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MiKaela Olsen MS, RN, AOCNS Oncology and Hematology Clinical Nurse Specialist Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Hospital Baltimore, Maryland

Byron G. Peters, BS Pharm, RPh Director of Pharmacy Alvin J. Siteman Cancer Center, Department of Medicine Division of Medical Oncology Washington University Medical School St. Louis, Missouri

Faculty Presenters:

MiKaela Olsen MS, RN, AOCNS Oncology and Hematology Clinical Nurse Specialist Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Hospital Baltimore, Maryland Byron G. Peters, BS Pharm, RPh Director of Pharmacy Alvin J. Siteman Cancer Center, Department of Medicine Division of Medical Oncology Washington University Medical School St. Louis, Missouri

Moderator:

Elena Beyzarov, PharmD Director of Scientific Affairs Pharmacy Times Office of Continuing Professional Education Plainsboro, New Jersey

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MiKaela Olsen MS, RN, AOCNS, and Byron G. Peters, BS Pharm, RPh,

have no financial relationships with commercial interests to disclose.

Pharmacy Times Office of Continuing Professional Education

Planning Staff—Judy V. Lum, MPA; Elena Beyzarov, PharmD; and Donna W. Fausak—have no financial relationships with commercial interests to

disclose.

Dannemiller Planning Staff—Michelle Montgomery and Gordon Ringler—have no financial relationships with commercial interests to disclose.

The contents of this webinar may include information regarding the use of products that may be inconsistent with or outside the approved

labeling for these products in the United States. Pharmacists should note that the use of these products outside current approved labeling is considered experimental and are advised to consult prescribing

information for these products.

This activity is cosponsored by Pharmacy Times Office of Professional Education and Dannemiller, and is supported by an educational grant from Becton, Dickinson and Company.

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Pharmacy Times Office of Continuing

Professional Education is accredited by

the Accreditation Council for Pharmacy

Education (ACPE) as a provider of

continuing pharmacy education. This

activity is approved for 1.0 contact hour

(0.1 CEU) under the ACPE universal

activity number 0290-9999-13-124-H04-

P. The activity is available for CE credit

through April 22, 2015.

Type of Activity: Knowledge

Dannemiller is approved by the California Board of

Registered Nursing, Provider Number 4229, for 1.0 contact hour. RNs outside California must verify with their licensing agency for approval of this course.

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Identify new and continuing concerns for health care workers handling hazardous drugs in the health care system

Examine current standards and recommendations for minimizing exposure to hazardous drugs

Explore the various available safety measures used in preventing occupational exposure to hazardous drugs

MiKaela Olsen MS, RN, AOCNS Oncology and Hematology Clinical Nurse Specialist Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Hospital Baltimore, Maryland

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Sue Crump- pharmacist in Seattle

◦ 23 years of experience compounding chemotherapy

◦ Died in 2010 of pancreatic cancer

April 2011: Washington State legislature passes 2 bills designed to protect nurses, pharmacists, pharmacy techs, and other health care workers (HCWs)

◦ Requires facilities (hospitals, clinics, physician offices, laboratories, and veterinarians) to handle hazardous drugs (HDs) according to the National Institute for Occupational Safety and Health (NIOSH) guidelines

◦ Requires facilities to maintain database of administered HDs and employees who handle them

Three-tiered approach with full implementation by 2014

Over 100 articles published on hazards associated with handling

chemotherapy and only 1 state mandates NIOSH guidelines

Eisenberg S. NIOSH safe handling of hazardous drugs guidelines becomes state law. J Infus Nurs. 2012;35:316-319.

8 million HCWs potentially exposed to HDs

◦ Pharmacy and nursing staff involved in mixing and administering at highest risk

In the United States, an estimated 23 million adult patient visits occur

annually for chemotherapy

◦ Approximately 19 million (84%) of those visits in ambulatory settings, largely by nurses

By 2050, due to the aging US population, the number of cancer cases are expected to double, increasing the use of antineoplastic drugs

Increasing use of HDs in nonmalignant conditions

Increasing use of higher doses, more combinations

Many biologically engineered drugs exist with unknown health risks

Currently, exposure monitoring not possible, and no permissible exposure limit

Bureau of Labor Statistics, 2011. Occupational and employment statistics homepage. May 2011 employment and wage estimates.

