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EXPOSURE TO ANTINEOPLASTIC AGENTS IN THE PHARMACY LABORATORY SETTING AND ONGOING NIOSH STUDIES. THOMAS H. CONNOR, Ph.D. Senior Service Fellow National Institute for Occupational Safety and Health Cincinnati, OH 513-533-8399 tmc6@cdc.gov. EXAMPLES OF HAZARDOUS DRUGS.

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exposure to antineoplastic agents in the pharmacy laboratory setting and ongoing niosh studies
EXPOSURE TO ANTINEOPLASTIC AGENTS IN THE PHARMACY LABORATORY SETTING AND ONGOING NIOSH STUDIES

THOMAS H. CONNOR, Ph.D.

Senior Service Fellow

National Institute for

Occupational Safety and Health

Cincinnati, OH

513-533-8399 tmc6@cdc.gov

examples of hazardous drugs
EXAMPLES OF HAZARDOUS DRUGS
  • Antineoplastic agents
  • Antiviral agents
  • Hormonal agents
  • Immunosuppressant agents
  • Some antibiotics
definition of hazardous drugs
DEFINITION OF HAZARDOUS DRUGS
  • Carcinogenicity
  • Teratogenicity/developmental toxicity
  • Reproductive toxicity
  • Organ toxicity at low doses
  • Genotoxicity
  • Structure/activity similar to known hazardous drug
antineoplastic agents
ANTINEOPLASTIC AGENTS

RECENT CONCERNS

  • More cancer patients
  • More combinations of drugs
  • Higher doses of drugs
  • More potent drugs
  • New procedures/settings
antineoplastic agents5
80-100 Agents

Alkylating agents

Antibiotics

Antimetabolites

Biologicals

Hormonal agents

Monoclonal antibodies

Nitrogen mustard derivatives

Plant alkaloids

Others

ANTINEOPLASTIC AGENTS
carcinogenicity of antineoplastic agents
CARCINOGENICITY OF ANTINEOPLASTIC AGENTS

IARC Classification

  • Class 1 (human carcinogen) 9 plus 2 combinational therapies
  • Class 2A (probable human carcinogen) 9
  • Class 2B (possible human carcinogen) 10
  • Combinational therapies currently being evaluated by IARC
potentially exposed groups
POTENTIALLY EXPOSED GROUPS
  • Workers in manufacturing
  • Pharmacists and technicians
  • Nursing personnel
  • Physicians
  • Operating room personnel
  • Housekeeping and laundry personnel
  • Veterinarians
  • Retail pharmacists
nature of the problem
NATURE OF THE PROBLEM
  • Primary concern is for the safety of the patient
    • Drugs must be prepared aseptically
    • Contamination can be fatal to the patient
  • Secondary concern is the safety of the healthcare worker
    • Exposure to hazardous drugs must be kept as low as possible
    • Many opportunities for exposure
worker protection
WORKER PROTECTION
  • Horizontal cabinets should not be used for hazardous drug preparation
  • Class II or Class III BSCs (+/-) must be used
  • Vented BSCs recommended
  • Leur-lock, needle-less and closed systems should be used for preparation and administration
routes of exposure
ROUTES OF EXPOSURE
  • INHALATION
    • Droplets/particulates
    • Vapors
  • DERMAL
  • ORAL
common sources of exposure
COMMON SOURCES OF EXPOSURE
  • DRUG PREPARATION
    • Drug dilution and transfer
  • DRUG ADMINISTRATION
    • Priming tubing
    • Disconnecting lines
    • Instillation procedures
  • DISPOSAL OF DRUGS AND WASTE
    • Emptying waste containers and cleaning contaminated areas
surface contamination study
SURFACE CONTAMINATION STUDY
  • SIX CANCER CENTERS IN U.S. AND CANADA
  • PHARMACIES AND TREATMENT AREAS
  • THREE DRUGS-CP, FU, IF
  • BSCs, COUNTERS, CARTS, FLOORS, CHAIRS, TABLES
  • 75 % PHARMACY AND 65 % TREATMENT AREA SAMPLES POSITIVE FOR AT LEAST ONE DRUG
  • ADJACENT AREAS CONTAMINATED

