Chemotherapy safety and handling-Thao's presentation
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Transcript of Chemotherapy safety and handling-Thao's presentation
Chemotherapy Safety and Handling
Thao K. Huynh, PharmD, BCOPAssistant Professor
Department of Pharmacy and TherapeuticsUniversity of Pittsburgh School of Pharmacy
Email: [email protected]
Outline•Risks of hazardous drug exposure• Engineering control• Storage •Compounding•Administration•Decontamination •Medical surveillance• Future steps for Vietnam
Outline•Risks of hazardous drug exposure• Engineering control• Storage •Compounding•Administration•Decontamination •Medical surveillance• Future steps for Hue
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
Who Potentially Experiences Chemotherapy Exposure?
Patients and family
members
Hospital Staff
Nurses
Pharmacy Staff
PhysiciansOR Personnel
Hazardous Drug Exposure by Profession
CAREX Canada 2006 estimates: http://www.occupationalcancer.ca/wp-content/uploads/2014/07/Antineoplastics-and-cancer-ENG.pdf
Hazardous Drug Exposure•Manufacturing• Shipping•Handling•Compounding•Dispensing
•Administration•Patient care activities•Disposal • Spills
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
Effects of Hazardous ExposureAcute Effects Chronic EffectsSore throatChronic coughInfectionsDizzinessEye irritationHeadaches
Malignancies- 7-50 cancer cases per year per million
workers exposed to cyclophosphamide
Reproductive abnormalities - Increase in fetal abnormalities - Fetal loss- Fertility impairment Congenital malformationStillbirths
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
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
Outline•Risks of hazardous drug exposure• Engineering control• Storage •Compounding•Administration•Decontamination •Medical surveillance• Future steps for Hue
Engineering Control• Compounding clean room must be a negative
pressure room • Contain an anteroom for garbing and
handwashing
VERY DIFFICULT IN DEVELOPING COUNTRIES
ASHP Guidelines on Handling Hazardous Drugs: http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspxUSP 800: http://www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf
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.aspxUSP 800: http://www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf
Outline•Risks of hazardous drug exposure• Engineering control• Storage •Compounding•Administration•Decontamination •Medical surveillance• Future steps for Hue
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
Outline•Risks of hazardous drug exposure• Engineering control• Storage •Compounding•Administration•Decontamination •Medical surveillance• Future steps for Hue
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
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
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
Outline•Risks of hazardous drug exposure• Engineering control• Storage •Compounding•Administration•Decontamination •Medical surveillance• Future steps for Hue
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
Outline•Risks of hazardous drug exposure• Engineering control• Storage •Compounding•Administration•Decontamination •Medical surveillance• Future steps for Hue
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
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
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.
Outline•Risks of hazardous drug exposure• Engineering control• Storage •Compounding•Administration•Decontamination •Medical surveillance• Future steps for Hue
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)
Outline•Risks of hazardous drug exposure• Engineering control• Storage •Compounding•Administration•Decontamination •Medical surveillance• Future steps for Vietnam
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
Chemotherapy Safety and Handling
Thao K. Huynh, PharmD, BCOPAssistant Professor
Department of Pharmacy and TherapeuticsUniversity of Pittsburgh School of Pharmacy
Email: [email protected]
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
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)
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
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
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