Safe Handling of Hazardous Drugs

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Safe Handling of Hazardous Drugs

• Dr. Irene Weru, Mpharm (Clinical Pharmacy)
• Senior Pharmacist Oncology Services, KNH

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Objectives

• To discuss current trends in safe handling
• Highlight Standards available
• Highlight some recommendations

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• Introduction

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Exposure Opportunity is Increasing
WHO estimates a 50 increase in cancer patients
in the next 20 years Use of drugs for
non-malignant diseases (RA, SLE) Anti-viral
agents for HIV and other viral illnesses Investig
ational (IND) Drug Development / Clinical
Trials Use of previously banned medicines
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Definition of Hazardous Drugs

• Carcinogenic
• Teratogenic
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxic
• Structure or toxicity similar to drugs classified
  as hazardous

(NIOSH, 2004)
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Cancer Risk in Workers

• Leukemia in nurses (Skov et al, 1992)
• Cyclophosphamide (Sessink et al, 1993)(1.4-10
  excess cases/million)
• NHL skin cancer (Hansen Olsen, 1994)
• Overall increased cancer risk (Martin, 2005

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Reproductive Risks in Workers

• Fetal abnormalities (Hemminki et al, 1985)
• Spontaneous Abortions (Stucker, 1990)
• Infertility (Valanis et al, 1997 Fransman,
  2007)
• Miscarriages (Valanis et al, 1999)

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Teratogenicity

• Conflicting opinion on exposure during 2nd and
  3rd trimesters
• Greatest danger during 1st trimester
• Case control study of Finish oncology nurses
  actively handling chemotherapy during 1st
  trimester demonstrated statistically significant
  increase in risk for malformations
• Hemminki K, Kyyronen P, Lindbohm ML. J Epidemiol
  Community Hlth 1985

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Modes of Contact for Drug Exposure

• Dermal
• Direct contact
• Contaminated surfaces
• Ingestion
• Food, gum
• Hand-to-mouth
• Inhalation
• Aerosols
• Vapors
• Injection
• Sharps
• Breakage

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• Standards

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Guidelines on hazardous drugs

• American society of health system pharmacists
• 1985,1990
• 2005 guidelines on handling hazardous drugs
• http//www.ashp.org/bestpractices/new/HD-Prepub-fi
  nal.pdf
• NIOSH (National Institute of Occupational Safety
  and Health)
• 2004NIOSH Hazardous Drug Alert
• Appendix A Sample list
• http//www.cdc.gov/niosh/docs/2004-165/
• ISOPP Standards
• International Society of Oncology Pharmacy
  Practitioners
• OSHA (Occupational Safety and Health
  Administration)
• 1986
• 1995 Controlling Occupational Exposure to
  Hazardous Drugs
• http//www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.h
  tml
• USP lt797gt United States Pharmacopeia (USP)

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ISOPP Standards of Practice

• Know Your Risk
• Staff Training
• Levels of Protection

ISOPP International Society of Oncology
Pharmacy Practice J Onc Pharm Pract 2007 13
Suppl.
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Training

• Must include at least
• Use of engineering controls
• use of PPE
• Preparation
• Transport
• Administration
• Disposal
• Management of spills
• Management of acute exposure

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Levels of Protection Top to bottom

• Level 1 Elimination/substitution/replacement
• Level 2 Isolation of the hazard/source
  containment
• Level 3 Engineering controls/Proper ventilation
• Level 3b Administrative controls/ Organization
  measures
• Level 4 Personal protective equipment (PPE)

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Safety work Benches

• Biological safety cabinets
• (Ventilated
• Cabinets)

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Isolators
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Personal Protective Equipment

• Overall/Protective gown
• Used for compounding, administration, spill
  control, waste management
• Closed up to neck
• Long sleeves with close-fitting cuffs
• Lint free
• Liquid repellent
• Single-use

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• Recommendations
• Current Trends

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Monitoring HCW

• Reproductive and General Health
• Physical Examination
• CBC, Urinalysis, LFTs

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Conclusion

• The world has moved from the bedside to CSTD

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