Washington, D.C. http://www.bls.gov/oes/home.htm

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Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care

Settings. NIOSH, 2004

Genotoxic Reproductive

toxicity

Teratogenic Carcinogenic

Structure or toxicity

similar to drugs

classified as

hazardous

Organ toxicity at

low doses

Universal approach to all HDs

o Antineoplastics, antivirals, hormonal agents, immunomodulatory drugs,

and others

Evaluation of HDs is an ongoing process, as new drugs approved

o NIOSH will review newly FDA-approved drugs on

regular basis

26 drugs added to list;15 removed

Challenge: Drug package inserts

not consistent, comprehensive,

or standardized Department of Health and Human Services. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare

Settings 2012. DHHS (NIOSH) Publication No. 2012-150. June

2012.

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Objective: ◦ Evaluate occupational risk of monoclonal antibodies

Methods:

◦ Systematic literature review

Results:

◦ Monoclonal antibodies have potential to cause harm

◦ All evaluated monoclonal antibodies were toxic to reproduction

◦ Some were mutagenic

◦ Authors recommended precautions

Halsen G, Kramer I. Assessing the risk to health care staff from long-term exposure to anticancer drugs-the case of monoclonal antibodies. J Oncol Pharm Pract. 2011;17(1):68-80.

Dermala

◦ Direct contact

Ingestion ◦ Food, gum ◦ Hand-to-mouth

Inhalation ◦ Aerosols ◦ Dust ◦ Vapors

Injection ◦ Sharps ◦ Breakage

a: Most common source of exposure

Preventing Occupational Exposure to Antineoplastic and Other Hazardous

Drugs in Health Care Settings. NIOSH, 2004

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Hazardous Drug

From Manufacturer

(External

contamination)

Environmental

contamination with

HD increasing risk

of dermal

exposure to HCW

Exposure or

inappropriate handling

of patient excreta.

Contamination in

restrooms

Exposure during linen

and waste disposal

Administration is

complete-

Improper disposal,

touch contamination,

improper use of PPE

Potential for exposure

exits if spiking or

unspiking, priming

tubing, dripping from

end of tubing, or

connections, handling

bag or pump

Drug is double

checked, IV pump and

tubing prepared for

administration. Double

gloves, gown, mask

with face protection

Drug uptake may

occur in work areas

due to contamination

of food, drink located

near drug handling

areas

Drug delivered to nurse

for administration

(External bag

contamination)

Pharmacy

Prepares drug

using BSC +/- a

CSTD

Pharmacy

contamination

Delivered to

health care

facility (shipping,

receiving, or

direct to

pharmacy)

Conditions for Exposure Widespread contamination of work environment makes skin contact highly probably

* BSC indicates b i ologic safety c abinet ;

CST D, closed sys tem transfer d ev ice; PPE, personal protective eq u ipment.

Objective:

◦ Evaluation of HCW exposure to HD

Methods:

◦ Cross-sectional study examined environmental surface wipe samples, task diary, urine and blood samples

Results:

◦ Environmental surface contamination is widespread

◦ Site that utilized a CSTD was the only area with no reported spills

Connor TH, DeBord G, Pretty JR, et al. Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer

centers. J Occup Environ Med. 2010;52(10):1019-1027.

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Spill: worst case scenario Lack of knowledge exists

regarding best way to clean up spill

Risk of spreading HD from spill to larger areas

Take every precaution to prevent spills

If spill occurs, conduct root cause analysis-record exact location

Leur connections- tighten carefully

Eliminate glass bottles for HDs

Never unspike HD bags Carefully consider

tubing/pump setup to maintain closed system

Utilize a CSTD

Nurse develops rash on 2 different occasions ◦ After dumping urine from patients who received

doxorubicin and vincristine

Nurse developed projectile vomiting, abdominal cramping, and diarrhea

◦ After spill that resulted in exposure of skin to carmustine

Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH,

2004

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Sore throat

Cough

Headache Dizziness

Abdominal pain

Diarrhea

Nausea and vomiting

Allergic reaction Nasal sores

Contact dermatitis, eczema

Partial alopecia (hair thinning)

Ocular (burning, irritation)

Kyprianou et al. Eur J Oncol Nurs. 2010; 14:278-282.

Valanis et al. Cancer Nurs. 1993; 16(4): 288-295. Valanis

et al. Am J Health-System Pharm. 1993;50: 455-462. Harrison et al. (2001).In M.C. Perry (Ed.), The chemotherapy source book. (3rd Ed., pp. 566-582). Philadelphia, PA. Lippincott, Williams, & Wilkins.

