Preventing Occupational Exposure to Hazardous Drugs

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Consultation Education and Training Division. Michigan Occupational Safety and Health Administration . www.michigan.gov/miosha. 517-284-7720. Module 2. Before Beginning Module 2. Please review . Module 1. ID: 667433 Download Presentation

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Preventing Occupational Exposure to Hazardous Drugs




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Presentations text content in Preventing Occupational Exposure to Hazardous Drugs

Slide1

Preventing Occupational Exposure to Hazardous Drugs

Consultation Education and Training DivisionMichigan Occupational Safety and Health Administration www.michigan.gov/miosha517-284-7720

Module 2

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Before Beginning Module 2

Please review Module 1 of this training series before proceeding.

Module 1 includes:An overview of the hazards of certain drugs

Personnel and procedures with greatest risk for exposureMIOSHA regulatory requirements

2

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Module 2 Training Overview

Identify routes of exposureList the hierarchy of controlsDescribe recommended procedures for controlling exposure during:PreparationAdministration

DisposalDecontamination and spill clean-upReview additional consideration, resources and references

3

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Routes of Exposure

Absorption – skin contactInhalation – aerosolizationIngestion – contamination of food or beveragesInjection – needlesticks

4

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Increasing Effectiveness

Eliminates the exposure

before it can occur

Requires a physical

change to the workplace

Requires employer/worker

to

DO

something

Requires worker

to

WEAR

something

Hierarchy of Controls

5

Slide6

Elimination and Substitution

Professional healthcare providers prescribing hazardous drugs:Consider possible elimination or substitution for less hazardous drugsForm or delivery of the drug (i.e. tablet vs. liquid)Thorough understanding of occupational health

hazards of prescribed drugs

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Engineering Controls: Highest Level Protection

Examples of controls*:Externally vented Biologic Safety Cabinet (BSC)Compounding Aseptic Containment Isolator (CACI)Closed system transfer device (CSTD)

Advantages:Isolates and Contains the hazardIndependent of the worker

ASHP, 2006; NIOSH, 2014; ONS, 2011

* U.S.

Pharmacopeial

Convention (USP <800>) requires the use of engineering controls when

administering antineoplastic HDs

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Slide8

Engineering Controls

Control

Location

Type

of Ventilation

Special Features

Containment

(Primary Control)

Inside a Compounding Room

Ventilated device (i.e.

biological safety cabinet, compounding aseptic isolator)

Nonsterile compounding:

external vent preferred

Sterile compounding:

external vent required

Compounding Room

(Secondary Control)

Physically

separated from other rooms

Externally vented through high-efficiency particulate air (HEPA) filter

Negative Pressure

Closed system device

(Supplemental)

Compounding and

adminstering

None

Not a substitute for a Primary Control when compounding

References:

U.S.

Pharmacopeial

Convention (USP <800>)

OSHA Technical Manual, Chapter 2

MIOSHA Part 520 Ventilation Controls

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Examples of Controls

Compounding aseptic isolator

Biological Safety Cabinet

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Administrative Controls

Examples:Written policies & procedures Hazardous Drug List*Education, training & competency*Medical SurveillanceAlternative duty around pregnancy - may be discriminatory

* Required by MIOSHA Hazard Communication Standard and USP <800>

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Work Practice Controls

Examples:Label HDs with appropriate hazard warningsTransport HDs in sealed bagsInspect HD containers for leaksWash hands after removing PPEAvoid touching unnecessary items with contaminated gloves

Avoid wearing PPE outside drug handling areasAvoid spiking & priming IV tubing (without a closed system)Discard used IV equipment intact

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Personal Protective Equipment (PPE): Gloves

Tested with hazardous drugs Powder-free Latex, nitrile, neoprene*Wear two pair

DonningInner glove worn under gown cuff

Outer glove worn over gown cuffDoffingRemove gloves one at a time

Turn gloves inside out while removing

Keep contaminated surface from touching uncontaminated

ASHP, ASTM, NIOSH, OSHA, ONS

*USP<800> requires chemo gloves to

meet ASTM standard D6978 (or its successor)

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PPE: Gowns

Gowns: DisposablePolyethylene or vinyl-coatedTested with hazardous drugsCuffs & back closure

Single-useRemove & discard gown:

When visibly contaminatedAt the end of handling activities

When leaving the handling area

Do not hang up & re-use

ASHP, NIOSH, OSHA, ONS

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Other PPE: Face/Eye/Respiratory

Eye protectionWhen splashing is possibleRespiratorFor aerosols & spillsFitted (tight seal) respirator

Appropriate to the hazardN 95 rated (filtering particulate respirator)Powered Air Purifying Respirator (PAPR)

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USP <800> requirements for PPE

Appropriate PPE MUST be worn when handling HDs during:

