Transcript HOTTOPICS IN CHEMOTHERAPY 2011

Objectives
1. Discuss best practice in chemotherapy
administration, including sequencing of
drugs and patient support in chemotherapy
drug shortage situations.
2.
Describe appropriate steps to address
environmental monitoring and employee
medical surveillance when working with
hazardous drugs.
HOT TOPICS IN CHEMOTHERAPY 2011
HOT TOPICS IN CHEMOTHERAPY 2011
Myra Davis-Alston, RN,MSN/Ed, OCN,CRNI
Oncology Staff Nurse
Las Vegas, NV.
November 5, 2011
HOT TOPICS IN CHEMOTHERAPY 2011
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Review Expert Opinions on “Best Practice”
for administration of Cancer Chemotherapy
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Develop an action plan for integrating “Best
Practice” guidelines in your clinical practice.
HOT TOPICS IN CHEMOTHERAPY 2011
American Society of
Clinical
Oncology/Oncology
Nursing Society
Chemotherapy
Administration Safety
Standards
HOT TOPICS IN CHEMOTHERAPY 2011
Goals:
Develop Chemotherapy
Safety Standards
• Standardization of care
• Reduce risk of errors
• Increase efficiency
• Provide a framework for
“Best Practice”
CRITERIA
1.
2.
3.
4.
Applicable to diverse outpatient
hematology/oncology practice settings
Understandable and clinically intuitive
Realistic to achieve with existing or
reasonable resource expectations
Valid, based on scientific evidence or strong
expert consensus
Jacobson, J., et al. (2009) American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards
CRITERIA – continued
5.
6.
7.
Reliable, allowing consistent
implementation and assessment over time
and across sites
Measureable, allowing performance
according to the standard to be assessed for
both internal quality assessment and
external quality monitoring
Actionable, informing practice processes,
policies or procedures
Jacobson, J., et al. (2009) American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY
“all antineoplastic agents used to treat cancer, given
through oral and parenteral routes or other routes as
specified in the standard.
Types include targeted agents, alkylating agents,
antimetabolites, plant alkaloids and terpenoids,
topoisomerase inhibitors, antitumor antibiotics,
monoclonal antibodies, and biologic and related agents.
Hormonal therapies are not included in the definition of
chemotherapy for the standards.”
Jacobson, J., et al. (2009) American Society of Clinical
Oncology/Oncology Nursing Society Chemotherapy
Administration Safety Standards
HOT TOPICS IN CHEMOTHERAPY 2011
Multidisciplinary
consensusbuilding process
HOT TOPICS IN CHEMOTHERAPY 2011
1
• Familiarize yourself with
ASCO/ONS Chemotherapy
Administration safety standards
2
• Explore how the standards apply
to individual practice settings
3
• Develop strategies to integrate
“Best Practice” to individual work
settings
HOT TOPICS IN CHEMOTHERAPY 2011
HOT TOPICS IN CHEMOTHERAPY 2011
1.
2.
3.
4.
Staffing-Related Standards
Patient consent and Education
Sequencing of Drug
Administration
Guidelines on use of Personal
Protective Equipment (PPE)
Jacobson, J., et al. (2009) American Society of Clinical
Oncology/Oncology Nursing Society Chemotherapy Administration
Safety Standards
HOT TOPICS IN CHEMOTHERAPY 2011
Staffing Related
Standards
 Chemotherapy
Planning: Chart
Documentation
Standards
 General
Chemotherapy
Practice Standards
 Chemotherapy Order
Standards
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Drug Preparation
Patient Consent and
Education
Chemotherapy
Administration
Monitoring and
Assessment
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HOT TOPICS IN CHEMOTHERAPY 2011
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2.
3.
4.
Policies, procedures, and or guidelines for
verification of training and continuing
education for clinical staff.
Nurse-Patient staffing ratio
Current certification in basic life support
Written Orders for parenteral and oral
chemotherapy
Jacobson, J., et al. (2009) American Society of Clinical
Oncology/Oncology Nursing Society Chemotherapy Administration
Safety Standards
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Policies, Procedures and/or guidelines for
verification of training
Chemotherapy Drug Preparation prepared
by qualified staff
Comprehensive education program for new
staff-including competency assessment
Standard mechanism for monitoring
competency at specified interval
Current Certification in basic life support
HOT TOPICS IN CHEMOTHERAPY 2011
HOT TOPICS IN CHEMOTHERAPY 2011
1. Alternative and or drug substitution for standard drugs
during national drug shortages
2. Confirm with the patient his/her planned treatment,
drug route, and symptom management
3. Verify accuracy of the drug including sign in record to
indicate verification was done
4. A licensed Independent practitioner is on site and
immediately available during all chemotherapy
administration.
