10/27/2012 1 Safe Handling of Hazardous Drugs [ Objectives • Discuss the history of safe handling • Identify the exposure risks and routes associated with handling of hazardous drugs • Review the current guidelines on the safe handling of hazardous drugs • Describe the evidence of exposure risks including genotoxicity of hazardous drugs • Describe and identify safe handling practices to protect the health care worker from exposure to hazardous drugs • Review the current clinical evidence on the use of closed system drug transfer devices 2 What is the Issue? Many healthcare workers are frequently exposed to hazardous drugs 3 • Numerous published studies document the presence of hazardous medications in the workplace • Multiple independent studies have documented hazardous drugs (HDs) in the urine of healthcare workers • Exposure and uptake present serious hazards to health and safety
Transcript
10/27/2012
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Safe Handling of
Hazardous Drugs
[
Objectives
• Discuss the history of safe handling• Identify the exposure risks and routes associated with handling
of hazardous drugs• Review the current guidelines on the safe handling of
hazardous drugs• Describe the evidence of exposure risks including genotoxicity
of hazardous drugs• Describe and identify safe handling practices to protect the
health care worker from exposure to hazardous drugs• Review the current clinical evidence on the use of closed
system drug transfer devices
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What is the Issue?
Many healthcare workers are frequently exposed to hazardous drugs
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• Numerous published studies document the presence of hazardous medications
in the workplace
• Multiple independent studies have
documented hazardous drugs (HDs) in the urine of healthcare workers
• Exposure and uptake present serious hazards to health and safety
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Advent of modern day
chemotherapy
First review of carcinogenic potential of
anticancer drugs
First case report of occupational exposure risk to HDs
First published guidelines for handling HDs
1942 1983
American Medical Association
guidelines for HDs
1985
Risk defined for occupational exposure to HDs
American Society of Hospital
Pharmacists Technical Advisory Bulletin (TAB) on handling cytotoxic
and hazardous drugs
OSHA Technical Manual: Control-ling occupational exposure to HDs
NIOSH Alert: Preventing occupational exposure to antineoplasticand other HDsin healthcare settings
2007
DHHS NIOSH 2007-117 Medical
surveillance for health care workers
exposed to HDs
2011
European Commission: Occupational
Health and Safety Risks in the
Healthcare Sector
WA State Legislation: NIOSH definition 2014 requirement
Who is Advocating for Protection?
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How are Workers Exposed?
Standard safe handling protocols may not prevent exposure
Healthcare workers can be exposed through:
CONTAMINATED AIR(Aerosols and vapors)
CONTAMINATED SURFACES(Direct contact with drugs)
CONTAMINATED PPE(Hand to mouth contamination)
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What’s the Concern?
Exposure to hazardous drugs is a proven danger
Hazardous drugs have at least one of these characteristics:1
• Carcinogenicity
• Teratogenicity/developmental toxicity
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxicity
Antineoplastic and other hazardous drugs can cause:• Cancer
• Unusual cell development
• Reproductive issues
• Organ damage
• Damage to DNA (chromosomes)
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How Serious is the Issue?
The same mechanisms that chemotherapy uses to kill cancer cells also
works to damage healthy cells.
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Hazardous drugs such as life-saving chemotherapy can be the only option for patients. However, chemo
is poison by design. It is a descendant of deadly mustard gas.
A Parallel: Radiation Exposure
Experience proves that no amount of radiation exposure can be
considered entirely risk free2
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Marie and Pierre Curie were awarded the 1903 Nobel Prize
in physics for their work on radioactivity.
1896 1900 1921 1934
Discovery ofradioactivity
First reported radiation injury - burns
First studies linking radiation to cancer
First guidelines to limit radiation exposure
Safety standards are now finally in place
How Pervasive is the Issue?
Contamination is widespread and prevalent
• More than 2/3 of all areas are contaminated where drugs are prepared and administered. • Surface and air contamination found despite use of biological safety cabinets.• Workers and even patients can be exposed
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Surface Contamination with Antineoplastic Agents3
Surface Contamination of Chemotherapy Preparation Areas in Hospital Pharmacy4
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Joint Statement Stresses the Issue
Recently OSHA, Joint Commission, NIOSH urged facilities to take a
leadership role in worker safety and health:5
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• “Every day in healthcare settings across America, workers are exposed to hundreds of powerful drugs used for cancer chemotherapy, antiviral treatments, hormone regimens and other therapies.”
• “While these drugs are used to relieve and heal patients, many of them present serious hazards to the health and safety of your workers.”
• “Some of these drugs have been known to cause cancer, reproductive and developmental problems, allergic reactions and other adverse effects that can be irreversible even after low-level exposure.”
What are the Risks?
