Sponsored by Chemotherapy SIG Session Coordinator/Speaker

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

HOT TOPICS IN CHEMOTHERAPY 2011
Objectives Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations. Describe appropriate steps to address environmental monitoring and employee medical surveillance when working with hazardous drugs. HOT TOPICS IN CHEMOTHERAPY 2011

Chemotherapy administration
HOT TOPICS IN CHEMOTHERAPY 2011 “Best Practice” In Chemotherapy administration Myra Davis-Alston, RN,MSN/Ed, OCN,CRNI Oncology Staff Nurse Las Vegas, NV. November 5, 2011

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. Give a brief overview of the presentation. Describe the major focus of the presentation and why it is important. Introduce each of the major topics. To provide a road map for the audience, you can repeat this Overview slide throughout the presentation, highlighting the particular topic you will discuss next. “Best Practice” in chemotherapy administration

American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards “Best Practice” in chemotherapy administration

Develop Chemotherapy 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” “Best Practice” in chemotherapy administration

Requirements for ASCO/ONS Chemotherapy Administration Standards
CRITERIA 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 “Best Practice” in chemotherapy administration

Requirements for ASCO/ONS Chemotherapy Administration Standards
CRITERIA – continued 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 “Best Practice” in chemotherapy administration

Definitions for ASCO/ONS Chemotherapy Administration Safety Standards
HOT TOPICS IN CHEMOTHERAPY 2011 Definitions for ASCO/ONS 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.” Jacobson, J., et al. (2009) American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards “Best Practice” in chemotherapy administration

Multidisciplinary consensus-building process
HOT TOPICS IN CHEMOTHERAPY 2011 Multidisciplinary consensus-building process “Best Practice” in chemotherapy administration

Overview 1 2 3 HOT TOPICS IN CHEMOTHERAPY 2011
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 “Best Practice” in chemotherapy administration

A QUESTION FOR YOU HOT TOPICS IN CHEMOTHERAPY 2011
“Best Practice” in chemotherapy administration

Staffing-Related Standards Patient consent and Education
HOT TOPICS IN CHEMOTHERAPY 2011 Which of the following are not included in ASCO/ONS Chemotherapy Administration Safety Standards 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 “Best Practice” in chemotherapy administration

ASCO/ONS Chemotherapy Administration Safety Standards
HOT TOPICS IN CHEMOTHERAPY 2011 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 “Best Practice” in chemotherapy administration

Nurse-Patient staffing ratio
HOT TOPICS IN CHEMOTHERAPY 2011 Which of the following guidelines are not identified in Staffing Related Standards in ASCO/ONS Chemotherapy Administration Safety Standards 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 Keep it brief. Make your text as brief as possible to maintain a larger font size. Jacobson, J., et al. (2009) American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards “Best Practice” in chemotherapy administration

Staffing-Related Standards
HOT TOPICS IN CHEMOTHERAPY 2011 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 “Best Practice” in chemotherapy administration

A question for you HOT TOPICS IN CHEMOTHERAPY 2011

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. “Best Practice” in chemotherapy administration

Working Toward Best Practice
Microsoft Engineering Excellence HOT TOPICS IN CHEMOTHERAPY 2011 Working Toward Best Practice Apply ASCO/ONS Chemotherapy Safety Standards Involve all stake holder Projects Worked On Get Familiar with Safety Standards Time Spent “Best Practice” in chemotherapy administration Microsoft Confidential

Summary Define your challenges Set realistic expectation
HOT TOPICS IN CHEMOTHERAPY 2011 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 “Best Practice” in chemotherapy administration

Microsoft Engineering Excellence
HOT TOPICS IN CHEMOTHERAPY 2011 Resources American Society Of Clinical Oncology Oncology Nursing Society “Best Practice” in chemotherapy administration Microsoft Confidential

Chemotherapy Drug Shortage
HOT TOPICS IN CHEMOTHERAPY 2011 Chemotherapy Drug Shortage Nousheen Samad, PharmD, BCOP MD Anderson Cancer Center, Houston, TX November 5, 2011

