Handling of Cytotoxic Drugs

1
Handling of Cytotoxic Drugs
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Handling of Cytotoxic Drugs

• Risks and threats in cytotoxic drug handling
• International Standards
• ASTM
• EN
• Local Safety Standards
• ISSA Nr. 2019 G - (PPE)
• Berufsgenossenschaft Health and Safety
• Prevention
• People
• Products

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Handling of Cytotoxic Drugs

• Risks and threats in cytotoxic drug handling
• Cytotoxic drugs are reported to be
• Mutagenic
• Carcinogenic
• Teratogenic (foetus changes)
• Can decrease fertility
• Can cause abortion
• Increase the risk of extra-uterine pregnancy
• High toxicity to certain internal organs

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Handling of Cytotoxic Drugs

• Risks and threats in cytotoxic drug handling
• Risk depends on
• Toxicity of cytotoxic drug
• Time of exposure
• Frequency of exposure
• Source of Contamination
• SKIN
• Inhalation
• Ingestion (food or drinks)

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Handling of Cytotoxic Drugs

• International Standards
• ASTM D6978-05 permeation of cytotoxic drugs
  through medical gloves
• ASTM F739-99 a  resistance of protective
  clothing materials to permeation by liquids or
  gases under conditions of continous contact 
• EN374-32003 protective gloves against chemicals
  (list of 12 chemicals on EN374-12003, but no
  cytotoxic drugs on the list)

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PREVENTION APPLICABLE STANDARDS AND HOW THEY
CONTRIBUTE TO PERSONAL SAFETY
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PREVENTION APPLICABLE STANDARDS AND HOW THEY
CONTRIBUTE TO PERSONAL SAFETY

• INFO D 6978 7 cytotoxic drugs as a must
• plus 2 for manufacturers choice
• 7 drugs as a must/given through norm
• Carmustine 5.3 mg/mL
• Cyclophosphamide 20.0 mg/mL
• Doyurubicin HCI (Adriamycin) 2.0 mg/mL
• Etopside 20.0 mg/mL
• Fluorouacil (Adrucil) 50.0 mg/mL
• Paclitaxel (Taxol) 6.0 mg/mL
• ThioTEPA 10.0 mg/mL

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Handling of Cytotoxic Drugs

• Local Safety Standards (some)
• ISSA Nr. 2019 G - International Social Securities
  Association Prevention Series Nr 2019 G (European
  yes, but not mandatory except in UK)
• Safe handling of cytotoxic drugs, basic
  documentation workpaper for health and safety
  people
• Berufsgenossenschaft Health and Safety in Germany
  - safe handling of cytotoxic drugs M620
• TRGS 525 Technical rules for working with
  dangerous material
• Suva (Schweizerische Unfallversicherungsanstalt)
  Check list PPE From. 6709/1
• Inst of Applied HC Sciences Quality Standards
  for the Oncologic Pharmacy Service
• Inst National de Recherche et de Sécurité INRS
  Les médicaments cytstatiques en milieu de soins.
• Toxicité et risques professionnels. Fiche
  Médico-Technique 33.
• Recommendations pour la prévention des risques
  professionnels. Fiche Médico-Technique 36

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PREVENTION NATIONAL STANDARDS AND HOW THEY
CONTRIBUTE TO PERSONAL SAFETY
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PREVENTION A SELECTION OF THE MOST APPROPRIATE
STANDARDS FOR MAXIMIZING PERSONAL SAFETY
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PREVENTION ORANGE NITRILE A NEW STANDARD IN
MAXIMIZING PERSONAL SAFETY
ORANGE NITRILE 300 mm solution Non-sterile
packed in dispenser box Sterile PE pouches pair
packed THE COLORED INDICATOR GLOVE
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PREVENTION Xtreme A NEW STANDARD IN MAXIMIZING
PERSONAL SAFETY
white NITRILE 300 mm Hand specific solution for
critical sterile Cleanrooms Sterile PE pouches
pair packed Together with ORANGE NITRILE 300 mm
THE COLORED INDICATOR solution
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PREVENTION NEW SOLUTIONS FOR HANDLING CYTOTOXIC
DRUGS

• Products
• ORANGE NITRILE 300
• Non sterile and sterile pair packed in PE packing
  available and tested against cytotoxic drugs
• Xtreme white Nitrile 300 Cleanroom
• Non sterile (ambi) and sterile(hand specific)
  available. Sterile version tested against
  cytotoxic drugs