Handling of Cytotoxic Drugs
With the 25% increase in cancer in Great Britain between 1977 and 2006 and chemotherapy drugs being at the forefront of our defence for tackling this disease, safety concerns regarding the preparation and handling of cytotoxic agents have increased.
Studies based primarily on animals have led to the International Agency for Research on Cancer classifying some cytotoxic drugs as possibly carcinogenic, mutagenic and teratogenic.
The potentially hazardous nature of these drugs has caught the attention of the HSE, who have published two information sheets on this subject: Safe handling of cytotoxic drugs and Handling cytotoxic drugs in isolators in NHS pharmacies (the latter in association with the MHRA).
Am I using the right Cytotoxic gloves for protecting myself AND the product?
In the busy environment of the hospital pharmacy, you can be forgiven for feeling confused about what criteria to use for selecting nitrile gloves when handling cytotoxic agents. The bewildering display of standards and pictograms only increases the complexity. However the hazardous nature of many cytotoxic drugs is widely recognised and therefore it is incumbent on employers to undertake the necessary risk assessment to ensure that employees are protected. To facilitate this process the following checklist may help to ensure that personnel enjoy the highest level of protection available with their right nitrile gloves / cleanroom gloves:
Are the gloves registered according to the Personal Protective Equipment Directive (89/686/EEC) as Complex Design (Category III)?
NO – Where the primary purpose of the gloves is personal protection from incidental exposure to chemical splashes, then only gloves that are registered as PPE gloves Complex Design (Category III) should be used.
YES – For extra security, request a Declaration of Conformity from manufacturer. This will declare unequivocally the regulatory status of the gloves.
Have the gloves been specifically tested against a wide range of chemotherapy drugs?
NO – Request permeation data from manufacturer.
YES – As part of the risk assessment having permeation data on the drugs to which employees are exposed may be prudent.
Have the gloves been tested for permeation according to ASTM D 6978-05?
NO – Whilst testing according to alternative standards such as EN 16523-1:2015 (supersedes EN 374-3:2003) may be suitable for general chemical protection, ASTM D6978-05 has been specifically developed for operators exposed to cytotoxic agents and would therefore seem preferable.
YES – There are a number of manufacturers that now provide data based on ASTM D6978-05.
Have I selected gloves with the highest level of resistance to penetration (EN 374-2:2014)?
NO – Harmful substances may pass through micro-porous holes in the gloves. Therefore selecting gloves with as low an AQL as possible could optimise barrier performance.
YES – A number of manufacturers provide gloves with an AQL of 0.65 (Level 3), which is likely to reduce the risk of porosity.
Where can I purchase gloves with the level of protection and comfort to handle Cytotoxic drugs?
SHIELD Scientific, are a market leading manufacturer of gloves within the laboratory and high technology sectors. The company’s aim is to bring to these markets Personal Protective Equipment (PPE, laboratory gloves and cleanroom gloves) that for the first time are adapted to the needs of these segments. Indeed up until now, the products typically sold to the laboratory and high technology sectors originate from the medical or industrial field. Accordingly Shield have set five priorities for responding to the real needs of users in these sectors.
PROTECTION AGAINST CHEMICAL RISK
PROTECTION AGAINST MICRO-BIOLOGICAL RISK
PROTECTION OF THE PROCESS
EXCELLENCE IN ASEPTIC PROCESSING
THE HIGHEST LEVEL OF COMFORT
Critical Environment Solutions Ltd are an authorised UK distributor Of gloves from Shield Scientific. We can provide advice, samples and technical support. Please click here to view a sample of the range of Shield Scientific gloves we have on offer. If you have a requirement for any other Shield Scientific glove please email here.
For further information on the handling of Cytotoxic Drugs please click here to download a full editorial by Nick Gardner of Shield Scientific.