Chemotherapy Drug Shortage

A drug shortage may occur due to:
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 Chemotherapy Drug Shortage

Drug shortages can result in:
Significant delays in patient care Subsequent shortage of alternate drug within the same class Large upsurge in drug price All of the above Chemotherapy Drug Shortage

The Past and the Present
HOT TOPICS IN CHEMOTHERAPY 2011 The Past and the Present 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 While shortages include a variety of drugs (such as antimicrobials and anesthetics), the FDA reports that about 74% of shortages involve sterile injectables Injectables: More issues with stability than oral dosage forms Many are the result of quality issues - Injectables take longer to manufacture Chemotherapy Drug Shortage

Complex Manufacturing Process
HOT TOPICS IN CHEMOTHERAPY 2011 Complex Manufacturing Process 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” Transition: so why now? Why are we facing this issue so acutely now? Today’s drug manufacturing is a more resource-intensive process Each production line used for multiple agents Problem with one batch can effects several drugs at once Focus on productions of items with high profit margins Older products get less precedent in production line-up Lack of available medically acceptable alternatives Many novel agents with unique mechanisms and narrow spectrum of activity (eg MoAbs) Increase in government control: “Red tape” “red tape”  increased oversight by FDA has helped shrink the profit margin so much that some manuf have had to shut down their plants 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, adulteration Overseen by Food and Drug Administration (FDA) Can be initiated by company or FDA Increasing in number and frequency Chemotherapy Drug Shortage

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

Top Oncologic Agents in Shortage
HOT TOPICS IN CHEMOTHERAPY 2011 Top Oncologic Agents in Shortage Drug name # of manufacturers Reason for shortage Bleomycin 4 Manufacturing delays, increased demand Carmustine 1 Manufacturing delays Cisplatin 3 Cytarabine Manufacturing delays, raw material issues Doxorubicin Etoposide Leucovorin Mechlorethamine Transfer to new manufacturing plant You may or may not have felt the effects of these shortages based on your hospital’s supply of these agents – and there usage. Most problematic aspect of the drug shortage is that many of these agents are the standard of care in oncology – Matthew Farber qoute (not direct) Just about every cancer has been affected by these shortages (Matthre Farber): colorectal, leukemia, breast, Hodgkin, Lung, testicular, prostate, esophageal, ovarian, pancreatic Chemotherapy Drug Shortage

Impact of Shortages on Healthcare
HOT TOPICS IN CHEMOTHERAPY 2011 Impact of Shortages on Healthcare 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 Disproportionate effect on smaller facilities Order on “as needed” basis May not have the buying power of larger institutions Larger hospitals: Carry stock items & use multiple suppliers Medication errors: dosage errors can occur when the doctors are forced to switch patients to unfamiliar agents (not standard of care) Chemotherapy Drug Shortage

Impact of Shortages on Patient Care
HOT TOPICS IN CHEMOTHERAPY 2011 Impact of Shortages on Patient Care Delay in drug therapy Use of less effective alternate therapy Prolonged hospital stays Increase cost to patient Insurance coverage Traveling to alternate treatment center Emotional impact Emergence of “grey market” Delay in drug therapy: anecdotal reports that some patients are not getting the drugs they should be, that they are not getting all the drugs they need, or are not getting any drugs at all for a time (Bona E Benjamin) - cont. qoute – that means they are not getting the best outcome that they should. Insurance coverage: alternative agent not reimbursed by insurance companies Emotional impact – difficult to measure Grey market: imported drugs that are of unknown purity and available typically on at high markups (10 to 1,000 times) “grey” market vendors: Create artificial shortages, Re-sell the product back to users at inflated prices - The profitability of pharmaceuticals and the pharmaceutical industry attracts vendors who may create artificial shortages by selectively purchasing excessive quantities of products and thereby depleting the available stock. These vendors then re-sell the products back to the users at inflated prices. Chemotherapy Drug Shortage