ReceiptStorage

Transport

Compounding (sterile and non-sterile)

Administration

Deactivation/decontamination, cleaning, and disinfecting

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Recommended Precautions: Administration

Form

/ Route of Administration

Double Gloves

Protective

Gown

Eye Protection

Respiratory

Protection

Engineering Control

Intact

tablet or capsule

No,

single glove

No

No

No

N/A

Tablet

or capsule (manipulated)

Yes

Yes

Yes

Yes, if not done in control device

Yes

Oral liquid

Yes

Yes

No

No

N/A

Topical Drug

Yes

Yes

Yes, if liquid

could splash

If inhalation

potential

N/A

Subq

/ IM

Injection

Yes

Yes

Yes,

if liquid could splash

Yes, if inhalation

potential

Yes – Sharps

protection

Intravenous Solution

Yes

Yes

Yes, if liquid

could splash

Yes, if inhalation potential

Recommend CSTD

Irrigation

Yes

Yes

Yes

Yes

N/A

Inhalation

Yes

Yes

Yes

Yes

Yes

NIOSH, 2014

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Hazardous Drug Spills

Spills happenSpraysDropped vials & bagsPunctured IV bagsBroken totes from wholesalersPatient unit / infusion area

Spill consequencesPersonnel / patient exposureEnvironmental contamination

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Cleaning Contaminated Surfaces - Summary

Cleaning Step

Purpose

Agents

Deactivation

Render compound

inert or inactive

As listed in the HD labeling or if no specific

information

available

, sodium hypochlorite or

other Environmental Protection Agency (EPA)-

registered oxidizer

Decontamination

Remove inactivated

residue

Sterile alcohol, sterile water, peroxide, or

sodium hypochlorite

Cleaning

Remove organic and

inorganic material

Germicidal detergent and sterile water

Disinfection

Destroy microorganisms

Sterile alcohol or other EPA-registered

disinfectant appropriate for use

Resource: U.S.

Pharmacopeial

Convention (USP <800>),

Table 5. Summary of Cleaning Steps

18

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Recommended Contents of a Spill Kit*

Sufficient supplies to absorb 1 literPPE to protect worker2 pair chemo-tested glovesUtility glovesCover-all or gown & shoe covers

Face shieldAbsorbent plastic-backed sheets or spill control “pillows”Disposable towels2 sealable, thick plastic waste bags

Disposable scoopPuncture-resistant container

*ASHP, 2006; ONS, 2014

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Assess the Spill

Evaluate:Drug spilledSurface(s) affectedFloor?

Countertop?Furniture?Size of spillPresence of vapors

Consider:

Glass debris

Liquid

Powder/Dust

Exposure or potential for exposure

Personal Protective needed

Need for additional assistance*

*Defined in policy

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Spill Notification

Restricted area vs. PublicIsolation of area (vapors)Need for evacuationInternal spill response team?External Haz Mat Team?

21

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Step 1:

Cover (contain) the spill

Liquid:Absorbent padsCloths/ paper

Spill control pillowsPowder:Dampen pads, cloths or paper

22

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Step 2:

Don PPE

Scoop debris

Do NOT use hands!

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Step 3:

Remove residue

Consider surface material

Refer to facility policy for methods to manage spills on carpet/ upholstery

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Post-Spill Decontamination & Deactivation*

Oxidizing agent2% sodium hypochlorite + detergentEffective for bleomycin

, daunorubicin, etoposide

, fluorouracil, mitomycin, vinblastine, vincristine

30-second contact time

Neutralizer

1% sodium thiosulfate

Effective for cyclophosphamide,

ifosfamide

,

melphalan

, methotrexate

30-second contact time

Rinse with water

*Hard, washable surfaces

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Contain Clean-up Materials

Place in disposal bag #1:Absorbent padsPapers/ clothsSpill control pillowsOther disposablesSharps in rigid container

Place in Disposal Bag #2:

Bag #1 with its contentsShoe coversOuter gloves

Face shield

Respirator (if disposable)

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Finally…

Place in Bag #2GownInner glovesClose bag #2Dispose of Bag #2 in designated containerWash hands with soap and water

(Image used with permission)

27

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Document the Spill

Recommend creating a designated spill report form:Who, what, where, whenParticipants in clean upSteps taken to clean the spillFollow-up

28

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Managing Acute Exposure

Type

of Exposure

Immediate

Care

Follow

Up

Skin exposure

Remove contaminated clothing/ PPE

Wash

affected area with soap & water

Consult SDS for drug-specific instructions.

Report to Employee Health Professional or Emergency Department, based on symptoms

Complete report of employee injury/ exposure

Follow policy related to Workers Compensation.

Eye Exposure

Flush eye(s)

with water or isotonic eye wash for 15 minutes.