Increased risk of cancer ◦ Leukemia, non-Hodgkin lymphoma , cancer of the breast,

bladder, or liver

Reproductive risks

◦ Menstrual cycle changes, infertility, premature delivery, low birth weight, ectopic pregnancy, miscarriages, congenital abnormalities, stillbirths, learning disabilities in offspring

Dranitsaris, et al. J Oncol Pharm Practice. 2005;11:69-78 2005. Fransman, et al. Epidemiology. 2007;18. 112-119. Martin. ONF. 2005;32, 425.

Petralia, et al. Am J Ind Med. 1999;36:159-165. Saurel-Cubizolies, et al. Lancet.1993;341:1169-1171. Skov et al, BJM. 1992;49:855-61. Skov et al.

Lancet. 1990;336:1446. Stucker, et al. Scand J Work Environ Health. 1990;16:

102-107. Valanis et al. Cancer Nurs. 1993;16(4): 288-295. Walusiak et al. Allergy. 2002 May;57(5):461

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Purpose ◦ Study of relationship between organizational structures

and processes of care in ambulatory setting associated with increased risk of unintentional chemotherapy exposure

Measures ◦ Sample of oncology nurses (n=1339)

Results ◦ Overall rate of exposure to skin or eyes in past year:

16.9%

◦ When nurses reported adequate staffing/resources and 2 RN dose verifications with chemotherapy: likelihood of exposure decreased

Friese, CR, Himes-Ferris L, Frasier MN, McCullagh MC, Griggs JJ. Structures and processes of care in ambulatory oncology settings and

nurse-reported exposure to chemotherapy. BMJ Qual Saf. 2012;21(9):753-759.

Chromosome 5 and 7 Abnormalities in

Oncology Personnel Handling Anticancer Drugs

Objective: To determine the frequency of “signature” chromosomal abnormalities in oncology workers handling anticancer drugs

Methods: Peripheral blood from health care personnel (n=109) examined for targets on chromosomes 5, 7, and 11

o Effect of drug-handling frequency on chromosome abnormalities

Results: Excess of structural (0.18 vs 0.02; P =.04) and total abnormalities (0.29 vs 0.04; P=0.01) of chromosome 5 observed in high-exposure group, compared with unexposed

o Increased incidence rate ratios (IRR) for abnormalities of chromosome 5 (IRR =1.24; P 0.01) and for either chromosome 5 or 7 (IRR =1.20; P 0.01) obtained at 100 handling events

o Effect sizes were augmented 2- to 4-fold when alkylating agent handling alone considered

Conclusions: Biologically important exposure to genotoxic drugs occurs in oncology work settings, despite reported use of safety practices

McDiarmid M, Oliver MS, Roth TS, Rogers, B, Escalante C. Chromosome 5 and 7 abnormalities in oncology personnel handling anticancer drugs.

J Occup Environ Med. 2010;52(10):1028-1034.

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67-year-old male patient with metastatic colorectal cancer and bowel/bladder incontinence taking oral chemotherapy ◦ Family caring for patient in home setting

◦ Linens and diapers soiled frequently

◦ Small children and animals in home

What are conditions for exposure to family?

What education is being done?

Package oral agents in blister packs or foil packs

◦ Uncoated tablets: Risk of exposure from dust inhalation or skin contact

Utilize gloves when handling oral drugs

Utilize full personal protective equipment (PPE) when handling liquid oral drugs

Do not crush, break, or compound solutions outside biologic safety cabinet

Do not place drugs in automated counting machines

Dispose of unused drug as cytotoxic waste

Educate patients and caregivers, provide written instructions

Goodin S, Griffith N, Chen B, et al. Safe handling of oral chemotherapeutic agents in clinical practice: recommendations from an international pharmacy

panel. J Oncol Pract. 2011;7(1):7-12.

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Occupational Safety & Health Administration : Employers subject to the OSH Act have general duty to provide work and workplace that is free from recognized, serious hazards

NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Healthcare Settings (2004)

◦ Safety and health topics (online)

HD exposures in health care

Occupational exposure to antineoplastic agents

Oncology Nursing Society (ONS): Polovich M, Whitford JM, and Olsen M (eds.) Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (3rd ed.) Pittsburgh, PA: Oncology Nursing Society; 2009.

American Society of Health-System Pharmacists (ASHP). ASHP Guidelines on Handling Hazardous Drugs: Am J of Health Syst Pharm. 2006;63:1172-1193.

