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EXPOSURE TO ANTINEOPLASTIC AGENTS IN THE PHARMACY LABORATORY SETTING AND ONGOING NIOSH STUDIES PowerPoint Presentation
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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

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EXPOSURE TO ANTINEOPLASTIC AGENTS IN THE PHARMACY LABORATORY SETTING AND ONGOING NIOSH STUDIES

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  1. 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

  2. EXAMPLES OF HAZARDOUS DRUGS • Antineoplastic agents • Antiviral agents • Hormonal agents • Immunosuppressant agents • Some antibiotics

  3. DEFINITION OF HAZARDOUS DRUGS • Carcinogenicity • Teratogenicity/developmental toxicity • Reproductive toxicity • Organ toxicity at low doses • Genotoxicity • Structure/activity similar to known hazardous drug

  4. ANTINEOPLASTIC AGENTS RECENT CONCERNS • More cancer patients • More combinations of drugs • Higher doses of drugs • More potent drugs • New procedures/settings

  5. 80-100 Agents Alkylating agents Antibiotics Antimetabolites Biologicals Hormonal agents Monoclonal antibodies Nitrogen mustard derivatives Plant alkaloids Others ANTINEOPLASTIC AGENTS

  6. 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

  7. POTENTIALLY EXPOSED GROUPS • Workers in manufacturing • Pharmacists and technicians • Nursing personnel • Physicians • Operating room personnel • Housekeeping and laundry personnel • Veterinarians • Retail pharmacists

  8. 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

  9. 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

  10. ROUTES OF EXPOSURE • INHALATION • Droplets/particulates • Vapors • DERMAL • ORAL

  11. 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

  12. 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)

  13. DRUG RECONSTITUTION WITH NEEDLE AND SYRINGE

  14. DRUG TRANSFER WITH NEEDLE AND SYRINGE

  15. 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

  16. FLOOR CONTAMINATION FROM CYCLOPHOSPHAMIDE SPILL NG/CM2 DAYS

  17. OCCUPATIONAL MONITORING • WIPE SAMPLES • Since 1992, 13 studies reported in literature • AIR SAMPLES • Since 1983, 12 studies reported in literature

  18. 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

  19. OCCUPATIONAL MONITORING • WIPE SAMPLES • Drugs that are commonly used for wipe sample studies • Cyclophosphamide • Ifosfamide • Fluorouracil • Methotrexate

  20. OCCUPATIONAL MONITORING • WIPE SAMPLES • Locations that have been sampled • Pharmacy and Preparation areas • Treatment Areas • Adjacent Areas

  21. OCCUPATIONAL MONITORING • AIR SAMPLING • Drugs that are commonly used for air sampling • Cyclophosphamide • Ifosfamide • Fluorouracil

  22. 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

  23. 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

  24. 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)

  25. 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)

  26. 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

  27. CURRENT NIOSH ACTIVITIES • PERSONAL PROTECTIVE EQUIPMENT STUDY • ASTM Standard for Chemotherapy Gloves • Four drugs • Several types of glove/gown materials

  28. CURRENT NIOSH ACTIVITIES • NIOSH ALERT ON HAZARDOUS DRUGS • All hazardous drugs • Focus on antineoplastic drugs • Release expected summer, 2003

  29. 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

  30. 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

  31. CURRENT NIOSH ACTIVITIES • VIAL CONTAMINATION STUDY • 4-6 Drugs • Wipe outside of vials • Determine extent of contamination of vials

  32. Thomas H. Connor, Ph.D. OCCUPATIONAL EXPOSURE RELATED TO ANTINEOPLASTIC AGENTS http://www.uth.tmc.edu/schools/sph/an_agents