Consult SDS for drug-specific instructions.

Inhalation

Exposure

Move to area with fresh air

Consult

SDS for drug-specific instructions

Ingestion

Do not induce vomiting

Consult SDS

for drug-specific instructions

Polovich, 2011

29

Slide30

MIOSHA Resources: Standards and Compliance

State Emphasis Program (SEP)Part 92 and 430 Hazard CommunicationPart 431 Hazardous Work in Laboratories

Part 33 and Part 433

Personal Protective EquipmentPart 451 Respiratory ProtectionPart 474 Sanitation

Part 554

Bloodborne

Infectious Diseases

Recording & Reporting of Occupational Injuries & Illnesses

30

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MIOSHA Resources: Consultation and Training

Preventing Exposure to Hazardous Drugs Training Module 1 – OverviewPreventing Exposure to Hazardous Drugs Training Module 2 – Staff Fact Sheet: Preventing Exposure to Hazardous Drugs

(doc)Hazard Communication Sample Plan (doc)

Personal Protective Equipment Guide (doc)

Respiratory Protection Program

(doc)

Bloodborne

Sample Exposure Control Plan

(doc)

31

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Federal Resources

Centers for Disease Control and Prevention:NIOSH Hazardous Drugs webpageOSHA:

Hazardous Drugs WebsiteHazardous Drugs eTool

Technical Manual Section VI: Chapter 2:Controlling Occupational Exposure To Hazardous Drugs

32

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Questions?

Consultation Education and Training DivisionMichigan Occupational Safety and Health Administration

www.michigan.gov/miosha517-284-7720

33

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Acknowledgements

Christopher R. Friese, PhD, RN, AOCN®, FAANAssistant ProfessorUniversity of Michigan School of NursingThomas H. Connor, PhD

Research BiologistDivision of Applied Research and TechnologyNational Institute fro Occupational Safety and Health

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References

American Society for Testing and Materials [ASTM]. (2013). D 6978-05 standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs. West Conshohocken, PA: ASTM.

American Society of Health-System Pharmacists. (2006). ASHP guidelines on handling hazardous drugs. American Journal of Health-System Pharmacy, 63

, 1172-1193. doi: doi:10.2146/ajhp050529

Fransman

, W.,

Roeleveld

, N.,

Peelen

, S., de

Kort

, W.,

Kromhout

, H., &

Heederik

, D. (2007). Nurses with dermal exposure to antineoplastic drugs: Reproductive outcomes.

Epidemiology, 18

, 112-119.

Hansen, J., & Olsen, J. H. (1994). Cancer morbidity among Danish female pharmacy technicians.

Scandinavian Journal of Work and Environmental Health, 20

, 22-26. doi

: 8016595International Agency for Research on Cancer. (2012). Agents Classified by the IARC. IARC Monographs, 1-104(March 2012). http://monographs.iarc.fr/ENG/Classification/ClassificationsGroupOrder.pdfLawson, C. C., Rocheleau, C. M., Whelan, E. A., Lividoti Hibert, E. N., Grajewski

, B., Spiegelman, D., & Rich-Edwards, J. W. (2012). Occupational exposures among nurses and risk of spontaneous abortion. American Journal of Obstetrics and Gynecology, 206(4), 327.e321-327.e328.

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References (cont’d)

Martin, S. (2005). Chemotherapy handling and effects among nurses and their offspring (Abstract). Oncology Nursing Forum, 32, 425.

McDiarmid, M. A., Oliver, M. S., Roth, T. S., Rogers, B., & Escalante, C. (2010). Chromosome 5 and 7 abnormalities in oncology personnel handling anticancer drugs. Journal of Occupational and Environmental Medicine, 52

(10), 1028-1034. doi: 10.1097/JOM.0b013e3181f73ae6

National Institute for Occupational Safety and Health. (2014).

NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014

. (Publication Number 2014-138). Cincinnati, OH: DHHS (NIOSH).

OSHA. (1999).

OSHA technical manual, TED 1-0.15A Sec VI, Chapter II Categorization of drugs as hazardous

Retrieved from http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html#2

Polovich, M. (Ed.). (2011).

Safe handling of hazardous drugs

(2nd ed.). Pittsburgh, PA: Oncology Nursing Society.

Polovich, M., Olsen, M., & LeFebvre, K. B. (Eds.). (2014).

Chemotherapy and Biotherapy Guidelines and Recommendations for Practice

(4th ed.). Pittsburgh, PA: Oncology Nursing Society.

Skov

, T.,

Maarup

, B., Olsen, J.,

Rorth

, M., Winthereik, H., & Lynge, E. (1992). Leukaemia and reproductive outcome among nurses handling antineoplastic drugs.

British Journal of Industrial Medicine, 49, 855-861.

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