HOT TOPICS IN CHEMOTHERAPY 2011
Projects Worked On
Apply ASCO/ONS
Chemotherapy
Safety Standards
Involve all
stake holder
Get Familiar
with Safety
Standards
Time Spent
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Define your challenges
 Technological as well as personal
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Set realistic expectation
 Mastery is not achieved overnight
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Keep your eye on the goal
 Mentorship programs
HOT TOPICS IN CHEMOTHERAPY 2011
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American Society Of Clinical Oncology
http://www.asco.org/ASCOv2/Practice+%26+Guidelines/Quality+Care/Quality+Measurement+%
26+Improvement/ASCO-ONS+Standards+for+Safe+Chemotherapy+Administration
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Oncology Nursing Society
http://www.ons.org/CNECentral/Chemo/Standards
HOT TOPICS IN CHEMOTHERAPY 2011
Nousheen Samad, PharmD, BCOP
MD Anderson Cancer Center, Houston, TX
November 5, 2011
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2.
3.
4.
Lack of drug discovery by pharmaceutical
companies
Outsourcing of drug manufacturing outside
the United States
Contamination of a drug during
manufacturing resulting in a large-scale
recall
FDA regulations on drug marketing and
distribution
Significant delays in patient care
Subsequent shortage of alternate
drug within the same class
3. Large upsurge in drug price
4. All of the above
1.
2.
HOT TOPICS IN CHEMOTHERAPY 2011
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1982: Johnson & Johnson recall - Tylenol®
2008: Baxter recall – heparin
2010: Amgen recall – Procrit®
Currently: one of the most severe shortages
for cancer treatment in last few decades
 74% involving sterile injectables
 11% of drugs on shortage list are oncologic agents
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More resource-intensive process
One production line used for multiple agents
Focused on productions of items with high
profit margins
Lack of available medically acceptable
alternatives
Increase in government control: “Red tape”
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Product is removed from the market due to a
defect or has the potential to cause harm
 Manufacturing issues
▪ Misbranding, contamination, adulteration
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Overseen by Food and Drug Administration
(FDA)
▪ Can be initiated by company or FDA
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Increasing in number and frequency
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A period of time when the total supply of all
versions of a drug available at the user level
will not meet the current demand for the
drug at the user level
 Recall of raw materials used in formulating agent
 Issues relating to manufacturing
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Usually no advance warning
 Occurs over short period of time (acute)
HOT TOPICS IN CHEMOTHERAPY 2011
Drug name
# of
manufacturers
Reason for shortage
Bleomycin
4
Manufacturing delays, increased demand
Carmustine
1
Manufacturing delays
Cisplatin
3
Manufacturing delays, increased demand
Cytarabine
3
Manufacturing delays, raw material
issues
Doxorubicin
3
Manufacturing delays, increased demand
Etoposide
3
Manufacturing delays, increased demand
Leucovorin
3
Manufacturing delays
Mechlorethamine
3
Transfer to new manufacturing plant
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Disproportionate effect on smaller facilities
Added staff time dealing with shortage
Increased cost per item due to short supply
Ripple effect: increased demand on
alternative agents
Stockpiling/hoarding by some institutions
Interruption in clinical trials
Medications errors
Dealing with patients’ frustrations and blame
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Delay in drug therapy
Use of less effective alternate therapy
Prolonged hospital stays
Increase cost to patient
 Insurance coverage
 Traveling to alternate treatment center
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Emotional impact
Emergence of “grey market”
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Interruption in drug supply infrastructure
 Shortage of raw material
 Manufacturing issues
 Natural disaster
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Voluntary recall of already manufactured
items
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Manufacturer discontinuation
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Manufacturer rationing
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Restricted distribution
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Industry consolidation
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Market shift
 Brand to generic
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Unexpected demand
 New indication or change in prescribing
 Disease outbreak
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Just-in-time inventories
HOT TOPICS IN CHEMOTHERAPY 2011
Department of Health and
Human Services
The Food and Drug
Administration
Protect the public health by ensuring safety,
effectiveness, and security of drugs, vaccines, and other
biologic products.
