Skip to 0 minutes and 15 secondsCytotoxic drug preparation poses the greatest risk of occupational exposure to workers. With adequate precautions, contamination of personnel and the work environment has been shown to be reduced. The risk of exposure may be reduced by ensuring that cytotoxic drugs are prepared by trained pharmacists or technicians in approved facilities. Exposure may occur through skin, eye or mucous membrane contact with cytotoxic material. It could occur through spills, also inhalation of aerosols and powders. Lastly the sharps injuries. To facilitate the safe preparation of cytotoxic drugs, consideration should be given to workplace design, set-up and maintenance regimes, or use of cleanrooms, or cytotoxic drug safety cabinets, or other specialized equipment.

Skip to 1 minute and 33 secondsEducation and training is crucial in ensuring that risk control measures and safe work procedures and practices are developed, understood, implemented, maintained, monitored and reviewed. Now we want to apply the hierarchy of risk control outlined in the last section. So we could manage the risk to the preparation of cytotoxic drugs. And the first one, we want to use the Level 1 Risk Control Measure, which is Eliminate the hazard. It is rarely possible to eliminate, substitute or replace a cytotoxic drug for a less toxic or non-toxic drug, therefore, the most practical first level risk control measure is to identify an alternative supply of cytotoxic drugs.

Skip to 2 minutes and 38 secondsThe Alternative arrangements could include purchasing and supplying prepared cytotoxic drugs in a single-dose delivery unit from a commercial. Establishing supply arrangements with a Health Service that has the required facilities, equipment and trained staff to provide prepared cytotoxic drug doses. It may be possible to prevent the potential risk of exposure of staff and the environment by containing the cytotoxic drug at its source. If possible, source containment should be continuous throughout the entire process of preparation. Drug preparation equipment

Skip to 3 minutes and 39 secondswe need to choose the Closed system drug transfer devices. Alternative devices that have been implemented to protect workers using this classic technique include luer-slip syringes only if luer-lock connections are incompatible, such as intrathecal needles, syringe-to-syringe connectors when transferring solutions from one syringe to another, or wide-bore needles, 18 gauge per 1.2 millimeter, to reconstitute and draw-up cytotoxic drugs, or filter needles, but only when the cytotoxic drug has been removed from a glass ampoule or if particulate matter is visible, for example, if coring of vial rubber has occurred, or air-venting devices, fitted with 0.2-micron hydrophobic filter, to equalize pressures and to prevent the passage of powder aerosols and fluid.

Skip to 5 minutes and 12 secondsIn terms of Drug storage, A dedicated storage area, including refrigeration, must be clearly marked and identifiable by all staff. Current safety data sheet for each drug should be located in each dedicated storage area. Damaged packages should be handled with care. Badly damaged packages should be safely contained and destroyed as per cytotoxic waste management procedures. Competent staff wearing appropriate personal protective equipment should open damaged packages When we still use the Level 2 Risk Control Measure to reduce the risk through engineering control. The Engineering controls use technological means to isolate or remove hazards from the work environment. In terms of Drug preparation facilities,

Skip to 6 minutes and 25 secondsa primary barrier to provide drug containment and aseptic manipulation. All preparation of cytotoxic drugs must take place in either a cytotoxic drug safety cabinet or a pharmaceutical isolator for drug preparation. a secondary barrier to prevent cytotoxic drug contamination of the outside environment. This should be provided by high efficiency particulate air filters, or HEPA filter, which supply filtered air to the cleanroom and the anteroom. Secondary containment provided by maintaining the cleanroom at a pressure lower than that of the anteroom. Any form of dilution will reduce the concentration of contamination.

Skip to 7 minutes and 29 secondsVentilation as a risk control measure discussed here may have a number of features, such as HEPA filters, controlled air flow and protection shields however, none of these features will prevent contamination once it has already occurred. Horizontal laminar flow hoods must never be used for preparing cytotoxic drugs due to the high risk of exposure to staff. Cytotoxic drugs are to be prepared in either a cytotoxic drug safety cabinet or a pharmaceutical isolator cabinet. Attention to ergonomic design principles, equipment layout and work practices will minimize operator error and risk mitigate the potential of exposure.

Skip to 8 minutes and 33 secondsFactors to consider in the organization of the physical environment and design include following, provision of access for cleaning and replacement of equipment, for example, cytotoxic drug safety cabinet, incorporation of seam-free, smooth and durable work surfaces and furniture, installation of recessed lights, limitation of the number of surfaces and shelves to minimize particle shedding or the accumulation of particle matter, installation of an accessible emergency shower outside the anteroom, maintenance of an effective airlock between the cytotoxic suite and the external environment, ensuring all equipment used is dedicated to the cytotoxic drug preparation cleanroom access to only one cleanroom facilities for donning personal protective equipment and checking that it fits correctly with full length mirror on wall.

Skip to 10 minutes and 2 secondsEnsuring the pass-through hatch has no direct access to the external environment unless a HEPA filter or equivalent is used to control emissions, interlocking door and is supplied with HEPA filtered air, provision of a means of communication between the cleanroom and other areas preferably a telephone, installation of a manometer to monitor the pressure differential within the cytotoxic drug preparation suite and record daily differential pressure readings, installation of a manometer alarm in case of inadequate pressure differentials, installation of a reverse airflow switch to minimize contamination to the external environment.

Risks of preparation and dispensing

Cytotoxic drug preparation poses the greatest risk of occupational exposure to workers. With adequate precautions, contamination of personnel and the work environment has been shown to be reduced.

Education and training is crucial in ensuring that risk control measures and safe work procedures and practices are developed, understood, implemented, maintained, monitored and reviewed.

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Essentials of Good Pharmacy Practice: The Basics

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