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Self‐Advocating for Protection Against Hazardous Drugs

Seth Eisenberg, RN, ASN, OCN® BMTCN™

Disclosures

• Consulting fee: Panoramic

• Speaker fees: ICU Medical, BD, ProCE,CareFusion, Astellas/Takeda, Medical LearningInstitute

• Advisory/Review Activities: Clinigen, LynxGroup

• Payment for developing educational materials:B. Braun, BD, Mobius Therapeutics, ONS, JointCommission Resources

The Dangers Are Not New

1979: Positive urine mutagenicity (Ames Test) in nurses and pharmacists handling chemotherapy

1985: Initial definition of hazardous drugs (HDs) by ASHP1. Carcinogenicity

2. Teratogenicity or other developmental toxicity

3. Reproductive toxicity

4. Organ toxicity at low doses

5. Genotoxicity

2004: Additional criteria added by NIOSH6. Structure and toxicity profiles of new drugs that mimic existing drugs 

determined hazardous

(Falck, 1979)

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HAZARDOUS DRUG GUIDELINE TIMELINE

1981 ASHP 1983 ASHP 1984 ONS

1986 OSHA2004 

NIOSH Alert2016 

USP<800>

Recent Key Studies

• Hon, C. Y., Teschke, K., Chu, W., Demers, P., & Venners, S. (2013). Antineoplastic drug contamination of surfaces throughout the hospital medication system in Canadian hospitals.[Research Support, Non‐U.S. Gov't]. Journal of occupational and environmental hygiene,10(7), 374‐383

– 36% of samples were above level of detection for CY• Hon, C. Y., Teschke, K., Demers, P. A., & Venners, S. (2014). Antineoplastic drug contamination

on the hands of employees working throughout the hospital medication system. [Research Support, Non‐U.S. Gov't]. The Annals of occupational hygiene, 58(6), 761‐770.

– 20% of the hand wipe samples were positive; highestconcentration on non‐nursing staff

• Hon, C. Y., Teschke, K., Shen, H., Demers, P. A., & Venners, S. (2015). Antineoplastic drugcontamination in the urine of Canadian healthcare workers. International archives ofoccupational and environmental health, 88, 933‐941.

– 55% urine samples were positive; no correlation betweenlevels and known CY contact

Recent Key Studies

• Janes, A., Tanguay, C., Caron, N. J., & Bussieres, J. F. (2015). Environmental Contamination with Cyclophosphamide, Ifosfamide, and Methotrexate: A Study of 51 Canadian Centres. The Canadian journal of hospital pharmacy, 68(4), 279‐289.

– 50% wipe samples were positive for Cy, including patientchairs

• Boiano, J. M., Steege, A. L., & Sweeney, M. H. (2014). Adherence to safe handling guidelines by health care workers who administer antineoplastic drugs. [Research Support, U.S. Gov't, P.H.S.]. Journal of occupational and environmental hygiene, 11(11), 728‐740.

Survey Item %

Touched IV pump or bed controls while wearing chemotherapy gloves 61

Always wear double gloves 20

Always wear recommended gown 58

Reported a spill within prior week 12

Spills not always cleaned up 10

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Chromosomal Damage

“Chromosome 5 and 7 abnormalities in Oncology Personnel Handling Anticancer Drugs”

• 3 Cancer Centers; n=109 (includes 46 control)

• Abnormalities seen for chromosome 5 inexposed versus non‐exposed (p=.04)

• Increased incidence of chromosome 5abnormalities seen with increased drug handling

• Hazard Ratio 8.54 (p=.01)  for alkylating agents

(McDiarmid M., et al., 2010)

Guideline Limitations

• NIOSH does not have enforcement capability

• OSHA does not have the resources

“Although this is an important safety and health issue, OSHA has not considered a standard to specifically address hazardous drugs in the healthcare setting. Unfortunately, OSHA does not have the resources to issue standards covering every safety and health hazard facing workers.”

Jordan Barab, Deputy Assistant Secretary of Labor for ASHA (2010)

(Smith, 2010) 

State Laws

• Washington State (2012)

• California (2013)

• North Carolina – legislation being rewritten

• Michigan legislation pending

• Maryland legislation pending

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• Most nurses have never heard of USP but you may have seen their name

• Who is USP?

• Why should I care?