United States Pharmacopeia (USP) <797>: Guidebook to Pharmaceutical compounding: sterile preparations. Rockville, MD: United States Pharmacopeia; 2008.

Environmental Protection Agency: 2013 Proposal to Address the Management of Hazardous Waste Pharmaceuticals. http://www.epa.gov/waste/hazard/generation/pharmaceuticals.htm.

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Byron G. Peters, BS Pharm, RPh Director of Pharmacy Alvin J. Siteman Cancer Center, Department of Medicine Division of Medical Oncology Washington University Medical School St. Louis, Missouri

HD exposure can have negative impact

Protective measures critical

Protection levels should run from top (Level 1) to bottom

(Level 4): Not free to choose

Cannot “cherry pick” levels of protection

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe

handling of cytotoxics. J Oncol Pharm Pract. 2007;13

(suppl):1-81. a ISOPP: International Society of Oncology Pharmacy

Practitioners.

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Elimination, substitution, replacement

“Change the product to another product which is non-toxic or less toxic”

Rarely possible when treating cancer patients

Targeted therapies may make this possible

If impossible or insufficient, apply Level 2

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of

practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81.

Isolation of hazard/source containment

“Contain the toxic product in it’s container or at the source”

Containment of persons or materials can be prevented if product contained at source

Source containment should not be limited to 1 point; continuous throughout process (preparation, administration, etc)

CSTD

If impossible or insufficient, apply Level 3

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP

standards of practice. Safe handling of cytotoxics.

J Oncol Pharm Pract. 2007;13 (suppl):1-81.

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Engineering controls/ventilation

“Apply local and general ventilation or extraction in order to dilute the toxic product”

Any form of dilution reduces the concentration of toxin/HD

Any form of extraction reduces the amount of toxin/HD

BSCs and isolators are Level 3

Contamination can still occur inside BSC or isolator

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP

standards of practice. Safe handling of cytotoxics.

J Oncol Pharm Pract. 2007;13 (suppl):1-81.

Administrative controls/organizational measures

“Organize work to reduce duration of exposure”

“Organize work to reduce number of exposed employees”

Maintain adequate number of trained employees

Use rotational schedule for potentially exposed staff

If not possible or insufficient, apply Level 4

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe

handling of cytotoxics. J Oncol Pharm Pract. 2007;13

(suppl):1-81.

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PPE

“Individual protection by using personal tools”

Temporary barrier between operator and contamination, created by use of gloves, gowns, masks, goggles or face shields, or other equipment

Employ “proven” resistant materials for PPE

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards of practice. Safe

handling of cytotoxics. J Oncol Pharm Pract. 2007;13

(suppl):1-81.

Polovich M. (Ed.) Safe Handling of Hazardous Drugs (2nd Ed). Pittsburgh, PA: Oncology Nursing Society; 2011. Polovich M,

Whitford JM, and Olsen M (eds.) Chemotherapy and Biotherapy

Guidelines and Recommendations for Practice (3rd Ed.) Pittsburgh, PA: Oncology Nursing Society; 2009.

Gloves

• Wear double gloves for all handling activities (eg, preparation, administration, handling of contaminated waste) • Disposable, powder-free gloves, tested for use with HDs • Inspect gloves for visible defects prior to use • Change gloves every 30 minutes or immediately if damaged or contaminated; DO NOT reuse gloves • Wash hands with soap and water after removing gloves

Eye and Face Protection

• Combination of mask and face shield when possibility of splashing exists

Gowns

• Disposable, lint-free, low-permeability fabric • Solid front with back closure, long sleeves, tight cuffs • Cloth fabrics, including lab coats, should not be used • Inner glove under gown, outer glove over gown • Discard if visibly contaminated, after handling drug, and before leaving area where drug is handled • Gowns are for single use only -DO NOT reapply

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In a self-reported survey of 330 oncology nurses:

◦ 96% reported usually wearing gloves during HD administration

◦ 98% reported usually wearing gloves while handling excreta

◦ 18% reported using double gloves during HD administration

◦ 52% reported usually wearing a chemotherapy gown during administration

Gown use was less common when disposing of HD-associated equipment (eg, tubing, bags) and when handling patient excreta

Polovich M, Martin S. Nurses’ use of hazardous drug-handling precautions and awareness of national safety guidelines. Oncol Nurs Forum.

2001;38(6):718-726.

