Cytotoxic drugs are used prominently in the treatment of cancer. Increasingly, they are also used in a variety of non-cancerous diseases. Due to their non-selective drug action, meaning that they act on both malignant and healthy tissues alike, they could have adverse health effects on patients as well as those handle the drugs. These drugs can cause irritation to skin and eyes if exposed. The common acute effects of these cytotoxic drugs include dizziness, nausea, headache, menstrual problems and others.
Safe Cytotoxic Drug Handling Guidelines and Solution
Cytotoxic drugs are used prominently in the treatment of cancer. Increasingly, they are also used in a variety of non-cancerous diseases. Due to their non-selective drug action, meaning that they act on both malignant and healthy tissues alike, they could have adverse health effects on patients as well as those handle the drugs. These drugs can cause irritation to skin and eyes if exposed. The common acute effects of these cytotoxic drugs include dizziness, nausea, headache, menstrual problems and others. The effects of drug exposure can last for years, and the commonly observed damages including those of liver, kidney, bone marrow, lung and heart. Their effects on reproductive health are also documented
Exposure risk for the general population and healthcare professionals occurs throughout the life cycle of the drug, from manufacturing to transportation and distribution, unpacking and storage, preparation for infusions, application of cytotoxic drugs in the wards, to waste disposal. Having said that, healthcare professionals, especially pharmacists and pharmacy technicians who handle pure drugs during preparation stage are exposed to the highest concentration of the drugs. In fact, cytotoxic drugs exposure to healthcare professionals is increasing with the use of cytotoxic drugs as population ages. The number and variety of healthcare workers, such as professionals in immunology, rheumatology, nephrology and dermatology, potentially exposed to cytotoxic drugs are also on the rise with this rapid expansion of cytotoxic drugs.
The use of closed-system drug transfer devices
Knowing the high risks of cytotoxic drug exposure and their deleterious effects, especially in pharmacy, standards and legislation are established for the use of Closed-System Drug Transfer Devices (CSTDs) when preparing these drugs. CSTDs are those devices which mechanically prohibit the transfer of environmental contaminants into the devices and the escape of hazardous drug or vapour concentrations outside the system. They are the only devices that have been specifically designed to protect healthcare workers from occupational exposure to hazardous substances. CSTDs are the best, most effective, preventive measure to avoid exposure to contamination during drug preparation and administration.
In order to improve healthcare workers’ safety, European Union (EU) promotes the use of effective CSTD, which protects healthcare professionals from being exposed to cytotoxic drugs. Recommendations and standards from various parties, including The International Society of Oncology Pharmacy Practitioners (ISOPP), National Institute for Occupational Safety and Health (NIOSH), and American Food and Drug Administration (FDA) are taken into considerations when establishing harmonized protocols for testing CSTD. NIOSH defines CSTD as “a device which mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapour concentrations outside the system”. These standards and recommendation make a clear distinction between a closed system in terms of microbiological contamination and a closed system in terms of hazardous chemical and vapour contamination. This highlights the difference between a typical Class II biological safety cabinet (BSC) and that specifically designed for cytotoxic drug handling. The German Standard DIN 12980 which addresses CSTD for handling cytotoxic drugs includes the requirement that the CSTD provides for the safe replacement of ¬filters contaminated with cytotoxic drugs. The biological decontamination methods ordinarily used with BSC prior to filter replacement have no effect on these hazardous chemicals. One of the major methods described in the standard to achieve safe replacement is having a triple filter BSC (Fig. 1).
Fig. 1 Schematic of Air Flow and Design of a Triple Filter Biological Safety Cabinet Where Filters Are Installed Beneath the Work Surface
In accordance with EU guidelines and to meet the market needs, Thermo Scientific Maxisafe 2030i Triple Filter BSC (Fig. 2) is a specially designed CSTD for cytotoxic drug handling. In addition to meeting the European EN12469 Standard for Class II Biological Safety Cabinets, the Thermo Scientific Maxisafe 2030i BSC is independently tested and certified to the German DIN 12980, the standard for “safety cabinets for handling cytotoxic substances”. It provides the highest personnel, sample and environmental protection when working with cytotoxic drugs, including the preparation of these drugs in healthcare compounding pharmacies and facilities. It also complies with the American USP <800>, the “standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment”.
The Maxisafe 2030i meets a minimum ISO Class 5 air quality in the work area, which is 100,000-fold better filtration efficiency than regular class II BSC with the use of a unique triple filter design (Fig. 3). The H14 HEPA filters are placed under the work surface, providing easy and safe HEPA filter changes under negative pressure (Fig. 4). The system is easy to clean, ideal for a cleanroom/GMP installation. The design is also more ergonomic and comfortable than traditional CSTD. The Maxisafe 2030i is also installed with an advanced full color touch screen user interface that provides easy navigation and convenient illustration of airflow safety, usage data, errors and event logs, password-controlled user accessibility, and remote wifi accessibility to address any lingering user concerns about the BSC integrity and performance (Fig. 5).
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Cytotoxic drugs are used prominently in the treatment of cancer. Increasingly, they are also used in a variety of non-cancerous diseases. Due to their non-selective drug action, meaning that they act on both malignant and healthy tissues alike, they could have adverse health effects on patients as well as those handle the drugs. These drugs can cause irritation to skin and eyes if exposed. The common acute effects of these cytotoxic drugs include dizziness, nausea, headache, menstrual problems and others.
