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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. Introduction. Exposure Opportunity is Increasing.
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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 KNH Oncology Symposium 13th April, 2012
Introduction KNH Oncology Symposium 13th April, 2012
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 KNH Oncology Symposium 13th April, 2012
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) KNH Oncology Symposium 13th April, 2012
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 KNH Oncology Symposium 13th April, 2012
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) KNH Oncology Symposium 13th April, 2012
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 KNH Oncology Symposium 13th April, 2012
Modes of Contact for Drug Exposure Dermal Direct contact Contaminated surfaces Ingestion Food, gum Hand-to-mouth Inhalation Aerosols Vapors Injection Sharps Breakage KNH Oncology Symposium 13th April, 2012
Standards KNH Oncology Symposium 13th April, 2012
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-final.pdf • NIOSH (National Institute of Occupational Safety and Health) • 2004:NIOSH 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.html • USP <797> United States Pharmacopeia (USP) KNH Oncology Symposium 13th April, 2012
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. KNH Oncology Symposium 13th April, 2012
Training Must include at least: Use of engineering controls use of PPE Preparation Transport Administration Disposal Management of spills Management of acute exposure KNH Oncology Symposium 13th April, 2012
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) 14 KNH Oncology Symposium 13th April, 2012
Safety work Benches • Biological safety cabinets (Ventilated Cabinets) KNH Oncology Symposium 13th April, 2012
Isolators KNH Oncology Symposium 13th April, 2012
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 KNH Oncology Symposium 13th April, 2012
Recommendations & Current Trends KNH Oncology Symposium 13th April, 2012
Monitoring HCW • Reproductive and General Health • Physical Examination • CBC, Urinalysis, LFTs KNH Oncology Symposium 13th April, 2012
Conclusion • The world has moved from the bedside to CSTD KNH Oncology Symposium 13th April, 2012