Regulates medical devices, the food supply, cosmetics,
dietary supplements, and products that emit radiation.
Can allow drug importation outside of normal channels
to respond to a crisis.
Drug Shortage Program:
Center for Drug Evaluation &
Research (CDER)
Facilitate prevention and resolution of shortages by
collaborating with FDA experts, industry, and external
stakeholders
Provide drug shortage information to the public,
healthcare professional organizations, patient groups,
and other stakeholders
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Very limited authorities directly related to
drug shortages
Limited notification requirement
Response from FDA is usually secondary
 Mitigate a problem that has already occurred
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No consequence for failure to notify
 Voluntary participation of industry
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FDA cannot dictate the production quantity
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Work with manufacturer to address issues
Encourage other firms to increase production
Expedite resolving issues related to shortages
Allow release of medically necessary
products
Temporarily import drug from unapproved
sources
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November 2010 – Bethesda, Maryland
American Society of Anesthesiologists
American Society of Clinical Oncology
(ASCO)
American Society of Health-System
Pharmacists (ASHP)
Institute for Safe Medication Practices (ISMP)
www.ashp.org/drugshortages/summitreport
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Identified major cause of shortages:
 Fewer manufacturers producing sterile injectables
 Production-line problems, delays,
discontinuations
 Increased FDA inspections of injectables
 Rising worldwide demand for chemotherapy
 No law requiring manufacturers to report to FDA
HOT TOPICS IN CHEMOTHERAPY 2011
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Recommendations:
 FDA be given the statutory authority to require
manufacturers to
▪ Report any disruption in supply chain
▪ Interruption in supply of raw materials
▪ Interruption in manufacturing process
▪ Provide notification 9 to 12 months before a drug is
pulled off the market
▪ Have more than one production site for a sole, essential
drug
HOT TOPICS IN CHEMOTHERAPY 2011
• Preserving Access to Life-Saving Medications
Act
▪ New bill proposed February 2011
▪ Amendment to Federal Food, Drug, and Cosmetic Act
▪ Will provide FDA with better capacity to prevent drug
shortages
▪ Status: Currently in the first step in the legislative process
GOAL: To increase transparency within the entire
supply process
HOT TOPICS IN CHEMOTHERAPY 2011
Preserving Access to Life-Saving Medications Act
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Manufacturer shall notify FDA
 Regarding manufacturing interruptions that could
result in drug shortages at least 6 months in
advance
 Civil monetary penalties for lack of reporting
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FDA shall publish information
 Regarding manufacturing delays and actual
shortages on their website
 Distribute this information to health care
providers and patient organizations
HOT TOPICS IN CHEMOTHERAPY 2011
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FDA shall develop criteria
 For identification of drugs susceptible to shortage
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FDA shall collaborate with manufacturers
 To create plans for continued supply of medically
necessary drugs
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FDA shall report to Congress
 On an annual basis describing the actions taken to
address drug shortages
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ASHP: Implement government incentive
program
HOPA: Implement system for emergency
importation of drugs
Manufacturers: implement strategies to
ensure uninterrupted supply schedules
Healthcare institutions: proactive in
obtaining stock by anticipating needs of
patients without hoarding
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Partnering with other hospitals/practice sites
 Share drug supply
 Share patient load
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Regular communication with vendors
 Collaborate with more than one vendor
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Honest communication with patients
 Expectations for shortage
 Facilitating change in plan of care
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US Food and Drug Administration (FDA)
American Society of Health-System
Pharmacists (ASHP)
 Drug Product Shortages Management Resource
Center
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Other organizations: ASCO, ISMP
Individual hospital shortage list
 Specific to each institution
HOT TOPICS IN CHEMOTHERAPY 2011
Nousheen Samad, PharmD, BCOP
MD Anderson Cancer Center, Houston, TX
November 5, 2011
HOT TOPICS IN CHEMOTHERAPY 2011
1.
2.
3.
4.
