Hemostasis Physiology and Clinical correlations by Dr Faiza.pdf
Chemotherapy safety and handling-Thao's presentation
1. Chemotherapy Safety and
Handling
Thao K. Huynh, PharmD, BCOP
Assistant Professor
Department of Pharmacy and Therapeutics
University of Pittsburgh School of Pharmacy
Email: t.huynh@pitt.edu
2. Outline
• Risks of hazardous drug exposure
• Engineering control
• Storage
• Compounding
• Administration
• Decontamination
• Medical surveillance
• Future steps for Vietnam
3. Outline
• Risks of hazardous drug exposure
• Engineering control
• Storage
• Compounding
• Administration
• Decontamination
• Medical surveillance
• Future steps for Hue
4. Hazardous Drug Exposure
• 8 million US healthcare workers experience potential exposure to
hazardous drugs every year
• National Institute of Occupational Safety and Health (NIOSH)
published Preventing Occupational Exposures to Antineoplastic and
Other Hazardous Drugs in Health Care Settings
• http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf
5. Who Potentially Experiences Chemotherapy
Exposure?
Patients and
family
members
Hospital
Staff
Nurses
Pharmacy
Staff
PhysiciansOR
Personnel
6. Hazardous Drug Exposure by Profession
CAREX Canada 2006 estimates: http://www.occupationalcancer.ca/wp-content/uploads/2014/07/Antineoplastics-and-cancer-ENG.pdf
7. Hazardous Drug Exposure
• Manufacturing
• Shipping
• Handling
• Compounding
• Dispensing
•Administration
•Patient care activities
•Disposal
•Spills
8. Potential Routes of Exposure
• Inhalation
• Fluorouracil and cyclophosphamide detected in air without proper ventilation
• Skin contact
• Body fluids, contaminated clothing, dressings, linens
• Ingestion
• Accidental ingestion from dermal contact
• Injection
• Accidental needle stick
9. Effects of Hazardous Exposure
Acute Effects Chronic Effects
Sore throat
Chronic cough
Infections
Dizziness
Eye irritation
Headaches
Malignancies
- 7-50 cancer cases per year per million
workers exposed to cyclophosphamide
Reproductive abnormalities
- Increase in fetal abnormalities
- Fetal loss
- Fertility impairment
Congenital malformation
Stillbirths
Valanis BG, et al. AAOHN J. 1987; 35:487–92.
Valanis BG, et al. Am J Hosp Pharm. 1993; 50:455–62.
Ensslin AS, et al. Occup Environ Med. 1994; 51:229–33
10. Response to Hazardous Drug Exposure:
United States Pharmacopeia (USP) 800
• Goal: promote patient safety, worker safety, and
environmental protection
• Includes any hazardous drug handling: receipt, storage,
compounding, dispensing, administration, and disposal
• Applies to all healthcare workers who handle hazardous drug
preparations
11. Outline
• Risks of hazardous drug exposure
• Engineering control
• Storage
• Compounding
• Administration
• Decontamination
• Medical surveillance
• Future steps for Hue
12. Engineering Control
• Compounding clean room must be a negative
pressure room
• Contain an anteroom for garbing and
handwashing
ASHP Guidelines on Handling Hazardous Drugs: http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx
USP 800: http://www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf
13. Engineering Control: Ventilation
• Designed to eliminate or reduce worker exposure
• Sterile compounding MUST be performed in class II biological safety cabinet
or compounding aseptic containment isolators
ASHP Guidelines on Handling Hazardous Drugs: http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx
USP 800: http://www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf
14. Outline
• Risks of hazardous drug exposure
• Engineering control
• Storage
• Compounding
• Administration
• Decontamination
• Medical surveillance
• Future steps for Hue
15. Storage of Hazardous Drugs
• Antineoplastic hazardous drugs must be unpacked in separate area
than compounding areas under neutral/normal or negative pressure
room
• Must be stored separately from non-hazardous drugs
• Restricted-access storage room must be under negative pressure,
externally vented, and have at least 12 air changes per hour
• Refrigerated antineoplastics must be stored in a hazardous drug
dedicated refrigerator
USP 800: http://www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf
16. Outline
• Risks of hazardous drug exposure
• Engineering control
• Storage
• Compounding
• Administration
• Decontamination
• Medical surveillance
• Future steps for Hue
17. Personal Protective Equipment for
Compounding: Gloves
• Nitrile or neoprene rubber and polyurethane gloves approved by the
American Society of Testing and Materials (ASTM)
• Use when handling drug packaging, cartons, vials
• Use double gloves
• Change gloves:
• Every 30 min (maximum time)
• Upon exit and re-entry of biologic safety cabinet
• Damage occurs (puncture, tear)
ASHP Guidelines on Handling Hazardous Drugs: http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx
18. Personal Protective Equipment for
Compounding: Gowns and Other
• Dedicated gowns for hazardous drug
• Change
• Every time inner pair of gloves changed
• Contamination
• Maximum 2-3 hours
• Shoe and hair covers
• Eye and face protection required
• NIOSH-certified N96 respirators required for compounding
ASHP Guidelines on Handling Hazardous Drugs: http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx
19. Compounding
• Spiking or priming an IV set with in a biological safety
cabinet BEFORE adding hazardous drug is added to the
solution
• Use of closed-system drug transfer devices
• PhaSeal shown to decrease environmental exposure
• Luer-Lok syringes and connections
ASHP Guidelines on Handling Hazardous Drugs: http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx
20. Outline
• Risks of hazardous drug exposure
• Engineering control
• Storage
• Compounding
• Administration
• Decontamination
• Medical surveillance
• Future steps for Hue
21. Administration
• Chemotherapy gown and gloves should be worn by nursing
• Chemotherapy should be transported in hazardous bag to prevent
contamination and never be placed in the biological safety cabinet
22. Outline
• Risks of hazardous drug exposure
• Engineering control
• Storage
• Compounding
• Administration
• Decontamination
• Medical surveillance
• Future steps for Hue
23. Chemotherapy Spill Kit
• 2 caution spill signs
• 1 chemotherapy gown
• 1 pair overshoes
• 1 Plastic safety glasses
• 1 Respirator mask
• 2 pairs heavy duty rubber gloves
• 2 absorbent pads
• 4 absorbent towels
• 1 waste bag
• 2 cable ties
• 1 small scoop to collect glass fragments
• 1 bottle of water
24. Hazardous Waste Disposal
• Stored in labeled, leakproof, spill-proof containers of nonreactive
plastic
• Can be initially contained in thick sealable plastic bags before being
placed in containers
25. Decontamination
• Sodium hypochlorite 0.5%
• 98% effectively removed contamination
• Wait 1 hour before using cleaned surface
• Isopropyl alcohol
• Best for hydrophilic compounds (cytarabine, anthracyclines)
• ~80.7% effective
Queruau Lamerie T, et al. Ann Occup Hyg. 2013 May;57(4):456-69.