Safe Cytotoxic Drug Handling Guidelines and Solution
Cytotoxic drugs are used prominently in the treatment of cancer. Increasingly, they are also used in a variety of non-cancerous diseases. Due to their non-selective drug action, meaning that they act on both malignant and healthy tissues alike, they could have adverse health effects on patients as well as those handle the drugs. These drugs can cause irritation to skin and eyes if exposed. The common acute effects of these cytotoxic drugs include dizziness, nausea, headache, menstrual problems and others. The effects of drug exposure can last for years, and the commonly observed damages including those of liver, kidney, bone marrow, lung and heart. Their effects on reproductive health are also documented
Exposure risk for the general population and healthcare professionals occurs throughout the life cycle of the drug, from manufacturing to transportation and distribution, unpacking and storage, preparation for infusions, application of cytotoxic drugs in the wards, to waste disposal. Having said that, healthcare professionals, especially pharmacists and pharmacy technicians who handle pure drugs during preparation stage are exposed to the highest concentration of the drugs. In fact, cytotoxic drugs exposure to healthcare professionals is increasing with the use of cytotoxic drugs as population ages. The number and variety of healthcare workers, such as professionals in immunology, rheumatology, nephrology and dermatology, potentially exposed to cytotoxic drugs are also on the rise with this rapid expansion of cytotoxic drugs.
The use of closed-system drug transfer devices
Knowing the high risks of cytotoxic drug exposure and their deleterious effects, especially in pharmacy, standards and legislation are established for the use of Closed-System Drug Transfer Devices (CSTDs) when preparing these drugs. CSTDs are those devices which mechanically prohibit the transfer of environmental contaminants into the devices and the escape of hazardous drug or vapour concentrations outside the system. They are the only devices that have been specifically designed to protect healthcare workers from occupational exposure to hazardous substances. CSTDs are the best, most effective, preventive measure to avoid exposure to contamination during drug preparation and administration.
In order to improve healthcare workers’ safety, European Union (EU) promotes the use of effective CSTD, which protects healthcare professionals from being exposed to cytotoxic drugs. Recommendations and standards from various parties, including The International Society of Oncology Pharmacy Practitioners (ISOPP), National Institute for Occupational Safety and Health (NIOSH), and American Food and Drug Administration (FDA) are taken into considerations when establishing harmonized protocols for testing CSTD. NIOSH defines CSTD as “a device which mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapour concentrations outside the system”. These standards and recommendation make a clear distinction between a closed system in terms of microbiological contamination and a closed system in terms of hazardous chemical and vapour contamination. This highlights the difference between a typical Class II biological safety cabinet (BSC) and that specifically designed for cytotoxic drug handling. The German Standard DIN 12980 which addresses CSTD for handling cytotoxic drugs includes the requirement that the CSTD provides for the safe replacement of ¬filters contaminated with cytotoxic drugs. The biological decontamination methods ordinarily used with BSC prior to filter replacement have no effect on these hazardous chemicals. One of the major methods described in the standard to achieve safe replacement is having a triple filter BSC (Fig. 1).
Fig. 1 Schematic of Air Flow and Design of a Triple Filter Biological Safety Cabinet Where Filters Are Installed Beneath the Work Surface
Thermo Scientific Maxisafe 2030i Triple Filter Biological Safety Cabinet
In accordance with EU guidelines and to meet the market needs, Thermo Scientific Maxisafe 2030i Triple Filter BSC (Fig. 2) is a specially designed CSTD for cytotoxic drug handling. In addition to meeting the European EN12469 Standard for Class II Biological Safety Cabinets, the Thermo Scientific Maxisafe 2030i BSC is independently tested and certified to the German DIN 12980, the standard for “safety cabinets for handling cytotoxic substances”. It provides the highest personnel, sample and environmental protection when working with cytotoxic drugs, including the preparation of these drugs in healthcare compounding pharmacies and facilities. It also complies with the American USP <800>, the “standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment”.
The Maxisafe 2030i meets a minimum ISO Class 5 air quality in the work area, which is 100,000-fold better filtration efficiency than regular class II BSC with the use of a unique triple filter design (Fig. 3). The H14 HEPA filters are placed under the work surface, providing easy and safe HEPA filter changes under negative pressure (Fig. 4). The system is easy to clean, ideal for a cleanroom/GMP installation. The design is also more ergonomic and comfortable than traditional CSTD. The Maxisafe 2030i is also installed with an advanced full color touch screen user interface that provides easy navigation and convenient illustration of airflow safety, usage data, errors and event logs, password-controlled user accessibility, and remote wifi accessibility to address any lingering user concerns about the BSC integrity and performance (Fig. 5).
Fig. 2 Thermo Scientific Maxisafe 2030i Triple Filter Biological Safety Cabinet
Fig. 3 Triple Filter Design Where H14 HEPA Filters Are Placed Under the Work Surface
Fig. 4 Replacement of Filters under Negative Pressure to Prevent Exposure
Fig. 5 The Maxisafe 2030i Advanced User Interface
References:
(ISOPP_Safe_Handling_of_Cytotoxics.pdf (creod.on.ca))
(Exposure-to-Cytotoxic-Drugs_Recommendation_DINA4_10-03-16.pdf (europeanbiosafetynetwork.eu))
https://assets.thermofisher.com/TFS-Assets/LPD/Product-Information/Herasafe-Maxisafe-2030i-BSC-Brochure-EN.pdf)(
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