Can decrease the toxicity of a chemo
regimen
Can increase the efficacy of a chemo
regimen
Is not clear for many chemo regimens
All of the above
HOT TOPICS IN CHEMOTHERAPY 2011
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Increase cytotoxic effect
 Attack different biochemical targets
 Overcome drug resistance
 Optimize dose of each agent
▪ Take advantage of kinetics of tumor growth
▪ Biochemical synergy
 Maintain acceptable level of toxicity
HOT TOPICS IN CHEMOTHERAPY 2011
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Increased risk of drug interactions
 Physiologic effects of each agent on cell cycle
 Pharmacodynamic/pharmacokinetic interactions
between the agents
 In vitro versus in vivo
 Clinically relevant versus non-relevant
 Sequencing
▪ Order of administration
▪ Same day versus next day administration
HOT TOPICS IN CHEMOTHERAPY 2011
HOT TOPICS IN CHEMOTHERAPY 2011
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Synergism:
 Exerting a greater than the expected additive
effect when using drugs in combination
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Antagonism:
 Observing a less than expected additive effect
HOT TOPICS IN CHEMOTHERAPY 2011
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Very little objective data published
 Laboratory data
 Animal studies
 Extrapolation of data to other agents in same
class
 Drug databases may not have most accurate data
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May be synergistic or antagonistic
HOT TOPICS IN CHEMOTHERAPY 2011
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Leucovorin
5-fluorouracil
 Increased cytotoxicity and efficacy of 5-
fluorouracil by stabilizing thymidylate synthase
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Leucovorin
Methotrexate
 Decreased toxicity from methotrexate by rescuing
normal cells
 If reversed: efficacy of methotrexate is decreased
HOT TOPICS IN CHEMOTHERAPY 2011
Paclitaxel
Gemcitabine
Cisplatin
neutropenia
Cisplatin
neutropenia
Docetaxel
Vinorelbine
neutropenia
Docetaxel
Topotecan
neutropenia
Doxorubicin
Docetaxel
neutropenia
Doxorubicin/Epirubicin
Paclitaxel
myelosuppression + mucositis
Liposomal doxorubicin
Vinorelbine
neutropenia
Topotecan
Cisplatin/Carboplatin
neutropenia + thrombocytopenia
Topotecan
Cisplatin
neutropenia + thrombocytopenia
Cyclophosphamide
Paclitaxel
cytopenias
Ifosfamide
Docetaxel
myelosuppression
Irinotecan
5-fluorouracil
neutropenia + diarrhea
HOT TOPICS IN CHEMOTHERAPY 2011
Irinotecan
5-fluorouracil
Efficacy
Fludarabine
Cytarabine
Efficacy
Pemetrexed
Gemcitabine
Efficacy
Paclitaxel
Cisplatin
Gemcitabine
Synergy
Irinotecan
5-fluorouracil
Methotrexate
Liposomal doxorubicin
Gemcitabine
Response rate
Cisplatin
Docetaxel
Response rate
Tolerability
Increase platinum-DNA adducts
HOT TOPICS IN CHEMOTHERAPY 2011
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Sequence of agents used in clinical trial
For regimens with no specified sequence
 Administer based on patient needs
 Bolus followed by continuous infusion
(outpatient)
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Develop institutional standards based on the
clinical information that is known
 Develop order sets with built-in sequence to
ensure correct sequencing
HOT TOPICS IN CHEMOTHERAPY 2011
Mille A. Toth, MS, RN, AOCN
Senior Nursing Instructor
M. D. Anderson Cancer Center
Houston, Texas
November 5, 2011
HOT TOPICS IN CHEMOTHERAPY 2011
HOT TOPICS IN CHEMOTHERAPY 2011
My institution provides “base-line” initial
employment physical and annual / periodical
laboratory evaluations
2. My institution states the use of closed systems,
PPE and education provided to staff eliminates the
need for medical surveillance program
3. My institution offers no established form of
medical surveillance and does not provide NIOSH
recommended closed systems
4. I don’t know how my institution addresses the
NIOSH and OSHA guidelines for Medical
Surveillance
1.