The Personal Reality
“Nurses, pharmacists and others who handle chemo drugs have been getting sick. Despite multiple studies that indicate the drugs actually may cause cancers, the federal government doesn't require safeguards on the job.”
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“Lifesaving drugs may be
killing health workers”6
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Short-Term Health Risks
Occupational exposure can lead to acute symptoms7
NAUSEA/VOMITINGNAUSEA/VOMITING
HEADACHESHEADACHES HAIR LOSSHAIR LOSS
MUCOSAL SORESMUCOSAL SORES
LIVER DAMAGELIVER DAMAGE
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DIZZINESSDIZZINESS
Long-Term Health Risks
Prolonged exposure can lead to irreversible adverse effects
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DEVELOPMENTALDEVELOPMENTAL
CANCERCANCER ORGANORGAN
GENETICGENETIC REPRODUCTIVEREPRODUCTIVE
Cancer Risks
Fact: Hazardous drugs can lead to increased rates of cancer
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Fact: Hazardous drugs can cause reproductive problems
Reproductive Risks
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• Nurses who handle cancer drugs11 have:
- 70% more birth defects
- 10% more miscarriages
• Incidence of miscarriages among nurses working with antineoplastic drugs is twice the norm12
Developmental, Organ and Genetic Risks
Fact: Hazardous drugs can harm developing fetusesHandling of cytostatic drugs was associated with malformations in the offspring.13
Fact: Hazardous drugs can damage internal organsThree consecutive head nurses handling cytostatic agents had liver damage.14
Fact: Hazardous drugs can damage DNAPharmacists and nurses who handle antineoplastic drugs have a 2.5 to 5-fold increase in chromosomal aberrations.15
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Increase in Chromosomal Aberrations
Genetic Risks
Fact: Healthcare workers using standard
safety precautions still have DNA damageIncreased aberrations are seen on Chr 5, 7 and 11 – signature markers for many leukemias and myelodyspastic syndromes.16
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Standard Safety Measures Aren’t Enough
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What are the Options?
How do We Protect the Providers?
ISOPP recommends following Hierarchic Order of Protection:
Industrial Hygiene Model
• Level 1: Elimination, substitution, replacement
• Level 2: Isolation of the hazard/source containment
• Defining Hazardous Drugs in the facility• Policies and Procedures addressing all aspects of handling hazardous drugs:
- Safe storage- Transport
- Administration- Disposal of HD’s
• All employees handling HDs should be required to wear PPE*• Policies should prohibit eating, drinking, smoking, chewing gum or tobacco,
applying cosmetics and storing food in areas HDs are used• Training and documentation of training for all employees that may come in contact
with HDs• Spills should be managed according to HD spill policy and procedure
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Work Practice Controls
• Designed to minimize occupational exposure to HDs• Minimize the generation of HD contamination and maximize
the containment of inadvertent contamination• Similar to administrative controls as they are established
procedures• Consistent and appropriate use of engineering controls and
PPE
Work Practice Controls
Work Practice Controls
• Avoid spiking and un-spiking bags or bottles• Disconnect and discard infusion bags with tubing intact• Place HD disposal containers near the workplace• Keep the lid closed on HD disposal containers• Avoid touching equipment when wearing gloves used to
handle HDs• Use PPE when stocking HDs• Clean countertops and other surfaces in the work area• Use a CSTD when working with HDs
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Personal Protective Equipment
Gloves:
•Designated Chemotherapy Gloves, thickness, type and time worn are major determinants of permeability of HDs
•For drugs to be labeled for use with chemotherapy they must be tested on
the following drugs:Carmustine,Cyclophoshamide,Doxorubicin,Etoposide, 5-FU,Paclitaxel
and Thiotepa
Gowns:No standard exists to test for permeability
•Cloth gowns do not provide adequate protection
•Gowns with polyethylene and vinyl coatings performed the best in a study conducted (Harrison and Kloos, 1999)
•Gowns should be changed after each use and not re-used or saved
Personal Protective Equipment
• Eye and Facial Protection
• Respiratory protection- Surgical mask is not a respirator and does not protect against aerosols or vapors
- Fit tested NIOSH approved N95 respirator or more protective respirator should be worn
Closed Systems Closed System Transfer Device(as defined by NIOSH)
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Elimination of human uptake
Do CSTDs Really Work?
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Workplace Contamination with Antineoplastic Agents in a
Cancer Hospital Using a CSTD.24
Using a CSTD to Reduce Personnel Exposure to Antineoplastic Agents23
BD PhaSeal 3rd party, peer-reviewed,
published clinical studies
• Validate clinical efficacy
• Show elimination of human uptake
* As tested on human samples
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Do CSTDs Really Work?
