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Safe handling of chemotherapy: New guidelines development. Dianne Kapty, BSc(Pharm) Pharmacy Professional Practice Leader BC Cancer Agency, Fraser Valley. Outline. history of safe handling in BC strategy for reviewing practices and procedures eg, surface contamination

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safe handling of chemotherapy new guidelines development

Safe handling of chemotherapy:New guidelines development

Dianne Kapty, BSc(Pharm)

Pharmacy Professional Practice Leader

BC Cancer Agency, Fraser Valley

  • history of safe handling in BC
  • strategy for reviewing practices and procedures
  • eg, surface contamination
  • new information -> paradigm shift?
  • other issues in safe handling
  • Mutagenicity in urine of nurses handling cytostatic drugs. Falck et al. Lancet 1979;1:1250-1 (letter).
  • 1982 CCABC pharmacy mixed for outpatients
  • 1983 BCCA pharmacy mixed for inpatients
  • 1983 WCB requirements
  • 1998 WCB updated
  • based largely on expert opinion
p4c strategy for reviewing guidelines
P4C strategy for reviewing guidelines

Provincial Pharmacy Professional Practice Council

  • evidence based
  • literature search
  • identify relevant articles
  • circulate to group
  • meet to discuss evidence
  • draft recommendations for P4C -> Systemic Therapy
literature search
Literature search
  • explode “antineoplastic agents”
  • explode “occupational exposure”
  • limit to human, English language
  • 242 hits (Medline 1966 to Oct week 5 2002)
  • “surface contamination” in title or article = 8 hits
1 surface contamination 1993
1. Surface contamination 1993
  • Exposure of hospital pharmacists and nurses to antineoplastic agents. McDevitt et al. J Occup Med 1993;35:57-60.
  • hospital oncology pharmacy and outpatient clinic
  • rare air samples with detectable cyclophosphamide
  • multiple surface wipe samples with measurable cyclophosphamide
2 surface contamination 1995
2. Surface contamination 1995
  • Occupational exposure to nor-nitrogen mustard; Chemical and biological monitoring. Thulin et al. Toxicology and industrial health 1995;11:89-97
  • production workers
  • surface contamination found even after decontamination
  • led to new decontamination routines and establishment of wipe test limits
3 surface contamination 1996
3. Surface contamination 1996
  • Quality-assurance testing of staff pharmacists handling cytotoxic agents. Harrison et al. AJHP 1996;53:402-7.
  • simulation testing with fluorescein and UV light
  • training in standard operating procedures
  • surface contamination found for 92% during pre test and 23% in the post test
4 surface contamination 1999
4. Surface contamination 1999
  • High-performance liquid chromatography of methotrexate for environmental monitoring of surface contamination in hospital departments and assessment of occupational exposure. Floridia et al. J Chromatogr B Biomed Sci Appl 1999;726:95-103.
  • spillage fractions as high as 5% on the polythene-backed paper disposable hood cover sheet
  • traces measured on floor surfaces, furniture and handles, even at a distance from the hood
5 surface contamination 1999
5. Surface contamination 1999
  • Surface contamination with antineoplastic agents in six cancer treatment centers in Canada and the United States. Connor et al. AJHP 1999;56:1427-32.
  • 3 sites in central Canada(14,800; 20,300; 26,400 doses per year)
  • 3 sites in United States(2,000; 18,000; 108,700 doses per year)
  • [BCCA FV comparison is 16,877 doses per year]
wipe tests blinded, frozen, sent to the Netherlands for analysis
  • measurable amounts detected in 75% of pharmacy samples and 65% of patient treatment area samples
  • pharmacy > patient treatment
  • need to strictly adhere to published guidelines
  • question reliance on BSC for total protection from exposure
6 surface contamination 1999
6. Surface contamination 1999
  • Measurement of surface contamination by certain antineoplastic drugs using high-performance liquid chormatography; Applications in occupational hygiene investigations in hospital environments. Rubino et al. Medicina del Lavoro 1999;90:572-83.
  • contamination measured on handles, floor surfaces, window panes, telephones, tables and furniture
  • spillage fractions between 1-5% measured on the disposable polythene-backed paper hood cover sheet
7 surface contamination 2002
7. Surface contamination 2002
  • Effectiveness of a closed-system device in containing surface contamination with cyclophosphamide and ifosfamide in an i.v. admixture area. Connor et al. AJHP 2002;59:68-72.
  • IV preparation area remodeled and refitted
  • new design with 6 Class II B3 BSCs vented outside, preparation area maintained under negative pressure
  • new cabinets, countertops and tables; floors, walls and ceilings remained from original pharmacy
phaseal system
PhaSeal® system
  • closed system using expansion chamber and double membranes to prevent escape of drug into the environment Cdn list:
  • protector (vial) $9.10
  • injector (syringe) $8.60
  • connector (syringe - patient’s iv line) $2.90
  • infusions set/infusion adapter (infusion) $4.35
study design - wipe samples in 18 locations at baseline, then every 4 weeks for 24 weeks
  • cyclophosphamide and ifosfamide were prepared using the PhaSeal system
  • fluorouracil (control) prepared using standard methods
  • conclusion: a closed-system device, in conjunction with the use of BSCs, appeared to contain surface contamination
“previously unsuspected aspects”:
  • few high values which stood out from background contamination, mostly due to spillage
  • detectable levels found after two months of construction and cleaning
  • one particularly high value was found outside of pharmacy where returned chemo pumps were stored
  • after early incident of breakage levels declined over weeks rather than days, calling into question the efficacy of floor cleaning procedures
8 surface contamination 2002
8. Surface contamination 2002
  • Monitoring method for surface contamination caused by selected antineoplastic agents. Larson et al. AJHP 2002;59:270-7.
  • objective - identify an acceptable method of evaluating surfaces for contamination (wipe material, absorption and desorption capabilities and sensitive at low concentrations)
cyclophosphamide, ifosfamide, doxorubicin, fluorouracil, paclitaxel
  • stainless steel (BSC), resin (countertop), vinyl (floor)
  • conclusion - filter-solvent-HPLC method was generally very good for detection on resin and stainless steel and acceptable for detection on vinyl floor tiles and sufficiently accurate and sensitive to evaluate typical surfaces
surface contamination
Surface contamination?
  • surface contamination occurs despite preparation of chemotherapy in biological safety cabinet using recognized safe handling procedures and equipment
new information vs paradigm shift
New information vs paradigm shift?

information  facts, data

paradigm  a philosophical and theoretical framework of a scientific school or discipline

paradigm shift  major change in the way we do business

what happens now
What happens now?
  • status quo?
  • wait for ASHP TAB? wait for CAPhO task force?
  • determine if surface contamination occurs at BCCA?
  • review and revise current procedures?
  • implement the PhaSeal system?
  • cost? benefit? business case?
  • consult WCB?
  • consult occupational hygienist?
  • wait for NIOSH alert?
other issues in safe handling
Other issues in safe handling
  • standards for housekeeping (eg, if contracted out)
  • vapourization of some chemo agents
  • surface contamination from manufacturer/distributor
  • decontamination vs cleaning
  • isolator vs BSC
  • transportation of dangerous goods
  • use of electronic balance for quality assurance
  • NIOSH study (surfaces, blood and urine)