A survey of 165 oncology nurses and a telephone interview of managers’ perspectives on safe handling demonstrated:

◦ Organization’s safety climate has an impact on safe handling

◦ Higher number of patients/day/nurse associated with lower use of HD precautions

◦ Availability of PPE is a barrier to HD precautions

◦ “Safe practice is a shared responsibility between employers and nurses”

Polovich M and Clark PC. Factors influencing oncology nurses’ use of hazardous drug safe-handling

precautions. Oncol Nurs Forum. 2012;39:E299-E309.

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Use of BSC (Class II or Class III)

Use of Compounding Aseptic Containment Isolators (CACI)

CSTD

Administrative controls

PPE (Pharmacy)

PPE (Nursing)

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP standards

of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81.

Eliminate/reduce worker exposure to hazards (eg, chemical, biologic)

Ventilated cabinets: designed for worker protection

Cytotoxic agents should never be prepared using horizontal laminar airflow (LAF) hood

Equipment: BSCs and isolators

BSC: Class I (not aseptic conditions), Class II, Class III

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP

standards of practice. Safe handling of cytotoxics.

J Oncol Pharm Pract. 2007;13 (suppl):1-81.

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Open front with inward airflow: personnel protection

Downward high-efficiency particulate air (HEPA)-filtered LAF: product protection

HEPA-filtered exhausted air: protect environment

Does not prevent generation of contamination inside cabinet

ISO Class 5 (Class 100), work surface

4 sub classification: A1, A2, B1, B2 (related to exhaust)

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP

standards of practice. Safe handling of

cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81.

Class II A1: Not recommended for volatile/toxic chemicals

Class II A2: Only minute quantity of toxic/volatile chemicals

Class II A: 30%-70% of air recirculated in BSC

Class II A: Exhaust-contaminated air back into workroom

Class II B: Offers alternative to Type-A

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP

standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81.

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Class II B1: Inflow air partially recirculated

Class II B2: Total exhaust (preferred)

Both suitable for cytotoxic drug preparation

Do not recirculate air in hood or return air to workroom

Environment meets standards for aseptic preparations

Vaporization of some chemotherapy (eg, Cytoxan), not prevented ◦ Contamination may still occur in BSC

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP

standards of practice. Safe handling of cytotoxics.

J Oncol Pharm Pract. 2007;13 (suppl):1-81.

Totally enclosed, vented cabinet; leak-tight construction

Operator uses fixed-glove access

Maintained with negative pressure through HEPA filter

Exhaust air exists via double HEPA filter

Products use double door pass-through box

Advantage: barrier between toxic product and operator

Use: highly toxic or infectious material (seldom used)

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP

standards of practice. Safe handling of cytotoxics.

J Oncol Pharm Pract. 2007;13 (suppl):1-81.

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Barrier isolator for aseptic preparations

Ventilated, controlled environment with fixed walls (floor and ceiling)

Supply air drawn in through HEPA filter

Exhaust air is HEPA filtered to outside of facility

Work area accessed using gloves, sleeves, air locks, etc

Does not prevent generation of contamination inside

International Society of Oncology Pharmacy Practicioners Standards Committee. ISOPP

standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81.

“A drug transfer device which mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system”

ISOPP and NIOSH definition of CSTD

System cannot be considered “semi-closed;” it is either closed or it is not (ISOPP)

Definition applies to preparation and administration of HD

Department of Health and Human Services. Preventing Occupational Exposures to Antineoplastic and Other

Hazardous Drugs in Health Care Settings. DHHS (NIOSH)

Publication No. 2004-165. September 2004. International Society of Oncology Pharmacy Practicioners Standards

Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81.

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Must indicate: if some steps not covered/properties retained

If properties retained for more than 1 vial

If studies demonstrated reduction in contamination

If containment guaranteed for which administration routes

If all steps in administration process covered or not

International Society of Oncology Pharmacy Practicioners

Standards Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-

81. American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J of Health Syst Pharm. 2006;63:1172-1193.

Air venting devices with filters (0.22 micron diameter) and HEPA filter do not retain vapor of cytotoxic products

Filters with active carbon absorb vapors on temporary basis

Data needed from manufacturers to indicate maximum load for filter, working conditions, and filter capacity

International Society of Oncology Pharmacy Practicioners

Standards Committee. ISOPP standards of practice. Safe

handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. American Society of Health-System Pharmacists.

ASHP Guidelines on Handling Hazardous Drugs: Am J of Health Syst Pharm. 2006;63:1172-1193.

