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Institute of Learning 2011 Sponsored by Chemotherapy SIG Session Coordinator/Speaker Millie Toth, MS, RN, AOCN Speakers Myra Davis-Alston Nousheen Samad, PharmD, BCOP

Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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Page 1: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

Institute of Learning 2011Sponsored by Chemotherapy SIG

Session Coordinator/SpeakerMillie Toth, MS, RN, AOCN

SpeakersMyra Davis-Alston

Nousheen Samad, PharmD, BCOP

Page 2: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 3: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 4: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 5: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

American Society of Clinical

Oncology/Oncology Nursing Society Chemotherapy Administration

Safety Standards

HOT TOPICS IN CHEMOTHERAPY 2011

“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION

Page 6: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 7: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 8: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 9: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 10: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

Multidisciplinary consensus-building process

HOT TOPICS IN CHEMOTHERAPY 2011

“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION

Page 11: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

• 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

Page 12: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

A QUESTION FOR YOU

HOT TOPICS IN CHEMOTHERAPY 2011

“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION

Page 13: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 14: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 15: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

A QUESTION FOR YOU

HOT TOPICS IN CHEMOTHERAPY 2011

“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION

Page 16: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 17: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 18: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

A QUESTION FOR YOU

HOT TOPICS IN CHEMOTHERAPY 2011

“BEST PRACTICE” IN CHEMOTHERAPY ADMINISTRATION

Page 19: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 20: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 21: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 23: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

HOT TOPICS IN CHEMOTHERAPY 2011

CHEMOTHERAPY DRUG SHORTAGE

Nousheen Samad, PharmD, BCOPMD Anderson Cancer Center, Houston, TXNovember 5, 2011

Page 24: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

A QUESTION FOR YOU

HOT TOPICS IN CHEMOTHERAPY 2011

CHEMOTHERAPY DRUG SHORTAGE

Page 25: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 26: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 27: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 28: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 29: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 30: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 31: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 32: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 33: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 34: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 35: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

Causes of Drug Shortages (cont.)

Manufacturer discontinuation

Manufacturer rationing

Restricted distribution

Industry consolidation

HOT TOPICS IN CHEMOTHERAPY 2011

CHEMOTHERAPY DRUG SHORTAGE

Page 36: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 37: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 38: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 39: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 40: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 41: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 42: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 43: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 44: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 45: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 46: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 47: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 48: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 49: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

HOT TOPICS IN CHEMOTHERAPY 2011

SEQUENCING OF CHEMOTHERAPY… DOES IT REALLY MATTER??

Nousheen Samad, PharmD, BCOPMD Anderson Cancer Center, Houston, TXNovember 5, 2011

Page 50: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

A QUESTION FOR YOU

HOT TOPICS IN CHEMOTHERAPY 2011

SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??

Page 51: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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 ??

Page 52: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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 ??

Page 53: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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 ??

Page 54: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

Cell CycleHOT TOPICS IN CHEMOTHERAPY 2011

SEQUENCING OF CHEMOTHERAPY … DOES IT REALLY MATTER ??

Page 55: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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 ??

Page 56: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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 ??

Page 57: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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 ??

Page 58: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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 ??

Page 59: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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 ??

Page 60: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 61: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 62: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

A QUESTION FOR YOU

HOT TOPICS IN CHEMOTHERAPY 2011

ENVIRONMENTAL MONITORING AND MEDICAL SURVEILLANCE

Page 63: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 64: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 65: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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?

Page 66: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

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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

Page 68: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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.

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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

Page 70: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

How Can We Gain “Control?”

Page 71: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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.

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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

Page 73: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

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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

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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

Page 76: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

Page 77: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

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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

Page 79: Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations

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

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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

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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