hospital benefit and cost analysis of the management of human tissues for orthopaedic allografts

A recent online first article published in the European Journal of Hospital Pharmacy (EJHP) analyses the hospital cost and benefit derived from a new centralised service characterised by thawing and washing human tissues for orthopaedic allografts. The transplantation of human tissues is a greatly expanding field of medicine with unquestionable benefits that raise questions about safety, quality and ethics. Since 1 October 2019, the Fondazione Banca dei Tessuti del Veneto (FBTV) stopped sending thawed and ready-to-be transplanted cadaveric human tissues to hospitals. A retrospective analysis of the period 2016–2019 found a significant number of unused tissues. This study shows how the centralised processing of human tissues in the hospital pharmacy makes the procedure safer and more efficient, demonstrating how the synergy between ifferent hospital departments, high professional skills and ethics can lead to a clinical advantage for patients and a better economic impact on the hospital.

Read the article HERE

[Consultations]

EMA Consultation: revision of the Guideline for the evaluation of medicines targeting acute respiratory distress syndrome

EMA launched a consultation on a concept paper on the revision of the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome. This consultation aims to address the need to re-consider the EU regulatory expectations regarding the data that should be generated to support the approval of novel agents, like e.g. (co)primary and secondary endpoints, time of assessment, stratification and functional assessment indices recorded in confirmatory studies. Comments should be provided by 31 July 2023.

Find the document HERE and contribute HERE

Bedside clinical pharmacists in Europe

In this research, organized by the Semmelweis University, Hungary the position of bedside clinical pharmacists in hospitals will be assessed to gain insight into the routine practices and the provided clinical pharmacy services. The researchers would like to hear your opinion based on your experiences, so there are no correct or incorrect answers. It takes about 15 minutes to complete the questionnaire.

Contribute HERE

European Paediatric Formulary: Clonidine hydrochloride oral solution

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 6 of Pharmeuropa PaedForm, in which the draft text for Clonidine Hydrochloride 10 micrograms/mL Oral Solution is published for public consultation with a view to its later inclusion in the European Paediatric Formulary. The deadline for comments is 30 June 2023. This is the seventh monograph elaborated on by the PaedF Working Party. EDQM welcomes all comments on this new monograph from users and interested parties.

Contribute HERE