Transcript KNH Symposium

Safe Handling
of Hazardous Drugs
Dr. Irene Weru, Mpharm (Clinical Pharmacy)
Senior Pharmacist – Oncology Services, KNH
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
Investigational (IND) Drug Development / Clinical Trials
Use of previously banned medicines
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Definition of Hazardous
Drugs
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Carcinogenic
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Teratogenic
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Reproductive toxicity
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Organ toxicity at low doses
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Genotoxic
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Structure or toxicity similar to drugs classified as hazardous
(NIOSH, 2004)
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Cancer Risk in Workers
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Leukemia in nurses
(Skov et al, 1992)

Cyclophosphamide
(Sessink et al, 1993)
(1.4-10 excess cases/million)
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NHL & skin cancer
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Overall increased cancer risk (Martin, 2005
(Hansen & Olsen, 1994)
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Reproductive Risks in Workers
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Fetal abnormalities
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Spontaneous Abortions
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Infertility
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Miscarriages
(Hemminki et al, 1985)
(Stucker, 1990)
(Valanis et al, 1997 ; Fransman, 2007)
(Valanis et al, 1999)
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Teratogenicity
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Conflicting opinion on exposure during 2nd and 3rd
trimesters
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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
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Dermal



Ingestion



Food, gum
Hand-to-mouth
Inhalation

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
Direct contact
Contaminated surfaces
Aerosols
Vapors
Injection


Sharps
Breakage
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Standards
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Guidelines on hazardous drugs

American society of health system pharmacists
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1985,1990
2005: guidelines on handling hazardous drugs
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NIOSH (National Institute of Occupational Safety and Health)
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2004:NIOSH Hazardous Drug Alert
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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.ashp.org/bestpractices/new/HD-Prepub-final.pdf
http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
USP <797> 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 closefitting 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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