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

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Presentation on theme: "Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations."— Presentation transcript:

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2 Objectives 1. Discuss best practice in chemotherapy administration, including sequencing of drugs and patient support in chemotherapy drug shortage situations. 2. Describe appropriate steps to address environmental monitoring and employee medical surveillance when working with hazardous drugs. HOT TOPICS IN CHEMOTHERAPY 2011

3 Myra Davis-Alston, RN,MSN/Ed, OCN,CRNI Oncology Staff Nurse Las Vegas, NV. November 5, 2011

4 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

5 American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards HOT TOPICS IN CHEMOTHERAPY 2011

6 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

7 CRITERIA 1. Applicable to diverse outpatient hematology/oncology practice settings 2. Understandable and clinically intuitive 3. Realistic to achieve with existing or reasonable resource expectations 4. 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

8 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

9 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

10 Multidisciplinary consensus- building process HOT TOPICS IN CHEMOTHERAPY 2011

11 F a m ili ar iz e y o u rs el f w it h A S C O / O N S C h e m o t h er a p y A d m in is tr a ti o n s af e t y st a n d ar d sF a m ili ar iz e y o u rs el f w it h A S C O / O N S C h e m o t h er a p y A d m in is tr a ti o n s af e t y st a n d ar d s 1 Explore how the standards apply to individual practice settingsExplore how the standards apply to individual practice settings 2 Develop strategies to integrate Best Practice to individual work settingsDevelop strategies to integrate Best Practice to individual work settings 3 Overview HOT TOPICS IN CHEMOTHERAPY 2011

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13 1. Staffing-Related Standards 2. Patient consent and Education 3. Sequencing of Drug Administration 4. 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

14 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

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16 1. Policies, procedures, and or guidelines for verification of training and continuing education for clinical staff. 2. Nurse-Patient staffing ratio 3. Current certification in basic life support 4. Written Orders for parenteral and oral chemotherapy Jacobson, J., et al. (2009) American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards HOT TOPICS IN CHEMOTHERAPY 2011

17 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

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19 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

20 Time Spent Projects Worked On Get Familiar with Safety Standards Apply ASCO/ONS Chemotherapy Safety Standards Apply ASCO/ONS Chemotherapy Safety Standards Involve all stake holder HOT TOPICS IN CHEMOTHERAPY 2011

21 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

22 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 Society http://www.ons.org/CNECentral/Chemo/Standards HOT TOPICS IN CHEMOTHERAPY 2011

23 Nousheen Samad, PharmD, BCOP MD Anderson Cancer Center, Houston, TX November 5, 2011

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25 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

26 1. Significant delays in patient care 2. Subsequent shortage of alternate drug within the same class 3. Large upsurge in drug price 4. All of the above

27 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 HOT TOPICS IN CHEMOTHERAPY 2011

28 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 HOT TOPICS IN CHEMOTHERAPY 2011

29 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 HOT TOPICS IN CHEMOTHERAPY 2011

30 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)

31 HOT TOPICS IN CHEMOTHERAPY 2011 Drug name# of manufacturers Reason for shortage Bleomycin4Manufacturing delays, increased demand Carmustine1Manufacturing delays Cisplatin3Manufacturing delays, increased demand Cytarabine3Manufacturing delays, raw material issues Doxorubicin3Manufacturing delays, increased demand Etoposide3Manufacturing delays, increased demand Leucovorin3Manufacturing delays Mechlorethamine3Transfer to new manufacturing plant

32 HOT TOPICS IN CHEMOTHERAPY 2011 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

33 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 HOT TOPICS IN CHEMOTHERAPY 2011

34 Interruption in drug supply infrastructure Shortage of raw material Manufacturing issues Natural disaster Voluntary recall of already manufactured items HOT TOPICS IN CHEMOTHERAPY 2011

35 Manufacturer discontinuation Manufacturer rationing Restricted distribution Industry consolidation HOT TOPICS IN CHEMOTHERAPY 2011

36 Market shift Brand to generic Unexpected demand New indication or change in prescribing Disease outbreak Just-in-time inventories HOT TOPICS IN CHEMOTHERAPY 2011

37 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 HOT TOPICS IN CHEMOTHERAPY 2011

38 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 HOT TOPICS IN CHEMOTHERAPY 2011

39 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

40 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

41 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

42 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

43 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

44 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

45 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 HOT TOPICS IN CHEMOTHERAPY 2011

46 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

47 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

48 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 HOT TOPICS IN CHEMOTHERAPY 2011

49 Nousheen Samad, PharmD, BCOP MD Anderson Cancer Center, Houston, TX November 5, 2011

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51 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

52 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

53 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

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55 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

56 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 HOT TOPICS IN CHEMOTHERAPY 2011

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60 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

61 Mille A. Toth, MS, RN, AOCN Senior Nursing Instructor M. D. Anderson Cancer Center Houston, Texas November 5, 2011

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63 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 dont know how my institution addresses the NIOSH and OSHA guidelines for Medical Surveillance HOT TOPICS IN CHEMOTHERAPY 2011

64 Advent of Modern day chemotherapy Loius Goodman and Alfred Gillmon use nitrogen mustard to treat non-Hodgkins 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 19421983 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 Pharmaceutical compounding-Sterile preparations American Society of Health-System Pharmacists Guidelines on handling hazardous drugs 1990199519991976197920042006 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

65 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 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?

66 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

67 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

68 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 havent 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 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.

69 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

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71 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.

72 Medical Screening is, in essence, only one component of a comprehensive medical surveillance program. It has a Clinical Focus on early diagnosis and treatment. Medical Surveillance is to detect and eliminate any underlying causes, such as hazards or exposures of any trends, thus a Prevention Focus. http://www.osha.gov/SLTC/medicalsurveillance/index.html HOT TOPICS IN CHEMOTHERAPY 2011

73 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.

74 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

75 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.comwww.pppmag.com, April 2008 HOT TOPICS IN CHEMOTHERAPY 2011

76 Nebraska Methodist Hospital Intermountain Healthcare, Utah Duke University, North Carolina Stanford University, California Columbia University HOT TOPICS IN CHEMOTHERAPY 2011

77 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

78 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 personnels 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.comwww.pppmag.com, April 2008 HOT TOPICS IN CHEMOTHERAPY 2011

79 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

80 Leave today INSPIRED to work on a Control Plan regarding Environment Monitoring and Medical Surveillance for Hazardous Agents at your institution. HOT TOPICS IN CHEMOTHERAPY 2011

81 Please plan to attend our follow-up Round Table Session TODAY ( 2:30 pm – 4:00 pm ) Ballroom H


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