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Transcript of Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs...
Institute of Learning 2011Sponsored by Chemotherapy SIG
Session Coordinator/SpeakerMillie Toth, MS, RN, AOCN
SpeakersMyra Davis-Alston
Nousheen Samad, PharmD, BCOP
HOT TOPICS IN CHEMOTHERAPY 2011
Objectives1. 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,CRNIOncology Staff Nurse
Las Vegas, NV.November 5, 2011
“BEST PRACTICE”IN
CHEMOTHERAPY ADMINISTRATION
OBJECTIVES
Review Expert Opinions on “Best Practice” for administration of Cancer Chemotherapy
Develop an action plan for integrating “Best Practice” guidelines in your clinical practice.
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
American Society of Clinical
Oncology/Oncology Nursing Society Chemotherapy Administration
Safety Standards
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
Goals: Develop Chemotherapy
Safety Standards• Standardization of
care• Reduce risk of errors• Increase efficiency• Provide a framework
for “Best Practice”
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
Requirements for ASCO/ONS Chemotherapy Administration Standards
CRITERIA
1. Applicable to diverse outpatient hematology/oncology practice settings
2. Understandable and clinically intuitive3. Realistic to achieve with existing or
reasonable resource expectations4. Valid, based on scientific evidence or
strong expert consensusJacobson, J., et al. (2009) American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy
Administration Safety Standards
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
Requirements for ASCO/ONS Chemotherapy Administration Standards
CRITERIA – continued
5. Reliable, allowing consistent implementation and assessment over time and across sites
6. Measureable, allowing performance according to the standard to be assessed for both internal quality assessment and external quality monitoring
7. Actionable, informing practice processes, policies or procedures
Jacobson, J., et al. (2009) American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
Definitions for ASCO/ONS Chemotherapy Administration
Safety Standards
Jacobson, J., et al. (2009) American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards
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.”
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
Multidisciplinary consensus-building process
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
• Familiarize yourself with ASCO/ONS Chemotherapy Administration safety standards
1• Explore how the
standards apply to individual practice settings
2• Develop strategies to
integrate “Best Practice” to individual work settings
3
Overview HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
A QUESTION FOR YOU
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
HOT TOPICS IN CHEMOTHERAPY 2011
Which of the following are not included in ASCO/ONS Chemotherapy Administration Safety Standards
1. Staffing-Related Standards2. Patient consent and
Education3. Sequencing of Drug
Administration4. 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“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
ASCO/ONS Chemotherapy Administration Safety Standards
Staffing Related Standards
Chemotherapy Planning: Chart Documentation Standards
General Chemotherapy Practice Standards
Chemotherapy Order Standards
Drug Preparation
Patient Consent and Education
Chemotherapy Administration
Monitoring and Assessment
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
A QUESTION FOR YOU
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
Which of the following guidelines are not identified in Staffing Related Standards in ASCO/ONS Chemotherapy Administration Safety Standards
1. Policies, procedures, and or guidelines for verification of training and continuing education for clinical staff.
2. Nurse-Patient staffing ratio3. Current certification in basic life
support4. Written Orders for parenteral and
oral chemotherapyJacobson, J., et al. (2009) American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
Staffing-Related Standards
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
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
A QUESTION FOR YOU
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
Which of the following guidelines are NOT included in the ASCO/ONS Chemotherapy Administration Safety Standards?
