The EAHP EU Monitor is a regular round up of news relevant to hospital pharmacy in Europe.
In mid-June, the members of the European Association of Hospital Pharmacists (EAHP) came together for their annual General Assembly. Like every year, EAHP’s 35 member associations discussed and approved new position papers developed for the profession. This year’s exchanges at the General Assembly focused on two topics important for patient care, namely access to medicines and the hospital pharmacy specialisation.
Hospital pharmacists are the key stakeholders responsible for medication management and safety in the hospital environment, covering both in- and out-patient services and supporting the seamless transition of care for patients moving within the healthcare system. Hospital pharmacy specialisation is important to provide the best treatment for all patients since it ensures that hospital pharmacists are prepared and able to operate in a complex hospital setting and work collaboratively within multi-disciplinary healthcare teams. The position centres around advancing the profession by harmonising the recognition of hospital pharmacy education, enhancing the role of the hospital pharmacist and preparing the profession for future challenges. To make a difference in medication by advancing the hospital pharmacy profession, EAHP
To adequately address future challenges linked to the ageing society, changing healthcare needs and other unknown factors, like future pandemics, EAHP also urges that Member States invest in better workforce planning for the hospital pharmacy profession, including the availability of hospital pharmacy services for all patients of each hospital.
Ensuring that patients receive the medication they need to improve their health and to prevent and cure diseases is the key topic of EAHP’s Position Paper on Access to Medicines. Given that growing healthcare expenditure has become a problem for many European countries that also affects patients who are increasingly faced with avoidable accessibility and affordability issues, EAHP has chosen to look at the barriers to access and enablers that could help improve it.
Lack of purposeful procurement practices, national pricing and reimbursement policy choices jeopardising patients' adequate access, medicine shortages and the unavailability in certain markets that are leading to inequity between Member States are the main barriers identified in the position. For the provision of affordable medicines of good quality that are given in a timely manner to patients, EAHP advocates for breaking down these barriers to treatment access and calls for uptake of enablers that promote and safeguard the access of patients to both new life-saving medicines and older, essential medicines must be increased. Enablers mentioned refer to health technology assessments (HTAs), including common reports at EU level, collaboration and best practice sharing on pricing and reimbursement, increasing the use of prevention measures and fostering innovation and research
To achieve an equilibrium between the barriers and the enablers to treatment access, the following has been put forward by EAHP:
In relation to the developments linked to the European Health Union aided by the implementation of the Pharmaceutical Strategy, EAHP underlined its commitment to working together with the European institutions and other stakeholders by giving a voice to access issues that otherwise might be forgotten.
Read the Position Paper on Access to Medicines HERE [1]
Read the Position Paper on Hospital Pharmacy Specialisation HERE [2]
The European Medicines Agency (EMA) has published its 2020 annual report that provides an overview of the Agency's major achievements and contributions to public health in Europe. The digital report outlines the most important highlights of the evaluation and monitoring of human and veterinary medicines and provides a high-level overview of key figures. Specific focus has been put on the response of the regulatory network’s response to the COVID-19 pandemic. An interactive timeline of EMA's main activities in 2020 allows users to explore each topic in more depth, for example through additional audio-visual materials, infographics, videos and documents.
In 2020, EMA and its partners within the European medicines regulatory network had to adapt processes to ensure a rapid response to the COVID-19 pandemic whilst maintaining core regulatory activities to protect public and animal health in the European Union. The report details EMA's work during the pandemic and highlights key lessons learnt in 2020. Additional topics covered by the report include the Agency's response to other public health challenges, such as antimicrobial resistance, and also EMA's relocation to a new permanent headquarters in Amsterdam, and the preparations for Brexit. The report also describes how the Agency marked its 25th anniversary and explains the steps EMA took to ensure that it is fit to tackle future scientific and technological challenges and take on new responsibilities. As usual, the second chapter of the report contains core statistics that illustrate the main outcomes of the Agency's regulatory activities, as well as interesting trends and changes observed in recent years.
Read the EMA annual report HERE [3]
Based on a request from the European Parliaments Committee on the Environment, Public Health and Food Safety (ENVI) the Policy Department for Economic, Scientific and Quality of Life Policies situated in the Directorate-General for Internal Policies conducted a detailed study looking at the access to medicinal products. Based on the findings it was concluded that important steps were taken since the adoption of the Resolution on options for improving access to medicinal products in 2017. Further advancements are however needed to guarantee full access for all patients and EU citizens.
Specific focus was put on the implementation of the 58 recommendations for improving access to medicines put forward by the European Parliament in its 2017 Resolution. These called for action across many different areas of policy, ranging from actions to promote competitive and fair pharmaceutical markets, to actions aimed at directing more pharmaceutical innovation to areas of unmet need and increased coordination between Member States to align policies. The study analysis the progress made in the last four years with a focus on the following: patients, markets, research, development and innovation, health systems, the regulatory framework and developing countries. It factors in the key actions taken between 2017 and 2021 and also looks at the influence of the COVID-19 pandemic.
In conclusion, it can be said that the European Commission Member States have taken many important steps towards improving access to medicines by for example working on medicines shortages, health technology assessments and the revision of existing legislation. In particular, the introduced or proposed legislative changes are aimed at directing more innovation to areas of unmet need whilst placing greater obligations on product developers to ensure affordability and availability of products that benefit from innovation incentives. Given that a large majority of the actions discussed by the report were only introduced within the last 18 months or are still in preparation it has been underlined that their full effect cannot be assessed yet.
Access the study results HERE [4]
In mid-June, the European Commission published a Communication looking at the early lessons learnt from the COVID-19 pandemic over the past 18 months and building on them to improve action at EU and national level. The information included in the communication will be used during this week’s discussion with heads of state and followed up with concrete deliverables in the second half of 2021.
