The handling of cytotoxic drugs can present many health risks from inadvertent exposure. James Tucker, Marketing Director, Ecolab Contamination Control, outlines an approach to reducing the risks through product development
Occupational exposure to cytotoxics is a serious issue within the pharmaceutical and compounding industry and is likely to occur when control measures are limited. The types of activities that put operators, pharmacists and laboratory staff at most risk are drug preparation and cleaning up residues and spills.
One of the key challenges posed by cytotoxics is that as well as being difficult to remove from surfaces and equipment they can continue to present a risk directly as waste. It is therefore essential that the right procedures and products are implemented to ensure contamination is kept to an absolute minimum.
Data collection and actions to identify and remedy exposure levels of cytotoxic drugs are on the increase
Under UK Health & Safety Executive Control of Substances Hazardous to Health regulations (COSHH), there needs to be comprehensive assessment of the risks arising from handling cytotoxic drugs at every stage of use and disposal. Control and monitoring of the effects of exposure has been studied in detail with a range of biological endpoints, including DNA damage, HPRT mutations and thioether excretion, which highlight the seriousness of this issue.
Analytical methods are also now being employed to measure the level of environmental contamination in the workplace, and numerous studies have been published on environmental wipe sampling for these drugs as the issue becomes more widely known. Similarly, data collection and actions to identify and remedy exposure levels of cytotoxic drugs are on the increase.
Two key agencies responsible for conducting research and making recommendations, the National Institute for Occupational Safety and Health (NIOSH) and Germany’s Institution for Statutory Accident Insurance and Prevention in the Health and Welfare Services (BGW), have taken steps to raise awareness of the subject.
NIOSH has published an alert on ‘Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings’,1 while in Germany BGW has conducted a study, Wipe Sample Monitoring on Workplace Contamination with Antineoplastic Drugs in Pharmacies,2 in which cytotoxic drugs were found on 61% of all wipes used in three sampling positions within pharmaceutical cleanrooms: worktop, floor and fridge.
Contamination levels in excess of 70%, 60% and 50% respectively were observed. This has led to the implementation of a reference value of 0.1ng/cm2 for pharmaceutical cleanrooms in Germany, Switzerland, Austria and Poland dealing with cytotoxic drugs.
Ecolab fully expects other national pharmaceutical industries to follow suit with specific legislation on this important subject, but it has yet to materialise. However, this should not deter responsible employers from taking the initiative and adopting their own proactive approach.
The elimination of cytotoxic drugs on surfaces, often caused by spillages, should be a major priority for the industry
The elimination of cytotoxic drugs on surfaces, often caused by spillages, should be a major priority for the industry. One definite way to achieve this is through the controlled use of contamination control products that have been manufactured in a cleanroom environment, with a proven and tested capability in their safe removal and destruction.
Ecolab Contamination Control has developed a range of products that are scientifically proven to reduce the risks associated with cytotoxics and to both remove and denature the cytotoxic residues when used in combination, making disposal safer and ensuring contamination control right along the waste removal journey.
The independent work performed by Germany’s Institute of Energy and Environmental Technology (IUTA) recommends a combined procedure of spraying a Klerwipe polyester dry wipe with Klercide Sporicidal Active Chlorine spray. Following a contact time of five minutes, the surface should then be wiped with Klerwipe 70/30 IPA impregnated wipes. This combination is proven to have optimum efficacy in removing a full range of cytotoxic compounds from surfaces, eliminating up to 99.9% of them.3
Other measures that form part of a robust operational best practice procedure to minimise exposure include the safe handling, storage and transport of cytotoxic drugs and waste material containing or contaminated by them, along with effective disposal. These are in addition to using totally enclosed systems where practical, controlling exposure at source by using adequate extraction systems and providing staff with the necessary protective equipment.
3. The trial was conducted using Ecolab’s Klercide and Klerwipe products; data is not transferable to similar products.