5.1 Drug Preparation:
The primary focus during the use of cytotoxic drugs must be on:
5.1.1 Control of the working environment.
5.1.2 Safe work practices.
5.1.3 Training of personnel.
5.2 Minimizing Exposure:
Exposure to cytotoxic Drugs can be minimized by:
5.2.1 The use of detailed, written procedures and safe work practices for all aspects of handling cytotoxic Drugs.
5.2.2 Adequate education and training of all persons involved in handling of Cytotoxic Drugs and related waste to ensure compliance with the procedures.
5.2.3 Periodic evaluation and validation of the training given through self-evaluation and oral evaluation.
5.2.4 The provision and correct use of protective equipment, facilities (e.g. biological safety Cabinets, Isolator, etc.) and clothing (e.g. gowns, gloves, breathing air pressure suits, etc.).
5.2.5 Adherence to safety precautions during operation meaning all staff must adhere rigorously to protective measures, which minimize exposure to these agents.
5.3 Personal Protective Clothing and Equipment:
The minimum requirements for protective clothing for personnel preparing cytotoxic drugs should include the following – a protective gown, shoe or boot covers, headwear, mask, and gloves and Goggles. Protective clothing should not be worn outside the work area.
5.3.1 Gowns:
Gowns should be made of lint-free fabric with low permeability to cytotoxic drugs. Protective gowns should have a closed front, long sleeves, and elastic or knit-closed cuffs that can be tucked under the gloves. All seams should be double stitched, bound and sealed to ensure that no needle holes exist and therefore seams are impervious to large particles and cytotoxic drug solutions.
5.3.2 Gloves:
Double Gloves is recommended – a double layer offers better protection than a single layer of gloves. Gloves should be removed immediately after over contamination, or if punctured.
5.3.3 Protective goggles or glasses, which should be washed thoroughly with water after use.
5.3.4 Adequate washing facilities and use of running tap water for immediate use in the event of exposure/contact of the eyes, mucous membranes or skin.
5.3.5 Washable, non-particle shredding boots should be worn, where ever required
5.3.6 Use of pharmaceutical isolators / biosafety cabinet for providing both product and Personnel protection in the dispensing and preparation of cytotoxic drugs.
5.4 Laundering of Contaminated Personal Protective Clothing:
Laundry personnel handling the contaminated garments should wear protective gloves and gowns and be trained in the special precautions required. Contaminated laundry should be placed in specially marked laundry bags and separately pre-washed before being added to other laundry for an additional wash.
5.5 Storage of Cytotoxic Drug:
All stocks of cytotoxic drugs should be kept in a secure area with adequately maintained environmental condition, with access limited to specified authorized personnel. Warning labels should be applied to all cytotoxic drug containers, as well as shelves and bins where these containers are permanently stored.
5.6 Spills and Contamination:
5.6.1 Strategy for the Management of Spills and Contamination.
5.6.2 Spills and breakages must be cleaned up immediately by a properly protected person trained in the appropriate procedures.
5.6.3 All personnel likely to be involved in a cytotoxic spill should be trained in:
5.6.4 The correct procedures for handling cytotoxic drugs or waste in order to prevent and minimize the risk of spills.
5.6.4.1 The location of the spill kit in their area.
5.6.4.2 The arrangements for the medical treatment of any affected personnel.
5.6.4.3 The procedure for the containment of the spill and decontamination of personnel and the environment.
5.6.5 The procedure for waste disposal according to the nature and extent of the spill.
5.6.6 The procedure for the safe handling of packages of cytotoxic drugs which may be damaged or leaking.
5.7 Waste management and related drugs:
5.7.1 All waste generated during the preparation and use of cytotoxic drugs and the cleaning up of spills must be segregated, packaged, and disposed.
5.7.2 All containers for cytotoxic waste should be marked with a symbol indicating cytotoxic waste.
5.7.3 All personnel involved in the routine handling of cytotoxic waste should wear appropriate protective clothing, whether the waste appears properly packaged or not. This should be removed immediately if contamination is suspected and disposed of accordingly.
5.7.4 The use of properly labeled, sealed, and covered containers should be handled only by trained personnel
5.7.5 Solid waste (except Glass vials and other non-incineration materials) should be double bagged and sent for incineration.
Note: Glass vials and other non-incineration material, if contaminated with cytotoxic material, first should be detoxified and properly labeled. This should be transferred to crushing room, where the material is crushed.
5.8 Waste Storage:
5.8.1 Storage of cytotoxic waste in healthcare establishments should be in a dedicated, secure area which can also be easily cleaned and maintained and should have an access only to authorized person.
5.8.2 Waste bins should be sealable and appropriately labeled.
5.9 On-Site Waste Transport:
5.9.1 Each facility should develop a safe internal collection system for its cytotoxic waste which ensures that personnel, other people, and the environment are not contaminated.
5.9.2 To prevent contact, handcarts or trolleys specifically for the internal transport of waste should be used whenever possible.
5.9.3 The collection of waste should be undertaken on a regular basis to avoid accumulation.
5.10 Off-Site Waste Transport:
5.10.1 Small quantities should be disposed off in appropriate waste containers.
5.10.2 Large quantities of cytotoxic waste should be treated and transported.
5.11 Waste Disposal:
5.11.1 The disposal of cytotoxic wastes (solid waste) should be by incineration.
5.11.2 Liquid waste must be drained off from ETP, after treatment of deactivating agents along with running sewage system.
5.11.3 Product wise list of deactivating agents and concentration to be used shall be prepared.
5.11.4 List of Neutralizing agents shall be revised based on deactivation study and shall be signed.
5.12 Labeling, Packaging, and Transport of Cytotoxic Drugs:
5.12.1 Labeling:
5.12.1.1 All Cytotoxic preparations should be clearly labeled with detailed, accurate, and legible.
5.12.1.2 Labels should be specifically designed and should state that there is a cytotoxic substance in the preparation. The label should also state the total amount and volume of the preparation, date after which it should not be used, and storage recommendations.
5.12.2 Packaging and Transport of Cytotoxic Drugs within the Facility:
5.12.2.1 Sealed, rigid impervious containers with appropriate leak-proof packaging and labeling should be used to transport liquid cytotoxic drug preparations within the premises.
5.12.2.2 This packaging must also offer protection from light if required. There should be sufficient adsorbent packaging to absorb the contents.
5.12.2.3 Packages should be clearly labeled as cytotoxic drugs.
5.12.2.4 Personnel involved in the transport of cytotoxic drugs should be cautioned and trained in Personnel involved in the transport of cytotoxic drugs should be cautioned and trained in the necessary precautions should a spill occur.
5.12.3 Packaging and Transport to Outer Facilities:
5.12.3.1 For transport outside facilities, compliance with relevant packaging standards is essential. Cytotoxic drugs should be packaged in such a way as to prevent breakage and subsequent contamination due to accidental damage during handling and transportation.
5.12.3.2 Drivers of transport vehicles should be informed of the potential hazards associated with handling cytotoxic drugs and related waste. They should be instructed in safe handling procedures and in procedures for dealing with any spillage or leakages.