Advent of Modern
day chemotherapy
Loius Goodman and
Alfred Gillmon use
nitrogen mustard to
treat non-Hodgkin’s
Lymphoma
1942
First case report
of occupational
exposure risk
with HDs
“Mutagenicity in
the urine of
nurses handling
cytostatic agents”
1976
First review of
carcinogenic
potential of
anticancer drugs
“The carcinogencity
of anticancer drugs: A
Hazard in Man”
1979
1981
First published
guidelines for
handling HDs
“Developing guidelines for working
with antineoplastic
drugs”
Source: Massoomi, 2007
Risk defined for
occupational
exposure to HDs
American Society
of Hospital
Pharmacists
Technical
advisory bulletin
(TAB) on handling
cytotoxic and
hazardous drugs
“Risk of handling
injectable
antineoplastic
agents”
1983
1985
American Medical
Association
guidelines for
HDs
“Guidelines for
handling parenteral
antineoplastics”
1990
1995
OSHA Technical
Manual: Controlling occupational
exposure to HDs
Chapter 21.
(OSHA instruction
CPL 2-2.20B CH4)
OSHA Technical
Manual Update:
Controlling
occupational
exposure to HDs
OSHA instruction
TED 1-0.15A
Section VI.
Chapter 2
1999
First US
evaluation of
PhaSeal
“Evaluation of
the PhaSeal
hazardous drug
containment
system”
NIOSH Alert
Preventing
occupational
exposure to
antineoplastic and
other HDs in
healthcare settings
USP <797>
”Pharmaceutical
compounding-Sterile
preparations”
2004
2006
2007
American Society of
Health-System
Pharmacists
Guidelines on
handling hazardous
drugs
DHHS NIOSH 2007117 “Medical
Surveillance for health
care workers exposed
to HDs”
HOT TOPICS IN CHEMOTHERAPY 2011
Environmental Monitoring
WARNING: Working with or near
hazardous drugs in healthcare
settings may cause:
 Skin rashes
 Infertility
 Miscarriage
 Birth defects
 Possibly leukemia or other cancers
THERE IS NO SHORTAGE OF GUIDELINES. They have been arount a LONG TIME …
Have you examined your work practice and identified risks of exposure to HDs?
HOT TOPICS IN CHEMOTHERAPY 2011
Perhaps, when we are fully aware of the potential danger…
we will be better able to “Control” survival?
It is estimated that 5.5 million health care workers are potentially exposed to
hazardous drugs or drug waste at their worksites.
American Journal of Nursing. November 2010.Volume 110, No.11, pg. 20
HOT TOPICS IN CHEMOTHERAPY 2011
Over the years environmental monitoring has continued to
reflect challenging organizational issues.
Tom Connor, a research biologist with NIOSH, studied surface
contamination in 1999 and 2010, with similar results of widespread
contamination on countertops, carts, trays and surfaces where IV bags
were placed.
 75 % of wipe samples were positive in drug preparation area
 65% of wipe samples were positive in drug administration areas
Often, because the side effects are not acute, personnel have a
reduced perception of the risk. Many deny the potential problem.
ALWAYS BE COMPETENT … NEVER BE “COMFORTABLE.”
HOT TOPICS IN CHEMOTHERAPY 2011
Monitoring studies are now even more sophisticated, addressing
cytogenetics: chromosomes 5, 7, and 11, which are signature
markers for therapy related MDS and AML.
Melissa McDiarmid, Professor and Director of Occupational Health
Program at the University of Maryland School of Medicine states,
“Recognition of the hazard is lagging behind the science. We
haven’t caught up with this yet.”
In her study of 63 healthy volunteers from three university hospitals,
more chromosomal damage was found in participants who had been
exposed and experienced increased events with handling
chemotherapy. Please know that these individuals work routinely
with chemotherapy and state that they follow NIOSH Guidelines.
“Chromosome 5 and 7 Abnormalities in Oncology Personnel Handling Anticancer Drugs.” Journal of Occupational & Environmental
Medicine. Volume 52, Number 10, October 2010, Pages 1028 – 1034.
HOT TOPICS IN CHEMOTHERAPY 2011
ARE WE “OUT OF CONTROL?”
Occupational Safety and Health Administration (OSHA)
indicates that safe levels of occupational exposure to hazardous
agents cannot be determined and there is no reliable method
of monitoring work-related exposure. Therefore, it is vital that
those who work with HDs are adherent to standards of practice
(SOP) designed to minimize occupational exposure.
CHAMPION the “ALARA” approach to handling and
preparing drugs. That is, “as low as reasonably achievable.”
