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]

mailto:[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

http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf

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

http://www.occupationalcancer.ca/wp-content/uploads/2014/07/Antineoplastics-and-cancer-ENG.pdf

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

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

http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx

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




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


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



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



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

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.

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]

mailto:[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

chemotherapy safety and handling-thao's presentation

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