Causes of Drug Shortages
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 Causes….”MULTIFACTORIAL” Drug supply infrastructure – aka supply chain? Shortage of raw material Shortage of natural source to extract from Interruption of importation from sources outside US Multiple drug manufacturer using same raw material Manufacturing issues Machinery, staffing, citations Natural disaster Unexpected damage to facilities interrupt operations Raw material shortages may have a profound impact on drug supply. This is especially true when multiple manufacturers are producing a drug product from which there is only one source of raw materials. Problems can also arise when the raw materials are difficult to process (eg, the raw material must be extracted froma natural source, such as a tree bark) An estimated 80% of the raw materials used in pharmaceuticals comes from outside the US (ASHP report 2009). Availability problems can arise when armed conflict or political upheaval disrupts trade, animal diseases contaminate tissue from which raw materials are extracted, climatic and other environmental conditions depress the growth of plants used to product raw materials, or raw materials are degraded or contaminated during transport. 80% from outside US Conflict Disease Climate changes Machinery: antiquated equipment Staffing: lack of experienced manufacturing personnel Citations: production halted by FDA Voluntary recall of already manufactured items due to Production issues Chemotherapy Drug Shortage

Causes of Drug Shortages (cont.)
HOT TOPICS IN CHEMOTHERAPY 2011 Causes of Drug Shortages (cont.) Manufacturer discontinuation Manufacturer rationing Restricted distribution Industry consolidation Manufacturer discontinuation Lack of financial incentive or demand Manufacturer rationing Temporary or permanent reduction in production to shift production or re-allocate resources Restricted distribution Limits supplies to select patient populations for which benefits outweigh risks Industry consolidation Company mergers result in discontinuations in order to narrow product line Chemotherapy Drug Shortage

Causes of Drug Shortages (cont.)
HOT TOPICS IN CHEMOTHERAPY 2011 Causes of Drug Shortages (cont.) Market shift Brand to generic Unexpected demand New indication or change in prescribing Disease outbreak Just-in-time inventories Market shift Shift from brand to generic product may cause a decrease in manufacturing of the innovator product Unexpected demand New indication or unlabeled uses Change in prescribing or clinical practice Disease outbreak (eg. anthrax) Just-in-time inventories Increased risk for sudden changes in supply or demand Changes in product form or formulation: Sustained release product Shifts in demand may be further complicated when the manufacturing process for the product is time consuming or raw materials needed to produce it are limited (blood-based products) Prime Vendors & Just-in-Time Inventories: Reduces amount of product in supply chain, Removes “buffer” provided by stockpiles - The increased use of prime vendors may have contributed to the drug shortage situation by reducing the amount of product available in the supply chain. It is no longer easy to weather shortages by relying on stockpiled inventories because both wholesalers and health systems maintain a minimum levels of stock. As a result, manufacturer supply issues are transmitted directly to the user without the benefit of an inventory buffer, thereby increasing the number of short-term shortages that may impact institutions. Chemotherapy Drug Shortage

Drug Shortage Oversight
HOT TOPICS IN CHEMOTHERAPY 2011 Drug Shortage Oversight 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. 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 CDER: Center for Drug Evaluation and Research oversees the DSP Drug Shortage Program (DSP) began in 1999 Mission: to address potential and actual drug shortages *Currently 4 full time staff and Coordinator Within FDA/CDER • DSP works with – Review division(s) in OND that regulates the therapeutic areas for the drug – Office of Generic Drug Products – Office of New Drug Quality Assessment – Office of Biotechnology Products – Office of Compliance (Office of Regulatory Affairs) – Other Chemotherapy Drug Shortage

Drug Shortage Oversight
HOT TOPICS IN CHEMOTHERAPY 2011 Drug Shortage Oversight Very limited authorities directly related to drug shortages Limited notification requirement Response from FDA is usually secondary Mitigate a problem that has already occurred No consequence for failure to notify Voluntary participation of industry FDA cannot dictate the production quantity Limited notification requirement Only requirement is notification of sole source discontinuation Chemotherapy Drug Shortage