United States Pharmacopeial (USP)

• The mission of USP is to set standards “for theidentity, strength, quality, and purity ofmedicines…”

USP Chapter 800

• USP<800> sets standards for HD handling from delivery to disposal

• Far reaching implications for compounding andadministration

• Enforceable by each state’s Board of Pharmacy or designated agency

• Will be tied into CMS and reimbursement

(CMS Standard §482.25(a))

United States Pharmacopeial (USP)

Enforcement of USP <800> begins July 1, 2018

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REVIEW OF CURRENT RECOMMENDATIONS

Hierarchy of ControlsLevel 1

Elimination or substitution

Level 2Engineering Controls (e.g., BSC, CSTD)

Level 3Administrative Controls 

(e.g., policies)

Level 4PPE

More Effective

Less Effective

Overview Of Current Recommendations

• Chemotherapy‐resistant gown

– “Single‐use” and disposable

– Solid front and elastic or knit cuffs

– Shown to resist HD permeability

• Worn during:

– Preparation

– Administration

– Disposal

– Spill clean‐up

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Overview Of Current Recommendations

• Double gloving with ASTM 6978‐05‐tested

chemotherapy gloves

• Closed System Transfer Device (CSTD) for

administration

– Required for administration

– Recommended for compounding

Overview Of Current Recommendations

• All personnel must be trained in HD safety prior

to handling

• Crushing or cutting oral HDs should be done

inside of a Biologic Safety Cabinet (BSC)

• IV bags spiked with neutral solution unless CSTD

is used

• Spill kit must be available

USP<800> Implications

• Spill training and appropriate respiratory protection for drugs that vaporize at roomtemperature

• Carmustine

• Etoposide

• Cyclophosphamide

• Thiotepa

• Nitrogen Mustard

• 5‐FU

• Cisplatin

• Ifosfamide

(Connor, Shults & Fraser, 2000;  Kiffmeyer et al, 2002)  

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Vapors And Aerosols

• Vapors: small particles (e.g. perfume)

• Aerosols: larger particles (e.g., Windex™)

• N95 or N100 are for aerosols and particles

• Vapors require a cartridge respirator or PAPR (Powered Air Purifying Respirator)

(Connor, Shults & Fraser, 2000;  Kiffmeyer et al, 2002)  

USP<800> Implications

• A CSTD will be required for administration ofchemotherapy

• Devices are designed to “restrict hazardous drug liquidor vapor from escaping into the environment.” (NIOSH 2015)

7 CSTD Systems Vvailable

• Halo (Corvida)

• Phaseal (BD)

• Equashield (Equashield Medical)

• OnGuard (B Braun)

• ChemoLock (ICU Medical)

• ChemoClave (ICU Medical) 

• Chemo Safety System (CareFusion/BD)

Designed to prevent leakage of chemotherapy during compounding and administration

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CSTD Effectiveness

• No standardized test for effectiveness

• NIOSH has developed a draft protocol which is currently 

under review

• Passed:

– ICU ChemoLock

– Phaseal

– Equashield

CHANGING PRACTICE AT THE STATE LEVEL

SELF‐ADVOCATING FOR PROTECTION:

Washington State

Reporter Carol Smith, who was investigating the dangers of HDs, met Chelsea Crump

Chelsea introduced Carol to her mother Sue Crump, a pharmacist who had recently developed pancreatic cancer

Sue talked about compounding HDs for 2 decades without proper safety precautions

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Washington State

Both Sue and Chelsea wanted to prevent more HD exposure and took the issue to state legislators

In 2011, a bill was passed adopting NIOSH guidelines for all facilities who handle HDs

The Department of Labor and Industries was charged with the rule‐making process and enforcement of the law, effective 2012

Washington State

• SB‐5594 requires the adoption of the NIOSHguidelines

• “beconsistentwithandnotexceedprovisionsadoptedbythenationalinstituteforoccupationalsafetyandhealth's(NIOSH)2004alertonpreventingoccupationalexposurestoantineoplasticandotherhazardousdrugsinhealthcaresettingsasupdatedin2010.”

• SB 5149 directs the department of health tocollect current and past employment informationin the cancer registry program

Timeline To Comply With Law

January 1, 2015

• Develop hazardous drug control program

July 1, 2015

• Complete employee training

January 1, 2016

• Complete ventilation controls (BSCs)

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Challenging Road

• Delays due to ventilation control issues

• Many hospital pharmacies are in thebasement or on first floor, limiting the abilityto provide required ventilation

• Culture change is difficult, despite legislation

Enforcement

• Division of Occupational Safety and Health(DOSH) Inspections staff may:

– Take samples, photographs, videotapes, or audiotapes

– Conduct tests or interviews 

• Citations may result in $5,000 fines per violation($70,000 max)

• May also result in violation of CMS “Conditions ofParticipation” (COPs) [Interpretive Guidelines§§482.23(c)(1), (c)(1)(i) and (c)(2)]

CHANGING PRACTICE AT THE LOCAL LEVEL

SELF‐ADVOCATING FOR PROTECTION:

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What Can YOU Do?

• Identify your areas of vulnerability

– Gap analysis between current policies and current guidelines

– Gap analysis between current practice and current guidelines

– Include analysis of PPE

• Examples:– Do your gloves meet the ASTM standard?

