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

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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

EXAMPLES OF HAZARDOUS DRUGS Antineoplastic operators Antiviral specialists Hormonal operators Immunosuppressant operators Some anti-toxins

DEFINITION OF HAZARDOUS DRUGS Carcinogenicity Teratogenicity/formative harmfulness Reproductive poisonous quality Organ danger at low dosages Genotoxicity Structure/action like known dangerous medication

ANTINEOPLASTIC AGENTS RECENT CONCERNS More disease patients More mixes of medications Higher measurements of medications More strong medications New techniques/settings

80-100 Agents Alkylating specialists Antibiotics Antimetabolites Biologicals Hormonal operators Monoclonal antibodies Nitrogen mustard subordinates Plant alkaloids Others ANTINEOPLASTIC AGENTS

CARCINOGENICITY 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

POTENTIALLY EXPOSED GROUPS Workers in assembling Pharmacists and experts Nursing faculty Physicians Operating room staff Housekeeping and clothing work force Veterinarians Retail drug specialists

NATURE 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

WORKER 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

ROUTES OF EXPOSURE INHALATION Droplets/particulates Vapors DERMAL ORAL

COMMON 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

SURFACE 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)

DRUG RECONSTITUTION WITH NEEDLE AND SYRINGE

DRUG TRANSFER WITH NEEDLE AND SYRINGE

OTHER 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

FLOOR CONTAMINATION FROM CYCLOPHOSPHAMIDE SPILL NG/CM 2 DAYS

OCCUPATIONAL MONITORING WIPE SAMPLES Since 1992, 13 contemplates reported in writing AIR SAMPLES Since 1983, 12 considers reported in writing

OCCUPATIONAL 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

OCCUPATIONAL MONITORING WIPE SAMPLES Drugs that are ordinarily utilized for wipe test ponders Cyclophosphamide Ifosfamide Fluorouracil Methotrexate

OCCUPATIONAL MONITORING WIPE SAMPLES Locations that have been examined Pharmacy and Preparation territories Treatment Areas Adjacent Areas

OCCUPATIONAL MONITORING AIR SAMPLING Drugs that are normally utilized for air inspecting Cyclophosphamide Ifosfamide Fluorouracil

OCCUPATIONAL 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

OCCUPATIONAL 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

OCCUPATIONAL 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)

DERMAL EXPOSURE PATHWAY THREE WORKPLACE SURVEYS Contamination from IV frameworks Contamination from patient pee Analysis of air particulates Kromhout et al, Ann Occup Health (2000)

SOURCES 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

CURRENT NIOSH ACTIVITIES PERSONAL PROTECTIVE EQUIPMENT STUDY ASTM Standard for Chemotherapy Gloves Four medications Several sorts of glove/outfit materials

CURRENT NIOSH ACTIVITIES NIOSH ALERT ON HAZARDOUS DRUGS All risky medications Focus on antineoplastic medications Release expected summer, 2003

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 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

CURRENT NIOSH ACTIVITIES VIAL CONTAMINATION STUDY 4-6 Drugs Wipe outside of vials Determine degree of pollution of vials

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