FDA / CDER / DSP Work with manufacturer to address issues
HOT TOPICS IN CHEMOTHERAPY 2011 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 “Flexibity” Allow release of medically necessary products with extra oversight and alerts for healthcare professionals and patients Chemotherapy Drug Shortage

Drug Shortages Summit November 2010 – Bethesda, Maryland
HOT TOPICS IN CHEMOTHERAPY 2011 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) Chemotherapy Drug Shortage

Drug Shortages Summit Identified major cause of shortages:
HOT TOPICS IN CHEMOTHERAPY 2011 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 The summit found that a major cause of shortages is that fewer manufacturers are producing the sterile injectables (most of which are generic) thereby limiting contributors to the supply chain --- not enough resiliency in the supply chain Fewer manufacturers producing sterile injectables The ones who are making them have limited capacity, they often discontinue these older agents in favor of newer/more profitable agents, when shortage occurs – limited ability of remaining firms to meet the shortfall Production-line problems, delays, discontinuations Ex: Teva Pharmaceuticals & Hospira Inc. -- >Shut down some production lines after not meeting quality control standards Increased FDA inspections of injectable products to meet GMP - based on “higher likelihood of harm” to patients Rising worldwide demand is also putting pressure on the system (due to globalization of drugs) Manuf are not required by law to alert the FDA when they d/c a product or when the production process is interrupted – this often leaves medical centers “off-guard” – frantically searching for new sources to obtain the drug * the FDA cannot force a manuf to produce a product and there is no penalty for not notifying the FDA when a product is d/c’d. Chemotherapy Drug Shortage

Drug Shortages Summit Recommendations: HOT TOPICS IN CHEMOTHERAPY 2011
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 Report any disruption in supply chain Interruption in supply of raw materials Interruption in manufacturing process Interruption in active pharmaceutical ingredients Chemotherapy Drug Shortage

Legislative Action Preserving Access to Life-Saving Medications Act
HOT TOPICS IN CHEMOTHERAPY 2011 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 Sponsor: Sen. Amy Klobuchar [D-MN] Senate bill: gives the FDA the authority to require early notification from pharmaceutical companies when they decide to limit or discontinue production of prescription drugs Increase transparency of the entire supply process Chemotherapy Drug Shortage

Preserving Access to Life-Saving Medications Act
HOT TOPICS IN CHEMOTHERAPY 2011 Preserving Access to Life-Saving Medications Act 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 Expand current statutory language related to reporting of information to FDA regarding manufacturing interruptions that could result in drug shortages Increased communication from FDA regarding drug shortages, including providing shortage information to healthcare providers Calls for FDA to develop evidence-based criteria for identification of agents vulnerable to shortage Calls for FDA to work with manufacturers to create “continuity of supply” plans that include processes to address drug shortages Reporting: In real time and describe plans to address the shortage Chemotherapy Drug Shortage

Preserving Access to Life-Saving Medications Act
HOT TOPICS IN CHEMOTHERAPY 2011 Preserving Access to Life-Saving Medications Act FDA shall develop criteria For identification of drugs susceptible to shortage FDA shall collaborate with manufacturers To create plans for continued supply of medically necessary drugs FDA shall report to Congress On an annual basis describing the actions taken to address drug shortages Chemotherapy Drug Shortage

Other Possible Solutions
HOT TOPICS IN CHEMOTHERAPY 2011 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 Healthcare Distribution Management Association (HDMA) McKesson Specialty Care Solutions + FDA In a recent survey, HOPA members recommended that the association lobby the FDA for allowance of emergency importing of drugs to deal with unanticipated shortages. HDMA: Collaborative advocacy effort with other associations to discuss causes/trends of shortages and explore mitigation strategies Manufacturers: Should plan ahead!! by adding redundancy to manufacturing & raw material supply to prevent shortages of medically necessary drugs • Commitment to quality: proactively identify & promptly correct issues • Prevent sudden lack of lifesaving medications for consumer • Notify FDA as soon as aware of an issue that could impact supply. Contact Drug Shortage Program at – 38 shortages prevented in 2010 due to early notification by firms – 99 shortages prevented in 2011 so far due to early notification What can we do as Healthcare professionals: support current bills! Chemotherapy Drug Shortage

