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Safe handling of cytotoxic drugs and cytotoxic waste
General ideas about types and hazards of cytotoxic drugs and cytotoxic waste Safe handling, storage, transportation Accidents and spillages Disposal of cytotoxic waste
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Types and Hazards of CMR‘s
Cytotoxic drugs = antineoplastic agents Antiviral drugs GENOTOXICITY Carcinogenic Mutagenic Reproductive toxicity T ACUTE TOXICITY LOCAL TOXICITY Vesiccant irritant
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Types and hazards of cmr‘s
120 antineoplastic agents in the EEC market 50 intravenous antineoplastic agents routinely used Supplied as: Solutions in Ampoules Powder in glass or plastic vials Solutions in glass vials in plastic bags plastic vials Special protected items (new)
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Precautions in Different Toxicity Classes ?
Precautions to Handling during preparation and disposal according to the type and nature of the risk Eg Protective Clothing: 1. Long-sleeved shirt 2. Gloves (dermaprene) 3. Rubber clogs or overshoes 4. Cap 5. Mask (optional)
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Precautions at pharmacy
Avoid occupational exposure to cytotoxics Centralized cytotoxics preparation area, Safety cabinet Always two persons working Protective clothing Gloves, clothes, overshoes, cap, (mask) Separate waste collection in leak-proof black containers and labelling for identification Safe storage Ensure high safety standards Written procedures Safety data sheets Procedures for accidents and spillages Education and training Zeigen: Pacto-Safe Broschür,
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Sources of occupational exposure and cytotoxic waste at Pharmacy Site
Surface contamination of the drug by manufacturing processes Contamination of the packages due to accidents during transportation from supplier to pharmacy Contaminated materials due to preparation Spillage on transportation to the wards Contaminated materials due to administration Contamination due to storage and disposal
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Example : Augsburg Cytotoxic Drugs Reconstitution Service
1 Pharmacist 5 Assistents preparations a year ( 140 / day) 50% Bolus injections 50% Infusion solution computer checking of the prescriptions
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Topics around cytotoxic service
Cytotoxics order separately from other drug orders separate storage places in pharmacy Highly sophisticated preparation techniques by specially trained personnel Safety Guidelines Waste management Procedures
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Separate ordering and shipment
Cytotoxics delivery Confirming shipment documents
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On-site Transportation and storage
transportation separated from other drugs Storage: preparation area
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Safe handling during preparation
Important : Trained personnel class II safety cabinets in clean room
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Protecting the preparations
Sealing the preparations Sealed infusion solution and bolus injection
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Transportation from pharmacy to wards
well closed and signed boxes
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Sorting waste at oncology wards
1. Non hazardous waste
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Cytotoxic waste segregation at wards
trace contaminated waste “empty“ items and items have been used during application cytotoxic waste ( bulk contaminated waste ) ( items that have not been used ) Hazardous Waste from Cytotoxic preparations
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Sorting waste at oncology wards
2. Segregating Hazardous Waste Trace Contaminated cytotoxic waste Coloured box: empty syringes empty infusion solutions Flushed Infusion lines Gloves, masks
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Sorting waste at oncology wards
Bulk Contaminated „Cytotoxic“ waste 2. Bulk contaminated Hazardous Waste Coloured box : Not administered preparations in syringes or infusion bags Accidentially perforated infusion bags prior to administration Accidents during storage or transportation
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Sorting normal waste at pharmacy reconstitution unit
Plastics Papers General waste Glass bottles (beyond hoods) General waste
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Segregation of Cytotoxic waste at reconstitution unit
trace contaminated waste “empty“ items and items have been used during preparation inside hood cytotoxic waste ( bulk contaminated waste ) ( USA: > 3% drug remaining in vial ) Waste from Cytotoxics preparation
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Treatment of trace contaminated waste from inside hoods
Empty vials / ampoules Used compresses Used syringes Used gloves Used cannulas Used mats Used trays
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Disposing trace contaminated waste from inside hoods
Example : Double packaging into grey box using pacto-safe ™
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Treatment of Cytotoxic waste generated inside the hoods
Rigid box being inside the hood Cytotoxic waste: expired cytotoxic drugs Residual drug solutions Filled syringes
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Treatment of cytotoxic waste from inside hoods