26. Outline
• Risks of hazardous drug exposure
• Engineering control
• Storage
• Compounding
• Administration
• Decontamination
• Medical surveillance
• Future steps for Hue
27. Alternative Duty and Medical Surveillance
• Attempting to conceive or father a child, pregnant, or breast-feeding
should be offered alternative duty
• Anyone who handles hazardous drugs should be routinely monitored
in a medical surveillance program provided in workplace
• Assessment and documentation of symptom complaints
• Physical findings
• Laboratory values (CBC)
28. Outline
• Risks of hazardous drug exposure
• Engineering control
• Storage
• Compounding
• Administration
• Decontamination
• Medical surveillance
• Future steps for Vietnam
29. Small Steps Vietnam Employees Can Take to
Ensure Safety
• Education and orientation program on hazardous drug handling
• Competency assessment
• Personal protective equipment
• Compounding
• Respirator/face shield, gown, double gloves, cap, shoe covers
• Receiving, transport, administration
• Gown, gloves
• Cytotoxic waste should be disposed in hazardous drug containers
• Decontamination (cleaning) with bleach (0.5% sodium hypochlorite)
for work area
• Pharmacy department preparation of chemotherapy
30. Chemotherapy Safety and
Handling
Thao K. Huynh, PharmD, BCOP
Assistant Professor
Department of Pharmacy and Therapeutics
University of Pittsburgh School of Pharmacy
Email: t.huynh@pitt.edu
31. USP 800 Requirements
• Train personnel to utilize related practices
• Occupational safety plan
• Engineering controls
• Safe work practices
• Proper use of Personal Protective Equipment (PPE)
• Policies for hazardous drug waste segregation and disposal
32. Exposure Control
• Engineering control
• Biological safety cabinet
• Administrative control
• Procedures and protocols to minimize worker exposure
• Ex. Wiping all vials and ampules prior to puncturing and opening
• Personal protective equipment (PPE)
• Barriers that protect workers from exposure (gloves, gowns)
33. History Continued
• 2010 Journal of Occupational and Environmental Medicine published
2 key studies
• Study of antineoplastic drug exposure of US healthcare workers a 3 university-
based healthcare centers showed continued surface contamination in
pharmacy and nursing areas despite hazardous drug handling guidelines
• Study that reported damage to healthcare workers’ chromosomes that are
related to secondary cancers in treated patients
• 2011: NIOSH, OSHA, and The Joint Commission sent a letter
discussing the safe handling of hazardous drugs
34. Airborne Risk and Common Chemotherapy
Agents
• Fluorouracil concentrations 0.12-82.26 ng/m2 without biological
safety cabinets
• Cyclophosphamide – detected on HEPA filters
• Opportunity for respiratory precautions
35. Personal Protective Equipment for
Compounding
• ASTM-tested chemotherapy gloves required when unpacking,
compounding, and administering antineoplastic hazardous drugs
• Dedicated gowns for hazardous drug compounding and administering
injectable antineoplastic agents
• Eye and face protection required for compounding
• NIOSH-certified N96 respirators required for compounding
• Half mask with multi-gas cartridge and P100 filter required if
unpacking hazardous drug not contained in plastic
• Dispose of hazardous drug and personal protective equipment
• Documented personnel training
Valanis BG, Hertzberg V, Shortridge L. Antineoplastic drugs: handle with care. AAOHN J. 1987; 35:487–92.
Valanis BG, Vollmer WM, Labuhn KT et al. Association of antineoplastic drug handling with acute adverse effects in pharmacy personnel. Am J Hosp Pharm. 1993; 50:455–62.
Dranitsaris G, Johnston M, Poirier S, Schueller T, Milliken D, Green E, Zanke B. Are health care providers who work with cancer drugs at an increased risk for toxic events? A systematic review and meta-analysis of the literature. J Oncol Pharm Pract. 2005 Jun;11(2):69-78.
ajph
Gloves
Handling drug packaging, cartons, vials
Nitrile or neoprene rubber and polyurethane gloves approved by the American Society of Testing and Materials (ASTM)
Double glove
Change gloves:
Every 30 min (maximum time)
Upon exit and re-entry of biologic safety cabinet
Damage occurs (puncture, tear)
Gowns
Compounding in the biologic safety cabinet
Administration
Spill control
Waste management
Change
Every time inner pair of gloves changed
Contamination
Maximum 2-3 hours
Pads to contain liquid spills
Towels for clean up after spills
Queruau Lamerie T, Nussbaumer S, Décaudin B, Fleury-Souverain S, Goossens JF, Bonnabry P, Odou P. Evaluation of decontamination efficacy of cleaning solutions on stainless steel and glass surfaces contaminated by 10 antineoplastic agents. Ann Occup Hyg. 2013 May;57(4):456-69.
Gohma H, Inoue Y, Asano M, Sugiura S. Testing the degradation effects of three reagents on various antineoplastic compounds. J Oncol Pharm Pract. 2015 Aug;21(4):268-73.