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Numerous national and international guidelines have addressed

CSTD in HD handling

Association of Pediatric Hematology/Oncology Nurses : “When reconstituting drugs in vials, avoid pressure build-up because it can lead to aerosolization. Use a closed-system device (eg, PhaSeal) if available.”

ONS: “Using a closed-system eliminates the exposure risk

associated with spiking and priming tubing.”

ASHP: “As products become available, they should meet the definition of a CSTD established by NIOSH and should be required to demonstrate effectiveness in independent studies.”

Kline NE (Ed). The Pediatric Chemotherapy and Biotherapy Curriculum (2nd Ed). Glenview, IL: Association of Pediatric Hematology/Oncology

Nurses; 2007. Polovich M. (Ed.) Safe Handling of Hazardous Drugs (2nd

Ed). Pittsburgh, PA: Oncology Nursing Society; 2011. American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous

Drugs: Am J of Health Syst Pharm. 2006;63:1172-1193.

ISOPP: “Only airtight and leak-proof devices prevent chemical contamination. To be a closed-system, a device must meet this. Thus, vented, filtered devices are not closed.”

NIOSH: “Evidence documents a decrease in drug contamination when a CSTD is used.”

USP 797: “The use of a CSTD is preferred because of their inherent closed-system process (ie, vial transfer systems that allow no venting or exposure of hazardous substances to the environment).” International Society of Oncology Pharmacy Practicioners Standards

Committee. ISOPP standards of practice. Safe handling of cytotoxics. J Oncol Pharm Pract. 2007;13 (suppl):1-81. Department of Health and

Human Services. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. DHHS (NIOSH)

Publication No. 2004-165. September 2004. USP Chapter <797>. Guidebook to Pharmaceutical Compounding: Sterile Preparations.

Rockville, MD: United States Pharmacopeia; 2008.

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New specific product code created by FDA (1/2013)

ONB: Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System

ONB: requires data to prove system is closed for HD use

ONB: requires data to demonstrate reduction in exposure to healthcare workers

ONB: clarifies misconceptions about chemotherapy devices

FDA: 21 Code of Federal regulations (CFR) . 880.5440

Three criteria needed to meet the requirement of ONB Code:

◦ “Nothing out”: No escape of HD or vapor concentration (leak-proof and airtight)

◦ “Noting in”: No transfer of environmental contaminants

◦ “Prevention of microbial ingress”

BD PhaSeal: First and only CSTD cleared under FDA’s new ONB code (for devices indicated to reduce exposure to HDs)

FDA: 21 CFR 880.5440 BD Medical; Franklin Lakes, NJ; January 2013.

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Comparison of surface contamination with cyclophosphamide and fluorouracil using CSTD versus standard preparation techniques

◦ Multicenter, randomized, blinded trial (independent analysis)

◦ 36-week study (12-week baseline; 12 weeks with CSTD (PhaSeal) and 12 weeks without CSTD

◦ 342 wipe samples collected

◦ Significant reduction in positive wipe samples when CSTD used (P = .0002)

◦ Conclusion: use of a CSTD reduced surface contamination

Harrison BR, Peters BG, Bing MR. Comparison of surface contamination with cyclophosphamide and fluorouracil using a

closed-system drug transfer device versus standard preparation

techniques. Am J Health Syst Pharm. 2006;63(18):1736-1744.

Policies and procedures should be in place for all situations and all areas

Develop a comprehensive safety program to address all aspects

of handling HDs

Safety program must be collaborative (all key disciplines)

Material safety data sheets must be readily available

Comprehensive training programs are needed (all staff)

Monitoring and medical surveillance (a necessary component) PPE must be addressed

American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J of Health Syst Pharm. 2006;63:1172-1193.

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PPE must be worn by personnel during the handling and preparation of HDs

Intended to protect operator (temporary barrier)

Ensure sterility of compounded products

HD contamination identified: on vials, counters, floors, BSC

◦ PPE needed during all aspects of preparation/handling

PPE includes: gloves; gowns; masks or respirators; eye and face protection; sleeve, hair, and shoe covers (in pharmacy)

American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J of Health Syst Pharm. 2006;63:1172-1193.

Widespread contamination of work environment makes skin contact highly probably

Organizations need to encourage safety and enforce safe handling guidelines

Appropriate use of containment equipment (eg, BSC, CACI), can reduce exposure to HDs

Use of a true CSTD may reduce exposure to HDs

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