Ten improvement areas have been identified in relation to enhancing the EU’s future crisis preparedness. These cover the following aspects:
Read the communication HERE [5]
The original research published in the online edition of the European Journal of Hospital Pharmacy (EJHP) describes the extent and relationship between clinical frailty and polypharmacy in a cohort of older emergency general critical care patients, and the effect of the critical care pathway on patient polypharmacy measures. A retrospective evaluation was undertaken in all patients ≥70 years of age, admitted as emergencies to the general critical care units of a single large UK academic hospital, over a 2-year period (March 2016 to February 2018) (n=762). In conclusion, the authors found that polypharmacy and frailty were very common in this UK single-centre cohort of older emergency critical care patients. There was a significant association between the degree of polypharmacy and frailty score. The critical care pathway created extensive changes in patient medication therapy.
Read the article HERE [6]
[COVID-19 Updates]
EAHP’s COVID-19 Resource Centre
To assist its member associations and individual hospital pharmacists in this critical time with the provision of the best possible care for patients, EAHP has decided to gather and make available information on COVID-19 relevant for the hospital pharmacy profession.
Access the Resource Centre HERE [7]
Irish Health Service Executive (HSE) - Interim Guideline for the Management of Covid-19 Infection in Paediatric Patients
Guideline for children outside of the paediatric intensive care unit (PICU) setting.
Access the guideline HERE [8]
Indian Council of Medical Research (ICMR) - National Institute for Research in Reproductive Health
Guidance for Management of Pregnant Women in COVID-19 Pandemic
Guidance for healthcare facilities providing obstetric care for pregnant patients with confirmed novel coronavirus disease (COVID-19) or pregnant persons under investigation (PUI) in obstetric healthcare settings.
Access the guidance HERE [9]
American Journal of Health-System Pharmacy - Optimization of critical care pharmacy clinical services: A gap analysis approach
The article analysis critical care pharmacy clinical services and provides suggestions for optimization.
Read the article HERE [10]
Hospital Pharmacy - In Vitro Assessment for Dose Preparation and Simulated Administration of Azithromycin Suspensions via Enteral Feeding Tubes
The aim of this study was an in vitro assessment for the dose preparation and simulated administration of azithromycin suspensions, prepared from tablets and capsules, via nasogastric feeding tubes (NGT).
Read the article HERE [11]
A new commented version of the European Statements of Hospital Pharmacy was approved at the 51st EAHP General Assembly. The Statements represent what we believe every European health system should aim for in the delivery of hospital pharmacy services, thus for EAHP is important to make sure that the Statements are up to date and easily understood by all stakeholders. The commented version of the Statements will be published in September and will include comments to clarify and further explain the meaning of some of the European Statement. Stay tuned for more!
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Consultations
European Commission – Public Consultation: Digital health data and services – the European health data space
To ensure that all possible views are considered in the design of a legal framework for a European Health Data Space (EHDS), the European Commission invites all interested individuals and stakeholders to share their views and experiences. Your contribution can help provide important insights, opinions and evidence to support the impact assessment accompanying the EHDS proposal on the problems to be tackled, the policy options to be considered and their likely impacts.
Deadline – 26 July 2021
Access the consultation HERE [12]
European Commission – Public Consultation: Cross-border healthcare – evaluation of patients’ rights
The Directive on patients’ rights in cross-border healthcare (2011/24/EU) aims to facilitate access to safe and high quality healthcare in another EU country. The European Commission invites all interested individuals and stakeholders to share their views and experience in seeking planned healthcare across the EU or in EU cooperation in the area of rare diseases.
Deadline – 27 July 2021
Access the consultation HERE [13]
European Commission – Public Consultation: Medicines for children & rare diseases – updated rules
This initiative will explore several options to address the shortcomings identified in the evaluation of the Regulations on medicines for children and rare diseases, in view of a revision of the existing legislation. With this public consultation, citizens and stakeholders are invited to share their views and experiences on the main obstacles they are facing concerning treatments for rare diseases and children, on possible ways to overcome these obstacles and on how to make the current legislation future-proof.
Deadline – 30 July 2021
Access the consultation HERE [14]
Links
[1] https://www.eahp.eu/practice-and-policy/access-medicines
[2] https://www.eahp.eu/practice-and-policy/hospital-pharmacy-specialisation
[3] https://www.ema.europa.eu/en/annual-report-2020/
[4] https://www.europarl.europa.eu/RegData/etudes/STUD/2021/662910/IPOL_STU(2021)662910_EN.pdf
[5] https://ec.europa.eu/info/sites/default/files/communication150621.pdf
[6] https://ejhp.bmj.com/content/early/2021/06/01/ejhpharm-2020-002618
[7] https://www.eahp.eu/hp-practice/hospital-pharmacy/eahp-covid-19-resource-centre
[8] https://rcpi-live-cdn.s3.amazonaws.com/wp-content/uploads/2020/04/CD19-038-001_Interim-guideline-for-the-management-of-SARS-COV-2-infection-in-paediatric-patients.pdf
[9] https://www.icmr.gov.in/pdf/covid/techdoc/Guidance_for_Management_of_Pregnant_Women_in_COVID19_Pandemic_12042020.pdf
[10] https://academic.oup.com/ajhp/advance-article-abstract/doi/10.1093/ajhp/zxab237/6290812?redirectedFrom=fulltext
[11] https://journals.sagepub.com/doi/10.1177/00185787211024216
[12] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12663-Digital-health-data-and-services-the-European-health-data-space/public-consultation_en
[13] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12844-Cross-border-healthcare-evaluation-of-patients%E2%80%99-rights/public-consultation_en
[14] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12767-Medicines-for-children-&-rare-diseases-updated-rules/public-consultation_en