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Klaus Meier in conversation about handling of cytostatic drugs (April 2025)

Question: What should be considered in the discussion about devices used in handling cytostatics?

Klaus: Since 1999, the pharmaceutical community has been debating how to optimize both the application and occupational safety in the preparation and handling of cytostatic infusion solutions. Initially, when using needles, special care was required to prevent overpressure in the drug container, which could lead to aerosol formation when the needle was removed. Later, transfer systems with filters were introduced to mitigate this risk.

Over the past 25 years, so-called Closed System Drug Transfer Devices (CSTD) have been increasingly promoted. According to manufacturers, these systems are designed to prevent user errors and improper handling. To support this claim, various studies have been presented—though many of them were financially backed by the manufacturers themselves.

For this reason, the European Society of Oncology Pharmacy (ESOP) decided 15 years ago to conduct independent studies on this matter. These investigations took place both in pharmaceutical production environments and later, in collaboration with the European Society for Medical Oncology (ESMO), in clinical settings involving nurses and physicians. The findings from these studies have been actively incorporated into discussions within EU committees.

In the EU Strategic Framework on Health and Safety at Work 2021–202726, published in 2021, the need to protect healthcare staff from hazardous medicinal products (HMPs) and other occupational risks was emphasized. In response, the European Commission and the European Agency for Safety and Health at Work (EU-OSHA) initiated extensive studies and discussions with experts and stakeholders to address these concerns.

Among these studies was COWI (2021), which highlighted strong stakeholder support for enhanced training, instruction, and guidance. It also identified challenges in implementing binding legislation to tackle this issue effectively.

The development of this guide was overseen by a tripartite Steering Group, established by the Directorate-General for Employment, Social Affairs and Inclusion, comprising representatives from governments, employers, and workers.

The following was recorded in the Guidance for the safe management of hazardous medicinal products at work in 2023 on page 98:

„Needle-free systems should be used, where possible. For example, using syringes with Luer locks, using needle-free systems with a physical barrier and using syringe-to-syringe connectors for transferring solutions.
A sterile, impermeable, single-use, waterproof and non-slip absorbent mat with the absorbent side up, should be used. This should be replaced daily, following contamination, or after a spill.
Fluid bags should be spiked, and tubing should be primed with a compatible fluid before the addition of HMPs.

There is differing information in the literature on the effectiveness of use of closed system transfer devices (CSTDs) for reducing the risks in the preparation of HMPs. It is the decision of the management/staff on whether CSTDs are to be used in accordance with the risk assessment performed and relevant legislation. The technical measures that are used should also be validated with appropriate monitoring techniques.“

Question: What should we make of the fact that some interested manufacturers and their field representatives are now saying in various places that a change to this recommendation and the mandatory use of CSTDs in all manufacturing areas can be expected next year?

Klaus: After consulting the Directorate-General for Employment, Social Affairs and Inclusion, Department EMPL.C — Working Conditions and Social Dialogue, Unit C.2 — Safety and Health at Work, there is no indication of an imminent change to the current recommendation.

In fact, the publication of the “Guidance for the Safe Management of Hazardous Medicinal Products at Work” (2023) in several European languages is imminent. Therefore, it can be safely ruled out that any short-term changes to this guideline will be made

The manufacturers’ freedom of choice therefore remains, and there is no obligation to use specific devices.

Protection of intellectual property (November 2024)

Question: How does the ESOP protect its members and their work results from intellectual exploitation?

Klaus: All colleagues know what has been waiting for them for 24 years. A small membership fee of 5 euros, but the opportunity to contribute both actively and with the support of the community to improving the care of cancer patients. From the very beginning, it was important to us that everyone could formally feel like a member with a small financial contribution and also actively and sustainably exchange ideas with colleagues in working groups. This has resulted in many projects, presentations and publications, and I would like to highlight the long-term studies on the effects of COVID, among other things.

We have never restricted the entire public, but have published all data on our website for everyone to access. Above all, this includes the continuous publication of the QuapoS in over 20 languages.

We have only made the 500-page commentary on the QuapoS available to members, so that everyone has access to their own personal working material. Now, as has been the case since 1996, we are working on the version of QuapoS 7, which can be approved by the delegates at the AGM on October 1 after a long period of committee work.

In connection with the fair treatment of the interested public with our results, however, we have to realize that some people who want to compete with us like to make extensive use of our work results.

Be it in lectures within the EUSOP specialization, in communication with our friendly societies or in other unfriendly actions, there is a misconception that they are trying to achieve supposed advantages for their own organization in the hope of gaining more support from the pharmaceutical industry.

Question: How do you yourself feel about negative behavior?

Klaus: I think that it is not okay to deprive our members of their work in order to gain financial benefits for your own purposes, and for this reason I believe that the people who represent our organization as officers must be clearly and unambiguously committed to the goals of the ESOP.

Reliability and clarity will be honored by all members. We disclose our objectives in publications and our finances in public statements, e.g. in the EU Transparency Register. We do not tolerate corruption or similar misconduct. It is good that the Committee for Fundamental Issues deals with this issue and presents the results to the delegates. I always assume that

ESOP Global: Response to the new EU pharmaceutical legislation proposal (2023)

About the past and present of ISOPP and ESOP Global (October 2023)

Question: Some colleagues have received an invitation for a virtual meeting of different nations with leadership. Where does the ISOPP get our email addresses from and what is this all about?

Klaus: Since we as ESOP operate our homepage openly for all interested parties, i.e. we allow everyone to participate in our activities free of charge, and all delegates can be contacted directly via the mailing list. The fact that the ISOPP is now showing interest in national issues in the context of oncological therapy only makes it clear that it has not missed the fact that we as ESOP Global have now brought together 70 countries and their active members for a fruitful exchange.

Question: Is this a new ISOPP strategy?

Klaus: We don’t know the decisions of the committees, but we can see the effects. When we founded the ESOP in 2000 because we thought it would be fruitful for better patient care to pass on knowledge to anyone who was interested, this was rejected by the countries, the majority of which belonged to the former Commonwealth. Since that days we propagate the goal worldwide: “Unity in diversity”

Question: Why is it that the ISOPP now wants to be open?

Klaus: There are certainly several reasons. Firstly, the ISOPP has started to organise its congresses annually rather than every two years, which puts it in strong competition with us. Especially in the years in which we organise the ECOP. The money that the industry, for example, budgets annually for advertising, including stands at congresses and satellite symposia, is limited. In this respect, the ISOPP is looking for national associations to participate in their congresses as co-organisers. On the other hand, the ISOPP also seems to have realised that the time of elitist associations is over if we not only want to support the development and use of new medicines, but also want to make knowledge available to all colleagues worldwide to support the entire treatment process. Through the EUSOP specialisation programme and the regional lectures it contains, we are not only strengthening our colleagues locally, but also our society. This also includes the ongoing and continuous development of quality standards. By already working on the 7th version, involving all experts worldwide, we are demonstrating our sustainability-orientated policy.

Question: You were the first elected president of the ISOPP in 1998. How do you feel about this unfriendly behaviour now?

Klaus: I don’t want to hide the fact that on the one hand this behaviour of long-time colleagues, such as the new ISOPP Vice President, who also participated as a delegate in the ESOP for the BOPA before BREXIT, hurts me. However, I have not given up hope of achieving fruitful cooperation in the future in the interests of patients. For this reason, on behalf of the ESOP Executive Committee, I have sent a detailed letter to the presidents of the ISOPP in which we offer a hand to reach an understanding on an equal footing, but at the same time make it a prerequisite to end the competition for finances and the organisation of the annual congress in the same year as the ECOP.