Presentation 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
Slide 2EXAMPLES OF HAZARDOUS DRUGS Antineoplastic operators Antiviral specialists Hormonal operators Immunosuppressant operators Some anti-toxins
Slide 3DEFINITION OF HAZARDOUS DRUGS Carcinogenicity Teratogenicity/formative harmfulness Reproductive poisonous quality Organ danger at low dosages Genotoxicity Structure/action like known dangerous medication
Slide 4ANTINEOPLASTIC AGENTS RECENT CONCERNS More disease patients More mixes of medications Higher measurements of medications More strong medications New techniques/settings
Slide 580-100 Agents Alkylating specialists Antibiotics Antimetabolites Biologicals Hormonal operators Monoclonal antibodies Nitrogen mustard subordinates Plant alkaloids Others ANTINEOPLASTIC AGENTS
Slide 6CARCINOGENICITY OF ANTINEOPLASTIC AGENTS IARC Classification Class 1 (human cancer-causing agent) 9 in addition to 2 combinational treatments Class 2A (plausible human cancer-causing agent) 9 Class 2B (conceivable human cancer-causing agent) 10 Combinational treatments at present being assessed by IARC
Slide 7POTENTIALLY EXPOSED GROUPS Workers in assembling Pharmacists and experts Nursing faculty Physicians Operating room staff Housekeeping and clothing work force Veterinarians Retail drug specialists
Slide 8NATURE OF THE PROBLEM Primary concern is for the security of the patient Drugs must be readied aseptically Contamination can be lethal to the patient Secondary concern is the wellbeing of the medicinal services laborer Exposure to unsafe medications must be kept as low as could be expected under the circumstances Many open doors for presentation
Slide 9WORKER PROTECTION Horizontal cupboards ought not be utilized for perilous medication arrangement Class II or Class III BSCs (+/ - ) must be utilized Vented BSCs suggested Leur-bolt, needle-less and shut frameworks ought to be utilized for planning and organization
Slide 10ROUTES OF EXPOSURE INHALATION Droplets/particulates Vapors DERMAL ORAL
Slide 11COMMON SOURCES OF EXPOSURE DRUG PREPARATION Drug weakening and exchange DRUG ADMINISTRATION Priming tubing Disconnecting lines Instillation systems DISPOSAL OF DRUGS AND WASTE Emptying waste compartments and cleaning tainted ranges
Slide 12SURFACE CONTAMINATION STUDY SIX CANCER CENTERS IN U.S. What's more, 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)
Slide 13DRUG RECONSTITUTION WITH NEEDLE AND SYRINGE
Slide 14DRUG TRANSFER WITH NEEDLE AND SYRINGE
Slide 15OTHER SOURCES OF EXPOSURE CONTACT WITH CONTAMINATED SURFACES Drug vials, ledges, consoles, IV sacks, tables, seats, squander holders CONTAMINATION IN AREAS THOUGHT TO BE DRUG-FREE Locations neighboring work regions POSSIBLE PASSAGE THROUGH HEPA FILTERS Vapors
Slide 16FLOOR CONTAMINATION FROM CYCLOPHOSPHAMIDE SPILL NG/CM 2 DAYS
Slide 17OCCUPATIONAL MONITORING WIPE SAMPLES Since 1992, 13 contemplates reported in writing AIR SAMPLES Since 1983, 12 considers reported in writing
Slide 18OCCUPATIONAL MONITORING WIPE SAMPLES All studies that have utilized wipe tests to screen natural pollution have shown quantifiable levels of the medications. 1-5 Drugs tested
Slide 19OCCUPATIONAL MONITORING WIPE SAMPLES Drugs that are ordinarily utilized for wipe test ponders Cyclophosphamide Ifosfamide Fluorouracil Methotrexate
Slide 20OCCUPATIONAL MONITORING WIPE SAMPLES Locations that have been examined Pharmacy and Preparation territories Treatment Areas Adjacent Areas
Slide 21OCCUPATIONAL MONITORING AIR SAMPLING Drugs that are normally utilized for air inspecting Cyclophosphamide Ifosfamide Fluorouracil
Slide 22OCCUPATIONAL MONITORING AIR SAMPLING Air testing regularly does not identify medicates or identifies low levels of medications May be because of specialized issues Glass fiber or paper channel materials Drugs in vapor stage
Slide 23OCCUPATIONAL MONITORING URINE ANALYSIS FOR SELECTED DRUGS Most studies have been performed in Europe In 18 concentrates, everything except two studies distinguished medications in the pee In four studies, medications were found in the pee of laborers who were not taking care of them
Slide 24OCCUPATIONAL MONITORING URINE ANALYSIS FOR SELECTED DRUGS Approximately 100 people/3years 14 German doctor's facilities Cyclophosphamide 40% Ifosfamide 14% Anthracyclines 4.5% Pethran et al, Int Arch Occup Environ Health (2003)
Slide 25DERMAL EXPOSURE PATHWAY THREE WORKPLACE SURVEYS Contamination from IV frameworks Contamination from patient pee Analysis of air particulates Kromhout et al, Ann Occup Health (2000)
Slide 26SOURCES OF EXPOSURE CONTAMINATION FROM PATIENT URINE Added a fluorescent material to bedpans and urinals to track conceivable medication defilement "Incessant and broad sullying was seen… " Soles of shoes Skin of patients and attendants
Slide 27CURRENT NIOSH ACTIVITIES PERSONAL PROTECTIVE EQUIPMENT STUDY ASTM Standard for Chemotherapy Gloves Four medications Several sorts of glove/outfit materials
Slide 28CURRENT NIOSH ACTIVITIES NIOSH ALERT ON HAZARDOUS DRUGS All risky medications Focus on antineoplastic medications Release expected summer, 2003
Slide 29CURRENT 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
Slide 30CURRENT NIOSH ACTIVITIES OCCUPATIONAL EXPOSURE STUDY OF HEALTHCARE WORKERS 3-4 Institutions Pharmacy and nursing faculty Minimum 50 uncovered/50 non-uncovered Several natural and organic endpoints
Slide 31CURRENT NIOSH ACTIVITIES VIAL CONTAMINATION STUDY 4-6 Drugs Wipe outside of vials Determine degree of pollution of vials
Slide 32Thomas H. Connor, Ph.D. Word related EXPOSURE RELATED TO ANTINEOPLASTIC AGENTS http://www.uth.tmc.edu/schools/sph/an_agents
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