The need to use a more appropriate acronym for CSTDs for administration of cytotoxic drugs

Proposal for including in the amendment of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work, a specific name for closed system used for administration of chemotherapy.

CytoPrevent[1], a Board of European experts, intends to be a contributor to the work undertaken by the European Commission on the risks faced by healthcare workers exposed to hazardous substances (including cytotoxic drugs falling under the scope of the CMD[2]). CytoPrevent fully supports this work aiming to define a legislative framework encouraging Member States to implement protective measures and controls, to improve worker’s safety.

The highest number of exposed healthcare personnel to cytotoxics, are nurses and pharmacy technicians preparing and administering these drugs. They would be the first to take advantage of a systematic adoption of closed safety systems that prevents them from being contaminated, in addition to the use of Personal Protective Equipment (PPE)[3].

For more than 20 years, healthcare professionals especially pharmacists and pharmacy technicians in charge of preparation of drugs have developed procedures and adopted equipment and devices, to protect them from exposure to cytotoxic drugs. Over time, devices and regulations have evolved. In 2004, NIOSH defined the recommended devices for the preparation of chemotherapy commonly referred to as CSTDs (Closed System Transfer Device)[4].

The CSTDs recommended for preparation and administration are generally composed of three parts: the protector, which is located on the vial; the injector, which is connected to a syringe and is placed on the protector to withdraw the drug from the vial, and the connector, which is used for administration.

Devices used for preparation and ones used for administration[5] are not the same and are not handled by the same professionals. The healthcare staff in a cancer ward (nurses administering chemotherapies but also cleaning staff) work in a less controlled environment and are at higher risk of exposure[6] as compared to pharmacy staff.

A more accurate designation of the devices used by nurses during administration and protecting them in addition to PPE, would be a significant step forward, in a comprehensive approach to reduce contamination as considered by the European Commission in the context of draft amendments to the CMD[7].

This is even more urgent due to current and rapid growth of cancers therapies and new treatments. The healthcare professionals in charge of delivering these substances, especially nurses, cannot be adequately protected if safety devices they use daily are not precisely defined and named.

For more clarity and to promote effective deployment of closed devices in administration of cytotoxic drugs, CytoPrevent recommends distinguishing between closed devices used for preparation and devices used for administration, by using two different acronyms.

For the latest we suggest:

CSSA: Closed Safety System for Administration

• used for administering the cytotoxic treatment when the administration routes and the dosage form allow
• is a connection between the distal end of an IV line and a venous-access device (including distal tubing of an elastomeric pump or tubing of a Cassette or a syringe filled up with cytotoxic drug)
• guaranteeing a barrier against bacterial and chemical contamination

CytoPrevent intends to spread out this proposal among various stakeholders to receive their views and support.

Read the original paper here.

[1] CytoPrevent: pluriprofessional board of European experts

[2] CMD: Carcinogens and Mutagens Directive (CMD) Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (sixth individual Directive within the meaning of Article 16 (1) of Council Directive 89/391/EEC).

[3] Personal Protective Equipment (glove, mask, gown…)

[4] A closed system drug transfer device (CSTD) is a device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system

[5] USP 800 requires CSTD for Hazardous Drug (HD) administration

[6] S. Ndaw et al. INRS 2018

[7] Directive 2019/983(EU) amending Directive 2004/37/EC