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Transcript of Hazardous Drug Exposure: Case-based Approach to · PDF fileExplore the various available...
4/16/2013
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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.
4/16/2013
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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