Safe handling of chemotherapy: New guidelines development

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Safe handling of chemotherapyNew guidelines
development

• Dianne Kapty, BSc(Pharm)
• Pharmacy Professional Practice Leader
• BC Cancer Agency, Fraser Valley

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Outline

• history of safe handling in BC
• strategy for reviewing practices and procedures
• eg, surface contamination
• new information -gt paradigm shift?
• other issues in safe handling

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History

• Mutagenicity in urine of nurses handling
  cytostatic drugs. Falck et al. Lancet
  197911250-1 (letter).
• 1982 CCABC pharmacy mixed for outpatients
• 1983 BCCA pharmacy mixed for inpatients
• 1983 WCB requirements
• 1998 WCB updated
• based largely on expert opinion

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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 -gt Systemic Therapy

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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

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1. Surface contamination 1993

• Exposure of hospital pharmacists and nurses to
  antineoplastic agents. McDevitt et al. J Occup
  Med 19933557-60.
• hospital oncology pharmacy and outpatient clinic
• rare air samples with detectable cyclophosphamide
• multiple surface wipe samples with measurable
  cyclophosphamide

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2. Surface contamination 1995

• Occupational exposure to nor-nitrogen mustard
  Chemical and biological monitoring. Thulin et al.
  Toxicology and industrial health 19951189-97
• production workers
• surface contamination found even after
  decontamination
• led to new decontamination routines and
  establishment of wipe test limits

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3. Surface contamination 1996

• Quality-assurance testing of staff pharmacists
  handling cytotoxic agents. Harrison et al. AJHP
  199653402-7.
• 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

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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
  199972695-103.
• 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

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5. Surface contamination 1999

• Surface contamination with antineoplastic agents
  in six cancer treatment centers in Canada and the
  United States. Connor et al. AJHP
  1999561427-32.
• 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

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• 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 gt patient treatment
• need to strictly adhere to published guidelines
• question reliance on BSC for total protection
  from exposure

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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
  199990572-83.
• 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

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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 20025968-72.
• 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

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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 - patients iv line) 2.90
• infusions set/infusion adapter (infusion) 4.35

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• 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

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• 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

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8. Surface contamination 2002

• Monitoring method for surface contamination
  caused by selected antineoplastic agents. Larson
  et al. AJHP 200259270-7.
• objective - identify an acceptable method of
  evaluating surfaces for contamination (wipe
  material, absorption and desorption capabilities
  and sensitive at low concentrations)

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• 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

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Surface contamination?

• surface contamination occurs despite preparation
  of chemotherapy in biological safety cabinet
  using recognized safe handling procedures and
  equipment

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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

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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?

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Other issues in safe handling

• standards for housekeeping (eg, if contracted
  out)
• vapourization of some chemo agents
• surface contamination from manufacturer/distributo
  r
• decontamination vs cleaning
• isolator vs BSC
• transportation of dangerous goods
• use of electronic balance for quality assurance
• NIOSH study (surfaces, blood and urine)