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Legislature declared that health care
personnel who work with or near hazardous
drugs are provided with appropriate
regulation of the handling of hazardous
drugs, regardless of setting, to protect health
care personnel from exposure
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An ACT requiring the department of health to
collect current and past employment
information in the cancer registry program
HOT TOPICS IN CHEMOTHERAPY 2011
Medical Screening is, in essence, only one
component of a comprehensive medical
surveillance program. It has a Clinical Focus
on early diagnosis and treatment.
Medical Surveillance is to detect and eliminate
any underlying causes, such as hazards or
exposures of any trends, thus a Prevention
Focus.
http://www.osha.gov/SLTC/medicalsurveillance/index.html
For detection and control of work-related health effects, jobspecific medical evaluations should be performed as follows:
 Prior to job placement
 Periodically during employment
 Following acute exposures
 At time of termination or transfer (exit exam)
http://www.osha.gov/dts/osta/otm/otm_vi?otm_vi_2.html
* The concept of a Medical Surveillance Program is only a NIOSH and OSHA
recommendation and is not mandated.
HOT TOPICS IN CHEMOTHERAPY 2011
Reproductive and general health questionnaires completed
at time of hire and periodically thereafter
 Laboratory work, including CBC and urinalysis completed at
time of hire and periodically thereafter. (LFT and
transaminase tests may also be considered)
 Physical examination completed at time of hire and as
needed when health questionnaire or blood work indicates
abnormal findings
 Follow-up for workers who have shown health changes or
who have had significant exposure to HD.
 Track trends with questionnaires and sick-calls
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http://www.cdc.gov/niosh/docs/wp-solutions/2007-117/
HOT TOPICS IN CHEMOTHERAPY 2011
Has established a 4-tier formal Surveillance Program
for Hazardous Drugs, including:
 Self-Surveillance
 Employer/Supervisor Surveillance
 Comprehensive Medical Surveillance
 Post-Exposure Surveillance (known or suspected)
www.pppmag.com , April 2008
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Nebraska Methodist Hospital
Intermountain Healthcare, Utah
Duke University, North Carolina
Stanford University, California
Columbia University
HOT TOPICS IN CHEMOTHERAPY 2011
The topic of Medical Surveillance has been discussed for many
years among comprehensive cancer centers.
“We depend on meticulous engineering controls, such as PhaSeal
closed system and use of PPE, such as chemotherapy gowns,
gloves and goggles … With these precautions there should not
be any significant exposure.”
“There is no scientific evidence to show that routine laboratory
testing is of use in detecting potential health effects from
handling and administration of hazardous drugs.”
“In event of accidental exposure due to tubing disconnection or
faulty equipment, Employee Health and Well-Being should be
notified immediately. Exposure follow-up is handled on a case
by case basis.”
Elizabeth Hudson,MSN, RN, FNP-BC, CCM, COHN-S
Employee Health and Well-Being at MDACC
HOT TOPICS IN CHEMOTHERAPY 2011
Conclusions:
“…costs associated with protecting health care workers from
exposure to hazardous chemicals is incalculable, in terms
of mortality and morbidity of health care personnel.”
“We do not fully understand the magnitude of hospital
personnel’s continuous exposure to HDs, but because we
are aware of the potential for risk, it is our obligation to
prevent harm to our employees.”
www.pppmag.com , April 2008
HOT TOPICS IN CHEMOTHERAPY 2011
National Institute for Occupational Safety and Health (NIOSH)
Recommends Primary Prevention to Protect
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Engineering Controls
•
•
•
•
•
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Biological Safety Cabinets (BSC)
Compounding aseptic containment isolators
Closed System Transfer Devices (CSTD)
Needleless systems
Luer-Lock connectors
Administrative Controls
• Management Policies / Procedures
• Education and Training
• Medical Surveillance (Form of secondary prevention)
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Personal Protective Equipment (PPE)
HOT TOPICS IN CHEMOTHERAPY 2011
Leave today INSPIRED to work on a “Control Plan”
regarding Environment Monitoring and Medical
Surveillance for Hazardous Agents at your institution.”
HOT TOPICS IN CHEMOTHERAPY 2011
Please plan to attend our follow-up
Round Table Session
TODAY ( 2:30 pm – 4:00 pm )
Ballroom H