Double packaging into black box By a second pacto-safe ™
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Treatment of cytotoxic drug spillage
Appropriate protective clothing Spill kit in the pharmacy
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Treatment of cytotoxic waste
From inside hoods „White box“ cytotoxic waste spillages From wards Bulk contaminated cytotoxic waste back from wards Leakages Not used but expired preparations From supplier contaminated vials do to manufacturer Damaged small or large amounts during transportation from manufacturer to pharmacy
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Bulk contaminated Cytotoxic waste back from the wards to pharmacy
Tightly closed Brought, not sent !! Document filled out by the waste generator
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Example of Transporting waste to central storage
Cytotoxic waste Trace contaminated waste, papers plastics
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Cytotoxic waste disposal options
Back to supplier !? Chemical destruction small amounts of solids and semi-solids, powders glassware aqueous solutions ( ampoules, vials injectable pharmaceutical preparations spills - solid compounds - aq. solutions and pharmaceutical preparations
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WHO recommended chemical destruction methods for cytotoxic drugs
commonly used reagents: Drugs H2SO4, KMnO VCR, VBL, 6-TG, 6-MP, Procarbacin NaOH /KMnO MTX HCl/ Na2S2O CTX Zn/H2SO4 or Al/HCl Cisplatin, Carboplatin NaOH/DMF CTX, IFO NaOCl MTX Neutralisation: Na2S2O3, NaOH, Ascorbic Acid Examples
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Chemical destruction methods for cytotoxic drugs
Apparatus: high quality standard laboratory equipment Methods: magnetic stirring or refluxing Surrounding: safety cabinet 1.Well founded chemical knowledge 2. in hospitals only at pharmacy 3. residual solutions must be free from remaining mutagenicity
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Chemical destruction methods for cytotoxic drugs
NaOCl 5,25% H2O2 30% Fentons Reagent or 15% (Fe-II-Cl2 3% in H2O2 30%) Easily peformable Reaction : 10ml Prepn ml Reagent in an Erlenmeyer flask for 1-3 hrs at room temp. then Neutralisation ( ice-bath) with Na2SO3 and 12M-HCl. In case of Fentons Reagent: take Erleneyer flask with 5 times the Preparation/Reagent-Volume. Int.Arch Occup Environ Health (1997) 69:
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Chemical destruction methods for cytotoxic drugs ( cont.)
Treatment of spillages – policies ??? For example Isolate the area Spillage warning Get spill kit Whipe up spilled liquids with dry cellulose ( In case of spilled powders first cover spillage with wet cellulose. Then whipe up stamp spillage with dry cellulose) Rinse area with NaOCl 5% for 1 hour Whipe up with dry cellulose Repeat step 6 and 7 Clean area with water and detergents
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cytotoxic waste disposal options
Back to supplier Chemical destruction Immobilisation High temperature Incineration a) regional policies b) Special authorization: 1000 – 1200 oC Amsacrin Cisplatin Dacarbazin 500 Melphalan Anthracyclines ca 800
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Final disposal of trace contaminated „cytotoxic“ waste
High risk double lined landfill High temperature Incineration
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Final disposal methods for cytotoxic waste answered questions by different countries
country definition Disposal method Belgium ( Centre Hospitalier New Paul Brien, Brussels Bottles, cannulas, syringes, clothes, compresses „Special waste“ UK (Queens Medical Centre Nottingham) Cytotoxic residues incl. Empty syringes or bags, all trace contaminated material as well as sharps High temperature incineration Netherlands (Akad. Ziekenhuis Utrecht) Cytotoxics and all materials having contact with Austria ( ÖNORM S 2104) Cytotoxics in higher concentration Contaminated materials like Gloves, infusion lines, gauzes, compresses Dangerous waste Must not be disposed according to dangerous waste disposal
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Final disposal methods for cytotoxic waste answered questions by different countries
country definition disposal method Sweden (Federation of swedish county councils) Residual Cytotoxics and all materials been in contact with; urine and excrement containing Municipal waste incineration Switzerland (Basel Hospital ) Unused/expired Cytotoxics, Residuals, and all materials been in contact with USA ( NIH recommendation) Trace contamin. Waste (<3%) Bulk contamin. Waste(>3%) Clinic based incineration Special authorized incineration facility
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Final disposal methods for cytotoxic waste answered questions by some german hospitals
definition Disposal method Freiburg Residual Cytotoxics from peparation > 20ml, stock solutions All materials had contact with cytotoxic drugs „Incineration“ Augsburg all „trace contaminated materials“ = all materials used during preparation or application. Unused/expired Cytotoxics and any residuals from preparations Municipal waste incineration (AVA) high temp. incineration by special authorized facility
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Not recommended final disposal methods for cytotoxic waste
STOP Sewer Fast flowing water course open uncontrolled dump or landfill. Burning in open containers
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