Connor et al, AJHP (1999)

other sources of exposure
OTHER SOURCES OF EXPOSURE
  • CONTACT WITH CONTAMINATED SURFACES
    • Drug vials, counter tops, keyboards, IV bags, tables, chairs, waste containers
  • CONTAMINATION IN AREAS THOUGHT TO BE DRUG-FREE
    • Locations adjacent to work areas
  • POSSIBLE PASSAGE THROUGH HEPA FILTERS
    • Vapors
occupational monitoring
OCCUPATIONAL MONITORING
  • WIPE SAMPLES
    • Since 1992, 13 studies reported in literature
  • AIR SAMPLES
    • Since 1983, 12 studies reported in literature
occupational monitoring18
OCCUPATIONAL MONITORING
  • WIPE SAMPLES
    • All studies that have used wipe samples to monitor environmental contamination have demonstrated measurable levels of the drugs.
    • 1-5 Drugs sampled
occupational monitoring19
OCCUPATIONAL MONITORING
  • WIPE SAMPLES
    • Drugs that are commonly used for wipe sample studies
      • Cyclophosphamide
      • Ifosfamide
      • Fluorouracil
      • Methotrexate
occupational monitoring20
OCCUPATIONAL MONITORING
  • WIPE SAMPLES
    • Locations that have been sampled
      • Pharmacy and Preparation areas
      • Treatment Areas
      • Adjacent Areas
occupational monitoring21
OCCUPATIONAL MONITORING
  • AIR SAMPLING
    • Drugs that are commonly used for air sampling
      • Cyclophosphamide
      • Ifosfamide
      • Fluorouracil
occupational monitoring22
OCCUPATIONAL MONITORING
  • AIR SAMPLING
    • Air sampling often does not detect drugs or detects low levels of drugs
    • May be due to technical problems
      • Glass fiber or paper filter materials
      • Drugs in vapor phase
occupational monitoring23
OCCUPATIONAL MONITORING
  • URINE ANALYSIS FOR SELECTED DRUGS
    • Most studies have been performed in Europe
    • In 18 studies, all but two studies detected drugs in the urine
    • In four studies, drugs were found in the urine of workers who were not handling them
occupational monitoring24
OCCUPATIONAL MONITORING
  • URINE ANALYSIS FOR SELECTED DRUGS
    • Approximately 100 individuals/3years
    • 14 German hospitals
    • Cyclophosphamide 40%
    • Ifosfamide 14%
    • Anthracyclines 4.5%

Pethran et al, Int Arch Occup Environ Health (2003)

dermal exposure pathway
DERMAL EXPOSURE PATHWAY
  • THREE WORKPLACE SURVEYS
    • Contamination from IV systems
    • Contamination from patient urine
    • Analysis of air particulates

Kromhout et al, Ann Occup Health (2000)

sources of exposure
SOURCES OF EXPOSURE
  • CONTAMINATION FROM PATIENT URINE
    • Added a fluorescent material to bedpans and urinals to track possible drug contamination
    • “Frequent and widespread contamination was seen…”
    • Soles of shoes
    • Skin of patients and nurses
current niosh activities
CURRENT NIOSH ACTIVITIES
  • PERSONAL PROTECTIVE EQUIPMENT STUDY
    • ASTM Standard for Chemotherapy Gloves
    • Four drugs
    • Several types of glove/gown materials
current niosh activities28
CURRENT NIOSH ACTIVITIES
  • NIOSH ALERT ON HAZARDOUS DRUGS
    • All hazardous drugs
    • Focus on antineoplastic drugs
    • Release expected summer, 2003
current niosh activities29
CURRENT NIOSH ACTIVITIES
  • NIOSH WORKING GROUP ON HAZARDOUS DRUGS
    • NIOSH, OSHA, FDA, VA
    • ONS, ASHP, ASTM, ANA, JCAHO
    • PHARMACISTS, NURSES, HOME HEALTH CARE
    • DRUG, BSC MANUFACTURERS
    • RESEARCHERS
current niosh activities30
CURRENT NIOSH ACTIVITIES
  • OCCUPATIONAL EXPOSURE STUDY OF

HEALTHCARE WORKERS

    • 3-4 Institutions
    • Pharmacy and nursing personnel
    • Minimum 50 exposed/50 non-exposed
    • Several environmental and biological endpoints
current niosh activities31
CURRENT NIOSH ACTIVITIES
  • VIAL CONTAMINATION STUDY
    • 4-6 Drugs
    • Wipe outside of vials
    • Determine extent of contamination of vials
thomas h connor ph d
Thomas H. Connor, Ph.D.

OCCUPATIONAL EXPOSURE RELATED TO

ANTINEOPLASTIC AGENTS

http://www.uth.tmc.edu/schools/sph/an_agents