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
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
Time Spent
Pro
ject
s W
ork
ed O
n
Get Familiar with Safety Standards
Apply ASCO/ONS Chemotherapy
Safety Standards
Working Toward Best Practice
Involve all stake holder
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
Summary
Define your challenges Technological as well as personal
Set realistic expectation Mastery is not achieved overnight
Keep your eye on the goal Mentorship programs
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
Resources
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
Oncology Nursing Societyhttp://www.ons.org/CNECentral/Chemo/Standards
HOT TOPICS IN CHEMOTHERAPY 2011
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Nousheen Samad, PharmD, BCOPMD Anderson Cancer Center, Houston, TXNovember 5, 2011
A QUESTION FOR YOU
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
A drug shortage may occur due to:
1. Lack of drug discovery by pharmaceutical companies
2. Outsourcing of drug manufacturing outside the United States
3. Contamination of a drug during manufacturing resulting in a large-scale recall
4. FDA regulations on drug marketing and distribution
CHEMOTHERAPY DRUG SHORTAGE
Drug shortages can result in:
1. Significant delays in patient care
2. Subsequent shortage of alternate drug within the same class
3. Large upsurge in drug price4. All of the above
CHEMOTHERAPY DRUG SHORTAGE
The Past and the Present
1982: Johnson & Johnson recall - Tylenol®
2008: Baxter recall – heparin2010: 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
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Complex Manufacturing Process
More resource-intensive process One production line used for multiple
agentsFocused on productions of items with
high profit marginsLack of available medically
acceptable alternatives Increase in government control: “Red
tape”
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Drug Recall
Product is removed from the market due to a defect or has the potential to cause harm Manufacturing issues
▪ Misbranding, contamination, adulterationOverseen by Food and Drug
Administration (FDA)▪ Can be initiated by company or FDA
Increasing in number and frequency CHEMOTHERAPY DRUG SHORTAGE
HOT TOPICS IN CHEMOTHERAPY 2011
HOT TOPICS IN CHEMOTHERAPY 2011
Drug Shortage
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
Usually no advance warning Occurs over short period of time (acute)CHEMOTHERAPY DRUG SHORTAGE
HOT TOPICS IN CHEMOTHERAPY 2011Top Oncologic Agents in
ShortageDrug name # of
manufacturersReason 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
CHEMOTHERAPY DRUG SHORTAGE
HOT TOPICS IN CHEMOTHERAPY 2011Impact of Shortages on
HealthcareDisproportionate effect on smaller
facilitiesAdded staff time dealing with
shortage Increased cost per item due to short
supplyRipple effect: increased demand on
alternative agentsStockpiling/hoarding by some
institutions Interruption in clinical trialsMedications errorsDealing with patients’ frustrations
and blame
CHEMOTHERAPY DRUG SHORTAGE
Impact of Shortages on Patient Care
Delay in drug therapyUse of less effective alternate
therapyProlonged hospital stays Increase cost to patient
Insurance coverage Traveling to alternate treatment center
Emotional impactEmergence of “grey market”
CHEMOTHERAPY DRUG SHORTAGE
HOT TOPICS IN CHEMOTHERAPY 2011
Causes of Drug Shortages
Interruption in drug supply infrastructure Shortage of raw material Manufacturing issues Natural disaster
Voluntary recall of already manufactured items
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Causes of Drug Shortages (cont.)
Manufacturer discontinuation
Manufacturer rationing
Restricted distribution
Industry consolidation
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Causes of Drug Shortages (cont.)
Market shift Brand to generic
Unexpected demand New indication or change in prescribing Disease outbreak
Just-in-time inventories
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Drug Shortage OversightDepartment 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.
Center for Drug Evaluation & Research
(CDER)
Drug Shortage Program:
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
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Drug Shortage Oversight
Very limited authorities directly related to drug shortages
Limited notification requirementResponse from FDA is usually
secondary Mitigate a problem that has already
occurredNo consequence for failure to notify
Voluntary participation of industryFDA cannot dictate the production
quantity
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
FDA / CDER / DSP
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
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Drug Shortages Summit
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
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Drug Shortages Summit
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
CHEMOTHERAPY DRUG SHORTAGE
Drug Shortages Summit
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
CHEMOTHERAPY DRUG SHORTAGE
Legislative Action
• 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
CHEMOTHERAPY DRUG SHORTAGE
Preserving Access to Life-Saving
Medications Act 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 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
Preserving Access to Life-Saving Medications Act
CHEMOTHERAPY DRUG SHORTAGE
FDA shall develop criteria For identification of drugs susceptible to
shortageFDA shall collaborate with
manufacturers To create plans for continued supply of
medically necessary drugsFDA shall report to Congress
On an annual basis describing the actions taken to address drug shortages
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Preserving Access to Life-Saving Medications Act
Other Possible Solutions
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
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Other Possible Solutions
Partnering with other hospitals/practice sites Share drug supply Share patient load
Regular communication with vendors Collaborate with more than one vendor
Honest communication with patients Expectations for shortage Facilitating change in plan of care
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
Information on Drug Shortages
US Food and Drug Administration (FDA)
American Society of Health-System Pharmacists (ASHP) Drug Product Shortages Management
Resource CenterOther organizations: ASCO, ISMP Individual hospital shortage list
Specific to each institution
HOT TOPICS IN CHEMOTHERAPY 2011
CHEMOTHERAPY DRUG SHORTAGE
HOT TOPICS IN CHEMOTHERAPY 2011
SEQUENCING OF CHEMOTHERAPY… DOES IT REALLY MATTER??
