11/6/2017 1 PREPARING FOR USP <800> Seth Eisenberg RN, OCN ® , BMTCN ® Professional Practice Coordinator, Infusion Services Seattle Cancer Care Alliance Seattle, WA October 2017 NCCS HAZARDOUS DRUG DEFINITION • Defined by NIOSH as having any of the following characteristics: • Carcinogenicity • Teratogenicity or other developmental toxicity • Reproductive toxicity • Organ toxicity at low doses • Genotoxicity • Structure mimicking existing HDs NIOSH 2016 DRUG LIST NIOSH HD GROUPS NIOSH, 2016 Group Comments 1 Antineoplastics Antineoplastics (chemotherapy) Does not include non-conjugated monoclonal antibodies 2 Non- antineoplastics Non-Antineoplastics 3 Reproductive risks Reproductive hazards for personnel attempting to conceive, or breast feeding
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11/6/2017
1
PREPARING FOR USP <800>
Seth Eisenberg RN, OCN®, BMTCN®
Professional Practice Coordinator, Infusion Services
Seattle Cancer Care Alliance
Seattle, WA
October 2017 NCCS
HAZARDOUS DRUG DEFINITION
• Defined by NIOSH as having any of the following characteristics:
• Carcinogenicity
• Teratogenicity or other developmental toxicity
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxicity
• Structure mimicking existing HDs
NIOSH 2016 DRUG LIST
NIOSH HD GROUPS
NIOSH, 2016
Group Comments
1 Antineoplastics
Antineoplastics (chemotherapy) Does not include non-conjugated monoclonal antibodies
2Non-antineoplastics
Non-Antineoplastics
3Reproductive risks
Reproductive hazards for personnel attempting to conceive, or breast feeding
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HAZARDOUS BUT NOT EQUAL
• While all HDs on the NIOSH list are hazardous, different precautions may be needed depending on the handling activity and formulation
• Example:
• “Unopened, intact tablets and capsules may not pose the
same degree of risk as IV medications. Cutting, crushing,
or otherwise manipulating tablets and capsules will
increase the exposure.”
NIOSH, 2016
TIMELINE
Positive urine mutagenicity (Ames Test) in nurses and
pharmacists handling chemotherapy
Falck, K. et al 1979 Lancet
HAZARDOUS DRUG GUIDELINES
ASHP ASHP ONS OSHANIOSH Alert
1981 1983 1984 1986 2004
ASHP ASHP ONS OSHAASHP ASHP ONS
2004 NIOSH ALERT
• Summarized literature on hazardous
(HD) exposure
• Made specific recommendations
for safe handling based on studies
and professional organizations
(ASHP, ONS)
• Covered chemotherapy and non-
chemotherapy agents
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CHEMOTHERAPY IS NOT GOING AWAY
RECENT STUDIES
WIPE TESTING
• 6 Canadian hospitals
• Wipe testing for cyclophosphamide (Cy)
• 438 surfaces in pharmacy and administration areas
Hon C., et al., 2013
WIPE TESTING EXAMPLE
Photo credit: Seth Eisenberg
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WIPE TESTING
• IV hooks
• IV pumps
• Calculators
• Carts
• Chairs
• Computer mice
• Countertops
• Pens
• Printers
• Patient bedside tables
• Elevator buttons
• Sink handles
• Examples of contaminated objects:
• 36% of all samples were above level of detection
HAND CONTAMINATION
• N = 110
• 225 wipe samples collected
• Sample included nurses, oncologists, dietitians, ward
clerks, volunteers, housekeeping
• 20% of the samples were positive
• Highest level of contamination on non-nurses
• Hand-washing did not prevent positive results
Hon C., et al., 2014
URINARY EXCRETION
• N = 103 disciplines
• 201 (24hr) samples collected
• 55% were positive for Cy
• Highest concentration in unit clerks and other
departments that did not prepare or administer
• No correlation between levels and known contact with Cy
Hon C., et al., 2015
MULTI-HOSPITAL WIPE TESTING1
• 51 Canadian hospitals
• 584 samples obtained
• 50% were positive for Cy
• Contamination found in pharmacy and patient care
areas including infusion chairs and on the counter
Janes A., et al., 2015
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MULTI-HOSPITAL WIPE TESTING2
• 48 Canadian hospitals
• 525 samples obtained
• 34% were positive for Cy
• Contamination found in pharmacy and patient care
areas including infusion chairs and on the counter
Poupeau C., et al., 2016
CHROMOSOMAL DAMAGEFLUORESCENT IN SITU HYBRIDIZATION (FISH)
• 3 US cancer centers
• N = 109 (includes 46 control)
• Abnormalities seen for chromosome 5 in exposed
versus non-exposed (p=.01)
• Increased incidence of chromosome 5 abnormalities
seen with increased drug handling
• Hazard Ratio 8.54 (p=.01) for alkylating agents
McDiarmid, M. et al, (2010) JOEM
CHROMOSOMAL DAMAGEMN (MICRONUCLEI) AND CA (CHROMOSOMAL ABERRATIONS)
• 5 hospitals in Italy
• N = 148 (71 study, 77 control)
• Signi cant increase in MN frequency (5.30 ± 2.99
and 3.29 ± 1.97; (p < 0.0001)
• CA detection (3.30 ± 2.05 and 1.84 ± 1.67; p < 0.0001)