Consultation Education and Training Division Michigan Occupational Safety and Health Administration wwwmichigangovmiosha 5172847720 Module 2 Before Beginning Module 2 Please review Module 1 ID: 667433
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Preventing Occupational Exposure to Hazardous Drugs
Consultation Education and Training DivisionMichigan Occupational Safety and Health Administration www.michigan.gov/miosha517-284-7720
Module 2Slide2
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
2Slide3
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
3Slide4
Routes of Exposure
Absorption – skin contactInhalation – aerosolizationIngestion – contamination of food or beveragesInjection – needlesticks
4Slide5
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
5Slide6
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
6Slide7
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
7Slide8
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
8Slide9
Examples of Controls
Compounding aseptic isolator
Biological Safety Cabinet
9Slide10
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>
10Slide11
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
11Slide12
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)
14Slide15
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
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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?
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Step 1:
Cover (contain) the spill
Liquid:Absorbent padsCloths/ paper
Spill control pillowsPowder:Dampen pads, cloths or paper
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Step 2:
Don PPE
Scoop debris
Do NOT use hands!
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Step 3:
Remove residue
Consider surface materialRefer 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)
27Slide28
Document the Spill
Recommend creating a designated spill report form:Who, what, where, whenParticipants in clean upSteps taken to clean the spillFollow-up
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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
29Slide30
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 Protection
Part 474 Sanitation
Part 554
Bloodborne
Infectious Diseases
Recording & Reporting of Occupational Injuries & Illnesses
30Slide31
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)
31Slide32
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
32Slide33
Questions?
Consultation Education and Training DivisionMichigan Occupational Safety and Health Administration
www.michigan.gov/miosha517-284-7720
33Slide34
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
34Slide35
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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