– Do your gowns meet the USP requirements?

(Eisenberg, 2016; Walton, 2012)  

What Can YOU Do?

• Identify your areas of vulnerability

– Does your education program meet the USP requirements

• Prior to HD handling

• Must be documented

• Must be performed annually

– How are spills managed?

– Do you have a CSTD for HD administration?

• Are staff using the CSTD?

(Eisenberg, 2016; Walton, 2012)  

What Can YOU Do?

• Identify barriers for HD safety compliance

– Poor staffing (workload)

– Lack of education about HD dangers

– PPE not meeting staff needs (e.g., gowns or gloves that do not fit)

– PPE location does not support workflow

– Workplace culture does not support HD safety

(Callahan 2016; Polovich & Clark 2012)  

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What Can YOU Do?

• Identify your workplace culture

– Find Hazardous Drug champions!

• Staff nurses

• Clinical Nurse Specialists

• Clinical educators

• Department manager

• Pharmacy manager

• Department medical director

• Risk manager

(Eisenberg, 2016)  

What Can YOU Do?

• Adopt a zero‐tolerance approach to preventing exposurewithin the workplace

• Increase nursing awareness of the risks associated with hazardous drugs through multiple mediums and methods

– Staff meetings

– Local ONS chapter presentations

– Newsletters

• Work with state legislators to enact laws requiring healthcare facilities to follow the latest guidelines

(Eisenberg, 2016)  

References

Boiano, J. M., Steege, A. L., & Sweeney, M. H. (2014). Adherence to safe handling guidelines by health care workers who administer antineoplastic drugs. [Research Support, U.S. Gov't, P.H.S.]. Journal of occupational and environmental hygiene, 11(11), 728-740. doi: 10.1080/15459624.2014.916809

Callahan, A., Ames, N., Manning, M., Touchton-Leonard, K., Yang., M., and Wallen, G. (2016). Factors influencing nurses’ use of hazardous drug safe-handling precautions. Oncology Nursing Forum. 43(3), 342-349.

Eisenberg, S. (2016). A Call to Action for Hazardous Drug Safety: Where We Have Been and Where We Are Now. Clinical Journal of Oncology Nursing. 20(4), 377-384.

Hon, C. Y., Teschke, K., Demers, P. A., & Venners, S. (2014). Antineoplastic drug contamination on the hands of employees working throughout the hospital medication system. [Research Support, Non-U.S. Gov't]. The Annals of occupational hygiene, 58(6), 761-770. doi: 10.1093/annhyg/meu019

Hon, C. Y., Teschke, K., Shen, H., Demers, P. A., & Venners, S. (2015). Antineoplastic drug contamination in the urine of Canadian healthcare workers. International archives of occupational and environmental health. doi: 10.1007/s00420-015-1026-1

Hon, C. Y., Teschke, K., Chu, W., Demers, P., & Venners, S. (2013). Antineoplastic drug contamination of surfaces throughout the hospital medication system in Canadian hospitals. [Research Support, Non-U.S. Gov't]. Journal of occupational and environmental hygiene, 10(7), 374-383. doi: 10.1080/15459624.2013.789743

Janes, A., Tanguay, C., Caron, N. J., & Bussieres, J. F. (2015). Environmental Contamination with Cyclophosphamide, Ifosfamide, and Methotrexate: A Study of 51 Canadian Centres. The Canadian journal of hospital pharmacy, 68(4), 279-289.

Medical Surveillance for Healthcare Workers Exposed to Hazardous Drugs, available at http://www.cdc.gov/niosh/docs/wp-solutions/2013-103/pdfs/2013-103.pdf

NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014. Available at http://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138.pdf.

Polovich, M. & Clark, P. (2012). Factors Influencing Oncology Nurses’ Use of Hazardous Drug Safe-Handling Precautions. Oncology Nursing Forum. 39(3), 299-315.

Polovich, M., Olsen, M. M., & LeFebvre, K. B. (2014). Chemotherapy and biotherapy guidelines and recommendations for practice / edited by Martha Polovich, PhD, RN, AOCN, MiKaela Olsen, MS, RN, AOCNS, Kristine B. LeFebvre, MSN, RN, AOCN (Fourth edition. ed.): ONS.

Smith, C. (2010). Livesaving Drugs, Deadly Consequences. Secondhand chemo puts healthcare workers at risk. Retrieved March 18, 2015, from http://www.invw.org/chemo-main

Walton, A., Mason, S., Busshart, M., Spruill, A.D., Cheek, S., Lane, A., Sabo, K., Taylor, A. (2012). Safe handling: implementing hazardous drug precautions. Clinical Journal of Oncology Nursing. 16(3), 251-254. doi:10.11888/12.cjon.251-254