Other Possible Solutions
HOT TOPICS IN CHEMOTHERAPY 2011 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 Chemotherapy Drug Shortage

Information on Drug Shortages
HOT TOPICS IN CHEMOTHERAPY 2011 Information on Drug Shortages US Food and Drug Administration (FDA) American Society of Health-System Pharmacists (ASHP) Drug Product Shortages Management Resource Center Other organizations: ASCO, ISMP Individual hospital shortage list Specific to each institution ASCO: American Society of Clinical Oncology ISMP: Institute for Safe Medication Practices FDA Webinar on Prescription Drug Shortages Sept. 30, 2011, 11:00 a.m. Chemotherapy Drug Shortage

Sequencing of Chemotherapy
HOT TOPICS IN CHEMOTHERAPY 2011 Sequencing of Chemotherapy … does it really matter?? Nousheen Samad, PharmD, BCOP MD Anderson Cancer Center, Houston, TX November 5, 2011

sequencing of chemotherapy … Does it really matter ??

The appropriate sequencing of chemotherapy agents:
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 sequencing of chemotherapy … Does it really matter ??

Combination Chemotherapy
HOT TOPICS IN CHEMOTHERAPY 2011 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 sequencing of chemotherapy … Does it really matter ??

Combination Chemotherapy
HOT TOPICS IN CHEMOTHERAPY 2011 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 Example: Cisplatin and paclitaxel Can this be extrapolated? sequencing of chemotherapy … Does it really matter ??

Cell Cycle HOT TOPICS IN CHEMOTHERAPY 2011
Mitosis and the Cell Division Cycle Cells that are growing and dividing go through a repeating series of events called the cell division cycle (or cell cycle). During the first phase (G1), the cell grows and prepares for DNA replication, which occurs in the subsequent S phase. Further growth takes place in the G2 phase, and finally mitosis occurs in the M phase. • G1, S, and G2 are collectively called interphase. • G1 stands for gap 1, or presynthesis; S for synthesis; G2for gap 2, or postsynthesis. • M is the mitotic division phase. sequencing of chemotherapy … Does it really matter ??

Synergism versus Antagonism
HOT TOPICS IN CHEMOTHERAPY 2011 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 sequencing of chemotherapy … Does it really matter ??

Chemotherapy Sequencing
HOT TOPICS IN CHEMOTHERAPY 2011 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 data May be synergistic or antagonistic sequencing of chemotherapy … Does it really matter ??

Leucovorin Leucovorin BEFORE 5-fluorouracil
HOT TOPICS IN CHEMOTHERAPY 2011 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 sequencing of chemotherapy … Does it really matter ??

Sequencing Resulting in Lower Toxicity
HOT TOPICS IN CHEMOTHERAPY 2011 Sequencing Resulting in Lower Toxicity Paclitaxel → Cisplatin ↓ neutropenia Gemcitabine → Cisplatin Docetaxel → Vinorelbine Docetaxel → Topotecan Doxorubicin → Docetaxel Doxorubicin/Epirubicin → Paclitaxel ↓ myelosuppression + mucositis Liposomal doxorubicin → Vinorelbine Topotecan → Cisplatin/Carboplatin ↓ neutropenia + thrombocytopenia Topotecan → Cisplatin Cyclophosphamide → Paclitaxel ↓ cytopenias Ifosfamide → Docetaxel ↓myelosuppression Irinotecan → 5-fluorouracil ↓neutropenia + diarrhea sequencing of chemotherapy … Does it really matter ??

