Background
Around 300,000 European patients rely on Plasma derived medicinal products (PDMPs) to treat a variety of rare and chronic and/or genetic diseases and serious, often life-threatening medical conditions. For individuals with these conditions, PDMPs replace their missing or deficient proteins. Without these treatments, many patients would either not be able to survive or would have a substantially diminished quality of life and productivity.
The availability of PDMPs is reliant on enough plasma being collected and manufactured into these lifesaving therapies. The Plasma needed for manufacturing is acquired through whole blood donation (recovered plasma) or through plasma donation in a process called plasmapheresis (source plasma). National blood services in Europe collect only a marginal amounts of plasma needed for manufacturing therapies, and currently Europe remains reliant on the U.S. for around 35% of its plasma. Today, just four European countries (Austria, Czech Republic, Germany and Hungary) contribute more than half of the total plasma collected in Europe by allowing the coexistence of publicly- and privately-owned collection centers and by compensating donors for their expenses and inconveniences related to the donation.
However, European plasma collectors are facing several challenges, one of which is the difficulty in finding enough physicians for plasma collection centers — current European regulations require at least one physician on site to provide medical expertise as well as donor oversight, evaluation, and management.
In Germany, Austria, Hungary and Czech Republic a physician needs to be present at all times in plasma collection centers . However, it becomes more and more difficult to fill these positions, with the consequences that often times center opening hours have to be adapted or shortened. Therefore, plasma collectors ask for more regulatory flexibility in this area. It should be possible to delegate the tasks to qualified medical staff such as nurses and be available on call for questions or emergencies.
The lack of physicians might ultimately have consequences on the availability of European plasma. These positions are generally difficult to fill, mainly due to the numerous competing career paths available for physicians. The job duty for a physician in a plasma collection center is essentially examining healthy people and not patients, which is significantly different from all other areas of medical practice.
Misson – Vision
The objective of this project is to develop a Specialist Nurse’s competent profile for plasma donation centers aiming to develop a competency framework for these nurses to expand their responsibilities and become the recognized ‘Qualified healthcare professionals’. The framework will be based on evidence-based practice roles and responsibilities based on the four pillars of advanced nursing practice that is: education, competencies, research and consultancy.
Goals
Ultimately nurses will be able to exercise tasks delegated by plasma center physicians in line with the European directives and national regulatory requirements without the physician being physically present at all times in the collection centers.
Presentation summary on project 26 February 2021
Prof. Afra Masia Plana from the ESNO 2021 conference, in short clips ‘Current challenges’ – Develloping Specialist Nurse Curriculum Plasma Donation Centers.
Timeline
- 2020
- June 2020: structure and project description
- July: recruiting nurse members for a working group
- September: online meetings with Nurse and Medical organisations
- October: draft a document outlining the nurses’ profile within the plasma donation centre
- 2021
- February 2021: presentation at ESNO congress
- March – June 2021: drafting and reviewing by ESNO and PPTA
- July 2021: finalise draft endorsed by ESNO and PPTA
- August 2021: evaluation
- September 2021 : publication
- 2022
- Launch of the Curriculum 2 March 14.00 – 15.00.
Activities
Timeline: 2020 – 2021 – 2022
- Collecting frameworks and exploring gaps
- Meetings with representatives Plasma Donation Centers
- Presentation ESNO congress about project
List of confimed organisations
PPTA-Global: Plasma Protein Therapeutics Association. The Plasma Protein Therapeutics Association (PPTA) represents the private sector manufacturers of plasma-derived and recombinant analogue therapies, collectively known as plasma protein therapies and the collectors of source plasma used for fractionation. https://www.pptaglobal.org/
FoNSE: Foundation of Nurse Specialists Europe. The Foundation shapes and implements all related projects under the auspices of the umbrella organisation of ESNO (European Specialist Nursing Organisation). All activities will be in line with the strategic plans and approved by the executive board of ESNO ensuring that the organization’s goals of providing relevant and high standard professional specialist nursing care in Europe is maintained. https://fonse-europe.com/
EDTNA: The European Dialysis and Transplant Nurses Association/European Renal Care Association (EDTNA/ERCA) is a multidisciplinary organization for those working in renal care. The mission of the Association is about ‘achieving the best level of education, standards and research for all renal care professionals caring and supporting their patients and families around the world’. To be able to live up to this mission, we are a group of multidisciplinary professionals from different parts of the world. Many tasks are split and shared amongst us, enabling us to be stronger and to achieve our goals.
Links
Publications
Plasmavigilance—Adverse events among US Source plasma donors
Plasma Politico ‘EU we have a plasma problem’
Project contributers
- Afra Masia Plana – EDTNA
- Ber Oomen – FoNSE
- Maria-Teresa – ESNO
- Corinne Scicluna -FoNSE
- Maarten van Baelen – PPTA
- Alexa Wetzel – PPTA
Contact
Please contact us with any questions or feedback:
Ber Oomen, Director FoNSE
projects@fonse.eu
0031-6-23343086
Sponsor
This project is sponsored by Plasma Protein Therapeutics Association, PPTA