Nousheen Samad, PharmD, BCOPMD Anderson Cancer Center, Houston, TXNovember 5, 2011
A QUESTION FOR YOU
HOT TOPICS IN CHEMOTHERAPY 2011
SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??
The appropriate sequencing of chemotherapy agents:
1. Can decrease the toxicity of a chemo regimen
2. Can increase the efficacy of a chemo regimen
3. Is not clear for many chemo regimens
4. All of the above
SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??
Combination Chemotherapy
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
SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??
Combination Chemotherapy
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
SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??
Cell CycleHOT TOPICS IN CHEMOTHERAPY 2011
SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??
Synergism versus Antagonism
Synergism: Exerting a greater than the expected
additive effect when using drugs in combination
Antagonism: Observing a less than expected additive
effect
HOT TOPICS IN CHEMOTHERAPY 2011
SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??
Chemotherapy Sequencing
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 dataMay be synergistic or antagonistic
HOT TOPICS IN CHEMOTHERAPY 2011
SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??
Leucovorin
Leucovorin BEFORE 5-fluorouracil Increased cytotoxicity and efficacy of 5-
fluorouracil by stabilizing thymidylate synthase
Leucovorin AFTER Methotrexate Decreased toxicity from methotrexate by
rescuing normal cells If reversed: efficacy of methotrexate is
decreased
HOT TOPICS IN CHEMOTHERAPY 2011
SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??
Sequencing Resulting in Lower Toxicity
Paclitaxel → Cisplatin ↓ neutropenia
Gemcitabine → 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
SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??
Sequencing Resulting in Higher Efficacy
Irinotecan → 5-fluorouracil ↑ Efficacy
Fludarabine → Cytarabine ↑ Efficacy
Pemetrexed → Gemcitabine ↑ Efficacy
Paclitaxel → Gemcitabine ↑ Synergy
Cisplatin → Irinotecan ↑ Response rate
5-fluorouracil → Methotrexate ↑ Response rate
Liposomal doxorubicin → Docetaxel
↑ Tolerability
Gemcitabine → Cisplatin ↑ Increase platinum-DNA adducts
HOT TOPICS IN CHEMOTHERAPY 2011
SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??
Clinical Application of Sequencing
Sequence of agents used in clinical trial
For regimens with no specified sequence Administer based on patient needs Bolus followed by continuous infusion
(outpatient)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
“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION
HOT TOPICS IN CHEMOTHERAPY 2011
Mille A. Toth, MS, RN, AOCNSenior Nursing Instructor
M. D. Anderson Cancer CenterHouston, TexasNovember 5, 2011
ENVIRONMENTAL MONITORINGAND
MEDICAL SURVEILLANCEIN YOUR WORK ENVIRONMENT
A QUESTION FOR YOU
HOT TOPICS IN CHEMOTHERAPY 2011
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
NIOSH and OSHA guidelines recommend that institutions provide a medical surveillance
program. How does your institution support this?