Sequencing Resulting in Higher Efficacy
HOT TOPICS IN CHEMOTHERAPY 2011 Sequencing Resulting in Higher Efficacy Irinotecan → 5-fluorouracil ↑ Efficacy Fludarabine → Cytarabine Pemetrexed → Gemcitabine Paclitaxel → Gemcitabine ↑ Synergy Cisplatin → Irinotecan ↑ Response rate 5-fluorouracil → Methotrexate Liposomal doxorubicin → Docetaxel ↑ Tolerability Gemcitabine → Cisplatin ↑ Increase platinum-DNA adducts sequencing of chemotherapy … Does it really matter ??

Clinical Application of Sequencing
HOT TOPICS IN CHEMOTHERAPY 2011 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 “Best Practice” in chemotherapy administration

Environmental monitoring In your work environment
HOT TOPICS IN CHEMOTHERAPY 2011 Environmental monitoring and Medical Surveillance In your work environment Mille A. Toth, MS, RN, AOCN Senior Nursing Instructor M. D. Anderson Cancer Center Houston, Texas November 5, 2011

Environmental monitoring and Medical Surveillance

NIOSH and OSHA guidelines recommend that institutions provide a medical surveillance program. How does your institution support this? My institution provides “base-line” initial employment physical and annual / periodical laboratory evaluations My institution states the use of closed systems, PPE and education provided to staff eliminates the need for medical surveillance program My institution offers no established form of medical surveillance and does not provide NIOSH recommended closed systems I don’t know how my institution addresses the NIOSH and OSHA guidelines for Medical Surveillance Environmental monitoring and Medical Surveillance

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 B CH4) OSHA Technical Manual Update: Controlling occupational exposure to HDs OSHA instruction TED A 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 1999 1976 1979 2004 2006 NIOSH Alert Preventing occupational exposure to antineoplastic and other HDs in healthcare settings 2007 DHHS NIOSH “Medical Surveillance for health care workers exposed to HDs” Source: Massoomi, 2007

Environmental Monitoring
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? Environmental monitoring and Medical Surveillance

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 Environmental monitoring and Medical Surveillance

HOT TOPICS IN CHEMOTHERAPY 2011 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.” Environmental monitoring and Medical Surveillance

HOT TOPICS IN CHEMOTHERAPY 2011 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. 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. Environmental monitoring and Medical Surveillance

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.” Environmental monitoring and Medical Surveillance

How Can We Gain “Control?”

State of Washington: Senate Bills 5149 and 5594 Passed 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 / Surveillance
HOT TOPICS IN CHEMOTHERAPY 2011 Medical Screening / Surveillance 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. 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) * 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:
HOT TOPICS IN CHEMOTHERAPY 2011 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 Environmental monitoring and Medical Surveillance

Nebraska Methodist Hospital (NMH)
HOT TOPICS IN CHEMOTHERAPY 2011 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) , April 2008 Environmental monitoring and Medical Surveillance

Many Institutions Starting to Support Medical Surveillance
HOT TOPICS IN CHEMOTHERAPY 2011 Many Institutions Starting to Support Medical Surveillance Nebraska Methodist Hospital Intermountain Healthcare, Utah Duke University, North Carolina Stanford University, California Columbia University Environmental monitoring and Medical Surveillance

Employee Health and Well-Being
HOT TOPICS IN CHEMOTHERAPY 2011 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 Environmental monitoring and Medical Surveillance

Nebraska Methodist Hospital (NMH)
HOT TOPICS IN CHEMOTHERAPY 2011 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.” , April 2008 Environmental monitoring and Medical Surveillance

Administrative Controls
HOT TOPICS IN CHEMOTHERAPY 2011 National Institute for Occupational Safety and Health (NIOSH) Recommends Primary Prevention to Protect 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) 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

Questions/Comments/Discussion
Microsoft Engineering Excellence Questions/Comments/Discussion HOT TOPICS IN CHEMOTHERAPY 2011 Please plan to attend our follow-up Round Table Session TODAY ( 2:30 pm – 4:00 pm ) Ballroom H Microsoft Confidential

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