Reduction in surface contamination
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Comparison of Surface Contamination with Cyclophosphamide and Fluorouracil:
CSTD vs. Standard Preparation26
% Reduction of Positive Surface Samples25
Surface contamination before the use of CSTD•Cyclophosphamide - 78% •Ifosfamide - 54%
•5-FU - 33%
Clinical Evidence Summary
Extensive clinical evidence from dozens of independent, peer-reviewed, published studies clearly documents the effectiveness of CSTDs.
What is the Evidence for CSTDs?
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Results
Only BD PhaSeal met the NIOSH and ISOPP definition of a CSTD.27
Only BD PhaSeal met the NIOSH and ISOPP definition of a CSTD.28
No leakage was observed in any of the manipulations with the BD PhaSeal system.29
Post implementaition, no positive urine samples.
Post implementaition, no positive urine samples.
Median values demonstrated reduction for all drugs (cyclophosphamide, ifosfamide, 5-FU) of 95%, 90% & 65% respectively.
Demonstrated protection outside of a biological safety cabinet.
Summary
Titanium tetrachloride was selected to simulate the escape of vapor from each product.
Fluorescein sodium was selected to simulate contamination with dry connectionsbetween the vial and syringe and between syringe and accessport.
Liquid with low pH was used as a substitute for active drug. Litmus paper was used as a pH indicator. Every component was tested for 10 manipulations.
Surface contamination with and personnel exposure to antineoplastic agents before and after the implementation of a CSTD.
Determined levels of environmental chemotherapy contamination in a new cancer hospital that had exclusively used a CSTD (BD PhaSeal).
114 wipe study samples selected from 22 hospitals.
Determined surface contamination of a CSTD in conjunction with standard preparation outside a BSC
Who has Endorsed CSTDs?
CSTDs are defined and endorsed by recognized organizations
33 * BD PhaSeal also meets ISOPP and APHON guidelines and definitions
NIOSH Definition “A drug transfer device that mechanically prohibits the transfer of environmental contamination into the system and the escape of hazardous drug or vapor concentrations outside the system.” Revised USP <797>
GuidelinesUSP <797> states that CSTDs are “vial transfer devices that allow no venting or exposure of hazardous substance to the environment” and that “The use of a CSTD is preferred because of their inherent
closed-system process.”30
OSHA, The Joint Commision, NIOSHRecommendations from OSHA, The Joint Commission and NIOSH to follow the 2004 NIOSH Alert for Hazardous Drugs.
ASHP Excerpts:•CSTDs mechanically prevent the escape of drug or vapor out of the system•Studies show reduction in environmental contamination•Consider using CSTDs while compounding hazardous drugs31
ONS Excerpt:•ONS (2005) “The PhaSeal System is the only documented closed system on the market. This system is designed to prevent leakage of drugs into the environment during preparation and administration.” 32
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The Future of HD Legislation?
Washington State bill unanimously passed the senate and house33
• Department of Labor and Industries must establish standards for the handling of antineoplastic and other hazardous drugs by health care personnel in consultation with the Department of Health
• Must describe drugs to be regulated, exposure control program for handling, engineering controls, safe work practices, use of PPE, notices to employees, emergency response, record keeping and any other
requirements to protect the health and safety of health care personnel
• Rules adopted and go into effect January 1, 2014
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The Time for Safety
is Now!
Safe Handling Today
Many healthcare workers are still exposed to harmful effects
• Handling of hazardous drugs in healthcare requires a systematic approach
• While use of engineering controls and standard personal protective equipment (PPE) has increased, state regulation is limited; federal legislation is non-existent
• However, use of CSTDs as a form of PPE is increasing nationwide
• Comprehensive safe-handling programs should begin with a hazard assessment and include multiple layers of protection including a CSTD
• CSTDs that meet the NIOSH and ISOPP definitions can reduce human uptake by:
- Preventing drug exposure
- Reducing surface contamination
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References
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Occupational Safety and Health. DHHS (NIOSH) Publication No 2012-150; 2012.
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5. April 4, 2011 Communication from Dr. David Michaels, Asst. Sec. Labor, OSHA; Dr. Paul Schyve, Sr. VP, The
Joint Commission, Dr. John Howard, Director NIOSH.
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13. Hemminki K, Kyronen P, Lindbohm ML. Spontaneous abortions and malformations in the offspring of nurses
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hospital using a closed-system drug transfer device. Hospital Pharmacy. 2007;42(3):219-225.
25. Sessink P, Connor T, Jorgenson J, Tyler T. Reduction in surface contamination with antineoplastic drugs in 22 hospital pharmacies in the US following implementation of a closed system transfer device. J Oncol Pharm
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fluorouracil using a closed-system drug transfer device versus standard preparation techniques. Am J Health Syst Pharm. 2006;63(18):1736-44.
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Presented at ASHP Midyear Clinical Meeting, December 2007.
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