1. 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 SurveillanceENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
HOT TOPICS IN CHEMOTHERAPY 2011
History of Safe Handling
Advent of Modern day chemotherapy
Loius Goodman and Alfred Gillmon use nitrogen mustard to treat non-Hodgkin’s Lymphoma
First review of carcinogenic potential of anticancer drugs
“The carcinogencity of anticancer drugs: A Hazard in Man”
First case report of occupational exposure risk with HDs
“Mutagenicity in the urine of nurses handling cytostatic agents”
1981
First published guidelines for handling HDs
“Developing guide-lines for working with antineoplastic drugs”
1942 1983
American Medical Association guidelines for HDs
“Guidelines for handling parenteral antineoplastics”
1985
Risk defined for occupational exposure to HDs
“Risk of handling injectable antineoplastic agents”
American Society of Hospital Pharmacists Technical advisory bulletin (TAB) on handling cytotoxic and hazardous drugs
OSHA Technical Manual: Control-ling 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
First US evaluation of PhaSeal “Evaluation of the PhaSeal hazardous drug containment system”
USP <797> ”Pharmaceutical compounding-Sterile preparations”
American Society of Health-System Pharmacists Guidelines on handling hazardous drugs
1990 1995 19991976 1979 2004 2006
NIOSH Alert Preventing occupational exposure to antineoplastic and other HDs in healthcare settings
2007
DHHS NIOSH 2007-117 “Medical Surveillance for health care workers exposed to HDs”
Source: Massoomi, 2007
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
HOT TOPICS IN CHEMOTHERAPY 2011
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
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?
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
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
Environmental Monitoring
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
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
Environmental Monitoring
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
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
These findings raise questions regarding individual and/or facility
compliance with safe-handling guidelines, Institutions MUST
effectively monitor and ensure work practices are consistent with
NIOSH recommendations and provide up to date education
regarding exposure risk.
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.”
HOT TOPICS IN CHEMOTHERAPY 2011
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
How Can We Gain “Control?”
State of Washington: Senate Bills 5149 and 5594Passed 2011, Regular Session of 62nd Legislature
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
An ACT requiring the department of health to collect current and past employment information in the cancer registry program
This legislation was spearheaded / supported by Seth Eisenberg, a past
Chemotherapy SIG Coordinator and current SIG Webmaster, in response to the
death of Sue Crump, a hospital pharmacist, who died from pancreatic cancer
after 23 years of mixing chemotherapy agents and years of toxic exposure.
Medical Screening / SurveillanceMedical 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
HOT TOPICS IN CHEMOTHERAPY 2011
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
OSHA Recommendations for Medical Surveillance *
For detection and control of work-related health effects, job-specific 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.
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
Elements of a Medical Surveillance Program for HDs should include:
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
http://www.cdc.gov/niosh/docs/wp-solutions/2007-117/
HOT TOPICS IN CHEMOTHERAPY 2011
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
Nebraska Methodist Hospital (NMH)
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
HOT TOPICS IN CHEMOTHERAPY 2011
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
Many Institutions Starting to Support Medical Surveillance
Nebraska Methodist HospitalIntermountain Healthcare, UtahDuke University, North CarolinaStanford University, CaliforniaColumbia University
HOT TOPICS IN CHEMOTHERAPY 2011
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
Employee Health and Well-Being
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
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
Nebraska Methodist Hospital (NMH)
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
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
Engineering Controls• 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)
Personal Protective Equipment (PPE)
HOT TOPICS IN CHEMOTHERAPY 2011
National Institute for Occupational Safety and Health (NIOSH) Recommends Primary Prevention
to Protect
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
Summary
Leave today INSPIRED to work on a “Control Plan” regarding Environment
Monitoring and Medical Surveillance for Hazardous Agents at your institution.”
ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE
HOT TOPICS IN CHEMOTHERAPY 2011
QUESTIONS/COMMENTS/DISCUSSIONHOT TOPICS IN CHEMOTHERAPY 2011
Please plan to attend our follow-up
Round Table SessionTODAY ( 2:30 pm – 4:00 pm )
Ballroom H